User Manual
EDITION: Date: December 2020 Document no.: 1000027791_B Version 2 SOFTWARE: User Software Version 1.0 TRADEMARKS: Microsoft and Windows are registered trademarks of Microsoft Corporation in the United States and/or other countries. Mozilla and Firefox are registered trademarks of Mozilla Corporation. Adobe, Acrobat and Adobe Reader are registered trademarks of Adobe Systems Incorporated.
TABLE OF CONTENTS 1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 1.1 1.2 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1 Typographical conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2 1.2.1 Terminology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 1.2.2 Display of warnings and notes . . .
3.4 Load . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-42 3.4.1 Load or unload samples, calibrators, and controls . . . . . . . . . . . . . . . . 3-43 3.4.2 Load or unload reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-55 3.5 Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-59 3.5.1 Filter and table header . . . . . . . . . . . . . . . . .
8 Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1 8.1 8.2 8.3 Accessories and Consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1 Spare parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1 Important consumable information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2 8.3.1 Anchor® Tips trays/Anchor® Tips. . . . . . . . . . . . . . . . . . .
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INTRODUCTION INTENDED USE 1 INTRODUCTION This manual was created to assist the laboratory user with the utilization of the KleeYa instrument. 1.1 INTENDED USE The KleeYa instrument is a fully automated chemiluminescence platform enabling the complete automation for immunoassay, like performing the sample processing (sample pre-dilutions, sample and reagent dispensing, incubations, wash processes) as well as the measurement and evaluation. Individual assays are carried out in disposable cuvettes.
INTRODUCTION TYPOGRAPHICAL CONVENTIONS 1.2 TYPOGRAPHICAL CONVENTIONS The warnings, notes and symbols described hereafter are used in the current manual, on the instrument and on its packaging. 1.2.1 TERMINOLOGY As used in this instruction manual in general and with regard to safety information, safety messages and warnings in particular, the following words have the following meanings: 1-2 May This word is understood to be permissive. You can do what is mentioned.
INTRODUCTION TYPOGRAPHICAL CONVENTIONS 1.2.2 DISPLAY OF WARNINGS AND NOTES DANGER Danger indicates a hazardous situation that, if not avoided will result in death or serious injury. WARNING Warning indicates a hazardous situation that, if not avoided, could result in death or serious injury. CAUTION Caution indicates a hazardous situation that, if not avoided, could result in minor or moderate injury. NOTICE Notice indicates information considered important, but not hazard-related (e.g.
INTRODUCTION TYPOGRAPHICAL CONVENTIONS 1.2.
INTRODUCTION TYPOGRAPHICAL CONVENTIONS 1.2.4 OTHER SYMBOLS CE mark Certification label of the Nemko North America, Inc. The instrument is a class 1 laser product according to IEC 60825-1:2014. It also complies with 21 CFR 1040.10 and 1040.11 except for conformance with IEC 60825-1 Ed. 3., as described in Laser Notice No. 56, dated May 8, 2019.
INTRODUCTION TYPOGRAPHICAL CONVENTIONS 1.2.5 SPECIAL TYPES LEDS AND SIGNAL LAMPS LEDs (light emitting diode) and signal lamps are printed in gray blue type. Example: Power LED, Error LED MENU ITEMS AND FIELDS Menu items and fields are printed in gray bold type. Example: File Menu BUTTONS Buttons are printed in gray blue bold type. Example: Open button. KEYS Keys are printed in gray slanted type. Example: Press Enter FILE EXAMPLES File examples are printed in typewriter font. Example: DRIVER=C:\S
INTRODUCTION QUALIFICATION FOR USER 1.3 QUALIFICATION FOR USER 1.3.1 QUALIFICATION FOR BASIC USER Medical laboratory assistant capable of performing laboratory examinations of sample fluids and tissue, in order to prevent, identify and treat diseases. REQUIRED KNOWLEDGE • Ability to follow basic laboratory procedures and techniques. • Ability to solve (troubleshoot) technical problems. • Ability to operate laboratory instruments. • Ability to perform basic instrument maintenance.
INTRODUCTION SAFETY INSTRUCTIONS 1.4 SAFETY INSTRUCTIONS The aim of this section is to bring the user's attention to the few residual risks that exist despite the constructive protective measures taken. The following safety instructions shall be observed at all times, both before and during operation and during maintenance. Handling of the user manual The user manual is provided for your safety and gives important instructions for the handling of the instrument described.
INTRODUCTION SAFETY INSTRUCTIONS 1.4.1 GENERAL SAFETY Non-observance of safety instructions The non-observance of safety instructions may result in serious personal injury and material damage. • Follow all safety instructions included in this manual. • Follow all warnings marked on the instrument. Improper use of the instrument Improper use of the instrument can cause personal injury, produce erroneous results and produce damage to the instrument.
INTRODUCTION SAFETY INSTRUCTIONS Overheating Improper placing of the instrument may cause fire or serious instrument damage in case of overheating. • Do not block or cover ventilation slots. • The air shall be able to circulate. Sharp edges Sheet metal parts and circuit boards located behind protective covers might have sharp edges. Contact might lead to injuries.
INTRODUCTION SAFETY INSTRUCTIONS 1.4.2 ELECTRICAL SAFETY Non-observance of rules and regulations Non-observance of rules and regulations will cause serious personal injury with deadly consequences and material damage. • National rules and legal regulations for the safe electrical operation of the instrument shall be observed.
INTRODUCTION SAFETY INSTRUCTIONS Electric shock by electrical devices on wet surfaces or due to spilled liquid Working with electrical devices on wet surfaces (floors, work table) or due to spilled liquid will cause serious injuries with deadly consequences and material damage due to electric shock. • Only work on dry surfaces (floors, work table). Emergency shutdown in case of functional disorder Functional disorder of the instrument will cause electrical shock, burns, cuts or bruises.
INTRODUCTION SAFETY INSTRUCTIONS 1.4.3 BIOLOGICAL SAFETY Risk of infection! The instrument shall be treated as potentially infectious. Improper handling of infectious parts will cause skin irritations, illnesses and possible death. • Strictly follow the local and national provisions, legislation and laboratory regulations. • Use appropriate gloves! • Use an appropriate lab coat! • Use an appropriate eye protection (e.g.
INTRODUCTION SAFETY INSTRUCTIONS 1.4.4 DISPOSAL AND DECONTAMINATION Infectious waste Potential infectious material and all parts that may come in contact with potential infectious material will cause severe environmental contamination. • Strictly follow the local and national provisions, legislation and laboratory regulations. Misuse of battery The product may contain an internal lithium manganese dioxide, vanadium pentoxide, or alkaline battery or rechargeable battery.
INTRODUCTION POSITIONS OF SAFETY LABELS AND TYPE LABEL 1.5 POSITIONS OF SAFETY LABELS AND TYPE LABEL Missing warnings Missing or unreadable warning labels or type labels will result in non-identified dangers. This could result in serious personal injury and material damage. • Check the instrument for missing or unreadable warning labels and type labels. • Missing or unreadable warning labels or type labels shall be replaced.
INTRODUCTION POSITIONS OF SAFETY LABELS AND TYPE LABEL 1-16 1. General warning label: • on the left and the right pipettor arm • inside the instrument, to the right and left of the Dispense Cartridges area • on the instrument side behind the wash buffer/system liquid containers drawer cover • on the instrument side behind the liquid waste containers drawer cover 2.
INTRODUCTION POSITIONS OF SAFETY LABELS AND TYPE LABEL 11.
INTRODUCTION RADIO INTERFERENCES 1.6 RADIO INTERFERENCES Electromagnetic Compatibility (EMC) This instrument complies with the emissions and immunity requirements as described in standard IEC 61326-2-6. This instrument has been developed and tested according to CISPR11 Class A. It may cause radio interference in domestic environments. • If the instrument causes radio interference, you may need to take measures to eliminate the interference.
INTRODUCTION CYBERSECURITY 1.7 CYBERSECURITY 1.7.1 INTRODUCTION The KleeYa main software (= specific KleeYa instrument software, PC software, which is used to control the instrument) is intended to be used in a defined and controlled environment. Access to the KleeYa main software is allowed only to trained and authorized users.
INTRODUCTION CYBERSECURITY 1.7.3 USER TRAINING AND EDUCATION Only trained and authorized end-users shall operate the KleeYa System, since these users are supposed to follow the intended use of the KleeYa System. Trained and authorized end-users are responsible for information security. In order to minimize the risks, users need to be trained on a regular basis on Cybersecurity best practices.
