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1 Ed. 2012/02 Next page

2 The VEDALAB EASY READER is an innovative meter for reading immunochromatographic rapid test cards using a high-resolution CCD-camera and integrated software created for analysing pictures. The EASY READER has a removable chip containing all the necessary software for rendering quantitative or semiquantitative results from the test lines absorbance values. Depending on the tested parameter, results can be obtained from whole blood, plasma, serum or urine samples. The meter also has an built-in printer for keeping archives of all the information related to each patient (name, date of birth and results) and to the user having performed the analysis. Key Features of the VEDALAB EASY READER Key Features of the tests Principle of the reaction Principle of the reader

3 Key Features - Compact, light (1Kg) and convenient - Fast, simple, easy and cost effective assays - No need of a batch or product specific code chip (common blank and calibration cards) - Built-in printer - Possibility to perform assays on the reader without any computer connection - Possibility to connect the reader to computer for increased memory storage capacity. - Possibility to connect the reader a barcode reader - No need additionnal controls - No service contract required of the VEDALAB EASY READER - Wide range of available parameters - High output: 60 samples per hour ( up to 120 without printing mode) Next page

4 Key Features of the tests - Reagents stable at room temperature - No need of a batch specific code chips - No dilution of samples needed in most of the cases - High self life (18 months at least) - Quantitative positive control available on request - Wide range of parameters of curently 22 items (continously increasing) - Tests supplied with all components needed to perform assays - Fast results (5 20 minutes) - Most of the tests could be run with very reduced amount of sample ( 50µL of whole blood or 25µL of serum/plasma) Next page

5 Principle of the reaction If present in the sample, the analyte reacts with the colored conjugate and flows to be caught by the reagents coated on the membrane. The intensity of the colored band appearing in the test zone on the stick is directly proportionnal to the concentration of the analyte. Positive result 2 line parameter sample conjugate Nitrocellulose membrane 3 line parameter 1st test line 2nd test line Control line Negative result sample conjugate Nitrocellulose membrane Next page

6 Principle of the reader The VEDALAB EASY READER is based on quantitative immunochromatographic technology by measuring the intensity of the reaction on a test cassette. The CCD camera of Easy reader can measure the colour intensity and determine the concentration of analytes in a sample. CCD camera Quantitative or qualitative result

7 Simplified procedure Detailed presentation Kit composition Connection Changing E-prom Changing paper Check Assay procedure Immediate or countdown mode Inserting the test card Results and printing

8 Simplified procedure 1) Place the instrument under non-corrosive environmental conditions, on a flat, even surface that is free of dust, water (or any liquid) and strong vibrations. 2) Install the required E-prom 3) First connect the keyboard to the reader 4) Connect the reader to a power source 5) Press the switch on the back of the reader to start using it. 6) Press the "" button 7) Select the parameter (only for multi-parameter E-prom) 8) Input the patient s data needed to identify the sample via the keyboard 9) Perform the assay procedure as indicated in the leaflet of the measured parameter. 10) Select immediate or countdown mode 11) Insert the test card into the meter 12) Read the result

9 Detailed presentation Kit composition - Easy reader - Electrical cords (adapter and adapter cord) - Keyboard - E-prom - Thermal paper roll - Calibration device - Blank device - Instructions for use Not in box but required to perform a test: - Timer - Gloves, alcohol wipes and bandages - Lab pipettes and tips Connection

10 Detailed presentation Connection Before connecting the reader to a power source, check that the local power source is compatible with the supplied adapter (input: 100 to 240 volts AC, 50 to 60 Hz). IF NOT, DO NOT CONNECT THE INSTRUMENT! 1 2 First connect the keyboard to the reader by inserting the keyboard cord into the connector labelled KEYBOARD at the back of the reader. Connect the supplied adapter cord to the connector labelled 7.5 V. 3A at the back of the reader Connect the other end of the adapter cord into the output connector of the adapter. Plug the male end of the adapter cord into a grounded outlet with the appropriate voltage. 3 Keyboard 5 Press the switch on the back of the reader to start using it. Changing the E-prom

11 Detailed presentation Changing the E-prom For the proper functioning of the EASY READER, an E-prom (chip) must be installed in the meter. Each E-prom (chip) contains the calibration data specific to each parameter or a range of several parameters. The following instructions describe how to replace a chip. Before changing the E-prom, switch the reader off 1. Open the protective cover. 3. Remove the E-prom. 4. Replace with the required E-prom. 2. Lift up the paper roll Changing paper

