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FAQ

Benchtop Incubator BT37
Blood gas, electrolytes and metabolites analyzer ABL 8xx series

Which are the limits for the operating temperature?


15C - 32C.

Which are the limits for the operating humidity?


20 – 80%

What means altitude correction?


ABL8xx FLEX is approved for up to 3000 meters above sea level at standard barometric pressure of 760 mmHg. ABL8XX FLEX has a built in barometer, measuring the atmospheric pressure. Altitude is needed for correction of pO2.

How many results can be stored?


Patient results: 2000 Calibration results: 1000 QC results: 1500 System messages: 5000

How many operators can be added?


There is no maximum, but no more than 1500 operators should be added.

What means test range, reference range, critical range, reportable range, measuring range?


Test range: The test range for a parameter is the range within which accuracy and precision of a measured parameter has been specified and intended to lie within specified limits. Reference range: The reference range is user definable and by default not entered. It can be used by the operators to indicate that a parameter value is considered normal, for the specific type of sample being measured, when it is within the reference range. It is possible to have the reference ranges displayed next to the measured results. When outside the reference range a single arrow up or down will be displayed next to parameter name. The result will be displayed. Critical range: The critical range is user definable and by default not entered. It can be used by the operators to indicate that a parameter value is outside a predefined range and is considered critical. When outside the critical range a double arrow up or down will be displayed next to the parameter name. The result will be displayed. Reportable range: The reportable range is user definable and by default not entered. It can be used by the operators to indicate that a parameter value is outside a predefined range and is considered critical. When outside the critical range a triple arrow up or down will be displayed next to the parameter name. The result will be displayed. Measuring range: The measuring range is the maximum limits for which the reportable ranges can be set to. The measuring range corresponds to the "range of indication" as defined in the "International vocabulary of basic and general terms in metrology" (VIM). Displayable range: The displayable range for a parameter is the range for which a parameter can be displayed. When outside the displayable range 5 dots will be displayed instead of the result.

How can I replace inlet gasket?


To replace the inlet gasket, do the following: •remove the capillary and then the syringe inlet flaps and record the action in the Hold mode. •remove the old inlet gasket unit by grabbing it on either side and lifting it upward. •slide the new inlet gasket unit onto the mount and press down the top of the unit to secure it in place. Mount the syringe inlet flap and then the capillary inlet flap. •press Restart.

Which are the intervals for replacements of the consumables at ABL8xx analyzers?


The replacement intervals are guidelines only. For an average of 40 samples per day: Replace Crea A and Crea B electrode membranes 14 days Replace metabolite membranes 1 month Replace blood gas and electrolyte electrode membranes 3 months Replace pump tubing 6 months Replace inlet gasket 6 months Replace fan filter as required Replace electrodes as required Replace reference electrode membranes: 40 samples per day: All analyzers, except ABL8xx FLEX analyzers 1 month ≤40 samples per day: ABL8xx FLEX analyzers only 14 days >40 samples per day: ABL8xx FLEX analyzers only 1 week

Why is there still solution left in the bottle when I have to replace it?


This is because over time some of the liquid in the bottle can evaporate, and thereby changing the Ion balance of the solution. Therefore there is a minimum volume of the solution which has to be left in the bottle in order to ensure the composition of the solution is correct. The bottles are designed so this minimum volume is ensured.

How can I clean and disinfection the ABL800 FLEX analyzer?


Cleaning. Covers and outer case. When cleaning the analyzer covers and outer case, use soapy water or a mild detergent. Do not use abrasive cleansers or pads, ethanol-based substances or aggressive detergents for cleaning. Please note that we have seen cases where the touch screen and display have been ruined by using an excessive amount of liquid. Please note it is still only meant to be cleaned with a paper towel or tissue slightly moistured. Disinfection. Surface. Disinfection of the outer surfaces is performed when appropriate. The frequency depends on local requirements and on the use of the analyzer. Prior to disinfection, always ensure that that analyzer surfaces are clean and without residues from blood and/or liquids. Wipe the outer surfaces of the analyzer and the touch screen, using a disinfectant on a paper towel or tissue. Disinfectants to use: 70 % isopropyl alcohol 70 % ethanol 4 % Diversol BX
Blood gas, electrolytes and metabolites analyzer ABL90 FLEX

How fast we can get a result on ABL90?


