210*285mm

Step 2: Lance the fingertip. Hold the sampler firmly against the side of
your finger. Press the release button. Massage the fingertip to
obtain a round drop of blood. Do not squeeze the puncture site

Accu-2Mi excessively. The blood sample should be at least 2µL in volume

or you may get an inaccurate result.

Total Cholesterol Test Strips BLOOD CHOLESTEROL TESTING

TC01 Step 1: Insert a test strip. Remove a test strip from the vial. Recap the
vial immediately. Insert a test strip, contact bars end first and
facing up, into the test port. Push it in until it will go no further.
The meter will turn on and the display check will appear briefly.
Then the code number will appear, followed by the symbol.
30℃
Be sure the meter and test strip codes match. If they do not,
0197 2 2℃
code the meter correctly.
Step 2: Apply sample. Using the adjustable blood sampler, obtain a
blood sample large enough to fill the confirmation window.
For self-testing and in vitro diagnostic use only When the symbol appears on the display, touch and hold the
drop of blood to the narrow channel in the top edge of the strip.
IMPORTANT:
Read this package insert and the user’s manual of the Accu-2Mi® DO NOT:
Multi-Monitoring Meter before testing your total cholesterol with these ● Apply sample to the front and back of the test strip.
test strips. The user’s manual contains all the information you need to ● Push your finger against the test strip.
perform a total cholesterol test. ● Apply a smeared sample.
Hold the blood drop to the top edge of the test strip until the
INTENDED USE
confirmation window is full before the meter begins to count down.
Accu-2Mi® Total Cholesterol Test Strips are used with the Accu-2Mi® If the confirmation window does not fill completely before the meter
Multi-Monitoring Meter for quantitatively measuring total cholesterol begins to count down, do not add more blood to the test strip; discard
in fresh capillary whole blood or Venous blood. Accu-2Mi® Total the strip and retest. If the confirmation window is not full you may get
Cholesterol Test Strips are intended for self-testing outside the an Er5 message or an inaccurate test result.
body (in vitro diagnostic use) by people at home and health care Step 3: Get accurate results in just 15 seconds. Your blood cholesterol
professionals in the clinical setting. result will appear after the meter counts down from 15 to 0.
STORAGE AND HANDLING Blood total cholesterol test results are automatically stored in
● Store the test strip package in 2℃-30℃. Keep away from direct the meter memory. Turn the meter off by removing the test strip.
sunlight and heat. Do not refrigerate. For detailed information on the test procedure and coding your meter,
● Store your test strips in their original vial only; do not transfer them to please refer to your Accu-2Mi® Multi-Monitoring Meter User's Manual.
a new vial or any other container.
● After removing a Accu-2Mi® Total Cholesterol Test Strip from the TEST RESULTS
vial, immediately replace the vial cap and close it tightly. Accu-2Mi® Multi-Monitoring Meter displays total cholesterol results
● Use each test strip immediately after removing it from the vial. between 2.5 and 10 mmol/L(100-400 mg/dL). If your test result is lower
● Write the date opened on the vial label. Discard remaining than 2.5mmol/L(100mg/dL), “Lo” will appear on the meter display.
Accu-2Mi® Total Cholesterol Test Strips 3 months after first opening This indicates severe low total cholesterol. If your test result is above
the vial. 10mmol/L(400mg/dL), “HI” will appear on the meter display. This
● Avoid getting dirt or food on the test strip. indicates severe high total cholesterol. You should seek immediate
● Do not use Total Cholesterol Test Strips beyond the expiration date medical assistance.
printed on the package since they may cause inaccurate results. RANGE OF EXPECTED VALUES
● Do not bend, cut or alter a Accu-2Mi® Total Cholesterol Test Strip in Total cholesterol management requires the help of a health care
any way. professional. Together you can set your own range of expected blood
● Use universal blood precautions when handling and disposing of cholesterol value, arrange your testing times, and discuss the meaning
blood cholesterol monitoring materials. All patient samples are of your blood cholesterol results. Expected blood cholesterol levels for
materials with which they come in contact are considered biohazards people is 2.5-5.2 mmol/L(100-208mg/dL).
and should be handled as if capable of transmitting infection. Follow
proper precautions in accordance with local regulations when If You Get Unexpected Results
disposing of all materials. IMPORTANT: Low or high blood cholesterol readings can indicate a
potentially serious medical condition. If your blood cholesterol reading
WARNING: Keep the test strip vial away from children; the cap is
is unusually low or high, or you do not feel the way your reading
a choking hazard. Also, the vial or cap may contain drying agent
indicates, repeat the test with a new test strip. If your reading is not
that are harmful if inhaled or swallowed and may cause skin or eye
consistent with your symptoms or if your blood cholesterol results is
irritation.
less than 2.5mmol/L(100mg/dL) or higher than 5.2 mmol/L(208mg/dL),
you should contact your healthcare professional and follow his or her
PRECAUTIONS TO OBTAIN ACCURATE RESULTS treatment advice.
● Code the Accu-2Mi® Brand Meter to match the
code number printed on the Accu-2Mi® Total QUALITY CONTROL: CHECKING THE SYSTEM
Cholesterol Test Strip vial. Acc u-2M i® Do a Control Solution Test:
● Use only Accu-2Mi® TC01 Total Cholesterol ● When you begin using a new vial of test strips
