Dr Trust 9001 Blood Glucose Monitoring System User Guide

Dr Trust 9001 Blood Glucose Monitoring System

QUICKSTART GUIDE

• Step 1
  Prepare your device for testing.

• Step2
  Wash and dry your hands well.

• Step3
  Turn on the glucometer and insert the test strip in it.

• Step4
  When Machine is ready, prick your finger with a lancet for getting a drop of blood sample.

• Step5
  Draw the drop of the blood to the edge of the test strip to get the blood sugar readings.

• Step 6
  Wipe away any remaining blood.
  NOTE:
  For a fasting blood glucose test, you can’t eat or drink anything except water for eight hours before your test. For random testing, you may eat and drink before testing.

INTRODUCTION

Regular monitoring of your blood glucose levels can help you and your doctor gain better control of your diabetes. Dr Trust Gold Standard Blood Glucose Monitoring System – 9001 is the next generation Blood Glucose monitor using advanced GDH-FAD Enzyme technology to measure accurate blood glucose using GDH-FAD enzyme. Fast and accurate testing in just 5 seconds is ensured with only 0.5 µL blood sample. While due to its compact size and easy operation, you can use it to easily monitor your blood glucose levels by yourself anywhere, anytime.

Intended Use:
This system is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and by health care professionals in clinical settings. It is intended to be used for the quantitative measurements of glucose (sugar) in fresh whole blood samples (from the finger, palm, forearm, and upper arm), and from venous whole blood. It should not be used for the diagnosis or screening of diabetes. Professionals may test with capillary and venous blood sample; home use is limited to capillarywhole blood testing.

Test Principle:
Your system measures the amount of glucose in whole blood. The glucose testing is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip. The meter measures the current, calculates the glucose level, and displays the result. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample.

IMPORTANT SAFETY PRECAUTIONS

• Use this device ONLYfor the intended use described in this manual.

• Do NOT use accessories which are not specified by the manufacturer.

• Do NOT use the device if it is not working properly or if it is damaged.

• This device does NOT serve as a cure for any symptoms or diseases. The data measured is for reference only. Always consult your doctor to have the results interpreted.

• Before using this device to test blood glucose, read all instructions thoroughly and practice the test. Carry out all the quality control checks as directed.

• Keep the device and testing accessories away from young children. Small items such as the battery cover, batteries, test strips, lancets and vial caps are choking hazards.

• Use this device in a dry environment, especially if synthetic materials are present (synthetic clothing, and carpets etc.) may cause damaging static discharges that may cause erroneous results.

• Do NOT use this device in close proximity to sources of strong electromagnetic radiation, as these may interfere with the accurate operation and results.

• Proper maintenance and periodically control solution tests are essential to maintain the longevity of your device.

• If you are concerned about accuracy of measurement, please follow all the instructions shared in this manual or take help from a medical practitioner.
  Important Note:

• Severe dehydration and excessive water loss may cause readings which are lower than actual values. If you believe you are suffering from severe dehydration, consult a healthcare professional immediately.

• If your blood glucose results are lower or higher than usual, and you do not have any symptoms of illness, first repeat the test. If you have symptoms and continue to get results which are higher or lower than usual, follow the treatment advice of your healthcare professional.

• Use only fresh whole blood samples to test your blood glucose. Using other substances wi I I lead to incorrect resu Its.

• If you are experiencing symptoms that are inconsistent, you’re your blood glucose test results and you have followed all the instructions given in this owner’s manual, contact your healthcare professional.

• We do not recommend using this product on severely hypotensive individuals or patients in shock. Please consult the healthcare professional before use.

• The measurement unit used for indicating the concentration of blood or plasma glucose can either have a weight dimension (mg/ dl) or a molarity (mmol/L). The approximate calculation rule for conversion of mg/dl in mmol/Lis:

For example:

1. 120 mg/dl + 18 = 6.6 mmol/L
2. 7.2 mmol/Lxl8 = 129 mg/dl approximately.

