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Host Interface Manual Version 2.1 October 2012...
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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. COPYRIGHT COPYRIGHT 2012 BY ROCHE DIAGNOSTICS.
cobas c 111 Host Interface Manual CONTENT: Preface .......................... 6 Revision history .......................... 6 Copyrights and trademarks ....................7 Manufacturer ..........................7 Intended use ..........................7 About this manual ...................... 8 Conventions used in this manual ..................8 Symbol listing ..........................8 Abbreviations ..........................
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cobas c 111 Host Interface Manual Messages used in cobas c 111 instrument Communication ........25 6.4.1 Messages received: Host Analyzer ................ 29 System behavior on communication errors ..............30 ASTM Protocol ......................30 General ASTM Protocol Information ................30 7.1.1 Background ..........................
Change of actual SW version October 2012 Template changed, company name changed. Published by Roche Diagnostics, a division of F. Hoffmann-La Roche; 4070 Basel, Switzerland. Questions or comments regarding the contents of this Installation Manual can be directed to the address below or to your Roche representative.
The above trademarks are owned by Roche Diagnostic Systems, a division of Hoffmann- LaRoche Limited/Limitee; used under License. Other countries: The above trademarks are either owned by or used under license by the Roche affiliate distributing this product. The following trademarks are acknowledged: Adobe Acrobat, Linux, Microsoft Windows.
cobas c 111 Host Interface Manual 2. About this manual This document details the specifications for the cobas c 111 host interface (HIF). This interface defines data transmission between the instrument and the Laboratory Information System (LIS) computer. This document gives the reader a basic understanding of the system operation with a host computer and describes the following: •...
cobas c 111 Host Interface Manual 2.3 Abbreviations The following abbreviations are used: Acronyms Underwriters Laboratories Inc. International Electro technical Commission Canadian Standard Association European Norm ASTM American Society for Testing and Materials ASCII American Standard Code for Information Interchange 3.
cobas c 111 Host Interface Manual 4. Overview 4.1 Introduction This document is written for technicians who must configure the cobas c 111 interfaces in the environment of a lab. Depending on the type of host system and workflows in the laboratory, the cobas c 111 host interface offers a set of configurable features.
cobas c 111 Host Interface Manual Pipetting Unit Sample Area LCD with Touch Screen Figure 1: cobas c 111 instruments System Architecture 4.4 System Information 4.4.1 Sample Carriers The cobas c 111 instrument has a direct sample reception area and does not use or support separate sample carriers such as racks.
cobas c 111 Host Interface Manual 4.4.4 Repeat / Rerun Repeating an order will just do the same basic processing again. Rerunning an order means to repeat according to the settings given in the application configuration, such as predefined dilution factors. Note: For easy reading only the term ‘Rerun’...
cobas c 111 Host Interface Manual In this mode the Order ID is equal to the Sample ID. The sample number is given by the operator while placing the sample on the system. 4.4.5.2 Independent ID Setting: Utilities/Configuration/Workflow/Sample ID handling -> Independent ID In this mode the Sample ID and the Order ID are not connected to each other and could be different.
cobas c 111 Host Interface Manual 4.4.6.2 Host Settings: Utilities/Configuration/Workflow/Working Mode -> Host During order definition, the tests are automatically selected; the test selection screen is not displayed. After identifying the sample, you are asked to place the sample. 5. LIS Interface configuration 5.1 Connection settings / General Setup The communication with a host computer is highly configurable and requires to be set according to the needs and capabilities of the laboratory equipment and the host interface...
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cobas c 111 Host Interface Manual The analyzer will send inquiries for test and rerun orders only when this function is enabled. If disabled, test orders have to be made either manually by the operator at the analyzer or by download from the host. Query Timeout Time before cobas c 111 instrument assumes that the host (10 - 300)
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cobas c 111 Host Interface Manual Host ID char[10] The host device identification *host Name used on reports and in communications for the host system or the ID number used to identify the host in communications with the analyzer. Note: Automatic result upload is only supported in Real-Time Communication mode. Version 2.1 16 / 93...
RS232 connector on the right side of the analyzer (marked as “Host”). You can use the “industry standard “null modem cable or the second one that can be ordered from the Roche stock and is also used for other instruments i.e. cobas Amplicor. 5.2.1 Maximum cable length...
