Dtn410k USER Manual Rev01

PHOTOMETER DTN-410 K USER MANUAL

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DIALAB PHOTOMETER DTN-410K USER MANUAL

Contents !- Warnings........................................................................................................ 7 1- Introduction................................................................................................... 9 1.1 General..................................................................................................... 9 1.2 Technical specifications..........................................................................10 1.3 Front view ...............................................................................................12 1.4 Rear view ................................................................................................12 1.5 Keyboards...............................................................................................13 2- Installation ...................................................................................................15 2.1 Accessories Kit .......................................................................................15 2.2 Main supply voltage ................................................................................15 2.3 Cautions..................................................................................................15 2.4 Start up ...................................................................................................16 2.4.1 Pump volume calibration ..................................................................17 2.4.2 Flowcell verification procedure.........................................................18 3- Operating modes..........................................................................................21 3.1 Single (sample) photometer mode ..........................................................21 3.2 Semi-automatic analyzer mode ...............................................................21 3.3 Methodologies.........................................................................................21 3.3.1 Method parameters ...........................................................................22 4- Photometer mode operation.........................................................................25 4.2 Photometer mode main menu .................................................................25 4.3 Method preparation (1 set method) ........................................................26 4.4 Measuring (2 Run Method) .....................................................................32 4.4.1 Methods with Standard .....................................................................33 4.4.2 Methods with factor ..........................................................................35 4.4.3 Methods with color blank (color/blk).................................................35 4.4.4 Kinetic measurements ......................................................................36 4.4.5 Recalibration.....................................................................................37 4.4.6 Controls ............................................................................................38 I3 I

DIALAB PHOTOMETER DTN-410K USER MANUAL

4.5 Operation with calibration curves ...........................................................38 4.5.1 Set Method........................................................................................38 4.6 Operation with Cut-off............................................................................40 4.6.1 Cut-off measurement ........................................................................41 4.7 Statistics .................................................................................................42 4.8 Photometry (continuous readings of absorbance and transmittance) ....43 4.9 Coagulation.............................................................................................43 4.9.1 Coagulation Parameters...................................................................44 4.9.2 Preparing a coagulation method ......................................................44 4.9.3 Coagulation measurement ...............................................................45 4.10 Utilities .................................................................................................46 4.10.1 Date & Time....................................................................................46 4.10.2 Calibration.......................................................................................47 4.10.3 Filter selection table ........................................................................47 4.10.4 Delay ready Led....................................................................................45 4.10.5 Automated cleaning ystem..............................................................................46

4.11 Air Gap .................................................................................................49 5- Semi-Automatic (patient) mode....................................................................50 5.1. Main menu overview...............................................................................51 5.2. Methods settings and operation.............................................................51 5.2.1. Create / Edit a method......................................................................51 5.2.2. Modifying method priority settings ..................................................52 5.2.3. Run method (single method operation)............................................52 5.2.4. Print Methods...................................................................................52 5.3 Profiles definition....................................................................................52 5.3.1. Adding new profiles .........................................................................53 5.3.2. Editing/Erasing an existing profile ...................................................53 5.4 Patients Menu .........................................................................................54 5.4.1 Adding patients .................................................................................54 5.4.2 Edit/erase patients ............................................................................55 5.4.3 Erase done patients ..........................................................................55 5.4.4 Send patients to PC ..........................................................................55 5.5 Running in batch mode ...........................................................................55 5.5.1 Start a Run ........................................................................................55 5.5.2 STAT procedure ................................................................................57 I4 I

DIALAB PHOTOMETER DTN-410K USER MANUAL

5.6 Results reports........................................................................................58 5.6.1 Results for a patient..........................................................................58 5.6.2 Results for a method.........................................................................58 5.6.3 Printing results for every patients.....................................................58 5.7 Controls ..................................................................................................59 5.7.1 Defining control values .....................................................................59 5.7.2 Running controls inside a batch run.................................................60 5.7.3 Review of control results ..................................................................60 6- Maintenance.................................................................................................63 6.1 General care and daily maintenance ......................................................63 6.2 Flow through micro-cell cleaning and care ............................................63 6.2.2 Change and cleaning of sample filter ................................................64 6.2.3 Flow-cell disassembly and cleaning .................................................65 6.3 Lamp replacement...................................................................................67 6.4 Installing thermal paper roll ...................................................................68 6.5 Pump tubing replacement .......................................................................69 6.6 Identifying accessories and consumable goods....................................69 7- Troubleshooting...........................................................................................70 7.1 Non operating display............................................................................70 7.2 Message: Standard Abs Low ..................................................................70 7.3 Inconsistent readings..............................................................................70 7.4.1 Constantly low values......................................................................71 7.4.2 Constantly high values.....................................................................71

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!- Warnings WARNINGS on Instrument and Laboratory practices Please read this information carefully prior to using this instrument. 1) The unit described in this manual is designed to be operated only by trained personnel. Any adjustments, maintenance and repair must be carried out as defined in this manual, by a person qualified to be aware of the hazards involved. Do not connect monitor, cables or connectors other than those furnished by our company for the RS232C port of the instrument. 2) Do not switch the instrument ON and OFF repeatedly. Allow 20 seconds at least before restarting. 3) In case main voltage is lower than 100 volts, use a 200W ferro-resonant voltage stabilizer or an uninterrupted power source (UPS). 4) Always follow the general care and daily maintenance routine shown in the maintenance section. 5) Empty cell with the SIP Key (to sip air) and clean the sipper with tissue paper between readings. 6) In order to keep flowcell clean: • Do not cover samples with cotton, gauze pieces or surgical bandages. Use rubber, polyethylene, PTFE or glass stoppers. • To operate the instrument wear adequate lintless clothing. Synthetic fabric aprons are recommended. • Filter reagents if they appear turbid after inspecting them against the light. • Follow the cell and filter cleaning instructions in the maintenance section when ending daily work. • Do not leave the flowcell empty overnight (keep filled with distillate water). 7) Clean flow-cell and filter after daily work. Please refer to section 4.2 for details. 8) Use standards in every run. Factor values can be used instead of standards in case: • Reagent belongs to the same lot for which factor was determined. • Instrument did not suffer a major repair (replacement of filters or lamp) since last calibration. 9) To ensure adequate quality control, normal and abnormal control with assayed values should be run as unknown samples: • At least every eight hours. • When a new container of reagent is used. • After any maintenance is performed or a critical component is replaced. 10) Control results are considered valid if: • Control values fall within the specified range. • Results for controls run at the beginning and end differ by an acceptable level of variation. Acceptable levels of variation are criteria determined by user or control manufacturer. 11) Handling of drain hose waste must be done according your local / national regulations on pathological residues.

