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Roche Diagnostics
COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24

Approvals for Cedex Bio HT Analyzer

The Cedex Bio HT Analyzer meets the requirements laid
down in:

• Directive 2014/30/EU of the European Parliament and

Council of 26 February 2014 relating to
electromagnetic compatibility (EMC).

• Directive 2014/35/EU of the European Parliament and

Council of 26 February 2014 relating to electrical
equipment designed for use within certain voltage
limits.

• Directive 2011/65/EU of the European Parliament and

of the Council of 8 June 2011 on the restriction of the
use of certain hazardous substances in electrical and
electronic equipment.

Compliance with the applicable directive(s) is provided by
means of the Declaration of Conformity.

The following marks demonstrate compliance:

Issued by Underwriters Laboratories, Inc. (UL) for
Canada and the US.

Complies with the provisions of the applicable EU
directives.
RoHS compliant from Serial No. 610001.

Issued by Underwriters Laboratories, Inc. (UL) for
Canada and the US.

Содержание Cedex Bio HT

Страница 1: ...COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Host Interface Manual Version 1 24 Software version 3 6 5 1...

Страница 2: ...Date handling problem in line 53 ORA 01840 with version 2 3 NT only Changed files i4_kp i_toc i_ver index Yes Jun 01 2005 1 18 Flags Change in the flag 22 added to the list of flags where no result i...

Страница 3: ...tion To avoid incorrect results ensure that you are familiar with the instructions and safety information r Pay particular attention to all safety notices r Always follow the instructions in this publ...

Страница 4: ...and the Cedex Bio HT Analyzer contain a user license between F Hoffmann La Roche Ltd and a license holder and only authorized users may access the software and use it Unauthorized use and distribution...

Страница 5: ...COBAS INTEGRA 400 plus analyzer The COBAS INTEGRA 400 plus analyzer meets the requirements laid down in Directive 98 79 EC of the European Parliament and of the Council of 27 October 1998 on in vitro...

Страница 6: ...elating to electrical equipment designed for use within certain voltage limits Directive 2011 65 EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certai...

Страница 7: ...lti configuration service blocks 76 Protocol version blocks 79 Control messages blocks 80 5 Line codes About line codes 83 List of line codes 84 Messages 6 Flags and error codes About flags 105 Flag X...

Страница 8: ...8 Table of contents Roche Diagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24...

Страница 9: ...only intended for the determination of analytes in aqueous solutions such as cell culture and fermentation media and is not intended for any kind of in vitro diagnostics applications Therefore the te...

Страница 10: ...e brackets indicate an ASCII control character _ Space character ASCII 20H that is used as a separator between single data fields within a data line Space character ASCII 20H that is used as a place h...

Страница 11: ...tion General Interface 190 Added information The following information was added u Line Code 56 Sample name 98 Extended host interface of Cedex Bio HT Analyzer The block codes and line codes were adde...

Страница 12: ...Roche Diagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 12...

Страница 13: ...he Diagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 Communication 1 About communication 15 2 About host interface features...

Страница 14: ......

Страница 15: ...nderstand the basics and concepts of the various communication elements In this chapter 1 Communication concept 17 Message structure 18 Block header 19 Block data 19 Block check 20 Communication contr...

Страница 16: ...1 About communication Roche Diagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 16 Table of contents...

Страница 17: ...the requests and the instrument provides responses Following a request from the host the instrument will transmit a specific response message Assuming there are no transmission errors and the message...

Страница 18: ...in a block can vary q Information inside the message is in ASCII code ASCII codes from 0 to 31 and 127 to 255 are not allowed within data fields Example Result response from an instrument In this sect...

Страница 19: ...ated topics Block codes 59 Line codes 81 Instrument code Instrument identifier Block code 09_ COBAS INTEGRA _ 04 LF Two digit code It identifies the type of instrument Sixteen digit alphanumeric It is...

Страница 20: ...terface Manual Version 1 24 20 Message structure Block check The block check contains a sequence counter SC and the block check sum BCS Instrument code 1 LF 562 LF The length of the block check sum fi...

Страница 21: ...e number of active data bits in each character is counted prior to transmission A parity bit is then added on so that the total number of binary 1 s in the complete character frame is either odd or ev...

Страница 22: ...hich alternates between 0 and 1 The SC is used by the host to initiate retransmit of data The host s SC must be synchronized to the instrument s SC Both SCs host and instrument must be updated simulta...

Страница 23: ...ured as described in this manual and has to be modified accordingly Instruments never change the block and line composition unless the relevant configuration settings have been changed u Related topic...

