Part no.
312-0000002-XXX
Product name
單片包試片說明書/GlucoRx HCT family /英(β-Ketone)
Spec
L250*W288mm/4折/雜誌紙65P/單面/黑
Designer
JF
Color
K 100
K 15
ver 1.0 2016/06
312-0000002-010
ATTENTION
The front side of the test strip should face up when inserting the test strip.
Test results may be wrong if the contact bar is not fully inserted into the test slot.
HCT Ketone Test Strips
Testing Your β-Ketone
Warnings
► For in vitro diagnostic use (for use outside of the body only).
► For single use only.
► Please read this sheet and your GlucoRx HCT & Ketone and GlucoRx HCT Connect Blood Glucose
Monitoring System Owner's Manual before you use this test strip. Use only GlucoRx HCT Ketone Test Strip
with GlucoRx HCT & Ketone and GlucoRx HCT Connect Blood Glucose Monitoring Systems to obtain
accurate results, and be covered by the manufacturer’s warranty.
► Results may be inaccurate when testing on patients with abnormally low blood pressure, or those who are
in shock.
► For patients with impaired peripheral circulation, collection of capillary blood from the approved sample
sites is not advised as the results may not be a true reflection of the physiological β-Ketone level. It may
apply under the following circumstances: severe dehydration as a result of diabetic ketoacidosis or due to
stress hyperglycaemia, hyperosmolar non-ketotic coma, shock, decompensated heart failure NYHA Class
IV or peripheral arterial occlusive disease.
► Keep test strips and lancets away from small children. If swallowed, consult a doctor immediately for
advice.
PLEASE WASH AND DRY YOUR HANDS BEFORE PERFORMING ANY TESTING.
STEP 1
Insert the test strip fully into the slot of your meter until it will go no further.
When the strip is fully inserted, the meter will do several self-checks.
Please make sure you have calibrated your meter with the code strip
according to the instructions in the Owner’s Manual before testing.
The code number for β-Ketone strip is three-digits; please ensure you are
using the β-Ketone strip for test.
STEP 2
Collect a blood sample for about 1.0 μL with the test strip. A sufficient
quantity of blood is required for the test to provide accurate results. Touch
the blood drop with the absorbent hole of the test strip, and wait until the
confirmation window is fully covered. Do NOT apply a smeared blood sample.
The meter will start counting down.
Intended Use
STEP 3
Within 10 seconds, the meter will display your β-Ketone level. The last
reading will be automatically saved in the meter. Turn it off by removal and
disposal of the used test strip.
GlucoRx HCT Ketone Test Strip is intended for the quantitative measurement of β-Ketone in venous whole
blood and fresh capillary whole blood from finger and palm. Testing is done outside the body (in vitro
diagnostic use). They are indicated for use at home as an aid to monitor the effectiveness of diabetes
control. GlucoRx HCT & Ketone and GlucoRx HCT Connect Blood Glucose Monitoring Systems are designed
for home use.
About Alternative Site Testing (AST)
Ketone
IMPORTANT: There are limitations for performing AST. Please read the Blood Glucose Monitoring System
Owner’s Manual and consult your doctor before you perform AST.
Alternative site testing (AST) is when individuals check their β-Ketone levels using areas of the body
other than the fingertip. The Blood Glucose Monitoring System allows AST to be performed on a site other
than the fingertip - namely the palm.
Do NOT use AST if:
■ You think your β-Ketone is low.
■ Your AST results are inconsistent with the way you feel.
■ Your routine β-Ketone results often fluctuate.
► Haematocrit: The haematocrit level is limited to between 10% and 70%. Please ask your healthcare
professional if you do not know your haematocrit level.
► Neonatal Use: This test strip must not be used for the testing of newborns.
► Altitude Effects: Altitudes up to 10,742 feet (3,275m) do not affect test results.
The following compounds, when determined to be in excess of their limitation and tested with the GlucoRx
HCT & Ketone and GlucoRx HCT Connect Blood Glucose Monitoring Systems, may produce elevated β-Ketone
results:
Summary of substances and concentrations in excess of limitation with interference
Limiting Concentration (μmol/L or mmol/L)
Captopril
> 23 μmol/L
L-DOPA
> 30 μmol/L
Dopamine
> 5.8 μmol/L
Gentisic acid
> 117 μmol/L
Paracetamol
> 1.7 mmol/L
Uric acid
> 1.4 mmol/L
Ascorbic acid
> 227 μmol/L
Unconjugated bilirubin
> 342 μmol/L
Cholesterol
> 12.9 mmol/L
Triglycerides
> 17 mmol/L
Storage and Handling
IMPORTANT: Do not use the test strips if they have expired.