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DIALAB PHOTOMETER DTN-410K USER MANUAL

Symbols used in the instrument: Biological Risk

Warning: Before using read instructions in Manual

Hazardous Voltage

Ground connection Representative for CE: CGA Strumenti Scientifici Via Luca Giordano 7b 50132 Florence – FI Phone +39055571476 Fax +390555000889 E-Mail –

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DIALAB PHOTOMETER DTN-410K USER MANUAL

1- Introduction 1.1 General The DIALAB DTN-410K is a semi-automated clinical chemistry analyzer, capable of storing 200 patients and up to 132 methods in memory, adequate for all routine tasks in Clinical and Analytical Chemistry. A flow-through micro-cell with programmable aspiration volumes enables sample load and sample recovery when required. Sample themosttating in cell is achieved through a Peltier system with an operating range of 20 to 40º C. Additionally, a builtin cell holder lodges standard or semi-micro cells for special purposes as coagulation or turbidmetric measurements. Versatile programming enables colorimetric, turbidmetric, endpoint and kinetic assays to be performed in a simple way, referred to a standard, factor or calibration curve. Statistics can be performed to controls for each stored method. Bichromatic work mode is employed to reduce undesired side effects such as turbidity, sample or reagent intrinsic color, presence of lint, dirt or small bubbles in flow-cell, etc., as it accounts for all effects present at both wavelengths. It is possible to perform analytical measurements using calibration curves obtained by interpolation, with up to 10 standards or samples of known concentration. Antibody dosage and other substances that require a cutoff value can be performed provided there is a formula related to a negative and positive control. The use of a calibration curve is recommended in all applications in which Lambert-Beer’s Law does not hold, meaning a linear ratio between absorbance and concentration is not attainable. Concentration values for the construction of such a curve are entered through the keyboard. The corresponding absorbances are read by the instrument or also keyed-in. This feature enables the import of calibration curves defined in other instruments. The optimum calibration curve is calculated once the standards have been measured or entered. Various alarms and parameter displays inform operator of error in data entry. This ensures user a reliable operation. The possibility of replicating entries for standards and controls, for calculation of the calibration curve or cutoff limit, ensures value verification. This photometer admits the recovery of samples and measured standards, without appreciable cross-contamination. Various readings can be averaged for accuracy enhance. Calibration curves and readings can be performed in endpoint or bichromatic endpoint modes. Samples and standards measured in this way are the result of reading at one wavelength, or the difference between absorbance readings at two wavelengths, or the slope of a kinetic process. I9 I

DIALAB PHOTOMETER DTN-410K USER MANUAL

This instrument’s calculation routine is always a quadratic interpolation by using a set of ten different mathematical functions. The logarithm of concentration is an added feature. This enables graphic printouts of curve in semi-logarithmic format. Curve fitting is performed by Least Squares method applied to a quadratic function. The auto-calibration and incorporated control programs ensures maximum reliability of instrument’s output, and fast diagnostics and verifications. Measurement printout of operation methods, methods stored in memory, calibration curves and kinetics are obtained through the graphic printer, enhancing information displayed in the 20x40 character liquid crystal display; backlight ensures comfortable viewing from any angle. A 25 key touchpad keyboard, co-related to displayed functions, provides user with simple and clear prompts. Serial RS232C interface allows bi-directional communication with PC IBM compatible computers and accessories. The equipment’s optical system consists of a highly collimated photometer, with stepper motor driven filter wheel, and high quality interferential filters. Factory pre-focused lamp reduces the need for tedious calibration after replacement. Calibration curves and factors are not affected by lamp change.

1.2 Technical specifications Methods: Enzymes. Substrates. Electrolytes. Hormones. Drugs. Optical system: Principle: monochromator with interferential filters. Wavelength range: 340-1000 nm. Wavelength selection: automatic 9-positions filter wheel. Factory mounted filters: 340, 405, 450,505, 550, 620 and 750 nm. Bandwidth: 10 ± 2 nm. Photometric range: -0.5 to 4.000 Abs. Precision: +/- 0,002 Abs. Linearity: better than ± 1,5% from 0 to 1,500 Abs. Light source: halogen lamp 6 V 10 W. Zero: automatic. Reading: monochromatic and bichromatic. Cuvette system: Two –way cuvette system 1. Metallic microflow cell: 18 ml – 10 mm light path with temperature control by Peltier system. Temperature: variable, pre-adjusted 25ºC, 30ºC and 37ºC. Stability ± 0.1ºC. I 10 I

DIALAB PHOTOMETER DTN-410K USER MANUAL

2. Standard 10 mm x 10 mm holder for macro or semi-micro cuvettes. Useful for coagulation tests and special methods. Aspiration system: Built in peristaltic pump driven by stepper motor; programmable; reversible for sample recovery. Reaction volume: variable 100 to 500ml per test. Carryover 400 ml. Operator´s interface: Membrane keyboard with 25 buttons for functions and numeric entries, external keyboard for patient handling. Data presentation: Graphic LCD display 20 x 40 characters with backlight. Printer: Thermal, graphic 24 characters per line. Programs: 132 open system tests. 30 non-linear calibration curves. Printer control. Variable aspiration rate and sample recovery.

Automatic calibration and test mode. Quality control. Analysis modes: Absorbance/Concentration Endpoint with and without blank Sample and reagent blank Standard or factor. Factor storage in all methods. Non linear calibration mode. Enzyme kinetics with and without sample blank. Two–point kinetics. Incubation up to 10 minutes. Measure time from 15 to 600 seconds. Direct coagulation reading in cuvette by turbidimetric variation. Absorbance plot for accurate threshold determination. Direct observation of the coagulation rate. Bichromatic operation. Interface: RS232 C Power requirements: 100 –240 VAC: 50/60 Hz: 150 VA Fuse: 3A type F Environmental requirements: Operative: 0 – 40º C, maximum relative humidity: 90% Non-operative: -10 – 50º C.

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Dimensions: 32 cm. x 38 cm. x 17 cm. Weight: 6 kg.

1.3 Front view Graphic 1-1 shows the essential elements that compose the Analyzer.

1.4 Rear view

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1.5 Keyboards External keyboard enables semi -automated clinical chemistry operation to allow load of patient information, use of profiles, creation of a worklist and simplifcation of laboratory tasks. Instrument stores up to 200 patients and up to 10 results per patient. When external keyboard is not connected, built-in multifunction keyboard allows single sample operation, as a standard spectrophotometer. When pressing a non-operative key, a low pitch sound is emitted indicating the operational error. The functions of the keys in the operational program are as follows:

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2- Installation 2.1 Accessories Kit The following accessories are included in the DTN-410’s kit: 1 Main supply chord 3 Fuses for type F, 3 amps 3 Thermal printer paper rolls 1 Plastic shaft for thermal paper roll 1 User’s manual 1 Pre-focused 6 v – 10 w halogen lamp 1 Hexagonal Wrench 1 #1 cross-recess screwdriver 1 Sample aspiration capillary tube 1 Peristaltic pump tube (kit x 3) 1 Drain hose 1 Set of sample filters 1 Cleaning solution #1 1 Soaking solution #2 1 Plastic semi micro cuvettes kit x 5 Check if the packing is in good condition before opening, and inform about any irregularity. After unpacking, inspect if all items are in good condition. Please report non-conformances to manufacturer or authorized dealer immediately.

2.2 Main supply voltage The analyzer is a Class I instrument that requires 100 to 240 VAC 50/60 Hz. This equipment requires a single-phase line with protective ground connection. The protective ground connection must fulfill regulatory requirements according to the voltage available at the place where the equipment is being connected. Check the protective ground connection before installation. Required fuse is type F (fast) for 3 amps.

2.3 Cautions 1) Place the instrument in well-ventilated environments, free from dust and corrosive fumes. 2) Do not install the equipment near to heaters, muffles, ovens, etc. Avoid places subject to drastic changes in temperature. 3) Do not use tables subject to intense vibrations. Vibrations caused by unbalanced centrifuges may affect the optic system. I 15 I

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2.4 Start up Once electrical requirements have been fulfilled, install the equipment in a clean environment free from dust and/or corrosive fumes, far from direct sunlight and from any directional lamps pointing to it. Remove the sipper protector. Disengage the pump tubing by removing one of the ends. Stretch the tubes and make sure it is not stuck due to the lack of continuous use. Place the tubes on the rotor once again.

1-Connect the instrument to the main line with power chord. Do not change the plug nor interrupt grounding connections. 2-Install the equipment on a vibration free area, leaving a space of at least 10 cm behind the instrument. 3-Place a thermal paper roll in the printer (see section 6.4) and connect external keyboard to instrument. 4-Turn the instrument ON by using the switch on rear panel (see graphic 1.2). The display will read: the instrument identification. 5-Press any key, and the following message will appear:

SYSTEM SET UP PLEASE WAIT

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2.4.1 Pump volume calibration From instrument main menu press down arrow key several times to access volume settings and then press “1” key on built-in keyboard to start volume calibration.

