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EKF Stanbio Altair 240 User Manual

EKF Stanbio Altair 240 User Manual

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Ran

ndom Ac

ccess An

alyzer

Use

er Man

nual

DAR# 17.1355 5

ROM.G6001.01

EFF

Date: 29 AUG

G 2017

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Summary of Contents for EKF Stanbio Altair 240

Page 1 ndom Ac ccess An alyzer er Man nual DAR# 17.1355 5 ROM.G6001.01 Date: 29 AUG G 2017...
Page 2 Altair™ 240 – User Manual Section i INTRODUCTION Section i INTRODUCTION i.1 Identification Data This document is considered part of the instrument. The user must carefully read all sections of this manual before performing any operation. The manufacturer takes no responsibility regarding partial and/or unauthorized copies of this document.
Page 3 "Software". EKF Diagnostics, reserves the right to modify this EULA at any time and without notice. DAR# 17.1355 ROM.G6001.01...
Page 4 "applets" incorporated into the SOFTWARE PRODUCT), the accompanying printed materials, and any copies of the Software are owned by EKF Diagnostics or its suppliers. The Software is protected by copyright laws and international treaty provisions. Therefore, you must treat the Software like any other copyrighted material.
Page 5 Altair™ 24 0 – User M Manual Sect tion i INTRODU UCTION • Dire ective IVD 98/79/CE - - In-Vitro D Diagnostic Medical D Devices • Dire ective 2002 2/96/EC – W Waste Elec ctrical and d Electronic c Equipme ent (WEEE) i.5 End o of Life Rec...
Page 6 Altair™ 240. It is intended for use by lab personnel that will be operating the analyzer. NOTE: Information in this manual allows for the proper use of the instrument in cases where the user has attended a training course held by EKF Diagnostics or by an authorized representative of EKF Diagnostics.
Page 7 Altair™ 240 – User Manual Section i INTRODUCTION i.9 Table of Contents Section i INTRODUCTION ....................2 Identification Data ......................2 i.1.1 Document ........................2 i.1.2 Instrument ........................2 i.1.3 Manufacturer ....................... 3 ...
Page 8 Altair™ 240 – User Manual Section i INTRODUCTION 2.5.4.1. Liquid Solutions for the System ..............36 2.5.4.2. Liquid Tanks ....................37 2.6. Software and Firmware Installation ................. 40 2.7. 4-channel ISE Module (option) ................41 ...
Page 9 Altair™ 240 – User Manual Section i INTRODUCTION 4.2.4.3. Washing Station and Pumps ..............103 4.2.5. Barcode Reader ....................106 4.2.6. Electronics ......................106 4.2.7. Power Supply Unit .....................107 4.2.8. Software and User Interface ................110 ...
Page 10 Altair™ 240 – User Manual Section i INTRODUCTION 5.1.12.1. Kinetics and Fixed-Time Methods OD graph ........197 5.1.12.2. Results and Methods Exported Files ............198 5.1.13. Repetitions Menu ....................201 5.1.14. Results by Methods Menu ................203 ...
Page 11 Altair™ 240 – User Manual Section i INTRODUCTION 5.3.4. Working Session, Status Menu .................265 5.3.5. Working Session Results and Warning on Results .........265 5.3.6. Troubleshooting Low Slope, Noise and Drift Error or other ISE Module Issues ...
Page 12 Altair™ 240 – User Manual Section i INTRODUCTION 5.4.11.3. Entering Values for Controls (QC) ............311 5.4.11.4. Viewing Levy-Jennings Graphs and Printing QC Values ....312 5.4.12. Memory Files - Database.................315 5.4.12.1. Searching and Handling Patient Results ..........315 ...
Page 13 Altair™ 240 – User Manual Section i INTRODUCTION 6.5.3.2. Sample Tray Cleaning Procedure – Semi-annual Maintenance ..333 6.5.4. Peristaltic Pump Heads Replacement ............336 6.5.5. Photometer Lamp Replacement ..............338 6.5.6. Sampler Probes Replacement ...............340 ...
Page 14 Altair™ 240 – User Manual Section i INTRODUCTION 8.10. Electrical Consumptions (with options) ............376 Section 9 ADDITIONAL INFORMATION ................377 General ........................377 9.1. Warranty Limitations ....................377 9.2. List of Spare Parts and Consumables ..............378 ...
Page 15 EKF Diagnostics declares that all internal parts of the instrument are designed and made so as to prevent all possible risks for the user, in accordance with established guidelines.
Page 16 Altair™ 240 – User Manual Section 1 SAFETY 1.1. General Instructions Every note and warning included in this manual, highlighted in bold and/or underlined must be read carefully and special attention must be given to the following sections: • Section “ Installation” •...
Page 17 Altair™ 240 – User Manual Section 1 SAFETY 1.2. Labelling Marking of instrument The following label is placed on the right-rear part of the instrument, close to the main-switch, and contains: the producer’s name, the instrument type, the instrument part number, the instrument serial number, the supply and consumption specifications, the type of protection fuses and the year of production.
Page 18 Altair™ 240 – User Manual Section 1 SAFETY b) Two of the following labels (icons) are placed on the instrument: one inside the instrument, on the AC/DC power supplies the other near the power inlet, to inform the qualified technician about the potential electrical risk. Figure 3: Electrical Risk Icons Laser Light Hazard The following labels are placed on the instrument.
Page 19 Altair™ 240 – User Manual Section 1 SAFETY Moving Parts Hazard This label is placed on the front part of the instrument work area and informs the user about the risk associated with certain moving parts within the work area of the instrument: sampler probes, washing station, sample tray and reagent tray.
Page 20 Altair™ 24 0 – User M Manual Secti on 1 SAFETY Figure 8: Bio ological Ri isk Icon Generic H Hazard A similar sy ymbol (ico on) is place ed on the instrument t protectio on cover. I t informs th he user of the po otential ris...
Page 21 Altair™ 24 0 – User M Manual Secti on 1 SAFETY Figure 1 1: Potentia ally Infectio ous Tank La abel WEEE Com mpliance The adhes sive label b bearing th his symbol is located on the re ar of the a analyzer, c close to the instrum...
Page 22 User assumes all responsibility in the operation of this instrument. Use of the instrument for purposes different from those specified, indicated or approved by EKF Diagnostics and any injuries or damages arising from such use is not covered under warranty.
Page 23 Altair™ 240 – User Manual Section 1 SAFETY Notes: DAR# 17.1355 ROM.G6001.01 EFF Date: 29 AUG 2017 23/386...
Page 24 Altair™ 24 0 – User M Manual Secti on 2 INSTAL LATION Section 2 2 INSTAL LATION Descrip ption of t he Instru ment The Altair™ ™ 240 is a a random m access a auto-analy yzer desig gned to o operate in safety mode an...
Page 25 Altair™ 240 – User Manual Section 2 INSTALLATION incubation temperature is constantly maintained at 37°C. Reagents are temperature controlled at about 12°C ±2°C. On the instrument left side, are two switches, one for the system/instrument (green color) and the other for the refrigeration unit (red color). The ON/OFF status of the refrigerator is completely separate and independent from the ON/OFF status of the instrument and from the ON/OFF status of the PC.
Page 26 Altair™ 240 – User Manual Section 2 INSTALLATION 2.2.2. Environmental Constraints The room where the instrument is installed should have an air conditioning/heating system to maintain constant temperature and constant relative humidity for optimum performance. Avoid placing instrument in direct sunlight. The operating environment temperature should be between +18°C (64°F) and +32°C(90°F).
Page 27 5 days from delivery. If the shipment is international you must ask for inspection within 3 days from delivery. 4. Immediately notify EKF Diagnostics or distributor representative. NOTE: The procedure above may be subject to change in order to conform with local rules and/or dependent on the shipping agent procedures, terms and conditions.
Page 28 Altair™ 24 0 – User M Manual Secti on 2 INSTAL LATION 2.4.3. Unpac cking the Instrume A minimum m of two people ar re required d to unpa ck and re emove the e instrumen nt from the crate. 1.
Page 29 Altair™ 24 0 – User M Manual Secti on 2 INSTAL LATION 3. Unsc crew all sc crews (if an ny) attach hing the cl ips of the crate’s wa alls to the crate’s e. Remove e the clips and save them for r re-use.
Page 30 Altair™ 240 – User Manual Section 2 INSTALLATION instrument support by means of a mount arm. The arm weight capacity is between 3.2kg (7lbs) and 9.2kg (20lbs). To attach the LCD monitor/PC on the support, use the mount arm supplied in the packing list by placing it on the hub: 1.
Page 31 Altair™ 240 – User Manual Section 2 INSTALLATION 3. Follow instructions below to tighten or loosen tension. Lift up and down: DAR# 17.1355 ROM.G6001.01 EFF Date: 29 AUG 2017 31/386...
Page 32 Altair™ 240 – User Manual Section 2 INSTALLATION Caution: DO NOT over-tighten fasteners. Over-tightening may cause damage to your equipment. 4. Forward and backward: Caution: DO NOT remove screws. Removing screws may cause damage to equipment. 5. Side to side: DAR# 17.1355 ROM.G6001.01 EFF Date: 29 AUG 2017...
Page 33 Altair™ 24 0 – User M Manual Secti on 2 INSTAL LATION IMPORTAN NT! This m mount arm m will nee ed tensio n adjustm ments onc ce installa ation is complete . Make su ure all eq quipment is properl ly installed d on the product...
Page 34 INSTALLATION 2.5. Instrument Installation The system is designed to perform precision measurements. A proper installation assures the user correct instrument operation. EKF Diagnostics recommends that the installation be performed by trained authorized personnel. 2.5.1. Steps to Follow During Instrument Installation After unpacking the instrument and preparing the work bench, the authorized technician should follow the step-by-step “System First Installation Check List”;...
Page 35 Altair™ 240 – User Manual Section 2 INSTALLATION desktop and log-in the software using the default Username “admin” and the default password “12345678”: the instrument will perform a complete hardware reset and then will enter the warm-up mode. If the system doesn’t reset (with cover closed) set and save the proper virtual COM port (in System Config menu) and restart the system.
Page 36 20 liter tank (Green connection). Use only deionized water with conductivity not higher than 1.5µS/cm. The Systemic Solution Concentrate must be from EKF Diagnostics. Avoid contact with the skin and with eyes; in case of contact with skin, wash immediately with plenty of water.
Page 37 5 liter tank (Blue connection). Use only deionized water with conductivity below 1.5µS/cm. The Cuvette Cleaner Solution must from EKF Diagnostics. This solution is an irritant to eyes and skin, and can cause burns. Use the solution only for its intended purpose.
Page 38 Altair™ 240 – User Manual Section 2 INSTALLATION 20L Systemic Solution 5L Cuvette Cleaner 20L Waste Tank (Green) Solution Tank (Red) Tank (Blue) Figure 16: Charging and Waste Tanks The following table shows the electrical connections from the tanks to the instrument: Tank wiring Instrument Low level sensor of 20L Systemic tank,...
Page 39 Altair™ 240 – User Manual Section 2 INSTALLATION ASTE X UVETTE LEANER YSTEMIC REEN Figure 17: Solutions/Waste Tanks Connections DAR# 17.1355 ROM.G6001.01 EFF Date: 29 AUG 2017 39/386...
Page 40 Altair™ 240 – User Manual Section 2 INSTALLATION 2.6. Software and Firmware Installation The instrument has been updated at factory with the latest firmware versions. The final user doesn’t need to install any firmware. In case of firmware upgrades, updates will be released and sent with the proper documentation and instructions for installation;...
Page 41 Altair™ 240 – User Manual Section 2 INSTALLATION 2.7. 4-channel ISE Module (option) The ISE Module, when included with the analyzer as an option, requires some set up for proper start-up and initialization. It can be supplied with different configurations depending on the number of electrodes installed (from 1 to 4).
Page 42 Altair™ 24 0 – User M Manual Secti on 2 INSTAL LATION ISE M EAGE DULE ISE M ODULE ECTOR SSEMBLY Figur re 18: ISE M Module, lo cation is in n the instru ument (beh hind the fr ront panel) Note: All Electrodes s, Reagen...
Page 43 Altair™ 240 – User Manual Section 2 INSTALLATION 2.7.2. ISE Module Installation The ISE Module has been installed into the instrument by the manufacturer. Electrodes must be installed before use. After installing the electrodes, they can be enabled or disabled using the software (see ISE Module Config menu). 2.7.2.1.
Page 44 Altair™ 240 – User Manual Section 2 INSTALLATION 1. ISE Reagent Pack, containing: • Calibrator A. It is used in both the two-point and single-point calibrations for sample analysis. • Calibrator B. It is used in two-points and single-point calibrations for urine sample analysis.
Page 45 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION Section 3 THEORY OF OPERATION The Instrument This system is a Random Access Automated Analyzer that is used for Clinical Chemistry and Turbidimetry, developed for use in the laboratory. Clinical chemistry analyzers determine the concentration of certain metabolites, electrolytes, proteins, and/or drugs in samples of serum, plasma, urine, cerebrospinal fluid (CSF), and/or other body fluids.
Page 46 Altair™ 24 0 – User M Manual Secti on 3 THEOR RY OF OPER RATION Figure 20: Reagent a and Samp ple Working g Area The system m can wo ork both in n Random Mode an nd in Batc ch Mode, with a co ommon...
Page 47 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION • automatic sample pre-dilution; • incubation of the reactions at constant temperature; • photometric direct reading of the reactions; • processing of photometric readings and presentation of the analysis results; •...
Page 48 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION up to 450µl total reagent volume for R1 and R2. Each of the reagents can be sampled from 1µl to 450µl, with 1µl minimum increment. The sampler arms perform the automated mixing of the reagent and sample into the cuvette.
Page 49 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION The system uses the following sampling procedure: • Reagent R1 + Sample, during a single sampling machine cycle, with dispensing and mixing into the reading cuvette of destination; • Reagent R2 only (in case of two-reagent application), during a single sampling machine cycle, with dispensing and mixing into the reading cuvette of destination;...
Page 50 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION The system provides a particular protocol for the data exchange with a LIS (Laboratory Information System) based on the ASTM standard. 3.1.1. PC and Management Software An external personal computer provides the control of the instrument through a bi- directional USB serial connection and constitutes the user interface.
