Europapa BS-602 Instruction Manual

2
BS-602 Blood Glucose Test Strips
Instruction Manual
Cautions:
·
For Use with the Europapa BG-710, Ease Blood Glucose Meter.
·Read the Owner's Manual of the Europapa BG-710 Blood Glucose Monitoring System before
using the product.
·The user should not take any decision of medical relevance without first consulting his or her
medical practitioner.
·The patient should only adapt the treatment if he has received the appropriate training to do so.
【Product Name】
Generic Name: Blood Glucose Test Strips
【Model】
BS-602
【Packing Type】
1 Test Strip/Bag, 10 Test Strips/Vial, 25 Test Strips/Vial, 50 Test Strips/Vial
【Product Description】
BS-602 Blood Glucose Test Strips
【Intended Use】
The Europapa BS-602 Test Strips are used with the Europapa BG-710 Blood Glucose Meters to quantitatively
measure glucose with fresh capillary whole blood for self-testing. The blood glucose concentration of venous
blood or neonatal blood measured by healthcare professionals. The fresh capillary whole blood collected from
fingertip and neonatal blood collected from heel. The system is intended for in vitro diagnostic home-use or by
healthcare professional in a clinical setting as an aid to monitor the effectiveness of diabetes control. This system
is not for use in the diagnosis of diabetes mellitus.
【Test Principle】
The Europapa BS-602 Test Strip is a plastic strip containing chemistries and electrodes. The strip measures glucose
by using amperometric technology employing a glucose dehydrogenase reaction. When whole blood or blood
glucose test control is drawn into the tip of a test strip, glucose in the sample reacts with chemicals and produces
an electrical current. The meter measures electrical current and calculates amount of glucose. The glucose result
is displayed as a calculated plasma value.
【Chemical Composition】
Glucose dehydrogenase ≥ 1.6 IU; Potassium Ferricyanide ≥ 0.2 mg; Stabilizer ≥ 0.1 mg ;
other elements 68%.Each package contains desiccating agent.
【Storage and Handling】
·Store the test strip and blood glucose test controls in a dry place at temperature between 1℃~30℃ (33.8℉~86℉).
·Use the test strips at temperatures between 5℃~45℃ (41℉~113℉), humidity between 10%~90%.
·Do not store the test strips in high heat and moisture environments. Avoid exposure test strips to sunshine.
·Do not freeze or refrigerate.
·Test strips must be store in original vial with cap tightly sealed.
·Test strip are valid before either 24 months after produced or 6 months past the opened date; write the first opened
date on the package.
·blood glucose test controls are valid before either 24 months after produced or 3 months past the opened date; write
the first opened date on the package.
·Immediately recap vial after removing a strip.
·Use the test strip immediately after it removed out from package.
【Accessories】
·Blood Glucose BG-710
·CS-201 blood glucose test controls
·Lancing Device
·Lancet
【Blood Sample Requirement】
·Use fresh capillary whole blood or venous blood or neonatal blood; Applying anticoagulant in blood sample may
affect test results.
·Capillary, venous and neonatal blood samples containing these anticoagulants are acceptable: EDTA, sodium
heparin. Othter anticoagulants are not recommended.
·Venous and neonatal whole samples collection and preparation should be obtained by healthcare professionals.
·To minimize the effect of glycolysis, venous blood glucose tests need to be performed within 20 minutes of the
blood samples. If collected blood samples cannot be tested immediately, please centrifuge and store them in a
refrigerator.
·Test strip has been tested with neonatal blood. As a matter of good clinical practice, caution is advised in the
interpretation of neonatal blood glucose values below 2.8 mmol/L (50mg/dL).
·Remaining water or alcohol on blood sample puncture site causes inaccurate results.
【Precautions】
·Test Strips are for in vitro (external) testing of Capillary, venous and neonatal blood.
·Operate the Blood Glucose Monitoring System at room temperature.
·Test strips are for single use only. Do not use test strips that are torn, bent, or damaged in any way.
·Lancing device can only be used for single person, exclusively; lancet is for single use only.
·Do not use expired test strips as it caused incorrect test results.
·Never use iodine solution to disinfect puncture site.
·Keep puncture site dry.
·Second drop of blood sample is recommended for measurement.
·If the test strip is cold, do not use until it has warmed to room temperature.
·To eliminate any chance of infection, discard the used test strips, lancing device and lancet properly follow the
local environmental affairs regulation.
Warnings:
·
Do not swallow test strips. Not for human consumption.
·Test strips have a sharper edge that may cause a small scratch.
·Keep the test strip vial or the foil pouch away from children.
【How to Test Your Blood Glucose
】
Read the BG-710 Owner's Booklet thoroughly before test.
