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INTENDED USE
The smartLAB®nG blood glucose systems are intended for the quantitative measure-
ment of glucose in venous blood or fresh capillary whole blood samples drawn from
the ngertip, palm or forearm. Testing is done outside the body (In Vitro diagnostic
use). It is indicated for self-testing by persons with diabetes, or in clinical settings
by healthcare providers, as an aid to monitor the effectiveness of diabetes control.
The system is not to be used on neonates, is not for the diagnosis of or screening
for diabetes mellitus, and that alternate site testing can only be used during steady-
state blood glucose conditions.
IMPORTANT
Please read this insert and the smartLAB®nG User’s Manual before using
smartLAB®nG Blood Glucose Test Strips. If you have any questions and/or need as-
sistance, please contact our authorized distributors in your country.
MEASUREMENT PRINCIPLE
Apply a blood sample to the blood collection area at the tip of the strip. The test
strip will draw the blood sample into the reaction zone. The FAD-binding glucose de-
hydrogenase catalyzes the glucose dehydrogenation. It will produce gluconolactone.
During the reaction, a mediator transfers electrons to the electrode surface and gen-
erates a current. The amount of the current is proportional to the amount of glucose
present in the blood sample. After 5 seconds, the smartLAB®nG system will show
glucose concentration on the screen.
REAGENT COMPOSITION
Each test strip contains the following reagent:
6 (w/w) % FAD glucose dehydrogenase
(Aspergillus oryzae, 2.0 IU/test strip)
56 (w/w) % Potassium ferricyanide
38 (w/w) % Non-reactive ingredients
STORAGE AND HANDLING
1. Store the test strip package in a cool, dry place, between 2°C~30°C
(36°F - 86°F). Do not freeze.
2. Keep out of direct sunlight and heat.
3. Write the date on the bottle when rst opened.
4. Discard test strips 6 months after rst opening date.
5. Replace the cap quickly after taking the test strip from the bottle.
6. Handle the test strip only with dry and clean hands.
7. Store your test strips in their original bottle only. Do not move them to
any other bottle or container
WARNINGS AND PRECAUTIONS
1. For in vitro diagnostic use only. Do not swallow.
2. Do not use the test strip after the expiration date.
3. Do not re-use test strips.
4. Do not cut, bend, scratch, or alter the test strip in any way.
5. Warning for potential biohazard
3
:
This warning is for the healthcare providers who use this system on multiple
patients. They should know the product comes in contact with human blood. After
cleaning, dispose of the product properly as if avoid transmitting viral disease.
6. If the readings are not consistent to your symptoms, check the manual rst. Make
sure you have followed all instructions, and then contact your doctor.
7. Never make any changes to your diabetes control program without consulting your
doctor.
8. The system should be used at a temperature between 10°C and 40°C (50°F and
104°F). Outside this range, the system may get incorrect results.
SUPPLIES FOR TESTING YOUR BLOOD GLUCOSE
smartLAB®nG Blood Glucose System.
smartLAB®nG Blood Glucose Test Strip.
Lancing Device
Lancets.
smartLAB®nG User’s Manual.
SAMPLE COLLECTION AND PREPARATION
This system is for use in fresh capillary or venous whole blood. The blood sample
must be used right away. The sample volume requires at least 0.6 micro-liters. To
obtain a drop of blood, follow these steps:
Step 1: Wash and dry your hands thoroughly.
Step 2: Prepare the meter according to the user’s manual.
Step 3: If you use an alcohol swab. Make sure that your nger is entirely dry before
lancing.
Step 4: Puncture and get a drop of blood. Avoid pressing too hard against the
punctured site.
ALTERNATE SITE TESTING (AST)
1.AST results may differ from ngertip results when glucose levels are changing
rapidly (e.g., after a meal, after taking insulin, or during or after exercise).
2.AST can only be used during steady-state blood glucose conditions. AST should
only be performed under the following conditions:
• Testing before a meal.
• In a fasting state.
• 2 hours or more after a meal.
• 2 hours or more after insulin dosing.
• 2 hours after physical activity.
Fingertip test only:
• If sick.
• If blood glucose is low.
• After exercising.
• When you have just taken insulin
• Two hours or less after eating.
• If you often do not notice when your blood glucose is low.
• After injecting rapid-acting insulin (2 hours or less).
3. Consult with your healthcare professional before you test palm and forearm.
TESTING YOUR BLOOD GLUCOSE LEVEL
Wash and dry your hands thoroughly. Insert the lancet into the lancing device.
Prepare the lancing device according to the user’s manual. To test your blood glucose
level, please follow these steps to test:
Step 1: Insert Test Strip. Take a test strip and replace the bottle cap quickly. Insert
the test strip into the slot of the meter. The meter will turn on.
Step 2: Apply Sample. Follow the sample collection procedures to get a drop of
blood. While the “
” appears, bring your blood to the collection area on the test
strip. The blood will automatically be drawn into the reaction zone. The meter will
begin to run.