Страница 24: ...Whenever the instrument detects any transmission error it expects the host to re transmit the previous message keeping the same sequence counter as before If you want to skip this retransmission send...

Страница 25: ...che Diagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 Aboutcommunication 25 Host communication handling w Suggestion for hos...

Страница 26: ...ence counter use Synchronization and sequence counter use The protocol only works properly when the sequence counters SC of both host and instrument have the same value Therefore whenever the host s c...

Страница 27: ...follow certain patterns and workflows In this chapter 2 About host interface modes and features 29 Patient mode 30 Patient entry 31 Patient modification 32 Patient deletion 32 Orders 33 Order entry 33...

Страница 28: ...2 About host interface features Roche Diagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 28 Table of contents...

Страница 29: ...atures 29 About host interface modes and features u Related topics Patient mode 30 Item Action Patient 1 1 Additional option When using patient mode the other 3 actions in the table are available Entr...

Страница 30: ...in patient mode q oWhen in patient mode set up the patient on the instrument prior to an order entry o When connected to a host we recommend working in sample mode WARNING Incorrect result assignment...

Страница 31: ...st Interface Manual Version 1 24 About host interface features 31 Patient entry Patient information is required by the instrument only when the instrument runs in patient mode Patient information is d...

Страница 32: ...24 32 Patient mode Patient modification Patient information is modified by means of BC42 Patient Modification u Related topics Block 42 Patient Modification 74 Patient deletion Patient information is...

Страница 33: ...ordered using BC10 Order Entry An order entry may contain up to 50 attached tests When using patient mode an order can only be entered if the patient information is already available in the instrumen...

Страница 34: ...barcodes are used to identify samples the barcode includes the order number and can also include the sample type When using barcodes both the parameters Sample Position Rack Number and Sample Position...

Страница 35: ...ut host interface features 35 Example of order entry with individual test numbers w Example of order entry with individual test numbers Example of order entry with ratio number q Because there are two...

Страница 36: ...erface Manual Version 1 24 36 Orders w Example of order entry with ratio number Example of order entry with profile number q Because of the remark in the order by ratio number above in this particular...

Страница 37: ...e features Roche Diagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 About host interface features 37 w Example of order entry...

Страница 38: ...eatures Roche Diagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 38 Orders Example of unspecific order request w Example of u...

Страница 39: ...to orders which already exist on the instrument is done by means of an Order Entry BC10 without the Order Information line LC54 u Related topics Block 10 Order Entry 69 Line code 54 Order Information...

Страница 40: ...response containing sample information To ensure an optimal host query function the host system has to transmit this request periodically e g one request every 30 seconds Following an MCS request a co...

Страница 41: ...rsion 1 24 About host interface features 41 w Recommended procedure and timing when using host query q Requests for samples without order lead to extensive database access Depending on the size of the...

Страница 42: ...res Roche Diagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 42 Host query mode Example of host query communication w Example...

Страница 43: ...ures Roche Diagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 About host interface features 43 w Example of host query commun...

Страница 44: ...r and Cedex Bio HT Analyzer allow requesting single results or collated results The BC09 LC10 thus contains a result type selector q We strongly advise against the use of collated results depending on...

Страница 45: ...ervals as long as possible e g 60 seconds We strongly recommend sending an Order Deletion block BC11 to the instrument as soon as all results associated with an order have been transmitted to the host...

Страница 46: ...features Roche Diagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 46 Result requests Example of result query w Example of res...

Страница 47: ...features Roche Diagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 About host interface features 47 w Example of result query...

Страница 48: ...S INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 48 Result requests w Example of result query communication continued Example of unspecific...

Страница 49: ...st Interface Manual Version 1 24 About host interface features 49 Example of result request with ratio collated result request q The HBA1C used in this example consists of two different ratios This is...

Страница 50: ...plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 50 Protocol version Protocol version The Protocol Version request BC92 is used to get the Version of the...

Страница 51: ...Roche Diagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 Reference 3 General codes 53 4 Block codes 59 5 Line codes 81...

Страница 52: ......

Страница 53: ...alyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 53 Table of contents General codes 3 All messages are based on the same block structure which is made up of different entities called...

Страница 54: ...3 General codes Roche Diagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 54 Table of contents...

Страница 55: ...version 3 6 5 1 Host Interface Manual Version 1 24 Generalcodes 55 ASCII code The following table shows the seven bit ASCII code in accordance with US standard ANSI X3 4 for the interchange of informa...