PREPARING THE GLUCOMETER FOR DAILY TESTING

METER OVERVIEW

1. Test Strip Ejector
   Eject the used strip by pushing up this button.

2. DisplayScreen
   Shows blood sugar numbers with other information.

3. Main Button (M)
   Enter the meter memory and silence a reminder alarm.

4. TestStripSlotwithStrip Indication Light

5. SET Button (S)
   Enter and confirm the me ter settings.

6. Battery Compartment
   For holding batteries

Display Screen

1. TestResult

2. Ke tone Warning

3. Error Warning

4. Memory Symbol

5. Control Solution Mode
   QC-control solution test

6. Measuring Mode

   • AC-before meal
   • PC-after meal
   • Gen-any time of day

7. Date

8. Time

9. Day Average

10. Alarm Symbol

11. FaceSymbol

12. Measurement Unit

13. Low Battery Symbol

14. TestStripSymbol

15. Blood Drop Symbol

Test Strip

1. Absorbe ntH ole
2. Confirmation Window
3. Test Strip Handle
4. Contact Bars

ATTENTION:

• The front side of teststripshould face up when inserting it.
• Test results might be wrong if the contact bar is not fully inserted into the tests lot.

NOTE:
The glucometer should only be used with the Dr Trust Test Strips. Using other brands test strips with this meter may give inaccurate results.

SETTING THE METER

Before using your meter for the first time, you should check and update these settings.

1. EnteringtheSettingMode

   • Start with the meter off (no test strip inserted). Press Setting Button (S) to move ahead.

2. Setting the Date

   • The sequence of the date setting is: YEAR-MONTH – DAY. With the YEAR/ MONTH / DAY flashing in sequence, press Main Button (M) to select the correct number. Press Sta move further.

3. Setting the Time Format

   • Press M to select the desired timeformat–12h or 24h. PressS to move to next setting.

4. SettingtheTime

   • With the HOUR / MINUTE flashing in sequence, press M until the correct hour/minute appears. Press Sta move ahead.

5. Settingthe Unit of Measurement

   • Press M to switch between mg/dlormmol/L. Press Sta move ahead.

6. Setting the Buzzer

   • With the buzzer displays, press M to switch between “On” and “OFF”. Press S to move ahead.

7. Deleting the Memory

   • With “del” and a flashing “M” on the display, press M and select “no” to keep the results in memory, and then pressS to skip.
   • To delete all the results, press M and select “yes” to delete all the memory records.

8. Settingthe reminder alarm

   • Your meter has four reminder alarms. The meterwill display “On” or “OFF’.

   • If you don’t want to set an alarm, press M to select “OFF”, and then press S to skip this step.
     Or select “On” and press S to proceed. With the hour/minute flashing in sequence, press M to select the correct hour/minute.

   • Press Sand go to the next alarm setting.

NOTE:

1. When the alarm beeps, press M to switch it off. Otherwise, it will beep for 2 minutes then switch off.
2. These parameters can ONLY be changed in the setting mode.
3. If the meter is idle for 3 minutes during the setting mode, it will switch off automatically.

THE FOUR MEASURING MODES

The glucometer has three general modes with Quality Control Testing(mode):

1. General Mode to monitor the level anytime.
2. AC Mode to check sugar level before you have breakfast.
3. PC Modefor checkingthe level of blood sugar after meal.
4. QC Modefor qualitycontroltesting.

ForGeneral Mode Testing:

• Insert a test strip to turn on the meter. The display start flashing ” ” and “Gen”.
• Press M to switch between Gen, AC and PC mode.

QUALITY CONTROL TESTING

When Should the Control Solution Test be Performed?

• If it is mandatoryfollowing the local regulations in your country,
• If you suspect the meter or teststrips are not working properly,
• If your test results are not consistent with how you feel, or if you think the results are not accurate,
• To practice the testing process, or if you have dropped or thinkyou may have damaged the meter.

Performing a Control Solution Test
To perform a control solution test, you will need: glucometer device, test strips and control solution.

1. lnsert theteststriptoturn on the meter.
   Insert the test strip into the meter. Wait for the meter to display the “ ” and” “

2. Press M to mark this test as a control solution test
   With displayof”QC”, the meterwill storeyourtest result in memory under”QC”. If you press M again, the “QC” will disappear, and this test is no longer a Quality Control Solution test.
   Warning:
   When doing the control solution test, you have to mark it so that the test results will NOT mix with the TEST RESULTS stored in the memory. Failure to do so will mix up the test results with the control solution test results in memory.