12 Detailed presentation Changing paper Please open the blue lid of the printer. A little section on the right hand side makes it easier to grip the lid. Cut the beginning of the roll of thermo printer paper in such a way as to create a triangular point on the right hand side. Insert the triangular point underneath the paper feed until the paper appears and you can pull it out by hand. If you can not manage this properly, it is possible to activate the linefeed using display menu. Paper input Paper output Please take care that the paper is never pulled out backwards against the mechanical linefeed. If a paper jam or a similar printer problem happens, please always cut the paper before printer paper input and then always cut the paper first and then pull it out by hand. Never turn the paper roll backwards. Check

13 Detailed presentation Check This step allows the control of the meter with a calibration device (check-card). Please read carefully the insert sheet for the calibration step, to be properly informed. On the check-card package are indicated the appropriate limits of tolerance for meter results. After selecting Check on the main menu, you will be asked to insert the blank device to set the baseline. Please follow the instructions. It is recommended to check the meter before starting the measurements. This process should be performed once a week to verify that the optical system of the reader is well calibrated. This step is necessary to allow exact measurements. Assay procedure

14 Detailed presentation Assay procedure CAUTION! Please perform the assay procedure as indicated in the leaflet of the measured parameter. Useful recommendations Selecting means activating the real measuring menu. By pressing the button below, a control is automatically made in order to check whether there is a current zero line setting or if such a setting should be done. In the case that a new zero line setting is necessary, please follow the reader instructions. After successful zero line setting (or if such a process was done on the last 24 hours and the meter was not switched off), you will be asked to input the patient s data needed to identify the sample via the keyboard. Assay procedure p.2

15 Detailed presentation Assay procedure Useful recommendations Page 1 P.2 P.3 P.4 Useful recommendations for more accurate results during test processing 1) Switch on the reader and wait for 5 minutes to let it warm up. 2) Place the cassette horizontally (sample well on the left-hand side) and add the sample (whole blood, plasma or serum) in the exact position as indicated in the picture by the arrow. Assay procedure p.2

16 Detailed presentation Assay procedure Useful recommendations P.1 Page 2 P.3 P.4 Useful recommendations for more accurate results during test processing 3) When using whole blood sample, wait for the complete absorption of the sample (less than a minute). This is very important to get a clear background. 4) Add four (4) drops of diluent without the bottle tip touching the cassette. Assay procedure p.2

17 Detailed presentation Assay procedure Useful recommendations P.1 P.2 Page 3 P.4 Useful recommendations for more accurate results during test processing 5) Keep the bottle vertical in order to always obtain the right volume of drops while adding the diluent into the sample well. 6) Push the cassette firmly into the reader. 7) Read exactly the result at the appropriate time indicated in the instruction leaflet corresponding to the tested parameter. Assay procedure p.2

18 Detailed presentation Assay procedure Useful recommendations P.1 P.2 P.3 Page 4 Useful recommendations for more accurate results during test processing 8) Please make sure that test cards will always be well placed in the correct position into the card holder. Assay procedure p.2

19 Detailed presentation Assay procedure p.2 Please input the family name and first name of the patient via the keyboard. the input by pressing the ENTER-button. Assay procedure p.3

20 Detailed presentation Assay procedure p.3 Please input the date of birth in the requested format. the input by pressing the ENTER-button. Slashes will be generated automatically. Immediate or countdown

21 Detailed presentation Immediate or countdown mode Immediate The immediate reading mode can be used only if the test has already been performed by the end-user and after waiting for the required migration time indicated in the specific test leaflet. Countdown The Countdown mode can be used in case the test has not been already performed by the end-user. The test card is put directly into the meter after adding the sample and other reagents, if required, as indicated in the specific test leaflet. The reader will automatically calculate the reaction time before the result measurement. After pressing the countdown button, the sample selection screen will appear. Depending on the parameter, select the corresponding matrix sample (whole blood, serum, plasma, urine). Inserting the test card

22 Detailed presentation Inserting the test card Insert the test card into the card holder with the sample well ( ) in the opposite direction of the meter. Checking of chemical reaction time and result measurement will be performed automatically. Information will appear on the display. Please make sure that the test cards are always well placed and pushed into the card holder until they are locked. The correct positioning of the card will avoid wrong measurements and error messages. When inserting the test card, you will feel a slight resistance before the exact final position is reached.continue to gently push the test card into the slot until it becomes locked in the correct position. Results and printing

23 Detailed presentation Results and printing The test result will be shown automatically and will be printed simultaneously, if the printer is ON. Result is expressed in the unit system compatible with the measured parameter. By selecting Measure, the next test starts. By selecting Readout, the result can be shown line by line on the display, if the printer is OFF. After having processed the test, the cassette should be considered potentially infectious and should be discarded accordingly.

