Glucose Product Insert - PDF file.
ML12000.266 Rev. A
Please carefully read this insert before using Q.STEPS™
Glucose Test Strips.
American Screening Corporation
7607 Fern Ave Suite 703
Shreveport, LA USA 71105
americanscreeningcorp.com
318-798-3306
Intended Use
Q.STEPS™ Glucose Test Strips are intended for in vitro diag-
nostic nse (Le. for external use only) for quantitative measure-..
ment of glucose in capillary whole blood from the fingertip with
only the Q.STEPSTM Biometer G/C Dual Monitoring System by
home users and also by the health care professionals in settings
such as clinical laboratories and physician office laboratories
(POLs) as an aid to diabetes management.
Summary and Principle
ASC has developed a unique test system to allow for quick
measurement of blood glucose using enzymatic electrochemi-
cal sensor technology. ASC's biosensor employs a dispos-
able dry reagent strip for glucose determination. When a drop
of blood 1s applied to the half-circular test spot of the test strip,
the redox reaction (the oxidation of D-glucose catalyzed by glu-
cose oxidase) causes electron transfer at the electrode surfaces.
Current (or charge) is generated and detected by the Q.STEPS™
Biometer G/C Dual Monitoring System. The magnitude of the
current (or charge) generated is proportional to the glucose con-
centration in blood.
m a a mre a AR A E
Reagents
Each Q.STEPS™ Glucose Test Strip contains the following
substances:
Glucose oxidase (Aspergillus niger) 20 IU
Other non-reactive ingredients 2.1mg
Storage and Handling
The Q.STEPS™ Glucose Test Strips are kept in a desiccated
vial. The vial cap contains 2 grams of silica gel as desiccant.
Store the test strips vial between 18°C and 30°C (64°F and 86°
F) and out of direct sunlight. Test strips in an unopened vial are
stable until the expiration date printed on the vial label. Each
strip should be used promptly after removing from the vial.
Important Test Strip Information
* DO NOT use Q.STEPS™ Glucose Test Strips that have past
the expiration date printed on the vial.
* DO NOT use test strips that have been damaged in anyway (e.g.
bent, wrinkled). Be sure that the silver contact bars are intact.
+ DO NOT touch the half-circular opening of the test strip.
* DO NOT re-use test strips.
e Calibrate your Q.STEPSTM Biometer G/C Dual Monitoring
System for each new vial of test strips being used (calibration
chip is packaged with the strips).
+ Use the test strip immediately after removing the test strip
from the vial.
ASC
* Close the cap tightly each time after removing the test strip
from the vial.
For reliable results, use only Q.STEPS™ Test Strips made by
Biomedix for the test.
* Write the date on the vial when opening a new vial of strips.
e Discard unused test strips three months after first opening the
vial.
Sample Collection and Preparation
* Q.STEPS™ Biometer G/C Dual Monitoring System is
designed for used with fresh finger blood. Blood obtained from
the finger must be used immediately.
Sit quietly for about 5 minutes before collecting the blood
sample.
* Before taking a blood sample, clean the puncture site with an
alcohol swab or with soap and warm water. BN
* Use the correct technique to obtain a blood sample and avoid
‘excessive squeezing of the puncture site.
Blood Glucose Testing
Step 1. Press the on/off button (D to turn the Biometer on. The
display will show “InS” and flash an image of strip.
Step 2. Insert the glucose strip. The display will show “GLU” an
image of one blood drop. Please make sure the calibra
tion code on the up right of display is same as that
printed of the vial.
Step 3. Place a drop of blood on the half circular reaction center
on the strip. See user manual page 19-20 for using the
Lancet Device and Lancet to get finger blood. If the
amount of blood is enough, it will move across the strip
and can be seen on the opposite side.
Step 4. The glucose test result will be shown in 15 seconds.
Setting the Calibration Code For Glucose
| ——— - -Тве Q:STEPS™ Biometer G/C calibration code must be set: ~~
* Each time a new lot of test strips 1s used.
* Each time a new Biometer 1s used.
Step 1. Press and hold the on/off button (D for approx 12
seconds until you see "Cod" sign flash on the display,
then release the button. Glucose calibrating code and
Glucose sign automatically display.
Step 2. Press the setting button S to select the desire code
number (01-32) of which matches the calibration code
number printed on the strip vial label.
Step 3. Press the on/off button (D once to return LCD display
back with “Ins”.
Meter Installation
1. Remove the cover on the back of the meter.
2. Place two AAA batteries.
3. Put the cover back on.
4. Press “ (17 to turn on the meter. It should display “InS” and
a flashing strip sign.
5. You can set the functions at this time, ex: calibration code,
date, time and the concentration display.
6. You can go to the next step, the blood glucose and cholesterol
test.
Setting the Date and Time of Meter
Step 1. Press and hold the on/off button (D for approx 15
seconds until you see the “y06” (year) sign flash on the
display. Then release the on/off button (1).
Step 2. Press the setting button (9) to select the desired year. Ex.
American
Screenin
Corporation
“y07” means 2007.
