EPS EGV1.1 Manual Download Page 51 | Manualshive

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EPS EGV1.1 Manual Download Page 51

51

ACCURACY STUDY

The accuracy of the SMBG System was assessed by comparing to laboratory results. The following results
were obtained by 153 subjects with diabetes at three independent clinical sites.
The regression statistics are derived from a plot of the capillary of fingerstick data versus YSI plasma data.

Slope

1.0100

Intercept

-0.9679 mg/dL

Number of subject

153

R-square

0.9696

Range tested

58.5– 433.5 mg/dL

Glucose level

≦

75mg/dL

within±5mg/dL

within±10mg/dL

within±15mg/dL

14/19 (73.68%)

19/19 (100%)

19/19 (100%)

Glucose level >75mg/dL

within±5%

within±10%

within±15%

within±20%

83/134(61.94%) 115/134(85.82%) 129/134(96.27%) 131/134(97.76%)

The accuracy of the SMBG System was assessed by comparing to laboratory results. The following results
were obtained by 153 subjects with diabetes at three independent clinical sites.
The regression statistics are derived from a plot of the AST data versus YSI plasma data.

Thenar testing-
Slope

0.9688

Intercept

4.8241 mg/dL

Number of subject

153

R-square

0.9481

Range tested

55– 459 mg/dL

Glucose level

≦

75mg/dL

within±5mg/dL

within±10mg/dL

within±15mg/dL

12/19 (63.16%)

17/19 (89.47%)

19/19 (100%)

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Summary of Contents for EGV1.1

Page 1: ...EGV1 1 Self Monitoring Blood Glucose System User s Manual Dear EGV1 1 SMBG System Owner Please read this User s Manual thoroughly Before using your blood glucose meter ...

Page 2: ... to the Quick Reference Guide Thanks again for choosing the EGV1 1 SMBG Intended Use The EGV1 1 Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip palm or forearm Testing is done outside the body In Vitro diagnostic use It is indicated for use at home over the counter OTC by a single patient w...

Page 3: ...hazardous and may transmit infection even if you have performed cleaning and disinfection Wash hands thoroughly with soap and water after handling the meter or lancing device For further information please see FDA Public Health Notification Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens Initial Communication 2010 http www fda gov MedicalDevices ...

Page 4: ... Strip Instructions Lancets 10 pcs Lancing device AST Lancing Device Cap User s Manual Quick Reference Guide Self Test Log Book EGV1 1 Level 2 Control Solution Control Solution Instructions Carrying Case EGV1 1 Level 3 Control Solution Note 1 EGV1 1 Level 2 Control Solution is included with the system 2 EGV1 1 Level 3 Control Solution are available For purchase please call the Customer Care Servic...

Page 5: ...e please call the Customer Care Service toll free at 866 994 3345 Eastern Standard Time Mon Fri 8 00AM 6 00PM During non service hours please contact your healthcare provider Please complete your warranty card and mail it so you receive the best customer service possible and news about product update Note Although the EGV1 1 SMBG System is easy to use you may need to consult with your healthcare p...

Page 6: ... not disassemble the meter as this may cause damage to the components resulting in incorrect readings Disassembling the meter will also void the warranty Always keep the meter clean and store it in a safe place Protect the meter from direct sunlight to ensure a longer lifespan You should not store the meter and test strips in a car bathroom or freezer Keep the meter test strips and lancing device ...

Page 7: ...lm or forearm Do not touch the strips with wet hands Do not use expired strips the expiration date is shown on the bottle Do not bend cut or twist the strips Altitude up to 10 000 feet above sea level has no effect on readings It should not be used to diagnose or screen for diabetes ...

Page 8: ...in the user s manual but still have symptoms that don t seem to match your test results contact your Healthcare Professional or physician immediately If you have questions regarding the use of the meter please call the Customer Care Service toll free at 866 994 3345 Eastern Standard Time Mon Fri 8 00AM 6 00PM During non service hours please contact your healthcare provider Please read your test st...

