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Cambridge Sensors USA, LLC

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Cambridge Sensors USA, LLC

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Summary of Contents for MicroDot Xtra

Page 1: ...Xtra OPERATIONS QUALITY ASSURANCE PROCEDURE MANUAL For Healthcare Professionals FAST ACCURATE EASY TO USE ...

Page 2: ...Xtra ...

Page 3: ...Log Sheets 7A Microdot Xtra BGMS In Service Form 7B Microdot Xtra BGMS Qualified Trainers Form 7C Microdot Xtra BGMS Qualified Trainer Operator Certification Form 7D Microdot Xtra BGMS Quality Control Record 8 Material Safety Data Sheets 8A Microdot Xtra Test Strips 8B Microdot Control Solutions 9 Troubleshooting the Microdot Xtra Meter 10 Manufacturer Cleaning Instructions Notes 8 10 11 12 26 27 ...

Page 4: ...t Xtra Test Strips 3 Microdot High and Low Control Solution These products have been designed tested and proven to work together as a system to produce safe and accurate results Use only Microdot Xtra Test Strips and Control Solutions with the Microdot Xtra Glucose Meter Your system includes Microdot Xtra Meter Anti microbial Meter Cover Quality Assurance Manual Warranty Registration Card 3V Lithi...

Page 5: ... strip Serial Number Located in the upper left hand corner of the meter Required when calling Customer Service for troubleshooting or meter replacement Battery Compartment Holds one 3V Lithium battery CR2032 SN 00023463 Customer Service 888 425 1149 Customer Service Number Located on the back of the meter Call this number if you have any questions or problems with the Microdot Xtra Glucose Meter 8...

Page 6: ... reaction takes place Only 600 nanoliters 0 6 microliters is needed The Microdot Xtra Test Strip consists of the following parts Top Edge Apply a drop of blood here where the white channel meets the top of the edge strip White Channel This is where you check if enough blood has been applied to the top edge Contact Bars Insert this end of the test strip into the meter Push firmly until the strip ca...

Page 7: ...on again will now toggle between US and International Time and Date formats For US 12h Time format mm dd begins with AM setting To accept the desired setting press the M button Step 2 Set the Hour The Hour will start to flash It can now be changed by pressing the C button The US setting will begin at 12 01 AM and will move to PM To accept the correct setting press the M button Step 3 Set the Minut...

Page 8: ...n This option is used to switch on or off the beeper When turned ON a sound will be heard when blood or control solution is applied to the strip and when the test is finished The sound will be heard when an error has occurred or if an alarm is triggered When the M button is pressed to accept the beeper option the meter will display END and switch off Chapter 2 6 Cambridge Sensors USA LLC Xtra ...

Page 9: ...he last result with Mem symbol time and date Step 2 Recall Test Results Previous results can be displayed by pressing the C button As long as the C button is held the meter will scroll through the memory displaying the result and the memory location Once the button is released the meter will display the selected result with its Time and Date When the memory is full 500 results stored the oldest re...

Page 10: ...tended period of time It is critical to follow the Operating Guidelines on the right to obtain accurate results while using the Microdot Xtra Glucose System Operating Guidelines Use only Microdot Control Solutions High and Low Check the expiration date on the control solution vial Do not use if expired or if the discard date has passed Control solution meter and test strips should come to room tem...

Page 11: ...ol Solution Test Procedure 1 Shake Low Control Solution bottle well before using 2 Remove cap and discard the first drop of Control Solution and wipe off the dispenser tip to ensure a good sample and an accurate result 3 Insert a test strip into the Microdot Xtra meter Be sure the black contact bars go into the meter Push the strip in firmly Be sure it can go no further 4 Invert bottle and squeeze...

Page 12: ... test strip vial check the following Was the vial at room temperature Did you shake the bottle of control solution before using Has the control solution expiration or discard date expired Is the meter malfunctioning 7 Repeat steps 1 6 for the High Control Solution procedure If the test result is still out of range call your Microdot Customer Service Representative at Toll Free 877 374 4062 DO NOT ...

Page 13: ...strips that are wet bent scratched or damaged Use each test strip immediately after removing it from the vial Patient Test Procedure What You Do Notes 1 Press the C button to turn the meter on and or insert test strip by pushing the two contact bars in firmly To verify all display symbols are working all symbols should appear at the same time If any of the symbols are missing or do not display com...

Page 14: ...rip the Microdot Xtra Meter will display three running dashes which indicates the meter is performing the test After 10 seconds the test result will display Dispose of used lancet in an approved sharps container 6 Dispose of test strip Simply press the eject button on the meter to dispose of used test strip Note If the blood test result is lower than 20 mg dL Lo will appear on the meter display Th...

Page 15: ...le wicks into strip 30 50 20 to 525 mg dL No interference from over 20 interfering substances Strip ejection by push button Auto code At least 20 relative to YSI in clinical trials Correction Coefficient of Regression 0 969 The strip variation is not greater than 6 4 Approx 5 years 10 90 storage 90 max non condensing 50 104 F 10 40 C Plasma equivalent 50 strips per vial Printed on vial label 3 mon...