On the ABL90 FLEX blood gas analyzer you get 17 parameters from blood samples as small as 65 μL in just 35 seconds. That is only about a third of the time required by other compact analyzers. A throughput of up to 44 samples per hour and daily uptime of up to 23:30 hours ensure the analyzer is ready for the next sample, giving you more time for patient care.

Which is the aspiration time for the sample?


The self-cleaning inlet automatically aspirates the sample from syringes, capillary or test tubes in just 5 seconds.

How many steps must be done until the result appears on the screen?


Testing is a quick, intuitive three-step process. 1. Simply scan the sample’s barcode or enter patient data directly on the touch screen. 2. The self-cleaning inlet automatically aspirates the sample either from a syringe, capillary or test tube. 3. After only 35 seconds, you’ll get a full panel of results on-screen, plus a paper printout. And data is automatically sent to the LIS/HIS, the bedside monitor, and even the physician’s PDA.

What consumables do I need for ABL90?


Putting in a new sensor cassette and solution pack are the only replacements needed on the ABL90 FLEX analyzer.

Is there a risk to enter in contact with patient blood?


On the ABL90 FLEX analyzer, you and your staff can avoid contact with blood or waste. Samples are automatically aspirated and blood waste stays in the closed solution pack. When using the safePICO syringes, the safeTIPCAP simplifies the removal of air bubbles and further limits the risk of contact with patient blood, also during transport and analysis.

What is a safePICO syringe?


A safePICO syringe is a self-filling arterial blood sampler for arterial puncture or A-linesampling. Prebarcoded, with a needle shield device, an integrated mixing device and a vented tip cap, helping to ensure the best sample quality, patient and operator safety.

There is a possibility to run a QC?


The built-in quality control system (AQM) – “ampoules in a bag”- automatically measures on three dedicated aqueous QC materials.

May I connect the analyzer with my IT system?


The ABL90 FLEX blood gas analyzer delivers complete data capture through continuous data synchronization with your LIS, HIS, CIS and DMS systems.

How many and which are the measured parameters?


ABL90 has a comprehensive acute care panel with 17 measured parameters: • pH/Blood gases: o pH (acidity) o pO₂ (carbon dioxide tension) o pCO₂ (oxygen tension) • Oxymetry: o ctHB (total hemoglobin concentration) o sO₂ (oxygen saturation) o FO₂Hb (fraction of oxyhemoglobin in total hemoglobin) o FCOHb (fraction of carboxyhemoglobin in total hemoglobin) o FHHb (fraction of deoxyhemoglobin in total hemoglobin) o FMETHb (fraction of methemoglobin in total hemoglobin) o FHbF (fraction of fetal hemoglobin) o ctBil (concentration of total bilirubin in plasma) o • Electrolytes: o cK⁺ (potassium ion concentration) o cNa⁺ (sodium ion concentration) o cCa⁺ (calcium ion concentration) o cClˉ (chloride ion concentration) • Metabolites: o cGlu (D-glucose concentration) o cLac (L(+)-lactate concentration)

Which is the in-use lifetime for the consumables?


On the ABL90 analyzer there is a period of 30-day in-use lifetime of consumables.
Blood gas, electrolytes and metabolites analyzer ABL90 FLEX - service

What can I do if the traffic light is in red color?


Red color means that an error has appeared in the system. If you want to see/remedy the error(s) you must follow the next steps: • Check which of the status button indicator is red on the Analyzer status screen. • Press the relevant button. Highlight the desired error. • Press Troubleshoot for error description and operator action. • Remedy the error as described in the troubleshooting dialog on the screen. • Remedy other error(s) if present. • After all errors have been remedied, press Back and Close till you return to the main screen.

Why the User-intervention-required screen appears?


User-intervention-required mode is used to correct errors by suspending all wet-section activities in case the following analyzer conditions occur: • Problems with the inlet leaking • Solution transport errors (e.g. leakage) • Problems with sensor cassette or solution pack • Thermostatting errors • HW/SW errors • Misc. calibration errors • Other unexpected situations

What can I do if the User-Intervention-required screen appears?


If the User-intervention-required screen has appeared you must follow the on-screen instructions. It might require several action to correct the condition. Until the condition has been corrected, the analyzer cannot be restarted.

I completed the actions that were required in the User-intervention-required screen, but the analyzer remains in this screen.


Press “Test again” to leave the User-intervention required screen.