24 After switching on, this screen appears a few seconds. Then the main menu appears automatically on the display (click on the slide to see the next one).

25 Click on the black buttons on the front of the reader to see information for «Check» or «Settings».

26 parameter Available only with the multi parameter E-prom

27 parameter Available only with the multi parameter E-prom

28 parameter Available only with the multi parameter E-prom

29 parameter Blankcard A control is automatically done in order to check whether there is a current zero line setting or if such a setting should be done. (Click on the slide to see the next one)

30 parameter Blankcard A control is automatically done in order to check whether there is a current zero line setting or if such a setting should be done. (Click on the slide to see the next one)

31 parameter Blankcard (click on the slide to see the next one)

32 parameter Blankcard (click on the slide to see the next one)

33 parameter Blankcard Patient Name Input the patient s data (family name and first name ) needed to identify the sample via the keyboard. the input by pressing the ENTER-button.

34 parameter Blankcard Patient Name Birthday Input the day of birth in the requested format. the input by pressing the ENTERbutton. Slashes will be generated automatically.

35 parameter Blankcard Patient Name Birthday Reading selection -By pressing Immediate, the test result will be read immediately without any countdown. -By pressing Countdown (the test has not been already performed by the end-user), the reader will automatically calculate the reaction time before the result measurement.

36 parameter Blankcard Patient Name Birthday Reading selection Countdown Select the sample type either serum/plasma/urine or whole blood by pressing the corresponding button.

37 parameter Blankcard Patient Name Birthday Reading selection Countdown New test (click on the slide to see the next one)

38 parameter Blankcard Patient Reading selection New test Name Countdown Birthday Remove the blank card before inserting a new test in the slot. (click on the slide to see the next one)

39 parameter Blankcard Patient Reading selection New test Name Countdown Birthday The test card is inserted directly into the meter after adding the sample and other reagents, if required, as indicated in the specific test leaflet. (click on the slide to see the next one)

40 parameter Blankcard Patient Reading selection New test Name Countdown Birthday The reader will automatically calculate the reaction time before the result measurement. (click on the slide to see the next one)

41 parameter Blankcard Patient Reading selection New test Result Name Countdown Birthday The test result will be shown automatically and will be printed silmutaneously, if the printer is ON. Result is expressed in the unit system compatible with the measured parameter.

42 parameter Blankcard Patient Reading selection New test Result Readout Name Countdown Birthday By selecting Readout, the result can be shown line by line at display, if the printer is OFF.

43 parameter Blankcard Patient Reading selection New test Name Immediate Birthday (click on the slide to see the next one)

44 parameter Blankcard Patient Reading selection New test Name Immediate Birthday Remove the blank card before inserting a new test. (click on the slide to see the next one)

45 parameter Blankcard Patient Reading selection New test Name Immediate Birthday The immediate reading mode can be used only if the test has already been performed by the end-user and after waiting for the required migration time indicated in the specific test leaflet. Reaction time is measured by the end-user with an external timer. (click on the slide to see the next one)

46 parameter Blankcard Patient Reading selection New test Name Immediate Birthday (click on the slide to see the next one)

47 parameter Blankcard Patient Reading selection New test Result Name Immediate Birthday The test result will be shown automatically and will be printed silmutaneously, if the printer is ON. Result is expressed in the unit system compatible with the measured parameter.

48 parameter Blankcard Patient Reading selection New test Result Readout Name Immediate Birthday By selecting Readout, the result can be shown line by line in the display, if the printer is OFF.

49 Check Blankcard Insert the blank device to set the baseline. Please follow the reader instructions. It is recommended to check the meter before starting the measurements. (click on the slide to see the next one)

50 Check Blankcard Insert the blank device to set the baseline. Please follow the reader instructions. It is recommended to check the meter before starting the measurements. (click on the slide to see the next one)

51 Check Blankcard (click on the slide to see the next one)

52 Check Blankcard (click on the slide to see the next one)

53 Check Blankcard Checkcard (click on the slide to see the next one)

54 Check Blankcard Checkcard Remove the blank card before inserting the check card in the slot. (click on the slide to see the next one)

55 Check Blankcard Checkcard This process should be performed once a week to verify that the optical system of the reader is well calibrated. This step is necessary to allow exact measurements. (click on the slide to see the next one)

56 Check Blankcard Checkcard (click on the slide to see the next one)

57 Check Blankcard Checkcard (click on the slide to see the next one)

58 Check Blankcard Checkcard Compare the obtained results with the expected values (limits of tolerance) of the calibration device. These values are printed on the calibration device pouch label.

