Elite 3 анализатор ошибка 1106

Анализатор гематологический ЭЛИТЕ 3 (ELite 3) с принадлежностями является полностью автоматическим гематологическим анализатором для подсчета клеток крови, разработанным для диагностики in vitro. Прибор предназначен для использования в малых и среднего размера лабораториях госпиталей и больниц для количественного и качественного исследования крови.

Описание

Анализатор гематологический ЭЛИТЕ 3 (ELite 3) с принадлежностями является полностью автоматическим гематологическим анализатором для подсчета клеток крови, разработанным для диагностики in vitro. Прибор предназначен для использования в малых и среднего размера лабораториях госпиталей и больниц для количественного и качественного исследования крови.

• Универсальный анализатор на 22 параметра с дифференциацией лейкоцитов по трем субпопуляциям
• Производительность: 80 тестов в час
• Режим предварительного разведения для работы с капиллярной кровью и образцами за границами линейности
• Очистка прожигом высоким напряжением в апертуре, методом обратного тока и химическая очистка в каждом измерительном цикле
• Цветной сенсорный LCD дисплей для ввода и отображения данных с гистограммами
• Простота в техническом обслуживании
• Интуитивно понятная встроенная программа контроля качества по 6 уровням с построением графиков Леви-Дженнингса
• Встроенный термопринтер для распечатки результатов анализа
• Небольшой размер для размещения в небольшой лаборатории
• Автоматическая система очистки узлов анализатора при выключении

Комплектация гематологического анализатора

• Руководство пользователя ELite 3
• Трубки для реагентов (обозначенные цветами):
• Трубка для разбавителя (зеленый)
• Трубка для лизирующего раствора (желтый)
• Трубка для очищающего раствора (голубой)
• Трубка для отходов (красный)
• Набор трубок для очистки
• Крышки для контейнеров с реагентами
• Контейнер отходов (20 л)
• Внешний блок питания
• Сетевой кабель (для 230В).
• Рулон термобумаги

Техническая характеристика гематологического анализатора

Производительность: 80 тестов в час, открытые пробирки

Принцип измерения:

• Кондуктометрический метод
• Фотометрический метод для измерения гемоглобина

Определяемые параметры: 22 параметра
WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, LYM, MID, GRA, LYM%, MID%, GRA%, RDW-SD, RDW-CV, PDW-SD, PDW-CV, MPV, PCT, P-LCC, P-LCR

3 Гистограммы

• WBC-3part (гистограмма распределения лейкоцитов по объему, с дифференцировкой по 3 популяциям)
• RBC (гистограммa распределения эритроцитов по объему)
• PLT Histogram (гистограммa распределения тромбоцитов по объему)

Объем образца: 25 мкл цельной крови

Минимальный объем забираемой цельной крови у пациента: 10 мкл

Количество реагентов: 2-х реагентная система + 2 очищающих раствора (безопасны для окружающей среды):

• Раствор дилюента Erba Diluent-Diff
• Лизирующий раствор Erba Lyse-Diff
• Очищающий раствор Erba Cleaner
• Раствор ERBA Hypoclean CC

Автоматическая очистка:

• метод обратного потока
• химическая очистка

Контроль качества: 6-ти уровневый контроль качества с построением графика Леви-Дженнингса

Калибровка:

• Автоматическая (по калибратору) по 1-му, 2-м или 3-м измерениям
• Ручная (по фактору) для RBC, MCV, RDW, WBC, HGB, PLT, MPV.

Интерфейс пользователя: Сенсорный ЖК-дисплей, разрешение 320 x 240 точек

Емкость памяти: 10000 результатов измерений, включая гистограммы

Интерфейс подключения:

• Порт для подключения ПК (USB)
• Порт для подключения внешней клавиатуры (USB)
• Порт для подключения внешнего принтера (USB)

Принтер: Встроенный термопринтер

Размеры (мм): 320×260×365 (Д х Ш х В)

Вес: 12 кг

• Page 1
  ELite 5 Hematology Analyzer USER MANUAL INS00068 Erba Lachema s.r.o., Karásek 2219/1d, 621 00 Brno, CZ…
• Page 2
  Introduction This user manual is intended to give detailed information for end users of the ‘ELite 5’ optical hematology analyzer. All information contained herein is the intellectual property of Erba Lachema s.r.o. and should not be used or reproduced without prior agreement of Erba Lachema s.r.o., the manufacturer.
• Page 3
  FITNESS FOR ANY PARTICULAR PURPOSE. Exemptions Erba Lachema’s obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Erba Lachema or repairs by people other than Erba Lachema authorized personnel.

• Page 4: Table Of Contents

  Emergency Situations ………………..15 Product Support ………………….. 16 Installation ………………….17 Package contents ………………….17 3.1.1 The ‘ELite 5’ Analyzer Package ………………….. 17 3.1.2 The Autosampler Package ………………….17 3.1.3 Small Sample Package (optional) ………………..17 Connecting the reagents ………………..18 Power connection ………………….

• Page 5
  5.7.11 Safety Access Codes ……………………43 5.7.12 SSM Menu Add-ons ……………………43 Start Up and Shut Down of ‘ELite 5’ …………….45 Start Up and Shut Down Overview …………….45 Starting Up the ‘ELite 5’ Analyzer …………….. 45 6.2.1 Visual Inspection ……………………..45 6.2.2…
• Page 6
  6.3.4 Emergency Shut Down ……………………52 6.3.5 Repackaging the ‘ELite 5’ Analyzer ………………..53 Sample Measurement ………………..55 Sample Types Supported by the ‘ELite 5’ …………..55 7.1.1 Supported Sample Tube Types …………………. 55 7.1.2 Sampling Depth ……………………..55 7.1.3 Open or Closed Sample Tubes …………………..
• Page 7
  Content Calibration ………………….93 10.1 Calibrating the ‘ELite 5’ ………………..94 10.1.1 View Calibrations ……………………… 95 10.2 SSM Calibration ………………….96 Quality Control ………………… 97 11.1 Set QC Reference ………………….97 11.2 QC Measure……………………. 99 11.3 View QC References ………………… 99 11.4…
• Page 8
  Content 15.1.3 User Maintainable Parts of the Analyzer ………………121 15.2 Maintenance Programs of the Analyzer …………… 122 15.2.1 Cleaning the Shear Valve ………………….123 15.2.2 Cleaning the Washing Head ………………….127 15.2.3 Cleaning the Measuring Chambers (Hard Cleaning) …………..128 15.2.4 Daily Cleaning ……………………..
• Page 9
  Content 20.2 Display Range ………………….141 20.3 Printed Report Formats ………………..142 20.4 Specifications ………………….144 20.4.1 Measured Parameters ……………………. 144 20.4.2 Technical Data ……………………..145 20.4.3 Performance Data ……………………148 20.4.4 Reagent System ……………………… 151 20.4.5 Tab File Format ……………………..152 20.5 Fluidic System………………….

• Page 10: For Your Safety

  To prepare the analyzer for shipping, storage or extended periods of inactivity, please drain the reagents and repackage the ‘ELite 5’ in its original packaging. Do not expose the ‘ELite 5’ to direct sunlight, extreme temperature or humidity (>80%).

• Page 11: Environmental Factors

  (59-86 °F) and a relative humidity range of 10% — 80%. The optimum operating temperature is 25°C (~77°F). Avoid exposing the ‘ELite 5’ analyzer to direct sunlight or to extreme high or low temperatures. If the ‘ELite 5’ analyzer was subjected to extreme temperatures during shipment or storage, the analyzer must be placed for at least one hour in a room whose temperature is within the operational range before installation or use.

• Page 12: Electrical Requirements

  Ensure there is enough clearance in front of the ‘ELite 5’ analyzer to open the front panel. Allow enough space if you want to use optional external keyboard, mouse or bar code reader.

• Page 13
  ELite 5, User Manual Figure 1. ELite 5 with Autosampler Space Requirements Page 13 of 159…

• Page 14: Weight Requirements

  Figure 2. ELite 5 Without Autosampler Space Requirements 1.7 Weight Requirements The ‘ELite 5’ analyzer weighs 35 Kg (77 lb) without the Autosampler. The ‘ELite 5’ with optional Autosampler weighs 47Kg (104 lb). Adding an external keyboard, printer etc. can bring the total weight up to 60 Kg (132 lb).

• Page 15: Waste Disposal

  1.10 Emergency Situations Always follow all applicable laws and regulations with regard to emergency situations. If the ‘ELite 5’ needs to be powered off due to an emergency situation (like fire, thunderstorm etc.), follow the procedures in chapter 6.3.4. In case of fire, do not use water to extinguish the fire unless the ‘ELite 5’ is…

• Page 16: Product Support

  2 Product Support Your sales representative is trained and qualified to answer questions about applications and the operation of the ‘ELite 5’ analyzer. If you have additional questions regarding the ‘ELite 5’, please ask for manufacturer support through your sales representative.

• Page 17: Installation

  ‘ELite 5’ analyzer packaging for future transportation and storage. 3.1.2 The Autosampler Package The Autosampler is an optional unit that attaches to the ELite 5. If the optional Autosampler unit was ordered, package should contain the following items: •…

• Page 18: Connecting The Reagents

  The waste container should be periodically emptied. You can place the reagent below or on the same level where the ‘ELite 5’ is installed. Do not place the reagents to a higher location than the bottom of the ‘ELite 5’, because in case of any tubing problem, valve error etc.

• Page 19: Visual Inspection

  Move the ‘ELite 5’ to the selected location. If it is hard to access the back of the ‘ELite 5’ after it is in the final location then connect the reagent tubes to the ‘ELite 5’ but not to the reagent containers. (For details see chapter 3.2) Be sure that the main switch (right next to the power connector) is in off position.

• Page 20: Connecting The Autosampler

  ‘ELite 5’, available from Erba Lachema. Place the reagent containers near the instrument, to an accessible location. Do not place the containers to a higher position than ‘ELite 5’. This is to avoid unintentional spilling of reagents.

• Page 21: General Overview And Principles Of Operation

  4 General Overview and Principles of Operation 4.1 General Overview The ‘ELite 5’ is a fully automated high quality hematology analyzer for in vitro diagnostic use in clinical laboratories. It provides precise and accurate 5-part differential measurement using a laser based optical measurement technology.

• Page 22: Approved Reagents And Control Materials

  4.1.2 Approved Reagents and Control Materials Always use reagents, control and calibration materials that are recommended and approved by the manufacturer. The ‘ELite 5’ analyzer, controls, calibrator and reagents are part of a system and are carefully designed and selected for optimal performance. Using unapproved reagents or controls may cause false flagging or incorrect, inaccurate results.

• Page 23
  ELite 5, User Manual HEM00003 Erb Dil-5P 20 l Additional cleaning solutions – use as needed HEM00017 Erba Clenz HEM00016 Erba Hypoclean For package insert for reagents and cleaning solutions please see Appendix Page 23 of 159…

• Page 24: Principles Of Operation

  This change is sensed by the ‘ELite 5’ electronics and converted to an electrical pulse. The quantity of pulses is proportional to the number of particles. The intensity of each pulse is proportional to the volume of the particle.

• Page 25: Optical Light Scatter And Diffraction Method

  The ‘ELite 5’ electronics convert these changes to electrical pulses which are gathered and stored for analysis. Five part population discrimination is based on analysis of the two dimensional volume and granularity distribution scatter diagram.

• Page 26
  Both low and high angles of light scatter are captured by optical sensors, providing the ‘ELite 5’ analyzer with two independent measurements for each cell crossing the path of the laser beam.
• Page 27
  ELite 5, User Manual Figure 9. 4DIFF Scatter Diagram Page 27 of 159…

• Page 28: Inside The ‘Elite 5’ Analyzer

  Automatic processing can be resumed after stat sample processing is complete. The START button allows easy one-hand operation of the ‘ELite 5’ analyzer. The color of the START button indicates the status of the ‘ELite 5’ analyzer: Green — ready to process samples Red –…

• Page 29
  Table 2. Reagent Connector Color Codes Main board back panel I/O Ports: these are the back panel computers of the ‘ELite 5’ analyzer main computer board. They provide standard connection to peripherals such as external keyboard and mouse, printers, bar code readers.