There is a risk to enter in contact with patient blood?


On the ABL90 FLEX analyzer, you and your staff can avoid contact with blood or waste. Samples are automatically aspirated and blood waste stays in the closed solution pack. When using the safePICO syringes, the safeTIPCAP simplifies the removal of air bubbles and further limits the risk of contact with patient blood, also during transport and analysis.

Is there a way to see the replacement status?


You must follow the next steps: • Press MenuAnalyzer statusReplacementsStatus. • Choose one of the following options: o Send status to printer o Sensor status Shows replacement information, such as date of installation, scheduled replacement date, reason for the replacement, time for the next sensor cassette replacement, when a new sensor should be conditioned, how many tests have been performed and when the sensor cassette expires. o Solutions status Shows replacement information, such as date of installation, scheduled replacement date, reason for the replacement, time for the next solution pack replacement, the lot number of the solution pack, how many activities have been performed and when the solution pack expires. • Press Back to return to Analyzer Status screen. • Press Close to return to the main screen.

Which are the storage temperature conditions for the consumables on ABL90?


The Sensor Cassette (SC) storage temperature range is 2-8C. The Solution Pack (SP) storage temperature range is 2-25 C.

Are there some spare parts to be replace during a preventive maintenance?


Yes, there are. They are called Inlet Gasket and Inlet Connector Gasket and they must be replaced periodically.

I cannot remember the procedure for changing Solution Pack.


This procedure is very simple. The analyzer warnings for low level of solutions. The analyzer screen goes in Replacements menu when one of the solutions from SP is empty. There is a steping video guidance which shows us how we must change the old SP with a new one. Every step must be validated before the passing to the next one.

What substance I must use to clean and disinfect the outer surface of the ABL90?


When cleaning the analyzer covers and outer case, use soapy water or a mild detergent. Do not use abrasive cleansers or pads, ethanol-based substances or aggressive detergents for cleaning. Cleaning the analyzer screen: 1. Put your thumb at an inactive place on the screen, e.g. on the Ready text in the upper left corner of the main screen and keep the thumb pressed against the screen. 2. Use a dry or lightly dampened soft lint-free cloth to clean the screen. Wipe the screen gently to remove fingerprints and/or dirt. To avoid streaking, an approved screen cleaner is recommended. 3. If you need to clean the place where you put your thumb, find another inactive place on the screen and put your thumb there. Disinfection of outer surfaces: Disinfection of the outer surfaces is performed when appropriate. The frequency depends on local requirements and on the use of the analyzer. Prior to disinfection, always ensure that that analyzer surfaces are clean and without residues from blood and/or liquids. NOTICE: Follow legal and local rules for safe work practices with chemicals. Wipe the outer surfaces of the analyzer and the touch screen, using a disinfectant on a paper towel or tissue. Disinfectants to use: 70 % isopropyl alcohol 70 % ethanol 4 % Diversol BX
Cardiac markers

Are the values for BNP and NT-proBNP on the same patient sample the same?


No, NT-proBNP values are always higher than BNP values (5 to 10 times).

Do BNP and NT-proBNP have the same clinical performance when the proper cut-offs are used?


Yes.

What is the primary reason for measuring NT-proBNP?


Reducing the diagnosis uncertainty in suspicious patients with shortness of breath.

Does a positive NT-proBNP value always mean that a patient has Acute Heart Failure?


No, small elevations can be found in patients with other pathologies involving ventricular dysfunction.

What is the official Radiometer-recommended NT-proBNP cut-off value?


125 ng/L but it is ok to say that additional independent studies have shown that 300 ng/L is a good cut-off for rule-out and that 300 is recommended by the ESC 125 ng/L but customers that have already used the age- adjusted values established by the PRIDE and ICON studies do not need to be discouraged to use these values

Should a small NT-proBNP elevation be a source of concearn?


Yes, regardless of the reason, these small elevations are associated with a worse prognosis compared to NT-proBNP negative patients.

Are NT-proBNP values meaningless in patients with renal disease?


No, patients with renal disease and elevated NT-proBNP values have a bad prognosis.

In patients with suspicious signs and symptoms of both chest discomfort and shortness of breath, is measuring NT-proBNP a good idea?


It's always a good idea because it will help clarify the diagnosis and also provide a good prognostic information whether the final diagnosis is Acute Heart Failure or Myocardial Infarction

What is the intended use of AQT90 FLEX NT-proBNP assay?


