Analyticon

Urilyzer 100 Pro QC-Management Setup Guide July 2019

Setup Guide

2 Pages

GB  QC-Management Urilyzer® 100 Pro – Setup  Step 1: To establish the quality management, please follow the instructions below. These steps are required whenever you change the LOT number of your CombiScreen® Dip Check (or CombiScreen® Drop Check) urine control. Further information are given in chapter 9 of the user manual.  ➧  ➧  ➧  1  ➧  030  ➧  4  6  8  3  2  9  CombiScreen® DIP Check CombiScreen® DIP Check  Catalog No.  93010  ® 93010 Analyticon 2 x 15CombiScreen mL Urine Test Strips  Analyte  Ascorbic Acid  Bilirubin Analyte Acid Ascorbic Analyte  10  ➧  Negative  1+ – 3+  Y 686 2020/05  Y 686 Expiry 2020/05 Lot No. Y 686 Expiry 2020/05 Instrumental (Analyticon CombiScan® / Urilyzer®)  CombiScreen® DIP Check  Visual 2 x 15 mL 93010  Lot No.  12  Level 1 Expiry  Level 1 Level 2 Analyticon CombiScreen® Urine Test Strips Negative Negative Visual Analyticon CombiScreen® Urine Test Strips Level 1 Level 2 Analyticon CombiScreen® Urine Test Strips Visual Negative 1+ – 3+ Negative Negative Visual Level 1 Level 2 Level 1  Level 2  Y 686 2020/05 Level 2  Level 1  Level 2 ®  Negative Negative *) Negative Negative  Negative 10 – 300 1+ – 3+ 1+Negative – 3+  Negative Normal Negative Negative *)  1+50 – 3+ – 1000 mg/dl 2.8 –3+ 56Ery/µl mmol/l 101+ – –300 1+ – 3+  Negative Normal Negative Negative *)  Negative Negative *) Negative *) Normal  Negative *) Negative Negative *)  Leucocytes Glucose Glucose Ketones  Negative Normal Normal Negative  – 3+Ery/µl 10(+) – 300 300 Ery/µl 1+10– – –1000 3+ 50 mg/dl 1+ – 3+ 2.8 – 56 mmol/l – 500mg/dl Leu/µl 5025 – 1000  Nitrite Ketones Ketones Leucocytes  Negative *) Negative Negative Negative  Positive (+) (+)– –3+ 3+ 25 – 500 Leu/µl  Negative *) Negative Negative  pH Leucocytes Leucocytes Nitrite  5–6 Negative Negative Negative *)  7–9 500Leu/µl Leu/µl 2525– –500 Positive  5–7 Negative Negative  Protein NitriteNitrite pH  Negative Negative Negative *) *) 5–6  30 – 500 mg/dl Positive Positive 7–9  Negative Negative Negative*)*)  5–7  30 – 500 mg/dl Positive Positive 0.3 – 5.0 g/l 1+ 6 –– 3+ 9  1.000 – 1.015 7–9 7–9 30 – 500 mg/dl 2 – 12 mg/dl **) 30 – 500 mg/dl – 200 µmol/l 3035 – 500 mg/dl 1.000 – 1.015 100 ––300 mg/dl 1.000 1.015 8.8 – 26.5 mmol/l 1.000 – 1.015 2 – 12 mg/dl **) – mg/dl 500 mg/l 352150 –– 200 µmol/l 12 **)  1.015 – 1.030 5–7  1.000 – 1.030 6–9  Normal Negative  5.0 g/l 2 0.3 – 12– mg/dl 30 –1+ 500 mg/dl – 3+ 30 –200 500 mg/dl 0.335 – –5.0 g/lµmol/l – 4+ – 5.0 g/l 1+1+ –0.3 3+  Ery/µl  Normal  Negative Normal Normal  50 – 1000 mg/dl 2.8 56 (+) –– –3+ 2.8 56mmol/l mmol/l  Negative  Negative  Negative *)  1+ – 3+  1 –– 1000 4 mg/dl 50 mg/dl 1 –2.8 4 mg/dl –– 17 –56 70mmol/l µmol/l 10 300 Ery/µl 171+ –1+ 70 µmol/l –– 1+ –5+ 3+ 3+ 1+ – 3+ 10 mg/dl 10– –300 300 Ery/µl 101.0 –1+ 300 Ery/µl mmol/l –30 3+ 50–– 1000 mg/dl 1+(+) – 3+ – 3+ 2.8 – 56 mmol/l  1+– –500 5+Leu/µl 25 50 – 1000 mg/dl 501+ – 1000 mg/dl – 