3. Apply control solution
   Shake the control solution vial thoroughly before use. Squeeze out the first drop and wipe it off, then squeeze out another drop and place it on the tip of the vial cap. Hold the meter to move the absorbent hole of the test strip to touch the drop. Once the confirmation windowfills completely, the meter will begin counting down.
   NOTE:
   To avoid contaminating the control solution, do not directly apply control solution on a strip.

TESTING WITH BLOOD SAMPLE

Preparing the Lancing Device for Blood Testing
Please follow the instructions in the lancing device insert for collecting a blood sample.

Preparing the Puncture Site
Stimulating blood perfusion by rubbing the puncture site before blood extraction has a significant influence on the glucose value obtained. Blood from a site that has not been rubbed exhibits a measurably different glucose concentration than blood from the finger. When the puncture site was rubbed prior to blood extraction, the difference was significantly reduced.

Please follow the suggestions below before obtaining a drop of blood:

• Wash and dry your hands before starting the test.
• Select the puncture site either at fingertips or another body parts (please see section “Alternative Site Testing” (ASD on how to select the appropriate sites).
• Rub the puncture site for about20 seconds before penetration.
• Clean the puncture site using cotton moistened with 70% alcohol and let it air dry.

Warning:
To reduce the chance of infection:

• Never share a lancet or the lancing device.
• Always use a new, sterile lancet. Lancets are for single use only.
• Avoid getting hand lotion, oils, dirt, or debris in or on the lancets and the lancing device.

COLLECTING BLOOD SAMPLE

Fingertip testing
Press the lancing device’s tip firmly against the lower side of your fingertip. Press the release button to prick your finger, and then a click indicates that the puncture is complete.

Blood from sites other than the fingertip
Replace the lancing device cap with the clear cap for AST. Pull the cocking control back until it clicks. When lancing the hand, avoid lancing the areas with obvious veins because of excessive bleeding.

NOTE:

• Choose a different spot each time you test. Repeated punctures at the same spot may cause soreness and calluses.
• Please consult your health care professional before you begin AST.

Performing a Blood Test:
To perform a blood test, you will need: glucometer device, test strip, lancing device and sterile lancet

1. lnsert theteststripto turn on the meter
   Wait forthe meter to display the “ “and ” “

2. .Select the appropriate measuring mode by pressing M.

3. Obtaining a blood sample
   Use the pre-set lancing device to puncture the desired site. The size of the drop should be at least as big as (actual size), which is 0.5 microliter(µL) of volume for blood glucose test.
   Gently squeeze the punctured area to obtain another drop of blood. Be careful NOTto smear the blood sample.

4. Apply the sample
   Gently apply the drop of blood to the absorbent hole of the test strip at a tilted angle. Confirmation window should be filled if enough blood samples have been applied. Do NOTremove yourfingeruntilyou hear a beep sound.
   NOTE:

   • Do not press the punctured site against the test strip or try to smear the blood.
   • If you do not apply a blood sample to the test strip within 3 minutes, the meter will automatically turn off. You must remove and reinsert the test strip to start a new test.
   • The confirmation window should be filled with blood before the meter begins to count down. NEVER try to add more blood to the test strip after the drop of blood has moved away. Discard the used test strip and retest with a new one. If
   • you have trouble filling the confirmation window, please contact your health care professional or the local customer service for assistance.

5. Read Your Result
   The result of your testwill appear after the meter counts down to 0. The result will be stored in the memory automatically.

Eject the used test strip

• Eject the test strip by pushing the eject button on the side. Use a sharp bin to dispose of used test strips. The meterwill switch itselfoff automatically.

Always follow the instructions in the lancing device for inserting and removing the lancet safely.
WARNING:
The used lancet and test strip may be biohazardous. Please discard them carefully according to your local regulations.

ALTERNATIVE SITE TESTING

You can test on a variety of locations on your body.

Important:

• There are limitations with AST (Alternative Site Testing).
• Please consultyour health care professional before you perform AST. Areas for the Hand

When to use AST?
Food, medication, illness, stress and exercise can affect blood glucose levels. Capillary blood at the fingertip reflects these changes faster than capillary blood at other sites. Thus, when testing blood glucose during or immediately after a meal, physical exercise, or any other event, take a blood sample from your finger only.

