Cobas integra 400 plus инструкция по эксплуатации

Автоматический биохимический анализатор Cobas Integra 400 plus фирмы Roche Diagnostics (Швейцария).

Cobas Integra 400 plus технические характеристики

Максимальная многосторонность в минимальном рабочем объеме. Это является характерной особенностью автоматического компактного анализатора. Он объединяет удобство и простоту загрузки образцов и кассет с реагентами  с обширным меню тестов. Возможен анализ более, чем 96 веществ и групп веществ. Также надежной и удобной автоматизацией всех функций.

Основное назначение анализатора – значительное повышение КПД анализаторов за счет сокращения затрат лаборатории на отдельные анализы.

Назначение анализатора Cobas Integra 400 plus

• Используемые в анализаторе 4 измерительные технологии — фотометрия, турбидиметрия, флуоресцентная поляризация и ионная селективная потенциометрия. Все это позволяет объединить множественные тесты в единую систему.
• Автоматический контроль работы с реактивами очень упрощает задачи оператора. Реагенты не требуют приготовления, имеют проверенные на заводе состав, упаковку и  спецификации. Они сразу доступные анализатору через систему считывания штрих-кодов. Это позволяет экономить рабочее время, избежать ошибок оператора, повышает точность и повторяемость результатов. Также сокращает затраты времени и материалов на калибровку. Калибровка необходима только при смене партии кассет с реагентами.
• Система миниторинга и  сигнализации всех стадий проведения анализов позволяет организовать непрерывную загрузку образцов. Также замену реагентов в аппарате без остановки его работы.
• Одноразовые реакционные кюветы повышают чистоту реакции  и точность результатов. Позволяют исключить постоянные затраты на промывку реакционной зоны. Система сбора отработанных кювет позволяет организовать утилизацию отходов в соответствии с санитарными нормами.
• Постоянное охлаждение образцов и реагентов на борту прибора повышает стабильность реагентов, калибраторов  и образцов, устраняя необходимость в их частой замене.
• Одно из преимуществ анализатора перед другими анализаторами – эффективная система обнаружения и удаления сгустков в образцах, которые могут вызвать засорение системы. Высоко чувствительные датчики прибора обнаруживают неправильное капание из пипетки, даже при 2µl объеме образца.
• Низкое потребление энергии и  воды, разумные габариты позволяют установить анализатор  без специальной подготовки и переделки существующих лабораторных помещений и экономно расходовать ресурсы.
• Анализатор обладает высокой ремонтопригодностью. Это позволяет с наибольшей легкостью и простотой заменять отдельные блоки и узлы прибора. Используя отдаленную диагностику во время проведения текущего обслуживания, технический персонал может без малейших трудностей идентифицировать те узлы прибора, которые требуют замены. Программное обеспечение прибора гарантирует достоверность и сохранность полученных результатов.

Cobas Integra 400 plus универсальный анализатор

Таким образом универсальный анализатор для клинической химии интегрирует на базе одного прибора большую часть лабораторных исследований. Основная концепция анализатора — консолидация. Объединение четырех надежных технологий и меню из 96 параметров. Они позволяют выполнить до 80% всех исследований в области клинической химии на одном анализаторе. Сюда относятся традиционная рутинная химия, лекарственный мониторинг, специфические белки и многое другое.

Система Cobas Integra 400 plus

Селективный дискретный анализатор с возможностью постоянного доступа. Интегрирует 4 измеряющих принципа:

• Абсорбционная фотометрия: Ферменты и субстраты
• Турбодиметрия: Специфические белки, наркотики
• Флюоресцентная поляриметрия: Лекарственный мониторинг
• Ион-Селективный модуль: Натрий, калий, хлор, литий 36 тестов на борту.

Производительность до 400 тестов в час.

Типы образцов

Сыворотка, плазма, моча, спино-мозговая жидкость, гемолизат, цельная кровь (HbA1c).

Образцы Cobas Integra 400 plus

90 первичных или вторичных пробирок на борту прибора.
До 6 x 15 RD рэков на борту прибора. Охлаждаемые позиции для контролей и калибраторов. Автоматическое разведение и концентрирование образца. Считывание баркодов с помощью лазерного сканера с немедленным распознаванием срочных тестов.

Типы пробирок Cobas Integra 400 plus

• Первичные пробирки: 5-10 мл, 16х100, 16х75, 13х100, 13х75 мм;
• Микропробирки для анализаторов Хитачи, 500 мкл;
• Стандартные пробирки для анализаторов Хитачи, 1,5 мл;
• Пробирки для анализаторов Cobas, 650 мкл (Cobacup);
• Пробирки фирмы Eppendorf, 1,5 мл.

Обьем образца Cobas Integra 400 plus

Обычно от 2 до 10 мкл на тест, непрямое определение электролитов – 20 мкл, прямое определение электролитов – 97 мкл.

Количество реагентов на борту Cobas Integra 400 plus

32 кассеты, 50-800 тестов на кассету. До 8 рэков с 4-мя кассетами каждый на борту прибора. Автоматический сигнал о необходимости замены кассеты. Позиции для реагентов охлаждаются до 10-15ºС. Стабильность на борту до 3-х месяцев, калибровка — только один раз на каждый лот.

Реакционные кюветы Cobas Integra 400 plus

Прибор содержит на борту до 1000 одноразовых реакционных кювет с шириной 5 мм и реакционным обьемом 120-240 мкл.

Рабочая станция

Рабочая станция HP с операционной системой Windows NT Intel Pentium III 800 c 256 MB RAM. Жесткий диск 15 GB, CD ROM, встроенный модем.

Системный интерфейс

RS-232 серийный двунаправленный интерфейс, встроенный модем для доступа сервисной службы ROCHE.

Требования к электроснабжению

100-125 / 200-240 Вольт, 50 или 60 Гц, низкое потребление э/энергии — до 1200 VA.

Потребление воды

До 2 литров деионизированной воды в час (в рабочем режиме) из отдельной емкости. Не требуется постоянная подача воды.

Размеры и вес

Длина – 135 см, ширина – 66 см, высота – 75 см. Размеры позволяют разместить анализатор на стандартном рабочем столе. Вес 230 кг.