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cobas c 111 Host Interface Manual Figure 4 : Host Interface Connection 3-wire Cable 3-wire cable. Host Cable wiring diagram for DB-9 type plug Analyzer Host Sig. Pin Sig. Pin Note Max cable length = 15 m Use the mapping in Figure2 : Host Interface Null modem Connection Cable Figure3 : Host Interface Connection Cable GMMI 28053391001 Version 2.1 18 / 93...
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cobas c 111 Host Interface Manual Figure 4 if you intend to work with the software handshake or without any handshake. Cables with the above mentioned pin mappings work with most connecting equipment installed in commercially available computers. However, depending on your particular computer configuration, you may require a cable with a different pin mapping.
cobas c 111 Host Interface Manual 6. Supported Work Flow 6.1 Communication methods cobas c 111 instruments support real-time communication and batch communication for test ordering and analytical data upload. 6.1.1 Automated Real-Time Communication (REAL) Real-time communication refers to a communication model where the reception of a sample on the system triggers an inquiry for test orders from cobas c 111 instrument to host.
cobas c 111 Host Interface Manual 6.1.1.4 Rerun Initiation Once a sample is processed, the measurements and result calculations are done according to the application definitions. When all measurements for a sample are finished, the cobas c 111 instrument system is ready to upload the results (automatically after the last result is available in real-time mode).
cobas c 111 Host Interface Manual 6.1.2.3 Analytical Data Transmission in Batch Mode The operator can initiate a Batch Data Transmission of routine results and of control sample results from the “Workplace/Result Review/Edit” screen on the analyzer. The host can also request results for a specific sample, but control sample results cannot be requested from the host.
Host Interface Manual 6.1.2.4 Application & Test Order Codes Each application (test) for cobas c 111 instruments is identified within Roche Diagnostics by an Application Code Number (ACN). This ACN is often referred to as “Test Number” that consists of a 3-digit number. For host orders, a mapping table is available to translate the laboratory-specific number space for applications into the cobas c 111 instrument ACN number space.
cobas c 111 Host Interface Manual 6.3 Physical Layer Specifications 6.3.1 Communication Options Host communication options such as baud rate can be found on the Utility / System / Host Communication Setting screen. Item Specifications Remarks Communication Speed 1200 , 2400 , 4800 , *9600 Baud rate [bps] 19200, 38400, 57600, 115200...
cobas c 111 Host Interface Manual 6.4 Messages used in cobas c 111 instrument Communication All messages are shown in Table 8.The following section shows detailed information for each of the messages and the included ASTM records. Communication Text Communication Automated Manually Direction...
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cobas c 111 Host Interface Manual Automated Communication Test Order Inquiry Return Test Order Inquiry Test Orders Return Test Order Host Analyzer Patient Sample Analytical Data Control Sample Analytical Data ISE Calibration Data Photometric Calibration Data Version 2.1 26 / 93...
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cobas c 111 Host Interface Manual Version 2.1 27 / 93...
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cobas c 111 Host Interface Manual Messages transmitted: Analyzer Host Messages transmitted by the analyzer (messages received by the host) are indicated in the table below. The identifier is set in the Comment or ‘Special Instruction’ field in the Message Header Record with the reason for the messages.
cobas c 111 Host Interface Manual {M.INV} such an inquiry Database factory EAR^U08 Reports the reception of the command or that reset response M.EQU the request has been ignored M.ECD M.ECR Table 5: Messages Transmitted by the Analyzer 6.4.1 Messages received: Host Analyzer Messages transmitted by the host are shown in the table below (messages received by the analyzer).
cobas c 111 Host Interface Manual 6.5 System behavior on communication errors There will be an error message sent to the alarm monitor (incl. red LED at button), if a host system does not confirm a data communication within a defined amount of time. The unconfirmed communication records are not re-sent.
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cobas c 111 Host Interface Manual Details of the ASTM protocol can be found in the Annual Book of ASTM Standards. Copyright American Society for Testing and Materials, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, USA. • ASTM E1381-97 Low Level Protocol Specification for Low Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems •...
cobas c 111 Host Interface Manual 7.1.3 ASTM Lower Layer ASTM lower layer receives messages for a transmission request from the upper layer. These messages are then split into frames and sent to a communication medium to be transmitted to other parties. ASTM lower layer also constructs frames received from a communication medium to recreate messages to be transferred to the ASTM upper layer as reception messages.
cobas c 111 Host Interface Manual 7.1.4 ASTM Syntax The structure of the sentences to be transferred is explained in this section according to ASTM Communication Regulation. Between the analyzer and the host, various data such as Test Orders and Results are transferred back and forth. All of these data conform to this syntax.