The NT-proBNP test is an aid in the diagnosis of persons suspected of having congestive heart failure and in the risk stratification of patients with acute coronary syndrome and congestive heart failure.

At which NT-proBNP concentration is the effect of interference from pharmaceutical drugs tested?


100 ng/L.

The AQT90 FLEX user wants to change the measureable range of the NT-proBNP assay so that the lowest reportable concentration has approximately 10 % CV. What will be the lowest reportable concentration?


73ng/L.

The AQT90 FLEX user wants to use a cutoff of 125 ng/L for NT-proBNP, is this alright?


Yes.

What is the intended use of the AQT90 FLEX Troponin I assay?


To be an aid in the diagnosis of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

What is the 99th percentile for the AQT90 FLEX Troponin I assay?


0.023 ug/L.

Which sample types can your customers use with AQT90 FLEX Troponin T assay?


EDTA or lithium-heparin whole-blood or plasma specimens.

Is one positive troponin result is sufficient to say that a patient is having myocardial damage?


Yes.

A customer is complaining that the central lab turn-around-time for troponin results is not consistently short; but the central lab offers high-sensitive troponin assay results as recommended by the ESC guidelines. What are the consequences of using a less sensitive assay in the ED such as AQT90 FLEX?


A few MI patients presenting early after chest pain will take a couple of hours longer to be accurately diagnosed.

Today, is there only 1 official definition for ”high-sensitivity” (“hs”) troponin assay?


Yes, the historical definition asking for a maximum of 10 %CV at the 99th percentile.

Are assays with a maximum of 10 %CV at the 99th percentile considered “hs” by Dr. Apple?


No, he also requires that they can measure troponin in at least 50 % of healthy individuals.

What is the most recent trend regarding the “hs” definition?


“hs” criteria claimed by manufacturers should also be observed in routine clinical use.

According to Dr. Apple’s definition, are most contemporary troponin assays also clinically usable?


Yes.

Are AQT90 FLEX Troponin assays clinically usable contemporary assays by Dr. Apple’s definition?


Yes.

Do manufacturers always report %CV in the same way?


No, some do not account for lot-to-lot and instrument-to- instrument variation.

What is the main benefit of “hs” troponin assays?


They accelerate the rule-in and rule-out of MI in patients arriving at ED early after onset of symptoms.

Should a patient be considered pregnant if the hCG result is above the reference range?


The interpretation that hCG <5 IU/L is considered negative for pregnancy, and hCG >25 IU/L is considered positive for pregnancy is in agreement with the general guidelines including those in the Tietz Textbook of Clinical Chemistry and Molecular Diagnostics (Burtis CA, Ashwood ER, Bruns DE (editors): TIETZ Textbook of Clinical Chemistry and Molecular Diagnostics, 4th Edition, Elsevier Saunders, St. Louis, 2006: 2160). This is also available at the American Pregnancy Association’s (APA) website: www.americanpregnancy.org/duringpregnancy/hcglevels.html. The general guidelines state that when borderline results are encountered (~above 5 IU/L and below 25 IU/L), patient samples should be redrawn 48 hours later. (This is because in the early phase of pregnancy the levels increase rapidly and after 48 h a great increase should be seen if the woman is pregnant). Furthermore, as always clinical biochemistry results have to be interpreted in the clinical context.

Can the AQT90 FLEX hCG test be used as a cancer marker?


No! The reason for this is that the design criteria of hCG assays for cancer detection and monitoring differ from those required for pregnancy tests. For cancer applications the antibodies used must be able to detect various modified forms of hCG with equal affinity. If the AQT assay was used as a cancer marker we would have a high risk of false-negative results in cancer patients.

If you run both TnI and TnT on the same samples will they always give the same clinical result - that is either both above the cut-off or both below the cut-off?


No. TnI and TnT are two different assays and will show the same clinical discrepancies as is always seen when different troponin assays are compared. Physiologically the concentrations of the two different molecules TnI and TnT will not reach the cut-off level at the same time. AMI diagnosis is based on serial measurements and when serial measurements are compared any discrepancies will be minimized.

Why has Radiometer chosen to add an automated hematocrit determination and adjustment to the AQT90 FLEX analyzer?


