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MediVena AC500 PRO, Operations & Procedures Manual

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MediVena AC500 PRO Operations & Procedures Manual Download Page 31

The ONE-CARE® PRO (Model AC500 PRO) Meter, ONE-CARE® PRO (Model AC500 PRO) Test 

Strip and 

ONE-CARE® PRO Control Solution are in conformity with the IVDD 98/79/EC. 

Manufactured for: 

MediVena 

1 Glenlake Parkway, Ste 700 

Atlanta, GA 30328, USA

(404) 514 2586 

[email protected] 

www.medivena.com

CUSTOMER SERVICE TOLL FREE NUMBER:

(888) 270 6457

 

The Lancing device and Lancets are in conformity with the MDD 93/42/EEC.

Limitations of the Procedure

Caution:

The ONE-CARE® PRO (Model AC500 PRO) Blood Glucose Monitoring System is designed for in 

vitro diagnostic use only and is not intended to test on newborns. Any change or administer of 

medication based on the ONE-CARE® PRO (Model AC500 PRO) blood glucose test results with-

out the consent advice of a physician or healthcare professional is not recommended.

The ONE-CARE® PRO (Model AC500 PRO) test strips are designed for use with fresh capillary whole 

blood samples obtained from the fingertip, palm and forearm. False results may occur when 

performing the test while severely dehydrated, severely hypotensive, in shock or in a hyperglyce-

mic-hyperosmolar state. If you believe you are suffering from any of the above symptoms, consult a 

healthcare professional immediately.

30

Summary of Contents for AC500 PRO

Page 1: ...ONE CARE PRO Blood Glucose Monitoring System Model AC500 PRO For in vitro diagnostic use only Operations Procedures Manual...

Page 2: ...lucose Level Preparing the Test Strip Obtaining a Blood Sample Applying Blood Sample to the Test Strip Available Alternate Sites Testing Palm and Forearm Control Solution Test Memory Features Transfer...

Page 3: ...System is Intended to be used for the quantitative measurement of glucose sugar in fresh capillary whole blood from fingertip palm or forearm The ONE CARE PRO Model AC500 PRO Blood Glucose Monitoring...

Page 4: ...ions and the manufacturer s disinfection procedures are followed Only auto disabling single use lancing devices may be used with this device Cleaning Solution and Disinfecting Solution CaviCide Surfac...

Page 5: ...s button to decrease number move forward in meter setting Press this button to set the reminder alarm and HI LO alarm Press this button to increase number move backward in meter setting Slide cover to...

Page 6: ...ws the average value of test results 9 Time 10 Blood Drop Symbol Flashes when it is ready to apply sample to test strip 11 Warning Symbol Appears when result is out of the range of your setting refere...

Page 7: ...Tapar inmediatamente Usar solo con ONE CARE PROMedidordeGlucosaenSangre Modele AC500PRO Manufactured for Manufacturado para MediVena 1 Glenlake Pwy Ste 700 Atlanta GA 30328 USA info medivena com TOLL...

Page 8: ...hen the low battery warning signal is shown the meter will provide accurate results for approximately 50 more measurements How to Replace the Battery 1 From the back of the meter gently slide and remo...

Page 9: ...Press M to set Fig 2 4 The number in the month position will now flash Press or to select the month Press M to set Fig 3 5 The day will now flash Press or to select the date Press M to set Fig 3 6 The...

Page 10: ...alarm setting mode If YES is chosen press M to confirm and the time will appear Fig 6 4 The number in the hour position will now flash Press or to seclect hour Press M to set Fig 7 5 The minutes will...

Page 11: ...0 400mg dL 6 0 21 0mmol L default is 180mg dL 10mmol L Fig 10 4 To change LO alarm setting Fig 11 press or until you reach your desired value and then press M to set Fig 12 You have now completed the...

Page 12: ...ff to enter this mode The bi and speaker icons display will appear Fig 13 2 If you want to hear a beep sound during testing press or to select On then press M to set To turn the beep sound off press o...