Page 51 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION Figure 21: Barcode Reader - internal The reader is a laser device, with integrated decoder that allows the decoding of barcodes of different types with recommended module ≥0,25mm. For samples, the following codes can be read: •...
Page 52 Altair™ 24 0 – User M Manual Secti on 3 THEOR RY OF OPER RATION preserves reagents at a cons stant temp perature o of about 1 2°C ± 2°C C (not less than a maximum of 14°C b elow the a ambient te emperatur re).
Page 53 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION 3.2. Operating Principles This system is an auto-analyzer for Clinical Chemistry and Turbidimetry intended as an integrated platform. 3.2.1. Operating Principle in Clinical Chemistry-Spectrophotometry The most common way to perform measurements is spectrophotometer analysis. Spectrophotometry is the process that determines the quantity of light absorbed by chemical mixtures at determined wavelengths;...
Page 54 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION Filter Detector METER Light source Cuvette Lens Figure 23: Photometer, Functional Drawing The polychromatic light, emitted by the light source (i.e. halogen lamp), is made practically monochromatic by crossing an appropriate interferential filter of a determinate wavelength.
Page 55 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION 3.2.1.1. Calibration in Clinical Chemistry Solutions having a known concentration, necessary for the determination of the factor F to be used for the determination of the results, are called “standard solutions” (or calibrators).
Page 56 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION The instrument reads the absorbance’s of said solutions and the values of OD are drawn on the ordinates of a Cartesian graph; the concentrations corresponding to the diluted solutions are drawn on the abscissas. If a straight line is drawing passing for the point that identifies a determined value of concentration (relative to one of the known concentration solutions) and perpendicular to the ordinates and another passing line for the corresponding value...
Page 57 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION 3.2.2. Method Timings and Result Calculations This paragraph shows the timing diagrams valid for processing the different method types in the instrument. Note that any operation during analysis routines is regulated by machine cycles. One machine cycle generally includes one or more of the following activities: reagent aspiration and dispensing, sample aspiration and dispensing, probe washing (after aspiration and dispensing), cuvettes washing, readings.
Page 58 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION : Reagent 1 dispensing. : Reagent 2 dispensing. : Sample dispensing. : Optical path = 0,6cm, inner distance between the two side walls orthogonal to the optical light-path, into the cuvette containing the reaction.
Page 59 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION In case of reagent quality check, the final absolute reagent color is taken - this reagent blank value will be compared against the reagent blank admissible range of the application and it must be included within those limits. When the blank is included in calculation, the system will perform on the separate cuvette the analysis of the reagent only, using the same application timing without sample dispensing –...
Page 60 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION Monochromatic ENDPOINT Method The result is the final absorbance taken on the Sample S mixed with the R1 (or with R1+R2) at the end of the incubation time and at one only fixed wavelength λ. END-POINT, MONO-REAGENT (R1+S) Read (1 filter) (R1+S)
Page 61 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION Calculation without Blank Value Calculation with Blank Value Interpolation with the Calibration Curve Interpolation with the Calibration Curve determined on the “n” values read for determined on the “n” values read for the “n”...
Page 62 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION END-POINT, TWO-REAGENTS (R1+S)+R2 Read (1 filter) (R1+S) Incubation time time from (R1+S) to R2 FIXED Reagent Blank measurement performed in separate cuvette (see below) Reagent Blank R1+R2 Read (1 filter) Incubation time time from R1 to R2 FIXED...
Page 63 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION Calculation without Blank Value Calculation with Blank Value Multi-Standard Concentration Result: Multi-Standard Concentration Result: ResEP = Intpol(OD ResEPb = Intpol(OD – OD Interpolation with the Calibration Curve Interpolation with the Calibration Curve determined on the “n”...
Page 64 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION Bichromatic ENDPOINT Method The result is the difference between the two final absorbance’s taken on the Sample S mixed with the R1 (or with R1+R2) at the end of the same incubation time on the same cuvette and at two fixed wavelength, λ...
Page 65 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION Calculation without Blank Value Calculation with Blank Value calculation of Factor F: calculation of Factor F: Δ − Δ − Δ Δ measured with the standard in measured with the standard in place of the sample place of the sample Multi-Standard Concentration Result:...
Page 66 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION BICHROMATIC END-POINT, TWO-REAGENTS (R1+S)+R2 Read (2 filters) (R1+S) Incubation time time from (R1+S) to R2 FIXED Reagent Blank measurement performed in separate cuvette (see below) Reagent Blank R1+R2 Read (2 filters) Incubation time time from R1 to R2 FIXED...
Page 67 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION Calculation without Blank Value Calculation with Blank Value Multi-Standard Concentration Result: Multi-Standard Concentration Result: ResBE = Intpol(ΔOD ResBEb = Intpol(ΔOD – ΔOD Interpolation with the Calibration Curve determined on the “n” values read for the “n”...
Page 68 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION Differential ENDPOINT – TWO REAGENTs Method The result is the difference between the two final absorbance’s taken at the end of the same incubation time on two different cuvettes: • The absorbance of the Sample S mixed with the reagent R1 at one fixed wavelength λ...
Page 69 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION Reagent Blank R2 CUVETTE 2blk R2 Read (1 filter) Incubation time Calculation without Blank Value Calculation with Blank Value Single-Standard Concentration Result: Single-Standard Concentration Result: ⎛ ⎞ ⎜ ⎜ ⎟ ⎟ Δ...
Page 70 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION Calculation without Blank Value Calculation with Blank Value Reagent blanks OD and OD taken on two separate cuvettes – one with R1 the other with R2; each blank value is deducted by the respective end point value for calculation purpose.
Page 71 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION Differential ENDPOINT – SAMPLE BLANK Method The result is the difference between the two absorbance’s taken, on the same cuvette, after (R1+S+R2) final incubation time and after (R1+S) first incubation time respectively, that means: •...
Page 72 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION Calculation without Blank Value Calculation with Blank Value Single-Standard Concentration Result: Single-Standard Concentration Result: ⎛ ⎞ ⎛ ⎞ ⎜ ⎜ ⎟ ⎟ ⎜ ⎜ ⎟ ⎟ ⎝ ⎠ ⎝ ⎠ ⎛...
Page 73 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION Differential ENDPOINT – Bichromatic SAMPLE BLANK Method The result is the difference between the two Δ-absorbance’s taken, on the same cuvette, after (R1+S+R2) final incubation time and after (R1+S) first incubation time respectively.
Page 74 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION Reagent Blank λ λ λ λ R1+R2 Blank Reads (2 filters) R1 Blank Reads (2 filters) or Final incubation time time from (R1+S) to R2 or 1 incubation time FIXED 1 machine cycle Calculation without Blank Value Calculation with Blank Value...
Page 75 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION Calculation without Blank Value Calculation with Blank Value Multi-Standard Concentration Result: Multi-Standard Concentration Result: ResDBb = Intpol(ΔOD – OD ResDB = Intpol(ΔOD Interpolation with the Calibration Curve Interpolation with the Calibration Curve determined on the “n”...
Page 76 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION FIXED TIME Method The result is the difference between the two absorbance’s taken, on the same cuvette, two different time instants, that means: • The absorbance of the Reagent R1 (or R1+R2) mixed with the Sample S taken at a fixed wavelength λ...
Page 77 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION FIXED-TIME, TWO-REAGENTS (R1+S)+R2 2 Read (1 filter) (R1+S)+R2 1 Read (1 filter) (R1+S) time from (R1+S) to R2 Incubation time = t Fixed-Time 2 read time = t FIXED (time to 1 read) (time to 2 read)
Page 78 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION Calculation without Blank Value Calculation with Blank Value measured with the standard in measured with the standard in place of the sample place of the sample Multi-Standard Concentration Result: Multi-Standard Concentration Result: ResFT = Intpol(ΔOD ResFTb = Intpol(ΔOD –...
Page 79 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION KINETIC Method The result is the slope of the absorbance’s measured during a given reading time starting at the end of the incubation time. Absorbances are taken on the same cuvette where the reaction takes place: sample S mixed with the R1 (or with R1+R2), at one fixed wavelength λ...
Page 80 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION KINETIC, TWO-REAGENTS (R1+S)+R2 n Read (1 filter) (R1+S)+R2 1 Read (1 filter) (R1+S) ..Incubation time Kinetic reading time time from (R1+S) to R2 FIXED Δ/min Reagent Blank measurement performed in separate cuvette (see below) Reagent Blank R1+R2 n...
Page 81 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION Calculation without Blank Value Calculation with Blank Value ⋅ − ⋅ ⋅ slope slope slope measured with the standard in measured with the standard in place of the sample place of the sample Multi-Standard Concentration Result: Multi-Standard Concentration Result: ResKT = Intpol(slope...
Page 82 Altair™ 24 0 – User M Manual Secti on 3 THEORY O OF OPERAT TION 3.3. The ISE E Module (option) The system m may in clude the e ISE Mod ule, an o option insta alled insid de the ch emistry analyzer it tself.
Page 83 Altair™ 24 0 – User M Manual Secti on 3 THEORY O OF OPERAT TION sample en ntry port a and the th ird (waste pump) p ulls sample es and ca alibrators t hrough the electro odes. The sampl e is dispen nsed by th e sampler...
Page 84 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION The ISE Module is designed to measure lithium, sodium, potassium, and chloride in biological fluids, using ion-selective electrode technology. A diagram of the electrode measurement system has been shown above. The flow-through sodium electrode uses a selective membrane, specially formulated to be sensitive to sodium ions.
Page 85 The instrument runs a cleaning cycle automatically after 50 samples have been processed. Note: EKF Diagnostics strongly recommends the User to run a Cleaning cycle (about 2 minutes) at the end of each work day before instrument shuts down.
Page 86 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION Calibrator A pump and then drawn through the electrodes by the waste pump. Calibrator A solution is also used for the pump calibration. Calibrator B is used in two-point and single-point calibrations for urine sample analysis.
Page 87 Altair™ 240 – User Manual Section 3 THEORY OF OPERATION 3.4. Bibliography • Carl A. Burtis and Edward R. Ashwood (1999) - Tietzt Textbook of Clinical Chemistry (3 Edition) – Saunders • Tiezt N. (1976) – Fundamentals of clinical chemistry - Saunders •...
Page 88 Altair™ 240 – User Manual Section 4 FUNCTIONS Section 4 FUNCTIONS Functions WARNING The use of this instrument for some analysis, which have been validated, could require approval or registration in certain countries by the overseeing Government Agency. 4.1. Instruments Functions This system can automatically process a number of Clinical Chemistry and Turbidimetry tests.
Page 89 Altair™ 240 – User Manual Section 4 FUNCTIONS • Positive identification of samples and reagents by barcode reader with ability to use different coding types for sample labelling. • High precision sample and reagent dispensing systems; it makes use of high precision micro-metering stepping motor pumps for high accuracy and reproducibility.
Page 90 Altair™ 240 – User Manual Section 4 FUNCTIONS 4.2. Functions The instrument includes the following functional sub-assemblies: • Loading trays: Sample tray and Reagent tray (within work area). • ARM assemblies, for dispensing reagents, patient samples, calibrators / standards and quality control sera; •...
Page 91 Altair™ 24 0 – User M Manual Secti on 4 FUNCTIO 4.2.1. Loadin ng Trays The loadin ng trays inc clude: • The Sample tr • The Reagent t tray and re eagent co ooling unit. REAGENT T 44 Positions s for 35mL/15 5mL Reagen nt Bottles,...
Page 92 Altair™ 24 0 – User M Manual Secti on 4 FUNCTIO 13mm dia meter and d 75mm-10 00mm heig ght or Hita achi like 3 mL sample e cups (dia ameter ® 12mm) w without sp pecial ad dapters. A All numb ered pos sitions are...
Page 93 Altair™ 24 0 – User M Manual Secti on 4 FUNCTIO The coole er is locate ed under t the reagen nt tray. Th e refrigera ation prese erves all re eagent bottles at t a consta ant tempe erature of f about 1 2°C±2°C;...
Page 94 Altair™ 24 0 – User M Manual Secti on 4 FUNCTIO 4.2.2. Dispen nsing Asse embly – S Sampler The system m includes s two sam mpler ARMs s that are used for aspiration , dispensin ng and mixing of s samples a nd reagen nts.
Page 95 Altair™ 24 0 – User M Manual Secti on 4 FUNCTIO After eac ch dispens sing/mixing g operatio on perform med in th e cuvette e, the inst rument automatic cally perfo orms, withi n the sam me machin ne cycle, a probe w washing c cycle in...
Page 96 Altair™ 24 0 – User M Manual Secti on 4 FUNCTIO 4.2.2.1. Sample er Probe Sub-asse embly This sub-as ssembly (o one for eac ch sample er arm) inc ludes the probe itse elf, the liqu id level sensor and d the obsta acle senso Sampler p...
Page 97 Altair™ 240 – User Manual Section 4 FUNCTIONS The diluter has two fittings: one for hydraulic connection with the sampler probe, through the Teflon tubing (thinner tube), the other for hydraulic connection with the electro valve (thicker tube). The electro valve itself is connected on the other side to the peristaltic washing pump.
Page 98 Altair™ 240 – User Manual Section 4 FUNCTIONS 4.2.2.4. Pumps for Probe Washing One peristaltic pump for each sampler ARM (Diluter pump) is used to move the systemic solution into the probe hydraulic circuits that must be washed. All washing pumps have been placed on a support located just behind the right side panel of the instrument;...