Page 9: ...tanding Control Solution Test Results 21 Chapter 3 Testing Your Blood Glucose 23 Using the Lancing Device 23 Inserting a Lancet into the Lancing Device 24 Running a Blood Glucose Test with Blood from Your Fingertip 26 Alternative Site Testing AST 28 Running a Blood Glucose Test with Blood from Your Forearm 30 Running a Blood Glucose Test with Blood from Your Palm 31 Discarding Used Lancets 32 Unde...

Page 10: ...roubleshooting 37 Inserting Batteries 37 Cleaning and Disinfecting Your Meter and Lancing Device 38 Cleaning and Disinfection Frequency 40 Maintenance and Testing 42 Screen Messages and Troubleshooting 43 Chapter 6 Technical Information 48 Specifications 48 Limitations 49 Accuracy Study 51 Device Information 53 Warranty 53 ...

Page 11: ...EGV1 1 Blood Glucose Meter Date on the left side AM Before Noon Time on the right side PM After Noon Control Solution AC Before Meal Alarm PC After Meal Test Result Error Insert strip Temperature Application of blood Glucose Unit Battery status ...

Page 12: ...etting and scroll through results Test Strip Slot Insert test strip here Battery Door Flip open the battery door by pushing the tab in the direction of the arrow Right Button Press to enter memory adjust setting and scroll through results Middle Button Press to turn on and off the meter confirm the setting ...

Page 13: ...ct the desired penetration depth Hub Unscrew or Recap the Cap Sleeve Hand Hold Area AST Lancing Device Cap Use this transparency cap for AST testing Sliding barrel Pull on until it clicks and then release to enable lancing device Test Strip Bottle Control Solution Bottle Lancing Device Strip Insert Direction Reaction Area Hand Hold Area Blood Collection Area Electrode Expiration Date ...

Page 14: ... battery door on the back of the meter by pushing the tab in the direction of the arrow 2 Insert two batteries The meter will beep to confirm the batteries are inserted correctly 3 Put the battery door back in place and snap it closed ...

Page 15: ...t step 2 to set the date and time The flashing field is the one you are currently setting 1 After inserting batteries the meter turns on automatically 2 The last 2 digits of the year flash at the center of the display Press and to adjust the year and Press to confirm the setting 4 The icon of flashes on the display The meter is ready to run the test ...

Page 16: ...t Record the date you open the test strip bottle Be sure to check the expiration date on the test strip bottle The test strip is good for three months from the date the bottle is opened or until the expiration date on the bottle whichever comes first Store the test strip bottle and your meter in a cool dry place Store the test strips between 36 F 86 F 2 C 30 C and 40 85 RH Do not freeze Do not app...

Page 17: ... strips are working properly to give reliable results You should run the control solution tests when You use the EGV1 1 Blood Glucose Meter for the first time You open a new bottle of test strips You think the meter or test strips may be working incorrectly You drop the meter You have repeated a test and the test results are still lower or higher than expected You are practicing the test procedure...

Page 18: ...rol solution that is past the expiration date Control solutions can stain clothing If you spill it wash your clothes with soap and water Close the bottle tightly after every use Left over control solution should not be added back into the control bottle Store control solution at room temperature between 36 F 86 F 2 C 30 C Do not freeze If you would like to purchase EGV1 1 Control Solutions please ...

Page 19: ...e bottle with a tissue 5 Squeeze the bottle until a tiny drop forms at the tip of the control solution cap Note Setting the meter in control solution mode CTL will prevent the control solution reading from being added to your memory 1 Put a test strip into the meter in the direction of the arrow and the icon of shows itself 2 Press or to set the mode of control solution Press to confirm the settin...

Page 20: ... reading falls within the range printed on the test strip bottle Note 1 The ranges appearing on this picture are examples only and not the ranges that the user should refer to when determining if their control solution test is acceptable 2 Level 2 and Level 3 ranges listed on your test strip bottle are the two different control solutions Please be sure that you are looking at the correct range 11 ...

Page 21: ...are the result to the correct level of control When the control solution result is inside the range 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 printed on your test strip bottle here are some things you can do to solve the problem Note Control Solution values will be included in the memory and aver...