INTRODUCTION CYBERSECURITY Type of threat source Description ADVERSE • Individual • Outsider • Insider • Trusted insider • Privileged insider • Group • Ad hoc • Established • Organization • Nation-State Individuals, groups, organizations, or 1. Obtaining unauthorized access to states that seek to exploit the sensitive system files based on organization’s dependence on cyber known system vulnerabilities. resources (i.e., information in 2.
INTRODUCTION CYBERSECURITY Type of threat source Description ENVIRONMENT • Disaster (natural or man-made) Natural disasters and failures of critical infrastructures on which the organization depends, but which are outside the control of the organization. Note: Natural and man-made disasters can also be characterized in terms of their severity and/or duration.
INTRODUCTION CYBERSECURITY B) Recommended actions/behavior All passwords are to be treated as sensitive, confidential information. 1. Access; only allow legitimate and trained users access to the KleeYa System with a password. 2. Individuality; each user shall have its own user name. Do not reuse the password for personal access for the KleeYa System. 3. Sharing passwords; passwords shall not be exchanged between authorized users. 4.
INTRODUCTION CYBERSECURITY access and observation by unauthorized personnel. Thus, access and espionage by unauthorized persons is prevented. 1.7.8 EXTERNAL MEDIA AND DEVICES Working with the computer of the KleeYa System can lead to voluntary or involuntary introduction of malicious software, like viruses, worms, spywares. Malwares are designed to infiltrate or damage a computer system without the owner's informed consent.
INTRODUCTION CYBERSECURITY 1.7.8.2 CONNECTION TO A KEYBOARD AND MOUSE The KleeYa System provides easy an intuitive menu navigation by touch-screen, thus neither the usage of a mouse nor a keyboard is required.
INTRODUCTION CYBERSECURITY d. Additionally updates of the antivirus software might affect the performance of the computer of the KleeYa System negatively, leading to a disruption of timing and failures in the subsequent data analysis processes. STRATEC is not the manufacturer of the antivirus software and cannot predict the effects updates would have on the functionality and performance of the KleeYa System.
INTRODUCTION CYBERSECURITY If for whatever reason network administrators decide to install security patches of the Operating System without known consent of STRATEC, the administrator bears full responsibility for the further correct functionality of the KleeYa System. STRATEC will not take over any responsibility for a System that was modified without consent. 1.7.10 PRIVACY OF DATA ON THE KLEEYA SYSTEM The KleeYa System generates analytical results in accordance with its intended use.
INTRODUCTION CYBERSECURITY This means that a multi-faceted strategy for security incident management must be implemented to ensure the IT environment is truly secure. The ISO/IEC Standard 27035 outlines a five-step process for security incident management, including: 1. Prepare for handling incidents. 2. Identify potential security incidents through monitoring and report all incidents. 3. Assess identified incidents to determine the appropriate next steps for mitigating the risk. 4.
INSTRUMENT DESCRIPTION INSTRUMENT OVERVIEW 2 INSTRUMENT DESCRIPTION 2.1 INSTRUMENT OVERVIEW ENVIRONMENT Compliance with the conditions required in terms of environment and electrical supply needs to be ensured in order to maintain the performance of the KleeYa instrument and to guranatee operators safety. The following environmental conditions are required for operating: • Ensure a surrounding temperature of 18°C to 30°C (64.4°F to 86°F). • The Humidity shall be 20 - 80 % non-condensing.
INSTRUMENT DESCRIPTION INSTRUMENT OVERVIEW Figure 2-1: 2-2 KleeYa instrument 1 Loading slot for cuvette stacks 2 Reagent pipettor with steel needle (SPOLV) 3 Cooled reagent loading bay for Reagent Cartridges 4 Dispense Cartridges 5 Double ring incubator with washers and measurement unit (luminometer) 6 Sample pipettor with Anchor® Tip adapter 7 Sample loading bay (for samples, calibrators, or controls) 8 Anchor® Tips loading bay 9 Touch screen 10 System liquid container with purified
INSTRUMENT DESCRIPTION INSTRUMENT OVERVIEW 12 Solid waste bag 13 PC (with own power switch) 14 Liquid waste containers 15 Power switch of the instrument (behind the touch screen on the instrument) Mains plug The mains plug can be found on the back of the instrument. CONTAINER NOTATION Figure 2-2: Container notation (e.g.
INSTRUMENT DESCRIPTION MODULES 2.2 MODULES TOUCH SCREEN AND PC The system is provided together with the user software, which is located on the PC of the KleeYa instrument. The user software provides access to the options and information required to operate the KleeYa instrument and is handled via a touch screen. All work processes and results are managed by the user software and stored on the PC. Optionally, the user software can communicate with devices in the laboratory network via the PC.
INSTRUMENT DESCRIPTION MODULES locations for the insertions of the Dispense Cartridges. Depending on the assay either two or just one Dispense Cartridge (Trigger Solution) might be needed. The Dispense Cartridges are placed on actuators on the measurement unit and dispense Trigger Solution into the cuvette from above. Please refer to the instruction for use of the corresponding assay for details. MEASUREMENT UNIT Cuvettes are transferred from the washer ring into a rotor inside the measurement chamber.
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BASIC FUNCTIONS TOUCH SCREEN 3 BASIC FUNCTIONS 3.1 TOUCH SCREEN For convenient interaction with the KleeYa instrument a touch screen is provided. All inputs can be made with a stylus (tip R0.8 or over) or a finger directly on the touch screen.Use: • Touch screen keyboard (alphanumeric inputs, e.g. A - Z, 0 - 9, etc.) • Single click and double click: • Single click: Tap the screen with your stylus/finger once. • Double click: Tap the screen with your stylus/finger twice.
BASIC FUNCTIONS MENU BARS (OVERVIEW) 3.2 MENU BARS (OVERVIEW) The user software provides access to the options and information required to operate the KleeYa instrument. Various fuctions of the instrument can be controlles via three menu bars. All functions of the instrument can be controlled via these menu bars. Figure 3-1: 3-2 Menu bars 1 Top menu bar (see chapter 3.2.1 on page 3-3) 2 Main menu bar (see chapter 3.2.2 on page 3-4) 3 Resources menu bar (see chapter 3.
BASIC FUNCTIONS MENU BARS (OVERVIEW) 3.2.1 TOP MENU BAR Shows the current time and date. Shows the current system status (e.g. initializing, ready). Start button to start a test run. Shows the user, who is logged in. Log off button to log off the current user. Started tests are executed further. Another user cannot use the instrument during this log off time. Shut down button to shutdown and switch off the user software. Help button to show the online help.
BASIC FUNCTIONS MENU BARS (OVERVIEW) 3.2.2 MAIN MENU BAR Overview This function/screen shows the status of all resources (Dispense Cartridges, cuvettes, Anchor® Tips, wash buffer, system liquid, solid waste and liquid waste) in the instrument. Additionally, these resources can be loaded and unloaded via this screen. Open maintenance tasks or errors are also shown. See chapter 3.3 on page 3-5 for detailed information.
BASIC FUNCTIONS OVERVIEW 3.3 OVERVIEW The Overview screen shows the status of all resources like Dispense Cartridges, cuvettes, Anchor® Tips, wash buffer, system liquid, solid waste and liquid waste and allows the loading and unloading. In addition, open maintenance tasks or event/ error messages are also shown. Figure 3-2: Overview screen 1 The Resources menu bar shows the state of the resources.
BASIC FUNCTIONS OVERVIEW PROCEDURE 1. 2. 3. 4. 5. RESOURCES MENU BAR Tap on the Overview button in the main menu bar or tap on a button in the resource bar to show the Overview screen. Load or unload resources: Tap on a button in the resource bar (1) or tap on the corresponding symbol (2) on the displayed instrument surface (see below).
BASIC FUNCTIONS OVERVIEW 3.3.1 LOAD OR UNLOAD DISPENSE CARTRIDGES The Trigger Solution detail view shows the available number of dispenses of the loaded Dispense Cartridges. Additionally the expiration date, the lot number and the ID of both Dispense Cartridges are shown. The KleeYa software reads the RFID label of the Dispense Cartridge and shows the information in the detailed view set. This includes the remaining dispense counters of all loaded trigger solutions.
BASIC FUNCTIONS OVERVIEW Figure 3-3: Trigger Solution detail view The filling status of the Dispense Cartridges are additionally displayed in color: • Grey: Liquid level ok. • Orange: Liquid level low. • Red: Dispense Cartridge empty. • Only borders of the cartridge: Dispense Cartridge not loaded (removed).
BASIC FUNCTIONS OVERVIEW PREPARATION DIATRON Trigger Solutions (Acridinium ester system): 1. Open the outer box with the Dispense Cartridges carefully. Figure 3-4: 2. Box Remove both boxes with the Dispense Cartridges from the outer box.