59 Settings

60 Settings User address 5 lines of information concerning the user (name, adress, tel, ) can be saved in the reader using the keyboard. (click on the slide to see the next one)

61 Settings User address (click on the slide to see the next one)

62 Settings User address (click on the slide to see the next one)

63 Settings User address (click on the slide to see the next one)

64 Settings User address (click on the slide to see the next one)

65 Settings Output

66 Settings Output Display

67 Settings Output Display Date/Time Adjust the date and the time using the three buttons on the front of the reader. Click next to go back to the main menu.

68 Settings Output Display Language Selecte the appropriate language. Click next to go back to the main menu.

69 Settings Output Display Language

70 Settings Output Print/Send

71 Settings Output Print/Send Printer There is a possibility of switching the printer reader ON or OFF.

72 Using the button below OFF or ON will bring the printer into the requested mode and then will lead to the appearance of the main menu.

73 Settings Output Print/Send Printer Linefeed Here you can start the linefeed () and stop it (Stop). Please use this position, to switch on or switch off the linefeed while putting paper into the printer.

74 Settings Output Print/Send Memory The memory contains a maximum of 28 results. Entering more than 28 results (new measurements) will always lead to the deletion of the other results. The results of check card measurements will not be stored.

75 Settings Output Print/Send Memory Please give a two-digit input of a number between 01 and 28 on the display using the keyboard. When entering 01 the last result will be shown.

76 Settings Output Print/Send Memory OK By choosing No or Quit, you will return to the main menu. By choosing Yes, the printing process will start.

77 Settings Output Print/Send Memory OK Yes

78 Simplified list Detailed list AFP CA125 FOB FRT LH M-ALB TSH CEA CK-MB FSH HCG MGL PRL CRP D-Dimers IgE Insulin PSA TRP-I

79 Simplified list Quantitative determination Reading time (min) AFP Alpha feto protein (tumor marker) ng/ml CA -125 Antigen 125 (Ovarian cancer) IU/mL CEA CarcinoEmbryonic Antigen (tumor marker) ng/ml CKMB Creatine Kinase MB (Acute myocardial infarction) ng/ml CRP C-Reactive Protein (inflammatory process) 5 or μg/ml EASY READER measuring range D-DIMERS D-Dimers (deep vein thrombosis) ng/ml FEU FOB (Faecal Occult Blood) Blood in feces (colorectal cancer) ng/ml FRT Iron deficiency (anemia) ng/ml FSH Follicle stimulating hormone (menopause) IU/L h-cg Human chorionic gonadotropin (pregnancy) IU/L IgE Immunoglobulines E (allergy) IU/mL INSULIN Insulin hormone (diabetes, insulinoma) μu/ml LH Luteinizing hormone IUL M-ALB Albumin in urine (diabetes) μg/ml MGL Myoglobin (acute myocardial infarction) ng/ml PRL Prolactin hormone (lactation) ng/ml PSA Prostate Specific Antigen (prostate cancer) ng/ml TRP I Troponin I (Acute myocardial infarction) ng/ml TSH Thyro Stimulating Hormone (Hypothyroidism) miu/l

80 Detailed list AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE INSULIN Normal values Abnormal values EASY READER measuring range Reading time And Interpretation AFP Alpha feto protein (tumor marker) Reading time: 10 min Adult < 40 ng/ml > 40 ng/ml ng/ml - Testicular teratocarcinomas (75%) - Pancreatic cancers (23%) - Gastric cancers (18%) - Cronchogenic cancers (7%) - Colon cancers (5%) Other diseases as: Child (<1 year) LH M-ALB MGL PRL PSA TRP-I TSH < 30 ng/ml > 30 ng/ml - Viral hepatitis (24%) - Postnecrotic cirrhosis (24%) - Laennec's cirrhosis (15%) - Primary biliary cirrhosis (5%).