Страница 56: ...haracters The following control characters are used for the communication protocol between an instrument and a host computer Hex value Dec value Description SOH 01H 01 Start of header STX 02H 02 Start...

Страница 57: ...iagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 Generalcodes 57 Instrument codes The instrument code for the COBAS INTEGRA...

Страница 58: ...3 General codes Roche Diagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 58 Instrument codes...

Страница 59: ...ion Result 63 Block 03 Control Result 64 Block 04 Patient Results 64 Block 05 Calibration Result with Lot Information 65 Block 06 Control Result with Lot Information 66 Block 07 Patient Results with L...

Страница 60: ...24 60 Table of contents Block 60 Multi Configuration Service MCS Request host query 76 Block 61 Slot Configuration 76 Block 62 Sample Tube Information 77 Block 69 Service Request Response 78 Protocol...

Страница 61: ...on 07 Patient Result with Lot Information 08 Result Request Response 00 Idle Block if no result available 10 Order Entry 19 Order Manipulation Response 11 Order Deletion 40 Patient Entry 49 Patient Ma...

Страница 62: ...zation blocks Idle and synchronization blocks In this section Block 00 Idle Block Sync Block 62 Block 00 Idle Block Sync Block Block 00 is used During synchronization procedure for connection tests As...

Страница 63: ...ult type selector 01 or 08 If an accepted and not yet transmitted calibration result is available If the instrument is configured accordingly Line code Description Iteration 1 2 1 m 1 to 6 m is the nu...

Страница 64: ...Results collated by control ID Result type selector 06 is used m 1 to of available tests m is the number of tests with not yet transmitted QC results n 1 one control ID per result block Block 04 Pati...

Страница 65: ...the number of standard rates in line 03 The sequence of m iterations must correspond to the sequence of values in line 03 In addition the number of iterations m has to be equal to the number of param...

Страница 66: ...request with result type selector 11 or 19 If an accepted and not yet transmitted control result is available If the instrument is configured accordingly Results always collated by test ID Result type...

Страница 67: ...ceiving a result request with result type selector 11 or 17 If an accepted and not yet transmitted patient result is available Block 08 Result Request Response A possible error of a result request wil...

Страница 68: ...Interface Manual Version 1 24 68 Result blocks Block 09 Result Request Polling for results is done by means of block 09 q oOnly accepted and not yet transmitted results will be sent to the host o Cali...

Страница 69: ...up defines whether the instrument runs in patient mode or sample mode No patient information is required if in sample mode New sample order Add tests to an existing sample order Line code Description...

Страница 70: ...again until the current one has completed Block 11 Order Deletion Delete sample order Order deletion is possible If the order has not yet been started Or if the order is finished and all results are...

Страница 71: ...entry or test addition with error in patient Response to an order entry or test addition with error in sample order Response to an incorrect order entry with error in test order Line code Description...

Страница 72: ...Iteration 1 1 x 1 to 200 96 Error Code 1 to x 53 Order ID 55 Test ID y Block 19 Response to a test addition with default sample type if the previously used sample type was not a default sample type Li...

Страница 73: ...Blockcodes 73 Response to an order or test deletion with default sample type if the order s sample type was not default sample type x 1 to 200 Line code Description Iteration 96 Error Code 1 to x 53...

Страница 74: ...lation Response 75 Block 40 Patient Entry Block 40 is used for entering a new patient Block 41 Patient Deletion Block 41 is used to delete patient information q Patient deletion is possible only if th...

Страница 75: ...end on the request The response message structure depends on the success of the request and also on the request type Response to a correct patient entry BC40 deletion BC41 or modification BC42 Respons...

Страница 76: ...y Block 60 has one line Block 60 provides requests for the following functions Block 61 Slot Configuration The reply to an MCS request with service 0 is block 61 with the current slot configuration Th...

Страница 77: ...the instrument e g every 60 seconds If there are no sample tubes without an associated order on the instrument a block 69 with line 96 service 61 is returned Timing and procedure are described in host...

Страница 78: ...o HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 78 Multi configuration service blocks Block 69 Service Request Response Status response to an MCS request is shown by block 69...

Страница 79: ...In this section Block 92 Protocol Version Request 79 Block 93 Protocol Version Data 79 Block 92 Protocol Version Request Block 92 is used to interrogate the software version of the protocol Block 92...

Страница 80: ...ntrol messages blocks Control messages blocks In this section Block 99 Control Message 80 Block 99 Control Message The control message block is transferred upon a general error e g transmission distur...