► Store the test strips in a cool, dry place between 2°C and 30°C (35.6°F and 86°F) and below 85%
relative humidity.
► Keep the test strips away from direct sunlight. Do not store the test strips in high humidity.
► Do not touch the test strips with wet hands.
► Do not bend, cut, or alter the test strip.
Strip Appearance
2
1. Absorbent Hole
Apply a drop of blood here.
The blood will be automatically absorbed.
2. Confirmation Window
This is where you confirm if enough blood has been applied to the
absorbent hole in the strip.
3
4
Additional Information for Healthcare Professionals
Always wear gloves and follow your facility’s biohazard control policy and procedures when performing tests
involving patient blood samples. Use fresh whole blood samples only. Professionals may use test strips to
test capillary and venous whole blood.
Sample Size: 1.0 μL
Reaction Time: 10 seconds
System Measurement Range: 0.1 mmol/L ~ 8 mmol/L
Haematocrit Range: 10% to 70%
Accuracy
Accuracy testing shows that results are comparable between trained professionals and lay users. Accuracy
was assessed with 111 patients (each patient was tested three times which had 333 test results) for
GlucoRx HCT & Ketone (TD-4279) and 240 patients (each patient was tested three times which had 720 test
results) for GlucoRx HCT Connect (TD-4140) respectively by comparing whole blood ß –OHB results with
plasma results obtained using reference laboratory instruments. Please see Table 1 for GlucoRx HCT &
Ketone and GlucoRx HCT Connect Blood Glucose Monitoring Systems (TD-4279 and TD-4140).
The reference method is B-Hydroxybutyrate LiquiColor®. The reagent can quantifiably detect the presence of
ketones in patients with suspected diabetic ketoacidosis.The results show high correlation in Table 1 for
GlucoRx HCT & Ketone and GlucoRx HCT Connect Blood Glucose Monitoring Systems (TD-4279 and
TD-4140).
Precision
Please refer to your Owner’s Manual for further information.
Precision testing shows that the CV% is 3.06% for GlucoRx HCT & Ketone (TD-4279) and 2.80% for GlucoRx
HCT Connect (TD-4140) - Please see Table 2
The used lancet and test strip are potentially biohazardous. Please dispose of them carefully according to
your local regulations.
TD-4279
Reading Your Result
blood (mmol/L).
Limitations
1
mmol/L
Chemical Components
> ß-Hydroxybutyrate Dehydrogenase (Pseudomonas sp.) ≧0.5 U
> Mediator
55%
> NAD
≧0.5 μg
> Enzyme protector
8%
> Non-reactive ingredients 29%
Table 1-Accuracy
Test meter with
Test results of the test device fulfilling specified
ketone strips
error limits at ketone value < 2 mmol/L
3. Test Strip Handle
Hold this part to insert the test strip into the slot.
4. Contact Bars
Insert this end of the test strip into your meter.
Push it in firmly until it will go no further.
The β-Ketone test measures Beta-Hydroxybutyrate (ß -OHB), the most important of the three β-Ketone bodies
in the blood. Normally, levels of ß -OHB are expected to be less than 0.6 mmol/L.
ß -OHB levels may increase if a person fasts, exercises vigorously or has diabetes and becomes ill. If your
β-Ketone result is 0.0 mmol/L, repeat the β-Ketone test with new test strips. If the same message appears
again or the result does not reflect how you feel, contact your healthcare professional. Follow your healthcare
professional’s advice before you make any changes to your diabetes medication programme. If your β-Ketone
result is between 0.6 and 1.5 mmol/L, this may indicate development of a problem that could require
medical assistance. Follow your healthcare professional’s instructions. If your β-Ketone result is higher than
1.5 mmol/L, contact your healthcare professional promptly for assistance. You may be at risk of developing
diabetic ketoacidosis (DKA).
Please consult your doctor to determine a target range that works best for you.
Questionable or inconsistent results
If your test results are unusual or inconsistent with how you are feeling:
■ Make sure the confirmation window of your test strip is completely filled with blood.
■ Check the expiration date of your test strips.
■ Check the performance of your meter and test strip with the ketone control key.