We strongly recommend that you perform AST ON LY at the following times:

• In a pre-meal or fasting state (more than 2 hours since the last meal).
• Two hours or more after taking insulin.
• Two hours or more after exercise.

Do NOT use AST if:

• You think your blood glucose is low.
• You are unaware of hypoglycemia.
• You aretestingfor hyperglycemia.
• Your AST results do not match theway you feel.
• Your routine blood glucose results often fluctuate.

METER MEMORY

The meter stores the 1000 most recent blood glucose test results along with respective dates and times in its memory. To enter the meter memory, start by switching off the meter.

RESULTS INTERPRETATION

Reviewing Test Results

1. Press and release M.
   “M” will appear on the display. Press M again, and the first reading you see is the last result along with date, time and the measuring mode.

2. Press M to recall the test results stored in the meter each time you press. After the lasttest result, press M again and the meterwill be turned off.

Reviewing Blood Glucose Day Average Results

1. Press and release

M.

| When “M” appears on the display, keep pressing M for 3 seconds until the flashing “DAY AVG” appears. Release Mand thenyour7-day average result measured in general mode will appear on the display.
---|---
__

2. Press M

| M to review 14-, 21-, 28-, 60- and 90- day average results stored in each measuring mode in the order of Gen, AC, and then PC.
__

3. Exit the meter memory.

| Keep pressing the Mand the meter will turn off after displaying the last test result.

NOTE:

• Any time you wish to exit the memory, keep pressing M for 3 seconds or leave it without any action for 3 minutes. The meterwiff switch offautomaticaffy.
• Control solution results are NOT included in the day average.

BATTERY

Your meter comes with two 1.5V AAA size alkaline batteries.
Low Battery Signal
The meter will display one of the messages below to alert you when the meter power is getting low.

1. The “ ” symbol appears along with display messages : The meter is functional, and the result remains accurate, but it is time to change the batteries.
2. The “ ” symbol appears with E-b, Error and low:The power is not enough to do a test. Please change the batteries immediately.

Replacing the Battery

To replace the battery, make sure the meter is turned off

1. Pressthe edge of the battery cover and lift it up to remove.
2. Remove the old batteries and replace with two 1.5V AAA size alkaline batteries.
3. Close the battery cover. If the batteries are inserted correctly, you will hear a “beep” afterwards.

NOTE:

• Replacing the batteries does not affect the test results stored in the memory.
• As with all small batteries, these batteries should be kept away from children. If swallowed, promptly seek medical assistance.
• Batteries might leak chemicals if unused for a long time. Remove the batteries if you are not going to use the device for an extended period (i.e.,3 months or more).
• Properly dispose of the batteries according to your local environmental regulations.

CARING AND MAINTENANCE

Glucometer:

Cleaning

1. To clean the meter exterior, wipe it with a cloth moistened with tap water or a mild cleaning agent, then dry the device with a soft dry cloth.
2. DoNOTrinsewithwater.
3. Do NOT use organic solvents to clean the meter.

Storage

• Storage conditions: -20°C to 60°C (-4° F to 140° F), below 95% relative humidity.
• Always store or transport the meter in its original storage case.
• Avoid dropping and heavy impact.
• Avoid direct sunlight and high humidity.

Disposal
The used meter should be treated as contaminated that may carry a risk of infection during measurement. The batteries in this used meter should be removed and the meter should be disposed in accordance with local regulations.
Test Strips:
Storage conditions:

• 2’C to 30’C (35.6’F to 86.0’F) temperature and below 85% relative humidity. Do NOT freeze.
• Store your test strips in their original vial only. Do not transfer to another container.
• Store test strip packages in a cool dry place. Keep away from direct sunlight and heat.
• After removing a test strip from the vial, immediately close the vial cap tightly.
• Touch theteststripwith clean and dry hands.
• Use each test strip immediately after removing it from the vial.
• Do not use test strips beyond the expiration date. This may cause inaccurate results.
• Do not bend, cut, or alter a test strip in anyway.
• Keep the strip vial away from children since the cap and the test strip may be a choking hazard. If swallowed, promptly see a doctor for help.

