Atlas Medical Reliance Gold User manual

Blood Glucose Monitoring System
For in vitro diagnostic use only.
INTENDED USE
Blood Glucose Monitoring System is intended to be used for the quantitative measurement
of glucose (sugar) in fresh capillary whole blood from fingertip, palm, up-per arm, or forearm.
It is intended for self-testing outside the body (in vitro diagnostic use) by people with
diabetes at home as an aid to monitor the effectiveness of diabetes control. This system
should not be used for the diagnosis of or screening for diabetes. Alternative site testing
should be done only during steady- state times (when glucose is not changing rapidly).
PRINCPLE OF THE USE
Blood Glucose Test Strip is designed with an electrode that measures glucose levels. Glucosein
the bloodsample mixes withreagentonthe teststripthatcauses asmall electric current. The
amount of current that is created depends on how much glucose is in the blood. The meter
measures the current that is created and converts the measurement to the amount of
glucosethatisintheblood. Thebloodglucose result is displayedonthe screen. Bytouchinga
drop of blood to the tip of the test strip, the strip’s reaction chamber automatically draws
the blood into the strip through capillary action. When the chamber is full, the meter
starts to measure the blood glucose level. It is a simple and practical system for the daily
monitoringofyourblood glucose level.
REAGENT COMPOSITION
Active Ingredient (per 100 strips)
 Glucose oxidase (GOD) 300 units .
 Potassium ferricyanide (mediator) 9.0 mg.
MATERIALS PROVIDED
 Blood glucose monitoring system (including glucose test, lancing device and lancet).
 Package insert.
METER SET UP
You should check and update the meter settings such as time and date before using your
meter or after changing the meter battery.
The Strip Stand-by screen appears on the display when the ON/OFF button is pressed.
Press and hold for 3 seconds on the strip Standby screen to enter the SET mode. You will
see the audible beep set mode at the first.
STEP-1: Setting the Audible Beep
1. Press the ON/OFF buttons in the test strip waiting screen for 3 seconds, and then the
beep sound setting screen appears, which is the first stage of setting of a meter.
2. Set the beep mode on or off by pressing the left or right button and then confirm the
preferred feature by pressing the ON/OFF button. When the audiblesignalisactivated,a
beepisgenerated;otherwise,ifyouselect the beep off feature, no sound is made.
Step-2: Setting the date and time
DateSetting
1. Set the correct year by pressing either the left or right button and then confirm the
correct year bypressingthe ON/OFF button.
2. The display to set the month and day format. The glucose meter can display the
date in the Month-Day (m-d) format or Day-Month (d-m) format. Set your
preferredformatonthe display bypressing the left or rightbuttonandthenconfirm
theselectionwiththeON/OFFbutton.
3. The display to set the date will appear next. Set the correct month and day on
the display by pressing the left or right button and confirming the selection with
the ON/ OFF button.
Time Setting
1. The screen to set the time format will be displayed next. The glucose meter can display
the time in the 12 hour or 24 hour format. Set your preferred format on the display by
pressingtheleftorright button and con-firm the selection with the ON/OFF button.
4. The display to set the time will appear next. Set the correct time on the display by
pressing the left or right button and confirm the selection with the ON/OFF button.
[Settingdate] [Setting time]
Meter Set up
PRECAUTION AND WARNING
1. This system is not designed to be a substitute for pathology laboratory equipment
andshouldnotbe usedfor thediagnosisofdiabetes.
2. Do not use this system to test neonates. It has not been validated for neonatal use.
3. Never make significant changes to your diabetes control program or ignore physical
symptomwithoutconsultingwithyourhealthcareprofessional.
4. Do not use this device to measure blood glucose in people who are experiencing
cardiovascular collapse (severe shock) or decreased peripheral blood flow.
5. Keep the test strip slot free of dust.
6. If the glucose meter is stored with the battery in, keep it ina low humidity room.
7. Usingotherteststripscancauseinaccuratetheresult.
8. After removing a test strip, close the container tightly.
9. Do not expose strips to heat, moisture or humidity. Temperatures outside the range
indicated above as well as humidity (as found, for example, in the bathroom, kitchen,
laundry room, car, or garage) can damage the strips and lead to inaccurate results. Severe
humidity condition (≥90%, ≤15%) may affect theresult.
10. Store test strips in their original container only to avoid damage or contamination.Do
not transfer the test strips to any other container and do not store them outside their
original container.
11. Do not use test strips from any container that is damaged or left open to air.
12. When you first open the container, write date when the container was first opened on
the container’s label. Dispose of the test strips after 6 month from date the container
was first opened.
13. Do not use the test strips past their expiry date (printed on the package) or disposal
date, whichever comes first. Utilizing expired test strips or strips whose container has
been open for over six months can lead to inaccurate results.
14. Blood Glucose Test Strips are for a single use only. Never re-use a test strip to which
blood or a control solution have already been applied.
15. Pay attention not to contaminate the test strip with dirt, food or liquids. You can touch
the test strip over its entire surface with clean and dry hands.