MAIN MENU PHOTOMETRICS SETTINGS ?VOLUME

MENU2 Instrument will ask for a graduate flask to perform volume calibration:

VOLUME CALIBRATION Insert tip on a graduate flask with at least 5ml of water

ASPIR When ASPIR is pressed, several consecutive aspiration cycles will be performed and once finished , instrument will request to write the measured volume (in uL) and internal adjust of peristaltic turn-to-volume ratio will be calculated.

Volume calibration is recommended once a month or when new peristaltic pump tubing is installed.

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2.4.2 Flowcell verification procedure After performing volume calibration and before operating instrument, a flowcell check must be performed: a) From main menu, press down arrow key on external keyboard several times and press enter key on Photometrics menu. Measurement parameters can be modified according to the user’s needs.

IMAGEN RETOCADA: VOLUME=700 Press

Next on built-in keyboard and the following message shall appear:

IMAGEN RETOCADA: VOLUME=700

Slide cell-compartment-cover open and select flow cell.

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Place a test tube with water in sipper and press pump actuator. PUMP ACTUATOR

Repeat until absorbance readings are stable within +/- 0.005 Abs. If readings are not stable, aspirate solution #1 and wait for 2 or 3 minutes. Then aspirate the same solution again, aspirate soaking solution #2 several times (3 at least). Finally, aspirate water and verify stability of reading.

Pump Actuator In Wash method: runs the pump In Run method: aspirates blank, standard and sample I 19 I

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3- Operating modes There are two possible operating modes available, depending if an external keyboard is detected during instrument startup.

3.1 Single (sample) photometer mode This mode is selected when instrument is turned on and external keyboard is not present. In this mode instrument operates as a standard photometer; built-in keyboard provides user interface; when required method is selected instrument asks for required blanks and calibrators. For details on single photometer operation mode see section 4.

3.2 Semi-automatic analyzer mode If an external keyboard is detected during instrument startup, instrument will boot in semiautomatic mode operation. This mode enables the use of an external keyboard to load patient data, analytes / profiles of insterest for each patient, and work according to a pre-defined table of priorities. Final results can be printed out by patient or by test (method). Storage capability: Instrument stores up to 200 patients with 10 results each, selectable from a list of 132 methods. It is also possible to define up to 10 profiles containing 10 methods each. For details on semi -automatic operation read section 5 “Semi-automatic mode”.

3.3 Methodologies There are two ways to setup methods, by using built-in keyboard of single photometer mode as described on chapter 4, or by using the external keyboard which simplifies data entry. In any case, rules for setting up methods are the same, please review section 4 and see section 5.2.1. (Create / Edit a method) to use external keyboard.

• END POINT METHOD Linear Factor (section 4.3 and 4.4.2) Standard, linear (section 4.3 and 4.4.1) Non linear (Calibration curve) Includes the reading of several sample standards (section 4.5) or manual data entry (section 4.5)

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All end point methods can be carried out in monochromatic as well as bichromatic mode (section 4.3). Besides, depending on the method, these methods can be performed with reagent blank or sample blank (Sample/blk, section 4.3 and 4.4). • KINETICS First order (15 readings) Factor (section 4.3 and 4.4.1) Standard (section 4.3 and 4.4.1) Curve with several standards (section 4.5) • TWO POINTS METHOD Factor (section 4.3 and 4.4.3.2) Standard (section 4.3 and 4.4.4.2) Curve (section 4.5) • PHOTOMETRICS Continuous readings in absorbance and transmittance (section 4.11) • TURBIDMETRICS Linear Factor (section 4.3 and 4.4.2) Standard (section 4.3 and 4.4.1) Non linear (Calibration curve) With reading of standards (section 4.5) Or manual data entry (section 4.5) Two points Turbidmetric methods can be performed with a unique blank or a blank for each sample (Sample/blk, section 4.3 and 4.4) Warning: Do not use bichromatic mode in turbidmetric methods • CUT-OFF (section 4.6) Methods with readings between positive and negative limiting values (section 3.6) • STATISTICS (section 4.14) Performs a statistical measurement of up to the last 10 contents of each method. • COAGULATION (section 4.6) 3.3.1 Method parameters A method is a set of parameters, which define the operating conditions for each assay type. Every stored method can be reviewed, modified, deleted or altered as desired. Methods are identified with a number between 0 and 130. If the method is already stored in the memory, each parameter, name or value shall be displayed on screen.

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Parameters composing a method, except for those of the "Cut off" or coagulation type, are as follows, in input order: 1) Method Number 2) Name 3) Wavelength of the method 4) Bichromatic (reference wavelength): When endpoint (non-turbidmetric) methods are being performed a reference wavelength can be included for the absorbance reading. This reference wavelength is sometimes very useful. The socalled bichromatic methods allow minimization or elimination of interferences due to turbidity, small bubbles, lint, opacity or dirt in the cell windows, etc. This alternative is similar, or even complementary to the reading of a blank for every sample (method type 4 color/blk). When the measuring peak wavelength has been entered, a reference wavelength can optionally be input. At this wavelength, the reagent should not absorb, allowing a compensation for turbidity or color in the sample. 5) Type of method 1- End point (with reagent blank) 2- End point (with sample blank) sample/blank 3- Kin (first order kinetics) 4- 2 point kinetics (called also fixed point). 6) Temperature: The temperature of the flow-through micro-cell can be programmed for any method within the range of 20/40 ºC. In the case of Endpoint techniques, it is convenient to select a temperature close to room temperature. In kinetics, follow the instructions supplied by the manufacturer of the reagents equipment. According IFCC, a temperature of 37º C must be selected. 7) Reference 1- Standard (methods #0 to #130) 2- Factor (methods #0 to #130) 3- Curve (methods #101 to #130) 4- Cut-off (methods #0 to #130) 8) Volume measured in microliters 9) Measuring time Only for kinetic methods. Time during which kinetic readings are performed is expressed in seconds. In Two Points kinetics the first reading is made at stating time (i.e. when Lag time is over) and the second at the end of Measure Time. 10) Lag time: Incubation time or time elapsed since the sample is sipped (or SAMPLE or STD keys are pressed), and the instrument performs the first reading

(measured in seconds). It is equivalent to an incubation of sample. The lag time can be programmed between 0 and 600 seconds. 11) Cell type 12) Units 13) Low normal limit 14) High normal limit 15) Depletion rate: Maximu m absorbance value (normalized to one minute) allowed during incubation of sample. This is only applied to kinetic methods provided that there is an incubation time of at least 30 seconds. If the value is bigger than the limit, the reaction will be interrupted, and display will show only an approximated value. In this case the sample must be diluted and the assay, repeated. I 23 I

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Recommended limits: Amilase, GPT (ALT), GOT (AST), CPK, CKNAC, CKMB, LD: 0.250 FAL (ALP), GGT: 0.160 Urea UV: 0.200 Creatinine kinetics: 0.350 End point: 0.000 In order to prepare a method it is important to define the type of variables to be introduced.

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4- Photometric mode operation Note: For choosing photometrics mode, instrument should be turned on with external keyboard disconnected.

4.2 Photometer mode main menu For access main menu press

.

Input numeric selection: Input the selected numerical option = Strike to Enable or Disable printer.