Step 3: Accurate results after 5 seconds. Your result will appear on the screen after
5 seconds.
Step 4: Thoroughly wash hands with soap and water after performing your glucose
testing.
For detailed information on the test procedure, please refer to the User’s Manual.
OPTIONAL: QUALITY CONTROL
It is recommended to test the performance of the smartLAB®nG self-monitoring
Blood Glucose System when
1.Begin using a new bottle of test strips.
2.Question your blood test results.
3.Check that the meter and test strips are working properly, and that you perform the
test correctly at least once.
4.Suspect the meter or test strips are working incorrectly.
5.Drop the meter.
6.Expose the test strips to temperatures outside the storage conditions.(2°C to
30°C,36°F to 86°F)
Use the control solution to check the performance of the meter and test strips.
Please follow the instructions described in the section “Control Solution Test” of the
User’s Manual. Use the smartLAB®nG Glucose Control Solution to test the system.
Don’t use other manufacturer’s control solution. Other control solution may provide
incorrect results.
IMPORTANT
If the control solution test results are outside the range, your meter and test strip
may not be working as a system. Follow the correct procedures and repeat the control
solution test. Make sure the control solution is clean without contamination. (e.g.
Turbid.) Do not use the meter until test results fall within the appropriate range. If
the problem continues, please contact your local dealer.
When the results fall within the specied ranges printed on the strip bottle label,
the system is working properly. If your control solution test results are outside the
range, repeat the control solution test. Results that fall outside the range may be
caused by:
1. Expired or contaminated control solution.
2. Error in performing the test.
3. Meter malfunction.
4. Test strip deterioration.
DO NOT use the system to test your blood until you get a control solution test result
within the specied range.
TEST RESULTS
If “LO” appears on the screen, your blood glucose level is lower than 20 mg/dL (1.1
mmol/L). If “HI” appears, that your blood glucose level is higher than 630 mg/dL
(35.0 mmol/L). When you get any questions for the readings, check the following
items rst and then repeat the test. If the results are still questionable, consult your
doctor:
1. If the strips are within the expiration date.
2. Make sure the drop of blood in the whole reaction zone.
3. Check meter and test strip performance with smartLAB® nG Glucose Control Solutions.
Expected Results:
The smartLAB®nG Blood Glucose test strips are plasma referenced and calibrated for
easier comparison to lab results.
• For Non-Diabetic
4
The American Diabetes Association recommends a post-meal glucose level of less than
140 mg/dL (7.8 mmol/L) and a pre-meal glucose of less than 100 mg/dL (5.6
mmol/L).
• For Non-Pregnant Adults with diabetes
5
The American Diabetes Association recommends a post-meal glucose level of less than
180 mg/dL (10.0 mmol/L) and a pre-meal glucose of 70-130 mg/dL (3.9-7.2 mmol/L).
CAUTION: Any low or high blood glucose readings can indicate a potentially serious
medical condition. If the readings do not reect your symptoms, repeat the test with a
new test strip. Contact your doctor when your reading is:
A. Not consistent with your symptoms.
B. Less than 60 mg/dL (3.3 mmol/L).
C. Higher than 240 mg/dL (13.3 mmol/L).
LIMITATIONS
The test strips are used for venous blood or fresh capillary whole blood samples.
1. DO NOT use serum or plasma sample.
2. DO NOT use anticoagulant NaF or potassium oxalate for venous sample preparation.
3. DO NOT use neonate blood sample.
4. Extreme humidity may affect the results. A relative humidity greater than 90% may
cause incorrect results.
5. Use this system at temperatures between 10°C and 40°C (50°F and 104°F). Outside
this range, the system may get incorrect results.
6. DO NOT reuse the test strips. The test strips are for single use only.
7. Hematocrit (HCT): HCT between 35% - 50% will not signicantly affect the results.
HCT at 30% - 35% and at 50% - 55% may affect the reading with±15%. HCT below 35%
may cause higher results. HCT above 50% may cause lower results. If you do not know
your HCT level, please consult with your doctor.
8. Altitude up to 3,048 meters above sea level has no effect on readings.
Healthcare providers – Please note these additional Limitations.
1. If the patient has the following conditions, the result may be inaccurate:
• Severely dehydrated.
• Severely hypotensive.(low blood pressure)
• In shock.
• In hypoglycemic-hyperosmolar state.(with or without ketosis)
2. Lipemic samples: Cholesterol level up to 500 mg/dL (12.92 mmol/L) and triglycerides
up to 3,000 mg/dL (33.6 mmol/L) do not affect the results. Do not test grossly lipemic
patient samples with smartLAB
®
nG System.
3. DO not use home-use blood glucose systems to test critically ill patients.
4. DO NOT use during xylose absorption testing. Xylose in the blood will interfere Self-
Monitoring Blood Glucose System.
5. Interfering Substances depend on the concentration.The below substances up to the
test concentration will not affect the readings.