Page 22: ...the affected bottle Is the control solution expired or contaminated If yes replace with a new control solution to check the performance of SMBG system Were test strips and control solutions stored in cool dry places If no repeat the control test with properly stored strips or control solutions Did you follow the testing steps properly Read Chapter 2 Control Solution Testing and test again Stop usi...

Page 23: ...by a second person who is providing testing assistance to the user the meter and lancing device should be cleaned and disinfected prior to use by the second person For cleaning and disinfection instruction please refer to Chapter 5 Maintenance And Troubleshooting Cleaning and disinfect your meter and lancing device Note Used test strips and lancets are considered bio hazardous waste in accordance ...

Page 24: ...nto the lancing device to get it ready for use 1 Unscrew the Cap 2 Insert the lancet into the lancing device firmly then twist off the protective cover 3 Recap the front cap Note Lancets are for single use only and a new sterile lancet should be used each time you perform a test ...

Page 25: ...ng lancing devices and lancets may transmit blood borne pathogens such as viral hepatitis 6 Set the lancing device aside until later in the test 5 Pull on the sliding barrel of the lancing device until it clicks and then release Now the lancing device is ready Do not prick your finger until your meter and strip are prepared 4 Select the desired penetration depth ...

Page 26: ...n flashes 3 Press or to set or and press to confirm the setting 4 When the blood drop flashes on the display swab the blood collection area on your finger with an alcohol swab Please wait at least 5 seconds until the intended area is dry and clean before sampling the blood 5 Gently squeeze your finger to assist the flow of blood Note Please make sure to apply blood when the blood drop appears on t...

Page 27: ...ure to get enough blood on the strip s reaction zone Otherwise an inaccurate reading may result 10 When the icon of shows the meter beeps sufficient blood is applied to the strip s reaction zone 11 The meter starts to count down from 5 seconds A result will appear on the display afterwards 12 Wash hands thoroughly with soap and water after handling the meter lancing device and test strips Apply bl...

Page 28: ...ince the last meal Two hours or more after taking insulin Two hours or more after exercise Do NOT use AST if You think your blood glucose is low You are unaware of hypoglycemia Your AST results do not match the way you feel You are testing for hyperglycemia Your routine glucose results are often fluctuating You are ill You are during times of stress What is AST Besides the fingertip you can test y...

Page 29: ...alk with your healthcare professional before you test palm or forearm Do NOT ignore symptoms of high or low blood glucose Fingertip samples are able to show the rapid change of glucose faster than forearm and palm samples Measurements from alternative site testing should never be used to calibrate a continuous glucose monitor CGM or entered into insulin dose calculators for insulin dosing recommen...

Page 30: ...ufficient 4 Wipe away the first drop with a tissue and use the second drop Note 1 Check with your healthcare professional before testing sites other that the fingertip 2 Please do NOT use the first drop of blood sample 1 Massage the puncture area of forearm for a few seconds 2 Press and hold the device with clear adjustable tip against the forearm ...

Page 31: ...and increase pressure until the blood sample size is sufficient 1 Massage the puncture area of palm for a few seconds Running A Blood Glucose Test With Blood From Your Palm Caution Measurements from alternative site testing should never be used to calibrate a continuous glucose monitor CGM or entered into insulin dose calculators for insulin dosing recommendations ...

Page 32: ...he lancet tip into its protective cover 3 Pointing the lancing device toward a container for sharp or biohazard material slide the ejection button down to release the covered lancet into the container 4 Wash hands thoroughly with soap and water after handling the meter lancing device and test strips ...

Page 33: ...rican Diabetes Association Standards of medical care in diabetes Diabetes care 2013 Vol 36 Suppl 1 S11 66 Unusual Test Results If your test result does not match the way you feel please follow these steps 1 Run a control test Chapter 2 Control Solution Testing 2 Repeat a blood glucose test Chapter 3 Testing Your Blood glucose 3 If your test results still do not reflect the way you feel call your d...