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4.3 Method preparation (1 set method) Methods are protected with password. Default factory value is 1234 When prompted Input key: user password. Password can be modified in

Main > Menu 2 > 7. Utilities > Main 2 > 3. Define methods key Each assay type is defined by its operating conditions as mentioned on 3.3. Methods are identified with a number between 0 and 130 depending on reference type. If the method is already stored in the memory, each parameter, name or value shall be displayed on screen. Values are temporarily accepted by pressing ENTER. Input of numerical variables When the cursor is positioned in a numerical variable, the option selection bar is replaced by a message, appearing on the last line, prompting for the input of a numerical variable. Then the cursor will start blinking in the first digit position. Use numerical keys and decimal dot data entry. When the first key is pressed, the old value is deleted. To correct any erroneous input, press DEL Once the variable is inputted, press ENTER When done, the cursor moves forward towards the next variable. If numerical, the previous process is repeated. Therefore, every time ENTER is pressed, variables can be sequentially edited. Input of alphanumerical variables When the cursor is placed upon an alphanumerical variable, a message prompting for a new input of the variable shall appear on the last line, and an alphabetical character option will be displayed for each of the four lower keys. When pressing one of these selection keys, either the next menu appears or a letter located where the cursor is blinking. If a number must be entered, press the corresponding key and the number will show where the cursor is blinking. and the cursor moves within the fields for editing. With the arrows If a mistake is made, it can be overwritten or erased with DEL. This key works as BACKSPACE. Once the input is completed, press ENTER and store the edited variable. The cursor will move to the next option. Input of logical variables Those variables that assume discrete/fixed values are considered logical variables. For example: the main wavelength. This can only accept fixed values: 340, 405, 450, 505, 550, 590, 650, 700, 767, etc. When the cursor is placed upon this kind of variable, the lower menu bar displays the first four possible values and the word MORE in case there were more than four options. Select the desired option by pressing the corresponding key. Afterwards, the new value will appear in the corresponding field. Press ENTER to confirm and access to the next variable for edition. To return to the previous menu, press ESC.

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Display

volumen cambiado a 600uL When developing a method, the following keys will be used:

Bottom bar options Opens the first screen in Main menu. Opens the second screen in Main menu. Loads the cell without reading. Recovers sample. Moves to the next screen of the selected method. Returns to the previous screen of the selected method. Increases a value. Decreases the method number: Example: if you are in method #10, it moves automatically to method #9. Prints out data showed in the screen. Enables or disables the printer. Other options. Modifies or changes data on screen. Selects a method. Repeats measurement. Changes the number of the following sample.

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Input of variables 1- Method number: Enter a method number from 0 to 131; confirm with ENTER. Afterwards the cursor will move to the field of method’s name. Display will show:

input method name

Select

2- Name of the method: Choose the letters to identify the method by using selection keys.

Example: name ALBUMIN.

Confirm with ENTER . Press

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3- Wavelength: The screen will display the following message:

Select

and choose the wavelength according to the programmed method.

If not displayed, press

and select.

Press Option none is to be used when converting a technique from monochromatic into bichromatic. WL values appearing in the various menus are taken from a table loaded in the menu of UTILITIES.

4- Reference wavelength:

When bichromatic operation is desired, press and select the reference wavelength. If 0 is selected, the instrument will operate in monochromatic mode. Press I 29 I

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5-Type of method Press and select the type of method. 1- EP/RB End point (with reagent blank) 2- EP/SB Endpoint (with sample blank) sample/blank 3- Kin (first order kinetics) 4- TWO P Two points. Press

6-Temperature: According IFCC, a temperature of 37º C must be selected. and type the desired temperature. Press Only the temperature in the microflow cell is controlled. The cuvette tray always operates at room temperature. Press

7- Reference: Both kinetic and endpoint techniques can be referred to a standard sample, to a previously calculated factor or to a factor determined by the manufacturer. Press

5tand select reference. Press

8- Volume (measured in microliters). Press 9- Measure time, Meas time: Press

and enter the time defined in the method. Press

10- Lag Time: Press

and input time in seconds. Press

11- Cell type: Select Flow-cell or cuvette by pressing

. Press

12- Units: Units are introduces with the same procedure used for the method name. Eg.: Mg/l, U.I., etc. Press The screen will show the FACTOR or STANDARD: Depending on the type of method, if no change is made, use ENTER. I 30 I

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If you wish to make a change: Press

and input value. Press

13- Low Limit 14- High Limit Enter the corresponding value pressing

The display will now show two new options: PRINT and PREV. prints out a copy of all the method’s parameters. returns to previous screen.

Example: Endpoint with reagent blank.

GLUCOSE Wavelength: 505 nm Ref. bichromatic: 700 nm Calibrator: 100 mg/dl Temperature: 25 ºC Volume: 500 ul Units: mg/dl Normal value: 70-100 Control: pool Range: 120-90

Example:

Kinetics GOT/AST Wavelength: 340 nm Ref.: factor Lag time: 30 seconds Meas time: 60 seconds Temperature: 37 ºC Volume: 600 ul Depletion: 0,160 Units: ul/L

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4.4 Measuring (2 Run Method) A method cannot be run unless previously programmed (see Set method chapter)

RUN A METHOD Select option 2 of the main menu The following will be displayed: Look for the processing method, either by striking:

Once found, press

Read water by Means of the pump actuator WATER

Read the reagent blank by means of the pump actuator. You might choose not to read the reagent blank pressing the key NO

REAGENT

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read water : Suggests reading the coater blank read Reagent/Blank : Suggests reading the reagent blank The screen also displays F =xxxx, where xxxx is a measure of the actual signal to noise ratio, also a measure of counts generated by the preamplifier. Its main function is to verify reproducibility of flow-cell readings and the state of the lamp before measuring process is commenced. , unload cell in the same way and reload; verify that the F Load the micro-cell by using reading vary in no more than one unit. If not, flow cell should be cleaned as detailed in chapter 4, page 26. F values should range from 2000 to 4700. In case they are under 2000, the cell should be cleaned. If cleaning does not improve the functioning, a standard cleaning should be carried out.

Next message is "Wait" Afterwards, "reading blank”

4.4.1 Methods with Standard After reading the blank, the Analyzer inquires whether the calibrator serum’s method selected will require the reading of the calibrator serum, or if it should use a stored factor obtained from a previous standard reading:

If YES is selected, a new standard should be read, and the new factor will be calculated and stored for the selected method. If NO is selected, then the factor calculated during the last reading of the calibrator serum will be used. Printout of screen values. Rotates pump backwards (recovery of sample or standard) Initiates the sipper action, sipping the samples or creating an air gap between samples. Once the calibrator serum is confirmed, the following prompts are displayed:

Read Standard #Replicates : 1 Press input the number of replicates of standard. readings. The instrument will employ the average value of readings.

Standard.

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Read the standard sample by using the pump actuator.

reading standard

A printout of the standard’s absorbance and the calculated factor Co/Ao is obtained, where Co is the standard’s concentration and Ao its absorbance. If the standard’s absorbance is lower than the blank’s (negative absorbance), an error message is displayed and the input of a new standard is expected.

To exit, press ESC anytime during the measuring cycle.

Then the reading cycle starts. Read next sample Read the following samples by using the pump actuator.

Sample 1

Screen Example

If a change in the sample number is desired, press SAMPLE and enter a new number, the next sample shall retain the new numbering sequence. If measurement falls within the high and low limits, the diagnostic message will be NORMAL. If value is higher or lower than the fixed limits, the message will be HIGH or LOW.

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4.4.2 Methods with factor The measuring cycle with factor omits reading a standard. read water read reagent/blank Factor Confirm the factor’s value with ENTER or change it with new factor and press ENTER.

, introduce

Water

Reagent

4.4.3 Methods with color blank (color/blk) The Absorbance value shown on display or in the printout is the difference between the sample absorbance and the absorbance of the corresponding blank.

