Blood β-Ketone testing with Optium Xceed training.pdfBlood β-Ketone testing with Optium Xceed...

Blood β-Ketone testing with Optium Xceed

First User Training

Optium Xceed Ketone Cascade pack v3 Mar09

Optium Xceed Ketone Cascade pack v3 Mar09 Company Confidential© 2005 Abbott

Optium Xceed Meter

Oversized Backlit Display

Backlight Button :On / Off

Forward Scroll Button :Scrolls forward through memory & averages

Changes settings i.e. date, time, etc.

Access LOT Memory & Error Codes

Mode Button :On / Off

Assigns Control Icon to QC Tests

Switch from Memory ~ Averages

Access Change Settings Mode

Access LOT Memory & Error Codes

Strip Port :Highlighted yellow for easy identification

Strip & Precision Link Port

Back Scroll Button :Scrolls back through memory & averages

Changes settings i.e. date, time, etc.

Battery Cover (at rear) :1 x CR2032 Lithium Battery


Medicines & Healthcare products Regulatory Agency

MHRA states* that training should include :

• Basic principles of testing

• Demonstrate proper use of system

• Consequences of improper use

• Instruction in sample collection

• Instruction in the importance of complete documentation of all results

• Appropriate calibration & QC testing

• Practical experience to satisfy instructor that the trainee is competent

*MDA DB 2002 (03) March 2002 – Management and use of IVD Point of Care Test Devices


Optium Xceed ß-Ketone Test Strips

The Optium Xceed Blood Ketone test strip :

• 1.5 µL sample size

• 10-second result countdown

• Assay Range 0.0-8.0 mmol/L

• Haematocrit Range 30-60%

• Individually foil wrapped test strips

• Top or tip sample application

• Visual confirmation of sufficient sample

• Fill trigger ensures sufficient sample

• Claim – capillary (finger) and venous* whole blood samples

* Venous whole blood samples must be used within 30 minutes of collection


ß-Ketone Benefits

Clinical Accuracy

• Measures ß-hydroxybutyrate (the most significant ketone body)• A quantitative vs. qualitative measure• Results unaffected by many common medications

Patient Convenience/Compliance

• Blood vs. urine sampling• Foil wrapped strips• Test integrated within blood glucose monitors

Top or End fill


Calibration

• To obtain an accurate blood β-Ketone reading, the meter must be calibrated immediately when a new box of test strips are opened

• Retain the calibration bar for the duration

of that particular box

• The meter will beep once the LOT number is displayed

Presenter

Presentation Notes


Quality Control Testing

• Quality Control tests must be carried out as per your hospital protocol

• Use MediSense Glucose and Ketone Control Solutions.

• Adhere to the 90-day shelf life, date the QC bottles once opened.

• Check results against strip instructions for use Quality Control ranges.


Consequences of not performing QC Tests

• If QC is NOT performed, misleading results may lead to inappropriate treatment

• Always follow your hospital protocol to avoid putting patients at risk

• Under MHRA (Medicines and Healthcare products Regulatory Agency) guidelines it is your responsibility to perform/document QC results

• QC solution is stable for 90 days after opening, so when opening a new bottle write the expiry date on the bottle label.


• Open the strip using the triangular notch in the foil tearing down & across the length of the strip

• Ensure the 3 electrodes enter the port facing upward

• Insert test strip and check display

• Check lot number

• Wait for flashing symbol

Performing a Quality Control (QC) Test

•(a)

•(b)


• A sample can be applied to the top or tip of the test strip

• Apply a sample with the meter in a horizontal (flat) position to avoid it entering the strip port

• Fill trigger electrode ensures a sufficient sample is applied

• The result is displayed after a 10-second countdown

Performing a Quality Control (QC) Test


• Open the strip using the triangular notch in the foil tearing down & across the length of the strip

• Ensure the 3 electrodes enter the port facing upward

• Insert test strip and check display

• Check lot number

• Wait for flashing symbol

Performing a β-Ketone Patient Test

•(a)

•(b)



• Prepare the sample site

• Collect a drop of blood

• Touch and hold the drop of blood to either tip or top of test strip

• Strip sample chamber provides a visual confirmation of sufficient sample

• Move finger away from the test strip when ascending bars appear at the top of the display (beep sounds if activated)



• The meter will commence the countdown from 10 seconds

• If the test fails to start, a second sample can be applied within 30 seconds of applying the first drop of blood


Result & Memory

• The result will be displayed (beep will sound if activated) and the meter will automatically turn itself off after 60 seconds

• To access the last result, only press the centre button once. The last result will appear on the screen, along with the recorded date and time

Please note: The Optium Xceed can display the last 450 results with date and time, this feature is recommended only for patients testing at home.


Display Messages

Message ExplanationHI Result above 8.0 mmol/L

Battery Icon

• When displayed with results, this means the battery is becoming low• When displayed alone, this means the battery is exhausted


Display MessagesMessage Explanation*Test Error 1 (E-1) Temperature is too hot or cold for the system to work correctly

Test Error 2 (E-2) Meter Error

Test Error 3 (E-3) Test Strip Error

Test Error 4 (E-4) i) Extremely high result or ii) Problem with test strip

Test Error 5 (E-5) Blood applied too soon

Test Error 6 (E-6) i) Calibration error or ii) Expired strips or

iii) Incorrect date in meter

Test Error 7 (E-7) i) Damaged strip ii) Used strip

Test Error 8/9 (E-8/E-9) Meter Error, repeat test, if error continues, contact POC Coordinator

* Refer to the Optium Xceed users manual for what action to take


Limitations of Use

• All test strips have limitations and these are detailed in every box of test strips in the instructions for use.

• The instructions for use should always be checked for limitation on specific areas.

• The system should always be used within these limitations to ensure accurate results and prevent inappropriate treatment.

• For the majority of tests the limitations will not be an issue

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Limitations of use

Care should be taken with those patients who are extremely unwell particularly if they are:

• Severely dehydrated• Severely hypotensive or in shock• In a hyperglycaemic-hyperosmolar state e.g. DKA.

• Test strips have not been evaluated for alternative site testing• Test strips have not been designed for use with arterial, neonatal,

serum or plasma samples

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Interpretation of Blood β-Ketone Results

Use Guidelines from the Optium β-Ketone Test Strip insertBlood Ketone Level

Below 0.6 mmol/LReadings below 0.6 mmol/L are in the normal range. No need to change anything.

0.6 mmol/L to 1.5 mmol/LWhen a blood β-Ketone reading is between 0.6 and 1.5 mmol/L and the blood glucose reading is higher than 16.7 mmol/L, this may indicate the development of a problem that may require medical assistance.

Above 1.5 mmol/LWhen a blood β-Ketone reading is higher than 1.5 mmol/L and the blood glucose reading is higher than 16.7 mmol/L, there is a risk of developing diabetic ketoacidosis (DKA). Take appropriate action.


Any Questions?


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