3+ 2.8 56 mmol/l ––mmol/l 300 mg/dl 2.8 10 – 56 1+ 30 mmol/l 1+ –1.0 5+–– 5+ Positive (+) – 3+ – 300 mg/dl 10 –10 300 mg/dl 1.0 30 mmol/l 1.0 25 – 30 ––mmol/l 500 Leu/µl (+) 3+ (+) – 1+3+–– 3+ 6–9 25 –25 500 Leu/µl – 500 Leu/µl 1+ –Positive 3+– 3+ 1+  Instrumental (Analyticon CombiScan® / Urilyzer®) 5–7 Negative  Level 1  Negative 1.015 – 1.030  n.a. – 1.030 1.015  1.015 – 1.030 Normal n.a. Normal  Urobilinogen Normal Creatinine 50 – 200 mg/dl *) Repeated dipping may yield false positives. Creatinine – 200 mg/dl 4.4 –5017.7 mmol/l **) Atypical color may occur. 4.4 – 17.7 mmol/l Creatinine 50 – 200 mg/dl 4.4––150 17.7mg/l mmol/l Microalbumin 30  – 200 µmol/l 2 35 – 12 mg/dl **) 35 ––200 100 300µmol/l mg/dl 100 – 300mmol/l mg/dl 8.8 – 26.5  150 – 500 mg/l  n.a.  Microalbumin 30 – 150 mg/l *) Repeated dipping may yield false positives. *) Repeated dipping may yield false positives. **) Atypical color color may may occur. **) Atypical occur. Level 1 (L1) *) Repeated dipping may yield false positives. **) Atypical color may occur.  150 – 500 mg/l  n.a.  Analyticon Urilyzer® 100  Normal n.a.  Negative – 20 mg/dl Negative – 1+ 8.8 – 26.5 mmol/l  100 – 300 mg/dl 8.8 ––26.5 150 500 mmol/l mg/l  6–9 30 – 500 mg/dl  1.000 – 1.030  1+ – 3+ n.a. 1.000 – 1.030  1.000 – 1.030 2 – 12 mg/dl  35 – 200 µmol/l 2 –n.a. 12 mg/dl – 4+ 35 –1+ 2 200 – 12µmol/l mg/dl 1+ – 4+ 35 – 200 µmol/l n.a.  n.a.  n.a.1+ – 4+  n.a. n.a.  n.a. n.a.  n.a.  n.a.  Level 2 (L2)  Level 1 (L1) Level 1 (L1)  Level Level22(L2) (L2)  Level 1 (L1)  Level 2 (L2)  Negative  Analyticon  Analyticon Urilyzer® 100 Urilyzer® 100 Analyticon Urilyzer® 100  10 – 300 Ery/µl 1+ – 3+  Enter the Lot-number and the expiry of the Combi­ 50 – 1000 mg/dl Screen®2.8Dip Check (10). – 56 mmol/l Save the input by pressing the arrow in the right cor(+) – 3+ ner (11).  Negative *)  Analyticon® Biotechnologies AG  Am Mühlenberg 10, 35104 Lichtenfels / Germany  (P93010_D-GB-F-I-ES-P-DK-NO-SE-FI_21_001_03.01_2019-04-09_Y686) S7/10  Use the target values written in the package insert Normal of the Combi­Screen® Dip Check on the right side in the column of Level 1 (LevNegative el 1 = L1) (12). Analyticon® Biotechnologies AG  Am Mühlenberg 10, 35104 Lichtenfels / Germany  (P93010_D-GB-F-I-ES-P-DK-NO-SE-FI_21_001_03.01_2019-04-09_Y686) S7/10  Analyticon® Biotechnologies AG  (P93010_D-GB-F-I-ES-P-DK-NO-SE-FI_21_001_03.01_2019-04-09_Y686) S7/10  Analyticon® Biotechnologies AG  (P93010_D-GB-F-I-ES-P-DK-NO-SE-FI_21_001_03.01_2019-04-09_Y686) S7/10  Am Mühlenberg 10, 35104 Lichtenfels / Germany Am Mühlenberg 10, 35104 Lichtenfels / Germany  25 – 500 Leu/µl  Negative  Positive  Negative *)  B  ®  BloodKetones Blood Glucose  30 – 150 mg/l  To enter the target values via barcode scanner, please follow these instructions (B):  Negative – 20 mg/dl Negative – 20 mg/dl ® ® Instrumental / Urilyzer Negative – 1+ (Analyticon CombiScan Negative – 1+ )  Bilirubin Glucose BloodBilirubin  Specific Gravity 1.020 – 1.030 pH 5–6 pH 5–6 Protein Negative Urobilinogen Normal Protein Negative Protein Negative Specific Gravity 1.020 – 1.030 Creatinine 50 – 200 mg/dl Specific Gravity 1.020 – 1.030 4.4 – 17.7 mmol/l Specific Gravity 1.020 – 1.030 Urobilinogen Normal Microalbumin 30 – 150 mg/l Urobilinogen Normal   Select „Main“ (1).  