1)Prepare system components:
BG-710 Blood Glucose Meter
BS-602 Test Strips
Lacing Device, Lancet
2)Measuring blood sample
1.Blood Sampling
·The blood glucose system requires a tiny of blood sample from your fingertip to test the blood glucose. Before
sampling your blood, wash your hands and the puncture site with an alcohol swab or soapy water. Rinse and dry
thoroughly.
·Turn the cap anti-clockwise to remove it. Insert a new sterilized lancet into the lancet holder and push it down
firmly until it stops.
·Twist off the protective disk until if separates from the lancet
·Slide the cap on until it stops (Avoid contact with the lancet pin)
·Adjust puncture depth by turning the Depth Adjusting Knob. The Depth Indicator shows the current depth selection.
There are 5 optional depths. The higher of the number, the deeper of penetration
·After slide the Ejection Spring Controller back until it clicks. The Lancing Device is ready to use.
·Wash your hands and the puncture site with an alcohol swab or soapy water. Rinse and dry thoroughly.
·Hole the Lancing device firmly against the side of your fingertip. Press the Release Button. Gently squeeze your
finger to assist the blood flow. This will help you to get a drop of blood.
Note: Choose two sides of your finger for the blood sampling site as it can reduce pain.
·Put the Protective Disk back on the lancet. Discard it properly.
2.Testing your blood glucose
·Insert a test strip, contact bar end first and facing up, into Strip Port. Push it in until stops. The meter will
automatically turn on and shortly display symbols on screen. Make sure all the symbols are completely displayed.
·After the meter run self check, a test strip symbol will appear in the top-right corner of the screen
The Blood Sample Reminder symbol flashes to remind applying blood.
·Touch the blood drop to Top Edge at the end of test strip. Hold until the Confirmation Window is full. The meter
begins testing with display countdown.
Note: "E-4" error will appear when the test strip moved during measurement.
·At the end of the countdown, the screen will display test result.
Note: To avoid inaccurate test results affect 7, 14, 28 day average, user may delete the last test result by
simultaneously pressing "S" Button and "M" Button.
·Remove the used test strip. The meter will store the test result and automatically turn off.
Note: To prolong battery life, remove the test strip to turn the meter off.
【Understand your test results】
·If you have symptoms that are not consistent with your test results, consult the system Owner's Booklet to check
for common testing errors. If the problem persists, contact your healthcare professional immediately.
·The result can be known within 5 seconds after the blood sample or blood glucose test control is added.
·The blood glucose meter can accurately measure blood glucose concentrations between 0.5 to 33.3mmol/L (9 to
600 mg/dL). "Lo" and "HI" messages indicate results outside of this range.
·"Lo" symbol will appear on screen if blood glucose is below 0.5 mmol/L (9 mg/dL).
·"HI" symbol means test result is higher than 33.3 mmol/L (600 mg/dL).
EN
·The blood glucose monitoring system needs at least 0.6 μl sample. "E-4" error code will appear when samples are
insufficient.
·If the screen displays error symbols, refer to Owner's Booklet for the troubleshooting.
【Blood Glucose Range Information】
Time
Before breakfast
Before lunch or supper
1 hour after meal
2 hour after meal
Between 2 AM and 4 AM
【Limitations】
·The Europapa blood glucose monitoring system BG-710 is designed for using with capillary, venous and neonatal
blood samples.
·Hematocrit range: 0% to 70%. Hematocrit above 70% may cause deviated results.
·Severe dehydration and excessive water loss may cause false low results. If you think you may be dehydrated,
consult your healthcare professional immediately.
·The interferent listed below were tested. Blood samples tested at the following substance concentration levels will
not interfere.
Substance
Acetaminophen
Bilirubin
Creatinine
Gentisic acid
Haemoglobin
Ibuprofen
L-Dopa
Methyl-DOPA
Tolbutamide
Triglycerides
Xylose
EDTA
【Traceability】
The calibrator of the Europapa Blood Glucose Monitoring System BG-710 is blood glucose test control. The
traceability of the blood glucose test control is referenced to the YSI Glucose Analyzer. The YSI Glucose Analyzer
is the reference method used to assess the accuracy with which glucose results are obtained using the system. The
value of the calibrator for glucose is traceable to the National Institute of Standards and Technology (NIST) Standard
Reference Material (SRM) 917c (D-Glucose). Concentration is 200 mg/dL.
【Performance Characteristics】
The performance of the system has been evaluated both in laboratory and in clinical tests .
·Range: The display range of the meter is 0.5 to 33.3mmol/L (9 to 600 mg/dL). "Lo" and "HI" messages indicate
results outside of this range.