• Page 30: Left Side Assembly

  • Small Measure buffer is a vacuum buffer used for impedance measurement. • Sheath buffer is a reservoir for Erba•Dil-5P diluent for optical measurements. • Diff-5P buffer is a reservoir for Erba•Diff-5P reagent. •…

• Page 31: Right Side Assembly

  ELite 5, User Manual 4.2.7 Right Side Assembly Optical Head Aspiration Needle Horizontal, Vertical Motion Unit Washing Head Power Supply Sample Rotor Autosampler Connector Figure 14 Right Side Assembly • Aspirating needle aspirates a blood sample from the sample tube.

• Page 32: Front Assembly

  The analyzer will aspirate 25 µl of whole blood and put it in to the pre-dilution chamber to dilute it to 1:6. • After pre-dilution, the needle will take 100 µl of diluted sample into the shear valve and ´ELite 5´ is going to proceed with the normal measuring process. Page 32 of 159…

• Page 33
  ELite 5, User Manual Pre-dilution chamber Figure 16. SSM installed instrument Sampling side with Pre-dilution chamber In small sample mode there is no possibility using the Auto Sampler. It is working only in manual feeding mode through the sample rotor.

• Page 34: User Interface

  If you find that the ‘ELite 5’ touch screen responds in a different area than the one you are tapping, then please perform a touch screen calibration procedure before calling for service or support.

• Page 35: Using An External Keyboard

  For selection of dates, a date keypad is presented. The touch-pad of the ‘ELite 5’ handles single taps only. The Shift and Symbol keys are ‘sticky’ on the virtual on-screen keypads like the ‘caps-lock’ on a PC key-board. Click/tap on the appropriate buttons to type in the required value.

• Page 36
  ELite 5, User Manual Figure 18. Sticky’ Shift and Symbol Buttons Figure 19. Numeric Virtual On-screen Keypad Figure 20. Date Virtual On-Screen Keypad Page 36 of 159…

• Page 37: Using The Graphical User Interface

  ELite 5, User Manual Using the Graphical User Interface The graphical user interface (GUI) of the ‘ELite 5’ is divided into three main sections. Refer to Chyba! Nenalezen zdroj odkazů. to see these sections: 1. Quick links to main functions (top section) 2.

• Page 38: Status Display

  The ‘ELite 5’ analyzer also has secondary functions that are available via two or more taps or clicks through the menu structure, or menu tree.

• Page 39: Start Automated Measurements

  • Review the details of selected measurements See section 9 for more details about accessing and using the ‘ELite 5’ database. 5.7.5 Initiate Printing Tapping or clicking the ‘Print’ icon with the printer graphic will print the active panel or measurement result according to the printer settings.

• Page 40: Main Menu

  Double click/tap the time display on the right side of the status display on the bottom of the screen to bring up a panel for adjusting the stored time and date of the ‘ELite 5’ analyzer. See section 13.9 for more information about time and date adjustment.

• Page 41: Menu Tree

  Log off: Logs off the current user session Shutdown: Prepares the ‘ELite 5’ for a complete shutdown See section 6.3 to learn how to power down the ‘ELite 5’ analyzer correctly Settings Customize…

• Page 42
  Profile limits: Enter normal ranges for various profile limits X-B: Change X-B limits and targets User: Add and manage users of the ‘ELite 5’ analyzer (only available to administrator users) Delete user: Initiates deletion of a user account Administrator: Selects or unselects administrator privileges for the currently selected user See section 13 for more details about ‘ELite 5’…

• Page 43: Safety Access Codes

  Undo reject: Restore a previously rejected X-B run and use in X-B calculations View X-B diagrams: Navigate directly to X-B diagrams See section 11 for more details about quality control on the ‘ELite 5’ analyzer Diagnostics Self test: perform electronic and/or pneumatic system self test…

• Page 44
  ELite 5, User Manual Figure 25. Calibration in small sample module • In QC menu there is a new feature for Small Sample Mode. • Under Diagnostics, Information menu there is a new line which is indicating the state (on/off) of the Small Sample Mode.

• Page 45: Start Up And Shut Down Of ‘Elite 5

  The ‘ELite 5’ analyzer also has a ‘prepare for shipment’ shut down option that performs an extended cleaning and emptying of the pneumatic components. This option can be used to prepare the ‘ELite 5’ analyzer for an extended period of inactivity or for shipping to a new location.

• Page 46: Start Up The User Interface

  To start up the internal user interface computer of the ‘ELite 5’ analyzer, flip the standby switch near the top of the rear panel of the ‘ELite 5’ analyzer to the ‘up’ position. The standby switch springs back to the ‘down’ position after activation.

• Page 47: User Login

  Before measuring any blood or control samples, the pneumatic system components of the ‘ELite 5’ analyzer need to be initialized and a blank measurement run and accepted. To start the pneumatic system and run a blank measurement, click or tap the ‘Measure’ icon with the single test tube graphic on the top left corner of the screen.

• Page 48: Exiting The ‘Elite 5’ Analyzer

  • HGB ≥ 100 g/dL If the ‘ELite 5’ was not in use for an extended period of time, the start up of the pneumatic system components can take significantly longer time and require more blank measurements. To prevent these problems, use the ‘prepare for shipment’ process when the ‘ELite 5’…

• Page 49: Shut Down

  6.3.3 Prepare for Shipment If the ‘ELite 5’ analyzer is not used for a significant period of time or is being transported to a new location then the ‘prepare for shipment’ procedure should be performed instead the regular shutdown procedure.

• Page 50
  The ‘Prepare for Shipment’ procedure should be used for following reasons: • The reagents may spill out if the ‘ELite 5’ is tilted, potentially causing electrical short circuit or corrosion. •…
• Page 51
  It is strongly recommended that the ‘Prepare for shipment’ procedure is used if the analyzer will be inactive for more than five days. Higher temperature or lower humidity decreases the period of time the ‘ELite 5’ can be idle without performing the ‘Prepare for shipment’ procedure.

• Page 52: Emergency Shut Down

  The immediate shut-down can be initiated by pressing the standby button near the top of the back panel of the ‘ELite 5’ analyzer. This is the same button which is used to start up the ‘ELite 5’ user interface computer. This shuts down the user interface computer without properly shutting down the pneumatic system components.

• Page 53: Repackaging The ‘Elite 5’ Analyzer

  Place the lower part of the carton box on the pallet, and place the lower packaging foam on the carton bottom. • Put the ‘ELite 5’ into the plastic bag, and place it into the bottom foam part. • Put a desiccant bag into the plastic bag and close it.

• Page 54
  ELite 5, User Manual Make sure to use shipping straps or band to hold the package fixed on the pallet, otherwise the analyzer can be seriously damaged during shipping. Do not apply excess force to the straps because that may break the carton box and damage the analyzer.

• Page 55: Sample Measurement

  Please note that the Sarstedt Monovette sample tubes have a false bottom that is not the same as the bottom of the sample tube. The sampling depth on the ‘ELite 5’ ® analyzer must be changed for a Sarstedt Monovette sample tube.

• Page 56: Open Or Closed Sample Tubes

  The sample tube does not vent properly and contains residual vacuum The viscosity of the blood is very high • The ‘ELite 5’ is unable to aspirate the last 8 mm (0.31 inches) or 0.3 to 0.5 ml of sample volume. •…

• Page 57: Sample Types And Modes

  Controls are used to check the long term stability of the ‘ELite 5’ analyzer. Calibration with a calibration material is not one of the ‘ELite 5’ sample modes, but a specific procedure that can be accessed from the Calibration icon on the main menu.

• Page 58: Running Samples

  Activate or deactivate the automatic generation of sample IDs. If the ‘Autoincrement mode’ check box is checked, then the ‘ELite 5’ will add 1 to the last sample ID if it was fully numeric or offer ‘0’ if the last sample ID had any non-numeric characters.

• Page 59
  Select the sample mode: Blank: a blank measurement will be processed. This is the only option available if the pneumatic system is not initialized, or the ‘ELite 5’ was inactive for an extended period of time. After performing and accepting a blank measurement the other modes will be available.
• Page 60
  After starting the measurement the sample door rotates and takes the sample tube inside the ‘ELite 5’ analyzer. This is a key safety feature of the ‘ELite 5’ and protects the operator from the sample needle during routine operation. The Start button changes color to red to indicate that the system is busy processing the sample.

• Page 61: Prediluted Mode

  ELite 5, User Manual 7.4.2 Prediluted mode The sample pre-dilute method test protocol has been specifically developed to allow Elite 5 users to measure CBC results on samples having only small volumes or when one of the counted parameter result is higher than its linearity range.

• Page 62: Automatic Mode

  Autosampler. QC samples and open tubes must be processed in manual mode. After starting up the ‘ELite 5’, select the ‘Measure’ quick link. A new blank must be processed if this is the first time a new measurement panel is opened since starting up, or if an earlier blank has expired due to inactivity.

• Page 63
  Sample A1 is the first sample processed and sample J10 is the last. 7.4.3.1 Supported Barcode Some of the ‘ELite 5’ analyzer automatic processing modes use the barcode on the sample tube to determine the sample ID of the sample tube. The following bar code symbols are…
• Page 64
  Barcode labels are in use, and • An LIS system rather than the ‘ELite 5’ is used to associate patients with sample results. In Full Scan mode it is possible to add more samples to the batch after starting the automated measurement.
• Page 65
  The sample ID is not editable as it is read from the barcode label. If the barcode label is missing or not readable, the ‘ELite 5’ analyzer assigns a default value and allows manual entry of the sample ID.
• Page 66
  The Autosampler allows the addition of sample tubes to a Full Scan process already in progress. To add more sample tubes, perform the following steps: • Click or tap the ‘Stop’ button. The ‘ELite 5’ will prompt you to wait until the current sample is completed. •…
• Page 67
  ELite 5, User Manual and sample positions. It is not possible to add additional samples to the batch in free list mode after automated measurement has started. Figure 45. Free List Mode Selection On the Free List mode panel you can: •…
• Page 68
  ELite 5, User Manual Figure 46. Preparing a Free List As with the Full Scan mode, the Autosampler will scan all the sample positions on the tray and rows with missing racks will be skipped. The Autosampler will only process tube types it recognizes with caps attached.
• Page 69
  Selected Samples mode. An accepted blank measurement is required as with all sample processing. In Selected Samples mode, the ‘ELite 5’ analyzer will only look for samples in the sample positions selected for analysis. All other samples in sample positions that are not selected will be ignored.
• Page 70
  To interrupt automatic processing for stat specimens, perform the following steps: • Click or tap the ‘Stop’ button. The ‘ELite 5’ will prompt you to wait until the current sample is completed. •…
• Page 71
  ELite 5, User Manual 7.4.3.6 Controlling the Autosampler Detailed information about the Autosampler is available from the Autosampler info panel. You can also reset the Autosampler from this panel. Double click or tap the Autosampler status in the bottom left corner of the screen to view the Autosampler info panel. With this panel, you can command the Autosampler to repeat the last command, or reset the Autosampler.

• Page 72: Result Display

  7.7 The Measurement Process The ‘ELite 5’ analyzer measures 24 parameters of whole human blood samples. Internal dilutions are made to allow measurement of particles in the sample. Manual or automatic mode samples are processed in the same way.

• Page 73
  BASO Figure 52. ‘ELite 5’ Measurement Process When you present the sample tube and press the Start button, the ‘ELite 5’ rotates the sample rotor and takes the sample tube inside the analyzer. The piercing needle pierces the sample tube cap (if present) and aspirates approximately 110 µL of primary blood sample.

• Page 74: Result Interpretation

  ‘ELite 5’ analyzer. 8.1 The Result Screen Figure 53. ‘ELite 5’ Result Screen The ‘ELite 5’ analyzer result screen is divided into 4 major areas: 1. Sample identification information: contains identifying information used to uniquely identify this sample’s information.

• Page 75: Parameter Information

  This is the sample mode selected for this specimen. Each sample mode Mode applies a different set of normal ranges to this sample run. Table 4. Sample Identification Information 8.3 Parameter Information The parameter information area of the ‘ELite 5’ analyzer result screen lists information on 26 parameters. Flag Value Unit/5p Normal Range Figure 54.

