EasyMax N LTC Manual
Contents
1. Blood Sample Fresh Blood from Fingertip or Forearm Hematocrit Hct 30 55 Battery Life Over 2 000 Tests Power 2 Alkaline 1 5V AAA Display Dimension 1 60 x 1 30 40 6 x 33 0 mm Device Dimension H x W x D mm 3 2 x 2 x 0 7 81 3 x 50 89 x 17 8 mm Weight 1 6 oz 45 5 Grams w o Batteries Principles Electrochemical Biosensor Technology Page 3 Caring for your Blood Glucose Meter in a LTC Setting In order to prevent the growth of microorganism make sure you cover all of the steps below 1 Make sure 2 Put on a pair of 3 Sanitize the glucose the meter is protective gloves meter with any EPA off before you start the approved disinfectant cleaning procedure product that meets the 1 10 bleach solution 2 minutes 2 minutes 2 minutes 4 Wipe the surface of the 5 If you find any blood 6 Air dry the meter to glucose meter including stains on the device sanitize completely the test strip port and make sure you clean it before next use communication port after with caution each use Be careful to make sure no liquid goes into either port Wipe the meter thoroughly the treated surface must remain visibly wet for a full 2 minutes to attain complete disinfection Page 4 Chapter 1 Understanding Your Meter The EasyMax N Blood Glucose Meter Test Records Transfer Data 27 to PC Apply Blood or a al Solution Batteries Status Blood Collection Area Reaction Area Hand2. MN LASYMax Long Term Care Manual EasyMax N Blood Glucose Monitoring System This Manual is intended for facilities where point of care testing is conducted by a healthcare professional Please thoroughly read the EasyMax N Owner s Guide and all product instructions before making use of this Manual JMN LASYMax EasyMax N Blood Glucose Monitoring System Manufactured by EPS Bio Technology Corp No 8 R amp D Road Ill Hsinchu Science Park Hsinchu Taiwan 30077 Customer Service 1 866 994 3345 Toll Free Mon Fri 9 00 AM 9 00 PM Introduction This manual has been created for Healthcare professionals for the purposes of performing point of care testing Caution Please carefully read the User s Manual and all product instructions before using this Long Term Care Manual and administering blood glucose tests Summary of Contents e An outline of the EasyMax N Blood Glucose Monitoring System e Quality Control Method including how to troubleshoot potential issues that may arise while performing EasyMax N blood glucose tests e Training information for healthcare professionals Intended Use The EasyMax N Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm Testing is done outside the body In Vitro diagnostic use It is indicated for use at home over the counter OTC by persons with diab
3. C 40 C This alerts users that an incorrect result may occur if the test continues Action Relocate the meter to a location with temperature between 50 F 104 F 10 C 40 C JMN LASYMax EasyMax N Blood Glucose Monitoring System Training Information for Healthcare Professionals Page 11 EasyMax N System Trainer Checklist You may use the following checklist to assess the trainee s ability to perform the following tasks 1 Identifies the equipment used with the EasyMax N System EasyMax N Blood Glucose Monitor EasyMax Blood Glucose Test Strips EasyMax Control Solutions Low High Normal Safety Lancet 2 Blood Glucose Meter Locates the serial number Identifies the strip slot Locates the on off button Locates the setting button 3 Blood Glucose Test Strip Locates the expiration date opened amp unopened Checks the lot number Identifies the blood collection area Understands the correct strip insert direction Locates the electrode end of test strip Identifies the designated hand hold area 4 Demonstrates proper test strip use Only uses EasyMax N blood glucose meter with EasyMax blood glucose test strips Runs a control solution test every time a new vial of test strips is opened Keeps test strips in their original vial Closes vial immediately after taking a test strip out to eliminate the contamination of the other test strips Knows test strips are single use only Do not re use Records
4. Hold Area Strip Insert Direction moo W gt Electrode M Button To turn on the meter or read records S Button To turn on the meter or go into Setting Mode Strip Slot To insert test strip or check strip 1 Press and hold the S 2 The time and date appear button until turning the meter on Press S button and release to display enter setting mode Page 5 on the display The year flashes at the center of the 3 Press M button to adjust the year Press and hold M button to scroll faster 06 08 02 03 cro Lt 4 Press and release S 5 Repeat step 3 and 4 to button to set the year set the date hour and The month will then minute The flashing field flash is the one you are setting Note The unit of Blood Glucose Meter is set at mg dL without any modification function Press the S button to confirm the setting The display will show SCL and the unit of measurement Press the S button again to go to the screen shown in Step 1 Press and hold S for more than 3 seconds and the meter will turn off Running a Control Solution Test You need the meter a test strip and control solution e 1 Puta test strip into the 2 Place the meter on a flat 4 Squeeze out 1 2 drops meter in the direction of surface Take the control of solution and discard the arrow The meter will solution between your automatically turn on fin