Page 34: ...ur meter it just means that time has elapsed and your blood glucose has changed If you want to compare your meter result to the lab result you must be fasting Bring your meter to the doctor s office and test yourself by fingertip within five minutes of having blood drawn from your arm by a healthcare professional Keep in mind that the lab could use different technology than EGV1 1 blood glucose me...

Page 35: ... have the correct time and date set in the meter Note 1 Do not change your therapy based on one individual result in memory 2 The memory is not lost when you replace the battery You do need to check that the time and date are still correct for future readings See Section Setting the time and date in Chapter 1 3 Once 480 results are in memory adding a new result causes the oldest one to be deleted ...

Page 36: ...g pressing and for 2 seconds 2 Press or to review all results in order from records of 480 to 001 3 To delete a test result press and for 3 seconds together and display shows dEL 4 Press to delete the test result The display shows OK 5 Press to cancel the delete and the meter will turn off in 1 5 minutes automatically 1 Press and meanwhile to review AC PC average values under and the average value...

Page 37: ...r replace with new batteries when the LP low power message and the low battery symbol appear on the display Note 1 The meter won t delete earlier records after you replace batteries 2 You should reset the time and date again after you replace the batteries See Section Setting the time and date in Chapter 1 3 1 5V AAA x 2 batteries are available at most stores You may take the old batteries with yo...

Page 38: ...il sites like amazon com medline com and Expression medical supply Inc http www exmed net Cleaning and Disinfection Instruction Please keep the meter and lancing device free of dirt dust bloodstain and water stains Please follow the following guidelines to clean and disinfect your meter and lancing device Cleaning and disinfection are both required but are different Cleaning is the removal of visi...

Page 39: ...y wet all the surface of the lancing device including cap or AST cap if used Treated area must remain visibly wet for a full 2 minutes Let the devices air dry for 0 5 minute Do disinfection once per week 1 Meter cleaning disinfection area 2 Lancing device cleaning disinfection area Do Not Get any moisture in the test strip slot Spray any cleaning solution directly onto the meter Put the meter unde...

Page 40: ...te Any printing on the lancing device meter or meter buttons is not legible Performance check of the meter and lancing device after cleaning and disinfection If you notice any of the following immediately stop using the meter and call the Customer Care Service toll free at 866 994 3345 Eastern Standard Time Mon Fri 8 00AM 6 00PM for assistance The meter does not power on or off does not beep or do...

Page 41: ...es and what to do about them To make sure the display is working properly turn off the meter Press and hold power button to see the complete display All the indicators should be clear and look exactly like the picture to the left If not please call the Customer Care Service toll free at 866 994 3345 Eastern Standard Time Mon Fri 8 00AM 6 00PM During non service hours please contact your healthcare...

Page 42: ...t your healthcare professional Message What it means What to do Humidified Used strips The meter has detected a problem with the test strip Repeat the test with a new strip Refer to pages 26 27 for information on sample application Low power The meter batteries do not have enough power to perform a test Replace with the new batteries ...

Page 43: ...Care Service toll free at 866 994 3345 Eastern Standard Time Mon Fri 8 00AM 6 00PM System error There may be a problem with the meter Replace the batteries first Refer to pages 14 and 38 If this error message appears again please call the Customer Care Service toll free at 866 994 3345 Eastern Standard Time Mon Fri 8 00AM 6 00PM ...

Page 44: ...994 3345 Eastern Standard Time Mon Fri 8 00AM 6 00PM During non service hours please contact your healthcare provider The test result is lower than 20 mg dL Re check your glucose level If the result is still LO try a control solution test and if the control solution test falls within the correct range please call the Customer Care Service toll free at 866 994 3345 Eastern Standard Time Mon Fri 8 0...

Page 45: ...t result may occur if the test continues Relocate the meter to a location with temperature between 10 C 40 C 50 F 104 F The Lt and thermometer icon appears Temperature is too low outside the required range of 10 C 40 C 50 F 104 F This alerts users that an incorrect result may occur if the test continues Relocate the meter to a location with temperature between 10 C 40 C 50 F 104 F ...

