Analyticon
Urilyzer 100 Pro QC-Management Setup Guide July 2019
Setup Guide
2 Pages
Preview
Page 1
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.
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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
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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
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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
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page 1/2
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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
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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.
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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.
GB
QC-Management Urilyzer® 100 Pro – Measurements
page 2/2
Step 2: To perform the QC measurement, please follow the instructions below. Further information are given in chapter 9 of the user manual.
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Select „QC“ (1).
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Dip the test strip in familiar way in the control solution Level 1 (L1: „negative” resp. „normal”).
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Select „Start measure: Solution L1” (2).
* Info: By pressing the button „Start measure: Check strip” the functionality and performance of the instrument is verified. Please deposit the check strip in the instrument before. (This option could be performed regularly with the quality control check. The check strip measurement is only necessary if an error occurs.) By selecting „QC Results” all existing values of the QC-measurements are visible.
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* QC measurements should
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This screen appears, if the target values for this lot (3) were not entered yet like described on page 1. In this case please perform the instructions described in „Step 1”.
The Lot-number and the Expiry are displayed automatically (3). Confirm the Lot-number with the right arrow.
The incubation time of the QC measurement is shown.
The QC results will be shown automatically. If you choose the marked arrow, you will get back to the QC menu (5).
Proceed with the control solution 2 (L2: „positive” resp. „pathological”) in the same way like before with L1 (6).
ideally be performed on a daily basis. Please make sure that you enter the respective target values whenever you change the LOT number of your CombiScreen® Dip Check urine control („Step 1”).
Analyticon Biotechnologies AG Am Muehlenberg 10 35104 Lichtenfels Germany [email protected] www.analyticon-diagnostics.com
IU100-QC_GB_27_001_03.01_20190725
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If the displayed LOT is different from the LOT of the urine control you are using, you can directly apply the instructions A or B (page 1/2) here to enter the correct target ranges. If you do so for Level 1, please do not forget to perform the procedure also for Level 2.