Page 99 Altair™ 24 0 – User M Manual Secti on 4 FUNCTIO 4.2.3. Probe W Washing Station The wash hing statio on is loca ated in m middle of the wor rking area a, betwee en the reagent/s ample wh heels and the readi ing cuvett te tray.
Page 100 Altair™ 24 0 – User M Manual Secti on 4 FUNCTIO 4.2.4. Incuba ation and d Reading g Assemb bly and W Washing Station This assem mbly is com mposed of the followi ing main p parts: • Cuv vette tray assembly for incuba ation of rea...
Page 101 Altair™ 24 0 – User M Manual Secti on 4 FUNCTIO 4.2.4.1. Incuba ation and d Reading g Assemb The incub bation and d reading assembly is based on a rota ating tray that cont ains 80 cuvettes m made of o optical pla stic.
Page 102 Altair™ 240 – User Manual Section 4 FUNCTIONS Halogen Selective Receiver Pre- Filter Auto-gain Conversion lamp filter and focal DIGITAL SECTION ANALOGIC SECTION Figure 38: Optical Group – Measurement Circuit The measurement chain includes an automatic gain control circuit in order to assure always similar signal dynamic ranges over the different wavelength and even in case the boundary conditions change.
Page 103 Altair™ 24 0 – User M Manual Secti on 4 FUNCTIO 4.2.4.3. Washin ng Station n and Pu The washi ing station n washes all of the cuvettes using ded dicated w washing so olutions. During the e routine, a cuvett te begins its washin ng cycle...
Page 104 Altair™ 240 – User Manual Section 4 FUNCTIONS ASP5/DI ASP4/DIS ASP3/DI ASP2/DIS ASP1/DIS POS.8 POS.7 POS.6 POS.5 POS.4 POS.3 POS.2 POS.1 Not Used Figure 40: Washing Station Scheme Each of the 5 dispensing peristaltic pumps has a one-to-one connection to one dispensing needle (from DIS1 to DIS5 - short ones) of the washing station.
Page 105 Altair™ 240 – User Manual Section 4 FUNCTIONS • Position 7 (asp needle): the cuvette is fully discharged. • Position 8 (tip): the cuvette is dried from residual liquid drops. Dedicated Start Up cycle is automatically run by the system during the power-up of the instrument, or on operator request, to assure the cleaning and control of each cuvette and the current updating of the auto-zero values.
Page 106 Altair™ 24 0 – User M Manual Secti on 4 FUNCTIO EEDLE PUMP : “A 2” HING “A 3” ATION EEDLES NLET EEDL FROM AS PUMP NEEDLES : “A 4”, “A 5” ” “A 6” UTLET TO WASTE Figure 42: : Washing Station, As spiration P...
Page 107 Altair™ 240 – User Manual Section 4 FUNCTIONS The digital control circuit, the data acquisition and signal conditioning circuits have been shielded and placed far away from the power circuits. Thus electrical switching noise influence has been minimized. The instrument provides several fans, automatically run by the system at start-up (one is internal to the unit power supply);...
Page 108 Altair™ 24 0 – User M Manual Secti on 4 FUNCTIO EFRIGE ERATION YSTEM REAKER REAKER UPPLY C LINE INLET CONNEC CTION OTECTION USES Figure 43: M Main Switc ch Block Each of th he interna l low volta age DC su upply lines is protect ted by a f...
Page 109 Altair™ 240 – User Manual Section 4 FUNCTIONS Other internal filtered power supplies are generated for powering the photometer lamp (+12Vdc) and the control electronics (+/-5Vdc). The refrigeration unit is fed with a dedicated section of the main power supply, separate from the one for management and control electronics;...
Page 110 PAUSED status. WARNING EKF Diagnostics does not recommend the running of any other software that is different from the User Interface; this could affect the operation and the communication between the PC and the instrument, and it could cause loss of data and function.
Page 111 Altair™ 24 0 – User M Manual Secti on 4 FUNCTIO All results a are stored d in the ext ternal PC memory a and they c can be se nt to an e external printer co onnected to the co omputer.
Page 112 Altair™ 240 – User Manual Section 4 FUNCTIONS From this menu it is also is possible to exit the application by running the Shutdown procedure. 4.2.8.3. Introduction to Work List Menu This menu allows the user to program the Work List for the next working session and to introduce the patient data for each sample.
Page 113 Altair™ 240 – User Manual Section 4 FUNCTIONS • To run sampler probe rinsing cycles (includes sampler Arms reset), using the proper ARM Rinsing command/s. • To run the optical group gain calibration cycles (includes cuvette washing and auto-zeroing procedures), using the Gain Calibration Cycle command. •...
Page 114 Altair™ 240 – User Manual Section 4 FUNCTIONS • To print reagent volumes on board. • To request a reagent position to move to the front of the instrument for loading/unloading purposes. 4.2.8.7. Introduction to Memory Files Menu In this menu it is possible to search, to visualize and to print the test results previously executed and stored;...
Page 115 Altair™ 240 – User Manual Section 4 FUNCTIONS 4.2.10. L.I.S. Interface The system is equipped with a L.I.S. Interface (Laboratory Information System). It is a link used for patient data to be exchanged with a host computer through a network; it is possible to manage patient work lists and results from a remote station.
Page 116 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Section 5 OPERATING PROCEDURES AND MENUS Overview This Section gives the operator the needed information to correctly use the instrument; it follows the organization below: • General description of the User Interface software through the detailed explanation of all menus;...
Page 117 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS PRINT Show Work List PRINT PRINT Start Work List Reagents WL Summary Start Status Repetitions PRINT PRINT PRINT Results by Results by QC/Std Start-up Patient Method Results PRINT PRINT Main Menu Chemistry Q.C.
Page 118 Altair™ 24 0 – User M Manual Secti on 5 OPERATING G PROCEDU URES AND MENUS 5.1.1. Main M Menu The lower tool-bar in ncludes the e following g sub-men nus and co ommands: • Wor rk List, allow ws Work List ts compila tion and m modificatio...
Page 119 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS • System Config, allows access to the user and system parameters setting pages. • ISE Module Conf., allows management of the Ion Selective Electrode Module (ISE - Electrolyte measurement system to be requested as option).
Page 120 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function • visualization of reagent tray configuration and of cuvette status; • System hibernation and wake-up. During the instrument running/work session, this menu allows for real time control of the analysis progress. The monitor displays: •...
Page 121 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.2. Work List Menu The operator enters this menu by selecting the command Work List from the Main Menu or from the Status menu. Figure 48: Work List Menu This menu gives the operator the opportunity to generate or to modify a Work List;...
Page 122 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Samples that have not been assigned a position on the sample tray are marked with position number “0” as well as the any additional patient samples that were ordered in case the tray is full.
Page 123 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS When the reagent blank is not programmed in a run, the system searches in memory for the last stored value and uses it for reagent blank check and eventually for final result calculation.
Page 124 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function sample tray. Samples not assigned to a position on the tray have number “0”. Sample ID: The operator can enter the sample identification code; this code can be composed by a maximum of 20 alphanumeric characters.
Page 125 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function UDP1: UDP1 stands for User Defined Parameter #1, this field allows the user to introduce, for each patient, a special value [value 1] to be computed in the formula of a “formula type”...
Page 126 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function readable); the system stores the old sample results and it sets the position as free. - Case of a sample that has been partially processed and the system doesn’t find it on the tray anymore;...
Page 127 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function the user; in this window it is possible to select one or more profiles for each sample to be introduced in the Work List. By selecting one profile the system automatically adds and associates all the included methods with the sample itself.
Page 128 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function position can be run; if not already programmed, the control icon [QC(x)] is not present. - Selection of Controls: For each method the selection is “cyclical” and sequential. For each click with the left mouse button on the QC icon, its status changes as follows: 1) Dark green →...
Page 129 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function In case of “BLK” programming: All possible reagent blank for methods set as “visible” will be displayed in this table. The selection of one parameter is “cyclical” and sequential. For each click with the left mouse button on the same icon, its status changes as follow: 1) Light green...
Page 130 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.2.1. Patient Private Data Window The operator can enter this window selecting the Patient Private Data command from the Work List menu. Figure 49: Patient Private Data Window The operative fields and the operational commands included have the following function: Field/Command Function...
Page 131 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function Format of the field: yyyy/mm/dd, where • yyyy → year, 4 digits • → month, 2 digits • → day, 2 digits. Age: This alphanumeric field allows the operator to add the patient age. Address: This alphanumeric field allows the operator to add the address of the patient.
Page 132 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.2.2. Work List Display Window The operator can enter this window by selecting the Show Work List command from Work List menu; it shows the actual programmed Work List. Figure 50: Show Work List Window The operative fields and the operational commands included have the following...
Page 133 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function operator must select the command Save in Work List. Move selected to pos.: A sample can be selected using the left mouse button. This command allows the operator to move that sample into another free position on the sample tray.
Page 134 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.3. Reagents Menu, During Work List programming By clicking on Next in the menu Work List or clicking on Reagents in the menu Methods, the operator is able to enter the Reagents menu; which allows the configuration of the reagent tray by assigning reagent positions on the tray.
Page 135 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS To remove a single reagent from its position on the tray, the operator has to click and drag the reagent out of the tray. To remove all reagents loaded on board, the operator has to click the command Empty rgt tray.
Page 136 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function been read and understood but the method is not included in memory). • Red: Unreadable Position used by a reagent bottle with unreadable barcode or without barcode. •...
Page 137 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.4. Work List Summary Menu The operator enters this menu by clicking the Next button from the Reagents menu during the WL programming. This menu summarizes, in the two windows named Samples and Reagents, what has been programmed and included in the current Work List to be run and allows the operator to check the positions of the reagents, of the samples, of the standards/calibrators and of the QCs to be processed.
Page 138 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function reagent number: R1 and R2. Reagent lot: This column, not editable, shows the reagent lot code (the word “lot” is shown in case code is missing). Commands Move rgt tray to: This command allows the operator to move the desired position of the reagent tray to the front of the instrument.
Page 139 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Figure 53: Starting session with alerts DAR# 17.1355 ROM.G6001.01 EFF Date: 29 AUG 2017 139/386...
Page 140 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.5. Status Menu The Status menu shows the operator the actual instrument status under various conditions. This menu can show one of two different conditions: system in running or system in Idle (stand-by).
Page 141 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Figure 54: Status Menu - WL in running Figure 55: Menu Status – System Pause during a run DAR# 17.1355 ROM.G6001.01 EFF Date: 29 AUG 2017 141/386...
Page 142 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Figure 56: Menu Status – Reagent text summary window The operative fields and the operational commands included have the following function: Field/Command Function Sample tray positions White position: It identifies a free position, or a position not used in the current Work List. Yellow position: It identifies a sample included in the Work List but not yet processed.
Page 143 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function • To refill the sample, • To close the cover, • Click using the left mouse button on Continue displayed on the monitor. Notes: 1- By clicking on any sample position with the left mouse button it is possible to open an information window showing sample analyses results and their status.
Page 144 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function analyses related to the method (Ignore); To go out leaving the reagent as it is and to postpone the decision (Exit - the system doesn't consider the run of analysis as finished until the operator decision whether to abort, to retry or to ignore).
Page 145 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function working correctly. If the outer area color is “red” then the ISE Module is in alarm (problem) status and requires attention from the operator. Commands Reagent text summary: This command displays the status of the reagents on-board.
Page 146 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS STATUS – For system in Idle Figure 57: Menu Status – System in Idle When the instrument is in stand-by (Idle status), waiting for commands, the operator can: • Run a short rinsing and reset cycle for the sampler probe; •...
Page 147 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS The operative fields and the operational commands included have the following meaning: Field/Command Function Sample tray positions As per Running status, previously described. Reagent tray positions As per Running status, previously described. Cuvette tray As per Running status, previously described.