Select „Options“ (2).  Select „Settings“ (3).  Select „QC Options“ (4).   Select „L1“ and „L2“ (5) to enter the target values of the Dip Check. (L1 and L2 = Control Solution Level 1 and 2). Select „Edit QC Lot” (6).  Select the used test strip (7) and „L1” (Level 1 of the control solution) (8). With the right arrow, you will get to the next menu (9).  Instrumental (Analyticon CombiScan / Urilyzer ) Negative 1 – 4 mg/dl ®Negative ® Negative – 20 mg/dl – 20 mg/dl 70 µmol/l Instrumental (Analyticon CombiScan17 /– Urilyzer Level 1 – 1+ Level 2 –) 1+ Negative Negative 1+ – 3+ Level 1 Level 2 Negative Negative – 20 mg/dl Negative – *) 20 mg/dl 10 – 300 Ery/µl Negative– –201+ Negative 1+ 1+ – 3+ Negative mg/dl Negative 20–mg/dl Negative 1 4– mg/dl Negative – 1+ Negative – 1+ 17 – 70 µmol/l  Ascorbic Acid Blood Ascorbic Acid Bilirubin  Microalbumin  11  Lot No.  Catalog No.  Analyte  2 x 15 mL  CombiScreen® DIP Check Expiry CombiScreen® DIP Check Lot No.  93010  Catalog No.  Level 2  2 x 15 mL  Catalog No.  n CombiScreen® Urine Test Strips  )  7  5  apply the following instructions (A): x 15 mL To enter the target values manually, please Lot No. Y 686 Expiry 2020/05 A  )  page 1/2  ➧  Level 2 Negative – 20 mg/dl Negative – 1+ 1 – 413 mg/dl 17 – 70 µmol/l 1+ – 3+ 10 – 300 Ery/µl 1+ – 3+  Enter the value range for each parameter of the 50 – 1000 mg/dl L12.8control solution in the – 56 mmol/l „low” and „high” column. 1+ – 5+ (The high value needs to 10 – 300 mg/dl be1.0entered first, since the – 30 mmol/l (+) value – 3+ cannot be higher low than high value.) Save 25 – the 500 Leu/µl 1+ –input 3+ the with the green tick (13). The instrument Positive to the QC-options returns screen (5–6).  After entering the target values for selection screen 7–9 5 – 7L1, please return to the 6 –strip 9 (7) and select „L2“ (Level 2 of the control solution). Repeat the procedure and enter the target values in the column of Level 2 in the package insert of the Dip Check. 30 – 500 mg/dl  Negative  30 – 500 mg/dl 0.3 – 5.0 g/l 1+ – 3+  1.000 – 1.015  1.015 – 1.030  1.000 – 1.030  ➧  ➧ 10  Please scan the barcode for Level 1 in the package insert of the CombiScreen® Dip Check. The Lot number and expiry as well as the target ranges for Level 1 will be entered auto­matically.  11  Save the input with the green tick (11). The instrument returns to the QC options screen (5–6).  After entering the target values for L1, please return to the strip selection screen (7) and select „L2“ (Level 2 of the control solution). Repeat the procedure and scan the barcode for Level 2 in the package insert of the CombiScreen® Dip Check.
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