81 Detailed list AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE INSULIN LH M-ALB MGL PRL PSA TRP-I TSH Normal values Abnormal values EASY READER measuring range Reading time And Interpretation CA -125 Antigen 125 (Ovarian cancer) Reading time: 15 min Adult < 35 IU/mL > 35 IU/mL IU/mL - Use in monitoring of epithelial ovarian cancer treatment. - May be also elevated in patients with cervical, fallopian tubes and uterine cancer and endometriosis.

82 Detailed list AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE INSULIN LH M-ALB MGL PRL PSA TRP-I TSH Normal values Abnormal values EASY READER measuring range Reading time And Interpretation CEA CarcinoEmbryonic Antigen (tumor marker) Reading time: 15 min < 5 ng/ml > 5 ng/ml ng/ml Increase in : - Colon, stomach, pancreas, lung cancers (75 %) - Breast, head and neck, ovary cancers (50%) -in 90 % of all with solid-tissue tumors especially with metastases to liver or lung. Other diseases as: - Alcoholic cirrhosis, chronic active hepatitis, obstructive jaundice. - Renal failure -Fibrocystic disease of breast. Other factor of CEA increased levels: - 19 % of heavy smokers and 7 % of former smokers have CEA > 5 ng/ml.

83 Detailed list AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE INSULIN LH M-ALB MGL PRL PSA TRP-I TSH Normal values Abnormal values EASY READER measuring range Reading time And Interpretation CKMB Creatine Kinase MB (Acute myocardial infarction) Reading time: 15 min < 10 ng/ml > 10 ng/ml ng/ml Myocardial tissue injury (AMI : Acute Myocardial Infarction)

84 Detailed list AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE INSULIN CRP Laboratories CRP Doctors office LH M-ALB MGL PRL PSA TRP-I TSH Normal values Abnormal values C-Reactive Protein (inflammatory process) EASY READER measuring range Reading time And Interpretation Reading time: 10 min Reading time: 5 min < 8 µg/ml > 8 µg/ml μg/ml Increase in : - acute bacterial infection ( µg/ml % cases). - acute viral infection (> 8 µg/ml and < 200 µg/ml). - Inflammatory disorders (RA, rheumatic fever, inflammatory bowel disease...). -Tissue injury or necrosis (Myocardial infarction, ischemia, rejection of kidney, marrow transplant, malignant tumors, after surgery : peaks at hrs and falls to normal within 5-7 days if no complications). Not increased in : - Autoimmune diseases (SLE, scleroderma...) - Pregnancy - Strenuous exercise - Angina - Cerebrovascular accident - Seizures - Asthma - Common cold - Rejection of heart transplant.

85 Detailed list AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE INSULIN Normal values Abnormal values D-DIMERS D-Dimers (deep vein thrombosis) Depends on age, sex and physiological profile LH M-ALB MGL PRL PSA TRP-I TSH < 400 ng/ml FEU > 400 ng/ml FEU EASY READER measuring range ng/ml FEU Reading time And Interpretation Reading time: 15 min Increased levels in : - Fibrinolysis - During thrombolytic or defibrination therapy with tissue plasminogen activator. - Deep-vein thrombosis. - Pulmonary embolism. - Arterial thromboembolism. - Disseminated intravascular coagulation. - Vaso-occlusive crisis of sickle cell anemia. - Pregnancy. - Maligancy. - Surgery.

86 Detailed list AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE INSULIN FOB (Faecal Occult Blood) LH M-ALB MGL PRL PSA TRP-I TSH Normal values Abnormal values Blood in feces (colorectal cancer) EASY READER measuring range Reading time And Interpretation Reading time: 10 min < 100 ng/ml > 100 ng/ml ng/ml Increase in : - Colorectal cancer, - Haemorrhoids, - Stomach irritations, - Ulcers.

87 Detailed list AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE INSULIN Normal values Abnormal values EASY READER measuring range Reading time And Interpretation FRT Iron deficiency (anemia) Reading time: 15 min Male ng/ml Increased or decreased levels Female ng/ml Children (newborn) Children (1 month) Children (2-5 months) Children (6 months-15 years) LH M-ALB MGL PRL PSA TRP-I TSH ng/ml ng/ml ng/ml ng/ml ng/ml Increased levels in: hemochromatosis, hemosiderosis, megablastic anemia, hemytic anemia, alcoholic/inflammatory hepatocellular disease, inflammatory disease, Hodgkin's disease and breast cancer. > 80 ng/ml essentially excludes iron deficiency. Decreased levels in: iron deficiency anemia, severe protein deficiency hemodialysis.