Определяемые показатели Cobas Integra 400 plus

Ферменты

• Аланинаминотрансфераза (АЛТ)
• Аспартатаминотрансфераза (АСТ)
• Щелочная фосфотаза
• Кислая фосфотаза
• Гамма-глютамилтрансфераза (ГГТ)
• Амилазa
• Панкреатическая амилаз
• Холинэстераза
• Липаза
• Лактатдегидрогеназа
• Креатининфосфокиназа
• Креатининфосфокиназа – МВ

Белки

• Альфа-1-антитрипсин
• Кислый альфа-1-гликопротеин
• Альбумин
• Альбумин (турбодиметрический, определение микроальбуминурии)
• Преальбумин
• Белок общий
• Белок общий в моче/ликворе
• Ревматоидный фактор
• Антистрептолизин О
• С-реактивный белок
• Церуплазмин
• Гаптоглобин

Метаболиты

• Креатинин
• Мочевина
• Мочевая кислота
• Аммиак
• Двуокись углерода (СО2)

Липиды

• Аполипопротеин А-1
• Аполипопротеин В
• Липопротеин А
• Триглицериды
• Холестерин
• (ЛПВП) Холестерин липопротеидов высокой плотности
• (ЛПНП) Холестерин липопротеидов низкой плотности

Пигменты

• Билирубин общий
• Билирубин прямой

Углеводы и продукты их обмена

• Глюкоза
• Фруктозамин
• Гликолизированный гемоглобин
• Молочная кислота

Сердечные маркеры

• Дигоксин
• Диготоксин
• Миоглобин

Метаболизм железа

• Железо
• Трансферин
• Рецептор трансферина растворимый
• Ферритин
• Общая железосвязывающая способность сыворотки

Лекарственный мониторинг

• Ацетаминофен                           
• N-ацетил-прокаинамид
• Амикацин                                    
• Опиаты
• Амфетамин                                
• Фенциклидин
• Барбитураты                              
• Фенобарбитал
• Бензодиазепин                           
• Дефинин свободный/общий
• Карбамазепин                            
• Примидон
• Кокаин                                        
• Прокаинамид
• Циклоспорин                             
• Квинидин
• Дигоксин                                    
• Салицилат
• Диготоксин                                
• Каннабиноид
• Этанол                                        
• Теофиллин
• Гентамицин                                
• Тобрамицин
• Лидокаин                                    
• Пропоксифен
• ЛСД                                             
• Вальпроевая кислота свобод./общ
• Метадон                                      
• Ванкомицин    

Иммунологические показатели

• Комплемент С3с
• Комплемент С4
• (Ig A) Иммуноглобулин А
• (Ig M) Иммуноглобулин М
• (Ig G) Иммуноглобулин  G

Показатели гемостаза

• Д-димер
• Антитромбин ІІІ

Микроэлементы

• Кальций
• Магний
• Фосфор неорганический

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Также смотрите биохимический анализатор Cobas c 311.

• Page 1
  COBAS INTEGRA 400 plus analyzer Cedex Bio HT Analyzer Host Interface Manual Version 1.24 Software version 3.6/5.1…

• Page 2: Publication Information

  — i_flags: Additional Flag X/C function for I400 V2.0 and I800 — i_lc55: Nov.1999 Test ID > Test No. y Revision history Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 3
  Roche Diagnostics. Leave tasks that are not described in the user documentation to trained Roche Service representatives. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 4
  COBAS INTEGRA 400 plus analyzer or Cedex Bio HT Analyzer. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 5
  The following marks demonstrate compliance: For in vitro diagnostic use. Complies with the provisions of the applicable EU directives. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 6
  RoHS compliant from Serial No. 610001. Issued by Underwriters Laboratories, Inc. (UL) for Canada and the US. ® Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 7: Table Of Contents

  About line codes Setting up the instrument for host List of line codes communication About the RS-232 serial interface Index Index Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 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…

• Page 9: Intended Use For Cobas Integra 400 Plus Analyzer

  Cedex Bio HT Analyzer instrument Host computer, laboratory information host system or other computer system connected to the instrument y Product names Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 10: What Is New In Publication Version 1.24

  Approvals for the Cedex Bio HT Analyzer The approvals for the Cedex Bio HT Analyzer were rephrased. u Approvals for Cedex Bio HT Analyzer (6) Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 11: What Is New In Publication Version 1.23

  Information about the Cedex Bio HT Analyzer has been added to this publication. • No other content changes have been made. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 12
  Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 13
  Communication About communication ………………15 About host interface features …………….27 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 15
  Host communication handling ….Synchronization and sequence counter use..Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 16
  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…

• Page 17: Communication Concept

  If the host does not receive a response upon a request within a certain time, a timeout should be activated. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 18: Message Structure

  1<LF> (0 or 2 lines) 562<LF> <EOT><LF> In this section Block header (19) Block data (19) Block check (20) Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 19: Block Header

  Related topics • Block codes (59) • Line codes (81) Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 20: Block Check

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

• Page 21: Communication Control

  (block 99). Host systems will use the error handling. u Related topics • Error handling (24) Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 22: Flow Control (Hardware/Software Handshake)

  We strongly recommend that you enable the block check. Otherwise you cannot be sure that all data are correctly transmitted. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 23: Check Of Block And Line Composition

  Incompletely received messages (without an <EOT> termination) will not be acknowledged by the instruments (host time-out). u Related topics • Error handling (24) Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 24: Error Handling

  General error message (block 99) was received • Time-out occurred u Related topics • Synchronization and sequence counter use (26) Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 25: Host Communication Handling

  About communication Host communication handling w Suggestion for host communication handling Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 26: Synchronization And Sequence Counter Use

  SCs. The following procedure is recommended: w Recommended procedure for sequence counter synchronization Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 27
  Protocol version ……. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 28
  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…

• Page 29: About Host Interface Modes And Features

  (1) Additional option. When using patient mode, the other 3 actions in the table are available. u Related topics • Patient mode (30) Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 30: Patient Mode

  Do not use the same patient ID for more than one patient. In this section Patient entry (31) Patient modification (32) Patient deletion (32) Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 31: Patient Entry

  Patient information is downloaded by means of BC40, Patient Entry. Example w Example of patient entry information u Related topics • Block 40: Patient Entry (74) Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 32: Patient Modification

  Patient deletion is possible only if there are no orders attached to it. u Related topics • Block 41: Patient Deletion (74) Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 33: Orders

  Those sets are programmed on the instrument and assigned to a number. A profile can contain individual tests or ratios. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 34
  Line code 54: Order Information (97) u Configuring barcode setup (192) Example of order entry communication w Example of order entry communication Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 35
  HbA1c, ordering one ratio will have the side effect of automatically ordering the second one. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 36
  Otherwise each test and ratio will be ordered two times Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 37
  About host interface features w Example of order entry with profile number Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 38
  Orders Example of unspecific order request w Example of unspecific order request Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 39: Order Modification (Add Tests)

  • The order is finished and all results are accepted u Related topics • Block 11: Order Deletion (70) Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 40: Host Query Mode

  Deletion block (Block 11) as soon as it has received all results belonging to a specific order. We recommend using the following procedure and timing when using host query: Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 41
  (e.g. 60 seconds). Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 42
  Host query mode Example of host query communication w Example of host query communication Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 43
  About host interface features w Example of host query communication (continued) …and so on. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 44: Result Requests

  Select Retransmit in the Process menu. We recommend using the following procedure and timing for the result request loop: Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 45
  Related topics • Block 09: Result Request (68) • Block 10: Order Entry (69) • Block 11: Order Deletion (70) Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 46: Example Of Result Query

  Result requests Example of result query w Example of result query communication Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 47
  About host interface features w Example of result query communication (continued) Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 48: Example Of Unspecific Result Request

  Result requests w Example of result query communication (continued) Example of unspecific result request w Example of unspecific result request Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 49: Example Of Result Request With Ratio (Collated Result Request)

  This is the reason why the two primary tests produce two calculated results. w Example of result request with ratio (collated result request) Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 50: Protocol Version

  The Protocol Version request (BC92) is used to get the Version # of the HIF Protocol. u Related topics • Block 92: Protocol Version Request (79) Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 51
  Reference General codes………………….53 Block codes ………………….59 Line codes……………………. 81 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 53
  Instrument codes ……Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 54
  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…

