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Consult Instructions for Use prior to using the Avie

 A1c System 

 

Serial Number:  The Reader serial number is located on the bottom of the 
Reader 

 

 

Temperature Limitation:  The Avie

 A1c system is intended to be used 

between 65 to 82°F (18 to 28 °C)  10 to 80% non-condensing relative 
humidity 

 

 

 

 
Do Not Reuse:  The Test Cartridges and Diluent vial  are intended for one 
time use only 

 

Use By:  Test Cartridge, Diluent, and Controls must be used by the 
expiration date marked on their labels. 
 

 

Batch Code:  The lot number of the Test Cartridge may be found on the 
cartridge vial and the Diluent on the vial and outer packaging.  
 

 

Manufacturer: MEC Dynamics, Inc. 
                         2225 Martin Ave. Suite I  
                         Santa Clara, California 95050 
 

    

 

 

1.7 

Ordering Information 

You may order the following products through your authorized MEC Dynamics Corp. 
distributor or by contacting the Customer Service Department at MEC at 408 844 9280 
          
          
       Part Number               Description 
          

FIN0003 Avie

 A1c Physician Directed Home Use System Kit 

FIN0004 Avie

 A1c Professional System Kit 

FIN0005 Avie

 A1c Reader 

FIN0006 Avie

 A1c Professional Test Cartridge (box of 100 with diluent) 

FIN0007 Avie

 A1c Physician Directed Home use Test Cartridge (box of 5 

with diluent) 

FIN0009 Avie

 A1c Battery Power Pack 

FIN0010 Avie

 A1c Printer and Cable 

LBM0001 Avie

 A1c System User’s Manual 

LPC0002 Avie

 A1c Use Quick Reference Guide 

FIN011 Avie

 A1c System Control Level I 

FIN012 Avie

 A1c System Control Level II 

 

Содержание Avie A1c

Страница 1: ...CHARACTERISTICS PRODUCT SPECIFICATIONS Performance Characteristics Product Specifications IV OPERATING INSTRUCTIONS Initial Setup Performing a Test Collecting a Fingerstick Sample V READER FUNCTIONS...

Страница 2: ...professional use and physician directed home use at the point of care to monitor glycemic control in diabetic patients The Avie A1c Test System provides a simple reliable way to monitor glycemic contr...

Страница 3: ...Battery section for more information and instructions on installing the batteries if a battery power pack is to be used Special Requirements To ensure that your Avie A1c Reader operates correctly be...

Страница 4: ...is less than 4 minutes The A1C test consists of two distinct quantitative areas of measurement The first area consists of a chamber where the met hemoglobin is photometrical read at 420 nm The optica...

Страница 5: ...Avie A1c Test Cartridge Power Button Turns the Reader on Display Screen shows test results and error messages Test Cartridge Guide Holds a test cartridge in place during testing Application Well...

Страница 6: ...sma Glucose GHB mg dL mmol l Interpretation 4 65 3 5 5 100 5 5 6 135 7 5 Non Diabetic Range 7 170 9 5 ADA Target 8 205 11 5 9 240 13 5 10 275 15 5 11 310 17 5 12 345 19 5 Above Target Mean blood gluco...

Страница 7: ...ally powered and Class II equipment Type BF patient applied parts System complies with EN 61326 EN61326 1 EMC Medical Products Warning This equipment generates uses and can radiate radio frequency ene...

Страница 8: ...Manufacturer MEC Dynamics Inc 2225 Martin Ave Suite I Santa Clara California 95050 1 7 Ordering Information You may order the following products through your authorized MEC Dynamics Corp distributor o...

Страница 9: ...hour before running the test Leave the cartridge in the sealed vial while doing this Avoid running the test in direct sunlight on hot cold or vibrating surfaces or near sources of heat or cold Do not...

Страница 10: ...y calluses or scars c Use the lancet as directed to puncture the skin d Apply gentle continuous pressure across the entire finger to form a hanging drop do not milk the finger see step 9 for collectio...

Страница 11: ...vial 5 times to mix the blood with the diluent DO NOT SHAKE The tube will not spill in the inverted position unless squeezed 11 Apply the sample Squeeze 3 drops of the mixture diluted sample into the...

Страница 12: ...trols are tested identically to a blood sample See section IV Operating Instructions If the results are out of range when compared to the number supplied with the control bottle repeat the test with a...

Страница 13: ...e test cartridge guide needs cleaning CAUTION DO NOT FLOOD READER WITH CLEANING SOLUTION 1 Check for blood lint or debris on the test cartridge guide If present 2 Remove by wiping with lint free cloth...

Страница 14: ...art Reader and reinsert cartridge If cartridge is used discard it ERROR REMOVE STRIP Remove Cartridge Cartridge not properly inserted or used cartridge inserted Be sure cartridge is fully inserted and...

Страница 15: ...14 A1C Repeat test if error recurs test by another method ERROR LA Result out of Range Result below 0 45 g dL A1C Repeat test if error recurs test by another method ERROR HA Result out of Range Result...

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