80 mg/dL
(4.4 mmol/L)
250 mg/dL
(13.9 mmol/L)
500 mg/dL
(27.8 mmol/L)
Ascorbic Acid 4 mg/dL (0.26 mmol/L) 10.89% -1.76% 4.55%
Ibuprofen 50 mg/dL (2.43 mmol/L) 3.10% 2.88% 4.62%
L-Dopa 1.8 mg/dL (0.09 mmol/L) 10.59% 7.91% 4.90%
Sodium Sali-
cylate
50 mg/dL (3.12 mmol/L) -2.59% 9.42% -0.84%
Tetracycline 1.5 mg/dL (0.03 mmol/L) -5.32% 3.81% 3.20%
Tolbutamide 100 mg/dL (3.70 mmol/L) -2.60% 12.30% 0.89%
Bilirubin-
unconjugated
2.4 mg/dL (0.04 mmol/L) -2.52% 4.05% -0.23%
Uric acid 8 mg/dL (0.48 mmol/L) 2.71% 9.55% -1.75%
Xylose 4 mg/dL (0.27 mmol/L) -5.12% -1.64% -4.44%
Use the anticoagulant EDTA or sodium Heparin or Lithium Heparin to preserve
the venous blood and capillary blood specimens would not affect the readings of
smartLAB®nG System. If the specimen was preserved by the anticoagulant NaF/potas-
sium Oxalate contained sodium uoride, the reading of smartLAB®nG System would be
seriously interfered.
PERFORMANCE CHARACTERISTICS
The test range is between 20 to 630 mg/dL (1.1~35.0 mmol/L). Validate the test strips
performance in both laboratory and clinical tests.
PRECISION
Precision of the smartLAB®nG Blood Glucose System was measured with both venous
blood and control solution in the laboratory. The results are shown in the table below:
Within-run
Blood av mg/dL (mmol/L) 40 (2.2)
Blood av mg/dL (mmol/L) 108 (6.0)
Blood av mg/dL (mmol/L) 137 (7.6)
Blood av mg/dL (mmol/L) 223 (12.4)
Blood av mg/dL (mmol/L) 399 (22.2)
Blood av mg/dL (mmol/L) 512 (28.4)
SD=2.9
CV=3.5%
CV=3.3%
CV=3.1%
CV=2.8%
CV=2.7%
Total-run
Control av mg/dL (mmol/L) 42 (2.4)
Control av mg/dL (mmol/L) 120 (6.7)
Control av mg/dL (mmol/L) 351 (19.5)
SD=2.5
CV=3.2%
CV=2.7%
ACCURACY
The accuracy of the smartLAB®nG Self-Monitoring Blood Glucose System was assessed
by comparison which was used in laboratories. The results below were obtained by 159
subjects with diabetes at three independent clinical sites. The regression statistics are
derived from a plot of the smartLAB® nG capillary data versus YSI plasma data
Slope 0.9803
Intercept + 2.9625 mg/dL (+ 0.1646 mmol/L)
Correlation coefcient 13.6852
Number of subject 159
Range tested 47.5–566.5 mg/dL or 2.64–31.74 mmol/L
R-square 0.9782
REFERENCES
1. Cass, A.E.G. et al., Anal. Chem., 56 (1984) p.667
2. Tietz N.: Fundamentals of clinical chemistry , 3rd Ed., W.B. Saunders Co., Philadelphia,
PA, 1987, p.427
3. NCCLS document M29-A, Protection of the laboratory worker from instrument biohazards
and infectious disease transmitted by blood, body uids, and tissue, 1997.
4. American Diabetes Association. Diagnosis and Classication of Diabetes Mellitus (Posi-
tion Statement). Diabetes Care 34 (Supp. 1) S66, 2011.
5. American Diabetes Association. Standards of medical care in diabetes. Diabetes care.
2013; Vol. 36, Suppl 1, S21
LIST OF SYMBOLS
Concentrations
of the interferance tested
Bias
Glucose
Level
NOTE ON smartLAB
®
„NO CODE“-TEST STRIPS
The smartLAB
®
nG blood glucose test strips compatible with smartLAB®nG
glucose
meters need not to be coded, any more.
HMM Diagnostics GmbH
Friedrichstr. 89
D-69221 Dossenheim, Germany
www.hmm.info
D/N D11450-08-03-20_R1_15/05/2014
!
IVD
CONTROL
D
2
LOT
REF
Caution. Please read manual thoroughly.
Expiration date
This product meets the requirements of
directive 98/79 CE for in-vitro diagnostic
medical devices.
Please read instructions thoroughly.
In-vitro diagnostics only. Not
to ingest.
Storage temperature range
Control solution
Opening date of test strip
vial.
Sufcient for
Single use only.
Manufactured by
Lot number
Catalogue number
Blood glucose test result in mg/dL
Blood glucose test result in mmol/L
6 months until the product
expires upon opening
insTrucTion
smartLAB
®
nG
TesT sTrips
2

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