cobas c 111 Host Interface Manual 7.1.4.3 Delimiters Delimiters are ASCII characters used to separate fields within a record and to separate components within fields. Below is a description of the delimiters and how they are commonly used: Character Name Used as vertical bar Field delimiter...
cobas c 111 Host Interface Manual Escape sequences other than these are skipped and treated as NULL value. &F& Indicates Field delimiter &S& Indicates Component delimiter &R& Indicates Repeat delimiter &E& Indicates Escape 7.1.4.3.6 Record Delimiter / End of Record Character The ASCII CR character (HEX 0D) is always used to indicate the end of a record.
cobas c 111 Host Interface Manual 7.1.4.4 Message Transmission Phases To establish which system sends and which system receives information and to ensure the actions of sender and receiver are well coordinated, there are three distinct phases in trans- ferring information: •...
cobas c 111 Host Interface Manual 7.1.5 Checksum Calculation/ Message Frame 7.1.5.1.1 The Intermediate Frame [STX] FN Text first char..Text last char. ETB CH CL [CR] [LF] 7.1.5.1.2 The End Frame [STX] FN Text first char..Text last char. ETX CH CL [CR] [LF] The ASCII code 2, indicating the beginning of a frame transmission.
cobas c 111 Host Interface Manual Example for Checksum Calculation [STX]1Test[ETX] Character Value (hex) [STX] ‘1’ ‘T’ +54h ‘e’ +65h ‘s’ +73h 15Dh ‘t’ +74h 1D1h [ETX] +03h 1D4h = 1D4h Mod 100h = D4h to be sent: [STX]1Test[ETX]D4[CR][LF] 7.2 Communication Text Content 7.2.1 Record Levels The following table shows the Standard Record types and levels (see ASTM E 1394-97 Section 5, 'Information Requirements in Clinical Testing')
cobas c 111 Host Interface Manual The Manufacturer Specific Records are specific for the cobas c 111 instrument and must be received by the host Level Record Name Identifier Photometry Calibration Result M.CR ISE Calibration Result M.ICR Photometric Raw Data M.RR Reagent Disk Loading INR^U06...
^Manufacturer cobas c 111 instrument transmits data: ^Instrument Type <Name > The analyzer name given ^SW Version ^<Manufacturer> “Roche” ^Protocol Vers. ^<Instrument Type> “c111” ^Serial Number ^<SW Version > Instrument e.g. 1.2.3.1234 ^<Protocol Vers.> Comm. Protocol 1 ^<Serial number>...
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cobas c 111 Host Interface Manual Field Name Reference Format H|7.1. Comments (Data Content) Comment or Special 07.1.11 A comment regarding the message is entered here. Instructions cobas c 111 instrument transmits data: To indicate the classification of the transmitted message from the analyzer one of the defined messages (see above) is transmitted.
cobas c 111 Host Interface Manual 7.2.2.3 Message Termination Record (L) This record occurs at the end of a message to indicate the end of a message. L|1|N{RT} Field Name Reference Format L|13.1. Comments (Data Content) Record Type ID (L) 13.1.01 ...
cobas c 111 Host Interface Manual 7.2.2.5 Test Order Record (O) This record holds information regarding analysis order and sample information to the analyzer (within test order message) and to the host (within result message). O|1||Sample1|^^^111\^^^121\^^^211\^^^212\^^^221|R||||||N|||||||||||||| Response when the host does not have tests to be requested for this patient O|1|Sample1|||R||||||A||||||||||||||Z Field Name...
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cobas c 111 Host Interface Manual Field Name Reference Format O|9.4. Comments (Data Content) Instrument Specimen 09.4.04 Identification for samples analyzer host. cobas c 111 instrument receives data: Field is ignored (09.4.03 is Sample ID / Sequence read) ^Rack ID / Carrier ID cobas c 111 instrument transmits data: The sample identification known by the instrument...
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General: Specifies treatment to be done on instrument: (A)utodilution, (D)ilution and factor, (C)oncentration and factor, etc., e.g. A, D100, etc. (Roche specific field). Note: concentration of samples is not supported on c111. cobas c 111 instrument receives data: Any Value but NULL dilution /...
