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Does the INRatio need to be calibrated?
No, the instrument does not need any calibration. INRatio provides the convenience of self calibration.
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Does the INRatio monitor need to be charged overnight?
No, the system can be used as it is.
The monitor can be powered by 4 AA batteries or an optional AC power adaptor. No components of the INRatio require charging or re-charging.
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Will the memory be lost if batteries are replaced or switched to using power supply?
No, the memory is not affected.
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What are the measuring ranges of the INRatio monitor?
The INRatio measures INR results between 0.7 and 7.5.
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What are the normal ranges of the INR?
HemoSense recommends you discuss with your physician any specific target ranges for your condition as many times the ranges can vary patient to patient. American College of Chest Physicians (ACCP) issues guidelines for the management of Oral Anticoagulation Therapy (OAT).
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When is the best time to start use of the INRatio system?
It is advisable to transition when the patient has been stabilized within his or her target range for at least the last two readings.
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How should the strips be stored?
The strips are good for 12 months from the date of manufacturing at room temperature, as long as the temperature does not exceed 90 Deg F.
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When do the strips expire?
The strips expire on the last day of the month of expiration, printed on the strip pouch.
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How do I order new supplies?
You will need to order your test strips and supplies through your distributor. This is most likely the same company that sent you the INRatio monitor.
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Where do I call in my INR results?
If you are a Self Test Patient, you should contact your Healthcare Professional or Supplier of your INRatio system. If you are receiving Medicare reimbursement you will need to report your results to your supply distributor in order to keep receiving reimbursement.
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What type of sample should be used with the INRatio system?
A fresh 15 µL (micro liter) whole blood sample obtained from a finger stick is the only approved sample for use with the INRatio system.
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Can I use any lancet?
Yes, as long as the needle is 21 gauge with minimum penetration of 0.81 mm.
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Can I use a capillary tube for sample collection?
Yes, non-anticoagulant micro safe capillary tubes can be used. The minimum sample required is 15 micro liters.
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How closely should the INRatio correlate to my current lab?
The INR value depends on many factors. For more information please see the Technical Bulletins. However as per the ISO 17593 draft titled “Clinical laboratory testing and in vitro diagnostic test systems in vitro monitoring systems for anticoagulant therapy”: Below INR 2.0, 90% of results shall be within +/- 0.5 INR, and between 2.0 to 4.0, 90% of results shall be within +/- 30%.
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What should be the time interval between tests if I am doing a correlation study?
The time interval between the finger stick performed on the INRatio and venous draw for the reference lab, should not be more than1 hour.
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Do I need to run external controls to check for accuracy?
There are no external controls that need to be used separately. The two on board controls on each strip are testing the integrity of the strip and sample each time a test is run.
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What are the QC ranges for the strips?
Each strip lot number has its own ranges for QC1 (Normal) and QC2 (Therapeutic) that are listed on the website as well as on the package and pouch of the strips.
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What is CLIA?
This is an abbreviation for the Clinical Laboratory Improvement Act of 1988. CLIA '88 applies to all laboratories, physician offices, pharmacies, or other entities that perform testing of materials derived from the human body for purposes of diagnosis, prevention, treatment or heath assessment. All users of waived tests are required to register with CMS (formerly HCFA) and obtain a CLIA Certificate of Waiver. The fee for the Certificate of Waiver is $150 and is valid for two years.
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