BASIC FUNCTIONS OVERVIEW Figure 3-6: 3. Open the desired box with the Dispense Cartridges in the middle by removing the pierced strip.
BASIC FUNCTIONS OVERVIEW 4. Remove the upper part of the box. Figure 3-8: 5. Opened box Open the inner foil package and remove the inside protective cardboard that stabilizing the Dispense Cartridge during transportation.
BASIC FUNCTIONS OVERVIEW 6. Remove only the Dispense Cartridge you want to use from the box. Store all other Dispense Cartridges in the box/according to information on label.
BASIC FUNCTIONS OVERVIEW UNLOADING 1. 2. 3. 4. Tap on one of the Dispense Cartridge buttons. The Trigger Solution detail view is shown on the Overview screen. Open the instrument cover. Pay attention to the correct Dispense Cartridge position. Press the locking of the empty Dispense Cartridge together (1). Figure 3-11: Unloading Dispense Cartridge 1 5. Drag them obliquely forward (2).
BASIC FUNCTIONS OVERVIEW Figure 3-12: Unloading Dispense Cartridge 2 6. 7. 8. 9. 3-14 Remove the Dispense Cartridge (3). Dispose the Dispense Cartridge. Store the Dispense Cartridge according to the consumable information (package insert) or dispose it according to the local and national provisions, legislation and laboratory regulations. Close the instrument cover or load a new Dispense Cartridge.
BASIC FUNCTIONS OVERVIEW LOADING 1. 2. 3. Tap on one of the Dispense Cartridge buttons. The Trigger Solution detail view is shown on the Overview screen. Open the instrument cover. Remove the cap (1) from the new Dispense Cartridge.
BASIC FUNCTIONS OVERVIEW 4. Insert the Dispense Cartridge port slanted into the correct position (2). Figure 3-14: Loading Dispense Cartridge 2 5. 6. 3-16 Press the locking together (3). Put up the Dispense Cartridge (4) and press it down slightly (5).
BASIC FUNCTIONS OVERVIEW Figure 3-15: Loading Dispense Cartridge 3 7. 8. 9. 10. Let the lock loose and make sure that it snaps into place. If necessary, unload/load the other Dispense Cartridge. Close the instrument cover. Check the shown Dispense Cartridge values in the Trigger Solution detail view on the Overview screen.
BASIC FUNCTIONS OVERVIEW 3.3.2 LOAD CUVETTES The Cuvettes detail view shows the number of loaded cuvettes and allows to load cuvette stacks. Cross-contamination by multi-use Repeatedly use of single-use cuvettes will cause cross-contamination. • Never reuse single-use cuvettes. Figure 3-16: Cuvettes detail view The filling status of the cuvettes are additionally displayed in color: • Grey: Number of cuvettes is high enough. • Orange: Number of cuvettes is low. • Red: No or not enough cuvettes loaded.
BASIC FUNCTIONS OVERVIEW PREPARATION 1. Open the box with the cuvette stacks carefully. Figure 3-17: Box with cuvette stacks 2. 3. Hold the cuvette bag on one corner and ensure that all cuvette stacks in the bag are below this area. Remove the upper end of the bag with a scissors and discard the cut-off part.
BASIC FUNCTIONS OVERVIEW LOADING Cuvette handling Hold the stack at the upper end. Don't touch the cuvette wall of the lowest cuvette! 1. Remove one cuvette stack from the bag. Figure 3-19: Load cuvettes 2. Insert one cuvette stack into the loading slot for cuvette stacks.
BASIC FUNCTIONS OVERVIEW 3. 4. Wait until the cuvette stack is completely loaded, the cuvette loading tower is turned, and the number in the cuvettes section is updated according to the new stack. If desired or necessary, repeat the loading procedure.
BASIC FUNCTIONS OVERVIEW 3.3.3 LOAD OR UNLOAD ANCHOR® TIPS The Anchor® Tips detail view shows the number of loaded Anchor® Tips and allows to load or unload Anchor® Tips. Cross-contamination by multi-use Repeatedly use of single-use Anchor® Tips will cause cross-contamination. • Never reuse single-use Anchor® Tips. Figure 3-21: Anchor® Tips detail view Please note the important consumable information (package insert) about the Anchor® Tips before use, see chapter 8.3.1 on page 8-3.
BASIC FUNCTIONS OVERVIEW PREPARATION 1. Open the shipping box with the Anchor® Tips carefully. Figure 3-22: Shipping box with Anchor® Tips 2. Remove one box from the shipping box.
BASIC FUNCTIONS OVERVIEW 3. Open the box with the Anchor® Tips tray boxes carefully.
BASIC FUNCTIONS OVERVIEW UNLOADING 1. 2. 3. 4. Tap on the Anchor® Tips button or on the corresponding symbol on the displayed instrument surface. The Anchor® Tips detail view is shown on the Overview screen. Open the sample/Anchor® Tips loading bay flap. Tap on the Unlock button of the desired Anchor® Tips tray. The closed Lock symbol changes to a opened Lock symbol. Pull out the drawer of the desired Anchor® Tips tray. Figure 3-25: Loading bay drawer with empty Anchor® Tips tray 5.
BASIC FUNCTIONS OVERVIEW 2. Remove one Anchor® Tips tray box. Figure 3-26: Anchor® Tips tray box 3. Open the Anchor® Tips tray box. Note that there are two Anchor® Tips trays in the box. The openings for them are at the top and bottom. Only one of the openings shall be opened at a time.
BASIC FUNCTIONS OVERVIEW 4. Remove the Anchor® Tips tray from the box. Note that the Anchor® Tips tray must only be held in the middle. Figure 3-28: Correct handling of the Anchor ®Tips tray 5. Insert the full Anchor® Tips tray into the drawer. Notice: It is NOT possible to insert a partially filled Anchor® Tips tray into the drawer.
BASIC FUNCTIONS OVERVIEW Figure 3-29: Loading bay drawer 6. Close the drawer. The opened Lock symbol changes to a closed Lock symbol. Figure 3-30: Load Anchor® Tips 7. 3-28 Close the sample/Anchor® Tips loading bay flap.
BASIC FUNCTIONS OVERVIEW 3.3.4 LOAD OR UNLOAD SYSTEM LIQUID MAIN CONTAINER The Liquids detail view shows the liquid level of the wash buffer main container, the system liquid main container and both liquid waste main containers in percent. The instrument needs purified water (also called system liquid): • to prime, fill and clean the reagent pipettor probe, • to dilute reagents if requested.
BASIC FUNCTIONS OVERVIEW SHOW INFORMATION UNLOADING 1. Tap on one of the Liquid container buttons or on the corresponding symbols on the displayed instrument surface. The Liquids detail view is shown on the Overview screen. 1. 2. Pull out the wash buffer/system liquid containers drawer. Raise the front of the (empty) system liquid main container approximately 2 cm (0.8 inch). Figure 3-32: Unloading system liquid main container LOADING 3. Pull the system liquid main container forward and remove it.
BASIC FUNCTIONS OVERVIEW 6. 7. Press the system liquid main container on the front down. Close the wash buffer/system liquid containers drawer.
BASIC FUNCTIONS OVERVIEW 3.3.5 LOAD OR UNLOAD WASH BUFFER MAIN CONTAINER The Liquids detail view shows the liquid level of the wash buffer main container, the system liquid main container and both liquid waste main containers in percent. Pooling Wash buffer pooling is prohibited! Consumable information (package insert) Read always the consumable information (package insert) of the used wash buffer.
BASIC FUNCTIONS OVERVIEW SHOW INFORMATION PREPARATION 1. Tap on one of the Liquid container buttons or on the corresponding symbols on the displayed instrument surface. The Liquids detail view is shown on the Overview screen. DIATRON 5x TBS wash buffer bottles: 1. Open the box with the 5x TBS wash buffer bottles carefully. Figure 3-35: Box 2.
BASIC FUNCTIONS OVERVIEW UNLOADING 1. 2. Pull out the wash buffer/system liquid containers drawer. Raise the front of the (empty) wash buffer main container approximately 2 cm (0.8 inch). Figure 3-37: Unloading wash buffer main container 3. 3-34 Pull the wash buffer main container forward and remove it.
BASIC FUNCTIONS OVERVIEW MIXTURE Prepare 10 l wash buffer: 1. Open the container screw cap (white cap) outside the instrument. 5x TBS Wash Buffer provided by Diatron is color coded (white lid, corresponding to white lid on the wash buffer container in the KleeYa instrument (main and intermediate). 2. If there is still liquid in the container, empty it completely! 3. Open the full 5x TBS wash buffer bottle. 4. Fill the 5x TBS wash buffer completely into the empty wash buffer main container.