Page 148 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function Moreover, the system can be programmed for automatic hibernation after a given time from initial Idle status (program this feature in System config. Menu); wake up modes and conditions are the same described above.
Page 149 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.6. Methods Menu By selecting Chemistry from the Main Menu or from the upper menu bar the operator can enter the Methods Menu. This menu allows the setting, modification and management of the analysis methods.
Page 150 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS In mono-reagent methods, the system dispenses the reagent R1 together with the sample in the same machine cycle. That means the system performs the following operations in sequence with reference to the dispensing phase of the entire cycle: •...
Page 151 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function • g/dl • mg/dl • µg/dl • mmol/l • mEq/l • U/L • % • g/l • mg/l • µmol/l • UI/ml • Abs • ng/mL • µg/mL •...
Page 152 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function ISE electrolytes selection: This pull down menu allows the operator to select the desired electrolytes. The following ISE methods are available: • Na+ • K+ • Li+ •...
Page 153 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function diluted analysis the multiplication applies only to the post-dilution factor (not to the composite overall factor). Modes: This field allows the user to introduce some text comments or notes to be printed on the result report.
Page 154 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Incubation/Reading Time [sec]section SEE THE DIFFERENT CASES BELOW (see also Section 4) Incubation/Reading Time [sec] section valid in case of MONO-REAGENT applications: END-POINT, DIFFERENTIAL TWO-REAGENTS, DIFFERENTIAL SAMPLE BLANK (mono or bi-chromatic) (R1+S) Read (1or 2 filters) (R1+S) Incubation time...
Page 155 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Incubation/Reading Time [sec] section valid in case of TWO-REAGENTS applications: END-POINT, DIFFERENTIAL TWO-REAGENTS, DIFFERENTIAL SAMPLE BLANK (mono or bi-chromatic) (R1+S)+R2 Read (1or 2 filters) (R1+S) Incubation time time from (R1+S) to R2 FIXED Final incub.: This field allows the user to enter the incubation time (in seconds) of the...
Page 156 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Incubation/Reading Time [sec] section valid in case of TWO-REAGENTS applications: KINETIC (R1+S)+R2 n Read (1 filter) (R1+S)+R2 1 Read (1 filter) (R1+S) ..time from (R1+S) to R2 Incubation time Kinetic reading time FIXED...
Page 157 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS A pull down menu gives the opportunity to choose one of the following selections (in terms of seconds): 30, 60, 75, 90, 120, 165, 195, 255, 300, 360, 390, 450, 510, 555, 600 or 660. Incubation/Reading Time [sec] section valid in case of TWO-REAGENTS applications: FIXED TIME (R1+S)+R2 2...
Page 158 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS order to convert results only for correlate them with alternative methods or other temperatures. If not used enter 1, zero causes all results = 0. This field allows the user to set the offset (intercept) for this test in order to convert results only for correlate them with alternative methods or other temperatures.
Page 159 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Reference Ranges (Results Normal Values) section Sample type: This pull down menu allows the user to select the sample type: serum, plasma, urine, CSF and any other added by the Extra-Procedures menu, whose normal values have to be set.
Page 160 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Formula Builder: This command is enabled only if a “Formula” method has been set. It allows the user to enter a formula builder calculator to fix the formula used to calculate the final result. Save: This command allows the user to save the method modifications;...
Page 161 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function that is used in calculation when blank is included. It is not shown for End- Point methods. Reagent lot: This column shows the lot number of the reagent used for the reagent blank measure.
Page 162 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Dilution ratios are as follows: 1:1, 1:2, 1:3, 1:4, 1:5, 1:6, 1:7, 1:8, 1:9, 1:10, 1:16, 1:20, 1:30, 1:40, 1:50 and 1:100. In the case of the ISE Module, the system automatically prepares a 1:10 dilution for a urine sample.
Page 163 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS only to the related method and the same dilution ratio is used by the instrument to pre-dilute all the available controls (C1, C2 or C3). The dilution process is done automatically by the instrument directly into a cuvette, soon before to prepare the final reaction.
Page 164 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function operator for confirmation. Out of linearity: With this selection the operator can enable the auto post-dilution in cases where the result is “out of linearity”. The post-dilution will be automatically performed by the system without asking the operator for confirmation.
Page 165 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS • Ability to print the reagent linearity value when the result overcomes that value (instead of stars); • Ability to print the detection limits value when the result is below that value (instead of stars).
Page 166 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.6.4. Formula Builder Calculator Submenu The Formula Builder menu allows the user to set specific calculations for computing the final result. It is generally used when a specific test result is related to other tests or parameters by a mathematical formula.
Page 167 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function • RGT_O.D., that is the reagent blank O.D. result (in Abs) • SMP_O.D., that is the final O.D. result (in Abs) • U.D.P.1, that a user defined parameter value 1 specific of each patient •...
Page 168 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.6.5. Dispensable Volumes During the programming of methods and while setting parameters, the sample and reagent reaction volumes to be dispensed in any single cuvette, must always be within the fixed limits. The total reaction sample and reagent volumes, dispensed into each cuvette, might range between 200µl and 500µl: the typical suggested reaction volume is from 200µL to 260µL;...
Page 169 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.6.6. Reading and Incubation Times With reference to the incubation and reading times, the following table is valid for the different type methods and gives the admissible ranges for diffrent instrument type (based on the machine cycle and throughput).
Page 170 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.7. View Restriction Menu The View Restriction menu allows the user to set specific restrictions for the current method, considered as “the contaminant”, in order to limit cross-contamination in the reading cuvettes, with the sampler probe and to resolve different reagents incompatibilities.
Page 171 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS The selected contaminant method will never run into a cuvette where just one test after (80 cuvette later = one complete turn of cuvette tray) the methods listed in the window “Do not execute before”...
Page 172 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS To delete a restriction, the operator has to click and to drag it out of the window, back onto the left side list or they can delete it in the “Restriction Summary” on the right.
Page 173 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function Do not execute before: This window includes the methods that can be contaminated if run just one test after the contaminant: then, the contaminant will not be run one test before the methods in this list.
Page 174 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.8. Reagents Menu By selecting the command Reagents in the Chemistry menu, the operator enters the Reagents menu which allows the setup of the reagent tray by assigning methods to the different positions on the reagent tray.
Page 175 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS To remove a single reagent from its position on the tray, the operator has to click, drag and release it out of the tray. To remove all reagents loaded on board, the operator has to run the command Empty rgt tray.
Page 176 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function been read and understood but the method is not included in memory); • Red: Unreadable Position used by a reagent bottle with an unreadable barcode or without a barcode; •...
Page 177 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.9. Profiles Menu By selecting the command Profiles from the menu Chemistry, the operator enters the menu Profiles; this allows one to program new profiles of analysis and to modify the existing ones.
Page 178 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function change a profile by modifying the selected methods and by saving it with the command Save. Delete: This command allows the operator to delete the selected profile. Save: This command allows the operator to save a profile that has been created or modified.
Page 179 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.10. Standards Menu The operator can enter the Standards menu by selecting the command Standards in the Chemistry menu. This menu allows the operator to manage calibrators and standards for all stored methods that are displayed. Within the special fields included in this menu, it is possible to load the values of the standards or the factors for each method, to set the number of replicates (if one or three –...
Page 180 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS value (the program gives evidence of actual standardization date and time). In the latter case that method works against a factor. To enable the calculation of the factor the operator must have previously introduced the value of the standard;...
Page 181 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS The operative fields and the operational commands included have the following function: Field/Command Function Name: This field, not editable, shows all methods, set in memory to be displayed. Lot: This field allows the operator to set the name and lot number of the standard/calibrator.
Page 182 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function Dil. ratio: This pull down menu allows the operator to select the needed dilution ratio from the concentrated standard (main standard). The operator can select a ratio for any row of the table associated with a position on the tray.
Page 183 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function obtained from the last standard measurement. These fields can be modified by the operator to build a calibration curve. Reagent blank: The fields of this column, not editable, will be automatically updated by the instrument with the absorbance value (O.D.) obtained as the reagent blank measurement on the cuvette with its reagent and without the sample (standard).
Page 184 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function can be omitted), negative number (the sign “-” must be included) which is used for a method with a decreasing reaction. Factor min: This field allows the user to introduce the minimum reference value for the factor admissible range (if this control is enabled).
Page 185 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.10.1. Calibration Curve Multi-standard methods make use of a calibration curve for extrapolation of results at different standard concentrations. The Methods menu includes the command Calibration Curve that allows the visualization of the Calibration Curve plot, OD values vs.
Page 186 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.11. Quality Control Menu The operator can enter the Quality Control menu by selecting the command Controls in the Chemistry menu. It allows for the management of the Quality Control serum values and parameters.
Page 187 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS The operative fields and the operational commands included have the following function: Field/Command Function Methods section Methods: This column, not editable, lists all methods set in memory as “visible”; when the operator selects one of the listed methods, the system displays the data of its controls on the right side of this menu.
Page 188 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function system will not consider that control as a valid one; this value cannot be equal to 0. Calculated QC data sub-section Min: This numeric field is automatically filled by the system and shows the operator the minimum value for the control (calculated over all of the QC results as the n standard deviation fixed in the method).
Page 189 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function real, the graph will show theoretical values or calculated values for the min (-n SD, n=1÷3), theoretical and max (+n SD, n=1÷3). Levey Jennings: This command allows the operator to display the Levy-Jennings graph. The graph includes the last 50 values, one for each day.
Page 190 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.11.1. QC and Levy-Jennings Graph For each of the three QCs that can be set and run for each method, the command View Levy-Jennings allows for the display of the Levy-Jennings graph on three levels. Figure 68: Levy-Jennings Graph Within the graph, the system plots a straight line crossing the theoretical (or mean)
Page 191 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS When the result of a control exceeds the range or “limit of action”, the system is statistically out of control for that method and that value is displayed in red color on the graph.
Page 192 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.12. Results by Patient Menu The operator can enter the Results by Patient menu by selecting the command Results in the Main menu. It shows the results for the analyses of each sample (patient).
Page 193 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Note: Results that are out of range or that have been detected as abnormal by the system or that are out of some internal automated controls (substrate depletion, linearity, detection limit, etc.) will be automatically highlighted in red or in orange to be easily recognized by the operator during the result validation.
Page 194 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function This column, not editable, shows the final raw value measured and expressed in absorbance (OD). This field is not printed on the report. This field is displayed only if the flag “Show reaction details in result page” in System Config menu has been enabled.