• Page 76: Scatter Diagrams And Histograms

  Table 7. High Blank Flag 8.3.1 Scatter Diagrams and Histograms The ‘ELite 5’ analyzer displays the results of the optical measurements in scatter diagram representation. Scatter diagrams represent two-dimensional data. There are two scatter diagrams in the patient report: the 4-DIFF and BASO scatter diagrams.

• Page 77: Warnings

  ELite 5, User Manual Neutrophils (Magenta) Eosinophils (Orange) Non-Basophil WBCs (Blue) Monocytes Artifact (Green) (Black) Basophils (Magenta) Lymphocytes (Blue Figure 56. Result Screen Scatter Diagrams RBC and PLT impedance-based measurements are represented by histograms. These diagrams show the number of cells on the Y axis and the cell size on the X axis. Smaller cells are displayed on the left side of the histogram, and larger cells are displayed on the right side.

• Page 78
  ELite 5, User Manual Figure 58. Warnings Section of Results Screen The ‘ELite 5’ analyzer provides Warning flags, Morphological flags, and Interpretive messages in the Warnings panel. The following tables describe these flags and messages in detail. It also provides guidance on actions the operator can take to correct the problem described by the flag.
• Page 79
  If not all the parameters reported or the sample is predicted as pathological then perform a manual count on a stained smear. Check cleanliness of the reagents and the ‘ELite 5’. Perform cleaning of the ’ELite 5’. Repeat blank WBC blank is high WBC >…
• Page 80
  Check cleanliness of the reagents and the ‘ELite 5’. Perform flow cell cleaning of the ’ELite 5’. Repeat More than 100 cells detected during the ’4Diff-blank’…
• Page 81
  If any of RBC,PLT or WBC results are lower than Low None limit exceeded linearity range limits. Check cleanliness of the reagents and the ‘ELite 5’. Perform cleaning of the ’ELite 5’. Repeat blank PLT blank high Last accepted blank result: PLT ≥ 15 * 103 cells/µl measurement.
• Page 82
  There is a (partial) clogging or leakage in the RBC Perform cleaning of the ’ELite 5’. Perform a self-test. WBC vacuum warning part of measurement system. A faulty/ worn-out pump If vacuum problems persist then call for service.
• Page 83
  The count in the region of (low — high angle scatter of Perform a manual count on a stained smear. Immature granulocytes ELite 5) where the Immature granulocyte typically located is > 3% of the total WBC count. The count in the region of (low — high angle scatter of…
• Page 84
  ELite 5, User Manual Interpretive flag Interpretive flags infer the presence of distributional abnormalities such as leukocytosis. Flag Meaning Lymphocytosis LYM ++ Monocytosis MON ++ Eosinophilia EOS ++ Basophilia BASO ++ Anemia RBC — or RBC — Polycythemia RBC + or RBC ++…

• Page 85: Database Functions

  Each sample result stored includes the complete parameter list, histograms, flags, and identifying data. The ‘ELite 5’ has a data capacity of up to 100,000 total records. To activate Database panel, clicking or tapping the Database quick link on the top of the screen will take you to the database view from any screen.

• Page 86: Scrolling The Database View

  Database records can be exported for storage and backup. Exported database information can be later imported for review. Imported records do not become part of your ‘ELite 5’ analyzer’s database. They are only imported for viewing, but can be sorted, selected, and managed in the same way as with the regular data stored inside the ‘ELite 5’…

• Page 87: Sorting Database Information

  Analysis Time Time and date this sample tube was analyzed Result ID Unique sequential identifier assigned by the ‘ELite 5’ to each records Table 11. Database Sort Criteria Clicking or tapping the same column heading again changes the ascending or descending order of values in the column.

• Page 88: Automatic Selection Of Database Records

  All data manipulation actions that change the data stored in the ‘ELite 5’ database are logged in the ‘ELite 5’ log. If the multi-user mode is enabled, the name of the operator logged on at the time the data manipulation occurs will also be stored in the log.

• Page 89: Select By

  ELite 5, User Manual 9.8.1 Select By Click or tap the ‘Select by’ button on the Manage Records panel to display the Select by panel. The Select by panel allows you to select a group of records with dates and Result IDs that match criteria entered into the panel.

• Page 90: Importing

  ‘Clear’ removes selected records from the imported records table, but does not permanently remove the cleared records from the stored database file. • ‘Back’ ends viewing of imported database information and returns to the ‘ELite 5’ stored database. Page 90 of 159…

• Page 91: Export

  Introduce a USB storage device (USB hard drive, memory stick, etc.) into an available USB port on the back panel of the ‘ELite 5’ analyzer. Select the directory to store the exported data and press the ‘Ok’ button to start the export.

• Page 92: Save Raw Data

  555. This password can be changed only by Erba Lachema certified service engineer. Insert a USB data storage device to one of the USB inputs on the back panel of the ‘ELite 5’ analyzer. Click or tap the ‘Save raw data’ button on the Manage records panel, then enter the correct confirmation password.

• Page 93: Calibration

  WBC, RBC, PLT, HGB, MCV and MPV. To view the calibration functions of the ‘ELite 5’ analyzer, select the ‘Calibration’ icon on the main menu to display the calibration panel. The Calibration panel displays an option to calibrate the ‘ELite 5’…

• Page 94: Calibrating The ‘Elite 5

  To perform the automated calibration procedure, ensure that the ‘ELite 5’ pneumatic system is started up and that a valid blank measurement has been accepted. Perform the following steps: •…

• Page 95: View Calibrations

  Manually entered factor values can be accepted in the same way as calculated factors from calibration sample runs, and are treated by the ‘ELite 5’ in the same way. 10.1.1 View Calibrations The view calibration features is helpful for reviewing the calibration history for the analyzer.

• Page 96: Ssm Calibration

  To delete a calibration, click or tap the ‘Delete’ button. The system will ask you for a confirmation password to avoid accidental deletion of calibration data. The confirmation password is set at the factory to 555, and can be changed by your Erba Lachema certified service engineer.

• Page 97: Quality Control

  Control materials must be well mixed before use. The ‘ELite 5’ analyzer does not limit the number of QC material lots or the number of QC measurement runs that are stored in the control database. Each QC measurement run is saved to the selected QC material lot.

• Page 98
  Enter the identifying information, and the target values and tolerance ranges for any parameters that are to be controlled with the ‘ELite 5’ QC system. To exclude a parameter from the QC procedure, leave its target value and tolerance range field empty. Press the ‘Save reference’…

• Page 99: Qc Measure

  11.3 View QC References Click or tap the ‘View QC References’ button to see a list of QC lot references stored in the ‘ELite 5’ analyzer control database. Target values and ranges can be viewed for any stored QC references.

• Page 100: View X-B Data

  Take attention to choose the proper values and ranges for QC. 11.6 View X-B Data ‘ELite 5’ offers X-B to facilitate trend analysis of samples run. The X-B moving average is an algorithm which is capable of tracking changes of the accuracy- alternating of the measurements.

• Page 101: View X-B Diagrams

  ELite 5, User Manual 11.7 View X-B diagrams View X-B diagrams displays X-B charts for MCV, MC and MCHC. View X-B data function displays X-B information in a table format similar to view QC data. Page 101 of 159…

• Page 102: Patients

  ELite 5, User Manual Patients The ‘ELite 5’ analyzer allows the operator to define and store patients in the patient database during manual measurement. Patients can also be predefined while creating a list for one of the automatic processing modes.

• Page 103
  ELite 5, User Manual Figure 75. Edit Patient Panel The ‘Save’ function saves any changes made. To discard any changes made, simply click or tap the ‘Back’ button. Page 103 of 159…

• Page 104: Settings

  ELite 5, User Manual 13 Settings The ‘ELite 5’ analyzer can be tailored to your laboratory’s needs by changing the settings. Click or tap the ‘Settings’ icon on the main menu to access the Settings panel. Figure 76. Settings Panel The options available on the Settings panel are: •…

• Page 105: Laboratory Settings

  The ‘skins’ has no effect on the behavior of the ‘ELite 5’. • Language – select the language that the ‘ELite 5’ analyzer user interface uses to communicate with the operator. Available languages are English, Spanish, French, Croatian, Hungarian, Italian, Polish, Russian, Turkish, Chinese, German & Greek.

• Page 106: External Devices

  • Sending port baud rate – select 9600 or 115200 baud for serial LIS connection. • Automatic LIS – The ‘ELite 5’ will transmit every measurement result as soon as it is available if this check box is checked. •…

• Page 107: System Settings

  (or LIS computer) to send it instruction. Consult your information technology staff regarding the configuration of the host computer and the ‘ELite 5’ analyzer for proper LIS operation. Your information technology staff person may need to consult your Erba Lachema certified service engineer to ensure the Internet Protocol (IP) settings of the ‘ELite 5’…

• Page 108: Units

  ELite 5, User Manual Figure 79. System Settings Panel 13.5 Units The Units panel allows the user to choose which units are displayed for certain parameters. The following options are available on the Units panel: • HGB unit – choose g/dL or g/L to change the displayed units for the HGB and MCHC parameters.

• Page 109: Printer Settings

  Automatic print – check this check box to print every sample or control as it is run. • Logo visible – check this box to print the Erba Lachema logo on every printed report. • Warning flags are visible – check this box to print warning flags on every printed report.

• Page 110: Profile Limits Settings

  The Profile Limits settings are used to view and modify the normal ranges associated with the ‘ELite 5’ analyzer’s five sample modes: Human, Male, Female, Alternate 1 and Alternate 2. NOTE: Alternate 1 and Alternate 2 are sample modes that are different than Human, Male and Female and have user-definable normal ranges.

• Page 111: X-B Settings

  ELite 5, User Manual Figure 82. Profile Limits Settings Panel In SSM mode we are using the same profile limits as we are using in normal mode. 13.8 X-B Settings The X-B panel displays the currently selected X-B constants. Change the values as needed, then click or tap Save to save the new values and return to the Settings panel, or select Back to discard any changes and return to the Settings panel.

• Page 112: User Settings

  ELite 5, User Manual 13.9 User Settings The User Settings panel allows administrators to delete users, or assign administrator rights. Figure 83. User Settings Panel Users with Administrator privileges can have access all over the system. Only an administrator user can grant or revoke administrator rights.

• Page 113: Date And Time Adjustment

  Click or tap ‘Cancel’ to exit the Time/Date settings without saving. Figure 84. Time/Date Settings The ‘ELite 5’ analyzer does not support automatic time zone or daylight savings time changes. Please change the time and date manually when necessary.

• Page 114: Instrument Diagnostics

  ELite 5, User Manual 14 Instrument Diagnostics This section allows the operator to perform diagnostic procedures, check the operational history of the instrument, set or check the status of the reagents and view stored information about the system. Click or tap the ´Diagnostics´ button on the main menu to view the available options in the Diagnostics panel.

• Page 115: Self Test Of The Analyzer

  ELite 5, User Manual 14.1 Self Test of the Analyzer Initiating a self test will test the key functions and components of the analyzer. The process takes approximately one minute and gives evaluation of each parameter. The acceptable ranges of each tested parameter or function can be found in the following table.

• Page 116
  ELite 5, User Manual Chamber -20 — 20mBar Noise/Pulse HGB head pls/5sec 0 — 2000 pulses HGB Dark 0 — 3000 pulses 20000pls 19990 — 20050 pulses HGB light 3000 — 60000 pulses TCU temperature Laser parameters Actual Reference +- 0.2 °C…

• Page 117: Daily Log

  The height of the bar shows the level in the container. These levels are also indicated on the screen in the status area. ELite 5 send special message if any of the reagents are running low. Check and change the reagent container and reset the reagent status bar on the screen.

• Page 118: Statistics

  ELite 5, User Manual 14.4 Statistics This menu item will display cumulative number of measurements and number of possible failure events experienced during operation. Statistical data can be reset by a certified service engineer only. Figure 89. Statistics display 14.5 Information…

• Page 119
  ELite 5, User Manual The information panel also contains a Collect button. By pressing this, there is a chance to save a .gz file to the selected path. This file can be sent to the local service engineer. The file contains valuable information about the instrument including self test, stress measurement and the calibration factors.

• Page 120: Maintenance

  ELite 5 is a completely automated hematology analyzer. Special ‘Erba Lachema ELite 5 Service Training’ is required to resolve major problems occurring during operation. Electrical and moving parts should always be serviced by trained person.