• Page 55: Ascii Code

  US standard ANSI X3.4 for the interchange of information among communication devices. The first 32 values are reserved for control codes. w ASCII code Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 56: Control Characters

  End of text <EOT> End of transmission <LF> Line feed <CR> Carriage return <Space> Space <DC1> <DC3> XOFF y Control characters Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 57: Instrument Codes

  General codes Instrument codes The instrument code for the COBAS INTEGRA 400 plus analyzer is “14”. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 58
  Instrument codes Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 59
  Block 49: Patient Manipulation Response..Multi-configuration service blocks….Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 60
  Block 99: Control Message ….Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 61: About Block Codes

  Notation of block codes (1) Number of iterations in all lines (2) Number of iterations in lines 02 and 12 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 62: Idle And Synchronization Blocks

  As an answer to a result request if no results are available Block 00 has no lines. Sync block configuration No block check. Idle block configuration Block check included. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 63: Result Blocks

  AGE rate line regardless of this parameter. If the AGE check was not required by the test, this line contains the values initialized by the instrument. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 64: Block 03: Control Result

  (2) n = 1 to 50. If result type selector 03 or 04 is used (results collated by order number) Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 65: Block 05: Calibration Result With Lot Information

  AGE rate line regardless of this parameter. If the AGE check was not required by the test, this line contains the values initialized by the instrument. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 66: Block 06: Control Result With Lot Information

  = 1 (one test ID per result block) • n = 1 to 6 Results of different control orders are not collated. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 67: Block 07: Patient Results With Lot Information

  A possible error of a result request will be answered by block 08. Line Description code Error Message y Block 08 The message contains the associated error code. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 68: Block 09: Result Request

  Calibration and control results are only transmitted if enabled. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 69: Order Blocks

  (1) w = 1 if in patient mode (2) w = 0 if in patient mode (3) x = 1 to 200 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 70: Block 11: Order Deletion

  If several identical test orders exist, the first one that is found will be deleted. Ratio and profile test orders cannot be deleted via the host interface. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 71: Block 19: Order Manipulation Response

  Block 19: Response to an incorrect order entry with error in test order (1) x = 1 to 200 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 72: Response To An Order Or Test Deletion

  Description Iteration code Error Code 1 to x Test ID y Block 19: Response to an incorrect test deletion Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 73
  Block 19: Response to an order/test deletion with default sample type if the order’s sample type was not default sample type x = 1 to 200 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 74: Patient Blocks

  Block 42 is used to change existing patient information Line Description code Patient ID Patient Information y Block 42 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 75: Block 49: Patient Manipulation Response

  Response to an incorrect patient entry, Line Description deletion, or modification code Error Message Patient ID y Block 49 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 76: Multi-Configuration Service Blocks

  Line Description code Slot State y Block 61 The rack numbers of the racks in the slots are sent. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 77: Block 62: Sample Tube Information

  If there is no sample tube information available, a block 69 with line 96 (service 61) is returned. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 78: Block 69: Service Request Response

  Status response to an MCS request is shown by block 69. Block 69 has one line. Line Description code Error Message y Block 69 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 79: Protocol Version Blocks

  Block 93 is the answer to block 92, protocol version request. Block 93 contains one line. Line Description code Protocol Version y Block 93 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 80: Control Messages Blocks

  Block 99 contains one line. Line Description code General Error Code y Block 99 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 81
  Line code 96: Error Code ….. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 82
  Line code 99: General Error Code … . . Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 83: About Line Codes

  Time format 2: hh:mm (hh in 24 h format) (used by COBAS Core/Core II). 5 character ASCII-string. Example: «22:07» y Formats of data fields used in 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…

• Page 84: List Of Line Codes

  Normal result without any flag: 00_•8.694475E+01_U/l•••_•• 0_••0_••0_••0_•0.000000E+00_•0.000000E+00<LF> «>TEST RNG» flag, HIF returns the value and the higher range limit: 00_10.694475E+01_U/l•••_•• 0_••0_•31_••0_•1.500000E+02_•10.00000E+00<LF> Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 85: Line Code 01: Result Time

  Line code 02: Control ID Description Format Range Line code QC-name y Line code 02: Control ID Example 02_ROC-N<LF> Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 86: Line Code 03: Standard Rates

  3 the K slope. • For all other electrodes, parameter 1 contains the associated slope value. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 87: Line Code 07: Abs Sample Check

  3rd value pair Absorbency value:6th wavelength, SR7.4 3rd value pair y Line code 07: ABS Sample Check Example 07_•0.0000_•0.0000<LF> Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 88: Line Code 10: Result Type Selection

  See Known host interface issues (178) u See Line code 53: Order ID (96) u See Configuring host communication (190) Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 89: Line Code 11: Reagent Lot Information

  Example, N123A will be N123A • • • • • (•) represents a filler space Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 90: Line Code 13: Calibration Lot Information

  Example 15_22:07:59_23/04/2006<LF> Access date time is the point when the measurements are started on the instrument (scheduled date time) Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 91: Line Code 16: Result Indexes

  A result will have a maximum of three indexes. If one index does not exist, it will be replaced with a right- justified zero. See the examples above. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 92: Line Code 40: Service Selection

  1 to 999 Rack number in slot 6 1 to 999 y Line code 41: Slot State Example 41_••3_350_••0_••0_••0_784<LF> Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 93: Line Code 42: Tube Information

  Test ID 1 to 999 Test state Test unavailable (blocked) Test available y Line code 43: Test State Example 43_•32_1<LF> Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 94: Line Code 44: Cal/Cs State

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

• Page 95: Line Code 51: Patient Information

  Special order type Calibration order Calibration correction order Control order Attribute Immediate y Line code 52: Special Order Selection Example 52_03_T<LF> Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 96: Line Code 53: Order Id

  If the sample type is not transmitted, the default sample type (defined by test or rack definition) is used. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 97: Line Code 54: Order Information

  Depending on database set-up parameters Leadertext 1 and 2 Sample leadertext 1 Sample leadertext 2 y Line code 54: Order Information Example 54_••4_•4_S_These•are•21•chars•••<LF> Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 98: Line Code 55: Test Id

  Line code Priority modification type Change work list priority to STAT y Line code 57: Priority Modification Example 57_•2<LF> Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 99: Line Code 96: Error Code

  Description Format Range Line code Error code 01 to 08 y Line code 99: General Error Code Example 99_01<LF> Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 100
  List of 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…
• Page 101
  Messages Flags and error codes ………………103 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 103
  List of line code 99 error codes ….114 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 104
  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…

• Page 105: About Flags

  Conditions under which result was generated Not yet used, currently set to ’0’ CALC Result error Evaluation of results Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 106: Flag X

  The control was not accepted. Not used y Sub Flag Q = (Flag X and 48)/16 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 107
  Result was generated after dilution. Result was generated after concentration. y Sub Flag ^ = Flag X and 3 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 108: Flag Calc (Result Error)

  Upper test range exceeded (please refer to following note) TEST BLOCKED Used with collated results if a test is blocked (see note) y List of flag CALC Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 109
  00 is either set to -9.999999E+99 or to 9.999999E+99. The range field is set to the appropriate value if applicable. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 110: Flag Qc

  > Critical Range Higher then critical Range DC > Delta Check in a value DC > Delta Check in percent y List of Flag QC Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 111: About Error Codes

