MHC Medical Products Easy-Touch Bedienungsanleitung PDF herunterladen (Seite 2)

Performance Characteristics

Measuring Range

20-600mg/dL (1.1mmol/L to 33.3 mmol/L)

Accuracy

The accuracy of the Easy•Touch

Blood Glucose Monitoring

System was compared with YSI 2300 Stat Plus glucose

analyzer with ngertip testing done by persons with

diabetes. The linear regression statistics are derived from

a plot of the Easy•Touch

capillary data (y) versus YSI

glucose analyzer (x). The linear regression equation for

the study was y=0.98x-0.52. The coefcient was 0.9789.

The sample numbers were 112. The glucose range of the

sample was 56-429mg/dL.

Fingertip results

For glucose results lower than 75mg/dL, the

percent (and the number) of meter results that

match the laboratory method within 15 mg/dL

100%

(12 / 12)

For glucose results at or higher than 75mg/dL,

the percent (and the number) of meter results

that match the laboratory method within 20%

98%

(98 / 100)

Total number of patients in the study

98%

(110 / 112)

Alternate site testing results

Palm Forearm

For glucose results lower than 75mg/

dL, the percent (and the number)

of meter r esults that match t he

laboratory method within 15 mg/dL

100%

(12 / 12)

100%

(12 / 12)

For glucose results at or higher

than 75mg/dL, the percent (and the

number) of meter results that match

the laboratory method within 20%

99%

(98 / 99)

97%

(96 / 99)

Total number of patients in the study

99%

(110 / 111)

97%

(108 / 111)

Precision

Between-run precision of Easy•Touch

Glucose Test Strips,

are measured with venous blood samples in the laboratory.

The pooled precision data for three hundred test strips from

3 lots (n=300) is shown in the tables below:

Between-Run Precision

Average Glucose

Concentration (mg/dL)

37.7 90.0 130 224 353

SD (mg/dL) 1.8 2.8 4.1 5.4 7.6

CV (%) 4.7 3.2 3.3 2.4 2.1

Chemical Composition

Glucose oxidase (Aspergillus niger) 1.4% w/w

Potassium ferricyanide 2.6% w/w

Non-reactive ingredients 96% w/w

References

1. Burtis CA Ashwood ER, eds.: Tietz Textbook of Clinical

Chemistry. 2

Edition. W.B. Saunders. Philadelphia.

1994. p. 2190.

2. American Diabetes Association Clinical Practice

Recommendations 2003, Diabetes Care, Vol.26,

Supplement 1, p.S22.

3. Atkins SH, Dasmahapatra A, Jaker MA, Chorost MI,

Reddy S: Fingerstick glucose determination in shock.

Ann Int Med 114:1020-1024. 1991

4. Sandler M, Low-Beer T: Misleading capillary glucose

measurements. Practical Diabetes 7: 210. 1990

5. Wickham NWR, Achar KN, Cove DH: Unrealiability of

capillary blood glucose in peripheral vascular disease.

Practical Diabetes 3: 100.1986.

For in vitro Diagnostic use only.

Made in Taiwan to Specications of:

MHC Medical Products, LLC

8695 Seward Rd.

Faireld, OH 45011

Questions or Comments?

Call 1.877.358.4342

info@EasyTouchProducts.com

B04Q101099(01)

DH-080411.6

Rev. date: 09/2011

Limitations

The Easy•Touch

Glucose Test Strips give accurate results

when the following limitations are observed:

1. Use only the Easy•Touch

Glucose Test Strips with the

Easy•Touch

Blood Glucose Meter.

2. Use only capillary whole blood from nger, palm and

forearm. Do not use plasma or serum.

3. Do not use neonate samples. Easy•Touch

Glucose

Test Strips are not validated for and should not be used

for testing neonatal blood specimens.

4. The system is tested to accurately read the measurement

of glucose in whole blood within the range of 20 to

600mg/dL (1.1-33.3 mmol/L).

5. This system can be used up to an altitude of 7545 feet.

6. The test strips are for single use only. Do not reuse test

strips.

Additional Information for Healthcare Professionals

7. Easy•Touch

Glucose Test Strip does not interfere

with the hematocrit at a normal range (35-55%) of

blood glucose.

8. Acetaminophen, uric acid, ascorbic acid (vitamin C),

and other reducing substances when occurring in normal

blood or normal therapeutic concentrations do not

signicantly affect results. However, abnormally

high concentrations in blood may cause inaccurately

high results.

9. Lipemic samples; Cholesterol up to 375 mg/dL or

triglycerides up to 2,000 mg/dL do not signicantly affect

test results. However, glucose values in specimens

beyond these levels, should be interpreted with caution.

10. Blood samples that contain a high concentration of

dissolved oxygen may lower the test result.

11. Antiglycolysis and anticoagulants in blood samples may

affect the test results.

12. Severe dehydration, diabetic ketoacidosis,

hyperosmolar non-kitotic state, hypotension, shock, or

peripheral vascular disease.

3,4,5

may cause inaccurate

results.

13. Critically ill patients should not be tested with home

use blood glucose monitors as it may lead to

inaccurate results.

Quality Control

Easy•Touch

Control Solution can be used to verify that

the Easy•Touch

Glucose Monitoring system is working

correctly and giving accurate results. The system is

performing correctly if the control solution test result falls

within the specic control solution range listed on your

Test Strip vial.

You are encouraged to use Control Solution on a

regular basis.

If you suspect your blood glucose test are not consistent

with how you feel or your test are higher or lower than

normal, you may validate the performance of your test with

Control Solution.

When a control solution test is done, you should get results

within the expected range printed on the test strip vial.

If control solution test results fall outside this range,

repeat the test. Results that fall outside the range may

be caused by:

• error in performing the test,

• expired or contaminated control solution,

• test strip deterioration or meter malfunction.

If the problem persists, the system may not be working

properly. DO NOT continue to use the system to test your

blood glucose level. If you continue to get results that fall

outside the specied range, please call Customer Service.

Note: Easy•Touch

Control Solutions are required but not

supplied with Test Strips for checking the system. For order

information, please contact Customer Service.

There are three Easy•Touch

Control Solutions at different

desired range of aqueous glucose (Low, Normal or High).

Two sets of control solution should be used, a high level

and a low level control solution of your choice. For more

information about the Control Solution, please read your

Control Solution package insert.

Unexpected Results

Low or high blood sugar readings can indicate a potentially

serious medical condition. If your blood sugar is unusually

low or high, or if you do not feel the way your results

indicate, repeat the test with a new test strip. If your

reading is not consistent with your symptoms or if your

blood glucose result is less than 60 mg/dL (3.3 mmol/

L) or higher than 240 mg/dL (13.3 mmol/L), you should

contact your healthcare professional and follow his or

her treatment advice.

1 2

Kommentare zu diesen Handbüchern

Keine Kommentare

MHC Medical Products Easy-Touch Bedienungsanleitung Seite 2

Kommentare zu diesen Handbüchern