Page 195 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function Commands Patient Private Data: This command opens a window whose fields can be populated with the personal and administrative patient data at any time. Store concluded: This command opens a special window that allows the operator to file in the archive a range of patients, whose analyses have been concluded.
Page 196 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function Repetitions: This command allows the operator to enter the Repetitions Menu. Status: This command allows the operator to go back to the Status Menu. Main Menu: This command allows the operator to go back to the Main Menu. Note: The user, by clicking on “Export concluded results”...
Page 197 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.12.1. Kinetics and Fixed-Time Methods OD graph This graph can be displayed using the pop-up menu (View Kin/Fixd Time graph) after selecting an analysis result in; Result for Patient menu (w/mouse right click). Figure 70: Kinetic Time graph This pop-up menu shows Kinetics or Fixed Time read ODs vs.
Page 198 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.12.2. Results and Methods Exported Files The command Export concluded results in the Result for Patient menu gives the operator the ability to export the results and the list of methods into files. The “Export Concluded Results”...
Page 199 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS • LastName = logged user’s last name • Name = logged user’s name. File Structure Format: Record delimiter character: ascii code 10 (Line Feed) Record Field delimiter: ascii code 59 (‘;’) Record fields: Patient Patient...
Page 200 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Location and Format of the Methods exported file This file gives the association between methods and their Id Code. This file is created every time a method is saved and over-writes the last one. Location: %ProgramRoot% \ MethodList File name:...
Page 201 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.13. Repetitions Menu The operator can enter the Repetitions menu by selecting the command Repetitions in any of the Results menu. This menu allows the repetition of samples, standards or controls by launching them within the Work List in progress or in the Work List to be run.
Page 202 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function Previous result: This column, not editable, shows the result of the previous analysis to repeat. Notes: This column, not editable, shows eventual notes on the previous analysis. Dil.
Page 203 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.14. Results by Methods Menu The operator can enter the Results by Method menu by selecting the command Results by Methods in the Results by Patient menu or in QC/Std Result menu. It allows the presentation of all results sorted by methods.
Page 204 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS In this menu the operator can: • Select the methods whose results need to be displayed; • Select one single test in order to view more details or to display the plot (valid for kinetics and fixed time);...
Page 205 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function Reference values: This column, not editable, shows the lower and the higher limits of the normal result range, as has been set in the Methods Menu. Flags: This column, not editable, shows any condition of results out of normal range.
Page 206 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function the actual work session and with different dilutions. Results by patient: This command allows the operator to go back to the Results by patient menu. Q.C./Std Results: This command allows the operator to enter the Q.C./Std Results Menu.
Page 207 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.15. QC/Std Results Menu The operator can enter the QC/Std Results menu by selecting the command QC/Std Results in the Results by Patient or in the Results by Methods menus. It allows the presentation of all results of the standards/calibrators and of QCs that have been processed.
Page 208 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS linearity, etc.) will be automatically highlighted in red or in orange to be easily recognized by the operator during the result validation. The operative fields and the operational commands included have the following function: Field/Command Function...
Page 209 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function Position: This column, not editable, shows the position of the standard. Status: This column, not editable, shows the progress of any single standard. The following conditions are possible: •...
Page 210 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function new dilution ratio (if needed). A different dilution ratio for each analysis of the same sample can be chosen. Dilutions are performed in the cuvette. Show blank details: Select it if the reagent blank details related to that measurement must be displayed.
Page 211 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.16. Memory Files Menu The operator can enter the Memory Files menu (archive of all results) by selecting the command Memory files in the Main Menu. This menu allows the operator to manage all standard, control and patient analysis results that have been filed.
Page 212 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function Search Panel section By last name: This field allows the operator to introduce the patient last name to search in archive. The system considers the content of this field only if this search option has been flagged.
Page 213 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function O.D.: This column, not editable, shows the final measured value in terms of absorbance (OD). Reagent blank: This column, not editable, shows the reagent blank measured value in terms of absorbance (OD).
Page 214 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.16.1. Patient Results Auto-exporting for Back Up The Memory files menu allows the operator to handle and display all results previously filed. The database can hold up to 150,000 records. When the records approach 150,000 the program removes the oldest 50,000 records from the database and automatically stores them into a special file “.csv”, available for the User as back up;...
Page 215 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS • Minimum Reference Minimum normal value Value: • Maximum Reference Maximum normal value. value: • • Date: Date of the analysis; format YYYY_MM_DD_hh_mm Where: YYYY= year MM= month DD= day hh= hour mm= minute.
Page 216 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS • m_idblankPtr: Internal id pointer - reserved • m_timeStamp: Date of the analysis; format YYYY_MM_DD_hh_mm where: YYYY= year MM= month DD= day hh= hour mm= minute • m_rgtLot: Lot of the reagent •...
Page 217 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS The operative fields and the operational commands included have the following function: Field/Command Function Patient private data section Sample ID: This alphanumeric field shows the ID number given to the sample. Patient unique id: This alphanumeric field shows the ID number considered unique for that specific sample (patient).
Page 218 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function found by the search process. Methods: This column, not editable, shows all methods executed for the patients found by the search process and the sample dilution ratio that has been used.
Page 219 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.17. Std/Q.C. Archive Menu The operator can enter the Std/QC Archive menu by selecting the command Std/QC Archive in the Memory Files menu. This menu allows the operator to manage all filed results related to standards and controls.
Page 220 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function By lot: This field allows the operator to introduce the lot number of the standard/controls that must be searched in the archive. The system considers the content of this field only if the option search “by lot” is flagged.
Page 221 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function Reagent blank: This column, not editable, shows the reagent blank value in terms of absorbance (OD). Date: This column, not editable, shows the date and time (hh:mm:ss) related to analysis of the standard.
Page 222 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.17.1. QC and Standard Results Exported Files The command Export in Std/Q.C. Archive menu gives the operator the opportunity to export the results of Standard and Controls into two different files. Those files include the result of the research carried out in the Std/QC Archive menu.
Page 223 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Record fields: Method Method Reagent Result Unit of Minimum Theoretical Maximum Date Internal Acronym Identifier Measu- Referen- Reference Reference Index * rement ce Value Value Value * See Method export file format Fields meaning: •...
Page 224 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS File name: expSTD_YYYY_MM_DD_hh_mm_LastName_Name.csv (i.e.: expSTD_2011_10_18_55_43_Rossi_Paolo.csv) Where: • YYYY = year • MM = month • DD = day • hh = hour • mm = minute • LastName = Logged user’s last name •...
Page 225 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS • Std OD8: It is the measured OD got for the standard number 8. • Date: date of the analysis; format YYYY_MM_DD_hh_mm where YYYY= year MM= month DD= day hh= hour mm= minute.
Page 226 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.17.2. QC and Standard results Auto-exporting for Back Up The system keeps in memory the results of Controls and Standards of the last twelve months (on-line QCs/STDs results); when capacity is reached, the system removes the oldest results daily from the database and automatically stores those into special files “.csv”, available for the User as back up.
Page 227 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Record fields: Method Method Unique Date Errors QC Lot Reagent name barcode Cal ID Identifier Result Fields meaning: • Method name: Analysis method. A list of the methods linked to the proper identification code is included in the file methods.csv;...
Page 228 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Where: • yyyy = year • mm = month. File Structure Format: Record delimiter character: ascii code 10 (Line Feed) Record Field delimiter: ascii code 59 (‘;’) Record fields: Method Method Unique...
Page 229 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.18. System Configuration Menu The operator can enter the System Configuration menu by selecting the command System Config from any menu; it is located in the upper menu-bar. This menu allows the user to set or to change general order system parameters like: PC COM port setting, default Sample tube types, L.I.S.
Page 230 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function the languages listed in memory. Any modification must be saved by the command Save; most modifications will be active immediately even if full activation will be operating on the next start up. Sample position locked: This field gives the operator the possibility to block and lock the system to aspirate the sample only from a given position on the tray even if other different positions have been programmed in the worklist.
Page 231 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function Lock tests execution in If this selection is active, the system does not allow the operator to run case of date expired: tests when reagent, standard/calibrators or controls are expired; they are locked and cannot be run.
Page 232 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function results reports. Lower field: This field allows the operator to introduce any text information like the laboratory info or notes. The system prints this data on any results reports. Hibernation settings Standby after (min): This field enables the automatic stand-by of the system after a given time...
Page 233 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function L.I.S. Management Enable L.I.S.: This selection allows the operator to enable the instrument P.C. to the L.I.S. (Laboratory Information System) connection with the host computer through the dedicated LAN bidirectional serial link. This L.I.S. connection (option) allows for bidirectional exchange of the results and the Work List data.
Page 234 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.19. Cuvette Status Menu The operator can enter the Cuvette Status menu by selecting the command Cvt Status from the System Config menu. This menu allows the operator to display the transparent values (autozeros) for each cuvette and for each wavelength;...
Page 235 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function Autozero plot This graph shows all wavelength transparent values for each of the 80 cuvettes by giving immediate feedback on the actual cuvette status. On the right side of the plot there is a cursor by which it is possible to magnify the plot, by just moving the cursor.
Page 236 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.20. Users Menu The operator can enter the Users menu by selecting the command Users from the System Config menu. This menu allows the operator to display the actual user logging data and to modify and save the password for accessing the different user levels.
Page 237 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function Password: This field allows the user to introduce the new password of the logged-in user. Confirm password: The user must again enter the new password in this field for confirmation. Any modification must be saved by clicking the command Save.
Page 238 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Administrator level This user can use all operative functions of the instrument; they can create accounts and modify the parameter of the menus: System Config and Users; Expert Technical level This user can use all operative functions of the instrument, they can modify methods parameters, but they cannot create new accounts;...
Page 239 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS The operative fields and the operational commands included have the following meaning: Field/Command Function Search panel By event type: From a pull down menu it is possible to select the type of event the operator is searching for (see menu below).
Page 240 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.21.1. Action Logs Auto-exporting for Back Up The system stores in memory and keeps on-line up to 3,000 main events; when reaching the 3,000 the program removes the oldest 1,500 from the database and automatically stores them in a special file “.csv”, available for the User as back up.
Page 241 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.22. ISE Module Config Menu This window is active and can be entered if the system includes the ISE Module hardware, configured by the manufacturer. The operator can enter the ISE Module menu by selecting the command ISE Module conf from any menu;...