The parameters that we measure are present in the plasma phase of a whole blood sample. The amount of plasma phase in the aspirated sample is dependent on the hematocrit value. If a default hematocrit value is used for patients with hematocrit values outside the hematocrit reference range they will get results which deviate too much from the „true‟ result. We measure the hematocrit automatically to be able to give the correct results on all patients, including those with abnormal hematocrit values, without the need for hematocrit determination on a separate instrument. The addition of the automated hematocrit determination and adjustment further improves the suitability of the AQT90 FLEX analyzer for use at point of care.

Why does Radiometer refer to the bi-Hct upgrade as “automated hematocrit determination and adjustment?”


Because the hematocrit is determined automatically during sample processing and because the true plasma concentration is calculated using the raw concentration measured by the instrument and the hematocrit value.

How does the bi-Hct module work?


The bi-Hct module measures on excess blood just after dispensing test blood into a test cup. The bi-Hct module is comprised of two titanium electrodes and a printed circuit board, all located in the waste block. The module measures the conductance of the blood at both a high and a low frequency. The circuit board transfers the conductance value to the analyzer’s processor, which converts the value into a hematocrit measurement. The analyzer then uses this hematocrit measurement to calculate the proportion of plasma in the sample.

How does the AQT90 FLEX analyzer determine a hematocrit correction factor for plasma samples?


In the case of a plasma sample, or samples with a hematocrit value below 15 %, the analyzer will use a value of “0 %” in the automated hematocrit correction. All sensors, including the bi-Hct sensor are validated to measure within a specified measuring range. For the bi-Hct sensor, the lower end of that range was chosen to be 15 %, due to the fact that clinically, it is very unlikely to find a living patient with hematocrit values below 15 %.

Does the AQT90 FLEX analyzer determine hematocrit per sample or per test?


The AQT90 FLEX analyzer determines the hematocrit per test.

Does the bi-Hct measurement have an influence on the analysis time required for analysis?


No. The measurement happens in parallel to the current measurement process and does not add any additional time.

Does the bi-Hct measurement have an influence on the sample volume size required for analysis?


No. The hematocrit measurement happens on excess blood and therefore does not change the sample volume size required for analysis for any test.

How is the hematocrit sensor within the bi-Hct module calibrated? Who does this? How often is this done?


The hematocrit sensor within the bi-Hct module is calibrated during installation on assay buffer from the Reagent Pack. This calibration process is based a validated procedure using the known conductance value of the assay buffer in the AQT90 FLEX Reagent Pack. The conductance cell within the bi-Hct module is checked as part of the analyzer’s process check every time the analyzer performs a hematocrit measurement. After installation, neither users nor service representatives need to perform calibrations on the bi-Hct module.

Do users need to perform Quality Control on the hematocrit sensor?


No. During installation of a built-in Hct upgrade to an AQT90 FLEX analyzer, the service representative will use the Control Liquid (927-068) to ensure the proper calibration and functioning of the built-in Hct module. Hereafter, the on-board process check of the sensor each time the analyzer performs a hematocrit measurement verifies the sensor is operating within specifications, as from the installation.

Is the bi-Hct module used during assay calibration adjustments?


No. There is no hematocrit determination used at any point during the assay calibration adjustments, therefore the bi-Hct module is not activated by the process.

Does the bi-Hct module detect clots or bubbles in the sample?


No. The performance of the module is only validated for the detection of conductance in liquids. Should there be bubbles or clots in the liquid during conductance determination, it is currently unknown what effect that has on the ultimate determination.

What is the measuring range of the bi-Hct module and how does the module make adjustments to samples with hematocrit values outside of this range?


The measuring range of the bi-Hct module is from 15 % to 62 %. For hematocrit values below 15 %, the analyzer will use a value of “0 %” in the automated hematocrit correction. The analyzer will assume values above 62 % are beyond the specified measuring range and will issue error code 1223: “Hematocrit determination shows sample cannot be correctly determined” and will not provide a result. Should a user encounter error code 1223 with a whole blood sample and would still like to use the AQT90 FLEX analyzer to perform analysis on the sample, the user should centrifuge the sample and aspirate the plasma phase of the sample on the instrument.

Is it possible to use an AQT90 FLEX analyzer-determined hematocrit value for diagnostic purposes?


No. The bi-Hct determination is a tool to be able to calculate the correct plasma concentration when a whole blood sample is measured.

How have you validated the hematocrit determination method on the AQT90 FLEX analyzer?