16. Do not bend, cut, or alter in any way the test strip.
17. Use only fresh capillary blood. Do not use serum or plasma or venous whole blood.
18. Severe dehydration (excessive water loss) may cause false low results. If you believe
you are suffering from dehydration, consult your healthcare professional right away.
19. Extremes in hematocrit may affect test results. Hematocrit levels less than 20% may
cause falsely high readings. Hematocrit levels greater than 60% may cause falsely low
readings. If you do not know your HCT, ask your doctor.
20. Interfering substances: the following compounds, elevated levels of ascorbic acid, uric
acid, acetaminophen, total bilirubin and triglycerides may affect results.
Material
Limitation
Acetaminophen
> 6mg/dL
Ascorbic Acid
> 4mg/dL
Bilirubin
> 40mg/dL
Total cholesterol
> 506mg/dL
Creatinine
> 30mg/dL
Dopamine
> 5mg/dL
EDTA
> 0.1mg/dL
Galactose
> 60mg/dL
Gentisic Acid
> 1.8mg/dL
Glutathione
> 4.6mg/dL
Hemoglobin
> 200mg/dL
Heparin
> 3,000U/L
Ibuprofen
> 50mg/dL
Levodopa
> 4mg/dL
Maltose
> 60mg/dL
Methyl-Dopa
> 2mg/dL
Sodium Salicylate
> 20mg/dL
Tolazamide
> 8.4mg/dL
Tolbutamide
> 4mg/dL
Triglycerides
> 1,026mg/dL
Uric Acid
> 9mg/dL
Xylose
> 60mg/dL
Pralidoxime Iodide
> 1.3mg/dL
Icodextrin
> 750mg/dL
Metformin
> 4mg/dL
Fructose
> 16.5mg/dL
Mannitol
> 810mg/dL
Warfarin
> 1.1mg/dL
21. The needle of lancet is sharp, keep the lancet away from children.
22. Keep the lancet and lancing device dry and avoid their direct exposure to sunlight,
intense heat and high humidity areas.
23. The lancet must be used for any purpose other than capillary blood sample
collection.
24. The lancet is for single use only. Do not reuse it.
25. Check the conditions of packaging before use; do not use the product in case of
anomalies.
26. If a lancet cap is loosed or needle of a lancet is exposed, you should not use it.
27. Dispose of used lancets in order to reduce the risk of infection.
PROCEDURE
1. Blood Collection procedure
Store at 2-32°C
3. Screw the device’s cap back on
4. Adjustthe prickingdepthbyrotatingthecomfort
dial.Thedialincludespositions from 1 to 5. The
lowest depth is ideal for delicate skin and
pediatric use, the highest depth is ideal for think
and calloused skin.
1. Unscrew the cap of lancing
device to remove it.
2. Insert the lancet into the lancing device holder
and push down firmly until it is fully engaged. Twist
the lancet capuntil itseparates from the lancet.

3. Strip Error: The test strip is defective or damaged, or is inserted
incorrectly. Discard the test strip and repeat the test with a new strip.
4. Blood Sample Error Aninsufficient amountof blood was applied. Discard
this teststrip and repeat the test with a new strip and proper blood sample.
5.Temperature Error If the ambient temperature is higher or lower than
the recommended rage, the icon of a thermometer will be displayed on the
screen Move to an area between 10- 45°C (50-113°F), wait for 30 minutes,
and perform a test. Do not heat or cool the glucose meter artificially
TEST RESULT
1. Normal blood glucoseresult:
Expected blood glucose values for non-diabetic adults are as follows.
- Before meals < 100 mg/dL (5.55 mmol/L)
- After meals < 140 mg/dL (7.8 mmol/L)
2. The meter reads blood glucose results at10-600 mg/dL.
- If ‘Hi’ is displayed, your blood glucose result may be higher than 600 mg/dL. You
may have high blood glucose.
- If ‘Lo’ is displayed, your blood glucose result may be lower than 10 mg/dL. You
may have low blood glucose.
UNEXPECTED RESULT
High or low blood glucose results can indicate potentially serious medical conditions.
In case of an unexpected result, you should repeat the test immediately using a new
test strip. If your reading is still unexpected or the reading is not consistent with how
you feel, you should treat as prescribed by your healthcare professional and/or
contact your healthcare professional immediately.
MAINTENANCE AND TROUBLR SHOOTING
Result Range
10 - 600
mg/dL (0.6 -
33.3
mmol/L)
Measurement
Unit
mg/dL , mmol/L
Calibration
Plasma-
equivalent
Display
LCD
Sample
Fresh capillary
whole blood
Control
3 Buttons
Sample Volume
0.9 microliter
Size
44 mm × 92 mm ×
18mm
Test Time
5 seconds
Weight
50g (with
battery)
Assay Method
Glucose
Oxidase
Memory
400 blood
glucose tests
Power Source
One replaceable 3 V
Lithium Battery (type
CR2032)
Operating TEMP.