Page 242 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function Lot: This field allows the user to introduce Lot number referred of the electrodes. Any modification must be saved by clicking the command Save. Exp. date (YYYY/MM): This field allows the user to introduce the expiration date of the electrodes.
Page 243 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function Reference values: This field cannot be edited and lists the reference range values [in mV] given for the calibration result of the electrode aside. Electrode lot: This field cannot be edited and shows the lot number of the related electrode used for calibration.
Page 244 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.22.1. ISE Calibration Auto-exporting for Back Up The ISE module config menu allows the operator to handle and display all the results previously filed. The database can contain 10,000 records. When records approach 10,000 the program removes the oldest 3,000 records from the database and automatically stores them into a special file “.csv”, available for the User as back up.
Page 245 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.23. ISE Module Calibration History Menu This window is active and can be entered only if the system includes the ISE Module hardware device. The operator can enter the Calibration history menu by selecting the command Calibration history from the ISE Module config Menu.
Page 246 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Field/Command Function By Date (yyyy mm dd) This field allows the operator to introduce the ISE Module calibration range From: starting date to search in archive. The system considers the content of this field only if this searching option has been flagged.
Page 247 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.24. Show Alerts Window and Actions This window will appear anytime an alarm or a warning condition is detected by the system. It can be closed by clicking on the “X” icon on the upper right corner. It can be recalled by selecting, from any menu, the command Show Alerts located in the upper menu-bar only.
Page 248 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS (i.e.: if some reagents are finished, the operator must decide if to abort the related analyses for that run or to refill the bottles and continue the run itself). Refer to the troubleshooting section of this manual for correct interpretation.
Page 249 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.25. Extra Procedures Pull-down Menu This pull-down menu can be opened from any menu by selecting the command Extra Procedures located in the upper menu-bar only. Figure 85: Extra Procedure Pull-down Menu It allows the operator to choose one of the following utilities: DAR# 17.1355 ROM.G6001.01...
Page 250 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS • Backup instrument data This procedure generates a special file that is stored into a folder. In this file the system saves all data and information included in the database. The file is created with the name YYYY-MM-DD.mbk, where YYYY, is the year MM, is the month...
Page 251 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS • Edit sample types This command opens a window giving the ability to create new sample types. Write a new type in the white field on the right and then click on the command Add new.
Page 252 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.1.25.1. Actual Statistics Window This window can be opened from any menu by selecting the command Extra Procedures located in the upper menu-bar only. This feature allows the operator to have better control over the instrument performance when counting the total number of test run monthly.
Page 253 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS The operative fields and the operational commands included have the following function: Field/Command Function Methods (Ref. month) This column lists all methods that have been run on the system. column: Total (Ref.
Page 254 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.2. Preparation for Operation Information provided here about reagent and consumable handling have general meaning. Thus, the manufacturer recommends the user read with care the product insert/instructions for use included with each product. 5.2.1.
Page 255 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS • serum, • urine, • plasma, • CSF, and other biological fluids resulting from sample treatment (read the section on the documentation accompanying the Reagent Kit). 5.2.2.2. Sample Pre-treatment Follow the specifications in the reagent kit for proper sample storage.
Page 256 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS SAMPLE TUBES Ø = 12mm - 13mm Ø = 12mm - 13mm h = 75mm h = 100mm Figure 87: Primary Tubes – Barcode labelling In order for the barcode reader to work properly, the label must be placed on the primary tubes (diameter=12/13mm, height=75/100mm), so that the printed barcode area is within the readable field identified in the previous illustration, figure 87.
Page 257 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS When convenient it is possible to use 3mL sample cups with prior special selection in the software (see Work List). WARNING The use of sample tubes that do not meet the conditions required could cause problems in sample aspiration/dispensation and may affect the final result.
Page 258 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS NOTE: Manufacturer recommends storing consumables far away from heat sources, and not to expose them to direct sun light, as they could be damaged and or the bottles could be deformed. 5.2.3.3.
Page 259 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS BAR CODE BAR CODE Figure 89: 15mL Reagent Bottle – Barcode Labelling DAR# 17.1355 ROM.G6001.01 EFF Date: 29 AUG 2017 259/386...
Page 260 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.3. ISE Module Configuration and Use (if included as an option) When the ISE Module is included as an option in the instrument, it must be configured as “enabled” in the user software interface before it can be used for electrolyte analysis.
Page 261 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 6. In case the first ISE Module initialization fails, click again on Initialize button to restart it (with system in Idle). Initialization includes the following automated steps: • Priming of Calibrator A, •...
Page 262 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS kind of electrode must be selected(if Na+, K+, Li+ or Cl-). Also, appropriate Results Normal Values should be introduced and Controls must be chosen. DAR# 17.1355 ROM.G6001.01 EFF Date: 29 AUG 2017 262/386...
Page 263 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.3.2. Reagents menu, Configuration of ISE Module Solutions When using the ISE Module, the user must configure positions for the Cleaning Solution and for the Urine Diluent (if some urine analyses have been requested) within the “Reagents”...
Page 264 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 2. After Starting, the Work List includes and processes the measurement for Li+, Na+, K+, and Cl- for the selected sample (or the measurement for the used electrodes); 3. After processing, four results for each sample (if four electrodes have been enabled) will be displayed in the Result menu.
Page 265 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.3.4. Working Session, Status Menu During the working session the Status Menu allows the user to control the instrument on-line. An ISE icon has been provided in the middle of the window to show the status of the ISE Module.
Page 266 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Deletion, repetition, filing and printing of results follow the same rules as per normal clinical chemistry analysis (see user manual). Possible warnings over results that are shown in Extended Detail when result is high-lighted in red color: Warning Description...
Page 267 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Warning Description Action into the reference electrode. 2. Check for electro- magnetic noise spike source near the instrument and remove it. 3. Replace reference electrode. See also next Troubleshooting paragraph. Ise Cal A Drift Cal A drift in Sample or Slope drift in calibration.
Page 268 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS has been performed, such as replacing the reference electrode and pump tubing. If that does not work, replace the questionable electrode(s) and see if this cures the problem. If not, salt contamination may be the source of the problems. In all types of Ion Specific Electrode (ISE) modules, the possibility of dried salt providing an electrical leakage path exists which can result in various errors including “Drift”...
Page 269 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Assuring proper and continuous instrument grounding is also necessary. Sometimes moving an analyzer to a different location will help determine if improper grounding or fluctuating strong EMF fields are involved with inducing errors (i.e. big elevator motors, …).
Page 270 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Values obtained from Calibration are displayed in the ISE Config menu and they can be printed out by user command. Calibration history is available upon dedicated command from ISE Config menu. For each electrode, values from both calibrations (in mV) are shown.
Page 271 As the procedure completes, the software exits and the Operating System can be closed. The instrument can then be powered down. WARNING EKF Diagnostics recommends the operator enable cuvette washing at the end of any work day in order to maintain performance. WARNING EKF Diagnostics recommends the operator never switch off the instrument before completing the shutdown procedure.
Page 272 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.4. Procedures 5.4.1. Operating Flow Chart System Start-Up Procedure (Instrument first and then PC) System Warm Up Work List Programming (Samples, Standard and Controls) Reagents on board check Sample Tray and Reagent Tray Summary Run of the...
Page 273 Altair™ 24 0 – User M Manual Secti on 5 OPERATING G PROCEDU URES AND MENUS The opera ator, throug gh the use er interfac ce, has the e ability to o program and to e xecute Work Lists that incl lude tests for each h patient,...
Page 274 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS b. The Green switch (for electronics), c. If required, the Red switch (for refrigeration), 5. Power ON the control PC and enter the Windows User account (by default no password is required to enter the “User”...
Page 275 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Figure 92: Software – Login User name and Password After running the software, the system resets and checks the status of all instrument assemblies (Auto-diagnosis test). It starts the automatic warm-up procedure and, after a successful login, the software displays the Main Menu.
Page 276 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS The User Interface program displays the Warm Up status on the monitor. During the Warm Up the user cannot select any functional command that can change the current instrument operative status. The shorter Warm Up procedure lasts 20 minutes (minimum time for lamp stabilization).
Page 277 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.4.5. Working Session Programming and Run The command Work List lets the operator enter the Work List menu for work session programming. The Work List menu shows on the right panel, all tests that can be run for each sample.
Page 278 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS During the manual programming, the operator will set tests for each of the samples; patient data must be entered manually for each sample if desired and requested. The system automatically assigns the available positions to STDs, CTRLs and Samples. When the L.I.S.
Page 279 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS “xxxx-yyyymmdd” Where xxxx=progressive number of the day, yyyy=year, mm=month, dd=day. Once given and saved, this ID Code number cannot be modified again. It can be deleted but not changed. 4.
Page 280 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS This data can be entered before or during the work session or, at the end of the session from the archive menu, after the results have been saved in the Memory files.
Page 281 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Any of the samples can be modified. Select the sample to modify and then click on the command Edit selected. The program focuses on that sample in the Work List Menu. Then execute modifications and save it again. Samples can be deleted.
Page 282 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS After selection, click on “Save in work list” to include the standard in the work session. The number between brackets stands for the number of standards to be performed. 14.
Page 283 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 17. Then proceed with the selection of the method/s whose reagent blank must be run (remember that they are included in the work list but they do not occupy any sample positions).
Page 284 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.4.5.2. Automatic Work List Programming with L.I.S. Connection When the L.I.S. connection has been enabled and is operative, the host remote workstation in the laboratory is linked with the system for data exchange. The link is based on an ASTM-like protocol described in the document cod.
Page 285 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS When the system receives new data from the host computer, it displays the following message on the monitor: The operator, in order to run a new WL or to add those new samples to a WL while running, has to click on OK and must enter the Work List menu.
Page 286 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS The operator will Start samples after having placed them on the sample tray. New free positions are cleared after validation and storing of concluded final results. Figure 95: Software, WL Menu - SMP If samples have been bar-coded for positive identification, the operator, after receiving the WL from L.I.S., places samples on board and runs the Scan sample barcode procedure.
Page 287 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS • Case of a sample that has been processed but not yet validated and archived: its position has been detected as free or in its position the reader has not detected a valid sample;...
Page 288 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Once the patient Work List to be run has been programmed, the user can include in the Work List the execution of the Standards and of the Quality Controls by choosing the methods among those listed in the reagent panel.
Page 289 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS • Ignore: The alert is ignored, analyses of that method is unlocked. When running the reagent blank in a separate cuvette, the systems also calculates the blank value that must be used in the calculation. This value is measured in accordance with the method parameters: absorbance final value for End-points, “delta”...