88 Detailed list AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE INSULIN Normal values Abnormal values EASY READER measuring range Reading time And Interpretation FSH Follicle stimulating hormone (menopause) Reading time: 10 min Males (Prepuberty) < 2 IU/L > 2 IU/L IU/L Increase in : - Primary hypogonadism (anorchia, testicular failure, menopause) - Gonadotropin-secreting pituitary tumors < 2 IU/L > 2 IU/L - Complete testicular feminization syndrom - Luteal phase of menstrual cycle. Males (Adults) 1-10 IU/L > 10 IU/L Females (Prepuberty) Females (Follicular phase) Females (Midcycle) Females (Luteal phase) Females (Postmenopausal) LH M-ALB MGL PRL PSA TRP-I TSH 1-10 IU/L > 10 IU/L 6-30 IU/L > 30 IU/L 1-8 IU/L > 8 IU/L IU/L > 100 IU/L Decrease in : - Secondary hypogonadism - Pituitary FSH deficiency - Gonadotropin deficiency.

89 Detailed list AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE INSULIN Normal values Abnormal values EASY READER measuring range Reading time And Interpretation H-CG Human chorionic gonadotropin (pregnancy) Reading time: 15 min week 1 < 5 IU/L I/UL IU/L Increase in: week 2 week 3 week 4 LH M-ALB MGL PRL PSA TRP-I TSH I/UL I/UL IU/L week week month 2 to nd trim rd trim Pregnancy - Ectopic pregnancy (Beta-hCG) - Hydatidiform mole of the uterus (Beta-hCG) - Choriocarcinoma of the uterus, testes or ovaries (Beta-hCG). Decrease in: - Threatened abortion - Incomplete abortion - Dead fetus.

90 Detailed list AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE INSULIN LH M-ALB MGL PRL PSA TRP-I TSH Normal values Abnormal values EASY READER measuring range Reading time And Interpretation IgE Immunoglobulines E (allergy) Reading time: 10 min < 150 IU/mL > 150 IU/mL IU/mL - Diagnosis of E-myelomas -Indicates various parasitic or allergic diseases. A normal IgE level excludes the diagnosis of bronchopulmonary aspergillosis. Increased levels in: - Exogenous asthma (60%) - Hay fever (30%) - Atopic eczema. -Parasitic diseases (ascarisis etc...) Decreased levels in: - Hereditary deficiencies - Acquired immunodeficiency - Ataxia-telangiectasia - Non-IgE myeloma.

91 Detailed list AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE INSULIN LH M-ALB MGL PRL PSA TRP-I TSH Normal values Abnormal values EASY READER measuring range Reading time And Interpretation INSULIN Insulin hormone (diabetes, insulinoma) Reading time: 15 min Adult < 20 µu/ml > 20 µu/ml μu/ml Not clinically useful for diagnosis of diabetes mellitus. Useful for diagnosis of insulinoma. Increase in : - Insulinoma - Factitious hypoglycemia - Insulin autoimmune syndrome - Untreated obese patients with mild diabetes - Patients with acromegaly - Reactive hypoglycemia after glucose ingestion. Absent in : - Severe diabetes mellitus with ketosis and weight loss. Normal in : - Hypoglycemia associated with nonpancreatic tumors - Idiopathic hypoglycemia of childhood except after administration of leucine.

92 Detailed list AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE INSULIN LH (in serum) Adult females (menstruating) Adult females (midcycle) LH M-ALB MGL PRL PSA TRP-I TSH Normal values Luteinizing hormone Abnormal values 4 30 UI/L Increased or decreased levels UI/L EASY READER measuring range Reading time And Interpretation Reading time: 10 min IUL Increase in : - Primary hypogonadism - Luteal phase of menstrural cycle Decrease in : - Secondary hypogonadism - Pituitary LH deficiency - Gonadotropin deficiency

93 Detailed list AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE INSULIN LH M-ALB MGL PRL PSA TRP-I TSH Normal values Abnormal values EASY READER measuring range Reading time And Interpretation M-ALB Albumin in urine (diabetes) Reading time: 10 min < 20 mg/l (urine) > 20 mg/l (urine) μg/ml Increase in : - Diabetes mellitus - Chronic and acute renal disease.

94 Detailed list AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE INSULIN LH M-ALB MGL PRL PSA TRP-I TSH Normal values Abnormal values EASY READER measuring range Reading time And Interpretation MGL Myoglobin (acute myocardial infarction) Reading time: 15 min < 80 ng/ml > 80 ng/ml ng/ml Increased levels in : - Myocardial infarction (earlier marker of AMI) - Skeletal muscle inflammatory (myositis) - Malignant hyperthermia. - Muscular dystrophy - Skeletal muscle ischemia - Rhabdomyolysis.