  Cedex Bio HT Analyzer uses the following error codes: • Line code 96 error codes • Line code 99 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…

• Page 112: List Of Line Code 96 Error Codes

  No test is loaded Service Action Status No Service Action definition is available y Line code 96 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…

• Page 113
  Sample type (undefined, *** or ??? are inappropriate) Any Order Manipulation Sample type (lab number) not found y Line code 96 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…

• Page 114: List Of Line Code 99 Error Codes

  Line format error Erroneous line configuration, or possibly transmission error if block check off y Line code 99 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…

• Page 115
  Extended host interface of Cedex Bio HT Analyzer Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 117
  Block 46: Test Status Response ….129 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 118
  Block 96: Serial Number Request….138 Block 97: Serial Number Response … . 138 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 119: About Block Codes For Extended Hif

  Notation of block codes (1) Number of iterations in all lines (2) Number of iterations in lines 02 and 12 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 120: Result Blocks

  (Line 06). There are 423 possible lines since each line is produced for every replicate (max. 3) and every cycle (max 141). Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 121: Block 03: Control Result

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

• Page 122: Block 04: Sample Results

  (5) y = 1 to z. The value of z is the total number of reruns executed for a single test result. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 123: Block 05: Calibration Result With Lot Information

  (Line 06). There are 423 possible lines since each line is produced for every replicate (max. 3) and every cycle (max 141). Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 124: Block 06: Control Result With Lot Information

  = 1 (one test ID per result block) • n = 1 to 6 Results of different control orders are not collated. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 125: Block 07: Sample Results With Lot Information

  (3) y = 1 to z. The value of z is the total number of reruns executed for a single test result. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 126: Operation Settings Blocks

  Line 96. The response message depends on the success of the request. Line code Description Error Message y Block 21 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 127: Service Action Blocks

  It is possible to retrieve all service action execution results after the specified date and time. Line code Description Date and time y Block 27 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 128: Block 28: Service Action Result Response

  Block 29 contains Line 96 and provides the eventual error encountered following request with Block 27. Line code Description Error Message y Block 29 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 129: Test Status Blocks

  Block 47 contains Line 96 and provides the eventual error encountered following request with Block 45. Line code Description Error Message y Block 47 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 130: Calibration Status Blocks

  Block 57 contains Line 96 and provides the eventual error encountered following request with Block 52. Line code Description Error Message y Block 57 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 131: Cassette Status Blocks

  Block 59 contains Line 96 and provides the eventual error encountered following request with Block 50. Line code Description Error Message y Block 59 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 132: Multi-Configuration Service Block

  1 to m Service Due Elapsed percentage y Block 64 (1) m is the total number of automatic service actions. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 133: Message Log Blocks

  Block 77 contains Line 96 and provides the eventual error encountered following request with Block 75. Line code Description Error Message y Block 77 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 134: Sample Order Status Blocks

  Otherwise if line 20 was used in block 80 only the requestd sample will be returned (m=1). Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 135: Block 85: Failed Order Status Request

  Block 85 contains Line 96 and provides the eventual error encountered following request with Block 80. Line code Description Error Message y Block 85 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 136: System Status Blocks

  Block 91 is the response to Block 90. It contains line 97. Line code Description System Status y Block 91 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 137: Date And Time Blocks

  Block 95 is the answer to Block 94, Date and time request. Block 95 contains one line. Line code Description Date and Time y Block 95 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 138: Serial Number Blocks

  Block 97 is the answer to Block 96, Serial Number request. Block 97 contains one line. Line code Description Serial Number y Block 97 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 139
  Line Code 36: Cassette definition….158 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 140
  Line Code 97: System status ….170 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 141: About Line Codes

  Time format 2: hh:mm (hh in 24 h format) (used by COBAS Core/Core II). 5 character ASCII-string. Example: «22:07» y Formats of data fields used in 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…

• Page 142: List Of Line Codes For Extended Hif

  12. Hence there can be up to 12 floating point numbers in the same Line. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 143: Line Code 08: Fp Raw Data

  Range description Line Code Validation Status Accepted Disabled Rerun Not handled y Line Code 14: Validation Status Example 14_1<LF> Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 144: Line Code 17: Test Execution

  Result differs from last result (up to n days before) by greater than defined value. %1% = [def. value] %2% = [unit] (F4) Result obtained using a dilution factor. (F1) y Flag codes Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 145
  No end of sample segment detected. It takes too long for a sample segment to reach the electrode assembly. The tubing may be blocked or leaking. (F3) y Flag codes Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 146: Line Code 18: Cassette Information

  Example, 62159401 will be 62159401•• (•) represents a filler space Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 147: Line Code 19: Calibration Information

  Detailed information in the table below y Line Code 19: Calibration Information Example 19_11/04/2016_09:00:12_07-3718- 6•_176121••••_30/05/2016_62159401••_68354•••••_??? ???????_00/00/0000_??????????_00/00/0000_????????? ?_00/00/0000_R0••••••_0.0007479•_F•••••••••_5286.7 620•_??????????_??????????_??????????_??????????_? ?????????_??????????_••0<LF> Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 148
  Nonlinear standard curve cannot be calculated due to calculation error. Action: Check calibration graph.Rerun calibration with fresh calibrators. (F3) y Flag codes Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 149
  Result obtained after a repeated run. (F1) New calibration overwritten with old accepted calibration Any Calibration-Flag. y Flag codes Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 150: Line Code 20: Order Id

  Control Result Control Unit Control Flag Refer to following table y 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> Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 151
  The result exceeds than the upper measurable test range. (F3) The value exceeds the upper limit of a limit control. (F4) y Flag codes Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 152
  Result (or a replicate) is erroneous or corrected. Result has not been accepted. Recommended action: Check results reaction curve to establish the cause of the deviation; repeat sample measurement. (F1) y Flag codes Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 153: Line Code 22: Order Id

  The messages are not cleared via host interface so, after a certain time, they should be deleted at the control unit. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 154: Line Code 25: Test Order Status

  No assigned values for control available Last control not accepted Repeat action not possible Test disabled y Blocking status flag codes Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 155: Line Code 26: Dilution Factor

  Line Code 26: Dilution Factor Example 26_••••2.1<LF> Samples on the instrument can only be diluted. The maximum dilution factor is 100. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 156: Line Code 27: Rerun Result

  If the calibration is required Calibration date When is the next calibration due. y Line Code 28: Test Status Example 28_17_•0_•••0_N_2_<LF> Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 157: Line Code 29: Cassette Status

  Calibration Pending Optional If the rack position is available Rack Position SlotID_RackNumber-RackPosition y Line Code 31: Calibrator status Example 31_07-6830-8••••••_CFAS••••_•6_•1_J•13-6••••<LF> Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 158: Line Code 32: Service Action Selection

  Lot number Cassette Lot number Cassette definition ID ID of the cassette type y Line Code 36: Cassette definition Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 159: Line Code 37: Tests Left

  Preparing Optional If the rack position is available Rack Position SlotID_RackNumber-RackPosition y Line Code 38: Diluent status Example 38_07-5635-0••••••_•1_O•140-8•••<LF> Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 160: Line Code 39: Cassette Status

