Welcome to Your One Drop Blood Glucose Monitoring System The One Drop Meter works with the One Drop for Diabetes App for iOS, or Android™ (the “One Drop App” or “App”) installed on a supported device. Data is transmitted between the One Drop Meter and the One Drop App via Bluetooth® wireless technology. Key Features in the One Drop Meter Convenient Connection – The One Drop Meter uses Bluetooth® wireless technology for an easy to use wireless connection to supported devices.
Blood Glucose Monitoring System Customer Service 1 (800) 437-1474 customerservice@onedrop.today In case of emergency, contact your healthcare professional or emergency medical response. By using the One Drop Blood Glucose Monitoring System (Meter) with the One Drop App (the App). You agree that the use of this software together with an iPod, iPhone or iPad (“Apple Product”) shall only be as a personal organization or supplemental data display tool and not as a source of medical advice.
Designed by One Drop in USA Manufactured exclusively for One Drop & Informed Data Systems, Inc. by AgaMatrix, Inc. 7C Raymond Avenue Salem, NH 03079 USA 8100-10216 Rev B ©2016 One Drop & Informed Data Systems, Inc. Meter Firmware ©2014-2016 AgaMatrix, Inc. US and International Patents Pending. All rights reserved. All trademarks and copyrights are the property of their respective owners. For patent information, see www.agamatrix.
Contents CHAPTER TITLE PAGE 1 Important Information About Your One Drop System 5 2 Important Safety Instructions 10 3 The One Drop Blood Glucose Monitoring System 11 4 About the One Drop Meter, One Drop Test Strips, and One Drop Lancing Device 12 5 Pairing and Syncing Your One Drop Meter with the One Drop App 16 6 Before You Test Your Blood — Important Healthrelated Information 21 7 How to Test Your Blood Glucose Level 24 8 Viewing Past Test Results on Your One Drop Meter 33 Importa
CHAPTER 4 TITLE PAGE 11 Error Messages 44 12 Troubleshooting 46 13 One Drop System Specifications 53 14 Electrical Safety and Standards 54 15 Warranty 56
CHAPTER 1 Important Information About Your One Drop System One Drop Blood Glucose Monitoring System Intended Use: The One Drop Blood Glucose Monitoring System is intended for quantitative measurement of blood glucose (sugar) levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared.
Limitations · Not for diagnosis of or screening of diabetes mellitus · Not to be used for patients who are dehydrated, hypotensive, in shock, critically ill, or in a hyperosmolar state · Not for persons undergoing Oxygen therapy · Not for testing the glucose levels in neonates (children under 4 weeks) · Not for testing glucose levels in arterial or venous blood samples · Not for testing glucose from sites other than samples drawn from the fingertip Getting Started This Owner’s Guide is intended to instruct
Owner’s Guide and practice the testing procedures before using the One Drop Blood Glucose Monitoring System. Blood glucose monitoring should be done under the guidance of a healthcare professional (HCP). Important Safety Instructions: Only one person should use the One Drop Meter, One Drop Lancing Device, and lancets. Never share One Drop Meter, One Drop Lancing Device, or lancets.
a sample of blood obtained by fingerstick is applied to the One Drop Test Strip. The blood sample size for the One Drop Meter is a minimum of 0.5 µL. The blood reacts with a reagent on the One Drop Test Strip that contains glucose oxidase, an electron mediator, and other materials. The chemical reaction with glucose that takes place on the strip generates an electrical signal that is measured and processed by the One Drop Meter. The meter computes a glucose concentration and displays the result.
test is performing correctly. To order either Level 2 or Level 4 Control Solution, please contact Customer Service at 1 (800) 437-1474. Bluetooth® Wireless Technology Bluetooth® wireless technology is a type of wireless RF (Radio Frequency) communication. Cell phones use Bluetooth® wireless technology as do many other devices. Your One Drop Meter uses Bluetooth® wireless technology to pair with compatible iOS and Android™ devices to send results to the One Drop App.
CHAPTER When the One Drop App is paired with your One Drop Meter, the data from your One Drop Meter will automatically sync with the One Drop App whenever the two devices are in range and the One Drop Meter is turned on. 2 Important Safety Instructions The One Drop Meter and One Drop Lancing Device are for single patient use.