Страница 81: ...Line code 07 ABS Sample Check 87 Line code 10 Result Type Selection 88 Line code 11 Reagent Lot Information 89 Line code 12 Control Lot Information 89 Line code 13 Calibration Lot Information 90 Line...

Страница 82: ...e Diagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 82 Table of contents Line code 98 Protocol Version 99 Line code 99 Gener...

Страница 83: ...g spaces or zeros 0 The decimal point is mandatory Example SR9 3 0077 123 Fx ASCII formatted floating point number right adjusted x Length of the whole data record Length x is fixed Shorter real value...

Страница 84: ...Standard Rates 51 Patient Information 04 Calibration Curve 52 Special Order Selection 07 ABS Sample Check 53 Order ID 10 Result Type Selection 54 Order Information 11 Reagent lot information 55 Test I...

Страница 85: ...n the concentration value even if the flag is TEST RNG or TEST RNG Range limit Contains the upper limit in the case that we get a TEST RNG flag Contains the lower limit in the case that we get a TEST...

Страница 86: ...ectrode has been measured parameter 1 contains the Li slope parameter 2 the Na slope and parameter 3 the K slope For all other electrodes parameter 1 contains the associated slope value Description Fo...

Страница 87: ...0 LF Description Format Range Compulsory Line code 07 Absorbency value 1st wavelength 1st value pair SR7 4 Absorbency value 2nd wavelength 1st value pair SR7 4 Optional Absorbency value 3rd wavelength...

Страница 88: ...Single patient or o Single calibration or o Control result collated by test ID 02 Reserved 03 Transmit patient results collated by order ID Results are only transmitted if all tests belonging to an o...

Страница 89: ...e N123A will be N123A represents a filler space Line code 12 Control Lot Information Example 11_N123A _23 04 2006 LF q o If no lot information is found or no lot was defined will be used and transmitt...

Страница 90: ...d transmitted without quotes o If the lot information is shorter than ten characters the string will be filled with spaces on the right side Example N123A will be N123A represents a filler space Line...

Страница 91: ...rised of the calibration index reference to the calibration with which the control was calculated and a control group index identifying the control itself q A sample result is comprised of o A calibra...

Страница 92: ...LF Description Format Range Range description Line code 40 Service request I1 0 Slot configuration 1 Sample tubes without orders 3 Reserved 4 List of all sample tubes y Line code 40 Service Selection...

Страница 93: ...ion rack number I3 0 Defined by barcode 1 to 999 Sample position tube number I2 0 Defined by barcode 1 to 15 Tube type I1 0 Fixed position tube 1 Barcode tube Order number S15 Barcode characters Optio...

Страница 94: ...unique r Do not use the same Patient ID for more than one patient otherwise results could be assigned to the wrong patient u Related topics Patient mode 30 Description Format Range Range description L...

Страница 95: ...pears in the database as patient name As the field identifier Name cannot be changed and is mandatory for transmission anyway this field should only be used to transmit the patient s name Line code 52...

Страница 96: ...his has the same effect as selecting a specific sample type on the order entry screen of the instrument instead of automatic which is the default in the drop down list q Orders o If the sample type is...

Страница 97: ...ent sample types the Order Entry Sample Type must be u Related topics Configuring barcode setup 192 Line code 11 Reagent Lot Information 89 Line code 54 Order Information Example 54_ 4_ 4_S_These are...

Страница 98: ...le test no profile IDs and Ratio IDs can be found in Configuration Test Definitions ID Line Code 56 Sample name Example 56_UrineWithDownregulatedProteinX LF Line code 57 Priority Modification Example...

Страница 99: ...ine code 98 Protocol Version Example 98_9561 LF Line code 99 General Error Code Example 99_01 LF Description Format Range Line code 96 Error code S2 00 to 99 y Line code 96 Error Code Description Form...

Страница 100: ...5 Line codes Roche Diagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 100 List of line codes...

Страница 101: ...Roche Diagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 Messages 6 Flags and error codes 103...

Страница 102: ......

Страница 103: ...anual Version 1 24 103 Table of contents Flags and error codes 6 Flags can be generated for the results of tests on samples calibrations or quality controls In this chapter 6 About flags 105 Flag X 10...

Страница 104: ...6 Flags and error codes Roche Diagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 104 Table of contents...

Страница 105: ...x Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 Flags and error codes 105 About flags The Flags are divided into four groups X Conditions under which result was generated...

Страница 106: ...X and 48 16 Flag X Decimal 0 255 Binary 1 1 1 1 1 1 1 1 Sub flag C Q R y Flag notation Value Name Meaning 0 no flag Result was calculated with an error free calibration 1 c The result was calculated w...