Test Strips with Accu-2Mi® LBM-01 Multi- ● When your blood cholesterol test results are not consistent with
Monitoring Meter to obtain accurate and how you feel, or when you think your results are not accurate
consistent Total Cholesterol results. ● At least once a week
● If you are experiencing symptoms that are not consistent with your ● Whenever you suspect that the meter or test strips are not working
blood cholesterol test results and you have followed all instructions properly
described in your Accu-2Mi® Multi-Monitoring Meter User's Manual. ● If you drop the meter
● Never make significant changes to your total cholesterol control
program or ignore physical symptoms without speaking with your When control solution is applied to the top edge of Accu-2Mi® Total
healthcare professional. Cholesterol Test Strips, 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
TEST PROCEDURE FOR BLOOD CHOLESTEROL MEASUREMENT may be caused by:
Materials provided: Accu-2Mi® Total Cholesterol Test Strips. ● Error in performing the test
Materials required but not provided: Accu-2Mi® Multi-Monitoring ● Test strip deterioration
Meter with User's Manual, Adjustable Lancing Device, New Sterile ● Failure to shake the control solution vial well enough (must shake
Lancet. vigorously）
● Meter malfunction
BLOOD SAMPLE COLLECTION
● Control solution is too warm or too cool
To obtain a drop of blood, follow these steps.
● Expired or contaminated control solution
Step 1: You may obtain a blood drop from a fingertip. Wash your hands
● Failure to discard the first drop of control solution
with warm, soapy water. Dry them thoroughly.
● Improper coding of the meter
IMPORTANT: If you continue to get Accu-2Mi® Control Solution test Table 3 System Accuracy Results for Cholesterol Concentration
results that fall outside the range printed on the vial, the Accu-2Mi® ≥4.2 mmol/L(168mg/dL)
Multi-Monitoring Meter may not be functioning properly. Do not use
the meter to test your blood until you get a control solution test result Within±5% Within±10% Within±15% Within±20%
that falls within the range. 264/518 398/518 467/518 509/518
LIMITATIONS
Accu-2Mi® Total Cholesterol Test Strips give accurate results (51.0%) (76.8%) (90.2%) (98.3%)
when the following limitations are observed:
● The test strips are for single use only. Do not reuse. Table 4 System Accuracy Results for cholesterol Concentration
● The test strips are specific to cholesterol and do not react to other Between 2.47mmol/L(98.8 mg/dL) and 10.25mmol/L(410 mg/dL)
things which may be present in blood.
● Use only fresh capillary whole blood. Do not use serum or plasma. Within ±0.83mmol/Lor ±20%
● Extremes in haematocrit may affect test results. Haematocrit levels
less than 20% may cause falsely high readings and haematocrit （ Within ±32.12mg/dL or ±20%）
levels greater than 60% may cause falsely low readings. If you do
649/660(98.3%)
not know your haematocrit level, consult your healthcare
professional.
● In-vitro Diagnosis. Precision:
Table 5 measurement repeatability
Healthcare professionals-please note these additional limitations:
● Fresh capillary blood may be collected into heparin-containing biochemical Multi-Monitoring Multi-Monitoring Multi-Monitoring
analyzer average Meter average Meter standard Meter variable
test tubes if the blood is used within 10 minutes. Do not use other value（mmol/L） value（mmol/L） deviation coefficient
anticoagulants or preservatives.
● Interferences: Acetaminophen, salicylates, uric acid, ascorbic sample 1 3.52 3.41 0.35 ——
acid(vitamin C), and other reducing substance(when occurring in sample 2 ——
4.85 4.63 0.29
normal blood or normal therapeutic concentrations) do not
significantly affect results. However, abnormally high concentrations sample 3 6.32 6.07 0.18 2.97%
in blood may cause inaccurately high results. sample 4 7.95 7.54 0.31 4.11%
● Patients undergoing oxygen therapy may yield falsely lower results.
● Test results may be falsely low if the patient is severely dehydrated, sample 5 9.52 9.32 0.23 2.47%
in shock, or in a hyperosmolar state (with or without ketosis).
● Critically ill patients should not be tested by Accu-2Mi® This study shows variability from strip to strip in blood tests of 4.33%
Multi-Monitoring Meter. or less.
TEST PRINCIPLE User performance evaluation
Cholesterol in the blood sample mixes with special chemicals on the A study evaluating cholesterol values from fingertip capillary blood
test strip and a small electrical current is produced. This current is samples obtained by 110 lay persons showed the following results:
measured by the Accu-2Mi® Multi-Monitoring Meter and displayed as 96.1% within ±0.83mol/L (±33.2 mg/dL) of the medical laboratory
your blood cholesterol results. The strength of these current changes values at cholesterol concentrations below 4.2mmol/L (168 mg/dL),
with the amount of cholesterol in the blood sample. and 98.8% within ±20 % of the medical laboratory values at cholesterol
concentrations at or above 4.2mol/L (168 mg/dL).
REAGENT COMPOSITION
Each Accu-2Mi® Total Cholesterol Test Strip contains: Measurement range: The measurement range of Accu-2Mi®
Cholesterol oxidase (Aspergillus niger)≥0.5IU; cholesterol Multi-Monitoring Meter is 2.5 to 10mmol/L(100-400mg/dL).
esterase≥0.8IU ；Other ingredient (mediator, buffer, etc.) ≥0.03mg.
The vial or vial cap contains approximately 1.4g silica gel or 2.8g Notes on Symbols and Marks
of molecular sieve.
STRIP Total Cholesterol Test Strips
PERFORMANCE CHARACTERISTICS Consult instructions for use
The performance of Accu-2Mi® Total Cholesterol Test Strips has been Caution
evaluated both in laboratory and in clinical tests. In vitro diagnostic medical device
Accurancy: the accurancy of Accu-2Mi® Cholesterol Test Strips and 30℃