Page 16: ...eTemperature Range 3 Set Time and Date of meter 4 Identify three parts of the Microdot Xtra Test Strips Top Edge Test Pad Contact Bars 5 Identify the following parts of the Microdot Control Solution Bottles Low vs High Discard Date Lot Number Expiration Date Storage Temperature Range 6 Properly insert the Microdot Xtra Test Strip 7 Perform control solution tests 8 Document and maintain Microdot Xt...

Page 17: ...YSTEM LOG SHEETS The forms in this chapter are Master Copies Please make photocopies for distribution If you need replacement documents please contact Customer Service at 877 374 4062 Chapter 7 15 Cambridge Sensors USA LLC Xtra ...

Page 18: ...crodot Xtra Blood Glucose Monitoring System Cambridge Sensors Representative Qualified Trainer Date Health Care Professional s Name The chart is designed for use during the initial training on the Microdot Xtra Blood Glucose System by a Cambridge Sensors Representative In Service Video or QualifiedTrainer Chapter 7 16 Cambridge Sensors USA LLC Xtra ...

Page 19: ...SE MONITORING SYSTEM QUALIFIED TRAINERS FORM Date Health Care Professional s Name Title Cambridge Sensors Representative Cambridge Sensors Representative Signature Date Chapter 7 17 Cambridge Sensors USA LLC Xtra ...

Page 20: ...Control Solution b When to perform a Control Test c Handling Control Solution results that are out of range IV Perform and explain the following procedures a Control Solution testing b Blood testing c Recalling test results d Changing the battery If all tasks were not properly completed have the operator repeat the procedure correctly When all tasks have been properly completed sign bottom of this...

Page 21: ...NTROL RECORD Date Microdot Xtra Meter Serial Number Month Year Station Initials Test Strip Lot Low Control Range mg dl High Control Range mg dl Low Control Result mg dl High Control Result mg dl Notes Chapter 7 19 Cambridge Sensors USA LLC Xtra ...

Page 22: ...upational Safety and Health Administration in the Hazard Communication Standard 29 CFR 1910 1200 or the equivalent standards generated by state agencies ACCORDINGLY NO MATERIAL SAFETY DATA SHEET IS REQUIRED FOR THIS PRODUCT MSDSs that represent non hazardous chemicals are not covered by the HCS Paragraph 29 CFR 1910 1200 g 8 of the standard requires that the employer shall maintain in the work pla...

Page 23: ...cupational exposure ingestion of the product may cause choking vomiting or nausea N A N A Section IV First Aid Measures Although no adverse health reactions are expected from the normal use of this product it is recommended to flush eyes with water and seek medical advise whenever there is a potential injury to the eye If contact with this product leads to reddening inflammation or irritation flus...

Page 24: ...orking with this product Upon completion of work activities involving this product wash hands thoroughly with soap and water Respiratory Protection Ventilation Protective Gloves Other Protective Equipment Other Engineering Controls Work Practices Hygienic Practices Not determined Not determined Use fire extinguishing media appropriate for site collections Structural fire fighting gear and self con...

Page 25: ... Not determined Not determined Not determined Not determined Not determined Not determined Not determined Stable Strong bases strong acids and water reactive materials Thermal decomposition may emit carbon monoxide and carbon dioxide Section XI Ecological Information Pure Substance or preparation Appearance Odor Odor Threshold Melting Freezing Partition Evaporation Rate Vapor Pressure mmHg Vapor D...

Page 26: ...ty for specific uses The information data and recommendations contained herein are based upon information believed by Cambridge Sensors USA after reasonable investigation and research to be accurate However Cambridge Sensors USA does not warrant the accuracy of this information All materials and mixtures may present unknown hazards and should be used with caution When necessary or appropriate inde...

Page 27: ...ow You can complete about 50 more tests from the time this symbol first appears This message indicates very high blood sugar You should recheck the blood glucose level If Hi again follow facility protocol This message indicates very low blood sugar You should recheck the blood glucose level If Lo again follow facility protocol Review the instructions and try again with a new test strip If the prob...

Page 28: ... 1 mL of household bleach 5 6 sodium hypochlorite solution in 9 mL of water to achieve a 1 10 dilution final concentration of 0 5 0 6 sodium hypochlorite The solution can then be used to dampen a paper towel do not saturate the towel Then use the damped towel to thoroughly wipe down the meter Please note that there are commercially available 1 10 bleach wipes from a variety of manufactures Germici...

Page 29: ...Notes 27 Cambridge Sensors USA LLC ...

Page 30: ...Notes 28 Cambridge Sensors USA LLC ...

Page 31: ...CAMBRIDGE SENSORS USA LLC 10051 Bode Rd Plainfield IL 60585 Customer Service toll free 877 374 4062 Monday Friday 9am 5pm CST www microdotcs com ...

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