Страница 107: ...asurement and the replicate were accepted 2 R The result is erroneous or corrected or the result of the replicate is erroneous The result of the first measurement and the replicate were not accepted 3...

Страница 108: ...d too many bubbles 13 13 ISE UNSTAB ISE measurement unstable 14 14 REAG RNG Low reagent range exceeded 15 15 REAG RNG High reagent range exceeded 16 16 EP UNSTAB Endpoint unstable 17 17 HIGH ACT High...

Страница 109: ...whenever a flag precludes the calculation of a result and the instrument displays the HIF will always transmit the result as 9 999999E 99 or to 9 999999E 99 o In case of a HIGH ACT LOW ACT TEST RNG T...

Страница 110: ...de 2s 4 R 4s Difference in two values greater than 4s 5 R4 1s 4 values outside 1s 6 R7v 7 consecutive values decrease 7 R7 7 consecutive values increase 8 R7x 7 consecutive values on one side of mean...

Страница 111: ...yzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 Flags and error codes 111 About error codes COBAS INTEGRA 400 plus analyzer and Cedex Bio HT Analyzer uses the fo...

Страница 112: ...al Order Entry Calibration Control request already set 23 Any Order Manipulation Order already locked e g by work area etc or Database time out 24 Any Order Manipulation Test not defined 25 Order Dele...

Страница 113: ...t No new message to send 81 Service Action Result Request No new service action result to send 91 Any Host Request General parameter range error e g rack not defined illegal cup position sex dates etc...

Страница 114: ...r possibly transmission error if block check off 04 Block too long Erroneous block configuration or possibly transmission error if block check off 05 Invalid message configuration Erroneous message co...

Страница 115: ...Roche Diagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 Extended host interface of Cedex Bio HT Analyzer...

Страница 116: ......

Страница 117: ...7 About block codes for extended HIF 119 Result blocks 120 Block 02 Calibration Result 120 Block 03 Control Result 121 Block 04 Sample Results 122 Block 05 Calibration Result with Lot Information 123...

Страница 118: ...esponse 131 Block 59 Failed Cassette Status Request 131 Multi configuration service block 132 Block 64 Service Action Status 132 Message Log blocks 133 Block 75 Message Log Request 133 Block 76 Messag...

Страница 119: ...28 Service Action Result Response 29 Failed Service Action Result Response 45 Test Status Request 46 Test Status Response 47 Failed Test Status Request 52 Calibration Status Request 54 Calibration Sta...

Страница 120: ...red accordingly Line code Description Iteration 1 2 3 1 m 1 to 6 m is the number of standard rates in line 03 The sequence of m iterations must correspond to the sequence of values in line 03 In addit...

Страница 121: ...llated by test ID Result type selector 01 or 09 is used m 1 one Test ID per result block n 1 to 6 q Results of different control orders are not collated Results collated by control ID Result type sele...

Страница 122: ...selector 03 or 04 is used results collated by order number 3 w 1 to 141 The value of w can be different from 1 only if the result was measured using an absorbance test Line 06 There are 141 possible l...

Страница 123: ...rrespond to the sequence of values in line 03 In addition the number of iterations m has to be equal to the number of parameters standard rates in line 03 2 y 0 or 1 The value of y depends on whether...

Страница 124: ...lt is available If the instrument is configured accordingly Results always collated by test ID Result type selector 11 or 19 is used m 1 one test ID per result block n 1 to 6 q Results of different co...

Страница 125: ...to 141 The value of w can be different from 1 only if the result was measured using an absorbance test Line 06 There are 141 possible lines since each line is produced for every cycle max 141 2 p 0 t...

Страница 126: ...ost The commands can be Start and Stop The possible status changes are q If the instrument is set from Operating to Standby and tests are running the tests are completed and then the instrument goes t...

Страница 127: ...128 Block 25 Service Action Execution Automatic Service Action can be performed from host In order to perform the automatic service actions the system needs to be in Standby mode The service action is...

Страница 128: ...des all the service action execution results after date sent with Block 27 Block 29 Failed Service Action Result Response Block 29 contains Line 96 and provides the eventual error encountered followin...

Страница 129: ...ts Block 47 Failed Test Status Request Block 47 contains Line 96 and provides the eventual error encountered following request with Block 45 Line code Description Iteration 1 2 3 4 5 1 m is the total...

Страница 130: ...to interrogate the calibration status Block 52 has no lines Block 54 Calibration Status Response This request provides the calibration status for all loaded tests Line 49 is added only if rack positi...

