Clarity BG1000 Procedures Manual Download Page 20

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PROCEDURE MANUAL

____________________________________________________________________________
Product Code: CD-BG1
Rev01.06042018

Page

Manufactured for:

Clarity Diagnostics, LLC.

1060 Holland Drive, Suite A&D

Boca Raton, FL 33487 USA

Call Customer Service Toll Free

Mon-Fri 8:30AM-5:30PM EST

1-877-722-6339

or visit our website www.claritydiagnostics.com

If you have questions or need assistance outside the operational days and times, please

contact your healthcare provider.

Summary of Contents for BG1000

Page 1: ... with FDA labeling regulation 21 CFR 809 10 Prepared in accordance with the guidelines recommended by the Clinical and Laboratory Standards Institute Wayne PA 19087 CLSI Document GP2 A2 Clarity Diagnostics provides CLSI procedures for your use The procedures are required to include the same information as listed in the package insert Any modifications to this document are the sole responsibility o...

Page 2: ...lucose measurements are reported as plasma equivalents This system uses a plasma equivalent method Results that use a plasma equivalent method are approximately 11 higher than those obtained with whole blood equivalent test strips Special Features Accurate result in 5 seconds using only 0 5µ1 blood sample The Clarity BG1000 Blood Glucose Meter identifies the test strip code automatically Stores up...

Page 3: ...dled at the same temperature For accurate test results keep the Clarity BG1000 Blood Glucose Monitoring System operating temperature at a range between 50 104 F for more than twenty 20 minutes before testing You may use this system at altitude up to 10 000 feet Keep your Clarity BG1000 Blood Glucose Meter lancing device and control solutions out of reach of children Clean and disinfect your Clarit...

Page 4: ...stitution A drop of blood is required to perform a blood glucose test Only fresh capillary blood can be used The Complete Medisign BG1000 Blood Glucose Monitoring System The Clarity BG1000 Blood Glucose Monitoring System includes the Clarity BG1000 Meter Carrying Bag User Manual Warranty Card and 2 3 0 Volt CR2032 Lithium Batteries Clarity BG1000 Test Strips Clarity BG1000 Glucose Control Solution...

Page 5: ...cose Test Strip Use Clarity BG1000 Blood Glucose Test Strips with the Clarity BG1000 Blood Glucose Meter Check the expiration date of your test strips before using Write the opening date of the new test strip vial in order to avoid using any expired products Explanation of Display Testing Your Blood Glucose Disinfect Before Testing Before testing let patients wash hands with soap and water and dry...

Page 6: ...agnostics Customer Support at 1 877 722 6339 3 When the blood symbol appears you can proceed with the test 4 Choose a sample site on the outer edge of one finger but try to avoid the index finger or thumb Place the sampling device s platform against the finger and take the sample Always choose a different finger each time to avoid soreness 5 Gently squeeze the patients finger to assist the flow of...

Page 7: ...ancing devices should be used Always dispose of the used auto disabling single use lancing devices in a biohazard container Keep your Glucose Meter test strips control solution and auto disabling single use lancing devices out of reach of pet or children at all times Do not reuse auto disabling single use lancing devices Those are for single use only The user needs to adhere to the Standard Precau...

Page 8: ...cise Do not use alternative site testing if patient glucose level is not as stable as usual or if you think the patient may have hypoglycemia low blood glucose hyperglycemia high blood glucose or you think the patients blood glucose may be rising or falling rapidly Do not use alternative site testing if the patients alternative site testing results do not match the way they feel AST measurements s...

Page 9: ...d flow to the forearm than to the fingertips To help patients get a large enough drop of blood you may gently massage or apply warmth to their site to increase blood flow Palm sampling Choose a fleshy area on the palm below the thumb or little finger Select an area away from veins or deep creases which may cause the blood sample to smear NOTICE You may need to wait a little longer to get a large e...

Page 10: ...he meter can be set to show the time in AM PM 12 hour format or 24 hour Military Time With the 12h blinking press the C Button to move between 12h and 24h then press the M Button to set and move to the hour setting 6 Setting the Hour When the hour blinks press and release the C Button until the correct hour appears then press the M Button to set the correct hour and move to the minute setting 7 Se...

Page 11: ... you have any questions about measuring units 10 Turning the Beep Sound On or Off The meter has the Beep sound defaulted to On To turn the Beep sound off on the meter press the C Button until OFF is displayed on the screen then press the M Button to confirm and move to Deleting Your Test Results NOTICE Turning the Beep sound On or Off does not affect your glucose measurement 11 Deleting Your Test ...

Page 12: ... the M Button to turn off the meter NOTICE The meter has an automatic shut off and will turn off in roughly two 2 minutes if no changes are detected Downloading Test Results to PC You can transfer test results from the Clarity BG1000 Blood Glucose Meter to a computer where they can be summarized in a report with graphs and tables To use this feature you will need to download the Clarity BG1000 Dia...

Page 13: ...ntrol solution to the tip of the test strip 4 When the test strip confirmation window is full the meter will beep The meter will count down from five seconds and then show the reading Make sure the reading on the screen is between the ranges displayed on your test strip vial refer to page 39 for the control solution ranges 5 Mark all control solution test with Control Solution Mark to distinguish ...

Page 14: ...u can get this product from large online retail distribution sites such as www amazon com www officedepot com etc CaviWipes disinfectant products have been shown to be safe for use with the Clarity BG1000 Blood Glucose Monitoring System Please note any disinfectant product with the EPA registration number of 46781 8 may be used on the Clarity BG1000 Blood Glucose Meter The Clarity BG1000 Blood Glu...

Page 15: ...tting Bloodborne Pathogens 2010 http www cdc gov injectionsafety Fingerstick DevicesBGM html For more information on cleaning and disinfecting contact Clarity Diagnostics Customer Service at 1 877 722 6339 CAUTION Squeeze the excess liquid from the cloth before you wipe the meter s surface The meter must be off when you clean or disinfect the meter Do not get moisture on the test strip or in the t...

Page 16: ...rner This indicates that there is only enough power left in the meter for about fifty more tests and the batteries should be replaced When replacing the batteries your test results will be stored in the meter however you may need to reset the date and time Refer to pages Setting up Your Meter for more information 2 Open the battery compartment lid on the back of the meter and remove the batteries ...

Page 17: ...PROCEDURE MANUAL ____________________________________________________________________________ Product Code CD BG1 Rev01 06042018 Page 17 of 20 Troubleshooting ...

Page 18: ...PROCEDURE MANUAL ____________________________________________________________________________ Product Code CD BG1 Rev01 06042018 Page 18 of 20 Technical Information and Warranty Specifications ...

Page 19: ... follows Before eating 100 mg dl 2 hours after meals 140 mg dl In case results are out of reference range please contact a healthcare professional and follow their advice Reference American Diabetes Association Clinical Practice Recommendations 2015 Diabetes Care Vol 38 Supplement 1 p S1 S93 EMC Test Results It is the manufacturer s responsibility to provide equipment electromagnetic compatibility...

Page 20: ...f 20 Manufactured for Clarity Diagnostics LLC 1060 Holland Drive Suite A D Boca Raton FL 33487 USA Call Customer Service Toll Free Mon Fri 8 30AM 5 30PM EST 1 877 722 6339 or visit our website www claritydiagnostics com If you have questions or need assistance outside the operational days and times please contact your healthcare provider ...

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