Bedienungsanleitung HMM smartLAB nG TS (Seite 2 von 2) (Deutsch, Englisch)

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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

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

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

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

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

TesT sTrips

HMM smartLAB nG TS Seite 2

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