Accu-2Mi® Multi-Monitoring Meter was assessed by comparing 2℃

Temperature limit
cholesterol results obtained using a reference method. Keep away from sunlight
The following results were obtained by 110 patients. 2 Do not re-use
Table 1 Regression Analyses Contains sufficient for < n > tests
Manufacturer
slope 0.9485
y-intercept 0.1859 mmol/L Date of manufacture
correlation coefficient 0.9747 REF Catalogue number
no.of samples 110 LOT Batch code
range tested 2.47-10.25 mmol/L Use-by date
Figure 1 Regression plot 0197 Conformity with Directive 98/79/EC
y = 0. 9485x + 0. 1859
Authorized representative in the European
regression analyse EC REP
R2 = 0. 9501 Community / European Union
Multi-Monitoring Meters (mmol/L)

12

10 Rev.0;2022-06-23
8 data point
data point
6
upper limit
4 lower limit

0
0 2 4 6 8 10 Guilin Royalyze Medical Instrument Co., Ltd.
HF240 biochemcal analyzer（mmol/ L) Add: 18 Li River Road, Qixing District, 541004, Guilin, China

Table 2 System Accuracy Results for Cholesterol Concentration

＜4.2 mmol/L(168mg/dL) EC REP Caretechion GmbH
Add: Niederrheinstr. 71, 40474 Duesseldorf, Germany
Within±0.28mmol/L Within±0.56mmol/L Within±0.83mmol/L
(±11.2mg/dL) (±22.4mg/dL) (±33.2mg/dL)
69/142（48.6%) 103/142(72.5%) 140/142(98.6%)