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cobas c 111 Host Interface Manual Field Name Reference Format O|9.4. Comments (Data Content) Not used / ignored by cobas c 111 instrument Others 09.4.07 … 09.4.11 Action Code 09.4.12 Indicates type of information for the report. cobas c 111 instrument receives data: A : Add tests to an existing order NOTE: If the sample does not exist it creates a new sample Needed if no tests for sample (see example page 43)
cobas c 111 Host Interface Manual Field Name Reference Format O|9.4. Comments (Data Content) Not used / ignored by cobas c 111 instrument Rest of List 09.4.27 09.4.31 EndOfRecord 7.2.2.6 Comment Record (following the Order Record) Record to transfer comments regarding the patient’s demographic data. This record is transmitted by the host (within test selection message) and the analyzer (within result message).
General: Specifies treatment to be done on instrument: (A)utodilution, (D)ilution and factor, (C)oncentration and factor, etc., e.g. A, D100, etc. (Roche specific field) cobas c 111 instrument : Dilution or Concentration depending on the treatment done according to the value entered in the application protocol D / C / <empty>...
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Above absolute high scale of assay (test range) ex. page 50 Normal Abnormal Technical problems Roche instruments provide more instrument specific flags than those defined above by ASTM. The detailed flag information is transmitted to the Host using an additional Comment Record.
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cobas c 111 Host Interface Manual Field Name Reference Format R|10.1. Comments (Data Content) Result Status 10.1.09 Indicates the number of the test conducted for the analytical data. Field Value Description Final Result: Used to indicate initial transmission of result (Validated Result) Correction of previously transmitted result (i.e., the result of a test-re-run is transmitted) Test cannot be completed:...
cobas c 111 Host Interface Manual 7.2.2.8 Comment Record (following the result record) Record to transfer comments regarding the analytical data. This record is transmitted by the analyzer only; it is not transmitted by the host (i.e. ignored when a cobas c 111 instrument receives such a record).
cobas c 111 Host Interface Manual 7.2.2.9 Request Information Record Record to request information from the other device. It is sent by the analyzer (within test order request message) and the host (within result request message) Q|1|^Sample1||ALL||||||||O Note: Up to SW v 2.0 the sequence number was missing. Corrected in SW v 2.0 and above Field Name Reference Format...
‘1’; for specifying several, sequence numbers starting from 1 are assigned. Record type sub-ID M.CR.03 CR^BM^c111^1 ^BMtag Roche specific record identifier ^Instrument ^Version# test number M.CR.04 Application Code (ACN - as given in masterset)
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cobas c 111 Host Interface Manual Field Name Reference Format M.CR Comments (Data Content) result states M.CR.12 A – Accepted (with or without flags) cobas c 111 instrument transmits data: A^<operator> the user who accepted the cal will be submitted O –...
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cobas c 111 Host Interface Manual Examples : Left Sodium Right : Chloride Corresponding HIF outputs below. Example Sodium 2M|1|CR^BM^c111^1|989^NAI|GSS_ONLY|mmol/L|EL^NA|^NA^0\^REF^0|I^R|1|200 81021130649|A^admin||4.914673E+01^5.640128E-03|SD^^^21461500|150^-149.76^- 149.76^^18^-263.31\150^-147.14^-147.14^^18^-254.12\110^-153.76^-153.76^^110^- 262.72 Example Chloride 2M|1|CR^BM^c111^1|991^CLI|GSS_ONLY|mmol/L|EL^CL|^CL^0\^REF^0|I^R|1|2008 1021130650|A^admin||-3.501088E+01^8.341931E-04|SD^^^21461500|115^-44.75^- 44.75^^18^67.35\115^-43.99^-43.99^^18^57.76\72^-36.87^-36.87^^110^67.04 Version 2.1 55 / 93...
‘M’ Sequence number M.RR.02 The field value is ‘1’ for one record. To specify several records, sequence numbers starting from 1 are assigned. Record type sub-ID M.RR.03 Roche specific record identifier ^BMtag RR^BM^c111^1 ^Instrument ^Version# Starting value M.RR.04 cobas c 111 instrument transmits data: ...
cobas c 111 Host Interface Manual 7.3 Manufacturer Specific Records (MSR) Newly introduced functions will use the MSRs specified in [7] – the use of specific fields for cobas c 111 instruments is outlined below. The collection of Manufacturer Specific Records bases on the standards, specified below: 1.
cobas c 111 Host Interface Manual 7.3.2 Database Factory Reset Request the database initialization to factory default from the other device. It is sent by the host. The system can only be reset in ‘Standby’ mode. Once such a command is received it will be confirmed an EAR and will then change to the ‘error’...
