Cambridge Sensors microdot Operation Manual

Operations & quality assurance procedure manual

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FAST. ACCURATE. EASY TO USE.
OPERAT IONS & Q U A L ITY A SSUR ANCE
PRO C E D U R E M ANUA L
For
Healthcare
Professionals

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Summary of Contents for Cambridge Sensors microdot

  • Page 1 FAST. ACCURATE. EASY TO USE. OPERAT IONS & Q U A L ITY A SSUR ANCE PRO C E D U R E M ANUA L Healthcare Professionals...
  • Page 3: Table Of Contents

    Contents TABLE OF CONTENTS Chapter Page 1. Microdot® Meter Overview & System Components 2 - 4 2. Initial Setup of the Microdot Meter 5 - 7 3. Control Solution Testing 8 - 10 4. Testing with Patients 11 - 12 5.
  • Page 4 Chapter 1 BLOOD GLUCOSE METER OVERVIEW ® This section provides general information on the Microdot Blood Glucose Monitoring System The Microdot Blood Glucose Monitoring These products have been designed, System is a portable whole blood testing tested and proven to work together...
  • Page 5: System Components

    877.374.4062 Battery Compartment: Holds one 3V Lithium battery (CR2032). Customer Service Number: Located on the back of the meter. Call this number if you have any questions or problems with the Microdot Glucose Meter. (877) 374-4062 Cambridge Sensors USA, LLC...
  • Page 6 ® The Microdot Blood Glucose Test Strip offers the latest advances in biosensor, auto-code technology. Blood is applied to the top edge of the Microdot Test Strip and is automatically drawn into the white channel where the reaction takes place. Only 600 nanoliters (0.6 microliters) is needed.
  • Page 7: Initial Setup Of The Microdot Meter

    INITIAL SETUP OF THE METER ® Before using the Microdot Meter for the first time, you should set the actual Time, Date and Year. The unit of measurement is preset and can not be changed. Setting the Time, Date and Year Enter the Set Mode.
  • Page 8 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. Cambridge Sensors USA, LLC...
  • Page 9 ® Using Meter Memory Your Microdot Meter stores the 500 most recent blood glucose and control solution test results and insulin data with date and time in the memory. It also provides you with 14-day averages of your blood glucose test results.
  • Page 10: Control Solution Testing

    Chapter 3 CONTROL SOLUTION TESTING This chapter describes the necessary steps to test with the Microdot® Control Solutions in order to validate the performance of the MicrodotMeter and Microdot Strips. Operating Guidelines: When Should You Conduct a Control Solution Test?
  • Page 11 Solutions only. It is used to check the meter and test strip performance. 3. Insert a test strip into the Microdot It is NOT a recommended range for meter. Be sure the black contact bars your blood glucose level. When go into the meter.
  • Page 12 5. Compare the results with the ranges of If the test result is still out of range, expected results shown on the test strip call your Microdot® Customer Service Representative at: vial. (Low = Blue Cap, High = Red Cap) 6.
  • Page 13: Testing With Patients

    Chapter 4 TESTING WITH PATIENTS This section describes the procedure to test patient blood samples using the Microdot® Blood Glucose System. Operating Guidelines Before attempting to test with real blood, make sure you have performed control solution tests correctly to ensure the meter and test strips are performing properly and to verify technique.
  • Page 14 Either reinsert the test strip or press the M button to turn the meter back on. After an adequate blood sample has been 4. Results in applied to the test strip, the Microdot® 10 seconds. Xtra Meter will display three running dashes, which indicates the meter is performing the test.
  • Page 15: Meter Specifications

    Glucose Units Total of 500 glucose results and insulin-input data Memory Power Source One replaceable 3V lithium battery (CR2032 or equivalent) One minute after last user action Automatic Shut-off 1 Year Manufacturer Warranty Warranty Cambridge Sensors USA, LLC...
  • Page 16: In-Service Training Outcomes

    Chapter 6 IN-SERVICE TRAINING OUTCOMES Once your Microdot® Meter in-service is complete, Health Care Professionals should be able to: 1. Locate and explain the following 5. Identify the following parts of the components of the Microdot Meter: Microdot Control Solution Bottles: Eject Button Low vs.
  • Page 17: Blood Glucose Monitoring System

    Chapter 7 BLOOD GLUCOSE MONITORING 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 Cambridge Sensors USA, LLC...
  • Page 18 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 Microdot Blood Glucose System by a Cambridge Sensors Representative, In-Service Video or Qualified Trainer. Cambridge Sensors USA, LLC...
  • Page 19 Chapter 7 BLOOD GLUCOSE MONITORING SYSTEM ® QUALIFIED TRAINERS FORM Date Health Care Professional’s Name Title Cambridge Sensors Representative Cambridge Sensors Representative Signature Date Cambridge Sensors USA, LLC...
  • Page 20 Control Solution Procedure c. Troubleshooting III. Explain proper procedure for: a. Dating of Microdot Xtra Test Strips and 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.
  • Page 21 Chapter 7 BLOOD GLUCOSE MONITORING SYSTEM ® QUALITY CONTROL RECORD Microdot Meter Serial Number Month/Year High High Control Control Control Control Station/ Test Strip Range Result Range Result Date Initials Lot # Notes: (mg./dl.) (mg./dl.) (mg./dl.) (mg./dl.) Cambridge Sensors USA, LLC...
  • Page 22 Blood Glucose Test Strips ® Section I - Identification Trade Name: Microdot Blood Glucose Test Strips Common Name: Blood glucose test strips for use with Microdot Blood Glucose Test System Supplier: Cambridge Sensors USA 10051 Bode Rd. Palinfield, IL 60585...
  • Page 23: Microdot Control Solutions

    MATERIAL SAFETY DATA SHEET Microdot® Control Solutions Section I - Identification Trade Name: Microdot Control Solutions Common Name: Control Solutions for use with Microdot Xtra Blood Glucose Test System Supplier: Cambridge Sensors USA 10051 Bode Rd. Palinfield, IL 60585 Emergency Phone Number:...
  • Page 24 Chapter 8 MATERIAL SAFETY DATA SHEET Microdot® Control Solutions Section V - Fire Fighting Measures Auto-flammability Not determined Flash Point (test method) Not determined Extinguishing Media Use fire extinguishing media appropriate for site collections. Special Fire Fighting Structural fire fighting gear and self-contained breathing...
  • Page 25 Chapter 8 MATERIAL SAFETY DATA SHEET Microdot® Control Solutions Section IX - Physical and Chemical Properties Pure Substance or preparation Preparation Physical Form Liquid Appearance/Odor Blue, odorless pH AS is neutral Odor Threshold Not determined Melting/Freezing Not determined Partition Not determined...
  • Page 26 Customer’s sole and exclusive remedy shall be replacement of the product or return of the product and refund of the purchase price, at Cambridge Sensors USA option. In no case can Cambridge Sensors USA be liable for incidental or consequential damages, including lost profits.
  • Page 27 The power replace the battery as soon as of the battery is getting low. You can possible. Battery type is complete about 50 more tests from the CR2032 3 volt. time this symbol first appears. Cambridge Sensors USA, LLC...
  • Page 28: Notes

    Notes Cambridge Sensors USA, LLC...
  • Page 29 Notes Cambridge Sensors USA, LLC...
  • Page 30 Notes Cambridge Sensors USA, LLC...
  • Page 31: Cambridge Sensors Usa, Llc

    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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