  Yellow Requires mixing Yellow Reconstituting Yellow Preparing Yellow Empty Not on board Missing definition (unknown fluid) y Status codes Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 161: Line Code 40: Service Selection

  Electrode service Activate electrodes Prime ISE calibrators Clean ISE tower automatically Condition ISE tubing Initialize ISE module y IDs Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 162: Line Code 46: Currently Time Or Tests Elapsed

  Percentage of days occurred for service action to be performed y Line Code 48: Elapsed percentage Example 48_••••••••40_•••••••••32<LF> Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 163: Line Code 49: Rack Position

  Samples in the instrument can only be diluted. The maximum dilution factor is 100. If the dilution factor is omitted, the 1:1 factor will be used. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 164: Line Code 58: Service Action Result

  Replace Abs. halogen lamp Replace cleaner bottle Electrode service Deproteinize electrodes Etch electrodes Activate electrodes Replace reference (Ref) electrode y IDs Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 165: Line Code 60: Calibration Due

  If the calibration is required Calibration date When is the next calibration due. y Line Code 60: Calibration due Example 60_4_25/05/2016<LF> Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 166: Line Code 61: Test Status And Blocked Status

  Calculation not possible No ISE Electrode Activation not performed ISE module not ready Error in ISE module y Status codes Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 167: Line Code 62: Calibrator Id

  Range Line Code Message Icon Refer to following table for details y Line Code 82: Message Icon Example 82_•71<LF> Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 168
  Temperature Okay Temperature Warning WasteDrain Error WasteDrain Okay WasteDrain Warning WaterSupply Error WaterSupply Okay WaterSupply Warning y Icon Codes Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 169: Line Code 83: Message String

  Format Range Line Code Serial Number SMP code and Serial Number y Line Code 94: Serial Number Example 94_CN123456<LF> Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 170: Line Code 97: System Status

  Cassettes Temperature in degrees temperature Cleaner Temperature in degrees temperature y Line Code 97: System status Example 97_•5_0_0_0_1_•853_0_•••37.1_•••12.6_•••24.2<LF> Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 171
  Troubleshooting Troubleshooting ………………..173 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 173
  Collated results ……179 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 174
  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…

• Page 175: About Troubleshooting

  The Message Handler does not trace the host interface communication when used in the default configuration. Thus use the following procedure to enable host interface tracing. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 176: Enabling Host Interface Tracing

  5 To make these settings permanent, choose the Save button. I These settings only remain until the next shutdown. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 177: Viewing The Trace File

  The display now shows the all traced host interface communication. Using this view, you may scroll through the complete trace file. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 178: Known Host Interface Issues

  Related topics • Line code 53: Order ID (96) Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 179: Collated Results

  10 03 rather than 10 04. u Related topics • Order entry (33) Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 180
  Known host interface issues Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 181
  Appendices Instrument setup………………..183 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 183
  Software-handshake ….. 197 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 184
  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…

• Page 185: Setting Up The Instrument For Host Communication

  Configure the racks for barcode reading. 6 Load your host application. • As a first check send an idle block. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 186: Preparing An Interface Cable

  9 Pin Conn 25 Pin Conn Signal Signal 25 Pin Conn. 9 Pin Conn SigGnd SigGnd y Pin assignments for RS-232 HW-handshaking Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 187: About The Connector Types

  Length The cable length should not exceed 15 m. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 188: Connecting The Interface Cable

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

• Page 189
  Data station rp5800 Host connector COBAS INTEGRA 400 plus analyzer and Cedex Bio HT Analyzer on the data station rp5800. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 190: Configuring Host Communication

  Handshake Hardware / Software Block Check True / False Line Terminator LF / CR+LF y Setup of interface parameters Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 191
  If sample-type specific racks are not used, this Sample Type Short Name has to be included in the barcode. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 192: Configuring Barcode Setup

  The instrument recognizes the barcode type automatically. Configuration General > Barcode Use Barcode On Use Barcode On Enable the barcodes in the section. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 193
  The barcode must not be shorter than the pattern you specified. Example of how to configure the barcode pattern and the alignment parameter Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 194
  Setting up the instrument for host communication Configuration Lab > Racks Barcode reading can be independently enabled / disabled for every rack group. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 195: About The Rs-232 Serial Interface

  «0» / space / on • +3 V to +15 V • «1» / mark / off • -3 V to -15 V Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 196: Signal Description

  Ready for sending (clear to send) Data set ready 108/2 Data terminal ready Receive line signal detector y Signal assignment Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 197: About The Handshake

  As soon as the COBAS Instrument software is started, the host interface is ready to receive data. No initial SW handshake is required. Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…

• Page 198
  About the RS-232 serial interface Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 199
  Index Index……………………..201 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 201
  Error codes, 103 Feedback, 5 Flags, 103 Host query, 40 Initilize, 26 Instrument codes, 57 Message structure, 18 Order entry, 33 Roche Diagnostics COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24…
• Page 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…

Accompanying Data:

Roche COBAS INTEGRA 400 plus Measuring Instruments PDF Host Interface Manual (Updated: Friday 20th of January 2023 02:06:32 AM)

Rating: 4.2 (rated by 33 users)

Compatible devices: Cedex Bio, Cedex HiRes, CoaguChek INRange, Cobas C111, CoaguChek XS System, CoaguChek XS Pro, cobas e 411, Accutrend Plus.

Recommended Documentation:

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• 7/24/2019 Cobas Integra 400 Plus

  1/10

  Instructivo para el manejo del COBAS INTEGRA 400 PLUS

  Cdigo:I-FQUI-LAC-11 Revisin:11 Pgina: 1 de 10

  Fecha de emisin:05/Enero/2009 Fecha de
  modificacin:07/septiembre/2015

  F-DGPLANEI-CC/GA-39/REV:01

  1.-OBJETIVO

  Brindar la informacin necesaria acerca de la manera correcta de
  operar el equipo deBioqumica Clnica COBAS INTEGRA 400 PLUS.

  2.- ALCANCE

  Aplica para todo el personal Qumico y estudiantes que procesen
  muestras biolgicas(sueros, sangre con EDTA, orina) en el rea de
  Bioqumica Clnica del LACSC de la UADY.

  3.- DESCRIPCIN DE LA OPERACIN

  1. Antes de encender el equipo COBAS INTEGRA 400 PLUS verificar:
  Que el contenedor de agua destilada este lleno. Que el contenedor
  de desechos lquidos se encuentre vaco. Que existan suficientes
  cubetas de reaccin limpias en el contenedor. Que el contenedor con
  Cleaner est en el nivel requerido. Que el contenedor de residuos
  slidos (cubetas) est vaco. Checar el nivel de reactivos de la
  bandeja ISE en las siguientes posiciones:

  Posicin 1: Hemolyzing Reagent Gen. 2. Posicin 2: Activador.
  Posicin 7: NaClDiluent 9%. Posicin 8: ISE Desproteinizer.

  2. Encender el monitor, la impresora, el equipo COBAS INTEGRA
  400 PLUS y la PC.Esperar a que verifique el software y el
  hardware.

  3. Una vez cargada la pantalla principal entrar al sistema a
  travs de las 2 opcionessiguientes:

  En la barra de estado dar doble click en ninguno (parte inferior
  de la pantalla) eingresar el ID UADYR (con maysculas) y la
  contrasea uadyr (con minsculas) yentrar al sistema.