(unique processing key required to identify the information). Conditional information, that is, information which is required in certain circumstances Optional information, supported by Roche universal ASTM driver, processed on instrument if applicable, transmitted if available on instrument. — Not processed / not required Version 2.1...
^text — cobas c 111 instrument transmits data: ^text — Format: |INV^RO^c111^1| ^RO (Roche specific record identifier) ^Instrument abbreviation (c111) ^Version# of protocol implementation (1) Substance Identifier — Format: |2-123^R1-GLUC| or |4-123^SR-GLUC| cobas c 111 instrument transmits data: only the first 2 fields <identifier (ST)>...
cobas c 111 Host Interface Manual Data # Field Name Description Type peat Position on Carrier — — Format: |1234567| cobas c 111 instrument transmits data: only the first field <identifier (ST)> SerialNbr (ST7) 10 Initial Quantity — Format: |100| cobas c 111 instrument transmits data: only the first field <identifier (ST)>...
cobas c 111 Host Interface Manual User-defined table – Manufacturer identifier Value Description Used for query of all inventory items 7.4.2.2 Substance status (CE) Components: <identifier (ST)> ^ <text (ST)> ^ <name of coding system (IS)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^ <name of alternate coding system (ST)>...
cobas c 111 Host Interface Manual 7.4.3.1 Reference command number (NM) Definition: This field contains the unique identifier for this particular command that should be used by the various components for future referral to this command. This number is generated by the originator of this command. 7.4.3.2 Response required (ID) Definition: This field identifies the mode of synchronization that is to be used in relation to the execution of the command.
In most cases it is sufficient to consider the 1 sub-component of component only. List of data types used in the Roche Diagnsotics ASTM 2.0 MSRs based on the HL7v2.4 chapter 13 is presented below. For details refer to the chapter 2 of the current version of HL7 standard.
cobas c 111 Host Interface Manual 8. Appendix A – Flags 8.1 Data Flags c111 Comment c111 Check Excessive Absorbance High Abs Description The absorbance value to be used for calculation and checks is > 2.0 Abs. Prozone Error Ag Excess Description The sample contains an excess antigen and a valid result cannot be calculated.
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cobas c 111 Host Interface Manual Outside of expected value (lower) Description For patient samples, the calculated concentration is less than the lower limit of the <RR expected value range. nnnnn is the actual value which was checked against Absorbance Maximum Over (nonLin curve) Description CALC RANGE The absorbance of a sample is found equal or greater than the maximum theoretical...
cobas c 111 Host Interface Manual 8.2 Calibration Flags c111 Comment c111 Check S1ABS abnormal >Reag Rng Description <Reag Rng During calibration the absorbance value of the lowest calibrator is below the lower defined range or above the upper defined range. DUPLICATE error Description >Repl Dev...
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cobas c 111 Host Interface Manual c111 Comment c111 Check No calibration curve could be calculated because the rates of the calibrators were non- monotonic. Description Curve out of range. Out of Rng The calibration curve is outside of the acceptable/ programmed range. Version 2.1 73 / 93...
cobas c 111 Host Interface Manual 8.3 QC-Flags c111 Comment c111 Check 2-2SA (Syst.Error 1 -2 Results) >R 2(2s) Description: <R 2(2s) Two sequential control measurements are above 2SD or below -2SD, both on the same side. 1-3SD (QC error 1) R 1(3s) Description: One control value is above 3SD or below -3SD.
cobas c 111 Host Interface Manual 8.5 Treatment Flags c111 Comment c111 Check Description > A rerun result with the same running parameters (repeated) Description A rerun result with diluted sample Version 2.1 75 / 93...
cobas c 111 Host Interface Manual 8.6 Flag Priority List The list defines the display priority in ascending order - The Flags of the Treatment Group are displayed in parallel with the result flag - The Flags of the Derived Group are represented separately in the detail and printout Flag-Name NG-Ref Check name...
In this section, the analyzer is shown as ‘c111’, External system is shown as ‘host’. 9.1 Order Query - Realtime / Analyzer to Host c111 08:41:04,761 [ENQ] HOST 08:41:04,761 [ACK] c111 08:41:04,870 [STX]1H|\^&|||c111^Roche^c111^2.0.0.0710^1^3334 44|||||host|TSREQ^REAL|P|1|20071210084106[CR][E TB]D6[CR][LF] HOST 08:41:04,870 [ACK] c111 08:41:04,917 [STX]2Q|1|^4456||ALL||||||||O[CR][ETB]01[CR][LF...
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