5. if the meter will not be used for one month or more e Do not touch the strips with wet hands Do not use expired strips the expiration date is shown on the bottle and once opened the strips have a 90 day shelf life Do not bend cut or twist the strips Altitude up to 10 000 feet above sea level has no effect on readings DO NOT reuse the test strips The test strips are for single use only Warning for potential biohazard Healthcare professionals using this system on multiple patients should be aware that all products or objects that come in contact with human blood even after cleaning should be handled as if capable of transmitting viral disease Page 1 e You should not test critically ill patients with home use blood glucose meters e Patients undergoing oxygen therapy may have inaccurate results e Ifthe patient has the following conditions the result may fail e Severe dehydration e Severe hypotension low blood pressure e Shock e Astate of hypoglycemic hyperosmolar state with or without ketosis e Lipemic samples Cholesterol level up to 500 mg dL and triglycerides up to 3 000 mg dL do not affect the results Grossly lipemic patient samples have not been tested and are not recommended for testing with EasyMax N Glucose Meter Interfering Substances depend on the concentration The below substances up to the test concentration will not affect the test results Substance mg dl mg dl mg dl mg dl Acetaminophen 8 102 65
6. the date the test strip bottle is opened Checks the Expiration Date on the test strip bottle The test strips are good for three months from the date the bottle is opened or until the expiration date on the bottle whichever comes first Stores the test strips between 35 6 F 86 F Do not freeze Follows proper disposal of used test strips according to your institution s policy Page 12 5 Demonstration of blood glucose testing Demonstrates proper safety lancet technique when collecting blood sample Understands the different sites that may be used with the meter Demonstrates appropriate disposal of safety lancet in accordance with institution s policy Demonstrates the correct way to insert the test strip into meter Understands symbols that appear on the meter screen and what if any corresponding action Demonstrates correct placement of blood on test strip Records results as specified per your institution Understands the protocool for inaccurate results re tests control solution test troubleshoot Knows the actions to be taken when results are abnormally high or low 6 Quality Control Performs a control solution test and can explain why it should be done Understands the dates listed on the control solution and how they apply to opened vs unopened vials Recognizes what it means when a control solution test result falls in the range listed on the vial and when the test result falls out of the range on the vial 7 Troubleshoo
7. 38 Ascorbic Acid 245 8 6 amp 8 53 2 4 3 Alternate Site Testing AST EasyMax N gives patients the option to test on their fingertip or their forearm Blood glucose test results obtained from the forearm may differ significantly from fingertip samples It is preferred that you Do NOT perform Alternate Site Testing AST if Your patient has frequent low blood glucose Your patient is unaware of hypoglycemia The AST results do not match the way the patient feels You are testing for hyperglycemia The patient s routine glucose results are often fluctuating If the patient is pregnant Quality Control If you are using the EasyMax N and the result seems lower or higher than expected it is recommended that you repeat the test with a new strip If you get the same result please conduct a control solution test to ensure your meter and test strips are working properly If you are evaluating the EasyMax N results and are comparing it to lab results please note that the patient should be fasting and the fingertip test should occur within five minutes of having blood drawn It is also important to know that the lab technology may be different than the EasyMax N technology therefore results may not always be a complete match Page 2 EasyMax N System Specifications Brand Name EasyMax N Blood Glucose Meter Range 20 600 mg dL Memory Sets 480 Test Results Operating Condition Relative Humidity R H lt 90 0 6 uL