  En la ventana Herramientas seleccionar la opcin Entrar/Salir
  Sistema e ingresar el IDUADYR (con maysculas) y la contrasea uadyr
  (con minsculas) y entrar al sistema.

• 7/24/2019 Cobas Integra 400 Plus

  2/10

  Instructivo para el manejo del COBAS INTEGRA 400 PLUS

  Cdigo:I-FQUI-LAC-11 Revisin:11 Pgina: 2 de 10

  Fecha de emisin:05/Enero/2009 Fecha de
  modificacin:07/septiembre/2015

  F-DGPLANEI-CC/GA-39/REV:01

  4. Introducir la bandeja ISE en la posicin O que es exclusiva
  para su uso y seleccionar laopcin aceptar. NOTA: Cuando se cambie
  un reactivo, sealar el recuadro del reactivo acambiar y dar click
  en aceptar.

  5. A las 7:30 am el COBAS INTEGRA 400 PLUS est programado
  automticamente parainiciar su servicio de mantenimiento diario
  (purgar sistema de fluidos, desproteinizar agujas).En caso que el
  equipo solicite el mantenimiento semanal (limpiar las agujas y la
  cubierta antisalpicaduras), ste debe realizarse por la maana con el
  equipo apagado, retirar la cubiertaanti salpicaduras del brazo
  mecnico, lavarla y secarla, limpiar las agujas con
  alcoholdesnaturalizado y dejarlas en su posicin inicial, luego
  colocar la cubierta en su lugar y se

  procede a encender el equipo.

  6. Terminado el servicio de mantenimiento esperar a que el
  equipo alcance la temperaturaadecuada para el analizador, cassettes
  y cleaner e introducir las bandejas anchas azules quecontienen los
  cassettes de los reactivos en las posiciones A-H (los cassettes de
  los reactivospuede ir en cualquier bandeja o posicin, ya que el
  equipo los reconoce por el cdigo debarras).

  7. Seleccionar la pestaa Cassettes y verificar el nmero de
  pruebas as como lascondiciones en las que se encuentra cada uno de
  ellos. Cambiar o colocar un cassetteadicional en caso de ser
  necesario.

  8. La posicin de las bandejas de Calibracin, Control de Calidad
  y de Muestras en el equiposern las siguientes: La bandeja delgada 1
  sample azul y la bandeja delgada 6 sample grisson exclusivamente
  para calibradores y controles, su ubicacin es la posicin I y J y
  laasignacin especfica para cada calibrador y control se muestra en
  la Tabla 1. Estasbandejas utilizan copas de 600 L. Las bandejas
  delgadas 2, 3, 4 y 5 son exclusivas paramuestras de pacientes y
  podrn utilizarse de la posicin J a la N. Las bandejas delgadas 2 y3
  sample gris son para muestras de suero y para la prueba de
  Hemoglobina Glicosilada(HbA1c) y se utilizan tubos primarios de 10
  x 100 mm (7 mL) y el tubocon EDTA (tapn colorlila). La bandeja
  delgada 4 sample amarilla para muestras de orina y utiliza tubos
  primariosde 10 x 100 mm (7 mL). La bandeja delgada 5 sample verde
  para muestra de suero con poca

  cantidad y utiliza COBAS cup.

• 7/24/2019 Cobas Integra 400 Plus

  3/10

  Instructivo para el manejo del COBAS INTEGRA 400 PLUS

  Cdigo:I-FQUI-LAC-11 Revisin:11 Pgina: 3 de 10

  Fecha de emisin:05/Enero/2009 Fecha de
  modificacin:07/septiembre/2015

  F-DGPLANEI-CC/GA-39/REV:01

  Tabla 1. Posicin de los calibradores y controles en las Bandejas
  1 y 6.

  Bandeja 1 Sample azul Bandeja 6 Sample grisPosicin 1:
  C.f.a.s.Posicin 2: Agua destiladaPosicin 3: C.f.a.s. LipidsPosicin
  4: Agua destiladaPosicin 5: C.f.a.s. HbA1cPosicin 6: C.f.a.s.
  PACPosicin 7: Agua destiladaPosicin 8: C.f.a.s. ProteinsPosicin 9:
  Preciset RF 5Posicin 10: Preciset RF 4Posicin 11: Preciset RF
  3Posicin 12: Preciset RF 2Posicin 13: Preciset RF 1Posicin 14:
  Solucin salinaPosicin 15: Serum Proteins T Standard

  Posicin 1: Biorad 1Posicin 2: Biorad 2Posicin 3: Precinorm
  ProteinPosicin 4: RF Control Set IPosicin 5: RF ControlSet
  IIPosicin 6: Precinorm L

  9. Para elaborar rdenes de trabajo de Calibracin sealar el icono
  rdenes para desplegarla ventana que incluye las opciones Lista de
  Trabajo, Muestra, Calibracin y Control deCalidad. Seleccionar la
  pestaa de Calibracin. Sealar los mensurandos a calibrar y

  seleccionar la opcin Guardar. Cargar los calibradores en la
  bandeja delgada 1 sample azulde acuerdo a las pruebas a calibrar,
  sealar el icono Iniciar» para qued inicio la calibracin.

  10. Para elaborar rdenes de Trabajo de Control de Calidad sealar
  el icono rdenes paradesplegar la ventana que incluye las opciones
  Lista de Trabajo, Muestra, Calibracin yControl de Calidad.
  Seleccionar la pestaa de Control de Calidad. Sealar los
  mensurandosa correr controles y seleccionar la opcin guardar.
  Cargar los controles en la bandeja delgada6 sample gris de acuerdo
  a las pruebas seleccionadas, sealar el icono Iniciar» para
  darcomienzo al Control de Calidad. NOTA: El contro l de HbA1c se
  corre como muestra.

  11. Para elaborar rdenes de trabajo de muestras de pacientes
  seleccionar el icono rdenes

  para desplegar la ventana que incluye las opciones Lista de
  Trabajo, Muestra, Calibracin yControl de Calidad. Seleccionar la
  pestaa de Muestra. En ID Paciente escribir el No. desolicitud y dar
  Enter, se despliega otra ventana donde se escriben el Nombre y Edad
  delpaciente, seleccionar el Sexo y la opcin Aceptar. En ID Orden
  escribir el No. de muestracorrespondiente al paciente. Para
  muestras de orina o repeticiones de muestras de suero elID Orden
  iniciar con el ID 101. En Tipo de muestra seleccionar Suero, en la
  opcin Posicinseleccionar la bandeja delgada 2 o 3 sample gris y el
  lugar donde ir la muestra. Sealar losmensurandos o perfiles a
  analizar y seleccionar la opcin Guardar. Si es una muestra

• 7/24/2019 Cobas Integra 400 Plus

  4/10

  Instructivo para el manejo del COBAS INTEGRA 400 PLUS

  Cdigo:I-FQUI-LAC-11 Revisin:11 Pgina: 4 de 10

  Fecha de emisin:05/Enero/2009 Fecha de
  modificacin:07/septiembre/2015

  F-DGPLANEI-CC/GA-39/REV:01

  urgente, seleccionar la opcin Urgente y luego Guardar. Repetir
  este procedimiento paraprogramar todas las muestras a correr.
  Terminada la lista de trabajo colocar las muestras enla bandeja e
  introducirlas en el equipo.