Page 13: ...E PRO Model AC500 PRO blood glucose test results without the consent and advice of a physician or healthcare fessional is not recommended Low or high blood glucose readings can indicate a potentially...

Page 14: ...d and a clockwise moving dotted lines will appear 5 After system checking ok a flashing symbol will appear You can press or to select the meal indicator for marking the test as premeal or postmeal tes...

Page 15: ...ntially infectious and are capable of transmitting blood borne pathogens between patients and healthcare professionals To reduce the chances of infection Only an auto disabling single use lancing devi...

Page 16: ...on of body fluid touch the tip of the test strip to the drop of blood Blood is automatically drawn into the test strip Hold the tip of the test strip touching the blood drop until the meter beeps 2 As...

Page 17: ...suggested that you review your testing procedure and test again with a new test strip to confirm the result If the same result occurs consult your healthcare professional immediately M 3 After the te...

Page 18: ...f alternate site testing is right for you With a little bit of education you can give your fingertips a rest and maybe test more often than you do now For people with diabetes more frequent testing is...

Page 19: ...There are three control solutions at different desired range of aqueous glucose Level 1 Level 2 or Level 3 For more information about the control solution please read your control solution package in...

Page 20: ...rts the countdown from 5 to 1 and the control solution test result will appear CAUTION Please remember that in order to prevent contamination follow the above instructions properly when performing the...

Page 21: ...on is pressed and test result with date and time the test was taken will display when button is released Fig 15 3 You can press or to scroll forward or backward through the results When appears on the...

Page 22: ...ood glucose results obtained during the last consecutive 7 14 30 day If there are not enough testing results for the calculation of 7 14 30 day averages the average result will not be shown 2 A result...

Page 23: ...ults With meter turned off connect the interface cable to a serial port on your computer then connect the other end of interface cable to the data port located on the side of the meter The word PC wil...

Page 24: ...time While there are many other options for disinfecting blood glucose meters MediVena has not tested the effectiveness of these products on the ONE CARE PRO meter If you use a product or method other...

Page 25: ...es a day for 5 years CARE AND STORAGE 1 Handle the meter with care Dropping or throwing the meter may cause damage to the device 2 Do not expose the meter test strips and control solution to extreme c...

Page 26: ...t is lower than 20 mg dL 1 1 mmol L Repeat the test using a new test strip If the result is still Low consult your physi cian immediately Temperature is too high to perform the test Repeat the test in...

Page 27: ...meter The preset alarm is ringing to remind it is time to perform blood glucose test Press any button to shut off or the alarm will turn off automatically after 30 sec The test strip has not been inse...

Page 28: ...1 1 33 3 mmol L Test Time 5 sec Memory Capacity 500 most recent results Average 7 14 30 days average results External Output USB interface Power supply Two AAA batteries Battery Life Approximately 100...

Page 29: ...ity Do not use if package is damaged Temperature limitation Batch code Use by Keep dry Do not reuse Serial Number Manufacturer In vitro diagnostic medical device Consult instructions for use Sufficien...

Page 30: ...n Isomalt Lactitol L DOPA L 3 4 dihydroxyphenylalanine Maltose Maltitol Mannitol Methyldopa Pralidoxime iodide PAM Salicylate Sodium Carbonate Sorbitol Tolbutamide Tolazamide Triglycerides Uric acid X...

Page 31: ...m is designed for in vitro diagnostic use only and is not intended to test on newborns Any change or administer of medication based on the ONE CARE PRO Model AC500 PRO blood glucose test results with...

Page 32: ...PRO Model AC500 PRO meter This warranty does not apply to the performance of a ONE CARE PRO Model AC500 PRO meter that has been accidentally damaged altered misused tampered with or abused in any way...

Page 33: ...ults Record Meter Month Year Results reviewed by Meter cleaned Y N Test strip lot lot range result Test strip expiration date Level 2 Control Level 1 Control Date Time Station shift Operator lot range...

Page 34: ...Notes...

Page 35: ...Notes...

Page 36: ...Distributed by Links Medical Products 9247 Research Drive Irvine CA 92618 email info linksmed com toll free 888 425 1149...

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