Страница 131: ...50 Cassette status request Block 50 is used to interrogate the cassette status Block 50 has no lines Block 55 Cassette Status Response This request provides the status for all cassettes on board Block...

Страница 132: ...ervice block Multi configuration service block In this section Block 64 Service Action Status 132 Block 64 Service Action Status This request provides the status for all automatic service actions Line...

Страница 133: ...e specified date and time Block 76 Message Log Response This request provides all the messages in the message log received after date sent with block 75 Block 77 Failed Message Log Request Block 77 co...

Страница 134: ...ng sample orders are retrieved If Line 20 is used the status of the specified sample will be retrieved regardless whether the sample is pending or not Block 81 Order Status Response This response prov...

Страница 135: ...T Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 Block codes for extended host interface 135 Block 85 Failed Order Status Request Block 85 contains Line 96 and provides the event...

Страница 136: ...136 System status blocks System status blocks In this section Block 90 System status request 136 Block 91 System status response 136 Block 90 System status request Block 90 is used to interrogate the...

Страница 137: ...ost interface 137 Date and time blocks In this section Block 94 Date and Time request 137 Block 95 Date and Time data 137 Block 94 Date and Time request Block 94 is used to interrogate the date and ti...

Страница 138: ...locks Serial number blocks In this section Block 96 Serial Number Request 138 Block 97 Serial Number Response 138 Block 96 Serial Number Request Block 96 is used to interrogate the instrument serial n...

Страница 139: ...142 Line Code 06 Absorbance Raw Data 142 Line Code 08 FP Raw Data 143 Line Code 09 ISE Raw Data 143 Line Code 14 Validation Status 143 Line Code 17 Test Execution 144 Line Code 18 Cassette Information...

Страница 140: ...Line Code 45 Service Action Definition 161 Line Code 46 Currently Time or Tests elapsed 162 Line Code 47 Service Due 162 Line Code 48 Elapsed percentage 162 Line Code 49 Rack Position 163 Line code 5...

Страница 141: ...e to be filled up with leading spaces or zeros 0 The decimal point is mandatory Example SR9 3 0077 123 Fx ASCII formatted floating point number right adjusted x Length of the whole data record Length...

Страница 142: ...n 40 Service Selection 18 Cassette Information 45 Service Action Definition 19 Calibration Information 46 Currently Time or Tests elapsed 20 Order ID Request 47 Service Due 21 Control Information 48 E...

Страница 143: ...replicated r times in the same Line r Total number of replicates Line Code 09 ISE Raw Data Example 09_ 78 20 LF Line Code 14 Validation Status Example 14_1 LF Description Format Range Line Code 08 Bl...

Страница 144: ...calibration may lead to erroneous results Action Review results Repeat calibration if necessary 32 Result is associated with an erroneous or corrected control The control has been accepted F1 34 Resul...

Страница 145: ...value 2 unit F4 2 Low Activity The absorbance change during measurement doesn t reached the accepted limit i e the reaction has taken off too slow 24 The intensity obtained in the parallel or perpendi...

Страница 146: ...t The sample has a cloudy color F2 14 Result calculated using an erroneous or corrected calibration which has not been accepted F1 70 Result calculated using a postponed calibration which has not been...

Страница 147: ...on S10 Cassette Serial Number used for Calibration S10 Calibrator ISE Solution 1 Lot Number S10 Calibrator ISE Solution 1 Expiration Date D1 dd mm yyyy Calibrator ISE Solution 2 Lot Number S10 Calibra...

Страница 148: ...kinetic range for calc mode Kinetic or Kinsearch F3 2 Low Activity The absorbance change during measurement doesn t reached the accepted limit i e the reaction has taken off too slow 3 Absorbance valu...

Страница 149: ...leaking F3 27 Unable to calculate the kinetic change Either change is not stable Kinsearch or non existent Kinetic The first and last part of the reaction have very different slopes F3 28 Curve is not...

Страница 150: ...ft over have to be filled with space s Line Code 21 Control Information Example 21_22 04 2016_08 31 37_07 7470 7 _186387 _31 05 2018_62159401 _68354 9 99 9999E 99_U L _ 17 LF Description Format Range...

Страница 151: ...ish the cause of the deviation repeat sample measurement F1 10 Serum proteins only The sample contains an excess of antigen 1 value is Test Range High F3 12 Insufficient calibrator or too many air bub...

Страница 152: ...Recommended action Repeat the measurement Inform Roche Service if flag appears again F3 44 Westgard rule 5 Difference between two consecutive control values is greater than 4 SD Action rerun with fres...