■ Make sure your monitor has correct coding, and the code is the same as the code printed on the individual
foil packet you are using. The code number for β-Ketone strip is three-digits; please ensure you
are using the β-Ketone strip for test.
PLEASE NOTE: Unusually high or low β-Ketone levels may be symptoms of a serious medical condition. If
most of your results are unusually high or low, please contact your healthcare professional.
Quality Control Testing
You can check the performance of the meter, test strip and your technique by comparing the control test
results with the range printed on your ketone strip foil packet using the ketone control key. Checking
regularly can ensure your test results are accurate.
Please follow the instructions step by step for ß-ketone Control Test.
For GlucoRx HCT & Ketone (TD-4279)
1. Insert Ketone Control Key
Insert the ketone control key into your meter. The meter displays the following in sequence: code
number, CH and then “
” and a flash “ ”.
2. Turn on the switch on the front side of the ketone control key.
3. Read and compare the result
After counting down to 0, the ketone control result will appear on the display. Compare this result with
the range printed on your individual ketone strip foil packet and it should fall within this range. If not,
please read the instructions again and repeat the control test. Make sure you turn off the switch on the
front side of the ketone control key after removing it from your meter.
For GlucoRx HCT Connect (TD-4140)
1. Insert Ketone Control Key
Insert the ketone control key into your device. A “Waiting Optimization” message will then appear on the
screen.
2. Turn on the switch on the front side of the ketone control key.
Turn on the switch on the front side of the ketone control key after the message of "take blood samples"
appears on the screen; the “processing” message will appear on your Smart phone screen. Your device
will tag this measurement as QC test automatically.
3. Read and Compare the Result
After the “Processing” message appears, the ketone control result will appear on the display. Compare
this result with the range printed on your individual ketone strip foil packet and it should fall within this
range. If not, please read the instructions again and repeat the control test. Make sure you turn off the
switch on the front side of the ketone control key after removing it from your device.
Test results of the test device fulfilling specified
error limits at ketone value ≧ 2 mmol/L
Within ±
The β-Ketone readings deliver plasma equivalent results and are displayed in millimoles of ketone per liter of
To obtain a blood sample from the alternative site, please rub the puncture site for approximately 20
seconds before following the procedures of “Testing Your β-Ketone”.
Substance
0.7
IMPORTANT: If the LCD displayed code is not the same as the code on your test strip package, and the
code number cannot be updated, please contact GlucoRx Customer care on 01483 755133 for
assistance.
n
±0.3mmol/L
Within ±
±0.5mmol/L
n
15%
20%
306 (100%)
27
23 (85.2%)
27 (100%)
Capillary blood sampling (Subjects, n=333)
306
BGMs
306 (100%)
Table 2-Precision
Low
Mid
Mean mmol/L
0.487
2.89
SD mmol/L
0.051
0.088
CV%
3.06
TD-4140
Table 1-Accuracy
Test meter with
Test results of the test device fulfilling specified
ketone strips
error limits at ketone value < 2 mmol/L
Test results of the test device fulfilling specified
error limits at ketone value ≧ 2 mmol/L
Within ±
n
±0.3mmol/L
Within ±
±0.5mmol/L
n
15%
20%
530 (99.3%)
186
174 (93.5%)
185 (99.5%)
Capillary blood sampling (Subjects, n=720)
534
BGMs
494 (92.5%)
Table 2-Precision
Low
Mid
Mean mmol/L
0.490
2.82
SD mmol/L
0.074
0.079
CV%
2.80
Symbol Information
Symbol
Referent
Symbol
Referent
in vitro diagnostic medical
device
Manufacturer
Consult instructions for use
Do not reuse
Temperature limitation
Authorised representative in
the European Community
Use by
Batch code
CE mark
Humidity limitation
Distributed by GlucoRx Ltd.
4 Wintonlea, Monument Way West, Woking, Surrey, GU21 5EN, UK
Website: www.glucorx.co.uk
Customer Careline: 01483 755133
TaiDoc Technology Corporation
B1-7F, No.127, Wugong 2nd Rd.,
Wugu Dist., 24888 New Taipei City, Taiwan
www.taidoc.com
MedNet GmbH
Borkstraβe 10, 48163 Mϋnster, Germany
Use Only With GlucoRx HCT & Ketone and GlucoRx
HCT Connect Blood Glucose Monitoring Systems
For self-testing.
30°C
85%
2°C
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