• Page 121: Closing The Front Panel

  Always make sure to re-tighten the thumb screws when reinstalling side panels. 15.1.3 User Maintainable Parts of the Analyzer There are three user maintenance points in ´ELite 5´ analyzer. Shear valve: this is a key component and is responsible for correct sampling and diluting procedures.

• Page 122: Maintenance Programs Of The Analyzer

  ELite 5, User Manual Measuring chambers: contamination induced problems such as noise, high blank values can usually be resolved by cleaning the plastic measuring chambers. General precautions: Always wear protective gloves when working on internal parts of the analyzer. 15.2 Maintenance Programs of the Analyzer Maintenance functions can be accessed from the menu system by clicking or tapping the Maintenance main menu.

• Page 123: Cleaning The Shear Valve

  ELite 5, User Manual software is going to prompt the user to add external cleaning reagent (Erba Hypoclean CC) in the sample position (manual measurement). Draining Drain Diff-5P: drains the Diff-5P reagent Drain sheath: drains the sheath buffer Drain Lyse-5P: drains the Lyse-5P reagent…

• Page 124
  Figure 94. Maintenance menu-shear valve The ‘ELite 5’ asks for confirmation to start the procedure. After clicking or tapping the ’OK’ button the ‘ELite 5’ empties the shear-valve and the connecting tubes. A small amount of liquid may remain inside the tubing and inside the shear-valve.
• Page 125
  ELite 5, User Manual Any salt build-up on the inner surface of the shear-valve may cause malfunction during operation. To avoid this problem, it is recommended to clean the shear valve after every 1200 samples. 1: Open the front cover and secure it with the latch. Locate the shear valve in the center of the analyzer.
• Page 126
  Remove the gloves. Close the front door and remove gloves. 13: Click or tap the ‘OK’ button to inform the ‘ELite 5’ that you completed the cleaning of the shear valve. The ‘ELite 5’ will check the movement and end-positions of the shear valve.

• Page 127: Cleaning The Washing Head

  ELite 5, User Manual 15.2.2 Cleaning the Washing Head The washing head cleans the outer surface of the aspirating tip with diluent. Any salt build-up on the lower surface may cause malfunction during operation. The wash head must be removed from the needle assembly for correct cleaning.

• Page 128: Cleaning The Measuring Chambers (Hard Cleaning)

  AND SMALL PARTICLES WILL FALL INTO THE SOLUTION WHICH CAN CAUSE CLOGGING IF ASPIRATED BY THE SAMPLING NEEDLE After this operation, you can leave ELite 5 on for the rest of the day. It will go into a low power state after a specified time.

• Page 129: Replacing Reagents

  ELite 5, User Manual 15.2.6 Replacing Reagents ‘ELite’ 5 analyzer is designed to be able to run continuously without the need to stop if a reagent container needs to be replaced. To support this feature, internal buffers keep regents sufficient for one measurement cycle.

• Page 130: Disposal Of Reagent Containers

  ELite 5, User Manual To replace reagent containers: • Prepare the new container, and place it near the place of operation. • Open the bottle (remove cardboard flaps if necessary (5L and 20L containers). • Unscrew the cap from the used container and place it into the new container.

• Page 131: Reagent Locking

  ELite 5, User Manual 16 Reagent Locking Reagent locking is a commercial feature of the ‘ELite 5’ ensuring that only manufacturer recommended and approved reagents are used with the analyzer. This way analyzer performance cannot be impaired by incompatible reagents. All necessary hardware and software elements are installed and configured on each ‘ELite 5’…

• Page 132: The Daily-Routine

  This chapter also contains some trick and tips. The below assumes that the laboratory works during ‘office hours’ only. The daily routine: Power up and start-up the ‘Elite 5’ analyzer. See Chapter 6.2.2. for details Perform the pneumatics initialization and blank measurement (tap the sampling tube icon)

• Page 133
  ELite 5, User Manual Cleaning: Perform cleaning / hard cleaning if: High blank results experienced; Clogging related flags are added systematically to measurement results; After service actions, service level maintenance; Measurement results, QC results are drifting (perform hard cleaning); Clog formation in the tubing (first remove the plugging, contamination);…

• Page 134: Troubleshooting

  ELite 5, User Manual 18 Troubleshooting Your ‘ELite 5’ software is equipped with all the functions to keep the analyzer in good working conditions. Despite careful planning and SW features, the analyzer can still encounter problems where user interaction is required or the user needs to be informed of situations when further help is required.

• Page 135: Mechanical Problems

  ELite 5, User Manual With the ‘Ok’ button, you can return to the current operation and retry the actual process. You can also tap on the Details button and then you will be able to get further informaion about the error. It will describe additional conditions of the failure. The numbers in the second row are important for the service personnel.

• Page 136: Sr Error Appears During Initialization Process

  ELite 5, User Manual 18.4.2 SR Error Appears During Initialization Process: • Check the washing head for contamination (blood and salt) • Contact service 18.4.3 The SR Does Not Turn Into the Analyzer Even With Open Front Panel • Check the washing head for contamination (blood and salt) 18.5 Needle Mechanics, Vertical Motor (Mvert) Problems…

• Page 137: Dilutor Errors

  ELite 5, User Manual 18.7 Dilutor Errors • Pinched, clogged tube around dilutor or at the rear reagent tubes • Physical obstruction (foreign material) 18.8 Priming Problems 18.8.1 The Analyzer Would Not Prime Liquids • The respective reagent is out •…

• Page 138: Measurement Results Related Problems

  18.12.1 Fluctuating PLT background values When the ELite 5 is used under increased workload, running even 300 samples a day (meaning 5 hours of continuous operation) is possible. Despite built-in maintenance programs, the system may require intensive cleaning from time to time.

• Page 139: Accessories

  ELite 5, User Manual 19 Accessories The following items can be found along with the analyzer: Power cord Reagent tube kit Cleaning tube kit Waste container (20L) Cardboard box for waste container Sample tube adapter User’s manual Page 139 of 159…

• Page 140: Appendices

  ELite 5, User Manual 20 Appendices 20.1 Reagent Consumption Function Reagent consumption / function (ml) Erba Lyse-5P Erba Diff-5P Erba Dil-Diff Start Up 13.6 Measure Blank Measure 5 part Measure Calibration Measure QC Measure SSM blank Measure SSM 5-part Measure SSM Calibration…

• Page 141: Display Range

  ELite 5, User Manual 20.2 Display Range Parameter Range Selectable Dimensions 1.00 – 99.99 * 10 / µl cells/l, cells/µl 0.00 – 9.99 * 10 / µl cells/l, cells/µl 0 – 300 g/l g/dl, g/l, mmol/l 0 – 100% percentage, absolute 0 –…

• Page 142: Printed Report Formats

  ELite 5, User Manual 20.3 Printed Report Formats Page 142 of 159…

• Page 143
  ELite 5, User Manual Page 143 of 159…

• Page 144: Specifications

  ELite 5, User Manual 20.4 Specifications 20.4.1 Measured Parameters White Blood Cells – WBC Number of leukocytes (cells/l, cells/µl) WBC = WBC cal x (cells/l, cells/µl) Red Blood Cells – RBC Number of erythrocytes (cells/l, cells/µl) RBC = RBC cal x (cells/l, cells/µl) Hemoglobin concentration — HGB Measured photometrically at 540 nm;…

• Page 145: Technical Data

  ELite 5, User Manual Mean Platelet Volume – MPV Average volume of individual platelets derived from the PLT histogram (fl) Thrombocrit – PCT Calculated from the PLT and MPV values PCTpercentage = PLT x MPV x 100 (percentage, absolute) PCTabsolute = PLT x MPV…

• Page 146
  Fine calibration: with calibration material (Polystyrene micro- particle or Polystyrene microsphere, 5 m) Reagents Erba Dil-Diff (20 liters) Erba Lyse-5P (5 liters) Erba Diff-5P (1 liter) Erba Hypoclean CC (100 ml) (Emergency cleaner) Dilution ratios WBC/BAS 1: 170 RBC/PLT 1: 21250…
• Page 147
  ELite 5, User Manual Peripheral ports USB (2.0) 4pc., Ethernet, PS/2 Power requirements Power supply input: 100-127VAC/200-240 VAC; 47Hz to 63Hz Power Consumption: maximum 400 VA Main fuse F 10A H 250V 15-30° C (59-86 °F); Operating temperature Maximum relative humidity 80%…

• Page 148: Performance Data

  ELite 5, User Manual 20.4.3 Performance Data 20.4.3.1 Precision Parameters Range CV ≤ 3% 4.7 * 10 / µl ≤ WBC≤ 38 * 10 / µl All 5 part parameters (NEU, LYM, MON, EOS, BAS abs and %) at 4.7 * 10 / µl ≤…

• Page 149
  ELite 5, User Manual 20.4.3.2 Accuracy Values And Ranges Accuracy Experienced Range coefficient Against Reference (Cell-Dyn 3700) r = 1.00 0.5*10 / µl ≤ WBC ≤ 56.3*10 /µl r = 0.99 2.2 *10 / µl ≤ RBC ≤ 6.3 * 10 /µl…
• Page 150
  ELite 5, User Manual 20.4.3.3 Linearity Values and Ranges Linearity Coefficient of determination Range 0.95 1*10 / µl ≤ WBC ≤ 100*10 /µl 0.95 0.4 *10 / µl ≤ RBC ≤ 7.5 * 10 /µl 0.95 13 g/l ≤ HGB ≤ 227 g/l 0.95…

• Page 151: Reagent System

  Isotonic solution, used to dilute whole blood and quantitative and qualitative determination of RBC, WBC, PLT and HGB concentration. 20.4.4.2 Lyser Erba Lyse — 5P WBC-5 Part: Reagent for stromatolysis of RBC and quantitative determination of WBC 5-part differentiation (LYM, MON, NEU, EOS, BAS) and HGB concentration measurement of human blood.

• Page 152: Tab File Format

  ELite 5, User Manual 20.4.5 Tab File Format This file format is composed of a header line and consecutive lines containing records selected for saving. Each parameter is selected by the <TAB> (08h) character, allowing easy interfacing or importing into most data processing applications, like Microsoft® Excel. Scatter diagrams and historgrams, flags are NOT saved in this format.

• Page 153: Fluidic System

  ELite 5, User Manual 20.5 Fluidic System Page 153 of 159…

• Page 154: Summary Of Cleaning Products And Procedures For Elite Hematology Analyzers

  The recommendation is to use this solution as daily cleaner (connected instead of Erba Cleaner) only in case of daily high workload. Erba Hypoclean is a < 9% hypochlorite solution for cleaning purposes. It should be used in case of massive dirt, dried blood etc. in the system. You can use it in vial and run cleaning cycle from software.

• Page 155: Known Problems

  ELite 5, User Manual 21 Known Problems The following problems are known at the time of the releasing of the software and this user manual: Long Sample ID is not visible on printout and on display. Tooltip info contains square character instead of upper index 6/9/12.