Control Solution Information:

• Use only our control solutions with your meter.
• Do not use the control solution beyond the expiration date or 3 months after first opening. Write the opening date on the control solution vial and discard the remaining solution after3 months.
• It is recommended that the control solution test be done at room temperature 20’C to 25’C (68’F to 77’F). Make sure your control solution, meter, and test strips are at this specified temperature range before testing.
• Use only our control solutions with your meter.
• Do not use the control solution beyond the expiration date or 3 months after first opening. Write the opening date on the control solution vial and discard the remaining solution after3 months.
• It is recommended that the control solution test be done at room temperature 20’C to 25’C (68’F to 77’F). Make sure your control solution, meter, and test strips are at this specified temperature range before testing.

ERROR MESSAGES & SYMBOLS

Symbol Messages

Error Messages

after the meter and test strip are in the above temperature range.
E-F| Appears when test strip is removed while counting down, or insufficient

blood volume.

| Review the instructions and repeat test with a new strip .

If the problem persists, please contact the local customer support for help.

---|---|---

E-0

|

Problem with the meter.

|

Repeat the test with a new test

E-A|  | strip. lfthe meter still does not
E-E|  | work, please contact the
E-C|  | customer support for
 |  | assistance.

TROUBLESHOOTING

1. lf the meter does not display a message after inserting a test strip:
   POSSIBLE CAUSE| WHATTODO
   ---|---
   Batteries exhausted.| Replace the batteries.
   Test strip inserted upside down or incompletely.| Insert the test strip with contact bars end first and facing up.
   Defective meter or test strips.| Please contact customer services.
2. lf the test does not start after applying the sample:
   POSSIBLE CAUSE| WHAT TO DO
   ---|---
   Insufficient blood sample.| Repeat the test using a new test strip with larger volume of blood sample.
   Defective test strip.| Repeat the test with a new test strip.
   Sample applied after automatic switch-off (3 minutes after last user action).| Repeat the test with a new test strip.

Apply sample only when flashing ”   “appears on the display.

Defective meter.| Please contact customer services.
3. lf the control solution testing result is out of range:
POSSIBLE CAUSE| WHAT TO DO
---|---
Error in performing the test.| Read instructions thoroughly and repeat the test again.
Control solution vial was poorly shaken.| Shake the control solution vigorously and repeat the test again.
Expired or contaminated control solution .| Check the expiry date of the control solution.
---|---
Control solution that is too warm| Control solution, meter, and test
or too cold.| strips should be at room

temperature 2o·c to 25°C (68°F to

 | 77°F) before testing.
Defective test strip.| Repeat the test with a new test strip.
Meter malfunction.| Please contact customer services.
Improper working of meter and test strip.| Please contact customer services.

DETAILED INFORMATION ABOUT BLOOD GLUCOSE RANGE

The blood glucose readings deliver plasma equivalent results and are displayed either in milligrams of glucose per deciliter of blood (mg/dL) or in millimoles of glucose per liter of blood (mmol/L).

Time of day| Normal plasma glucose range for people without diabetes (mg/dL)
---|---
Fasting and before meal| < 100 mg/dL (5.6 mmol/L)
2 hours after meals| < 140 mg/dL (7.8 mmol/L)

SPECIFICATION

condensing)

Meter Storage/Transportation Conditions:

-20°C to 60°C (-4°F to 140°F), belo w 95% R.H.

Strip Storage/Transportation Conditions:| 2°C to 30°C (35.6°F to 86.0°F ), belo w

85% R.H.

Measurement Units:

|

Either mg/dL or mmol/ L

Measurement Range:

|

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

CUSTOMERSUPPORT

CONTACT ADDRESS
USA
Nureca INC.USA
276 5th Avenue, Suite 704-397,
New York (NY) -10001, USA
INDIA
Corporate Office (Mumbai)
Nureca Limited
128 Gala Number Udyog Bhavan,
1st Floor Sonawala Lane, Goregaon East
Mumbai City Maharashtra 400063
Contact us
India: +91-7527013265 /+91-9356658436
Website: www.drtrust.in
Corp Website: www.nureca.com
Email: customercare@nureca.com
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