Abs = Am - Abm Am: sample absorbance Abm: absorbance blank sample

This kind of technique is used for bi or mono-reagent assays with a high serum/reagent ratio. Example: Ferremia, Bilirrubin. Read water Read reagent/Blk Read sample/Blk Factor Confirm with ENTER or modify with

, if standard samples is used. I 35 I

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read next blank “ 1 “ read next sample “ 1 “ Next, the absorbance reading of the difference between sample and blank is displayed. Afterwards:

Read next blank “ 2 “ Read next sample “ 2 “ And so until the the whole sample lot is processed.

4.4.4 Kinetic measurements Kinetic measurements can be performed using a factor, a standard or a calibration curve in analogy with Endpoint methods. Therefore, all considerations of sections 4.4, 4.4.1, 4.4.2 and 4.5 remain valid. However, each read standard (in case a standard is to be read) and every read sample are performed within a cycle that includes: 1) Incubation during the pre-fixed time (LAG TIME) 2) Measuring during the pre-fixed time (MEASURE TIME) At the end of every measurement, a high pitch sound will tell the operator that the Analyzer is ready for the next sample.

4.4.4.1 First order kinetics Each measurement consists of 15 readings fixed at intervals; i.e. the total measurement time is automatically divided into 15 equal parts. Measurement is carried out calculating the slope that best fits the 15 read values by following the method of least squares. Select method to process.

Read blank factor - confirm factor with Enter Read sample 1 Wait Remember that kinetics includes a lag time and a measuring time. The result of the absorbance in the chosen units will be obtained together with the correlation coefficient of the kinetic reaction. Next, sip consecutive samples. When operating in kinetic mode, plot of reaction is seen while reaction is in progress. Absorbance data are also shown. IMPORTANT: In fast kinetic measurements a blank must be sipped even though its readings are not used in the difference calculations. This is necessary allow the instrument performing the internal calculation of the absorbance scale. I 36 I

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The correlation coefficient written on the printer after the diagnostic is a mathematical measurement of the reaction’s linearity. An ideally linear reaction will have a coefficient of 1.00 (positive or negative depending whether the absorbance grows or decreases during the measuring time). A non-linear reaction will produce values near 0.00. The closer the value is to 1.00, the more linear the reaction will be, hence the more reliable the data will be. During the incubation readings are performed to warn the user in case the substrate’s consumption is excessive. If so, a message is generated in the printer indicating the need to increase sample dilution.

Dilute Sample The informed result will only be considered an approximation, and the measuring process shall be aborted.

4.4.4.2 Higher order kinetics (2 points) Kinetics methods which absorbance rate of change is not constant in time (positive or negative), i.e. that do not produce constant absorbance rates, are usually measured taking readings in two points along their development. The measuring process using these methods in the Analyzer is similar to normal kinetic methods (15 points). The only actual difference is that during the MEASURE TIME two readings are performed instead of 15, one at the beginning (coinciding with the completion of the LAG TIME) and another at the end. This type of method is also called fixed point.

4.4.5 Recalibration At any time, the user can recalibrate both the blank or standard. When the screen shows a message requesting to read sample, if the key pressed, the message is replaced by:

BLANK is

Read blank Place the tube containing blank in the sipper tube and then press the pump actuator. Once the blank readjustment is performed (including a new reading of "0" transmittance) instrument automatically returns to the sample reading cycle. If the key BLANK was pressed by mistake, the blank reading can be aborted pressing ESC before confirming the reading. The same procedure is employed to recalibrate the standard in the case of those techniques programmed with a standard as reference. When pressing STD a message is generated:

Read Standard Place the tube with standard in the sipper tube and press the pump actuator. The standard’s absorbance reading generates the calculation of a new factor, which will be used I 37 I

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from that moment onwards for future readings. By completing that factor’s calculation the instrument automatically retur ns to the sample reading cycle.

4.4.6 Controls The Analyzer allows the storage of up to 30 control readings, performs the corresponding statistics and prints them for each of the 130 available methods. When measuring and storing a control sample is desired, inform to the instrument that the next sample to read is a control. Start the measuring process as usual, according to the method type and references used. A printout will be obtained.

Refer to STATISTICS for viewing and printing controls (section 4.7).

4.5 Operation with calibration curves When a method does not produce a linear result concentration, measurements must be referred to a calibration curve. 4.5.1 Set Method Input sequentially the parameters as shown in 4.3. When reaching reference, press

. The message will read:

method reference

Select

. The input volume, lag time, place, unit. Then

# standards: input the calibrator number to be used

, the number, and then

ENTER. Enter the concentration value of each standard. I 38 I

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Once completed, press “ABS 1”____ “ABS 3”____

“ABS2”____ _____

Press

Read water Read reagent / Blk Before reading standard 1, empty cell by using

Read Std 1 Empty cell; press

Read Std 2 And so until all standards are completed. Press

print factor? Yes No Press the corresponding key The calibration curve is shown in the display, and if print out is desired press

Measurements The effective measurement of samples is carried out in the same way used for methods with factor or standard concentration. Take into account that a method with calibration curve is after all a method with variable factor. To perform a measurement press key 2 in the main menu (RUN METHOD) and input the selected method number pressing

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Read water

Read reagent/Blk

Read Sample Press the corresponding key The calibration curve is shown in the display, and if you wish to print it press

Empty cell and clean sipper with tissue paper between readings.

4.6 Operation with Cut-off The cut-off is an absorbance value which establishes a limit between normal and abnormal samples. This value is normally defined with a formula that depends on positive and negative controls. In order to program the method, proceed as in 4.3, except when defining the REF:

Then press Values to be entered correspond to the coefficients of the equation:

Cut-off = An • A + Ap • B + C Where An y Ap are the positive and negative control’s absorbances average, respectively. The A, B and C values to be entered are supplied by the reagent manufacturer.

Uncertainty: % around the value of the CUT– OFF absorband for which the results are not reliable and should be repeated.

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Input corresponding values pressing

value and ENTER.

Scroll through parameters using Exit the menu using Input A, B, and C.

4.6.1 Cut-off measurement Select 2 in main menu, search previously programmed method with

Read blank Next, the screen will display the message "# negatives", i.e. how many negatives are to be read. Input the corresponding number and press ENTER Example: 2 negatives

Read negative #1 Read negative #2

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PLS verify negatives Please verify negatives with , scroll through all the read negatives. Using DEL you will be able to eliminate any displayed value. the measuring cycle will be resumed. Message “#positives” How many positives? Example: 2 positives.

Read positive #1 Read positive #2 The same procedure is followed. Once finalized press

read next sample (#1) The printout will indicate if the read value is positive or negative.

4.7 Statistics Select option 3 from main menu to access statistics. Statistics correspond to the last 10 controls entered during runs of the selected method.

Statistical data correspond to the last 10 read controls for the corresponding method.

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4.8 Photometry (continuous readings of absorbance and transmittance)

The Analyzer can be used as a direct reading instrument. Select 4 in the main menu. Enter wavelength, volume and temperature and then Read Blank Once the blank is read, read any sample in continuous mode. Read Sample

4.9 Coagulation Main menu. Select 5 coagulation. The system allows the programming and storage of up to 4 methods coagulation.

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Inside the parameters’ option, there are two possible selections: 4.9.1

Coagulation Parameters 1-Plot limit 2-Delay

Plot limit: It defines the graphic range in screen of the coagulation process; in order to define the threshold accurately, the graphic is extended from –0.2 to the defined plot limit, in absorbance units. Delay: It is the time interval from the moment when the time measurement is started till the beginning of the absorbance measurement. As during the first seconds absorbance remains practically unchanged, it is convenient to start the reading only after a few seconds, hence preventing the turbulence effects of the mixing and exterior light from creating a fake threshold. A five-second delay (for example) is enough to dispense, mix and close the cell’s cover without altering the absorbance measures. Nevertheless, actual time measure starts when Sample button is pressed.

4.9.2

Preparing a coagulation method

Select 1 Set method.