Page 290 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.4.6. Set Reagents on Board during WL Programming In the Reagents menu, the user can set reagents on board configuring manually or automatically by bar-code (when provided), the tray positions. Figure 96: Software, Reagents Menu 1.
Page 291 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS If reagents have been provided with proper bar-coding and the system includes the reader, the operator can simply place the reagent bottles on the reagent tray positions and then by clicking the button: The system will auto-configure the reagent tray positions on the screen.
Page 292 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.4.7. Running a Work List In the WL Summary menu, the user can control samples, reagents, standards and controls to be positioned on the different trays. In the reagents window the system solutions will be highlighted in blue.
Page 293 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Figure 98: Software, Error Message on WL Start 5. In the case of errors, the software opens a special message window explaining any inconsistency on the work list to run, the eventual action to take and the ability to Start the session or to Quit (button Cancel) and to correct the errors.
Page 294 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.4.8. Working Session The Status Menu allows the user to control the instrument on-line during the work session. In the bottom-right of this window, the system displays the status of each scheduled analysis.
Page 295 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS • To add new samples in the current Work List; • To display and to print results of concluded analyses; • To operate in the Memory files Menu (Archive); In the absence of system error messages, the user should wait until the work session is completed and then validate and print all the final Results from the Results Menu before running a new Work List.
Page 296 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 3. Open the cover and perform the needed operations within the work area – do not change position of reagents running in the Work List. 4. Close the cover. 5.
Page 297 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 10. Select the command Next. 11. In the Reagent page add the missing reagent bottles if needed then select Next again and enter the Work List Summary menu. 12. Select the command Start Random or Start Batch according to the previous selection.
Page 298 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 14. In the Reagent page add the missing reagent bottles if needed then select Next again and enter the Work List Summary menu. 15. Select the command Start Random or Start Batch according to the previous selection.
Page 299 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.4.9. Working Session Results The Results menu allows the operator to handle and display all results obtained in the last work session or in the current run (for analyses concluded). This section provides two menus: •...
Page 300 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 4. In the window that opens on the command above, choose the first and the last patient of the range whose results will be archived then click on the command Store.
Page 301 Altair™ 24 0 – User M Manual Secti on 5 OPERATING G PROCEDU URES AND MENUS 5.4.9.3. Deletin ng a Sam mple and its Analy yses’ Resu When all analyses of a pati ent have to be de eleted, th e proced ure is des scribed...
Page 302 Altair™ 24 0 – User M Manual Secti on 5 OPERATING G PROCEDU URES AND MENUS The proce edure is de escribed be elow: 1. From m the Resu ult by Patie ent menu s select the command d Print pat ient report 2.
Page 303 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.4.10. Reagents Control System Using the Chemistry Menu and all its sub-menus, the user can manage reagent, standard and controls’ data. 5.4.10.1. Reagent Panel: Manual Configuration The following procedure allows for the manual creation of a panel for a reagent tray configuration: 1.
Page 304 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 7. Repeat the operations 3 to 6 for every method to be introduced in the tray. 8. To delete a method from the configuration, click and drag it out of the tray. More reagent bottles of the same method can be placed in the same panel.
Page 305 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.4.10.3. Reagents Barcode Scanning The command Scan rgt barcode allows the operator to run the automatic identification of the reagents loaded. The procedure has been described in the previous paragraph and is available with the installed Barcode reader. Note: The program can connect a method to a barcoded bottle, read in the tray, only if the barcode number has been saved in the database.
Page 306 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 1. Select the Reagent whose lot must be modified; 2. Double click the field lot to be modified and enter the new lot number and the expiration date. 5.4.10.5. Programming Profiles The following procedure allows for Profile programming: 1.
Page 307 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.4.10.6. Deleting Profiles The following procedure allows for profile deletion: 1. Enter the Profiles menu. 2. In the Profile Name select the profile to delete. 3. Click on Delete to delete the selected profile. DAR# 17.1355 ROM.G6001.01 EFF Date: 29 AUG 2017...
Page 308 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.4.11. Working with Standards and Controls The following paragraphs describe how to set standards/calibrators and Controls data. Figure 102: Software, Std Menu 5.4.11.1. Mono-standard Methods The following procedure allows the operator to include set standard values and/or factor for mono-standard methods: 1.
Page 309 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 2. Just after selection, the right section of the display shows the data: dilution ratio, standard value and factor related to the selected method. 3. In the fields Lot and Expiry date, enter the lot number and the date of expiration of the standard to be used.
Page 310 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Once the standard has been measured, the system automatically overwrites the following fields: • O.D., with the measured absorbance value. • Reagent Blank, with the reagent blank value measured a machine cycle before the standard dispensing.
Page 311 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5. In the field Nr. of Repetition, select 1 (one run) or 3 (for triplicate – it repeats any point of the curve 3 times taking the average of the two closest results for each).
Page 312 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Figure 103: Software, Quality Control Menu 1. In the Q.C. menu, select the method whose control values and data have to be filled. 2. Select Control 1 tab, or Control 2 tab or Control 3 tab. 3.
Page 313 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 3. Click on command Calculate values to compute and to show the Calculated QC data over QC results; fields min, average and max will be filled if more than two QC results are available.
Page 314 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5. To print the data reported in the QC Results window, click on the command Print and choose whether to include or not include the graph in the print. The printed out report data contents depends on the previous selection: Calculated or Theoretical.
Page 315 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 5.4.12. Memory Files - Database The Memory files menu allows the operator to handle and to display all results previously filed for samples, standards and controls. The user can run result research in the database by entering any combination of the searching keys.
Page 316 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 4. In the field By method, it is possible to enter the test to search for, if test name is needed as research key. 5. In the field By Unique Cal. ID, it is possible to enter the calibrator unique identification number given by the system, if it is needed as research key.
Page 317 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 10. If some data modifications are needed in the patient Report window, make them and then select the command Save or select the command Print patient report to print the results report, or close the Report window to exit. 11.
Page 318 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS Figure 105: Software, Std/Q.C. Archive Menu 1. In the field By method, it is possible to enter the test to search for, standard/control, if test name is needed as a search key. 2.
Page 319 Altair™ 240 – User Manual Section 5 OPERATING PROCEDURES AND MENUS 6. Click the command Search; the search results will be displayed in the right side windows when the search has been completed. The upper window list QC results, the lower window lists Standard results. 7.
Page 320 It’s possible to exit the current user and enter a new one without restarting the software by using the command Change user. WARNING EKF Diagnostics recommends the user enable cuvette washing during shut down at the end of any work day in order to preserve performance and to extend cuvette life. WARNING EKF Diagnostics recommends the user never switch off the instrument before completing the software shut down procedure.
Page 321 This section provides the user with recommendations for proper maintenance of the instrument. NOTE: EKF Diagnostics reminds the user that the periodic visual inspection of the instrument is the first and easiest way to guarantee the best performance of the instrument itself.
Page 322 Altair™ 240 – User Manual Section 6 MAINTENANCE Carefully read Section 1 (“Safety”) and paragraph “Safety precautions” of this Section before performing the instrument maintenance. • During maintenance of the instrument complete protection should be worn: gown with long sleeves (ending with elastic bands), shock-resistant rubber gloves and protective glasses.
Page 323 Altair™ 240 – User Manual Section 6 MAINTENANCE Solution A bottles from position 41 and 43 and replace with the bottles previously occupying these positions. Press the GREEN button to turn on the instrument and restart the software. After warm up is completed go to the status page. Press the “Arm 1 rinsing”...
Page 324 Altair™ 240 – User Manual Section 6 MAINTENANCE 6.2. Safety Precautions Any maintenance operation left to the user must be carried out with the instrument switched OFF and with the power supply cable disconnect from the power socket. WARNING Carefully read Section 1 (“Safety”) before the instrument maintenance. 6.3.
Page 325 Altair™ 240 – User Manual Section 6 MAINTENANCE shutdown procedure in order to clean reading cuvettes. Remember to replace and keep permanently on board a full EW Cvt solution bottle (Extra Wash Cuvette bottle). 2. Clean the outside surface of the metallic Sampler Probes with an ethanol solution (70%).
Page 326 Altair™ 24 0 – User M Manual Secti on 6 MAINTEN NANCE 6.3.3. Six Mo nth Main ntenance e Schedul The user m must follow w the instruc ctions desc cribed be low for the e six month h maintena ance.
Page 327 Altair™ 240 – User Manual Section 6 MAINTENANCE 6.4. ISE Module Maintenance Scheduling This section provides the user with recommendations for the proper maintenance of the ISE Module when integrated into the system (option). NOTE: The manufacturer advises the user that the periodic visual inspection of the device is the first and easiest way to guarantee the best performance of the device itself.
Page 328 Altair™ 240 – User Manual Section 6 MAINTENANCE WARNING Liquid waste can be potentially infectious and can be hazardous to health. It must be disposed according to national and international guidelines for the safe disposal of Bio-hazardous waste. 6.4.1.2. One Month Maintenance Scheduling The user must follow the following instructions for the monthly ISE maintenance.
Page 329 Altair™ 240 – User Manual Section 6 MAINTENANCE 6.4.2. Scheduling for HIGH Volume Users In the following paragraphs is the scheduled periodic maintenance to be carried out on the ISE Module by high volume users (processing greater than 100 samples/day). Carefully read all instructions.
Page 330 Altair™ 240 – User Manual Section 6 MAINTENANCE 6.4.2.3. Six Months Maintenance Scheduling Replace following electrodes components semi-annual maintenance. 1. Pump tubing. 6.4.2.4. At 3,000 Samples Maintenance Scheduling Replace the following electrode after 3,000 samples. 1. Li+ Electrode. 6.4.2.5. At 10,000 Samples Maintenance Scheduling Replace the following electrodes after 10,000 samples.
Page 331 General Refer to the following paragraphs for the ordinary maintenance operations including part replacement. To get the correct part number refer to the EKF Diagnostics Spare Parts and Consumables List – contact the local authorized distributor or EKF Diagnostics for the latest version.
Page 332 (ending with elastic bands), shock-resistant rubber gloves and protective glasses. NOTE: Replace cuvettes only with original ones provided by the EKF Diagnostics. Never reuse cuvettes that have been previously removed even if washed. Replace the cuvette following the instructions below, one by one: 1.
Page 333 Altair™ 24 0 – User M Manual Secti on 6 MAINTEN NANCE UVETTE TO REPLACED Figu ure 106: Cu uvette Rep placement Alternative ely it is also o possible to replac ce the who ole cuvett te rotor by y unfasten ing the cuvette co over and r...
Page 334 Altair™ 240 – User Manual Section 6 MAINTENANCE Use non-corrosive metal cleaners to perform the requested operation. Hydrocarbon based washing agents must be used to carry out the cleaning process. Electromechanical contact cleaner and lubricant is acceptable. 1. Remove, clean residue and any fluid leakage from the sample tray and disinfect.
Page 335 Altair™ 240 – User Manual Section 6 MAINTENANCE 3- Clean the slip-rings using the same dust- free cloth slightly soaked with the cleaner solution. Perform this procedure when needed and in case the sample tray does not operate with a free rotation. Note: Execute the procedure above wearing complete protection –...
Page 336 (ending with elastic bands), shock-resistant rubber gloves and protective glasses. Replace peristaltic pump heads only with original parts provided by the EKF Diagnostics. Replace the peristaltic pump heads following the instructions below: 1. Open the front pump panel of the instrument.
Page 337 Altair™ 240 – User Manual Section 6 MAINTENANCE 3. Turn about 30° Counter Clockwise (CCW) the pump head and slip the head off from its motor shaft. 4. Plug the new heads on its motor shafts (same angle) and turn 30° back CW until a “click”...