BASIC FUNCTIONS OVERVIEW 6. LOADING 7. 8. After completion of the wash buffer preparation, the cap must be placed lightly on the wash buffer main container to allow proper degassing of the wash buffer solution. Wait 2 hours for the micro-bubbles to disappear from the solution before use. Close the wash buffer main container screw cap. 9. Insert the wash buffer main container into the instrument. Figure 3-40: Loading wash buffer main container 10.
BASIC FUNCTIONS OVERVIEW 3.3.6 LOAD OR UNLOAD SOLID WASTE BAG The Solid Waste detail view shows the filling level of the solid waste in percent and allows to empty the solid waste bag (foil bag). Figure 3-41: Solid Waste detail view To display the filling status of the solid waste bag the instrument counts the cuvettes and Anchor® Tips since the last emptying. The filling status of the solid waste bag is additionally displayed in color: • Grey: Level ok. • Orange: Level become full.
BASIC FUNCTIONS OVERVIEW Figure 3-42: Solid waste bag 3. 4. 5. 6. 7. Unhook the full bag from the tensioner in the back of the flap. Unhook the full bag from the front of the flap. Remove the full bag. Close the full bag. Dispose the full bag according to the local and national provisions, legislation and laboratory regulations. Do not close the solid waste flap during replacement of the solid waste bag. LOADING 1. 2. 3. 4.
BASIC FUNCTIONS OVERVIEW 3.3.7 LOAD OR UNLOAD LIQUID WASTE MAIN CONTAINER The Liquids detail view shows the liquid level of the wash buffer main container, the system liquid main container and both liquid waste main containers in percent. Figure 3-43: Liquid detail view The filling status of the containers are additionally displayed in color: • Grey: Liquid level ok. • Orange: Liquid level high. • Red: The container is full. Re-usable containers The liquid waste main containers are re-usable.
BASIC FUNCTIONS OVERVIEW UNLOADING 1. 2. Pull out the liquid waste container drawer. Notice: Pay attention to the control light on the connector and remove only unused liquid waste main containers (the control light is off). Pull the joint level sensor and liquid waste connector (1) out of the full liquid waste main container (5) and put the liquid waste connector in the tube (2) behind the containers. Figure 3-44: Unloading system liquid main container 3. 4. 5. 6. 7. 8. 9. LOADING 3-40 1. 2. 3. 4.
BASIC FUNCTIONS OVERVIEW Figure 3-45: Loading system liquid main container 5. Close the liquid waste liquid container drawer.
BASIC FUNCTIONS LOAD 3.4 LOAD The Load screen gives an overview of all loaded samples, calibrators, controls, and assay reagents. The loading and unloading of samples, calibrators, controls, and reagents is also possible. Figure 3-46: Load screen PROCEDURE 1. 2. 3-42 Tap on the Load button in the main menu bar to show the Load screen. Below the Load button appears a sub menu with further buttons: • Samples: Tap on the button to show the Sample loading screen (see chapter 3.4.1 on page 3-43).
BASIC FUNCTIONS LOAD 3.4.1 LOAD OR UNLOAD SAMPLES, CALIBRATORS, AND CONTROLS Samples, calibrators, or controls are loaded into the sample loading bay within socalled sample racks. For positive sample identification, the sample loading bay is provided with a camera (on the left hand side). By means of this camera, the barcodes, on the (test) tubes can be read and used for identification. Barcodes of calibrators additionally contain data for the corresponding master curve.
BASIC FUNCTIONS LOAD TUBE AND SAMPLE RACK SPECIFICATIONS All used tubes (sample test tubes, calibrator tubes, or control tubes) must fulfill the following specifications: Tube height Tube diameter Sample rack type 1 92 - 100 mm 12 mm A12 2 92 - 100 mm 13 mm A13 3 92 - 100 mm 15 mm A15 4 92 - 100 mm 16 mm A16 5 75 mm (+ spacer in sample rack) 12 mm B12 6 75 mm (+ spacer in sample rack) 13 mm B13 7 75 mm (+ spacer in sample rack) 15 mm B15 8 75 mm (+ spacer in sample rack)
BASIC FUNCTIONS LOAD STATUS INFO The Load screen shows the status of individual samples, calibrations, controls, and sample racks: Symbol/Time Description Selected lane to load a sample rack. Sample rack is finished (shown below the sample rack). Time Sample rack is processed until xx:xx o’clock (shown below the sample rack). Tap to select the lane.
BASIC FUNCTIONS LOAD Symbol Description Calibration tube Control tube Empty position in the sample rack. Sample test tube assigned tests. Sample test tube with barcode/sample ID. Sample test tube with duplicate barcode/sample ID. Tube without or unreadable barcode/sample ID. STAT: Sample/calibration/control to be tested in priority. A STAT test is defined as a quick turnaround time, such STAT tests are ordered when the result is needed quickly for a decision regarding patient management.
BASIC FUNCTIONS LOAD • • LOADING 1. 2. 3. 4. 5. 6. Air bubble formation or clotting Air bubble formation or clotting of the samples must be avoided as these may alter the liquid detection functionality and hence cause unreliable results. To avoid clots, the samples should be treated accordingly (e.g. centrifuged) prior to the use in the KleeYa instrument.
BASIC FUNCTIONS LOAD Figure 3-47: Sample loading bay 7. 8. 9. UNLOADING 1. 2. 3. 4. Test and dilution assignment: a. Automatic test and dilution assignment: If the instrument is connected to a LIS- or LAS-system, the samples will be automatically assigned to one or more tests, see chapter 3.4.1.1 on page 3-49. b. Manual test and dilution assignment: It is always possible to assign samples to one or more tests manually, see chapter 3.4.1.2 on page 3-50. If desired, load additional sample tube racks.
BASIC FUNCTIONS LOAD 3.4.1.1 AUTOMATIC TEST AND DILUTION ASSIGNMENT If the instrument is connected to a LIS- system, the instrument will query the host for test orders automatically, when the sample rack is loaded. Problems with the automatic test assignment If the instrument is connected to a LIS-system, but the samples, calibrators, or controls won’t be automatically assigned to one or more tests, then: • Check if the test request was sent from the LIS-system to the instrument.
BASIC FUNCTIONS LOAD 3.4.1.2 MANUAL TEST AND DILUTION ASSIGNMENT It is possible to assign samples, calibrators, or controls manually to one or more tests. For any loaded sample rack, the sample rack details allow test order assignment. In addition, a dilution factor can also be selected for samples, calibrators, or controls, if dilutions are intended for the respective assay. By default, the smallest selectable dilution factor (e.g. none - undiluted) is assigned.
BASIC FUNCTIONS LOAD b. c. 5. 6. DILUTIONS Tap on the desired set of tests. The set of tests is assigned to the selected sample, calibrator, or control and displayed in the table line. An assigned profile is marked in dark grey in the Profile tab. Repeat the assignment for further set of tests. If necessary, tap on the STAT button to start the test(s) with high priority. The STAT symbol is displayed in the table line and the STAT button is marked in dark grey.
BASIC FUNCTIONS LOAD b. 4. SELECT ALL OR SEVERAL Tap on the desired set of tests. The set of tests assignment is canceled. c. If necessary, repeat the steps for further set of tests. If necessary, tap on the STAT button to cancel the assigment. It is also possible to select all or several samples, calibrators, or controls to assign tests or STAT to them together: 1. Tap on the checkbox in the first column of table headings. Instead of the position number in the lines an already marked checkbox appears.
BASIC FUNCTIONS LOAD 3.4.1.3 MISSING ID (BARCODE ERROR) In some cases it may happen that the barcode of a test tube cannot be read. Troubleshooting: CHECK BARCODE LABELS 1. 2. 3. 4. 5. EDIT SAMPLE ID(S) Note the affected test tube position(s) on the screen and remove the affected sample rack. Ensure that the barcode labels face towards the left (open side of the sample rack). Check the barcode label of the affected test tubes: • on damages, • on wrinkle, • or on bad printing.
BASIC FUNCTIONS LOAD 5. Enter the ID. Calibrator IDs must start with $Cal. It is recommended to use max. 20 characters (letters, numbers, special characters) for the ID. Optionally, the barcode can also be scanned with a hand-held barcode scanner. The repeated entering of the ID is then not necessary. 6. Tap on the Next button. 7. Retype the ID. 8. Tap on the Ok button. 9. If necessary tap on the next marked test tube with unknown ID. 10. Insert the sample rack again.
BASIC FUNCTIONS LOAD 3.4.2 LOAD OR UNLOAD REAGENTS The reagent loading bay is used for loading reagents located in Reagent Cartridges into the instrument by means of so-called reagent racks. By means of the pipettor, the reagents can then be distributed in the course of a test run. For positive reagent identification, the reagent loading bay is provided with a RFID label system. By means of this RFID label system, the RFID label, on the Reagent Cartridges can be read and used for identification.