Input the displayed parameters. Wavelength: 405nm recommended.

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Measure time: Maximum time during which coagulation may occur; between 15 and 300 seconds. Higher limit: Upper range in seconds. Lower limit: Lower range in seconds. Threshold: Threshold absorbance that defines the time of coagulation (not larger than 2 absorbance units). Correction: It is an additive or subtractive value in seconds measured to create compatibility with data produced by other measuring methods. 4.9.3 Coagulation measurement Set the instrument in the cuvette measuring mode. Select 2 Run Method.

Coagulation measurements are done in disposable semi-micro 10 x 10 x 45mm cuvettes. Do not use the flow-cell. This could result in permanent damages to the instrument. Follow the instructions on screen. Read next sample “1” Place the reactive with serum in the cuvette inside the cuvette tray, simultaneously pressing SAMPLE. After the “delay” time defined in 4.9.1, the analyzers will start to examine the absorbance variation of the sample. Once the measurement is finalized, a beep will indicate that the threshold plus the correction have been surpassed. Press any key and the coagulation time will be displayed on screen.

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4.10 Utilities Press 7 in the main menu. The following will be displayed:

4.10.1

Date & Time

Press 1 and the screen will display:

After pressing the screen will show: Month: Input the number of the month, confirm with ENTER. Afterwards, Day will appear: Enter the day and press ENTER. Year will also be shown on screen: input the last two digits of the year and confirm with ENTER. When is pressed, the following is displayed: Hours: Input the hour, confirm with ENTER. Minute: Input the minutes then confirm with ENTER. Finally input the seconds and ENTER. When time and date are completed, exit with I 46 I

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4.10.2 Calibration There is a function that performs the complete fully automatic calibration of the instrument . It is recommended to run this function every time the lamp is replaced. Do not forget to fill the cell with distillated water. Keep the cuvette tray empty. Press the key dot (·) to perform this calibration. The instrument requests the input of the number of consecutive calibration runs. At least two calibrations is recommended. In case the FLOWCELL position was not selected, the Analyzer will give a sound signal. The amplifier calibration is started, after which the calibration of the cell’s lamp tension is carried out. The instrument requests a change into CUVETTE position. The calibration of the lamp is now performed for this position. Next, the calibration for each of the filters takes place. The instrument requests once again a change of position, this time into FLOWCELL. Last, the calibration for each one of the filters in the flow-cell position is performed. 4.10.3 Filter selection table

In the main menu, press 7 and enter the Utility Menu and press 6. Press the number of the filter you wish to change or add and enter the wavelength, then press ENTER. Once the filters’ data are introduced, press ESC. If you wish to print the table, press 4.10.4 Delay ready Led

Led indicates when capillary tube can be removed from sample vial. Default value is set to 2 seconds. This value can be modified in Main > Menu 2 > 7. Utilities > Main 2 > 4. Delay Ready Led If too long time is required before solution stops movin in capillary tube, replace sample filter. I 47 I

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4.10.5 Automated cleaning system.

To access to automated cleaning menu press: Menu 2 > 7 UTILITIES > Menu 2 > 5. FLOW CELL CLEANING Screen shows: FLOWCELL CLEANING

Put cleaning solution. Leave capillary tube inside. Press actuator.

Capillary intake tubing must be immersed in cleaning solution for about 5 minutes. Solution will be aspirated and released to vial. This will enhance cleaning effectiveness. When cleaning is finished, in screen it will be read instructions for positioning a distilled water reservoir. Intake will be 10 aspiration volumes, approximately. Cleaning operation will be automatically requested if more than 12 hours elapsed from the last cleaning operation. This will occur whenever attempting to run a method defined with micro cell operation. Operator can select not cleaning this time but message will show up again and again each time a method is selected for running. Additional recommendations related to cleaning: • • • • •

Perform cleaning operation when daily work is finished. Do not reject instrument cleaning warnings Verify effectiveness of cleaning solution. Always keep vial capped. Avoid direct sunlight. Take a small amount for the day and discard it at the end. Automatic method does not request the use of rinsing solution. Nevertheless, after each cleaning cycle load cell with it, leave for about two minutes and flush with distilled water. If regular cleaning is not enough for cell cleaning and bubbles still produce anomalous values, fill cell with a 10% in water Nitric Acid and leave cell loaded for about 15 minutes. Repeat operation 4 times and flush cell with water.

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4.11 Volume Calibration allows getting an accurate ratio between peristaltic pump turns and aspirated volume expressed in microliters. Press 1 and follow instructions written in the screen. Measure volume with a graduated flask and introduce it. Remember that it must be done in microliters. The Air gap function allows the emptying of the cell after the reading. This parameter can take values from 0 to 1500uL. With 0, the emptying of the cell is suppressed after the reading.

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5- Semi-Automatic mode When an external ke yboard is detected during instrument startup, instrument is automatically set to the semi-automatic mode and operation is controlled by the use of external keyboard: Enter key

is used to confirm or select an entry and to move the cursor to the next input field.

Backspace key

is used to delete the numerical character to the left of the cursor.

Up/Down arrow key

moves the cursor to the next option on a menu or entry during an edition.

Delete key

Erases a patient.

Pg Up/Pg Dn key

navigates on a list of results.

Left/right arrow keys

navigates on a list of methods.

Esc key

Cancels a menu or option.

When instrument is running a worklist or when it is on settings – utilities menu, additional control is achieved by the built-in keyboard as follows: Pump actuator

reads water/blank/standard or sample as required by the instrument.

Selection keys

chooses between different available options shown on instrument display.

SIP / RCVR selection key Load the cell without reading or recovers sample. Enter

confirms factor or data.

Blank key

recalibrates blank (at any time)

Standard key

recalibrates standard (at any time)

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5.1. Main menu overview MAIN MENU

Ver 5.xxx

>PATIENTS RESULTS CONTROLS PROFILES METHODS START MEASURE MENU 1

MAIN MENU

Instrument main menu is divided into two main screens, MENU 1 screen options include the loading and edition of patients, printing of results by method or patients, definition and review of control results, definition/running of methods and profiles, and start of the run for the loaded patients.

Ver 5.xxx

screen option includes the access to absorbance reading mode, instrument internal settings (printer status, keybaord settings and calibration utilities), and calibration of peristaltic pump volume. MENU 2

>PHOTOMETRICS SETTINGS VOLUME

MENU 2

5.2. Methods settings and operation METHODS >SET METHOD RUN METHOD SET PRIORITIES PRINT METHODS MAIN MENU

Method screen allows definition, run, priorities setting and printing of methods. Select “Set method” option to edit a new method.

5.2.1. Create / Edit a method

This option defines a new method or modifies an existing one. The arrow keys navigate through the available me thods. Enter key selects the method to be modified. Once the values are changed, the instrument will ask to confirm the changes. For details on method types and preparation, please see section 4.3. – Method preparation.

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5.2.2. Modifying method priority settings

During sample batch processing, it can be necessary to run some methods earlier than others to ensure that fast reactions will be measured properly (e.g. kinetics reactions are stable for few minutes while color reactions are stable for about half an hour). Priority setting table defines the order for processing each chemistry.

Methods BIC AC ALB AMI

CAL CAC CKN CKM

HDL LDL CHE CRE

FOS FRU GGT GLU

FER LDH MAG PRO

Use arrow keys and spacebar to select two methods to be swapped on the priority list. Repeat the operation to obtain desired ordering and press enter key when finished.

Spacebar Pg Dn Pg Up

5.2.3. Run method (single method operation)

This option allows running a method outside from the batch (e.g. stat mode operation). Details are provided on section 4.4 – Measuring. 5.2.4. Print Methods

Stored method parameters can be printed by using this option. Use the built-in keyboard to print the list of methods, the parameters of a specific method or the parameter of every method.