• Page 156: Index

  ELite 5, User Manual 22 Index aperture, 24, 30 BASO, 26, 73, 76, 80, 82, 83, 84, 145 blank, 25, 39, 45, 47, 48, 50, 51, 57, 58, 59, 62, 64, 66, 69, 74, 75, 76, 79, 80, 81, 90, 94, 95, 99, 122, 128, 132, 133, 144…

• Page 157
  ELite 5, User Manual needle, 10, 28, 31, 47, 55, 60, 73, 127, 136 NEU, 21, 24, 25, 75, 80, 83, 108, 141, 145, 148, 149, 151, 152 noise, 83, 122, 135 normal ranges, 42, 57, 59, 66, 69, 75, 105, 110, 146…

• Page 158: Contact

  ELite 5, User Manual 23 Contact For customer and technical support: Manufacturer: Erba Lachema s.r.o., Karásek 2219/1d, 621 00 Brno Czech Republic Tel: +420 517 077 111 e-mail: diagnostics@erbamannheim.com Website : https://www.erbamannheim.com/en/product-support/ Contact your local technical support: (Print this page and write or paste contact information…

• Page 159: Appendix- Package Inserts For Reagents And Cleaning Solutions

  ELite 5, User Manual Appendix- package inserts for reagents and cleaning solutions Revision 3.0 Date of Revision 07/2017 HEMA/PI/27/17/C Page 159 of 159…

• Page 160
  Please refer to the instrument’s User Manual for further in- — Store Erba Lyse-5P lysing reagent between +15 and +30°C. formation. — The shelf life of the Erba Lyse-5P lysing reagent is 24 INGREDIENTS months from date of manufacture, if stored at the prescribed Surfactants <…
• Page 161
  < 0.5 % and +30°C. in ion-free water — The shelf life of the Erba Diff-5P WBC-5-part reagent is 24 HANDLING PRECAUTIONS months from date of manufacture, if stored at the prescribed — Erba Diff-5P differentiation reagent is environmental frien- temperature range.
• Page 162
  15 and 30°C. P303+P361+P353 IF ON SKIN (or hair): Take off immedia- — The shelf life of the Erba Hypoclean CC is 15 months from tely all contaminated clothing. Rinse skin with water/shower. date of manufacture, if stored at the prescribed temperature P305+P351+P338 IF IN EYES: Rinse cautiously with water range.
• Page 163
  — Store Erba Dil-5P diluent between +15 and +30°C. Stabilizers < 0.4 % — The shelf life of the Erba Dil-5P is 36 months from the date in ion-free water of manufacture, if stored at the prescribed temperature range. — Do not use reagent beyond the expiration date printed on HANDLING PRECAUTIONS the container label.
• Page 164
  Store Erba Clenz enzymatic cleaner reagent between 15 – 30°C. Erba Clenz HEM00017 The shelf life of Erba Clenz is 24 months from the date of manufacture, if stored at the prescribed temperature range. For in vitro diagnostic use only Do not use reagent beyond the expiration date printed on the container label.
• Page 165
  < 1.0% Store Erba Hypoclean hypochlorite cleaning reagent between 15 – 30°C. Sodium hydroxide < 0.5% The shelf life of Erba Hypoclean is 24 months from the date of manufacture, Stabilizers < 0.4% if stored at the prescribed temperature range.

• Page 1
  ELite 5 Hematology Analyzer USER MANUAL INS00068 Erba Lachema s.r.o., Karásek 2219/1d, 621 00 Brno, CZ…
• Page 2
  Introduction This user manual is intended to give detailed information for end users of the ‘ELite 5’ optical hematology analyzer. All information contained herein is the intellectual property of Erba Lachema s.r.o. and should not be used or reproduced without prior agreement of Erba Lachema s.r.o., the manufacturer.
• Page 3
  FITNESS FOR ANY PARTICULAR PURPOSE. Exemptions Erba Lachema’s obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Erba Lachema or repairs by people other than Erba Lachema authorized personnel.

• Page 4: Table Of Contents

  Emergency Situations ………………..15 Product Support ………………….. 16 Installation ………………….17 Package contents ………………….17 3.1.1 The ‘ELite 5’ Analyzer Package ………………….. 17 3.1.2 The Autosampler Package ………………….17 3.1.3 Small Sample Package (optional) ………………..17 Connecting the reagents ………………..18 Power connection ………………….

• Page 5
  5.7.11 Safety Access Codes ……………………43 5.7.12 SSM Menu Add-ons ……………………43 Start Up and Shut Down of ‘ELite 5’ …………….45 Start Up and Shut Down Overview …………….45 Starting Up the ‘ELite 5’ Analyzer …………….. 45 6.2.1 Visual Inspection ……………………..45 6.2.2…
• Page 6
  6.3.4 Emergency Shut Down ……………………52 6.3.5 Repackaging the ‘ELite 5’ Analyzer ………………..53 Sample Measurement ………………..55 Sample Types Supported by the ‘ELite 5’ …………..55 7.1.1 Supported Sample Tube Types …………………. 55 7.1.2 Sampling Depth ……………………..55 7.1.3 Open or Closed Sample Tubes …………………..
• Page 7
  Content Calibration ………………….93 10.1 Calibrating the ‘ELite 5’ ………………..94 10.1.1 View Calibrations ……………………… 95 10.2 SSM Calibration ………………….96 Quality Control ………………… 97 11.1 Set QC Reference ………………….97 11.2 QC Measure……………………. 99 11.3 View QC References ………………… 99 11.4…
• Page 8
  Content 15.1.3 User Maintainable Parts of the Analyzer ………………121 15.2 Maintenance Programs of the Analyzer …………… 122 15.2.1 Cleaning the Shear Valve ………………….123 15.2.2 Cleaning the Washing Head ………………….127 15.2.3 Cleaning the Measuring Chambers (Hard Cleaning) …………..128 15.2.4 Daily Cleaning ……………………..
• Page 9
  Content 20.2 Display Range ………………….141 20.3 Printed Report Formats ………………..142 20.4 Specifications ………………….144 20.4.1 Measured Parameters ……………………. 144 20.4.2 Technical Data ……………………..145 20.4.3 Performance Data ……………………148 20.4.4 Reagent System ……………………… 151 20.4.5 Tab File Format ……………………..152 20.5 Fluidic System………………….

• Page 10: For Your Safety

  To prepare the analyzer for shipping, storage or extended periods of inactivity, please drain the reagents and repackage the ‘ELite 5’ in its original packaging. Do not expose the ‘ELite 5’ to direct sunlight, extreme temperature or humidity (>80%).

• Page 11: Environmental Factors

  (59-86 °F) and a relative humidity range of 10% — 80%. The optimum operating temperature is 25°C (~77°F). Avoid exposing the ‘ELite 5’ analyzer to direct sunlight or to extreme high or low temperatures. If the ‘ELite 5’ analyzer was subjected to extreme temperatures during shipment or storage, the analyzer must be placed for at least one hour in a room whose temperature is within the operational range before installation or use.

• Page 12: Electrical Requirements

  Ensure there is enough clearance in front of the ‘ELite 5’ analyzer to open the front panel. Allow enough space if you want to use optional external keyboard, mouse or bar code reader.

• Page 13
  ELite 5, User Manual Figure 1. ELite 5 with Autosampler Space Requirements Page 13 of 159…

• Page 14: Weight Requirements

  Figure 2. ELite 5 Without Autosampler Space Requirements 1.7 Weight Requirements The ‘ELite 5’ analyzer weighs 35 Kg (77 lb) without the Autosampler. The ‘ELite 5’ with optional Autosampler weighs 47Kg (104 lb). Adding an external keyboard, printer etc. can bring the total weight up to 60 Kg (132 lb).

• Page 15: Waste Disposal

  1.10 Emergency Situations Always follow all applicable laws and regulations with regard to emergency situations. If the ‘ELite 5’ needs to be powered off due to an emergency situation (like fire, thunderstorm etc.), follow the procedures in chapter 6.3.4. In case of fire, do not use water to extinguish the fire unless the ‘ELite 5’ is…

• Page 16: Product Support

  2 Product Support Your sales representative is trained and qualified to answer questions about applications and the operation of the ‘ELite 5’ analyzer. If you have additional questions regarding the ‘ELite 5’, please ask for manufacturer support through your sales representative.

• Page 17: Installation

  ‘ELite 5’ analyzer packaging for future transportation and storage. 3.1.2 The Autosampler Package The Autosampler is an optional unit that attaches to the ELite 5. If the optional Autosampler unit was ordered, package should contain the following items: •…

• Page 18: Connecting The Reagents

  The waste container should be periodically emptied. You can place the reagent below or on the same level where the ‘ELite 5’ is installed. Do not place the reagents to a higher location than the bottom of the ‘ELite 5’, because in case of any tubing problem, valve error etc.

• Page 19: Visual Inspection

  Move the ‘ELite 5’ to the selected location. If it is hard to access the back of the ‘ELite 5’ after it is in the final location then connect the reagent tubes to the ‘ELite 5’ but not to the reagent containers. (For details see chapter 3.2) Be sure that the main switch (right next to the power connector) is in off position.

• Page 20: Connecting The Autosampler

  ‘ELite 5’, available from Erba Lachema. Place the reagent containers near the instrument, to an accessible location. Do not place the containers to a higher position than ‘ELite 5’. This is to avoid unintentional spilling of reagents.

• Page 21: General Overview And Principles Of Operation

  4 General Overview and Principles of Operation 4.1 General Overview The ‘ELite 5’ is a fully automated high quality hematology analyzer for in vitro diagnostic use in clinical laboratories. It provides precise and accurate 5-part differential measurement using a laser based optical measurement technology.

• Page 22: Approved Reagents And Control Materials

  4.1.2 Approved Reagents and Control Materials Always use reagents, control and calibration materials that are recommended and approved by the manufacturer. The ‘ELite 5’ analyzer, controls, calibrator and reagents are part of a system and are carefully designed and selected for optimal performance. Using unapproved reagents or controls may cause false flagging or incorrect, inaccurate results.

• Page 23
  ELite 5, User Manual HEM00003 Erb Dil-5P 20 l Additional cleaning solutions – use as needed HEM00017 Erba Clenz HEM00016 Erba Hypoclean For package insert for reagents and cleaning solutions please see Appendix Page 23 of 159…

• Page 24: Principles Of Operation

  This change is sensed by the ‘ELite 5’ electronics and converted to an electrical pulse. The quantity of pulses is proportional to the number of particles. The intensity of each pulse is proportional to the volume of the particle.

• Page 25: Optical Light Scatter And Diffraction Method

  The ‘ELite 5’ electronics convert these changes to electrical pulses which are gathered and stored for analysis. Five part population discrimination is based on analysis of the two dimensional volume and granularity distribution scatter diagram.

• Page 26
  Both low and high angles of light scatter are captured by optical sensors, providing the ‘ELite 5’ analyzer with two independent measurements for each cell crossing the path of the laser beam.
• Page 27
  ELite 5, User Manual Figure 9. 4DIFF Scatter Diagram Page 27 of 159…

• Page 28: Inside The ‘Elite 5’ Analyzer

  Automatic processing can be resumed after stat sample processing is complete. The START button allows easy one-hand operation of the ‘ELite 5’ analyzer. The color of the START button indicates the status of the ‘ELite 5’ analyzer: Green — ready to process samples Red –…

• Page 29
  Table 2. Reagent Connector Color Codes Main board back panel I/O Ports: these are the back panel computers of the ‘ELite 5’ analyzer main computer board. They provide standard connection to peripherals such as external keyboard and mouse, printers, bar code readers.

• Page 30: Left Side Assembly

  • Small Measure buffer is a vacuum buffer used for impedance measurement. • Sheath buffer is a reservoir for Erba•Dil-5P diluent for optical measurements. • Diff-5P buffer is a reservoir for Erba•Diff-5P reagent. •…

• Page 31: Right Side Assembly

  ELite 5, User Manual 4.2.7 Right Side Assembly Optical Head Aspiration Needle Horizontal, Vertical Motion Unit Washing Head Power Supply Sample Rotor Autosampler Connector Figure 14 Right Side Assembly • Aspirating needle aspirates a blood sample from the sample tube.

• Page 32: Front Assembly

  The analyzer will aspirate 25 µl of whole blood and put it in to the pre-dilution chamber to dilute it to 1:6. • After pre-dilution, the needle will take 100 µl of diluted sample into the shear valve and ´ELite 5´ is going to proceed with the normal measuring process. Page 32 of 159…

• Page 33
  ELite 5, User Manual Pre-dilution chamber Figure 16. SSM installed instrument Sampling side with Pre-dilution chamber In small sample mode there is no possibility using the Auto Sampler. It is working only in manual feeding mode through the sample rotor.

• Page 34: User Interface

  If you find that the ‘ELite 5’ touch screen responds in a different area than the one you are tapping, then please perform a touch screen calibration procedure before calling for service or support.

• Page 35: Using An External Keyboard

  For selection of dates, a date keypad is presented. The touch-pad of the ‘ELite 5’ handles single taps only. The Shift and Symbol keys are ‘sticky’ on the virtual on-screen keypads like the ‘caps-lock’ on a PC key-board. Click/tap on the appropriate buttons to type in the required value.

• Page 36
  ELite 5, User Manual Figure 18. Sticky’ Shift and Symbol Buttons Figure 19. Numeric Virtual On-screen Keypad Figure 20. Date Virtual On-Screen Keypad Page 36 of 159…

• Page 37: Using The Graphical User Interface

  ELite 5, User Manual Using the Graphical User Interface The graphical user interface (GUI) of the ‘ELite 5’ is divided into three main sections. Refer to Chyba! Nenalezen zdroj odkazů. to see these sections: 1. Quick links to main functions (top section) 2.