· “FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication” (2010) 1 · “CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens” (2010) 2 CHAPTER · “Infection Prevention during Blood Glucose Monitoring and Insulin Administration” (2012) 3 3 The One Drop Blood Glucose Monitoring System The One Drop Blood Glucose Monitoring System Contains:
CHAPTER 4 About the One Drop Meter, One Drop Test Strips, and One Drop Lancing Device About the One Drop Meter Please note the correct orientation of the device in the sample image below. 1 3 2 (1) Display Area: Glucose test results, symbols, and messages appear here. Inspect the display for damage by viewing the Intro Animation. You will see the Intro Animation every time you insert a One Drop Test Strip or press the meter button.
Note: The batteries are pre-installed in the One Drop Meter. About the One Drop Test Strips Use your system and your fingertip to test your blood glucose. Testing with the system requires a small sample size, 0.5μL of blood, about the size of a pinhead. 3 1 5 2 4 (1) Front of the One Drop Test Strip The front of the One Drop Test Strip is black in color.
(4) Sample Area Blood should be applied to the tip of the One Drop Test Strip here. (5) Visual Fill Window This window will turn red when enough blood has been applied. Important Test Strip Information: • Store the One Drop Test Strip vial in a cool, dry place at 46°F to 86°F (8°C to 30°C) and at a relative humidity of 10% to 90%. • Keep away from direct sunlight and heat.
• Apply only fresh capillary blood to the sample area of the One Drop Test Strip. • Use One Drop Test Strips only once. • Only use One Drop Test Strips with the One Drop Meter. • Dispose of used One Drop Test Strips properly. About the One Drop Lancing Device 2 1 3 5 6 8 + - 7 4 (1) Cocking Handle Cocks the device so it is ready to lance. (2) Depth Adjustment Slider Adjusts how deep the lancet will lance the skin. (3) Lancet Ejector Ejects the lancet. (4) Release Button Fires the lancet.
(7) Lancet Lances the skin to produce a drop of blood. CHAPTER (8) Lancet Cover Covers the lancet for safety. Remove after inserting into the lancet holder (cup). 5 Pairing and Syncing Your One Drop Meter with the One Drop App The One Drop App is an application that allows users to add, modify, and view health data, including glucose, insulin, carbs, and weight.
IMPORTANT: Please note that the One Drop App stores sensitive health-related information on your supported device. We recommend keeping your supported device up-to-date with the latest security software. For more information on keeping your supported device and information safe, please contact the manufacturer of your supported device.
and date will be displayed on your One Drop Meter with “--:--“ and “--/--“ in place of the time and date. Go to: http://onedrop.today/setup This website includes up-to-date instructions on how to get set up and pair your meter. The One Drop Meter and the One Drop App must be within 10 feet of each other in order to pair and transfer data. Note: Test results taken prior to the time and date being set will not have a time and date associated with them on the One Drop Meter.
logbook history and statistics to be incorrect. How to Pair an Additional One Drop Meter Follow the same steps above to pair additional One Drop Meters. Automatic Data Transfer (Sync) The first time your One Drop Meter pairs with your supported device it will set the date and time on your One Drop Meter.
Example of 12 hour time: Example of 24 hour time: For example: a date of “10/12” will mean Oct 12 if your supported device set to MM/DD, and it will mean Dec 10 if your supported device is set to DD/MM. Note: Test results taken prior to the time and date being set will not have a time and date associated with them on the One Drop Meter, and will not sync to the One Drop App. You can manually add these readings to the One Drop App to include them in your statistics.
Force Data Transfer (Sync) If you suspect that data is not being transferred from the One Drop Meter to the One Drop App, you can force the two to sync. [1] Open the One Drop App. [2] On your One Drop Meter, press and hold the Meter Button until the Bluetooth® wireless technology symbol displays with a checkmark. CHAPTER All new data will transfer to the One Drop App and the One Drop Meter will be set with the time and date of your supported device.
[4] Results below 70 mg/dL may mean low blood glucose levels (hypoglycemia). [5] Results over 240 mg/dL may mean high blood glucose levels (hyperglycemia). Checking ketones may be advisable. [6] If you get results below 70 mg/dL or above 240 mg/dL and do not have symptoms of hypoglycemia or hyperglycemia, repeat the test.
blood glucose ranges that are right for you. [12] Prior to performing a blood glucose measurement be sure the testing environment is between the operating temperature and relative humidity range of your system (found at the back of this Guide). Expected Values/Reference Range Expected blood glucose levels for people without diabetes: Fasting <100 mg/dL, two hours after meals <140 mg/dL.4 Test Site The One Drop Meter only requires a small droplet of blood (0.