·Accuracy: The accuracy of the system was assessed by comparing blood glucose results from fresh capillary whole
blood obtained by patients with those obtained using a YSI Glucose Analyzer, a laboratory instrument.
Table1. System accuracy results for glucose concentration < 5.55mmol/L (100mg/dL)
Within ±0,28 mmol/L (5 mg/dL) Within ±0,56 mmol/L (10 mg/dL) Within± 0,83 mmol/L (15 mg/dL)
108/168(64.3%)
Table 2. System accuracy results for glucose concentration ≥ 5.55 mmol/L (100mg/dL)
Within ±5 %
360/432(83.3%)
This study shows that the system compares well with a laboratory method and meets the minimum acceptable
performance criteria defined in ISO 15197.
·Precision:
The repeatability evaluation performed with venous whole blood and the intermediate precision evaluation
performed with control materials.
Intermediate Precision
Repeatability
【Literature Reverences】
1. Clin Chem 51, 2005:1573-1576
2. Stedmans Medical Dictionary, 27th Edition, 2000:2802
3. American Diabetes Association: Clinical Practice Recommendation 2007 Diabetes Care 30 (Suppl.1), 2007:
S4-S41
【Symbol Index】
On the packaging, you may encounter the following symbols shown below. They have the following meanings:
Europapa Handels GmbH
Am Bahndamm 5
41334 Nettetal, Germany
Email: info@europapa.com
Website: de.europapa.com
【Manufacturer】
.
【EU Representative】
The product conforms to the requirements of the EC Directive IVDD 98/79/EC on in vitro
diagnostic medical devices, "0197" is the identification number of notify body.
Date of Issue: 2023.01.03
Document No.: DBS-0604-004
Version: C
Normal Blood Glucose Range
3.9-5.8 mmol/L (70-105mg/dL)
3.9-6.1mmol/L (70-110mg/dL)
Less than 8.9mmol/L (≤160mg/dL)
Less than 6.7mmol/L (≤120mg/dL)
Greater than 3.9mmol/L (≥70 mg/dL)
Concentration Substance
1.11 mmol/L (20 mg/dL) Ascorbic acid
2.22 mmol/L (40 mg/dL) Cholesterol
0.56 mmol/L (10 mg/dL) Dopamine
1.25 mmol/L (22.5 mg/dL) Glutathione
1111.11 mol/L (20000 mg/dL) Heparin
2.78 mmol/L (50 mg/dL) Icodextrin
0.03 mmol/L (0.5 mg/dL) Maltose
0.22 mmol/L (4 mg/dL) Salicylate
5.55 mmol/L (100 mg/dL) Tolazamide
83.33 mmol/L (1500 mg/dL) Uric acid
2.78 mmol/L (50 mg/dL) Pralidoxime Iodide
11.11 mmol/L (200 mg/dL) Galactose
156/168(92.9%)
Within ±10 %
410/432(94.9%)
blood glucose test controls 2.4 mmol/L SD=0.13
av
blood glucose test controls 7.4 mmol/L CV=3.4%
av
blood glucose test controlsav 20.8 mmol/L CV=2.7%
Blood 2.4 mmol/L SD=0.13
av
Blood 5.1 mmol/L SD=0.19
av
Blood 7.4 mmol/L CV=3.4%
av
Blood 12.2 mmol/L CV=3.4%
av
Blood 20.8 mmol/L CV=2.1%
av
Consult instructions for use Sufficient for
30℃
In vitro diagnostic medical device Temperature limitation
1℃
Caution Keep dry
Batch code Do not reuse
Manufacturer Use by
Authorized representative in the European Community
The product conforms to the requirements of the EC Directive IVDD
( 98/79/EC ) on in vitro diagnostic medical devices.
Importer
Hangzhou Sejoy Electronics & Instruments Co., Ltd.
Area C, Building 2, No.365, Wuzhou Road, Yuhang Economic Development Zone,
Hangzhou City, 311100 Zhejiang P.R. China
Tel: +86-571-81957767
Fax: +86-571-81957
Shanghai International Holding Corp.GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg, Germany
Tel: 0049-40-2513175
Fax: 0049-40-255726
Concentration
0.17 mmol/L (3 mg/dL)
27.78 mmol/L (500 mg/dL)
1.1 mmol/L (20 mg/dL)
2.17 mmol/L (39 mg/dL)
500 IU/dL
60.8 mmol/L (1094.4 mg/dL)
555.56 mmol/L (10000 mg/dL)
3.33 mmol/L (60 mg/dL)
0.56 mmol/L (10 mg/dL)
1.33 mmol/L (24 mg/dL)
0.83 mmol/L (15 mg/dL)
0.83 mmol/L (15 mg/dL)
167/168(99.4%)
Within ±15 %
430/432(99.5%)