• Page 38: Status Display

  The ‘ELite 5’ analyzer also has secondary functions that are available via two or more taps or clicks through the menu structure, or menu tree.

• Page 39: Start Automated Measurements

  • Review the details of selected measurements See section 9 for more details about accessing and using the ‘ELite 5’ database. 5.7.5 Initiate Printing Tapping or clicking the ‘Print’ icon with the printer graphic will print the active panel or measurement result according to the printer settings.

• Page 40: Main Menu

  Double click/tap the time display on the right side of the status display on the bottom of the screen to bring up a panel for adjusting the stored time and date of the ‘ELite 5’ analyzer. See section 13.9 for more information about time and date adjustment.

• Page 41: Menu Tree

  Log off: Logs off the current user session Shutdown: Prepares the ‘ELite 5’ for a complete shutdown See section 6.3 to learn how to power down the ‘ELite 5’ analyzer correctly Settings Customize…

• Page 42
  Profile limits: Enter normal ranges for various profile limits X-B: Change X-B limits and targets User: Add and manage users of the ‘ELite 5’ analyzer (only available to administrator users) Delete user: Initiates deletion of a user account Administrator: Selects or unselects administrator privileges for the currently selected user See section 13 for more details about ‘ELite 5’…

• Page 43: Safety Access Codes

  Undo reject: Restore a previously rejected X-B run and use in X-B calculations View X-B diagrams: Navigate directly to X-B diagrams See section 11 for more details about quality control on the ‘ELite 5’ analyzer Diagnostics Self test: perform electronic and/or pneumatic system self test…

• Page 44
  ELite 5, User Manual Figure 25. Calibration in small sample module • In QC menu there is a new feature for Small Sample Mode. • Under Diagnostics, Information menu there is a new line which is indicating the state (on/off) of the Small Sample Mode.

• Page 45: Start Up And Shut Down Of ‘Elite 5

  The ‘ELite 5’ analyzer also has a ‘prepare for shipment’ shut down option that performs an extended cleaning and emptying of the pneumatic components. This option can be used to prepare the ‘ELite 5’ analyzer for an extended period of inactivity or for shipping to a new location.

• Page 46: Start Up The User Interface

  To start up the internal user interface computer of the ‘ELite 5’ analyzer, flip the standby switch near the top of the rear panel of the ‘ELite 5’ analyzer to the ‘up’ position. The standby switch springs back to the ‘down’ position after activation.

• Page 47: User Login

  Before measuring any blood or control samples, the pneumatic system components of the ‘ELite 5’ analyzer need to be initialized and a blank measurement run and accepted. To start the pneumatic system and run a blank measurement, click or tap the ‘Measure’ icon with the single test tube graphic on the top left corner of the screen.

• Page 48: Exiting The ‘Elite 5’ Analyzer

  • HGB ≥ 100 g/dL If the ‘ELite 5’ was not in use for an extended period of time, the start up of the pneumatic system components can take significantly longer time and require more blank measurements. To prevent these problems, use the ‘prepare for shipment’ process when the ‘ELite 5’…

• Page 49: Shut Down

  6.3.3 Prepare for Shipment If the ‘ELite 5’ analyzer is not used for a significant period of time or is being transported to a new location then the ‘prepare for shipment’ procedure should be performed instead the regular shutdown procedure.

• Page 50
  The ‘Prepare for Shipment’ procedure should be used for following reasons: • The reagents may spill out if the ‘ELite 5’ is tilted, potentially causing electrical short circuit or corrosion. •…
• Page 51
  It is strongly recommended that the ‘Prepare for shipment’ procedure is used if the analyzer will be inactive for more than five days. Higher temperature or lower humidity decreases the period of time the ‘ELite 5’ can be idle without performing the ‘Prepare for shipment’ procedure.

• Page 52: Emergency Shut Down

  The immediate shut-down can be initiated by pressing the standby button near the top of the back panel of the ‘ELite 5’ analyzer. This is the same button which is used to start up the ‘ELite 5’ user interface computer. This shuts down the user interface computer without properly shutting down the pneumatic system components.

• Page 53: Repackaging The ‘Elite 5’ Analyzer

  Place the lower part of the carton box on the pallet, and place the lower packaging foam on the carton bottom. • Put the ‘ELite 5’ into the plastic bag, and place it into the bottom foam part. • Put a desiccant bag into the plastic bag and close it.

• Page 54
  ELite 5, User Manual Make sure to use shipping straps or band to hold the package fixed on the pallet, otherwise the analyzer can be seriously damaged during shipping. Do not apply excess force to the straps because that may break the carton box and damage the analyzer.

• Page 55: Sample Measurement

  Please note that the Sarstedt Monovette sample tubes have a false bottom that is not the same as the bottom of the sample tube. The sampling depth on the ‘ELite 5’ ® analyzer must be changed for a Sarstedt Monovette sample tube.

• Page 56: Open Or Closed Sample Tubes

  The sample tube does not vent properly and contains residual vacuum The viscosity of the blood is very high • The ‘ELite 5’ is unable to aspirate the last 8 mm (0.31 inches) or 0.3 to 0.5 ml of sample volume. •…

• Page 57: Sample Types And Modes

  Controls are used to check the long term stability of the ‘ELite 5’ analyzer. Calibration with a calibration material is not one of the ‘ELite 5’ sample modes, but a specific procedure that can be accessed from the Calibration icon on the main menu.

• Page 58: Running Samples

  Activate or deactivate the automatic generation of sample IDs. If the ‘Autoincrement mode’ check box is checked, then the ‘ELite 5’ will add 1 to the last sample ID if it was fully numeric or offer ‘0’ if the last sample ID had any non-numeric characters.

• Page 59
  Select the sample mode: Blank: a blank measurement will be processed. This is the only option available if the pneumatic system is not initialized, or the ‘ELite 5’ was inactive for an extended period of time. After performing and accepting a blank measurement the other modes will be available.
• Page 60
  After starting the measurement the sample door rotates and takes the sample tube inside the ‘ELite 5’ analyzer. This is a key safety feature of the ‘ELite 5’ and protects the operator from the sample needle during routine operation. The Start button changes color to red to indicate that the system is busy processing the sample.

• Page 61: Prediluted Mode

  ELite 5, User Manual 7.4.2 Prediluted mode The sample pre-dilute method test protocol has been specifically developed to allow Elite 5 users to measure CBC results on samples having only small volumes or when one of the counted parameter result is higher than its linearity range.

• Page 62: Automatic Mode

  Autosampler. QC samples and open tubes must be processed in manual mode. After starting up the ‘ELite 5’, select the ‘Measure’ quick link. A new blank must be processed if this is the first time a new measurement panel is opened since starting up, or if an earlier blank has expired due to inactivity.

• Page 63
  Sample A1 is the first sample processed and sample J10 is the last. 7.4.3.1 Supported Barcode Some of the ‘ELite 5’ analyzer automatic processing modes use the barcode on the sample tube to determine the sample ID of the sample tube. The following bar code symbols are…
• Page 64
  Barcode labels are in use, and • An LIS system rather than the ‘ELite 5’ is used to associate patients with sample results. In Full Scan mode it is possible to add more samples to the batch after starting the automated measurement.
• Page 65
  The sample ID is not editable as it is read from the barcode label. If the barcode label is missing or not readable, the ‘ELite 5’ analyzer assigns a default value and allows manual entry of the sample ID.
• Page 66
  The Autosampler allows the addition of sample tubes to a Full Scan process already in progress. To add more sample tubes, perform the following steps: • Click or tap the ‘Stop’ button. The ‘ELite 5’ will prompt you to wait until the current sample is completed. •…
• Page 67
  ELite 5, User Manual and sample positions. It is not possible to add additional samples to the batch in free list mode after automated measurement has started. Figure 45. Free List Mode Selection On the Free List mode panel you can: •…
• Page 68
  ELite 5, User Manual Figure 46. Preparing a Free List As with the Full Scan mode, the Autosampler will scan all the sample positions on the tray and rows with missing racks will be skipped. The Autosampler will only process tube types it recognizes with caps attached.
• Page 69
  Selected Samples mode. An accepted blank measurement is required as with all sample processing. In Selected Samples mode, the ‘ELite 5’ analyzer will only look for samples in the sample positions selected for analysis. All other samples in sample positions that are not selected will be ignored.
• Page 70
  To interrupt automatic processing for stat specimens, perform the following steps: • Click or tap the ‘Stop’ button. The ‘ELite 5’ will prompt you to wait until the current sample is completed. •…
• Page 71
  ELite 5, User Manual 7.4.3.6 Controlling the Autosampler Detailed information about the Autosampler is available from the Autosampler info panel. You can also reset the Autosampler from this panel. Double click or tap the Autosampler status in the bottom left corner of the screen to view the Autosampler info panel. With this panel, you can command the Autosampler to repeat the last command, or reset the Autosampler.

• Page 72: Result Display

  7.7 The Measurement Process The ‘ELite 5’ analyzer measures 24 parameters of whole human blood samples. Internal dilutions are made to allow measurement of particles in the sample. Manual or automatic mode samples are processed in the same way.

• Page 73
  BASO Figure 52. ‘ELite 5’ Measurement Process When you present the sample tube and press the Start button, the ‘ELite 5’ rotates the sample rotor and takes the sample tube inside the analyzer. The piercing needle pierces the sample tube cap (if present) and aspirates approximately 110 µL of primary blood sample.

• Page 74: Result Interpretation

  ‘ELite 5’ analyzer. 8.1 The Result Screen Figure 53. ‘ELite 5’ Result Screen The ‘ELite 5’ analyzer result screen is divided into 4 major areas: 1. Sample identification information: contains identifying information used to uniquely identify this sample’s information.

• Page 75: Parameter Information

  This is the sample mode selected for this specimen. Each sample mode Mode applies a different set of normal ranges to this sample run. Table 4. Sample Identification Information 8.3 Parameter Information The parameter information area of the ‘ELite 5’ analyzer result screen lists information on 26 parameters. Flag Value Unit/5p Normal Range Figure 54.

• Page 76: Scatter Diagrams And Histograms

  Table 7. High Blank Flag 8.3.1 Scatter Diagrams and Histograms The ‘ELite 5’ analyzer displays the results of the optical measurements in scatter diagram representation. Scatter diagrams represent two-dimensional data. There are two scatter diagrams in the patient report: the 4-DIFF and BASO scatter diagrams.

• Page 77: Warnings

  ELite 5, User Manual Neutrophils (Magenta) Eosinophils (Orange) Non-Basophil WBCs (Blue) Monocytes Artifact (Green) (Black) Basophils (Magenta) Lymphocytes (Blue Figure 56. Result Screen Scatter Diagrams RBC and PLT impedance-based measurements are represented by histograms. These diagrams show the number of cells on the Y axis and the cell size on the X axis. Smaller cells are displayed on the left side of the histogram, and larger cells are displayed on the right side.

• Page 78
  ELite 5, User Manual Figure 58. Warnings Section of Results Screen The ‘ELite 5’ analyzer provides Warning flags, Morphological flags, and Interpretive messages in the Warnings panel. The following tables describe these flags and messages in detail. It also provides guidance on actions the operator can take to correct the problem described by the flag.
• Page 79
  If not all the parameters reported or the sample is predicted as pathological then perform a manual count on a stained smear. Check cleanliness of the reagents and the ‘ELite 5’. Perform cleaning of the ’ELite 5’. Repeat blank WBC blank is high WBC >…
• Page 80
  Check cleanliness of the reagents and the ‘ELite 5’. Perform flow cell cleaning of the ’ELite 5’. Repeat More than 100 cells detected during the ’4Diff-blank’…
• Page 81
  If any of RBC,PLT or WBC results are lower than Low None limit exceeded linearity range limits. Check cleanliness of the reagents and the ‘ELite 5’. Perform cleaning of the ’ELite 5’. Repeat blank PLT blank high Last accepted blank result: PLT ≥ 15 * 103 cells/µl measurement.
• Page 82
  There is a (partial) clogging or leakage in the RBC Perform cleaning of the ’ELite 5’. Perform a self-test. WBC vacuum warning part of measurement system. A faulty/ worn-out pump If vacuum problems persist then call for service.
• Page 83
  The count in the region of (low — high angle scatter of Perform a manual count on a stained smear. Immature granulocytes ELite 5) where the Immature granulocyte typically located is > 3% of the total WBC count. The count in the region of (low — high angle scatter of…
• Page 84
  ELite 5, User Manual Interpretive flag Interpretive flags infer the presence of distributional abnormalities such as leukocytosis. Flag Meaning Lymphocytosis LYM ++ Monocytosis MON ++ Eosinophilia EOS ++ Basophilia BASO ++ Anemia RBC — or RBC — Polycythemia RBC + or RBC ++…

• Page 85: Database Functions

  Each sample result stored includes the complete parameter list, histograms, flags, and identifying data. The ‘ELite 5’ has a data capacity of up to 100,000 total records. To activate Database panel, clicking or tapping the Database quick link on the top of the screen will take you to the database view from any screen.