CHAPTER 4. American Diabetes Association. Classification and diagnosis of diabetes. Sec. 2. In Standards of Medical Care in Diabetes—2016. Diabetes Care 2016;39 (Suppl. 1): S13–S22 7 How to Test Your Blood Glucose Level IMPORTANT: You must pair your One Drop Meter to the One Drop App to be able to sync readings and to set your One Drop Meter’s time and date. For instructions on how to pair refer to Chapter 5.
+ - Pull the Lancet Cover Off: Hold the lancet firmly in place with one hand and use your other hand to pull off the lancet cover. Keep the lancet cover. It should be used when discarding your used lancet. + - Replace Lancing Device Cap: Replace the lancing device cap until it snaps into place. Be careful not to touch the exposed needle on the lancet. Set the Lancing Level: The One Drop Lancing Device offers five depth settings. Slide the depth adjustment slider to the desired setting.
[2] Insert a Test Strip: Insert a new One Drop Test Strip into the One Drop Meter’s test strip port. Make sure you insert the One Drop Test Strip, with the contact bars facing towards you, into the test strip port. The One Drop Meter will turn on. [3] Meter Ready For Test: The meter now displays the apply Apply Sample to Test Stripfor [3] One to Drop Ready indicating sample testMeter strip animation, it is now ready For Theblood.
Do not squeeze directly around the lanced area! [6] Bring One Drop Test Strip to Blood Sample Immediately bring the One Drop Meter with the inserted One Drop Test Strip to the blood sample at a 90 degree angle. The test strip fills from the tip. Do not try to smear blood on the top surface. The One Drop Test Strip acts like a sponge and draws the blood into itself through the sample area. This is the visual fill window. DO NOT apply blood here.
[7] Remove Your Finger From the One Drop Test Strip When the Visual Fill Window Completely Turns Red and the One Drop Meter Beeps During testing, the sample applied symbol will appear on the One Drop Meter’s screen and the One Drop Meter will beep when you should remove the One Drop Test Strip from the blood sample. window will turn RED. CAUTION: If the visual fill window does not completely fill, you may get an inaccurate result. Retest and ensure that the visual fill window is completely full.
PRECAUTIONS: • Remove the One Drop Test Strip from the blood sample as soon as the One Drop Test Strip’s visual fill window completely turns red (you will also hear a beep). • Do not press the One Drop Test Strip against the test site. • Do not scrape blood onto the One Drop Test Strip. • Do not apply blood to the top side of the One Drop Test Strip. • Do not apply blood to the One Drop Test Strip when the One Drop Test Strip is out of the One Drop Meter.
Carefully read the test results on the One Drop Meter screen before making any treatment decisions. Glucose Display Messages CAUTION: Low or high blood glucose test results can indicate a potentially serious medical condition. Follow your healthcare professional’s recommendations. LOW MESSAGE: Glucose test result is lower than 20 mg/dL. This low result may indicate hypoglycemia (low blood glucose). It also indicates that the result is below our measuring range. The low result is stored in the meter.
may indicate hyperglycemia (high blood glucose). It also indicates that the result is above our measuring range. The high result is stored in the One Drop Meter. On the One Drop App it will be saved as a test result of >600 mg/dL with time and date. The value will be represented as 600 mg/dL in the statistics in the One Drop App. ACTIONS: If you feel symptoms such as fatigue, thirst, excessive urination, or blurry vision, follow your healthcare professional’s recommendations.
careful not to touch the lancet tip. Place the lancet cover onto a hard, even surface (such as a tabletop) with the open end facing up. While the lancet is still in the lancing device, bring the lancet tip to the lancet cover to recover the used lancet. You can then safely handle the used lancet. + - Extract the Lancet from the Lancet Holder Cup by holding the body of the lancing device and sliding the Lancet Ejector forwards to push the Lancet out of the Lancet Holder Cup.
CHAPTER WARNING: The information from the One Drop App should only be used as a reference. Do not make treatment decisions based solely on the information provided by the One Drop App. All health-related decisions should be made in conjunction with the advice of a qualified healthcare professional (HCP). It is important that you and your HCP understand how the statistics are calculated before making any adjustments to treatment.