The team validated the performance of the bi-Hct module by comparing of the module’s computed values with values obtained from corresponding, centrifuged samples. Most laboratories consider the centrifugation method as the “gold standard” of hematocrit concentration determination.

What effect does the anticoagulant used (Li-Hep, EDTA or Citrate) have on the AQT90 FLEX’s hematocrit determination?


The anticoagulant used on the AQT90 FLEX’s has no effect on the bi-Hct module’s hematocrit determination.

How often should users run a System Clean?


Radiometer strongly recommends users run a System Clean once every 200 tests to minimize the likelihood of the build-up of protein or matter on the electrodes of the bi-Hct module. The SW can prompt the user when it is time to perform a system clean.

How long does it take to a System Clean?


It takes 6 minutes and 30 seconds to run a System Clean on the AQT90 FLEX analyzer. It is not possible to run test during the system clean. But a sample can be placed in the inlet and can automatically start once the system clean is done.

Can users customize when the analyzer alerts them to perform a System Clean?


Yes. Software 8.3 allows users to enter a “Warning limit” that will turn the traffic light yellow when the analyzer reaches a specified number of tests since the last System Clean. Software 8.3 also allows users to enter a “Critical limit” that will turn the traffic light red and prevent the analyzer from performing a measurement. See section 3-32 “Maintenance Setup” in the AQT90 FLEX Reference Manual for details.

Is it mandatory for users to run System Clean?


Yes. By default the analyzer will be locked after 220 tests and can only be unlocked by running a System Clean.

Does System Clean use solution from the Solution Pack?


Yes. System Clean consumes an amount of solution from the Solution Pack equal to that of 1 non-dilution test.

What are the logistics and storage conditions of the System Clean consumables?


The Cleaning Solution tubes (905-843) must be transported and stored from 2-8 C. At launch, the tubes have a 4 month shelf life that will grow to 12 months by mid-2012. The Blank Cartridge (942-962) can be transported and stored at room temperature. The Blank Cartridge has an onboard stability of 12 months as well as a shelf life of 12 months.
HbA1c analysis using the Quo-Test analyzer

How long does it take to perform a glycated hemoglobin (HbA1c) test?


Once a blood sample has been introduced into the Quo-Test results are reported within 4 minutes.

How much blood is required?


Just 4μL is required from a finger prick, capillary or venous sample.

What technology is being used?


Quo-Test uses a patented Boronate Fluorescence Quenching Technology (BFQT) associated with simple yet powerful multiple optical measurements.

What is the benefit of BFQT?


Based on well documented boronate affinity for glycated hemoglobin, the BFQT has similar performances as the boronate affinity chromatography systems used in reference laboratories. However, as it does not require physical separation it assures a simple, fast and accurate measurement. The Quo-Test system using the BFQT has the advantage of not being affected by hemoglobin variants, labile glycated hemoglobin or hematocrit levels.

How are results reported?


Results are displayed on the digital display and reported in IFCC, DCCT, % JDS, eAG mg/dl and eAG mmol/l values.

Does it store patient results?


Yes, the Quo-Test can store up to 7,000 results which can be downloaded to a PC via a USB cable.
Hemoglobin analysis using the Hemo Control analyzer

How long is the typical measuring time?


The typical measuring time is in the range of 25 to 60 seconds.

What measuring method is used?


The azide methemoglobin method is used.

What is the measuring range of the instrument?


From 0 - 256g/L; 0 - 25.6g/dL; 0 - 15.9 mmol/L

What is the conversion factor for calculating the hematocrit value?


Hb in g/dL x 2.94 (% in hematocrit)

What are the factors for conversion into the various Hb units?


Conversion:• g/L in mmol/L - 1 g/L = 0.062 mmol/L • mmol/L in g/L - 1 mmol/L = 16.129 g/L

Does the device need to be calibrated?


No, it is factory calibrated.

How often should the optics be cleaned?


We recommend that the optics of the device are cleaned at least once each month and if the control cuvette or the control solutions cannot be measured correctly. The EKF Cleaner should be used for cleaning the optics. Additionally the cuvette holder should be removed from the instrument and cleaned with a cleaning solution or an aqueous disinfectant solution.

How long is the life span of a fully charged battery?


Typical values:• Continuous operation: 100 hours• Stand-by mode: 30 days

Is it necessary to replace the integrated rechargeable battery?