Page 338 Altair™ 24 0 – User M Manual Secti on 6 MAINTEN NANCE 6.5.5. Photom meter Lam mp Repla acement Replace t he Photom meter halo ogen lamp p with the i instrument t powered d off; wait a at least 5 minutes from the shutdown...
Page 339 Altair™ 240 – User Manual Section 6 MAINTENANCE Do not remove the lamp from its metallic support. The lamp height has been calibrated at the factory and is fixed onto the support. To replace the photometer lamp follow the instructions below (ref. to the previous pictures): 1.
Page 340 Altair™ 24 0 – User M Manual Secti on 6 MAINTEN NANCE 6.5.6. Sample er Probes s Replace ement Replace t the samp ler probe with instr ument OF FF. Use on nly probes s supplied byEKF Diagnostic Make sure e that the n new probe e does not...
Page 341 Altair™ 240 – User Manual Section 6 MAINTENANCE 1. Unfasten the arm protection cover by slightly stretching it, and slide it backwards to lift it. 2. Unscrew the cap and slide it, together with the spring, along the Teflon tubing. 3.
Page 342 Altair™ 240 – User Manual Section 6 MAINTENANCE 6.6. ISE Module Maintenance Procedures Refer to the following paragraphs for details about the main maintenance procedures over the ISE Module when integrated in the system (option). AMPLE NTRY ALIBRATOR Li+ E LECTRODE ALIBRATOR Na+ E...
Page 343 Altair™ 240 – User Manual Section 6 MAINTENANCE 2. Press the yellow button of the ISE Reagent Pack Connector and disconnect it from the pack; 3. Connect the ISE Reagent Pack Connector onto the new pack and be sure that it is connected firmly;...
Page 344 Altair™ 240 – User Manual Section 6 MAINTENANCE 6.6.2. Electrodes Replacement When electrodes have expired they must be replaced with new ones. Replace Electrodes only with the system powered OFF. Follow the procedure below: 1. From the ISE module conf menu run the command Maint to purge the ISE Module path;...
Page 345 Altair™ 240 – User Manual Section 6 MAINTENANCE 6.6.3. Electrodes Storage Within a few days of the power being off, the user might notice that it may take some time for the electrodes to regain stability. The longer this period, the more acute the problem will be.
Page 346 Altair™ 240 – User Manual Section 6 MAINTENANCE 2. Remove tape from K+ and Li+ electrodes; 3. Remove the yellow flag from Reference electrode and if necessary soak the reference electrode in warm water until the lumen of the electrode has been cleared of salt build-up (do not throw away the yellow flag with its flow path line –...
Page 347 Altair™ 240 – User Manual Section 6 MAINTENANCE Cal. A & Cal. B Pumps 1. Remove the pump tubing from the Cal. A pump by 1 removing the two (2) yellow tube clips from the pump brackets. 2. Next, push the yellow colored, tube tension bar (located at the bottom of the pump roller) down with your finger to remove tension from the tubing, while removing the tubing from the pump roller with your free hand.
Page 348 Altair™ 240 – User Manual Section 7 PROBLEM SOLVING Section 7 PROBLEM SOLVING Introduction This section provides the user with guidelines for effective corrective actions. 7.1. General Corrective actions allow the user to solve ordinary problems through easy maintenance operations. WARNING Read carefully Section 1 –“Safety”...
Page 349 Altair™ 240 – User Manual Section 7 PROBLEM SOLVING The system also displays warning windows in case of alarm or functional notice such as (empty loading tanks, full waste tank, cover open, etc.) The instrument activates an acoustic beeper in the following events: •...
Page 350 Altair™ 240 – User Manual Section 7 PROBLEM SOLVING Problem Possible Cause Corrective Action SAMPLER PROBE/S FAILURES 1. Arm tubing not connected or Verify that the Teflon tubing is ® DURING ASPIRATION AND damaged: correctly plugged on the sampler DISPENSION probe without any leakage.
Page 351 Altair™ 240 – User Manual Section 7 PROBLEM SOLVING Problem Possible Cause Corrective Action 2. Teflon tubing between Diluter Verify that the Teflon tubing ® ® electrovalve and Diluter fittings between Electrovalve and damaged: Diluter Head are correctly fastened, undamaged and that tubing is not bent or obstructed.
Page 352 Altair™ 240 – User Manual Section 7 PROBLEM SOLVING Problem Possible Cause Corrective Action are undamaged, otherwise change them with new ones. 4. Dirty cuvettes: Run a Start up cycle, take out the cuvette and control that their narrow walls are clean inside and outside;...
Page 353 Altair™ 240 – User Manual Section 7 PROBLEM SOLVING Problem Possible Cause Corrective Action 4. Drying Tip: Verify that the Washing Station drying tip is undamaged. If damaged, contact service. 5. Washing Station aspiration Verify that the longest needles of needles: the Washing Station are clean and not damaged nor...
Page 354 Altair™ 240 – User Manual Section 7 PROBLEM SOLVING 7.4. Instrument Status Messages The Status menu of the User Interface software constantly shows the performance status of the instrument during operation. The system shows the message window only when alarm or warning conditions occur. Message Meaning LOADING...
Page 355 Altair™ 240 – User Manual Section 7 PROBLEM SOLVING Code Message Cause Action Warning: Systemic solution Systemic solution is ending. Sampling is arrested. Reading of is going to finish. reactions actually in incubation will be continued up to the end. After a time out, the system washes readings cuvettes and waits for tank refilling.
Page 356 Altair™ 240 – User Manual Section 7 PROBLEM SOLVING Code Message Cause Action Warning: Some samples Some sample are finished. A Click on the RED sample and are empty. In the Status sample that is finished is follow the instructions on the menu click on red marked in RED on the Status screen.
Page 357 Altair™ 240 – User Manual Section 7 PROBLEM SOLVING Code Message Cause Action shutdown the program, the PC and the instrument and then restart the system. If the problem persists contact service. Alarm: Sample ARM is The Sample ARM crashed Remove any obstacle on the crashing.
Page 358 Altair™ 240 – User Manual Section 7 PROBLEM SOLVING Code Message Cause Action Alarm: X-Sample ARM The Sample ARM doesn’t Verify the absence of obstacles motion not properly rotate correctly. on the working area. working. In run press Press the button Continue in the Continue button or else Status menu to retry, the system restart the System.
Page 359 Altair™ 240 – User Manual Section 7 PROBLEM SOLVING Code Message Cause Action shutdown the program, the PC and the instrument and restart the system. If the problem persists contact service. Alarm: Diluter Reagent The reagent ARM diluter fails Verify the absence of obstacles ARM motion not properly during motions.
Page 360 Altair™ 240 – User Manual Section 7 PROBLEM SOLVING Code Message Cause Action Warning: Hardware over The temperature of electronics Shutdown the program, the PC temperature. Shutdown environment is too high. and the instrument and verify the system and control that the operating ambient ambient temperature.
Page 361 Altair™ 240 – User Manual Section 7 PROBLEM SOLVING Code Message Cause Action Database error. Restart Internal database error. At the end of the actual working the system. session shutdown and restart the system. If the problem persists contact service. Problem during the filing Error during filing of patients in None, results are lost.
Page 362 Altair™ 240 – User Manual Section 7 PROBLEM SOLVING Code Message Cause Action To refill the standard: click on Pause and wait that ARMs stop, open the cover and refill the cup; close the cover and click on Continue, then click on Retry. Warning: some dilution Some diluted samples are Click on the RED sample dilution...
Page 363 Altair™ 240 – User Manual Section 7 PROBLEM SOLVING Code Message Cause Action Warning: ISE module Some air is in the Calibrator B Reinitialize ISE Module from ISE purge B error. In Status tubing or the Calibrator B is module conf menu. Do it more page click on ISE icon.
Page 364 Altair™ 240 – User Manual Section 7 PROBLEM SOLVING Code Message Cause Action Warning: ISE module air in Calibrator A is segmented with Check for electrodes properly cal A. In Status page click air or fibrin is plugging the seated and compressed. Check on ISE icon.
Page 365 Altair™ 240 – User Manual Section 7 PROBLEM SOLVING Code Message Cause Action tubing is free. Check for electrodes properly seated and the O-ring are in place. Re-initialize ISE Module from ISE module conf menu. If the problem persists contact service.
Page 366 Altair™ 240 – User Manual Section 7 PROBLEM SOLVING Code Message Cause Action anyway analyses; press Exit to exit the window without any decision and change. Warning: LIS Server not LIS interface not answering. Restart the system. active or not enabled. If the problem persists contact service.
Page 367 Altair™ 240 – User Manual Section 7 PROBLEM SOLVING Code Message Cause Action restart the system. Verify if some obstacles is into cuvette tray to stop the rotation. If the problem persists contact service. Warning: Invalid ISE The reagent pack is not Use only ISE Reagent Pack Reagent Pack.
Page 368 Altair 240 – User Manual Section 8 TECHNICAL SPECIFICATIONS Section 8 TECHNICAL SPECIFICATIONS General This section contains the technical specifications and environmental requirements of the system in its different configurations. 8.1. Instrument Technical Specifications 8.1.1. Sample Tray • Tube positions (dynamic usable for any routine and STAT samples, standards/calibrators and QCs): •...
Page 369 Altair 240 – User Manual Section 8 TECHNICAL SPECIFICATIONS 8.1.4. Reagent Tray Reagent tray configuration: 44-bottle positions • Total positions (for bottle R1 or R2): • Mono-reagent positions: 44 max • Reserved positions: • Reagent bottle (R1) type 1: 35mL •...
Page 370 Altair 240 – User Manual Section 8 TECHNICAL SPECIFICATIONS • Diluter precision: < 1%, dispensing 2% of total volume • Max diluter volume (including air gaps and protection): 500μL • Sampling volume (increment= 1μl) for sample: 1-300μL • Sampling volume (increment= 1μl) for reagent: 1-450μL •...
Page 371 Altair 240 – User Manual Section 8 TECHNICAL SPECIFICATIONS • Reading time (Kinetics methods): programmable @ max 600 sec. • Reading time (Fixed Time methods): programmable @ max 600 sec. • Cuvettes washing and drying: automatic washing station 8.1.8. Optical Group •...
Page 372 Altair 240 – User Manual Section 8 TECHNICAL SPECIFICATIONS 8.1.9. Washing Station • Total on-line washing and drying steps: • Dispensing/Aspirating couple of needles: • Additional aspirating needle: • Drying tip: • Cuvette Cleaner solution dispensing: Position 2 • Systemic solution dispensing: Positions: 1 and 3- 8.1.10.
Page 373 Altair 240 – User Manual Section 8 TECHNICAL SPECIFICATIONS 8.1.11. Control Electronics • Structure: modular, real- time • Number of microcontrollers: 3, multi- processor • PCB assembly Technology: • Communication Bus: double, for data and synchro • Serial link with ext. PC: USB 2.0 (connector Type B)
Page 374 Altair 240 – User Manual Section 8 TECHNICAL SPECIFICATIONS 8.2. Control System Technical Specifications External control PC • Intel Pentium IV 2.8GHz Hyper Threading tech. or Intel Dual Core 2.8GHz minimum • RAM: 512 MByte • Hard Disk: ≥ 40GByte •...
Page 375 Altair 240 – User Manual Section 8 TECHNICAL SPECIFICATIONS 8.4. Power Supply Requirements • Supply line voltage for instrument (without selection): 100-240Vac • Supply line voltage for PC (with selection): 100-240Vac • Supply line frequency: 50-60Hz • System Line UPS – requested for the instrument and PC 1kW minimum 8.5.
Page 376 Altair 240 – User Manual Section 8 TECHNICAL SPECIFICATIONS 8.8. Emissions Average emission level respects international normative. There is not any gas emission, implosion or explosion risk. 8.9. Electromagnetic Compatibility The instrument has been produced in conformity with EN61326-1 normative. 8.10.
Page 377 Warranty Period only. Unless agreed in writing by EKF Diagnostics, the Warranty period cannot be extended as a result of defects or repairs. Transfer of the ownership of the product by the Client to a third party does not extend the warranty period, which remains bound by the above conditions.
Page 378 9.5.1. Training Courses All the training courses are organized by EKF Diagnostics and take place in the EKF Diagnostics facility in Boerne, Texas - USA - or they are scheduled by the local EKF Diagnostics distributor. 9.5.2. Firmware and Software Upgrades Software and firmware upgrades must be performed by Authorized Service Personnel only.
Page 379 Altair™ 240 – User Manual Section 10 GLOSSARY Section 10 GLOSSARY Glossary This section describes the list of acronyms and abbreviations and the list of terms used in this document. 10.1. List of Acronym and Abbreviations Ampere Applicable Document Absorbance AC/DC AC/DC Power Supply ASTM...
Page 380 Altair™ 240 – User Manual Section 10 GLOSSARY Continuous Voltage Watt Work List 10.2. List of Terms Sampler probe It is used to dispense, mix and dispense liquids: reagents, dilutors, calibrators, standards, samples and extra-wash solutions. Absorbance It is correlated to color intensity of a liquid. The light that crosses a dark liquid it is “absorbed”.
Page 381 Altair™ 240 – User Manual Section 10 GLOSSARY Pump to aspire the waste liquids or to dispense the Peristaltic pump washing liquids. System composed by a light source, interferential filters Photometric Reading and detector. It is used to measure the color intensity of System the liquid in the cuvettes at the end of the reaction.
Page 382 Altair™ 240 – User Manual Appendix A POSSIBLE FLAGS AND ALERTS ON RESULTS Appendix A POSSIBLE FLAGS AND ALERTS ON RESULTS This Appendix A describes the list of flags and alerts that can be signaled by the system. Also the related countermeasures or actions have been mentioned. The cause generating a flag or an alert must always be investigated and identified.
Page 383 Altair™ 240 – User Manual Appendix A POSSIBLE FLAGS AND ALERTS ON RESULTS Alert Cause Note Out of best fit Kinetic linear regression FIT is Printed on compact Lab report and below the limit set in Method result in clear. menu Printed on patient report and result in clear.
Page 384 Altair™ 240 – User Manual Appendix A POSSIBLE FLAGS AND ALERTS ON RESULTS A.2 List of Flags and Alerts for ISE Module and Actions The following tables show the flags on results that could be generated by the system for the ISE Module electrolyte test set. Ranges, triggers, limits and automatic actions can be set individually in the Chemistry menu for each single method.
Page 385 Altair™ 240 – User Manual Appendix A POSSIBLE FLAGS AND ALERTS ON RESULTS Alert Cause Note Actions ISE Cal A drift Cal A drift in Sample or Printed on compact Lab Repeat analysis. Slope drift in report and result in clear. Re-initialize the ISE Module calibration.
Page 386 Altair™ 240 – User Manual Appendix A POSSIBLE FLAGS AND ALERTS ON RESULTS Alert Cause Note Actions ISE Mv out mV reading out of Printed on compact Lab Repeat analysis. admissible range (for report and result in clear. Re-initialize the ISE Module Cal B or Sample).