Element

Element
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Element

Product catalog summary
Introduction
The ElementTM Blood Glucose Monitoring System is designed for self-testing of blood glucose levels to aid in diabetes management. It is intended for in vitro diagnostic use only and should not be used for diagnosing diabetes or testing newborns. The system is calibrated for plasma to allow easy comparison with laboratory methods.
System Components
The kit includes a test meter, test strips, a lancing device, sterile lancets, an operation manual, a warranty registration card, a patient logbook, a carrying case, and two 3V Li-CR2032 batteries.
Usage Instructions
Setting Up the Meter: Features automatic coding, user ID options, and stores test results with date and time. Ensure correct test unit and date/time settings.
Testing Procedure: Use fresh capillary whole blood only. Store test strips in a cool, dry place and avoid expired strips.
Glucose Control Solution Test: Perform if meter or strips are suspected faulty or results are inconsistent with symptoms. Solution expires 3 months after opening.
Maintenance and Safety
Care: Keep the meter away from moisture, dirt, and direct sunlight. Do not disassemble.
Safety: Handle blood samples carefully and keep the system out of reach of children.
Limitations and Interferences
Accurate with fresh capillary whole blood. May not be accurate for individuals in shock, with dehydration, or certain medical conditions. High concentrations of substances like acetaminophen or vitamin C may affect results.
Performance Characteristics
Measurement range is 10 to 600 mg/dL (0.6-33.3 mmol/L). Functions accurately at altitudes up to 10,000 feet.
Troubleshooting and Support
Consult troubleshooting section or contact a representative for assistance. Consult healthcare professionals for diabetes management guidance.
Specifications and Recommendations
Guidelines for using the test meter and control solutions. Emphasizes correct range on test strip vial and potential issues if results fall outside expected range. Recommends using control solutions at room temperature with different levels for accuracy.
Testing Procedures
Ensure all necessary items are available before testing. Advises against sharing lancing devices and emphasizes using new, sterile lancets for each test. Provides detailed steps for preparing the lancing device, collecting a blood sample, and using the test meter.
Precautions and Best Practices
Do not reuse lancets, avoid contamination, and dispose of used lancets in biohazard containers. Avoid testing under direct sunlight and ensure correct blood volume for accurate results.
Data Management
The meter stores up to 365 test results and calculates average sugar levels over preset periods. Instructions for using user ID and activity options to organize test data.
Alternative Site Testing (AST)
Discusses using alternative sites for testing and warns of potential differences from fingertip samples. Recommends fingertip testing for hypoglycemia concerns.
Blood Sample Collection Procedure
Massage the test site to bring fresh blood to the surface. Use the lancing device and apply the blood glucose test strip to the drop. Ensure the blood fills the strip completely.
Data Transfer and Software
Test results can be transferred to a computer using a USB cable. Software available for download from the manufacturer's website.
Maintenance and Cleaning
Keep the meter clean and stored in its case. Clean the lancing device with soap and water, and disinfect with a bleach solution.
Battery Replacement
Uses two 3V Lithium batteries (CR2032). Replace when the low battery icon appears. Dispose of batteries according to local regulations.
Troubleshooting
Common issues include problems with the test strip, insufficient blood samples, and temperature-related errors. Follow specific actions to resolve these issues.
Specifications
Operates with capillary whole blood, has a test range of 10-600 mg/dL, and provides results in 3 seconds. Functions within a temperature range of 10-40°C and humidity of 10-90%.
Warranty
Comes with a three-year warranty covering defects, excluding misuse or damage. Applies to the original purchaser.
Symbols and Compliance
Includes symbols for compliance and safety standards, such as in vitro diagnostic medical devices and waste disposal regulations.
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Catalog excerpts

Element-1

Blood Glucose Monitoring System

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Element-2

Blood Glucose Monitoring System

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Element-3

Dear ElementTM Blood Glucose Monitoring System Owner Thank you for choosing the ElementTM Blood Glucose Monitoring System. This booklet has important information you must know about the ElementTM Blood Glucose Monitoring System. Please read it carefully. We understand that self-testing of blood glucose level provides a way to control your diabetes and may give you peace of mind by testing regularly. As a result ElementTM was developed to provide you with a fast and accurate reading with a convenient and simple process. Our goal at ElementTM is to provide the best quality healthcare products coupled...

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Element-4

Intended use of Element™ Blood Glucose Test Meter 7 Element™ Blood Glucose Monitoring System Kit Contents 8 Element™ Blood Glucose Test Meter 9 Element™ Blood Glucose Test Meter Display 10 Element™ Blood Glucose Test Strip Information 11-12 Setting your blood glucose test meter 13-14 Performing a Glucose control solution test 16-17 3. Testing Your Blood Glucose Testing Your Blood-Preparation 18 Collecting a Drop of Blood 19-21 Testing Your Blood - Case of Setting user Option and ID 25 Test Strip Ejector Funtion 26 4. Reviewing Your Results 27-28 5. Deleting Test Results 29 6. Alternate Site Testing...