10 - 45°C (50 -
113°F)
Battery Life
Around
1,000 tests
Hematocrit (%)
20% - 60%
Catalogue Number
Temperature limit
In Vitro diagnostic
medical device
Caution
Contains sufficient for
<n> tests and Relative size
Consult instructions for
use (IFU)
Batch code
Manufacturer
Use-by date
Do not use if package is
damaged
Manufacturer fax number
Manufacturer
telephone number
5. Cock the lancing device back.
the lancing device firmly against the side
of finger and then press the release button.
1. Insert the 3V battery into the
housing with “+” side set upwards.
2. Insert the test strip into test strip slot until it will
go no further with gold coloredbars printed ‘G-
Mentor’ word facing up and toward the meter.
Then, the meter turns on automatically.
3. Obtainadropofbloodsample
using the lancet and lancing
device refer to the blood
collectionprocedure
4. Touch and hold drop of blood to the edge of the
strip until the yellow window is completely filled
with blood. The blood will be absorbed to the
strip automatically.
1. Replace battery: Battery power is low. Replace the battery
immediately. If the ON/OFF button is pressed when the battery is
discharged, the icon of battery will flash and the glucose meter will
switch off automatically ten seconds later.
2. Errormessagefromtheglucosemeter.Turnoffameter.
Then turn onthe meter again
Product Technical Information
< 100mg/dL (5.55mmol/L)
Within ±5mg/dL
Within ±10mg/dL
(within ±0.28mmol/L)
(within ±0.56mmol/L)
100/204
185/204
< 100mg/dL (5.55mmol/L)
Within ±5%
Within ±10%
Within ±15%
290/396
376/396
Total System Accuracy (35.0-486.5mg/dL (1.94-27.01mmol/L))
Within ±15mg/dL (0.83mmol/L) or 15%
594/600
99.0%
REFERENCES
1. Health Care Facility Recommendations for Standard Precautions (2007). World
Health Organization, Geneva, Switzerland.
2. Centers for Disease Control and Prevention. Transmission of Hepatitis B Virus
among Persons. Undergoing Blood Glucose Monitoring in Long-Term -- Care
Facilities --- Mississippi, North Carolina, and Los Angeles County, California, 2003-
2004. Morbidity and Mortality Weekly Report (MMWR Weekly) March 11,
2005/54(09);220-223.
3.Centers for Disease Control and Prevention. Recommended Infection-Control
and Safe Injection Practices to Prevent Patient-to-Patient Transmission of
Bloodborne Pathogens. http://www.cdc.gov/hepatitis/Populations/PDFs/
diabetes_handout.pdf - accessed March 2009.
4.. Rutala WA, Weber DJ, et al. Guideline for Disinfection and Sterilization in
Healthcare Facilities, 2008. Centers for Disease Control and Prevention.
http://www.cdc. org - accessed July 13, 2009.
5. American Diabetes Association: Diabetes Care, 2015;38(Suppl. 1):S8-S16
6. Ellen T. Chen, James H. Nichols, Show-Hong Duh, Glen Hortin, MD: Diabetes
Technology & Therapeutics, Performance Evaluation of Blood Glucose Monitoring
Devices, Oct 2003, Vol. 5, No. 5 : 749 -768
7.. “FDA Public Health Notification: Use of Fingerstick Devices on More than One
Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication”
(2010) http://www.fda.gov/
MedicalDevices/Safety/AlertsandNotices/ucm224025. htm
8. “CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person
Poses Risk for Transmitting Bloodborne Pathogens” (2010) http://www.cdc.gov/
injectionsafety/Fingerstick-DevicesBGM.html
Atlas Medical
Ludwig-Erhard Ring 3 ,15827 Blankenfelde-Mahlow , Germany
Tel: +49 - 33708 –3550 30, Email: [e-mail]
PPI1550A01
Rev B (20.01.2020)
2. Testing procedure
PERFORMANCE CHARACTERISTIC
Performance characteristic of the system shall be evaluated with a series of
measurements within a short interval of time in accordance with EN ISO 15197:2015.
Precision
The acceptable criteria are within standard deviation (STD) 3mg/ dL at the below
100mg/dL(5.55mmol/L), and coefficient of variation(CV) 4% at the above
100mg/dL(5.55mmol/L).
Repeatability
Range (mg/dL)
REF (mg/dL)
STD(mg/dL) / CV(%)
30-50
47.8
1.8mg/dL
51 - 110
81.5
2.1mg/dL
111 -150
139.0
3.6%
151-250
212.5
3.5%
251-400
315.0
3.6%
Intermediate Precision
< 100mg/dL
(5.55mmol/)
≥ 100mg/dL (5.55mmol/L)
Level M
1.6mg/dL
3.4%
System Accuracy
The accuracy of the system was assessed by comparing with the blood glucose test
results by YSI 2300 STAT Plus, a glucose laboratory instrument, as the reference.
The acceptable criteria for system accuracy are following; 95% of the measured glucose
values shall fall within either ±15mg/dL (0,83mmol/L) of the average measured values
of the reference measurement procedure at glucose concentrations <100mg/ dL
(5,55mmol/L) or within ±15% at glucose concentrations ≥100mg/dL (5,55mmol/L).