• Page 86: Scrolling The Database View

  Database records can be exported for storage and backup. Exported database information can be later imported for review. Imported records do not become part of your ‘ELite 5’ analyzer’s database. They are only imported for viewing, but can be sorted, selected, and managed in the same way as with the regular data stored inside the ‘ELite 5’…

• Page 87: Sorting Database Information

  Analysis Time Time and date this sample tube was analyzed Result ID Unique sequential identifier assigned by the ‘ELite 5’ to each records Table 11. Database Sort Criteria Clicking or tapping the same column heading again changes the ascending or descending order of values in the column.

• Page 88: Automatic Selection Of Database Records

  All data manipulation actions that change the data stored in the ‘ELite 5’ database are logged in the ‘ELite 5’ log. If the multi-user mode is enabled, the name of the operator logged on at the time the data manipulation occurs will also be stored in the log.

• Page 89: Select By

  ELite 5, User Manual 9.8.1 Select By Click or tap the ‘Select by’ button on the Manage Records panel to display the Select by panel. The Select by panel allows you to select a group of records with dates and Result IDs that match criteria entered into the panel.

• Page 90: Importing

  ‘Clear’ removes selected records from the imported records table, but does not permanently remove the cleared records from the stored database file. • ‘Back’ ends viewing of imported database information and returns to the ‘ELite 5’ stored database. Page 90 of 159…

• Page 91: Export

  Introduce a USB storage device (USB hard drive, memory stick, etc.) into an available USB port on the back panel of the ‘ELite 5’ analyzer. Select the directory to store the exported data and press the ‘Ok’ button to start the export.

• Page 92: Save Raw Data

  555. This password can be changed only by Erba Lachema certified service engineer. Insert a USB data storage device to one of the USB inputs on the back panel of the ‘ELite 5’ analyzer. Click or tap the ‘Save raw data’ button on the Manage records panel, then enter the correct confirmation password.

• Page 93: Calibration

  WBC, RBC, PLT, HGB, MCV and MPV. To view the calibration functions of the ‘ELite 5’ analyzer, select the ‘Calibration’ icon on the main menu to display the calibration panel. The Calibration panel displays an option to calibrate the ‘ELite 5’…

• Page 94: Calibrating The ‘Elite 5

  To perform the automated calibration procedure, ensure that the ‘ELite 5’ pneumatic system is started up and that a valid blank measurement has been accepted. Perform the following steps: •…

• Page 95: View Calibrations

  Manually entered factor values can be accepted in the same way as calculated factors from calibration sample runs, and are treated by the ‘ELite 5’ in the same way. 10.1.1 View Calibrations The view calibration features is helpful for reviewing the calibration history for the analyzer.

• Page 96: Ssm Calibration

  To delete a calibration, click or tap the ‘Delete’ button. The system will ask you for a confirmation password to avoid accidental deletion of calibration data. The confirmation password is set at the factory to 555, and can be changed by your Erba Lachema certified service engineer.

• Page 97: Quality Control

  Control materials must be well mixed before use. The ‘ELite 5’ analyzer does not limit the number of QC material lots or the number of QC measurement runs that are stored in the control database. Each QC measurement run is saved to the selected QC material lot.

• Page 98
  Enter the identifying information, and the target values and tolerance ranges for any parameters that are to be controlled with the ‘ELite 5’ QC system. To exclude a parameter from the QC procedure, leave its target value and tolerance range field empty. Press the ‘Save reference’…

• Page 99: Qc Measure

  11.3 View QC References Click or tap the ‘View QC References’ button to see a list of QC lot references stored in the ‘ELite 5’ analyzer control database. Target values and ranges can be viewed for any stored QC references.

• Page 100: View X-B Data

  Take attention to choose the proper values and ranges for QC. 11.6 View X-B Data ‘ELite 5’ offers X-B to facilitate trend analysis of samples run. The X-B moving average is an algorithm which is capable of tracking changes of the accuracy- alternating of the measurements.

• Page 101: View X-B Diagrams

  ELite 5, User Manual 11.7 View X-B diagrams View X-B diagrams displays X-B charts for MCV, MC and MCHC. View X-B data function displays X-B information in a table format similar to view QC data. Page 101 of 159…

• Page 102: Patients

  ELite 5, User Manual Patients The ‘ELite 5’ analyzer allows the operator to define and store patients in the patient database during manual measurement. Patients can also be predefined while creating a list for one of the automatic processing modes.

• Page 103
  ELite 5, User Manual Figure 75. Edit Patient Panel The ‘Save’ function saves any changes made. To discard any changes made, simply click or tap the ‘Back’ button. Page 103 of 159…

• Page 104: Settings

  ELite 5, User Manual 13 Settings The ‘ELite 5’ analyzer can be tailored to your laboratory’s needs by changing the settings. Click or tap the ‘Settings’ icon on the main menu to access the Settings panel. Figure 76. Settings Panel The options available on the Settings panel are: •…

• Page 105: Laboratory Settings

  The ‘skins’ has no effect on the behavior of the ‘ELite 5’. • Language – select the language that the ‘ELite 5’ analyzer user interface uses to communicate with the operator. Available languages are English, Spanish, French, Croatian, Hungarian, Italian, Polish, Russian, Turkish, Chinese, German & Greek.

• Page 106: External Devices

  • Sending port baud rate – select 9600 or 115200 baud for serial LIS connection. • Automatic LIS – The ‘ELite 5’ will transmit every measurement result as soon as it is available if this check box is checked. •…

• Page 107: System Settings

  (or LIS computer) to send it instruction. Consult your information technology staff regarding the configuration of the host computer and the ‘ELite 5’ analyzer for proper LIS operation. Your information technology staff person may need to consult your Erba Lachema certified service engineer to ensure the Internet Protocol (IP) settings of the ‘ELite 5’…

• Page 108: Units

  ELite 5, User Manual Figure 79. System Settings Panel 13.5 Units The Units panel allows the user to choose which units are displayed for certain parameters. The following options are available on the Units panel: • HGB unit – choose g/dL or g/L to change the displayed units for the HGB and MCHC parameters.

• Page 109: Printer Settings

  Automatic print – check this check box to print every sample or control as it is run. • Logo visible – check this box to print the Erba Lachema logo on every printed report. • Warning flags are visible – check this box to print warning flags on every printed report.

• Page 110: Profile Limits Settings

  The Profile Limits settings are used to view and modify the normal ranges associated with the ‘ELite 5’ analyzer’s five sample modes: Human, Male, Female, Alternate 1 and Alternate 2. NOTE: Alternate 1 and Alternate 2 are sample modes that are different than Human, Male and Female and have user-definable normal ranges.

• Page 111: X-B Settings

  ELite 5, User Manual Figure 82. Profile Limits Settings Panel In SSM mode we are using the same profile limits as we are using in normal mode. 13.8 X-B Settings The X-B panel displays the currently selected X-B constants. Change the values as needed, then click or tap Save to save the new values and return to the Settings panel, or select Back to discard any changes and return to the Settings panel.

• Page 112: User Settings

  ELite 5, User Manual 13.9 User Settings The User Settings panel allows administrators to delete users, or assign administrator rights. Figure 83. User Settings Panel Users with Administrator privileges can have access all over the system. Only an administrator user can grant or revoke administrator rights.

• Page 113: Date And Time Adjustment

  Click or tap ‘Cancel’ to exit the Time/Date settings without saving. Figure 84. Time/Date Settings The ‘ELite 5’ analyzer does not support automatic time zone or daylight savings time changes. Please change the time and date manually when necessary.

• Page 114: Instrument Diagnostics

  ELite 5, User Manual 14 Instrument Diagnostics This section allows the operator to perform diagnostic procedures, check the operational history of the instrument, set or check the status of the reagents and view stored information about the system. Click or tap the ´Diagnostics´ button on the main menu to view the available options in the Diagnostics panel.

• Page 115: Self Test Of The Analyzer

  ELite 5, User Manual 14.1 Self Test of the Analyzer Initiating a self test will test the key functions and components of the analyzer. The process takes approximately one minute and gives evaluation of each parameter. The acceptable ranges of each tested parameter or function can be found in the following table.

• Page 116
  ELite 5, User Manual Chamber -20 — 20mBar Noise/Pulse HGB head pls/5sec 0 — 2000 pulses HGB Dark 0 — 3000 pulses 20000pls 19990 — 20050 pulses HGB light 3000 — 60000 pulses TCU temperature Laser parameters Actual Reference +- 0.2 °C…

• Page 117: Daily Log

  The height of the bar shows the level in the container. These levels are also indicated on the screen in the status area. ELite 5 send special message if any of the reagents are running low. Check and change the reagent container and reset the reagent status bar on the screen.

• Page 118: Statistics

  ELite 5, User Manual 14.4 Statistics This menu item will display cumulative number of measurements and number of possible failure events experienced during operation. Statistical data can be reset by a certified service engineer only. Figure 89. Statistics display 14.5 Information…

• Page 119
  ELite 5, User Manual The information panel also contains a Collect button. By pressing this, there is a chance to save a .gz file to the selected path. This file can be sent to the local service engineer. The file contains valuable information about the instrument including self test, stress measurement and the calibration factors.

• Page 120: Maintenance

  ELite 5 is a completely automated hematology analyzer. Special ‘Erba Lachema ELite 5 Service Training’ is required to resolve major problems occurring during operation. Electrical and moving parts should always be serviced by trained person.

• Page 121: Closing The Front Panel

  Always make sure to re-tighten the thumb screws when reinstalling side panels. 15.1.3 User Maintainable Parts of the Analyzer There are three user maintenance points in ´ELite 5´ analyzer. Shear valve: this is a key component and is responsible for correct sampling and diluting procedures.

• Page 122: Maintenance Programs Of The Analyzer

  ELite 5, User Manual Measuring chambers: contamination induced problems such as noise, high blank values can usually be resolved by cleaning the plastic measuring chambers. General precautions: Always wear protective gloves when working on internal parts of the analyzer. 15.2 Maintenance Programs of the Analyzer Maintenance functions can be accessed from the menu system by clicking or tapping the Maintenance main menu.

• Page 123: Cleaning The Shear Valve

  ELite 5, User Manual software is going to prompt the user to add external cleaning reagent (Erba Hypoclean CC) in the sample position (manual measurement). Draining Drain Diff-5P: drains the Diff-5P reagent Drain sheath: drains the sheath buffer Drain Lyse-5P: drains the Lyse-5P reagent…

• Page 124
  Figure 94. Maintenance menu-shear valve The ‘ELite 5’ asks for confirmation to start the procedure. After clicking or tapping the ’OK’ button the ‘ELite 5’ empties the shear-valve and the connecting tubes. A small amount of liquid may remain inside the tubing and inside the shear-valve.
• Page 125
  ELite 5, User Manual Any salt build-up on the inner surface of the shear-valve may cause malfunction during operation. To avoid this problem, it is recommended to clean the shear valve after every 1200 samples. 1: Open the front cover and secure it with the latch. Locate the shear valve in the center of the analyzer.
• Page 126
  Remove the gloves. Close the front door and remove gloves. 13: Click or tap the ‘OK’ button to inform the ‘ELite 5’ that you completed the cleaning of the shear valve. The ‘ELite 5’ will check the movement and end-positions of the shear valve.