BASIC FUNCTIONS LOAD STATUS INFO The Reagent screen shows the status of individual Reagent Cartridges and reagent racks: Symbol/Time Description Please wait while the RFID label is read and the particles are shaken up. Shaking magnetic beads. Name Name of the Reagent Cartridge. No cartridge Empty position in the reagent rack. Number Number of remaining test count (shown below the Reagent Cartridge). Error: • Expiration date or the on-board stability is expired.
BASIC FUNCTIONS LOAD Figure 3-54: Reagent rack with two Reagent Cartridges 4. 5. 6. 7. Keep the rack straight and move it jerkily from top to bottom. This movement is intended to loosen the liquid from the sealing foil and the top edge. Repeat the jerky movement if necessary. Remove the foil from the Reagent Cartridge(s). Open the reagent loading bay flap.
BASIC FUNCTIONS LOAD UNLOADING 1. 2. 3. 4. 5. 3-58 Open the reagent loading bay flap. Press the white button (1) on the handle of the unused/finished reagent rack and press the handle a short-time against the pressure of the spring. The reagent rack is set free. Pay attention to the corresponding state of the reagent loading lane in the user software. Remove the reagent rack carefully. Close the reagent loading bay flap.
BASIC FUNCTIONS RESULTS 3.5 RESULTS The Results screen gives information about all results of the process, calibration curves, reports and the event log. On the KleeYa instrument, it is not necessary to wait for the entire processing to be finished to view the results. As soon as the processing of one sample test, calibration, or control is finished, the instrument generates the result for it. The completed results can be accessed via the main category Results as well as its several sub categories.
BASIC FUNCTIONS RESULTS • Event Log: Tap on the button to show the Event Log screen (see chapter 3.5.5 on page 3-72). The screen shows information about all events and errors. See chapter 3.5.1 on page 3-61 for using filters or setting table columns.
BASIC FUNCTIONS RESULTS 3.5.1 FILTER AND TABLE HEADER 3.5.1.1 USE OF FILTER The filter function makes it possible to focus on the results of highest interest. PROCEDURE New filter: 1. 2. Tap on the Add filter button above the table to create a new filter. Select the desired Filter Type. Figure 3-57: Add new Filter window 3. Tap on the Next button. Depending on the selected filter, a further window appears in which the corresponding filter value(s) can be entered.
BASIC FUNCTIONS RESULTS Combine filters: In order to get a detailed result list, different filters can be combined with each other. Functionality: The second filter is applied to the results of the first filter (AND combination). Further filters can also be added to the combination. 1. 2. 3. Create the first filter (see add). Create the second filter (see add). If necessary, create further filters. 3.5.1.
BASIC FUNCTIONS RESULTS 4. Tap on the Done button to activate the configuration. Reset the user configuration: 1. Tap on the Configure table header button above the table. 2. Tap on the Reset button to the table configuration back to the default configuration.
BASIC FUNCTIONS RESULTS 3.5.2 TESTS The Tests screen shows all results since the last database maintenance. If filters are activated, only the respective results are displayed. The table contains information on all tests in each job status (scheduled, loaded, processing, finished, canceled, data reduction pending).
BASIC FUNCTIONS RESULTS Table (depending on the selected group and column configuration): Selected Allows to select one or more result lines. Sample ID Shows the ID of the sample, calibrator, or control. Assay Shows the assay used for the test. If several tests have been made with one sample, the test results appear in separate lines. Estimated Time to Result Shows until when the test result is expected. Completion Date Shows when the test result was available.
BASIC FUNCTIONS RESULTS Location Shows the sample position (Lane, Position). Mean Conc. Shows the mean concentration of all replicates of the sample for this assay. Mean Response Shows the mean RLU value of all replicates of the sample for this assay (dark count corrected value). Reagent Lots Shows the lot number of the Reagent Cartridge(s). Replicate Conc. Shows the concentration of the sample in the unit defined by the assay developer.
BASIC FUNCTIONS RESULTS Allows the use of filters (see chapter 3.5.1.1 on page 3-61). Allows to configure the table columns (see chapter 3.5.1.2 on page 3-62). PROCEDURE 1. 2. 3. 4. Tap on the Results button in the main menu bar to show the Results screen. Tap on the Tests button to show the Tests screen. Tap on the desired group to show the results of this group. Tab on the desired line in the table to start further actions.
BASIC FUNCTIONS RESULTS 3.5.3 CALIBRATION AND MASTER CURVES The Calibration Curves screen and the Master Curves screen show information of all created calibration curves and the underlying master calibration curves. Figure 3-61: Results - Calibration Curves screen Calibration curves (also standard curves or working curve) are used to compensate the differences between reagent lots, different analyzers and environmental conditions.
BASIC FUNCTIONS RESULTS Example: Figure 3-62: Calibration and master curves A measured calibration curve can be exported and imported as master curve to transfer the data to different instruments as file. Alternatively, master curves can be delivered as 2D barcodes on the recalibrators with assay reagent kits (see instruction for use of the relevant assay for details, indications may vary per assays).
BASIC FUNCTIONS RESULTS 3.5.4 REPORTS The Reports screen allows reports of results, calibration curves, used reagents, controls, messages, and maintenance as formatted output. The reports can be printed and/or saved as PDF or XLS files. Figure 3-63: Results - Reports - Sample Results Report screen GROUPS The Report screen is divided into Report Types groups: Maintenance Report group Shows which maintenance tasks have been carried out. Message Log Report group Shows the event log as report.
BASIC FUNCTIONS RESULTS PROCEDURE 1. 2. 3. 4. 5. Tap on the Results button in the main menu bar to show the Results screen. Tap on the Reports button below the Results button. Next to the button appears another menu with the Report Types groups. Tap on the desired Report Types group. Tap on the desired entries or tap on the Select All button to select all desired entries. Tap on the Preview Report button. Figure 3-64: Preview Report screen 6. Use the functions of the Preview Report screen.
BASIC FUNCTIONS RESULTS 3.5.5 EVENT LOG The Event Log screen shows all instrument messages (information, warning, or error messages). The newest message is on the top of the list. Figure 3-65: Results - Event Log screen Functions: Pause This function allows you to interrupt the automatic updating of the table. This allows you, for example, to view older entries without the display jumping to the first line of the table when a new entry is made. New entries are not lost due to the interruption.
BASIC FUNCTIONS RESULTS Warning messages A warning message shows/requires: • a problem of the instrument, which could be fixed. The instrument continues to work • a problem that arises when the user does not intervene (e.g.
BASIC FUNCTIONS RESULTS Red Red notifications show/requires: • the reasons why no or not all tests can be started: e.g. • missing resources to start assigned tests • due maintenance tasks that block sample processing • the user must intervene in all cases of a red notification PROCEDURE 1. 2. 3-74 Tap on the Overview button in the main menu bar to show the Overview screen. Tap on the task or message to get further information.
BASIC FUNCTIONS MAINTENANCE 3.6 MAINTENANCE The Maintenance screen gives an overview about the maintenance tasks (e.g. Start of Day Maintenance Task) and allows performing necessary maintenance tasks to obtain the KleeYa instrument performance. Special access rights In most cases, special access rights are required for the described functions (e.g. edit, delete). Figure 3-67: Maintenance screen The Maintenance screen shows all available maintenance tasks with the most important details in a table.
BASIC FUNCTIONS MAINTENANCE Status of the Last Run Shows the state of the last run. Allows the use of filters (see chapter 3.5.1.1 on page 3-61). Allows to configure the table columns (see chapter 3.5.1.2 on page 3-62). PROCEDURE 1. 2. Tap on the Maintenance button in the main menu bar to show the Maintenance screen. Tap on a button below the table to call various functions: Note that depending on the number of selected maintenance tasks, not all functions are available.
BASIC FUNCTIONS MAINTENANCE 3.6.1 RUN OF A MAINTENANCE TASK The Perform Task window shows details of a running maintenance task. Figure 3-68: Perform Task window Lock Log off button to log off the current user. Started maintenance tests are executed further. Another user cannot use the instrument during this log off time. Next Step Some tasks may require confirmation before they are run.
BASIC FUNCTIONS DEFINITIONS 3.7 DEFINITIONS Special access rights In most cases, special access rights are required for the described functions. The Definitions screen gives information about assays, controls and data reduction. PROCEDURE 1. 2. 3-78 Tap on the Definitions button in the main menu bar to show the Definitions screen. Below the Definitions button appears a sub menu with further buttons: • Assays: Tap on the button to show the Assay screen (see chapter 3.7.1 on page 3-79).