95 Detailed list AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE INSULIN Normal values Abnormal values EASY READER measuring range Reading time And Interpretation PRL Prolactin hormone (lactation) Reading time: 10 min Adult male < 20 ng/ml > 20 ng/ml ng/ml ng/ml : seen in craniopharyngioma, Adult female Pregnant female LH M-ALB MGL PRL PSA TRP-I TSH 0-20 ng/ml ng/ml / hypothyroidism, effect of drugs ng/ml : 25 % chance of a pituitary tumor ng/ml : 50 % chance of a pituitary tumor ng/ml : 100 % chance of a pituitary tumor. Other causes of increased levels: - Amenorrhea/galactorrhea - Hypothalamic lesions - Other endocrine diseases. - Pregnancy - Liver failure - Idiopathic causes.

96 Detailed list AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE INSULIN LH M-ALB MGL PRL PSA TRP-I TSH Normal values Abnormal values EASY READER measuring range Reading time And Interpretation PSA Prostate Specific Antigen (prostate cancer) Reading time: 10 min Male < 70 years Male > 70 years < 4 ng/ml < 6.5 ng/ml > 4 ng/ml > 6.5 ng/ml ng/ml Increase in : - Cancer, - Prostatitis, - Benign prostatic hypertrophy, - Acute urinary retention. Decrease in: - Ejaculation within hours, - Castration, - Use of antiandrogen drugs, - Radiation therapy, - Prostactectomy, - PSA falls 17 % in 3 days for patient lying in hospital bed.

97 Detailed list AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE INSULIN Normal values Abnormal values EASY READER measuring range Reading time And Interpretation TRP I Troponin I (Acute myocardial infarction) Reading time: 20 min (plasma/ serum) LH M-ALB MGL PRL PSA TRP-I TSH < 0.8 ng/ml > 0.8 ng/ml 0-50 ng/ml The most specific marker of acute myocardial infarction (AMI). (whole blood) < 1.0 ng/ml > 1.0 ng/ml

98 Detailed list AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE INSULIN Normal values Abnormal values EASY READER measuring range Reading time And Interpretation TSH Thyro Stimulating Hormone (Hypothyroidism) Reading time: 15 min Possible hypothyroidism Possible hyperthyroidism Borderline miu/l LH M-ALB MGL PRL PSA TRP-I TSH / / > 5.0 miu/l < 0.10 miu/l 2-80 miu/l Increase in: - Primary untreated hypothyroidism - Patients with Hashimoto's thyroiditis - Use of various drugs (Iodine containing drugs, dopamine antagonists). - Neonatal period - Thyrotoxicosis due to pituitary thyrotroph adenoma. / Decrease in: - Hyperthyroidism - Acute psychiatric illness - Severe dehydration - Drug effect - First trimester of pregnancy.

99 Reader technical data Useful recommendations Answers Maintenance Error messages Troubleshooting

100 Reader technical data Display range: Sample material: Display: Printer: Memory capacity: Dimension: Weight: Qualitative results (negative or positive) Whole blood, plasma, serum or urine samples LCD-Display 2 x 24 characters Thermal paper printer, roll width 54 mm 28 results 200 x 200 x 70 mm 822 g without power supply unit, 1104 g with power supply unit Power supply: 7.5 V DC with power supply unit ( V ~) Consumption : Optimal working temperature: 8 W Relative humidity: < 95% +15 C to +30 C Storage and transportation conditions (reader): EMC compatibility: -10 to +60 C, < 95% humidity This instrument is EMC-tested and fulfils requirements of guidelines EN 61326:1997, 55022, /-3, /-3/-4/-5/-6/-11.

101 Useful recommendations Page 1 P.2 P.3 P.4 Useful recommendations for more accurate results during test processing 1) Switch on the reader and wait for 5 minutes to let it warm up. 2) Place the cassette horizontally (sample well on the left-hand side) and add the sample (whole blood, plasma or serum) in the exact position as indicated in the picture by the arrow.

102 Useful recommendations P.1 Page 2 P.3 P.4 Useful recommendations for more accurate results during test processing 3) When using whole blood sample, wait for the complete absorption of the sample (less than a minute). This is very important to get a clear background. 4) Add four (4) drops of diluent without the bottle tip touching the cassette.