5.3 Profiles definition A profile is a group of tests to be run together on a sample. Profiles are usually defined by instrument user to ease loading of required tests by a patient. Usual profiles include routine, hepatic, lipidic, cardiac and kidney. PROFILES >ADD PROFILE EDIT/ERASE MAIN MENU

Choose “Profiles” to add, edit or erase from the main menu.

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5.3.1. Adding new profiles

PROFILES ENTRY Profile 1

To add a profile, type its name and press enter, then press enter again to select profile components from the available list of methods.

Name: HEPATIC Components:

F2=SAVE

ESC=Prev

Methods BIC* AC * ALB* AMI BTO BDI

CAL CAC CKN CKM CDS COL

HDL LDL CHE CRE FAC ALP

FOS FRU GGT GLU GOT GPT

FER LDH MAG PRO PRU TRA

Use arrows keys and press spacebar to highlight profile´s component, then press enter to confirm methods and press F2 key to save the new profile.

Spacebar Pg Dn Pg Up

5.3.2. Editing/Erasing an existing profile

PROFILES ENTRY Profile 1

Use the left and right arrow keys to choose profile to be modified and press enter key to edit it or Del key to erase it.

Name: GLUCID Components: GLU CHO

Enter=Edit

Del=Erase

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5.4 Patients Menu

PATIENTS

From main menu select “Patients” to add, edit, tranfer to PC or erase.

>ADD PATIENT EDIT/ERASE ERASE DONE PATIENTS SEND PATIENTS TO PC MAIN MENU

Instrument stores up to 200 patients conta ining 10 test results each from a list of 132 methods.

5.4.1 Adding patients PATIENT

1

To add a patient, type protocol, name, gender (M or F), age, and press enter on methods field to choose required profiles/methods.

Protocol: 23421 Name: RON HUXLEY Gender: M Methods:

Age: 30

F2=SAVE

Profiles

If profiles are defined, use up/down arrow keys and spacebar to select the required profiles. Selected profiles will be marked with an “*” asterisk. Press enter to advance to next screen.

> ROUTINE HEPATIC CARDIAC LIPIDIC Checked Methdos: 0 BIC AC ALB AMI

Methods BIC* AC * ALB* AMI BTO BDI

CAL CAC CKN CKM CDS COL

HDL LDL CHE CRE FAC ALP

FOS FRU GGT GLU GOT GPT

FER LDH MAG PRO PRU TRA

The methods screen will show a summary of tests to be run on the current patient, it is posible to use the arrow keys and spacebar to toggle method selection. Once finished, press enter key to go back to the first screen of patient loading and press F2 key to save patient settings.

Spacebar Pg Dn Pg Up

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5.4.2 Edit/erase patients

PATIENT

1

Protocol: 23421 Name: RON HUXLEY

To modify or erase a patient, use the left/right arrow keys to choose and press DEL key to erase or Enter key to edit patient as explained before.

Gender: M Age: 30 Methods: GPT GOT GGT ALP CHO GLU DEL=ERASE

5.4.3 Erase done patients

This option scans all patients database and releases memory by erasing completed (finished) patients. Before doing this operation, instrument will ask for confirmation. 5.4.4 Send patients to PC

This option will transfer patient information by the USB interfase to a PC. Once selected this option the instrument will wait for the connection, press ESC to cancel.

5.5 Running in batch mode 5.5.1 Start a Run

Once required methods, profiles, priority table, and patient data are loaded, it is possible to start a run by choosing start measure from main menu.

MAIN MENU

VER 5.xxx

PATIENTS RESULTS CONTROLS PROFILES METHODS >START MEASURE

To begin the run, choose “Start measure” from main menu.

MENU 1

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METHOD:0 WL.PEAK:340

GLUCOSE WL.REF:700

Instrument will ask first for reading water.by means of the pump actuactor.

F:2863 T:37.0 Read Water PRINT RCVR

METHOD:0 WL.PEAK:340

WATER SIP

GLUCOSE WL.REF:700

Then instrument will ask for the reagent blank. It is possible to choose not to read the reagent blank by pressing the key NO. F:2863 T:37.0 Read Reagent/Blank PRINT RCVR

SIP

REAGENT

The screen also displays F =xxxx, where xxxx is a measure of the actual signal to noise ratio, also a measure of counts generated by the preamplifier. Its main function is to verify reproducibility of flow-cell readings and the state of the lamp before measuring process is started. , unload cell in the same way and reload; verify that the F Load the micro-cell by using reading vary in no more than one unit. If not, flow cell should be cleaned as detailed in chapter 4, page 26. F values should range from 2000 to 4700. In case they are under 2000, the cell should be cleaned and a loopsetup should be performed. If cleaning does not improve the functioning, a standard cleaning should be carried out. METHOD:0 WL.PEAK:340

GLUCOSE WL.REF:700

T:37.0 Read Protocol: 23412 REPEAT RCVR PRINT more

After confirm reading of standard / value of factor instrument will ask the user to read a given protocol.

SAMPLE After that, in case reaction is kinetics type, instrument will plot the measurement points.

After processing the complete batch, results for each patient will be printed.

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5.5.2 STAT procedure

In case it is required to run STAT samples, press ESC key on built-in keyboard to interrupt the batch run and then use external keyboard to choose from main menu Methods and then run Method. After doing STAT samples it is posible to continue working with the pending batch by selecting start measure on main menu.

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5.6 Results reports

5.6.1 Results for a patient

PROTOCOL: 2343 Ron Huxley MET RESULT UNIT DIAGNOSTIC ALB 5.13 G/DL HIGH CAL 6.22 MG/DL LOW CRE 0.61 MG/DL LOW GGT 80.9 U/L HIGH < >

Choose “Results” from the main menu and then “By patients”, use left and right arrow keys to navigate through. Use Prt Scr key to print the values.

up/down Print Scr

5.6.2 Results for a method

METHOD: GGT UNITS: U/L PROTOCOL 2343 2344 2345 2346

RESULT 80.9 8.2 78.2 82.3

>Next SET CONTROLS LIST CONTROLS SEND TO PC MAIN MENU

Choose “Controls” from main menu and then set controls.

SELECT CONTROL > Control A Control B NOT DEFINED NOT DEFINED NOT DEFINED

Choose an existing control or enter a name for a new control.

SET CONTROL Control 0

Use the arrow keys to select a control and then press enter key to confirm and edit. It is possible to change control components and then edit control limits for each component.

Name:Control A Components: GLU ALP BIL F2=SAVE

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SET LIMITS GLUCOSE

Use the arrow keys to select a method, press enter key to edit limits, then press Page Up/down to return to previous menu.

Low Limit: 80.0 High Limit: 108.0 Mean : 94.0

< > Page Up/Down

Enter

5.7.2 Running controls inside a batch run METHOD:0 WL.PEAK:340

GLUCOSE WL.REF:700

When instrument asks for a sample, press more and then CTRL on built-in keyboard to run a control.

CONTROL

T:37.0 Read Protocol: 23412 REPEAT RCVR PRINT more

5.7.3 Review of control results SELECT CONTROL

Choose “Controls” from main menu and then list controls, then press enter and select method for the control to review.

> Control 0 Control 1 NOT DEFINED NOT DEFINED NOT DEFINED

CONTROL: Control 0 METHOD : GPT RESULT 185 194 187 185

DATE 07/04/05 07/05/05 07/06/05 07/07/05

>Next

Menu 2 > 7. Utilities

> Menu 2 > 5. FLOW CELL CLEANING

1) Fill a vial with about 3 ml of wash solution #1 Cat. Nr.1631/1600. Insert the capillary tube on it and leave immersed. Answer YES to the request of cleaning. Press actuator. 2) In about 5 minutes you will be prompted to remove cleaning solution and put distilled water. 3) When cycle is complete, fill cell with Soak Solution #2 Cat. Nr.1632/1600 twice. Leave the micro-cell filled with Soak Solution. 4) Flush several times with distilled water before reusing. 5) If results are not repetitive, repeat procedure procedure detailed in (1), (2) and (3).