BASIC FUNCTIONS DEFINITIONS 3.7.1 ASSAYS The Assay screen allows to select an assay from the assay list on the instrument and shows information about the selected assay or allows to edit assay parameters. On the Assay screen it is also possible to import assays from an external source. Figure 3-69: Definitions - Assays screen Functions of the Information field: User Shows the user who created or last changed the assay. Vendor Shows the supplier of the assay.
BASIC FUNCTIONS DEFINITIONS Vendor Shows the supplier of the assay. Sample Replicates Number of sample replicates. Version Information Versions information entered by assay developer. Description Assay description entered by assay developer. Functions of the Trigger 1 + 2 field: Require Same Lot Number Allows to check the trigger LOT numbers. The assay is then only executed if the LOT numbers match. Vendor ID ID of the supplier.
BASIC FUNCTIONS DEFINITIONS Functions of the Reruns field: Allows Reruns Allows reruns of the assay. The rerun rules are set by the assay developer. Functions of the Laboratory Normal Result Range field: Laboratory specific result range: Different to the assay range but within the assay range set by the assay vendor. Minimum Lower limit of laboratory normal result range (must be equal or higher than lower limit of assay range).
BASIC FUNCTIONS DEFINITIONS 3.7.2 GROUPS & PROFILES The Groups & Profiles screen shows information on defined groups and profiles for tests (assays) and allows to add/edit/delete groups and profiles. The Groups & Profiles screen is divided into two groups: Groups Shows all groups. A group allows the thematic sorting of single tests. Profiles Shows all profiles. There is the possibility to arrange several assays as a profile.
BASIC FUNCTIONS DEFINITIONS Add a group or profile: 1. Tap on the Add button. 2. Enter the new group or profile name. 3. Tap on the Create button. The new group or profile is added to the list. Edit a group or profile: 1. Tap on the desired group or profile name. 2. If necessary, edit the group or profile name in the Assays area. 3. If necessary, select or unselect one or more test(s) in the Assays area. All assigned test(s) are displayed in the Selected Assays list.
BASIC FUNCTIONS DEFINITIONS 3.7.3 CONTROLS The Controls screen shows information on defined controls and allows to add/ delete controls. All Quality Control samples being used contain a fixed concentration (target value) for a specific analyte. By testing this sample with the analytical method it should produce an expected result. If one or more results of control samples have a difference from the expected results, an issue in the analytical system or method may be detected.
BASIC FUNCTIONS DEFINITIONS Functions: Add Allows to add a control. Delete Allows to delete the selected control. Details Allows to view details of the selected control. Print Allows to print the selected control. Copy Allows to copy the selected control with all its parameters except the control ID. After assigning a new Control ID, changes in the assay assignment can be made. QC now Starts the QC now software. The QC now software provides long-term statistics of control results.
BASIC FUNCTIONS DEFINITIONS Show details of a control/edit a control: 1. Tap on the desired control in the table. 2. Tap on the Details button (see chapter 3.7.3.1 on page 3-86). Delete a control: 1. Tap on the desired control in the table. 2. Tap on the Delete button. 3.7.3.1 DETAILS OF A CONTROL The details screen shows all settings and assignments of a control. Figure 3-71: Details screen General Parameters field: 3-86 Name Name of the control. Type Routine control or control of a Kit.
BASIC FUNCTIONS DEFINITIONS Control ID Unique ID (barcode) of the control. Expiration Expiration date of the control. Assigned Assay list: No Sequential number of assigned assays. Assay Name of the assigned assay. Method Shows the chosen validation method (see Edit tab). Frequency Shows after how many tests (with the same assigned assay) a test with this control is performed. Interval Shows after how many hours a test with this control should be performed.
BASIC FUNCTIONS DEFINITIONS EDIT TAB Validation Method Allows to select the validation method from the dropdown menu: • Range: Allows to define the concentration range for control validation. The control will be only valid if the measured concentration is within this range. • CV/SD: Allows to define the concentration range for control validation. The control will be only valid within the concentration range mean +/- 2 SD. (E.g.
BASIC FUNCTIONS DEFINITIONS Start Conditions field: Frequency (tests) Specifies after how many tests (same assay) a test with this control should be performed. Every (hours) Specifies after how many hours a test with this control should be performed. On STAT samples Performs a test with this control if STAT samples are used. New reagent cartridge Performs a test with this control when the reagent cartridge has been replaced.
BASIC FUNCTIONS SETUP 3.8 SETUP Special access rights In most cases, special access rights are required for the described functions. The Setup screen gives information about the instrument settings, user accounts and report settings and allows to change it. PROCEDURE 1. 2. 3-90 Tap on the Setup button in the main menu bar or tap on a button in the resource bar to show the Setup screen.
BASIC FUNCTIONS SETUP 3.8.1 SYSTEM SETTINGS The functions of the System Settings screen allows to view or change the instrument settings. Functions: AUTOMATIC LOCK OUT TIME Enable Automatic Lock Enables automatic logout of the current user if the user out has not worked with the software for a defined period of time. Started tests are executed further. Another user cannot use the instrument during this log off time. Lock out Time Shows the time in minutes that must elapse before the user is logged out.
BASIC FUNCTIONS SETUP 3.8.2 ACCOUNT MANAGEMENT The functions of the Account Management screen allows to view or change the access rights of existing or new users. Functions: USER NAME Add Allows to add an new user account. The user name shall be unique. Delete Allows to delete a selected user. Change Password Allows to change the password of the selected user Shows a list of all registered users. However, only those users are displayed who have the same or less rights than yourself.
BASIC FUNCTIONS SETUP Functions Lab. User Lab. Admin.
BASIC FUNCTIONS SETUP 3.8.3 REPORT SETTINGS The functions of the Report Settings screen allows to customize the report settings. Functions: REPORT HEADER CUSTOMIZATION 3-94 Company Name Name of the laboratory. Company Logo Logo of the laboratory Change Logo Allows to change the laboratory logo. Tap on the button to select a picture file on the PC.
BASIC FUNCTIONS TROUBLESHOOTING AND ERROR MESSAGES 3.9 TROUBLESHOOTING AND ERROR MESSAGES Troubleshooting manual Please refer to the separate KleeYa Troubleshooting Manual on error messages and troubleshooting.
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USE OF THE INSTRUMENT SAFETY AND HINTS 4 USE OF THE INSTRUMENT 4.1 SAFETY AND HINTS Emergency shutdown in case of functional disorder Functional disorder of the instrument will cause electrical shock, burns, cuts or bruises. • Pull out the mains plug to separate the instrument from the mains supply! Erroneous operation of the instrument or the software Malfunctions can cause serious injuries with deadly consequences or damage of the instrument.
USE OF THE INSTRUMENT BRIEF SEQUENCE PLAN 4.2 BRIEF SEQUENCE PLAN Start-up • Switch on the instrument • Switch on the PC. chapter 4.3 on page 4-3 Preparations • Load full Dispense Cartridges: • Load cuvette stacks • Anchor® Tips: • Unload empty Anchor® Tip trays • Load full Anchor® Tip trays • Fill wash buffer container with wash buffer • Fill system liquid containers with purified water • Waste: • Empty liquid waste containers • Empty solid waste bag • Run open maintenance tasks. chapter 4.
USE OF THE INSTRUMENT START-UP 4.3 1. 2. 3. 4. 5. 6. 7. START-UP Close all instrument flaps. Switch on the instrument. Pull out the liquid waste containers drawer to access the PC. Switch on the PC. Close all drawers. Wait until the KleeYa user software has been started. Enter your Username. Figure 4-1: Log in window 8. Enter your Password. 9. Tap on the Enter button. 10. Wait until the instrument is initialized.
USE OF THE INSTRUMENT PREPARATIONS 4.4 PREPARATIONS 1. Tap on the Overview button in the main menu bar. DISPENSE CARTRIDGES 2. 3. Check the number of available number of dispenses of the Dispense Cartridges. If necessary, load full Dispense Cartridges (see chapter 3.3.1 on page 3-7). CUVETTES 4. 5. Check the number of available cuvettes. If necessary, load cuvette stacks (see chapter 3.3.2 on page 3-18). ANCHOR® TIPS 6. 7. 8. 9. 10. 11. Open the sample/Anchor® Tips loading bay flap.
USE OF THE INSTRUMENT PREPARATIONS MAINTENANCE TASKS 20. Start the daily maintenance task "Start of Day Maintenance Task" and fulfill all instructions (see chapter 5.2.1 on page 5-4 and chapter 3.6.1 on page 3-77). 21. If necessary, run all required maintenance tasks.