Страница 153: ...06_22 07 59 LF q The messages are not cleared via host interface so after a certain time they should be deleted at the control unit Description Format Range Line Code 22 Order number S15 Sample Order...

Страница 154: ...Calculated 3 Running 4 Finished 5 Failed 6 Blocked y Status flag codes Blocking status flag code Description 0 Okay 1 No fluid in sample cup 2 Reagent not on board 3 Reagent is empty 4 No cassette def...

Страница 155: ...module 30 Error in Fp Module 31 Fatal HW Error 32 Activator not on board 33 Activator is empty 34 No activator definition found 35 Etcher not on board 36 Etcher is empty 37 No etcher definition found...

Страница 156: ...tration F13 9 999999E 99 to 1 0E 99 Rerun Order I2 Dilution Flag S6 1 X with X going from 1 to 100 y Line Code 27 Rerun Result Description Format Range Range description Line Code 28 Test status I2 3...

Страница 157: ...er to table displayed in Line 39 Optional If the rack position is available Rack Position S10 SlotID_RackNumber RackPosition y Line Code 29 Cassette status Description Format Range Range description L...

Страница 158: ...Backup 4 Initialize ISE module 5 Electrode Service 6 Activate Electrodes 7 Prime ISE Calibrators 8 Clean ISE Tower 9 Condition ISE Tubing y Line Code 32 Service Action selection Description Format Ran...

Страница 159: ...at Range Line Code 37 Tests left I4 The number of tests left for the specific cassette Total tests I4 The total number of tests originally available for the specific cassette Optional If the cassette...

Страница 160: ...and Green The following table shows the possible returned status with corresponding meaning and colour Description Format Range Line Code 39 Status I2 Detailed information is provided in the table be...

Страница 161: ...Slot configuration 1 Sample tubes without orders 3 Reserved 4 List of all sample tubes 5 Status of all automatic service actions y Line code 40 Service Selection Description Format Range Range descrip...

Страница 162: ...LF Description Format Range Line Code 46 Counts of Time or Tests Elapsed I10 Days since last service action I10 y Line Code 46 Currently Time or Tests elapsed Description Format Range Line Code 47 Ho...

Страница 163: ...ratio handling Use ratio number to order ratio Ratio and individual tests results will be delivered The available test no profile IDs and Ratio IDs can be found in Configuration Test Definitions ID S...

Страница 164: ...drum 3 Clean internal water reservoir 4 Clean wash station 5 Clean ext water reservoir fluid waste 7 Clean instrument 8 Clean waste box fitting 101 Prime fluid system 102 Roche service 103 Backup data...

Страница 165: ...place potassium K electrode 309 Replace lithium Li electrode 310 Prime ISE calibrators 311 Replace ISE module tubing 312 Clean ISE tower automatically 313 Clean ISE tower manually 314 Condition ISE tu...

Страница 166: ...locked status Status code Meaning 0 Okay 1 No fluid in sample cup 2 Reagent not on board 3 Reagent is empty 4 No cassette definition found 5 Diluent not on board 6 Diluent is empty 7 No diluent defini...

Страница 167: ...36 Etcher is empty 37 No etcher definition found 38 Deproteinizer not on board 39 Deproteinizer is empty 40 No deproteinizer definition found 41 ISE module disabled 42 Fp module disabled 43 Cleaner n...

Страница 168: ...opped 140 Cassette Temp Okay 141 Cassette Temp Warning 22 Cleaner Error 20 Cleaner Okay 132 Cleaner Temp Error 130 Cleaner Temp Okay 131 Cleaner Temp Warning 21 Cleaner Warning 32 Cuvette Error 30 Cuv...

Страница 169: ...rter also the line will be shorter o If a newline character is present in the message string this will be displayed as NL in order to tell it apart from LF which is used in the Hif Protocol structure...

Страница 170: ...s I2 0 Sleeping 1 Initializing 2 Stopped 3 Service 4 Cover Open 5 Standby 6 Running 7 Fatal Error 8 Power Down 9 Auto Service 10 Power On Cleaner status I1 0 Ok 1 Warning 2 Error Cuvette status I1 0 O...

Страница 171: ...Roche Diagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 Troubleshooting 9 Troubleshooting 173...

Страница 172: ......

Страница 173: ...terface Manual Version 1 24 173 Table of contents Troubleshooting 9 There are various supporting features that help you identify error situations In this chapter 9 About troubleshooting 175 Enabling h...