8. cisions based on an error message If you have any concerns please contact Customer Service Toll Free 1 866 203 2761 Eastern Time Mon Fri 9 00 AM 9 00 PM Humidified Used strips Action Replace with a new strip Low Power Action Replace with new batteries Test result is higher than 600 mg dL Action Test again If the result is still the same try a control solution test and if the control solution test falls within the correct range then please take immediate medical action The test result is lower than 20 mg dL Action Test again If the result is still the same try a control solution test and if the control solution test falls within the correct range then please take immediate medical action System Fault Action Replace the batteries first If 001 ERROR appears again please call Customer Service toll free 1 866 994 3345 The Ht and thermometer icon appears Temperature is too high outside the required range of 50 F 104 F 10 C 40 C This alerts user that an incorrect result may occur if the test continues Action Relocate the meter to a location with temperature between 50 F 104 F 10 C 40 C Page 10 System Fault Action Replace the batteries first If Err appears again please call Customer Service toll free 1 866 994 3345 The Lt and thermometer icon appears Temperature is too low outside the required range of 50 F 104 F 10
9. etes or in clinical settings by healthcare professionals as an aid to monitor the effectiveness of diabetes control Questions If you have questions or need assistance please call Customer Service toll free at 1 866 994 3345 Eastern Time Mon Fri 9 00 AM 9 00 PM You can also visit www oaktree int com for diabetes management tools and product demonstrations mpm Information About the EasyMax N System EasyMax N blood glucose meter is designed and approved for testing fresh capillary blood from fingertip and forearm The meter is for outside the body in vitro use It should not be used to diagnose diabetes e Only use EasyMax N blood glucose meter with EasyMax Blood Glucose Test Strips Using other test strips will give inaccurate results e Testing is not valid for neonatal blood specimen e Do not disassemble the meter as this may cause damage to the components resulting in incorrect reading Disassembling the meter will also void the warranty e Always keep the meter clean and store it in a safe place Protect the meter from direct sunlight to ensure a longer lifespan e The system should be used at a temperature between 50 F 104 F 10 C 40 C Outside this range the system may get incorrect results e You should not store the meter and test strips in a car bathroom or refrigerator e Elevated levels of acetaminophen uric acid gentisica acid levodopa dopamine ascorbic acid and methyldopa may affect results e Remove batteries
10. g Control Solution Test Results Important Please follow your institution s control solution testing regulations and procedures The label on your test strip bottle shows the acceptable ranges for the Control Solution The result you get should be inside this range Make sure you compare the result to the correct level of control When the control solution result is inside the range See 1A on the test strip bottle your test strips and your meter are working properly If your control solution result is not inside the acceptable range here are some things you can do to solve the problem as mie tee strip expesed OPEN all Or Repeat the control test with properly stored strips long period of time This will humidify strips inside Replace the test strips Replace with new control solution to check the performance of the system Repeat the control test with properly stored strips and or control solutions Read Chapter 2 in the manual Control Solution Testing and test again Stop using the meter if you Did you follow the testing steps properly continue to obtain the inaccurate results Call Customer Service Toll Free 1 866 994 3345 Eastern Time Mon Fri 9 00 am 9 00 pm Page 8 Performing a Blood Glucose Test Please adhere to your institution s medical device handling and site preparation procedures 3 Please wait at least 5 1 Wash your patient s hands 2 Put a test strip into the meter seconds until t
