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OPERATIONS & QUALITY ASSURANCE

PROCEDURE MANUAL

For

Healthcare

Professionals

CAMBRIDGE SENSORS USA, LLC

10051 Bode Rd. Plainfield, IL 60585

Customer Service:

toll free: 877.374.4062 Monday–Friday 8am–5pm CST  

www.microdotcs.com

FAST. ACCURATE. EASY TO USE.

Summary of Contents for microdot

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

Page 2: ......

Page 3: ...dot Blood Glucose Meter Log Sheets 7A Microdot BGMS In Service Form 7B Microdot BGMS Qualified Trainers Form 7C Microdot BGMS Qualified Trainer Operator Certification Form 7D Microdot BGMS Quality Con...

Page 4: ...Microdot 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 Te...

Page 5: ...test 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 bat...

Page 6: ...reaction takes place Only 600 nanoliters 0 6 microliters is needed The Microdot Test Strip consists of the following parts Top Edge Apply a drop of blood here where the white channel meets the top of...

Page 7: ...n 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...

Page 8: ...ton 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...

Page 9: ...e 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 memo...

Page 10: ...ed period of time It is critical to follow the Operating Guidelines on the right to obtain accurate results while using the Microdot Glucose System Operating Guidelines Use only Microdot Control Solut...

Page 11: ...rol 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...

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...

Page 13: ...ips 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 ins...

Page 14: ...ip 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...

Page 15: ...ple 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 Coeffic...

Page 16: ...Temperature Range 3 Set Time and Date of meter 4 Identify three parts of the Microdot Test Strips Top Edge Test Pad Contact Bars 5 Identify the following parts of the Microdot Control Solution Bottles...

Page 17: ...SYSTEM 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 C...

Page 18: ...the Microdot 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 M...

Page 19: ...COSE MONITORING SYSTEM QUALIFIED TRAINERS FORM Date Health Care Professional s Name Title Cambridge Sensors Representative Cambridge Sensors Representative Signature Date Chapter 7 17 Cambridge Sensor...

Page 20: ...ontrol 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...

Page 21: ...Y CONTROL RECORD Date Microdot 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...

Page 22: ...tional 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 REQUI...

Page 23: ...upational 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 pro...

Page 24: ...rking 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 Equipm...

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 ca...

Page 26: ...y 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 Ho...

Page 27: ...low 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 pro...

Page 28: ...Notes 26 Cambridge Sensors USA LLC...

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 8am 5pm CST www microdotcs com...

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