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Element-5

ElementTM Blood Glucose Monitoring System KIT Contents ElementTM Blood Glucose Test Meter Test Strip Port: Insert the ElementTM test strip here Test Strip Ejector Display Screen: Displays your test results, symbols and messages. Function Button: Powers the meter on/off, prompts memory data and acts as an enter button during setup and after tests. Up/Down Arrow Buttons: Adjusts setting, scrolls through memory Serial Number 1. ElementTM Blood Glucose Test Meter 2. ElementTM Blood Glucose Test Strips 3. Lancing Device 4. Infolet sterile lancents 5. Operation Manual 6. Warranty Registration Card...

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Element-6

Element™ Blood Glucose Test Meter Display < III Low Battery Warning Symbol Strip Code Symbol Blood drop symbol for test ^) Before Having a Meal (Q) After Having a Meal P After Sports Activity After Taking Medication BB'BB Time / Test Result Amount ■■M/LM/dL Test Result Unit Symbol ^ Control Solution Symbol AVR Average Test Result System Element™ Blood Glucose Test Strip Information Storage and Handling Caution 1. Keep out of direct sunlight. 2. Store the Element™ Blood Glucose Test Strip vials in a cool, dry place between 2-30 3. Make a notation of the discard date on the vial label when you...

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Element-7

ElementTM Blood Glucose Test Strip Information Limitations of System : ElementTM blood glucose test strips provide accurate results when the following constraints are observed: • Use Element™ blood glucose test strip with Element™ blood glucose test meter and Element™ Multi test meter. • Use fresh capillary whole blood only. Do not use plasma or serum. • Do not use neonate samples. • The blood glucose test strips are for single use only. Do not reuse. • Dehydration may higher test results. If you are severely dehydrated, contact your physician immediately • Inaccurate results may occur when in...

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Element-8

Setting Your Blood Glucose Test Meter Auto-Coding Function 1. ElementTM has automatic code recognition function. AVR Temperature unit Press and release eithe buttons to set or button. Number of days for average or Alarm on/off After pressing and releasing either or buttons to set the number of days for average calculation (3 different possible), confirm with . After pressing and releasing either or buttons to turn the alarm on/off, confirm with . Alarm time After pressing and releasing either or buttons to set the alarm hour and minute, confirm with . 2. It recognizes automatically the code number....

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Element-9

Performing a Glucose Control Solution Test The glucose control solution should be used when there is suspicion that the blood glucose test meter or the blood glucose test strips are not working properly. For example: if strips have been exposed to extreme conditions or if you drop the blood glucose test meter. Check the expiration date before performing a glucose control solution test. Do not use if expired. Once opened, solution expires after 3 months. The Glucose control solution should be used • Whenever you suspect the blood glucose test meter or blood glucose test strip is not functioning...

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Element-10

Testing Your Blood - Preparation Before testing, be sure to read this section and blood glucose test strip package insert found in the blood glucose test strip box carefully. Make sure you have all the necessary items to begin testing: • ElementTM blood glucose test meter • ElementTM blood glucose test strip • Lancing Device • Sterile Lancets CAUTION To reduce the chance of infection. • The Lancing Device and sterile lancets should NOT be shared with others. • Always use a new, sterile lancet and new blood glucose test strip. • Lancets are for single use only. DO not reuse. • Avoid getting hand...

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Element-11

Collecting a Drop of Blood Collecting a Drop of Blood Disposing of your lancet 1. Unscrew the tip of the lancing device by turning it counter-clockwise while holding the base firmly. 2. With two fingers, pull out the lancet carrier and hold it in place. 3. While holding the lancet carrier, insert a new sterile lancet into the bottom of lancet carrier. 1. Push the needle into the protective cover. 2. Pull the lancet out and discard accordingly. Recommended Available Lancing Device infopia®, Element™ sterile Lancet is used with a Lanzo Lancing device. Note : Please, contact your supplier to make...

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Element-12

Testing Procedure Testing Procedure Correct Completely Filled Incorrect Step 1 • Firmly insert the blood glucose test strip into the blood glucose test meter port with the “infopia” facing towards you. • The blood glucose test meter automatically turns on displaying the code, ambient temperature and the date and time. • The ElementTM will automatically recognize the blood glucose test strip code number. • A blinking blood glucose test strip will appear at the top of the screen indicating the blood glucose test meter is ready for testing. * For a more accurate test results avoid testing under...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.