Страница 174: ...9 Troubleshooting Roche Diagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 174 Table of contents...

Страница 175: ...essage Handler The Message Handler runs in the background as soon as the instrument software is active q o All Message Handler information is written to the log Trace log file Please ensure to have th...

Страница 176: ...cing Enabling host interface tracing r To enable host interface tracing 1 Switch to the Message Handler task 2 From the menu choose Monitor Filter 3 Select the 1023 TRACE_HIF_LINE trace 4 Choose the O...

Страница 177: ...HIF communication 1 From the menu choose File Open trace File 2 Select Trace tra 3 Choose the Open button 4 Wait until the trace file is loaded completely before proceeding to the next step 5 From th...

Страница 178: ...the instrument instead of automatic which is the defaulting the drop down list See also details line code 53 As soon as the sample racks are inserted into the instrument the order number and the samp...

Страница 179: ...e ratios will be collated with other results This is different from the behavior in SW V3 3 where ratios where delivered in a separate block as they had automatically a different sample type Collated...

Страница 180: ...9 Troubleshooting Roche Diagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 180 Known host interface issues...

Страница 181: ...Roche Diagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 Appendices 10 Instrument setup 183...

Страница 182: ......

Страница 183: ...chapter 10 Setting up the instrument for host communication 185 Setting up the instrument for host communication 185 Preparing an interface cable 186 About the RS 232 cable 186 About the connector ty...

Страница 184: ...10 Instrument setup Roche Diagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 184 Table of contents...

Страница 185: ...instrument for host communication 1 Prepare an interface cable and connect the cable to the host and the instrument 2 To enable host interface transmission choose Configuration Processing Result Outp...

Страница 186: ...OBAS INTEGRA 400 plus analyzer or the Cedex Bio HT Analyzer The correct pin assignment is defined in the ISO 2110 standard for 25 pole connectors and in the ISO 4902 standard for 9 pole connectors Pin...

Страница 187: ...ommend connecting the cable shield to the SUB D chassis of the interface connector on one side only q NEVER connect the cable shield to the signal ground Connector housing To prevent electromagnetic i...

Страница 188: ...nstrument for host communication Connecting the interface cable The COM1 Serial port is dedicated to serve as a host interface port It is a SUB D male type with 9 pins The picture shows the connectors...

Страница 189: ...n 3 6 5 1 Host Interface Manual Version 1 24 Instrumentsetup 189 Data station dc7800 Host connector on COBAS INTEGRA 400 plus analyzer and Cedex Bio HT Analyzer on the data station dc7800 Data station...

Страница 190: ...e parameters have to be set to the same value Parameter Value Description Sample Selected Sample results are sent to host Control Selected Control results are sent to host Calibration Selected Calibra...

Страница 191: ...have to be assigned to an existing patient i e prior to downloading orders the relevant patient information has to be downloaded The instrument generally works with patient data Not selected The inst...

Страница 192: ...n Configuring barcode setup Barcode types q The instrument recognizes the barcode type automatically Configuration General Barcode Use Barcode On Enable the barcodes in the Use Barcode On section Supp...

Страница 193: ...ther the sample type can either be specified by using sample type specific racks or it also has to be a part of the barcode q The barcode must not be shorter than the pattern you specified Example of...

Страница 194: ...400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 194 Setting up the instrument for host communication Configuration Lab Racks Barcode reading can be...

Страница 195: ...nstrument serial interface is based on international standards The relevant standards are EIA RS 232D and CCITT V 24 The RS 232 serial interface is an asynchronous interface with ASCII character trans...

Страница 196: ...signals defined in the standard of CCITT V 24 Normally only some of these are used CCIT EIA Signal name Description 9 pin connector 25 pin connector 101 AA PG Protective ground 1 102 AB SG Signal grou...

Страница 197: ...to receive data it sets its DTR line to active This signals the sender the receiver is ready whereupon the sender starts data transmission 3 As long as the sender s CTS signal is active it can transm...

Страница 198: ...10 Instrument setup Roche Diagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 198 About the RS 232 serial interface...

Страница 199: ...Roche Diagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24 Index Index 201...

Страница 200: ......

Страница 201: ...232 186 types 187 Codes instrument 57 Collated results 44 Connectors cables 186 locations 188 types 187 E Error codes 103 F Feedback 5 Flags 103 H Host query 40 I Initilize 26 Instrument codes 57 M M...

Страница 202: ...Index 202 Index Roche Diagnostics COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Software version 3 6 5 1 Host Interface Manual Version 1 24...

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