  12. Para muestras de HbA1c realizar el mismo procedimiento del
  paso 11 cambiando en laopcin Tipo de Muestra a Hemolizado y en la
  opcin Posicin seleccionar la bandeja delgada2 o 3 sample gris y el
  lugar donde ir la muestra. Sealar el perfil M, la opcin Urgente
  yseleccionar Guardar. Repetir este procedimiento para programar
  todas las muestras a correr.Mezclar los tubos por inversin, quitar
  los tapones de los tubos, colocarlos en la posicin quese grabaron e
  introducir la bandeja en el equipo.

  13. Para muestras de suero con poca cantidad realizar el mismo
  procedimiento del paso 11cambiando en la opcin Posicin la bandeja
  delgada 5 sample verde y el lugar donde ir lamuestra. Repetir este
  procedimiento para programar todas las muestras a correr. Marcar
  lasCOBAS cup con el No. de Solicitud de los pacientes, agregar 500
  L del suero del pacienteen la copa correspondiente y colocarlas en
  la posicin en las que se grabaron e introducir labandeja en el
  equipo.

  14. Para muestras de orina realizar el mismo procedimiento del
  paso 11, cambiando en laopcin Tipo de muestra a Orina, en la opcin
  Posicin seleccionar la bandeja delgada 4sample amarilla y el lugar
  donde ir la muestra, seleccionar el mensurando que se varealizar,
  dar click con el botn derecho del mouse sobre la prueba ingresada
  seleccionar

  dilucin e ingresar la dilucin deseada, dar Aceptar y Guardar.
  Repetir este procedimientopara programar todas las muestras a
  correr e introducir la bandeja en el equipo. Nota: Losresultados de
  las muestras proporcionadas por el rea de Uroanlisis y Coproanlisis
  sonreportados en el Syslabs por el responsable de la misma y los
  resultados de las muestrasque pertenezcan al rea de Bioqumica
  Clnica son reportados por el responsable de lamisma.

  15. Terminado el proceso de cada una de las pruebas realizadas a
  los pacientes, losresultados se imprimen automticamente siempre y
  cuando estn dentro de los lmites dereferencia establecidos en el
  equipo. Los resultados se pueden visualizar seleccionando elicono
  Resultados, pestaa Muestra y despliega la lista de cada paciente
  con sus respectivas

  pruebas.

  16. Cuando los resultados se encuentran fuera de los valores de
  referencia indicados en elequipo, se tienen que validar para que se
  puedan imprimir. En el icono Resultados, pestaaValidar se despliega
  la lista con el ID Orden del paciente y sus respectivas pruebas,
  sealarlapruebas que se requiera validar y seleccionar la opcin
  Aceptar todo para que se puedaimprimir el resultado.

• 7/24/2019 Cobas Integra 400 Plus

  5/10

  Instructivo para el manejo del COBAS INTEGRA 400 PLUS

  Cdigo:I-FQUI-LAC-11 Revisin:11 Pgina: 5 de 10

  Fecha de emisin:05/Enero/2009 Fecha de
  modificacin:07/septiembre/2015

  F-DGPLANEI-CC/GA-39/REV:01

  17. Si un resultado se encuentra fuera del rango de linealidad,
  se reprocesa nuevamente.Seleccionar el icono rdenes, pestaa Lista
  de Trabajo, seleccionar el No. de Solicitud areprocesar y dar click
  en Editar. Automticamente despliega los datos que se
  encuentranalmacenados del paciente, sealar el mensurando que se
  requiere reprocesar y dar click conel botn derecho del mouse,
  seleccionar la opcin dilucin e ingresar la dilucin a realizar ydar
  Aceptar, dar click en Guardar. Al obtener el resultado y validarlo
  ste se imprime. Tachael primer resultado y escribir a un lado del
  segundo resultado entre parntesis Repeticin y ladilucin
  utilizada.

  18. Terminado de procesar, validar e imprimir los resultados de
  las muestras de lospacientes, stos se transfieren por medio del
  SyslabsConect Interfaz analizadores al software

  Syslabs, donde se verifican por el Responsable del rea para su
  posterior impresin enrecepcin. Nota:El blog de resultados impresos
  por el equipo es firmado por el Responsabledel rea o Qumico
  designado en el rea en su primera hoja.

  19. Terminando el trabajo del da se retiran las bandejas de
  reactivos, calibradores, controlesy muestras, se proceder a
  Archivar los resultados y Purgar rdenes y resultados del da.

  20. Para Archivar los resultados del da, en la barra de
  herramientas seleccionar el menFichero, aparecer el cuadro de
  dilogo Archivar resultados, se despliega la ventana dondese
  introduce la fecha del da en curso (la misma de inicio y de fin) y
  se le da Archivar.

  Aparecer el cuadro de dilogo archivar resultados y se especifica
  el nombre del archivo el

  cul siempre ser la fecha del da de trabajo, dar click en
  Aceptar.

  21. Para Purgar las rdenes del da en la barra de herramientas
  seleccionar el menHerramientas, sealar Purgar rdenes y dar Aceptar
  para que el contador regrese al IDOrden 101.

  22. Para Purgar los resultados del da en la barra de
  herramientas seleccionar el menHerramientas, sealar Purgar
  resultados y aparecer el cuadro de dilogo Purgar
  resultados,escribir la fecha que se desea suprimir los resultados
  en la casilla A. Haga click en Purgar. Alllevar a cabo la accin de
  purgado el equipo deber de encontrarse en el modo de Standby,no
  deber haber ninguna bandeja de muestras cargada en el analizador y
  se debi realizar la

  transferencia de cada uno de los resultados del da al
  Syslabs.

  23. Apagar el equipo seleccionando en la barra de herramientas
  el men Fichero, dar click enla opcin Apagar, se despliega una
  ventana que nos solicita confirmar el apagado y se daEnter. Apagar
  el COBAS INTEGRA 400 PLUS y el monitor. NOTA: Cuando no
  tienenexistencia de reactivos el proveedor, las muestras de los
  pacientes se mandan a unlaboratorio subcontratado.