103 Useful recommendations P.1 P.2 Page 3 P.4 Useful recommendations for more accurate results during test processing 5) Keep the bottle vertical in order to always obtain the right volume of drops while adding the diluent into the sample well. 6) Push the cassette firmly into the reader. 7) Read exactly the result at the appropriate time indicated in the instruction leaflet corresponding to the tested parameter.

104 Useful recommendations P.1 P.2 P.3 Page 4 Useful recommendations for more accurate results during test processing 8) Please make sure that test cards will always be well placed in the correct position into the card holder.

105 Answers Maintenance The reader does not require regular maintenance. With normal usage, the device will not become dirty. The surface of the meter can be cleaned with a slightly moistened, soft cloth. Please strictly avoid any liquid penetrating into the meter. If needed, the black test card holder can be completely pulled out of the meter and be cleaned with tap water. Disinfection using isopropanol is possible. Please make sure that the test card holder is completely dry before putting it back into the meter. To obtain good and consistent results, you should note the following: a) Do not expose the instrument to direct sunlight or severe temperature fluctuations. b) Set up the instrument in humidity-free conditions. c) Always keep the test card holder dust and dirt free.

106 Answers Error messages E04 WRONG CODEKEY E05 NO CODEKEY E06 SAMPLE INVALID E10 WRONG POSITION E14 User memory full E14 User memory empty E20 WRONG DATE E22 CALIBRATION ERROR E23 PRINTER ERROR E25 EXTERNAL LIGHT E28 BLANK/OPTIC FAULT E30 WRONG FORMAT A wrong version of E-prom (chip) is inserted into the slot. Switch off the reader. Remove the chip and replace it with an E-prom of the right version. Switch on the reader. Reader internal error. Not possible to repair by the user. Please contact your supplier immediately. The reader has detected an abnormal reaction on the test card. Perhaps the sample was haemolytic or the test card was defective. Repeat the measurement with a new test card. Position of test card in the meter is not correct. Check whether the test card was placed in the meter in the right position following the arrow (sample well ( ) and not in the opposite direction. Also check that it is fully inserted into the slot (until locked). The maximum memory capacity (28 results) is reached; every further examination will cause the deletion of the oldest result. No results stored. Therefore, no stored results can be shown. Wrong date programmed. Please make sure that the entered date is correct. The reader has detected a wrong internal calibration. Please switch off device and then switch on again. Please set a new zero line with the blank device. The reader has detected an internal printer error. Please check the correct paper position. Switch off meter and then on again. If the problem persists, please contact your supplier. Optical compounds have recorded too much external light. Please avoid positioning the reader in too intensive external light (e.g. sunlight, halogen beamer) towards the card holder opening. Zero line setting was not accepted. Please try again as per the instructions. If the problem persists, please contact your supplier. Wrong format. Please follow the advice shown on the display. Repeat this step.

107 No output to screen. Message on screen : E25 : EXTERNAL LIGHT Message on screen : E28 : BLANK/OPTIC FAULT Message on screen : E06 : SAMPLE INVALID No print Answers The printing quality is not correct. Expected results are not correct. Date and Time are not correct. Commands are blocked and forbid the use of the reader. Results for check card are rendered as 2 values not 3. Message on screen : E 04 : WRONG CODEKEY Troubleshooting a. Check that the Easy Reader is plugged into the electrical supply. b. Check the position of on/off button. It should be positioned on ON. Interference due to external light. The reader should be repositioned to avoid direct light. The device used to perform Blank strip operation is not a true blank device. Test bands are not detected by the camera : a. Blank device has been read. b. The sample has not correctly migrated on the membrane (no Control line). The test is non valid. c. The test device has not been well positioned in the reading slot or has not been pushed in enough. a. Check the Settings menu to verify whether the printer has been deactivated. b. Check that the paper is correctly positioned in printer as described in MD Part IX (General instructions leaflet). Clean the printer (printing heads are probably dusty) using a soft brush. a. Blank operation has not been performed using a true blank device. b. Test device has been reversed or has not been pushed completely into the reading slot. Check Settings menu and set the Date and Time parameters to the correct values. E-prom not designed for this version. Switch off the reader and try again. If still blocked, the reader must be returned to VEDALAB. The parameter to be assayed is a 2 line parameter. Only a few parameters (hcg, CRP, Micro -Albumin) will show 3 values for the check card. Check the inserted E-prom. The E-prom version is not designed for C version reader.