11. gertips and roll the solution back and forth to mix up the solution 3 Twist off control solution bottle cap and wipe the tip of the bottle with a tissue 5 Now squeeze out another drop of solution onto the control solution cap Take the cap and touch the drop to the blood collection area at the end of the test strip The strip will sip in the control solution DO NOT apply the control solution directly from DO NOT apply the control solution or capillary the control solution bottle into the strip This can whole blood on TOP of the strip This will lead cause cross contamination with the enzyme from to an inaccurate reading or no reading at all the strip and the entire control solution bottle will no longer be accurate on future tests Page 8 Close the control solution vial tightly Wipe the tip of the control cap with a tissue to remove any excess solution 6 When the meter beeps 7 Remove the test strip Expiration date EASYMas there is enough control and throw it away after This date applies to HGH ocol solution in the the strip you have compared the unopened bottles only l The meter counts down reading to the range Once opened the control from 5 seconds and will printed on the test strip i 2010 74 display the results Do bottle solution has a shelf life i not remove the strip yet of 90 days Check if the reading falls within the range printed on the test strip bottle Understandin
12. he intended with soap and warm water in the direction of the arrow area is dry and clean before Rinse and dry thoroughly Your The meter will automatically sampling the blood institution may require that turn on A When tne bleed drop Taches you use an alcohol prep pad Please ensure that the test site is completely dry before proceeding on the display obtain a drop of blood from fingertip using the safety lancet See image above In a Long Term Care facility setting we recommend that a safety lancet be used for each individual blood glucose test For demonstration purposes we are using SteriLance s Pressure Activated Safety Lancets 1 Carefully pull off the protective cap 2 Push the lancet firmly onto the chosen site to fire 3 Gently apply intermittent pressure near the puncture site to obtain the required blood volume EasyMax N system requires a small 0 6 microliter blood sample 5 Touch the blood drop tothe 6 The meter will beep when 7 Discard the used safety lancet tip of the transparent window enough blood has entered and test strip into an of the test strip Do not put the strips reaction zone The appropriate sharps or blood on top of the strip Be result will appear on the biohazard container sure to get enough blood on display after 5 seconds the strip s reaction zone Otherwise an inaccurate reading may result Page 9 Troubleshooting Screen Messages Please do not make treatment de
13. ontrol solution test 6 If you are performing a blood glucose test and you get this error what should you do first A Re test B Replace the battery C Turn the meter off and on again D Replace with a new strip 7 The memory will store results A 300 B 250 C 480 D 1000 Page 14 8 Name two substances that have the potential to interfere with an accurate blood glucose result 9 Describe how test strips should be inserted into the meter 10 If you get this message the blood glucose result is lower than mg dL 11 What type of battery does the EasyMax N require A 3 Volt Lithium B Alkaline 1 5 Volt AAA C Alkaline 1 5 Volt AAAA D None of the above 12 Describe the proper way to dispose of a safety lancet 13 The appropriate way to clean the meter is Answers available upon request Page 15 EasyMax N Blood Glucose Quality Control Results Log Monitor Facility Name Results Reviewed by Month Year Action Taken O On co O Result igh Control Range Result Ea Control Range Res Control Page 16
14. ting Guidelines Understands the steps to follow when troubleshooting Knows the warranty of meter Knows how to handle defective meter strips etc next steps manufacture customer service service phone number 8 Proper Care Understands how to maintain the meter Locates proper storage Demonstrates proper cleaning Demonstrates proper battery installation 9 Documentation Understands what information must be documented by law and what is required by your institution Page 13 EasyMax N Quiz This quiz is multiple choice fill in the blank and true false ie The EasyMax N system does not require calibration True False 2 EasyMax control solution once opened and assuming the expiration on the vial has not expired first has an expiration date of A 60 days B 6 months C 3 months D 45 days 3 You should perform a control solution test when A You think the meter or test strips may be working incorrectly B You drop the meter C You have repeated a test and the test results are still lower or higher than expected D All of the Above 4 When performing a blood glucose test where should you apply the blood A On top of the test strip B On the side of the test strip C The tip of the test strip D The middle of the test strip 5 When conducting a quality control test which of the following steps will be taken A Turn the meter off and on again B Push the setting button twice C Change the battery D Perform a c
Download Pdf Manuals
Related Search