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Glucometer Abbott FreeStyle Optium Neo H SOP

Contents

1 Aim

To provide clear written instructions to colleagues so that they can safely use the Glucometer to check blood glucose in the monitoring of diabetes mellitus, and ketone values in the monitoring of ketosis.

2 Scope

All colleagues using Glucometers.

3 Link to overarching policy

The overarching policy for this standard operating procedure is the medical devices management policy.

Other associated documents that should be read in conjunction with the procedure are:

4 Procedure

4.1 Intended use

This medical device is for use by healthcare professionals to check blood glucose in the monitoring of diabetes mellitus, and ketone values in the monitoring of ketosis.

4.2 Blood Glucometer use

  1. Decontaminate hands and don personal protective equipment (PPE) appropriate to the procedure.
  2. When starting a new box of test strips or after doing a ketone test insert the plastic calibration strip into the meter then check that the lot number of the test strip foil appears.
  3. Insert a test strip into the meter, the machine will turn on and the sample drop symbol will show on the meter’s display. When holding a test strip, ensure it is held by the wrapper as touching either end of the strip could interfere with the results.
  4. Fingertip blood samples only must be used, ensure patient’s hand(s) have been washed with soap and water and dried well before obtaining a blood sample. Massage finger with thumb toward tip to stimulate blood flow. Use a safety lancet to puncture the finger, then milk to form a drop of blood. Wipe away then milk the finger again to form a second drop of blood.
  5. Dispose of safety lancet into sharps container.
  6. Apply the blood sample to the white area at the end of the test strip until you see 3 short lines on the screen which shows enough blood has been applied. A 5 second countdown will start. Do not move or remove the test strip during the countdown, the result is then shown on the meter’s display.
  7. The meter shows results in mmol/L, from 1.1 to 27.8mmol/L
  8. Never reuse a test strip.
  9. The meter will turn off by pressing the butterfly symbol or if it is inactive for 2 minutes.
  10. Discard used test strip into offensive waste stream (tiger stripe) bag.
  11. Clean machine using a Clinell universal wipe.
  12. Remove PPE and decontaminate hands.

4.3 Ketone use

Same procedure as for blood glucose but the countdown is 10 seconds for ketones and the reading range is from 0.0 to 8.0 mmol/L.

4.4 Recording on SystmOne

Record the date, device type, batch number, expiry and result.

4.5 Actions following results of tests

The following actions are to be taken following results of tests, including abnormal results:

  • low blood glucose results, treat the hypoglycaemic event and repeat the test
  • high blood glucose results, undertake ketone testing
  • high ketone results, repeat the test dependent upon the test result and as per guidance below
  • low ketone results, repeat the test dependent upon the test result and as per guidance below

Ketone test results guidance:

  • Under 0.6mmol/L, a normal blood ketone value
  • 0.6 to 1.5 mmol/L, indicates that more ketones are being produced than normal. Advise patient to increase fluid intake of non-sugary fluids, ideally water, (at least 100ml every hour) and seek medical advice as it may be appropriate to give a correction dose of insulin at this point to help prevent further ketones from developing. Check for typical symptoms of diabetic ketoacidosis, such as abdominal pain, nausea, vomiting, headache, any change from usual physical or mental health state, drowsiness, confusion, increase in rate of respiration or rapid breathing. Repeat blood ketone test in 2 hours and review
  • 1.6 to 3.0 mmol/L, a high level of ketones and presents a high risk of diabetic ketoacidosis if left unmanaged. This needs to be managed as a medical emergency. Advise patient to increase fluid intake of non sugary fluids, ideally water, (at least 100ml every hour) and contact Healthcare team (diabetes specialist nurse or general practitioner) for urgent medical advice, as will need a correction dose of insulin at this point to help reduce the level of blood ketones. Check for typical symptoms of diabetic ketoacidosis, such as abdominal pain, nausea, vomiting, headache, any change from usual physical or mental health state, drowsiness, confusion, increase in rate of respiration or rapid breathing. If patient is experiencing any symptoms or feels unwell in any way, ring 999. Repeat blood ketone test in 2 hours and review
  • above 3.0mmol/L, a dangerous level of ketones and a very high risk of Diabetic Ketoacidosis. This is a medical emergency ring 999. If able to drink, advise non sugary fluids, such as water immediately. If patient has a plan for correction doses of insulin, please ensure this is followed

4.6 Training requirements

Read the operator’s manual and practice the testing procedures before using the meter. The device can be used by any suitably trained member of a trust healthcare team as part of their clinical activity.

4.7 Safety warnings

  • Care should be taken to avoid mix up of blood glucose (blue) and ketone (purple) strips as the boxes and strips look similar.
  • Ketone strips should be stored away separately.
  • Refer to blood glucose poster for clear pictorial guidance.
  • Observe caution when using around children as small parts may constitute a choking hazard.

4.8 Control solution test, this should be done daily or if used less frequently, before first use

  1. Decontaminate hands.
  2. Insert a test strip into the meter, the machine will turn on and the sample drop symbol will show on the meter’s display. Check that the lot number of the test strip foil appears.
  3. Press the bottle symbol until the ticked box appears. Shake the control solution then apply to the white area at the end of the test strip until you see 3 short lines on the display.
  4. The result should be in the range shown on the test strip instructions. The result will be stored in the device’s memory.
  5. If the result is out of range, please repeat the test. If it is out of range for a second time, please stop using the device and email rdash.purchasing-dg@nhs.net.

4.9 Control solution lifespan

Discard control solution 3 months after opening or on the expiry date on the bottle, whichever is first. Write the discard date on the bottle when you open it.

4.10 Test strip lifespan, storage and operating temperature

  • Test strips are individually wrapped, ensure the Expiry Date is checked before use.
  • Storage temperature: 4 degrees C to 30 degrees C. Do not leave in a car overnight due to risk of low temperatures.
  • Operating temperature: Use between 15 degrees C and 40 degrees C for best results.

4.11 Glucometer storage and operating temperature

  • Storage temperature: negative 20 degrees C to 60 degrees C
  • Operating temperature: 10 degrees C to  50 degrees C

4.12 Incident reporting

If there is an incident or fault whilst using a Glucometer, this should be reported on an IR1 in accordance with the incident management policy.

4.13 Troubleshooting

If a meter has an error code or doesn’t seem to be working properly, please try the below:

  • replace the batteries with new ones, even if the screen is on there might not be enough battery lift to perform the test correctly
  • set the time, turn the meter on by pressing the butterfly, then press and hold on the time on the screen till it flashes, then use the up and down arrows to set the time and date and press the butterfly to confirm.
  • get a new box of test strips (checking the expiry date) and insert the plastic calibration strip into the meter, the calibration code should appear on the screen
  • then insert a test strip from the same new box into the machine, ensuring you don’t touch either end of the strip, you should then get the drips on the screen to indicate to perform the test and the machine is working
  • if there is QC showing on the screen this means that the quality control test needs to be undertaken

5 Appendices

Appendix A Manufacturer’s instruction


Document control

  • Version: 1.
  • Unique reference number: 1062.
  • Date approved: 5 September 2023.
  • Approved by: Clinical policy review and approval group.
  • Name of originator or author: Medical devices and duty of candour officer, senior buyer, purchasing, community practice educators, diabetes specialist nurses.
  • Name of responsible individual: Executive director of nursing and AHP.
  • Date issued: 2 October 2023.
  • Review date: 31 October 2025 (new document).
  • Target audience: Glucometer users.

Page last reviewed: May 07, 2024
Next review due: May 07, 2025

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