USE OF THE INSTRUMENT LOAD SAMPLES AND REAGENTS 4.5 1. 2. 3. 4. 5. 6. 7. 8. Tap on the Load button in the main menu bar to show the Load screen. Tap on the Samples button below the Load button. Load all test tubes into sample rack(s). Load the sample rack(s), one after the other, into the sample loading bay (see chapter 3.4.1 on page 3-43). If necessary, assign desired tests and dilutions to the samples. Tap on the Reagents button below the Load button.
USE OF THE INSTRUMENT RESULTS 4.7 RESULTS View or export results as list: 1. 2. 3. 4. 5. Tap on the Results button in the main menu bar to show the Results screen. Tap on the Test button to show the Tests screen with a table of all tests (finished and in process) with numerous information (e.g. the status, raw results and calculated concentration, flags), see chapter 3.5.2 on page 3-64. Tap on the Results group to show the results of all finished tests.
USE OF THE INSTRUMENT UNLOAD AND RELOAD SAMPLES AND REAGENTS 4.8 UNLOAD 1. 2. UNLOAD AND RELOAD SAMPLES AND REAGENTS Remove unused/finished sample rack(s) carefully (see chapter 3.4.1 on page 343). The corresponding LED over the sample loading lane must be off. Remove the unused/finished reagent rack(s) (see chapter 3.4.2 on page 3-55) Pay attention to the corresponding state of the reagent loading lane in the user software. The square above the lane must be gray. RELOAD 1. 2. 3. 4. 5. 6. 7. 8.
USE OF THE INSTRUMENT RELOAD RESOURCES 4.9 RELOAD RESOURCES 1. Tap on the Overview button in the main menu bar. 2. 3. 4. Check the position of the empty Dispense Cartridge (see chapter 3.3.1 on page 37). Unload the empty Dispense Cartridge. Load a full Dispense Cartridge. CUVETTES 5. Load cuvette stacks (see chapter 3.3.2 on page 3-18). ANCHOR® TIPS 6. 7. 8. Check the position of the empty Anchor® Tip tray (see chapter 3.3.3 on page 322). Unload the empty Anchor® Tip tray.
USE OF THE INSTRUMENT EVENT/ERROR MESSAGES AND MAINTENANCE TASKS 4.10 EVENT/ERROR MESSAGES AND MAINTENANCE TASKS EVENT/ERROR MESSAGES • Check all event/error messages (see chapter 3.5.5 on page 3-72). MAINTENANCE TASKS • Start the daily maintenance task "End of Day Maintenance Task" and fulfill all instructions (see chapter 5.2.1 on page 5-4 and chapter 3.6.1 on page 3-77). If necessary, run all required maintenance tasks (see chapter 5 on page 5-1 and chapter 3.6 on page 3-75).
USE OF THE INSTRUMENT SHUT DOWN 4.11 1. 2. 3. 4. 5. 6. 7. SHUT DOWN Tap on the Shutdown button. Tap on the Yes button to confirm the warning message. Wait until the PC is shutdown (touch screen is black). Switch off the instrument. Remove all sample racks. Remove all reagents and store them or dispose it *. Remove both Dispense Cartridges and store them or dispose it *.
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MAINTENANCE AND SERVICE SAFETY AND HINTS ABOUT CLEANING/DECONTAMINATION 5 MAINTENANCE AND SERVICE Unchecked instrument Only checked instruments enable correct operation. • Pay attention to the Operation Qualification (OQ) form . • Check the instrument after installation, maintenance or repair. 5.
MAINTENANCE AND SERVICE SAFETY AND HINTS ABOUT CLEANING/DECONTAMINATION Unapproved or improper maintenance work Unapproved or improper carried out maintenance work will result in serious personal injury and material damage. • Follow all safety instructions in chapter 1.4 on page 1-8 and this chapter. • Take off watches and jewelry before performing any maintenance works. • Only perform maintenance procedures described in this manual. • Closely follow the steps contained in the individual instructions.
MAINTENANCE AND SERVICE SAFETY AND HINTS ABOUT CLEANING/DECONTAMINATION Damage of touch screen while cleaning Improper cleaning could damage the touch screen surface. • Use a soft and lint-free cloth with neutral detergent or with ethanol to clean the touch screen. • Do not use any chemical solvent, acidic or alkali solution. • If dust is accumulated on the case surface, remove it by using a special vacuum cleaner for computers.
MAINTENANCE AND SERVICE MAINTENANCE AND CLEANING 5.2 MAINTENANCE AND CLEANING 5.2.1 DAILY MAINTENANCE Start of Day DURATION 6 min PROCEDURE 1. Start the daily maintenance task "Start of Day Maintenance Task" and fulfill all instructions (see chapter 3.6.1 on page 3-77). End of Day DURATION 4 min PROCEDURE 1. 2. Start the daily maintenance task "End of Day Maintenance Task" and fulfill all instructions (see chapter 3.6.1 on page 3-77).
MAINTENANCE AND SERVICE MAINTENANCE AND CLEANING 5.2.3 MONTHLY MAINTENANCE DURATION 1 hrs 30 min (weekly + monthly maintenance), without the duration of the maintenance task "Database Maintenance" TOOLS • • • • • • PROCEDURE Surfaces and containers: 1. Wipe the surfaces of the instrument with a soft and lint-free cloth. 2. Pull out the wash buffer/system liquid containers drawer. 3.
MAINTENANCE AND SERVICE MAINTENANCE AND CLEANING Figure 5-1: 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 5-6 Wash buffer/system liquid containers Put the cap (1) on the additional intermediate container and tighten it loosely. Prime the washers (cleaning): a. Start the maintenance task "Prime Washer". b. Wait 5 minutes after finishing the task. c. Repeat the cleaning procedure 4 times in total. Open the cap (3) of the intermediate system liquid container (4) behind the system liquid container.
MAINTENANCE AND SERVICE MAINTENANCE AND CLEANING 16. Close the wash buffer/system liquid containers drawer. 17. Remove the additional intermediate container. Database: 1. Start the maintenance task "Database Maintenance".
MAINTENANCE AND SERVICE MAINTENANCE AND CLEANING 5.2.4 QUARTERLY MAINTENANCE DURATION 2 hrs 12 min (weekly + monthly maintenance) TOOLS • • • Soft and lint-free cloths Liquinox® Distilled water PROCEDURE 1. Moisten a soft and lint-free cloth with Liquinox® and wipe the steel needle (SPOLV) of the reagent pipettor. Moisten a soft and lint-free cloth with distilled water and wipe the steel needle (SPOLV) of the reagent pipettor.
MAINTENANCE AND SERVICE MAINTENANCE AND CLEANING 8. 9. 10. 11. 12. 13. 14. Put the cap (1) on the additional intermediate container and tighten it loosely. Prime the steel needle (SPOLV) (cleaning): a. Start the maintenance task "Prime Pipettor". b. Wait 5 minutes after finishing the task. c. Repeat the cleaning procedure 3 times in total. Open the cap (1) of the additional intermediate wash buffer container. Put the cap (1) on the intermediate system liquid container (2) and tighten it by hand.
MAINTENANCE AND SERVICE MAINTENANCE AND CLEANING 5.2.5 CHECK SAMPLE RACK Depending on the frequency of their usage, the sample racks will show signs of wear and tear at the push-push snap in site (yellow circles). If there is too much wear observable the sample racks shall be exchanged. Sample racks that do not snap in smoothly anymore must be exchanged immediately. Otherwise the push-push mechanism at the sample bay can be damaged.
MAINTENANCE AND SERVICE SERVICE 5.3 SERVICE 5.3.1 TUBE AND SAMPLE RACK SPECIFICATIONS Each tube type (see chapter 3.4.1 on page 3-43) requires a dedicated sample rack type with a specific label and in special cases also with spacers: • Sample rack types (label) (see chapter 5.3.1.1 on page 5-11) • Spacers for sample racks (see chapter 5.3.1.2 on page 5-14) 5.3.1.1 SAMPLE RACK TYPES (LABEL) Each tube type requires a dedicated sample rack type.
MAINTENANCE AND SERVICE SERVICE Figure 5-5: 5-12 Sample rack labels KleeYa - User Manual - Version 2
MAINTENANCE AND SERVICE SERVICE ADD A LABEL 1. Place the sample rack so that you can stick the label on the front position. Figure 5-6: 2. Label position Carefully remove the desired label from the label sheet.
MAINTENANCE AND SERVICE SERVICE 3. Note that the 2D barcode on the label must face up (in the picture on the right). Stick the label straight into the recess. Figure 5-8: 4. Glued label If necessary, add spacers to the sample rack (see chapter 5.3.1.2 on page 5-14). 5.3.1.2 SPACERS FOR SAMPLE RACKS For 75 mm tubes an additional spacer is required in the sample position of a sample rack. Please note that all sample positions must be equipped with a spacer. There are no spacers for 30 mm tubes.