• 7/24/2019 Cobas Integra 400 Plus

  6/10

  Instructivo para el manejo del COBAS INTEGRA 400 PLUS

  Cdigo:I-FQUI-LAC-11 Revisin:11 Pgina: 6 de 10

  Fecha de emisin:05/Enero/2009 Fecha de
  modificacin:07/septiembre/2015

  F-DGPLANEI-CC/GA-39/REV:01

  TABLA DE PERFILES COBAS INTEGRA 400 PLUS

  PERFIL CDIGO MENSURANDOSA Q4 Glu, Urea, Creat, Ac. rico

  B Q6 Glu, Urea, Creat, Ac. rico, Col, Tg

  C Q1 Glu, Col, Tg

  D Q2 Glu, Ac. rico, Col, Tg

  E P. LPIDOS Col, Tg, HDL, LDL

  F Q4 + P. LPIDOSGlu, Urea, Creat, Ac. rico, Col, Tg, HDL,

  LDL

  G PFH BT, BD, PT, ALB, AST, ALT

  H TRANS AST, ALT

  I BILS BT, BD

  J PT PT, ALB

  K Q8 Glu, Urea, CreatL Q7 Col, Tg

  M HbA1c Hb-W2, A1-W2

  O CLDL2 HDL, LDL

  P Col. HDL Col, Tg, HDL

  Q Col. LDL Col, Tg, LDL

  R PFH 3 BT, BD, PT, ALB, AST, ALT, ALP, LDH, GGT

  S Q4 + PLC

  Glu, Urea, Creat, Ac. rico, Col, Tg, HDL,

  LDL, APO A, APO B

  T P. DE INMUNOGLOBULINAS IgG, IgA, IgM

  U P. REUMTICO PCR, FR, ASO

  V P. DE HIERRO Hierro, UIBC

• 7/24/2019 Cobas Integra 400 Plus

  7/10

  Instructivo para el manejo del COBAS INTEGRA 400 PLUS

  Cdigo:I-FQUI-LAC-11 Revisin:11 Pgina: 7 de 10

  Fecha de emisin:05/Enero/2009 Fecha de
  modificacin:07/septiembre/2015

  F-DGPLANEI-CC/GA-39/REV:01

  4.- DOCUMENTOS DE REFERENCIA

  Cdigo Nombre del documento Lugar de almacenamiento

  N/A Manual del usuario COBAS INTEGRA 400 plus rea de Bioqumica
  Clnica

  I-FQUI-LAC-06Instructivo para el Procesamiento de las
  MuestrasBiolgicas del rea de Bioqumica Clnica

  rea de Bioqumica Clnica

  5.- CONTROL DE REGISTROS

  IdentificacinNombre del

  registroLugar de

  almacenamientoResponsable de

  su proteccinTiempo deretencin

  Disposicin delos registros

  F-FQUI-LAC-59

  Bitcora deMantenimiento y

  Uso diario

  COBAS INTEGRA400 PLUS

  rea deBioqumica

  Clnica

  Responsable derea y/o Qumico

  designado en el

  rea.

  1 ao Archivo muerto

  6.- GLOSARIO

  6.1 .- SIGLAS

  UADY: Universidad Autnoma de Yucatn.

  LACSC:Laboratorio de Anlisis Clnicos de Servicio a la
  Comunidad.HbA1c:Hemoglobina Glicosilada.EDTA:cido
  etilendiaminotetraactico

• 7/24/2019 Cobas Integra 400 Plus

  8/10

  Instructivo para el manejo del COBAS INTEGRA 400 PLUS

  Cdigo:I-FQUI-LAC-11 Revisin:11 Pgina: 8 de 10

  Fecha de emisin:05/Enero/2009 Fecha de
  modificacin:07/septiembre/2015

  F-DGPLANEI-CC/GA-39/REV:01

  6.2 .- DEFINICIONES

  Mensurando:Magnitud que se desea medir. Es la cantidad de objeto
  de medida, es decir, la cantidado concentracin de analito. El
  mensurando es una cantidad que se somete a una medicin en
  unacomparacin con un patrn que proporciona la informacin
  requerida.

  Dilucin: Es la reduccin de la concentracin de una sustancia
  qumica en una disolucin.

  Linealidad:Es la aproximacin que tiene una curva de calibracin a
  una lnea recta especificada.

  Muestra biolgica. Parte anatmica o fraccin rganos o tejido,
  excresiones o secresiones obtenidasde un ser humano o animal vivo o
  muertopara su anlisis.

  Orden de trabajo. Formato en el cul se asigna un nmero para
  identificar la muestra (o muestras)del usuario y que presenta las
  pruebas que se le van a realizar.

  SysLabs: Software diseado para automatizar la gestin
  administrativa y apoyar las operaciones delLaboratorio Clnico.

• 7/24/2019 Cobas Integra 400 Plus

  9/10

  Instructivo para el manejo del COBAS INTEGRA 400 PLUS

  Cdigo:I-FQUI-LAC-11 Revisin:11 Pgina: 9 de 10

  Fecha de emisin:05/Enero/2009 Fecha de
  modificacin:07/septiembre/2015

  F-DGPLANEI-CC/GA-39/REV:01

  7.- CONTROL DE REVISIONES

  Nivel derevisin

  Seccin y/opgina Descripc in de la modificacin y mejora Fecha de
  modifi cacin

  01 2, 3, 4 y 5 Cambio de analizador. 10/09/09

  02 2 y 3Se modific el orden de encendido. Las bandejas 2 y 3usan
  tubos primarios de 12 x 75 mm y la 4 y 6 tubos de13 x 100 mm.

  04/05/10

  03 4 y 6 Se agreg el sistema Syslabs y se cre el perfil R.
  18/02/11

  04 4 Se aadi el procesamiento para las muestras de orina.
  10/06/11

  05 6 Se cre el perfil S y T. 19/10/11

  06 Todo eldocumento

  Se cre el perfil U y VSe modific la redaccin de todo el
  documento.Se modificaron las posiciones de los controles
  ycalibradores en la Bandeja 1 sample azul.Se asign exclusivamente
  la bandeja 6 sample gris paracalibradores y controles.Se elabor el
  objetivo y alcance del instructivo.

  14 /11/12

  07 Todo eldocumento

  Se asign la bandeja 1 sample azul para calibradores yla bandeja
  sample gris para controles.Se modific la Tabla 1. Posicin de los
  calibradores ycontroles en las Bandejas 1 y 6.Se modific la
  redaccin de todo el documento.Se modific el nombre del responsable
  sanitario.

  09/07/13

  08 7 Cambio de Director de la Facultad de Qumica. 15/08/13

  099 Se modific el nombre del responsable sanitario. 12/11/13

  10 5, 7 y 8 Se modific la seccin descripcin de la
  operacin,documentos de referencia y control de registros.
  25/08/14

• 7/24/2019 Cobas Integra 400 Plus

  10/10

  Instructivo para el manejo del COBAS INTEGRA 400 PLUS

  Cdigo:I-FQUI-LAC-11 Revisin:11 Pgina: 10 de 10

  Fecha de emisin:05/Enero/2009 Fecha de
  modificacin:07/septiembre/2015

  F-DGPLANEI-CC/GA-39/REV:01

  Nivel derevisin Seccin y/opgina Descripc in de la modificacin y
  mejora Fecha de modificacin

  11 Todo eldocumentoRevisin ortogrfica.Se modific la seccin
  descripcin de la operacin.Se modific el nombre del Responsable
  Sanitario.

  Actualizacin al nuevo formato de la DGPLANEI.

  07/09/15

  Nota: sta seccin ser utilizada a partir de la primera
  modificacin a este documento. La revisin 00, semantendr en
  blanco.

  Elabor

  EBC. Diana Prez VzquezResponsable del rea de Bioqumica

  Clnica

  Revis

  EBC. Ricardo Jess May CastilloResponsable Sanitario

  Aprob

  Dra. Zulema Osiris Cantillo CiauDirectora de la Facultad de
  Qumica

  Las firmas avalan la responsabilidad de las personas que:
  elaboran el documento, revisan suadecuacin y aprueban para su
  implementacin dentro del Sistema de Gestin de la Universidad

  Autnoma de Yucatn.