If it was a control solution test result, the control solution icon will appear to the right of the test result. Example Result: Test results without a set time and date will be displayed on your One Drop Meter with “--:--“ and “--/--“ in place of the time and date. These readings will not sync to the One Drop App. [2] Viewing All Stored Test Results Continue pressing the One Drop Meter button to view every test result, starting from the most recent and ending with the oldest.
of infectious diseases thereby killing the bacteria and viruses that you cannot see. Cleaning Cleaning is the physical removal of organic soil from the One Drop Meter and lancing device surfaces. Cleaning allows for successful disinfection when using the recommended wipes and process for cleaning and disinfecting outlined below. Disinfection Disinfection is a process that destroys pathogens, such as viruses and other microorganisms, on the One Drop Meter and One Drop Lancing Device surfaces.
When should you clean and disinfect your One Drop Meter and One Drop Lancing Device? · We recommend that you clean and disinfect once a week, since you are the only person operating them. · If the One Drop Meter is being operated by a second person who is providing testing assistance to the user, the One Drop Meter and One Drop Lancing Device should be cleaned and disinfected prior to being handled by the second person.
test result falls out of control range, call Customer Service at 1 (800) 437-1474.
ing method: a. Wipe up and down 3 times. b. Wipe left and right 3 times. c. Avoid getting disinfectant inside the One Drop Test Strip port. [2] With a new disinfecting wipe, disinfect your One Drop Meter and One Drop Lancing Device using the disinfecting wipe listed in the table above and follow the instructions below. In addition, follow the instructions on the disinfecting wipe container label for safe handling of the wipes.
You should wash your hands thoroughly with soap and water after handling the One Drop Meter, One Drop Lancing Device, lancet, and One Drop Test Strip. CHAPTER If you require technical assistance regarding cleaning and disinfecting your One Drop Meter or lancing device, call Customer Service at 1 (800) 437-1474. 10 Batteries Your One Drop Meter comes with two preinstalled CR2032, 3 volt, lithium batteries. CR2032 CR2032 Batteries are harmful if swallowed. Keep away from small children.
batteries must be replaced. IMPORTANT: When the batteries are replaced, the time and date will be erased from your One Drop Meter. You must sync your One Drop Meter with your supported device to ensure your readings have time and date. To sync your One Drop Meter, see instructions in Chapter 5, Page 17. Removing the batteries does not affect the stored glucose records. NOTE: Dispose of used batteries according to your local environmental regulations. Your One Drop Meter is also an electronic device.
[3] Install the New Batteries Install the new batteries with the positive (+) sign facing up towards you. CR2032 CR2032 CHAPTER [4] Close Battery Door Slide the battery door onto the One Drop Meter. Make sure that the battery door is completely closed before using One Drop Meter. 11 Error Messages The One Drop Meter is designed to work accurately under most usual conditions. On rare occasions, the One Drop Meter will display an error message instead of a glucose result.
CAUTION: In certain cases, the One Drop Meter may return an error code or provide an inaccurate result if it is being used near electrical equipment, like a power generator. CAUTION: If you get repeated error messages and are experiencing symptoms of hypo or hyperglycemia, contact your healthcare professional immediately as this may indicate low or high glucose. If this error code persists on retesting, consult your healthcare professional.
ing a new One Drop Test Strip. Ensure that enough blood is applied to the One Drop Test Strip when retesting. [2] The sample may not be blood or control solution. Retest using a new One Drop Test Strip. Ensure that the test site is clean prior to performing a blood glucose test or that the control solution bottle tip is wiped clean prior to performing a control solution test. Error 3 The meter has detected that the One Drop Test Strip is in poor condition.
The One Drop Meter was unable to produce a result or unusual One Drop Test Strip problems have occurred that may be related to extreme conditions. [1] This error may be caused by extremely high glucose. If you are experiencing symptoms of hyperglycemia, contact your healthcare professional immediately. If this error code persists on retesting, call Customer Service or consult your healthcare professional.