It is not necessary to replace the battery.

What happens if the reset button is pressed?


The date and time must be re-entered. All other settings remain as they were.

Why is the hematocrit value not shown on the display?


The display must be set up to show the hemocrit result. If this has been done but the hemocrit still does not appear, the value is out of normal range for hemoglobin (120 - 180 g/L or 7.44 - 11.16mmol/L).

What control features are available with the Hemo Control?


Unlike other brands, Hemo Control comes with 3 methods for quality control: 1) Each time the device is turned on a self test is performed automatically. 2) The control cuvette can be used. This is not compulsory but we do recommend the control cuvette is used as a visible quality control. 3) Liquid quality control (Hb-con) is available.

What is the impact of air bubbles on the measured result?


Air bubbles can affect the measured result. We recommend that if an air bubble is present the cuvette should be disposed of.
Spirometry

How long can a spirometer run if it works only on batteries?


Spirometers can work up to 8 hours, without interruption and without recharging the batteries.

Which are the main competitors of MIR?


Micromedical, Cosmed, NDD, SUI, Piston, Eymasa

How often do spirometers need calibration?


MIR spirometers have infrared vortex wheels that do not need calibration! However you can ask for a calibration check, but not more than once in 3 months.

How many tests can be stored by Spirolab / Spirolab II?


Up to 1500 tests.

How many tests can Spirobank / Spirobank G store?


Spirobank / Spirobank G can store up yo 750 tests..

How many programmed tests are included in Metacholina protocole?


Up to 70 programmed tests.

How many tests can be seen simultaneously following a spirometry?


MIR spirometers have an unique display of up to 8 tests at the same time! The best 3 tests are then stored!

What type of printer do MIR Spirolab spirometers use?


Spirolab has an internal thermostatic printer, less noisy and much faster than those of our competitors.

How can we control blood oxygen saturation (SPO2)?


You have to buy a Spirodoc or Spirotel with a SPO2 option!

What does it means the message “KEY PRESSED: 225”, for example? I cannot use the device?


In acest caz exista un scurtcircuit la tastatura corespunzator unei taste (in cazul prezentat tasta ”MENU”). Problema poate fi de la tastatura sau/si de la placa electronica a tastaturii.

The printer does not print. What can I do?


Make sure that suitable convenient thermal printer is inserted (112 mm width).

The device does not measure at all. What can I do?


Check the free rotation of the turbine. Check the cable for any visible damage.

What is the procedureto clean the reusable turbine?


To clean the reusable turbine, first remove it by pulling it gently from the Spirolab III turning it anti-clockwise and pressing lightly. It can be helpful to push it gently from underneath with one finger. Immerse the turbine in a cold sterilising liquid and move it within the liquid to remove any impurities which may be deposited inside. Leave it to soak for at least the time recommended by the producer of the cleaning solution, as shown in the relevant instructions (in general at least 20 minutes). Rinse the turbine by immerging it in clean water (not hot). Shake off the excess water from the turbine and leave it to dry, standing it vertically on a dry surface. Once the turbine has been cleaned insert the turbine tube in its place following the instructions indicated by the closed lock symbol printed on the plastic casing of the Spirolab III.

How can I check that the reusable turbine works well ?


To ensure that the turbine is functioning correctly before replacing it inside the instrument, it is good practice to make a visual check of the rotation blade. Placing the turbine tube horizontally and moving it gently from left to right and vice versa, the rotation blade (rotor) must rotate freely. Otherwise, accurate measurement is no longer guaranteed and the turbine must be replaced.

How many types of turbines can be used on Spirolab III?


There are 2 types of turbines used on Spirolab III: ”single-patient” disposable and reusable.

It is necessary to clean the reusable turbine after each patient?


Yes. To avoid the cross-contamination the reusable turbine must be cleaned after each patient.

Can I use the disposable turbine for more than 1 patient?


No. As the name indicates, the disposable turbine must by used for a single patient.

Why I cannot use the disposable turbine for more than 1 patient?


If you are going to perform the spirometry test with a “single-patient” disposable turbine it is important to use a new turbine for every new patient. The characteristics, accuracy and the hygiene of the disposable turbine can only be guaranteed if it has been conserved beforehand in its original sealed packaging.

Can I save the patient database from the Spirolab III?


Yes, the patient database can be downloaded onto a computer using WinSpiro Pro software.


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