Page 46: ...NOT enough Repeat the test with a new strip If Err appears again please call the Customer Care Service toll free at 866 994 3345 Eastern Standard Time Mon Fri 8 00AM 6 00PM No result in memory The meter doesn t run any test yet You can still perform a blood glucose test and get an accurate test result ...

Page 47: ...90 R H Storage and transportation condition Temp 36 F 86 F 2 C 30 C Relative Humidity 40 85 RH Blood sample 0 6 μL Fresh blood from fingertips palm or forearm Hematocrit Hct 20 60 Power 2 x Alkaline Battery Battery life Over 2000 tests Display dimension 1 27 x 1 59 32 3 40 4 mm Device dimension H W D mm 3 23 x 1 97 x 0 87 82 0 50 0 22 0 mm Weight 1 41 oz 40 1 grams w o batteries Principles Electro...

Page 48: ...midity may affect the results A relative humidity greater than 90 may cause incorrect results Operate your system between 30 90 RH 6 The system should be used at a temperature between 50 F and 104 F 10 C and 40 C Outside this range the system may get incorrect results 7 DO NOT reuse the test strips The test strips are for single use only 8 Hematocrit The hematocrits between 20 and 60 will not sign...

Page 49: ...dL Yes 31 0 80 mg dL 18 2 120 mg dL The highest no interference concentration is 2 6 mg dL Gentisic Acid 6 mg dL No NA Ibuprofen 50 mg dL No NA L Dopa 4 mg dL Yes 16 3 80 mg dL 11 4 120 mg dL The highest no interference concentration is 2 mg dL Methyldopa 2 mg dL No NA Sodium Salicylate 50 mg dL No NA Tetracycline 1 5 mg dL No NA Tolbutamide 100 mg dL No NA Galactose 20 mg dL No NA Maltose 20 mg d...

Page 50: ...terference or no Bias blood glucose Conc Note Bilirubin unconjugated 25 mg dL No NA Cholesterol 500 mg dL No NA Creatinine 30 mg dL No NA Triglycerides 1000 mg dL No NA Uric Acid 15 9 mg dL Yes 14 3 80 mg dL 17 5 120 mg dL The highest no interference concentration is 11 9 mg dL ...

Page 51: ... 10mg dL within 15mg dL 14 19 73 68 19 19 100 19 19 100 Glucose level 75mg dL within 5 within 10 within 15 within 20 83 134 61 94 115 134 85 82 129 134 96 27 131 134 97 76 The accuracy of the SMBG System was assessed by comparing to laboratory results The following results were obtained by 153 subjects with diabetes at three independent clinical sites The regression statistics are derived from a p...

Page 52: ...within 15mg dL 9 19 47 37 16 19 84 21 18 19 94 74 Glucose level 75mg dL within 5 within 10 within 15 within 20 66 134 49 25 95 134 70 90 113 134 84 33 129 134 96 27 Arm testing Slope 1 0263 Intercept 4 6425 mg dL Number of subject 153 R square 0 9503 Range tested 50 514 mg dL Glucose level 75mg dL within 5mg dL within 10mg dL within 15mg dL 8 19 42 11 14 19 73 68 19 19 100 Glucose level 75mg dL wi...

Page 53: ...nts the original purchaser for a period of 4 years from the date of purchase This means during the warranty period if the Self Monitoring Blood Glucose System does not work for any reason other than obvious abuse EPS will replace it with a new system or an equivalent product free of charge Please read EGV1 1 User s Manual before operation If you have any questions and or need assistance please con...

Page 54: ...STERILANCE MEDICAL SUZHOU INC 68 LiTangHe RD XiangCheng Suzhou China 215131 Tel 86 512 65799308 Fax 86 512 67217663 E mail guopings xinda medical com Lancet Meets the requirements of MDD 93 42 EEC Manufacturer SAE HAN MEDICAL CORP 700 113 PUB GOT DONG IL SAN GU GOYANG CITY KYUNGGI DO KOREA TEL 82 31 923 4330 FAX 82 31 923 4331 E mail saehan saehanmed com P N 71800528A_0077A_01 ...

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