[2] If this error code persists on retesting, call Customer Service. The phone number is printed on the back of your One Drop Meter. Error 7 One Drop Meter problems have occurred that are beyond your control. Contact Customer Service for assistance. The phone number is printed on the back of your One Drop Meter. Error 8 A problem has occurred related to the One Drop Meter hardware. Contact Customer Service for assistance. The phone number is printed on the back of your One Drop Meter.
of 50°F to 104°F (10°C to 40°C) and relative humidity range of 10% to 90%. Wait for the One Drop Meter and One Drop Test Strips to reach the new temperature (usually 10-20 minutes) before using the One Drop Meter or performing a test. HIGH TEMPERATURE MESSAGE The One Drop Meter is above its system operating temperature range of 50°F to 104°F (10°C to 40°C). CHAPTER ACTIONS: Move to an area with an ambient temperature range of 50°F to 104°F (10°C to 40°C) and relative humidity range of 10% to 90%.
down, wrong end in, or incompletely inserted into the One Drop Meter. ACTION Remove the One Drop Test Strip from the One Drop Meter’s test strip port. Reinsert the One Drop Test Strip with the black side up and the end of the One Drop Test Strip with contact bars inserted up into the One Drop Meter’s test strip port. Ensure that the One Drop Test Strip is fully inserted. [3] CAUSE Defective One Drop Meter or defective One Drop Test Strips. ACTION Call Customer Service.
sample. [3] CAUSE Defective One Drop Meter. ACTION Call Customer Service. The phone number is printed on the back of your One Drop Meter. Troubleshooting Situation #3 Meter results are not syncing to the supported device. [1] CAUSE The One Drop Meter and supported device are not properly paired or were not initially synced. ACTION See Chapter 5 to pair your One Drop Meter with your supported device.
will not sync to the One Drop App. See Chapter 5 to pair and sync your One Drop Meter with your supported device. The date and time on the One Drop Meter will be set to the date and time on your supported device. Future blood glucose test results will have a time and date and will sync to the One Drop App. [5] CAUSE One Drop Meter is paired with more than one supported device and blood glucose test results are syncing to another supported device.
Troubleshooting Situation #4 One Drop Meter is paired with more than one supported device but results are not syncing to all supported devices. (For example, your One Drop Meter is paired with an iPhone® and Android™ phone, but results are only syncing to the iPhone®). CAUSE One Drop Meter only establishes a connection with one supported device at a time. ACTION If you sign in to your account on both devices, results will sync between the devices through the cloud.
[3] CAUSE One Drop Meter is paired with another supported device. ACTION Turn off Bluetooth® wireless technology on any devices already paired with your meter. This will ensure connection with your additional supported device. Troubleshooting Situation #6 Passkey does not appear on the One Drop Meter when pairing with a supported device. [1] CAUSE The One Drop Meter has previously been paired with the supported device.
supported device. The date and time will be set to the date and time on your supported device. Future blood glucose test results will appear with a date and time. [2] CAUSE One Drop Meter has not synced after replacing the batteries. ACTION See Chapter 5 to sync your One Drop Meter with your supported device. [3] CAUSE Meter time and date has returned an error. ACTION Remove batteries, wait 30 seconds, then re-install. Sync meter with your supported device before attempting another test.
CHAPTER 13 One Drop System Specifications TECHNICAL SPECIFICATIONS Assay Method: Dynamic Electrochemistry Maximum Altitude: 10,000 feet Calibration: Plasma equivalent Coding: No Code Control Solution Storage Temperature: 36°F to 86°F (2°C to 30°C) Sample: Whole blood, capillary Blood Sample Size: 0.
Equipment not suitable for use in the presence of flammable mixtures. CHAPTER When disposing of your One Drop Meter follow all local environmental regulations. 14 Electrical Safety and Standards In locations where cell phone use is not permitted, such as some hospitals and some healthcare professional offices, the meter should be off. The One Drop Meter has been tested and found to be appropriate for use at home.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. FCC guidelines help ensure that the One Drop Meter will not affect the operation of other nearby electronic devices. Additionally, other electronic devices should not affect the use of your meter.
CHAPTER Contains Transmitter Module FCC ID: QOQBLE113 15 Warranty Warranty Terms We offer customers who buy (“You”) a new blood glucose meter (defined as “One Drop Meter”) within the United States the following purchase protections. We extend a limited lifetime warranty to customers who buy a new One Drop Meter. Under this limited warranty, Your new One Drop Meter is covered for the period of ownership as long as it has not been modified, altered, or misused.
8100-10216 Rev B