• Page 127: Cleaning The Washing Head

  ELite 5, User Manual 15.2.2 Cleaning the Washing Head The washing head cleans the outer surface of the aspirating tip with diluent. Any salt build-up on the lower surface may cause malfunction during operation. The wash head must be removed from the needle assembly for correct cleaning.

• Page 128: Cleaning The Measuring Chambers (Hard Cleaning)

  AND SMALL PARTICLES WILL FALL INTO THE SOLUTION WHICH CAN CAUSE CLOGGING IF ASPIRATED BY THE SAMPLING NEEDLE After this operation, you can leave ELite 5 on for the rest of the day. It will go into a low power state after a specified time.

• Page 129: Replacing Reagents

  ELite 5, User Manual 15.2.6 Replacing Reagents ‘ELite’ 5 analyzer is designed to be able to run continuously without the need to stop if a reagent container needs to be replaced. To support this feature, internal buffers keep regents sufficient for one measurement cycle.

• Page 130: Disposal Of Reagent Containers

  ELite 5, User Manual To replace reagent containers: • Prepare the new container, and place it near the place of operation. • Open the bottle (remove cardboard flaps if necessary (5L and 20L containers). • Unscrew the cap from the used container and place it into the new container.

• Page 131: Reagent Locking

  ELite 5, User Manual 16 Reagent Locking Reagent locking is a commercial feature of the ‘ELite 5’ ensuring that only manufacturer recommended and approved reagents are used with the analyzer. This way analyzer performance cannot be impaired by incompatible reagents. All necessary hardware and software elements are installed and configured on each ‘ELite 5’…

• Page 132: The Daily-Routine

  This chapter also contains some trick and tips. The below assumes that the laboratory works during ‘office hours’ only. The daily routine: Power up and start-up the ‘Elite 5’ analyzer. See Chapter 6.2.2. for details Perform the pneumatics initialization and blank measurement (tap the sampling tube icon)

• Page 133
  ELite 5, User Manual Cleaning: Perform cleaning / hard cleaning if: High blank results experienced; Clogging related flags are added systematically to measurement results; After service actions, service level maintenance; Measurement results, QC results are drifting (perform hard cleaning); Clog formation in the tubing (first remove the plugging, contamination);…

• Page 134: Troubleshooting

  ELite 5, User Manual 18 Troubleshooting Your ‘ELite 5’ software is equipped with all the functions to keep the analyzer in good working conditions. Despite careful planning and SW features, the analyzer can still encounter problems where user interaction is required or the user needs to be informed of situations when further help is required.

• Page 135: Mechanical Problems

  ELite 5, User Manual With the ‘Ok’ button, you can return to the current operation and retry the actual process. You can also tap on the Details button and then you will be able to get further informaion about the error. It will describe additional conditions of the failure. The numbers in the second row are important for the service personnel.

• Page 136: Sr Error Appears During Initialization Process

  ELite 5, User Manual 18.4.2 SR Error Appears During Initialization Process: • Check the washing head for contamination (blood and salt) • Contact service 18.4.3 The SR Does Not Turn Into the Analyzer Even With Open Front Panel • Check the washing head for contamination (blood and salt) 18.5 Needle Mechanics, Vertical Motor (Mvert) Problems…

• Page 137: Dilutor Errors

  ELite 5, User Manual 18.7 Dilutor Errors • Pinched, clogged tube around dilutor or at the rear reagent tubes • Physical obstruction (foreign material) 18.8 Priming Problems 18.8.1 The Analyzer Would Not Prime Liquids • The respective reagent is out •…

• Page 138: Measurement Results Related Problems

  18.12.1 Fluctuating PLT background values When the ELite 5 is used under increased workload, running even 300 samples a day (meaning 5 hours of continuous operation) is possible. Despite built-in maintenance programs, the system may require intensive cleaning from time to time.

• Page 139: Accessories

  ELite 5, User Manual 19 Accessories The following items can be found along with the analyzer: Power cord Reagent tube kit Cleaning tube kit Waste container (20L) Cardboard box for waste container Sample tube adapter User’s manual Page 139 of 159…

• Page 140: Appendices

  ELite 5, User Manual 20 Appendices 20.1 Reagent Consumption Function Reagent consumption / function (ml) Erba Lyse-5P Erba Diff-5P Erba Dil-Diff Start Up 13.6 Measure Blank Measure 5 part Measure Calibration Measure QC Measure SSM blank Measure SSM 5-part Measure SSM Calibration…

• Page 141: Display Range

  ELite 5, User Manual 20.2 Display Range Parameter Range Selectable Dimensions 1.00 – 99.99 * 10 / µl cells/l, cells/µl 0.00 – 9.99 * 10 / µl cells/l, cells/µl 0 – 300 g/l g/dl, g/l, mmol/l 0 – 100% percentage, absolute 0 –…

• Page 142: Printed Report Formats

  ELite 5, User Manual 20.3 Printed Report Formats Page 142 of 159…

• Page 143
  ELite 5, User Manual Page 143 of 159…

• Page 144: Specifications

  ELite 5, User Manual 20.4 Specifications 20.4.1 Measured Parameters White Blood Cells – WBC Number of leukocytes (cells/l, cells/µl) WBC = WBC cal x (cells/l, cells/µl) Red Blood Cells – RBC Number of erythrocytes (cells/l, cells/µl) RBC = RBC cal x (cells/l, cells/µl) Hemoglobin concentration — HGB Measured photometrically at 540 nm;…

• Page 145: Technical Data

  ELite 5, User Manual Mean Platelet Volume – MPV Average volume of individual platelets derived from the PLT histogram (fl) Thrombocrit – PCT Calculated from the PLT and MPV values PCTpercentage = PLT x MPV x 100 (percentage, absolute) PCTabsolute = PLT x MPV…

• Page 146
  Fine calibration: with calibration material (Polystyrene micro- particle or Polystyrene microsphere, 5 m) Reagents Erba Dil-Diff (20 liters) Erba Lyse-5P (5 liters) Erba Diff-5P (1 liter) Erba Hypoclean CC (100 ml) (Emergency cleaner) Dilution ratios WBC/BAS 1: 170 RBC/PLT 1: 21250…
• Page 147
  ELite 5, User Manual Peripheral ports USB (2.0) 4pc., Ethernet, PS/2 Power requirements Power supply input: 100-127VAC/200-240 VAC; 47Hz to 63Hz Power Consumption: maximum 400 VA Main fuse F 10A H 250V 15-30° C (59-86 °F); Operating temperature Maximum relative humidity 80%…

• Page 148: Performance Data

  ELite 5, User Manual 20.4.3 Performance Data 20.4.3.1 Precision Parameters Range CV ≤ 3% 4.7 * 10 / µl ≤ WBC≤ 38 * 10 / µl All 5 part parameters (NEU, LYM, MON, EOS, BAS abs and %) at 4.7 * 10 / µl ≤…

• Page 149
  ELite 5, User Manual 20.4.3.2 Accuracy Values And Ranges Accuracy Experienced Range coefficient Against Reference (Cell-Dyn 3700) r = 1.00 0.5*10 / µl ≤ WBC ≤ 56.3*10 /µl r = 0.99 2.2 *10 / µl ≤ RBC ≤ 6.3 * 10 /µl…
• Page 150
  ELite 5, User Manual 20.4.3.3 Linearity Values and Ranges Linearity Coefficient of determination Range 0.95 1*10 / µl ≤ WBC ≤ 100*10 /µl 0.95 0.4 *10 / µl ≤ RBC ≤ 7.5 * 10 /µl 0.95 13 g/l ≤ HGB ≤ 227 g/l 0.95…

• Page 151: Reagent System

  Isotonic solution, used to dilute whole blood and quantitative and qualitative determination of RBC, WBC, PLT and HGB concentration. 20.4.4.2 Lyser Erba Lyse — 5P WBC-5 Part: Reagent for stromatolysis of RBC and quantitative determination of WBC 5-part differentiation (LYM, MON, NEU, EOS, BAS) and HGB concentration measurement of human blood.

• Page 152: Tab File Format

  ELite 5, User Manual 20.4.5 Tab File Format This file format is composed of a header line and consecutive lines containing records selected for saving. Each parameter is selected by the <TAB> (08h) character, allowing easy interfacing or importing into most data processing applications, like Microsoft® Excel. Scatter diagrams and historgrams, flags are NOT saved in this format.

• Page 153: Fluidic System

  ELite 5, User Manual 20.5 Fluidic System Page 153 of 159…

• Page 154: Summary Of Cleaning Products And Procedures For Elite Hematology Analyzers

  The recommendation is to use this solution as daily cleaner (connected instead of Erba Cleaner) only in case of daily high workload. Erba Hypoclean is a < 9% hypochlorite solution for cleaning purposes. It should be used in case of massive dirt, dried blood etc. in the system. You can use it in vial and run cleaning cycle from software.

• Page 155: Known Problems

  ELite 5, User Manual 21 Known Problems The following problems are known at the time of the releasing of the software and this user manual: Long Sample ID is not visible on printout and on display. Tooltip info contains square character instead of upper index 6/9/12.

• Page 156: Index

  ELite 5, User Manual 22 Index aperture, 24, 30 BASO, 26, 73, 76, 80, 82, 83, 84, 145 blank, 25, 39, 45, 47, 48, 50, 51, 57, 58, 59, 62, 64, 66, 69, 74, 75, 76, 79, 80, 81, 90, 94, 95, 99, 122, 128, 132, 133, 144…

• Page 157
  ELite 5, User Manual needle, 10, 28, 31, 47, 55, 60, 73, 127, 136 NEU, 21, 24, 25, 75, 80, 83, 108, 141, 145, 148, 149, 151, 152 noise, 83, 122, 135 normal ranges, 42, 57, 59, 66, 69, 75, 105, 110, 146…

• Page 158: Contact

  ELite 5, User Manual 23 Contact For customer and technical support: Manufacturer: Erba Lachema s.r.o., Karásek 2219/1d, 621 00 Brno Czech Republic Tel: +420 517 077 111 e-mail: diagnostics@erbamannheim.com Website : https://www.erbamannheim.com/en/product-support/ Contact your local technical support: (Print this page and write or paste contact information…

• Page 159: Appendix- Package Inserts For Reagents And Cleaning Solutions

  ELite 5, User Manual Appendix- package inserts for reagents and cleaning solutions Revision 3.0 Date of Revision 07/2017 HEMA/PI/27/17/C Page 159 of 159…

• Page 160
  Please refer to the instrument’s User Manual for further in- — Store Erba Lyse-5P lysing reagent between +15 and +30°C. formation. — The shelf life of the Erba Lyse-5P lysing reagent is 24 INGREDIENTS months from date of manufacture, if stored at the prescribed Surfactants <…
• Page 161
  < 0.5 % and +30°C. in ion-free water — The shelf life of the Erba Diff-5P WBC-5-part reagent is 24 HANDLING PRECAUTIONS months from date of manufacture, if stored at the prescribed — Erba Diff-5P differentiation reagent is environmental frien- temperature range.
• Page 162
  15 and 30°C. P303+P361+P353 IF ON SKIN (or hair): Take off immedia- — The shelf life of the Erba Hypoclean CC is 15 months from tely all contaminated clothing. Rinse skin with water/shower. date of manufacture, if stored at the prescribed temperature P305+P351+P338 IF IN EYES: Rinse cautiously with water range.
• Page 163
  — Store Erba Dil-5P diluent between +15 and +30°C. Stabilizers < 0.4 % — The shelf life of the Erba Dil-5P is 36 months from the date in ion-free water of manufacture, if stored at the prescribed temperature range. — Do not use reagent beyond the expiration date printed on HANDLING PRECAUTIONS the container label.
• Page 164
  Store Erba Clenz enzymatic cleaner reagent between 15 – 30°C. Erba Clenz HEM00017 The shelf life of Erba Clenz is 24 months from the date of manufacture, if stored at the prescribed temperature range. For in vitro diagnostic use only Do not use reagent beyond the expiration date printed on the container label.
• Page 165
  < 1.0% Store Erba Hypoclean hypochlorite cleaning reagent between 15 – 30°C. Sodium hydroxide < 0.5% The shelf life of Erba Hypoclean is 24 months from the date of manufacture, Stabilizers < 0.4% if stored at the prescribed temperature range.