6.2.2 Change and cleaning of sample filter Cat. Nr.1633/1600 sample filter is an important element to stop lint and fibers from entering into the cell. To avoid a decrease in the sipping speed, filters should be cleaned or replaced frequently. To ensure reliable readings frequent replacement and cleaning of the filter is absolutely necessary.

To clean filter, there are two possible procedures: Load several volumes of liquid in cell and then invert pump operation, or Remove filter and insert the exit end in a syringe previously filled with water or detergent solution. Press till particles and fibers are expelled. Remember the following recommendations as well: a) Wear adequate lintless clothing to operate the instrument. Synthetic fabric aprons are recommended. b) Do not cover samples with cotton, gauze pieces or surgical bandages. Use rubber, polyethylene, PTFE or glass stoppers. c) Filter reagents if they appear turbid after visual inspection. d) When ending daily work follow cell-cleaning instructions obtained in 6.2.1. I 64 I

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6.2.3 Flow-cell disassembly and cleaning

In case of the cleaning processes described in 6.2.1 were not sufficient to restore repeatability in the results, the micro-cell will have to be disassembled, in order to perform a direct cleaning of both the cell and the windows. The various components of the cell can be observed in graphic 4-1. To disassemble and clean the cell proceed as follows: 1) Turn off and unplug instrument from mains. 2) Tear down the instrument. Use the supplied cross screwdriver to loose and remove the cross-recessed screw in base. See drawing 4.2. 3) Disconnect connector and drain hose. Connector has a lateral retainer. Press firmly with the thumb to release. Gently lift the metal body. 4) Use an Allen wrench to loose and remove the screws holding the window frames. 5) Remove windows and remove the silicon gaskets. 6) Clean quartz windows with detergent, isopropylic alcohol or toluene. Check for residues. Remove any particle left in the cell using optic or very thin tissue paper. 7) Carefully watch the cell body and remove any object or particle. Pay special attention to the inlet and outlet fittings.

Cell bores are polished to prevent particles and bubbles from adhering. Do not scratch with tools or hard objects while cleaning. This could produce measurement damage. To reassemble, proceed as follows: 1) Reinstall gaskets on glass windows. Clean any trace of fingerprints left on the glass. 2) Insert 2 screws in cell and screw window frames on, one at a time. Clean the glass windows with a tissue paper. Check the surface for any rest of lint or powder. If possible, use a magnifier. 3) Insert cell assembly through cell compartment, verifying that it is correctly lodged. Tighten the screws as much as possible. Repeat the whole operation with the window on the other side. 4) Reconnect the drain hose and the plug. Check if the connector’s retainer is adequately positioned. Reinstall the sample filter Cat. Nr. 1633/1600. 5) Check the state and position of the sipper. Look for any defect in the tube, and verify that it is firmly inserted in the sipper guide tube that is part of the cell. I 65 I

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6) Reinstall and check that the electric wires and the drain hose have not been crushed during the assembly.

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6.3 Lamp replacement The analyzer’s lamp has an electronic protection system, which reduces lamp burnout to the minimum. In case of replacement, though, the following disassembly procedure should be followed: 1) Turn off and unplug the instrument from mains. 2) Disengage sipper guide tube (figure 1.1) 3) Locate and remove the screw in the base. 4) Carefully lift the instrument cover. 5) Disconnect the J10 connector on the left side of the circuit board (M160x – P193) (this connector’s wires reach the lamp, see graphic 4.4) 6) Remove the long plastic screw that fixes lamp assembly and remove lamp. 7) Install new lamp assembly by following every step in reversed direction. 8) Once the lamp is assembled, and the instrument closed, plug it and turn it on. Press Enter to access main menu. 9) Select Utility. –See section 4.10.2 10) Select calibration. 11) Select 2 and follow the instructions as described in section 4.10.2

Protective gloves should be worn when handling replacement lamp to prevent damage from finger marks.

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6.4 Installing thermal paper roll

This Analyzer requires the use of thermal standard paper, 57 mm wide, fax quality, Cat. Nr.1605/1 600. Its is easily replaced by following these instructions: 1) Remove printer cover by pulling gently upwards. 2) Cut paper’s end forming an acute angle. 3) Insert paper’s end through the slot in roll compartment. Push the paper so it will slide into printer head and show up through front slot. Pull out about 5 cm. 4) Thread through printer cover and reinstall cover.

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6.5 Pump tubing replacement The Analyzer’s tubes are made of a material that resists most of the acids and alkalis used in the clinical laboratory. The sipper is made of PTFE. It is most relevant to check that the end connected to the cell is not cracked, so that air will not come into the system. Due to its own characteristics and functions the pump tubing, is the most frequently replaced element. This happens when there is a significant reduction in sample volume. In order to replace the tubing, pull the drain hose from the support. Place the new tubing and insert in the support as shown in graphic 4-6. Fit the tube around the rotor and slide the other end into its support bracket.

6.6 Identifying accessories and consumable goods Product Wash solution Peristaltic pump tubing Aspiration filter kit x20 Thermal paper roll kit x10 MTP201-G166 printer 1m Aspiration capillary Drainage tube Lamp with socket Flow-cell Keyboard Keyboard and display Printer board Position sensor Preamplifier board Peristaltic pump motor Filter wheel motor Power switching Power board CPU-DTN410 Interferential filters

Catalogue number 204120 204121 204122 204123 204125 204127 240128 240129 240130 240131 240132 240133 240134 240135 240136 240137 240138 240142 240144 240143 I 69 I

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7- Troubleshooting The most common failures are herein described, as well as their possible solutions.

7.1 Non operating display 1)Turn instrument off 2) Disconnect from mains 3) Verify that main supply voltage is correct for instrument setting. 4) Inspect and replace the fuse if necessary. 5) Connect to mains, turn on and check the instrument’s operation. 6) Check if the socket has a ground connection.

7.2 Message: Standard Abs Low 1) Check the wavelength 2) Replace the blank and the standard 3) Check the F value (4.10 Utilities). 4) Review the method adaptation.

7.3 Inconsistent readings 1) Check the F value (4.10 Utilities). If the F value is erratic or low, the causes could be: a.- Low sample volume. Solution: increase the sample volume. b.- Bubbles: Dirty cell or air inside the tubing. Solution: Clean the cell. (See section 6.2.1) c.- Dirty cell. Solution: Clean the cell. (See section 6.2.1) d.- Obstructed cell. Solution: Disassemble and clean the cell (6.2.3) e.- Obstructed sample filter. Solution: replace the filter. f.- Stretched pump tubing. Solution: Change the pump tubing. (See section 6.5)

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7.4 Anomalous readings in kinetics 7.4.1

Constantly low values

• Reagent: Change to another brand or lot. • Temperature: Verify cell temperature. Solution: measure temperature or use a higher value. • Wrongly adapted method: Solution: Check lag time. Check meas time. Check initial absorbance of reagent. Check wavelength. 7.4.2

Constantly high values

• Temperature: Solution: change into a lower temperature. • Wrongly adapted method: Solution: Check: Lag time. Check meas time. • Use control serum: Solution: Verify that readings are really anomalous.

7.5 Systematic errors in endpoint • Check the standard: Prepare more than one standard and use replications when performing measurements.

7.6 Errors in coagulation • TP and APTT systematically long times Solution: Verify that the serums and reagents temperature is 37º C. • Too short TP Solution: Verify that the cover of the cell unit is correctly closed before ending the delay, which usually lasts 5 seconds

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