Step 3. Press the on/off button (1) to confirm the year;
meanwhile go to set the month. The number of “ month”
will flash on the display. Repeat the procedure - press
button Oto change, press the button (1) to confirm and
go next, to finish setting month, day, hour, minutes.
Step 4. There is one Beep after confirmed the minutes setting.
The meter will automatically return to the “InS” display.
Setting the Concentration Display of Meter
Step 1. Press and hold the on/off button (D) for approx 20
seconds until the concentration sign appears ("mg/dL" or
"mmol/L").Then release the on/off button (D .
Step 2. Press the setting button (Sto switch the unit of
concentration, "mg/dL" or "mmol/L".
~ Step 3. There is one Beep after confirmed the concentration
mode setting. The meter will automatically return to the
“InS” display.
Recalling the Test Results
Step 1. With the Biometer off, press and hold the on/off button
D for approx 5 seconds to enter the memory mode. You
will see “M” flash on the up left of display, then release
the button, “GLU” or “CHO” appear on the display.
Step 2. After few seconds, the display will show the last test
result reading including the dateand time of the test.
Step 3. Press Obutton once to read the second last test result.
Up to 99 readings of glucose and cholesterol can be
stored in the Biometer’s memory.
Step 4. Press on/off button (D to return back to “Ins” display.
Procedure
Please read the Q.STEPS™ Biometer G/C User's Manual for
detailed testing and calibrating procedures.
Components provided with package:
Q.STEPS™ Glucose Test Strips
Q.STEPS™ Glucose Test Strip Insert
Important Information About Test Results:
« If patient’s blood glucose result seem to be lower or higher
than expected, recalibrate the Biometer and repeat the test
using a new test strip.
* Please consult your physician if:
1. Patient’s blood glucose result is not consistent with his or her
— physical symptoms after you have ruled out common errors
in technique. |
2. Patient’s blood glucose level is too low (<50 mg/dl) or too
high (>400 mg/dl).
3. Patient’s glucose ranges for non-diabetic, non-pregnant adults:
| Glucose fasting 70mg/dL - 110mg/dL
(3.9mmol/L - 6.1mmol/L)
— | Mhourafter meall— | <I60mg/dL (<8.9mimoVL) | —
Limitations
* The Q.STEPSTM Glucose Test Strips are designed for use with
capillary finger blood samples only.
* DO NOT use serum or plasma samples.
* Recent illness, pregnancy, birth control pills, or pathological
condition may affect patient's glucose level. Consult patient's
physician 1f you have any question.
* Hematocrit levels below 30% and above 55% will cause inac-
curate results.
Interference Substances
* Twenty-three commonly tested interference substances were
examined in this study. No interference was observed in bili-
rubin, glucose, creatinine, and citrate at physiological levels
except for uric acid.
* No interference was observed in ibuprofen, aspirin and tetra-
cycline.
* No interference was observed at therapeutically ranges of acet-
aminophen, ascorbic acid, 1-dopa, dopamine, methyldopa and
tolazamide. Some interference was observed at higher dosages
of these compounds.
* No interference was observed in EDTA (blood preservatives),
d-galactose, K,Fe(CN),, d-mannose, d-xylose, and maltose.
Performance Characteristics
- The Q.STEPSTM Biometer С/С Dual Monitoring System has
been evaluated in clinical studies. In these studies, the system
was calibrated and used according to instructions in the Q.STEPS
™ Biometer G/C User's Manual.
Detection range
50 to 400 mg/dL
Precision* |
Using commercial glucose reference solutions, 5 different con-
centrations of glucose were measured and for each level, two
glucose measurements were performed in the morning and then
in the afternoon. These day-to-day tests were performed for 20
days. The C.V. was less than 7.1%.
Accuracy*
The accuracy of the Q.STEPSTM Biometer G/C Dual Monitoring
System was assessed by comparison with the YSI 2300 STAT
PLUS (Yellow Springs Instrument) as used in clinical labora-
— tories. The following data was obtained using capillary whole
blood:
N = 167
Y = 1.01(x) + 3.12mg/dL
R = 0.98
Range of Sample Tested: 65 - 334 mg/dL.
*Data obtained from Biomedix's Clinical and Internal Trial in
Fremont, CA.
References
1. Krall, LP and Beaser, RS: Joslin Diabetes Manual. Lea and
Febiger. (1989) 138.
2. Davidsohn & Henry, Clinical Diagnosis by Laboratory
Methods. Todd-Sanford.
3. Salvi, R.M. Methyldopa. Applied Toxicology Centre PURCS;
Internet: http://www.inchem.org/documents/pims/pharm/
methldo.htm
4. Merk Manual. Disorders of Carbohydrate Metabolism Sec. 2,
mia ——
Internet:
http://www.merck.com/mrkshared/mmanual/section2/
chapter13/13a.jsp
Protected by U.S. Patent 5,522,977 (1996) and any other patent pending.
American Screening Corporation
7607 Fern Ave Suite 703
Shreveport, LA USA 71105
americanscreeningcorp.com
318-798-3306
EMERGO EUROPE
Molen straat 15
REP 2513 BH, The Hague
The Ne therlands
Tel: +31 (0)70 345 8570
Fax: +31 (0)70 346 7289
ASC
American
Screening
Corporation
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