MAINTENANCE AND SERVICE SERVICE Figure 5-9: Loosen spring 1 Figure 5-10: Loosen spring 2 2. Use the pen to remove the spring from the front by pushing it upwards.
MAINTENANCE AND SERVICE SERVICE Figure 5-11: Remove spring 3. Repeat the steps to remove all springs. Insert the spacers into all 12 sample positions: 4. Place the spacer into the sample position and move it downwards with your fingers. Use your finger to move the spacer along the protruding spring guide. The spacer must be pushed to the front to make sure it does not collide with the spring guide.
MAINTENANCE AND SERVICE SERVICE Figure 5-13: Bottom position 5. 6. Make sure that the spacers are pushed to the bottom of the rack and sit plain inside the rack. If necessary use the pen, your finger or a sample tube and push down the spacer. Repeat the steps to insert all spacers. Re-insert the springs into all 12 sample positions: 7. Place the spring into the sample position from above. Make sure the spring runs under the spring guide when pushing it down. The spring snaps into place with a click.
MAINTENANCE AND SERVICE SERVICE Check: 9. Check all sample positions for correct mounting of spacers and springs. Spacers must be pushed to the bottom and sit plain inside the rack. All springs must be inserted and correctly snapped in. Example (in the figure from left to right): • all is well • the spacer does not fit properly • the spring is not properly snapped in Figure 5-15: Check Sample rack type label: 10. Stick the correct type label onto the sample rack (see chapter 5.3.
MAINTENANCE AND SERVICE SERVICE 5.3.2 AUTOMATIC INSTRUMENT CHECKS/ INITIALIZATION The instrument performs some checks during power up and initialization automatic system. For each module, the instrument carried out dedicated sequences for integrity check.
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INSTALLATION AND REMOVAL OF THE INSTRUMENT INSTALLATION OF THE INSTRUMENT 6 INSTALLATION AND REMOVAL OF THE INSTRUMENT 6.1 INSTALLATION OF THE INSTRUMENT Instability of instrument Due to improper placing of the instrument, the instrument can tilt and fall down. The user can be heavily injured or the instrument can be seriously damaged. • Observe the technical specifications of the instrument (see chapter 7.4 on page 7-3).
INSTALLATION AND REMOVAL OF THE INSTRUMENT REMOVAL OF THE INSTRUMENT 6.2 REMOVAL OF THE INSTRUMENT Removal by unauthorized personnel Improper removal will cause damage. • Removal shall be executed by authorized field service engineer. Omitted reinstallation If the instrument moves within the plant, the authorized service personnel shall perform a complete reinstallation.
TECHNICAL DATA POWER REQUIREMENTS 7 TECHNICAL DATA Specification Values are achieved under optimal conditions and can vary depending on environmental conditions, instrument status and processing conditions! Specifications are subject to change with notice according to STRATEC`s “Change control system”. 7.1 POWER REQUIREMENTS Instrument: Voltage: 100 V - 240 V ±10% Frequency: 50 - 60 Hz Input current: 5 - 2.1 A Fuses: primary 250 VAC / T6.
TECHNICAL DATA COMPUTER AND CONNECTIONS Maximal output power: < 1 mW Wave length: 650 nm 7.3 COMPUTER AND CONNECTIONS Hardware: The following specifications are the minimum requirements. Processor: Pentium, 3.2 GHz or better Memory (RAM): 4 GB Hard disk: 500 GB or more Ports: • 1 Gigabit Ethernet port • 4 or more USB ports Modem: External modem via USB or internal PCI card modem Monitor/Graphic card: Resolution: 1366 x 768 pixel or more 18.
TECHNICAL DATA INSTALLATION DIMENSIONS AND WEIGHT Width: 175 cm (68.9 in) Depth: 110 cm (43.3 in) Height: 173 cm (68.1 in) Dimensions without touch screen: Width: 133 cm (52.4 in) Depth: 70 cm (27.6 in) Height: 147 cm (57.9 in) Instrument weight: 277 kg (610.
TECHNICAL DATA ENVIRONMENTAL CONDITIONS 7.5 ENVIRONMENTAL CONDITIONS The following table shows the range of conditions needed to run the system safely. Environmental condition: The system is made for Indoor use only. Temperature: Operating: 18°C to 30°C (64.
TECHNICAL DATA PACKAGING 7.7 PACKAGING Number of Boxes: 3 (2 pallets) Box A: Contents: Instrument Dimensions (WxDxH): 145 cm x 80 cm x 172 cm (57.1 in x 31.5 in x 67.7 in) Weight: 347 kg (765 lb) Box B and Box C: Two boxes are packed together on a pallet. Contents: Box 2/3: Covers Box 3/3: Touch screen, PC Dimensions (WxDxH): 148 cm x 80 cm x 140 cm (58.3 in x 31.5 in x 55.1 in) Weight: 131 kg (288.8 lb) {121 kg + 11 kg (266.8 lb + 24.
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APPENDIX ACCESSORIES AND CONSUMABLES 8 APPENDIX 8.1 ACCESSORIES AND CONSUMABLES Non-recommended accessories and consumables The usage of non-recommended accessories and consumables can produce erroneous results or damage to the instrument. • Use only the accessories and consumables described herein.
APPENDIX IMPORTANT CONSUMABLE INFORMATION 8.3 IMPORTANT CONSUMABLE INFORMATION See integrated original documents in the next sub-chapters.
APPENDIX IMPORTANT CONSUMABLE INFORMATION 8.3.
APPENDIX IMPORTANT CONSUMABLE INFORMATION 8-4 KleeYa - User Manual - Version 2
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APPENDIX IMPORTANT CONSUMABLE INFORMATION 8.3.
APPENDIX IMPORTANT CONSUMABLE INFORMATION KleeYa - User Manual - Version 2 8-7
APPENDIX IMPORTANT CONSUMABLE INFORMATION 8-8 KleeYa - User Manual - Version 2
APPENDIX IMPORTANT CONSUMABLE INFORMATION 8.3.
APPENDIX IMPORTANT CONSUMABLE INFORMATION 8-10 KleeYa - User Manual - Version 2
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APPENDIX IMPORTANT CONSUMABLE INFORMATION 8-12 KleeYa - User Manual - Version 2
APPENDIX IMPORTANT CONSUMABLE INFORMATION 8.3.
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APPENDIX IMPORTANT CONSUMABLE INFORMATION 8-16 KleeYa - User Manual - Version 2
APPENDIX IMPORTANT CONSUMABLE INFORMATION 8.3.
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CONTACT 9 GERMANY CONTACT STRATEC SE Gewerbestraße 37 75217 Birkenfeld Germany Phone: +49 (0) 7082 7916-0 Fax: +49 (0) 7082 7916-999 E-Mail: info@stratec.com Internet: www.stratec.
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GLOSSARY 10 GLOSSARY Anchor® Tip Disposable tip CE Conformité Européenne (European conformity) CFR Code of Federal Regulations (Codes of FCC, US government) Fatal Error An unexpected and non-recoverable termination of instrument operation including, but not limited to assay processing,maintenance, service, start-up, and shut-down. FCC Federal Communications Commission, US government Host In computer networking a host is a main computer (e. g. server, central computer).
GLOSSARY Recall mode During recall mode, the sample rack can be removed from the instrument to resolve problems with the barcode. The position of the test tubes shall not be changed. RFID Radio frequency identification RLU Relative light unit RoHS Restriction of Hazardous Substances RS232 Serial bus standard to connect devices to a computer. STAT Short turnaround time (sample to be tested in priority) USB The Universal Serial Bus is a serial bus standard to connect devices to a computer.
INDEX 11 INDEX A Accessories ......................................................8-1 Anchor® tip trays .............................................8-3 Anchor® tips .....................................................8-3 Anchor® Tips (load or unload) .....................3-22 Antivirus .........................................................1-19 Appendix ..........................................................8-1 B Barcode error .................................................
INDEX Liquid waste main container (load or unload) . Q Load or unload Qualification for user ......................................1-7 3-39 Anchor® Tips ..................................................3-22 Cuvettes .........................................................3-18 Dispense Cartridges .........................................3-7 Liquid waste main container ..........................3-39 Solid waste bag ..............................................3-37 System liquid main container .......
INDEX Warning ...........................................................1-4 System liquid main container (load or unload) 3-29 T Technical data ..................................................7-1 Terminology .....................................................1-2 Test definitions ..............................................3-79 Tests ................................................................3-64 Automatic test assignment ............................3-49 Manual test assignment ...............
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