FlexLink - Medical Equipment Accu-Chek - Free user manual and instructions

USER MANUAL FlexLink Accu-Chek

Cannula casing Disconnect cover I Disconnect cover Transfer set J Luer-lock connector

Side wings Contents of the pack There are two packages with dierent contents: Infusion set Infusion set cannula

• Disconnect cover The head set from the infusion set cannula package must be used with the transfer set from the infusion set package. pi_04537246001_N.indd 5pi_04537246001_N.indd 5 25.06.2021 16:20:4725.06.2021 16:20:476 Intended use The Accu-Chek FlexLink infusion set is intended for the subcutaneous infusion of insulin administered with an insulin pump. These instructions for use feature the following symbol:

This symbol draws your attention to a warning. A warning must be heeded because it indicates a risk of injury or of damage to your health or the health of others. Not heeding the warnings can lead to life-threatening situations. General warnings

• Read these instructions for use carefully before using the infusion set. Also read the information about insulin pump therapy contained in the User’s Manual of the insulin pump.

• When you use the infusion set for the first time, your healthcare team must be present.

• Prepare the infusion site as instructed by your healthcare professional before you insert the cannula.

• This product is sterile packaged. Do not use the product if the package has already been opened or is damaged.

• Protect the product from excessive humidity, sunlight and heat. Store the product at room temperature.

• Do not allow the infusion set to come into contact with disinfectants, perfumes, deodorants or insect repellents.

• Dispose of the used product according to local regulations. Do not clean or sterilise the used product.

• Avoid mechanical stress on the infusion set and infusion site.

• The infusion set contains small parts. There is a risk of suffocation if small parts are swallowed. Keep all parts of the infusion set away from persons who may not be aware of the risks and may put small parts in their mouth, for example, small children.

• Pay attention to the tubing of the infusion set connected to your body. There is a risk of strangulation if the tubing becomes wrapped around your neck. In case of doubt, use the shortest tubing length to minimise the risk of strangulation. Product-specific warnings

• Change the cannula at least every 3 days and the transfer set at least every 6 days. Otherwise, there is a risk that the infusion site may become inflamed or the insulin may not be as effective.

• If the infusion site is inflamed, replace the infusion set immediately and choose another infusion site.

• Check your blood glucose level at least four times a day and at least once within 1 to 3 hours of replacing the transfer set or cannula.

• Do not replace the cannula or transfer set immediately before going to bed.

• If your blood glucose level should unexpectedly increase, or if an occlusion alarm occurs, check the infusion set for occlusions or leaks. If you are not sure whether the infusion set is working properly, replace it immediately.

• Never fill the tubing or attempt to remove an occlusion in the tubing while the infusion set is connected to your body as you may deliver an uncontrolled quantity of insulin.

• The soft cannula can kink while you are inserting it or when you are wearing it. Check regularly that the cannula is not kinked and that it is completely under the skin. If the cannula is kinked or has slipped out, replace it immediately.

• Check the connection between the luer- lock connector and the tubing every 3 hours and before you go to bed. If the connection is damaged, replace the transfer set immediately.

• Do not insert the removed introducer needle back into the cannula as this may damage the cannula. pi_04537246001_N.indd 8pi_04537246001_N.indd 8 25.06.2021 16:20:4725.06.2021 16:20:479

Attaching the infusion set

Choose an infusion site away from your waistline, any scar tissue, bones, navel and recent infusion sites.

Disinfect the chosen infusion site as instructed by your healthcare team.

Let your skin dry completely.

Hold the head set by the handling aid (A). Remove the needle cover (G).

To avoid contamination or injury, do not touch the introducer needle or cannula after removing the needle cover.

Keep the needle cover. You will need it later to safely dispose of the introducer needle.

Remove both parts of the protective film (D) from the adhesive pad (C).

Form a skin fold at the chosen infusion site.

Insert the introducer needle quickly and vertically (at a 90° angle) into the skin fold. Ensure that the cannula does not kink.

Make sure you insert the introducer needle into the skin quickly and in a single motion. Otherwise, the cannula may kink and you may receive a reduced amount of insulin or no insulin at all.

Hold the adhesive pad (C) in place.

Press the side wings (B) of the handling aid (A) together.

Remove the handling aid (A) in the direction of the arrow.

Hold the cannula casing (H) in place.

Remove the introducer needle straight upwards.

Dispose of the introducer needle in such a way that it will not cause injury to anyone. Place the introducer needle back into the needle cover or into a cannula disposal container.

Screw the luer-lock connector (J) into the insulin pump adapter.

Do not use any tools to screw the luer-lock connector into the insulin pump adapter as this may damage the luer-lock connector.

Fill the transfer set as described in the User’s Manual of the insulin pump until insulin drips from the needle inside the connector (L). There must not be any air bubbles in the cartridge or transfer set. pi_04537246001_N.indd 10pi_04537246001_N.indd 10 25.06.2021 16:20:4725.06.2021 16:20:4711

You must fill up the transfer set completely before you connect it to the cannula. The transfer set must not contain any air bubbles.

Hold the cannula casing (H) in place.

Push the connector (L) onto the cannula casing (H). You must hear and feel the connector click into place.

If you do not hear and feel the connector click into place, replace the head set and the transfer set.

Fill the cannula casing (H) with a U100 insulin bolus of 1.0U (10µL).

If you do not fill the cannula casing with an insulin bolus, you will receive too little insulin. Connecting and disconnecting the insulin pump This infusion set allows you to disconnect and remove the insulin pump for showering and swimming, for example. You can reconnect the insulin pump without having to replace the infusion set. pi_04537246001_N.indd 11pi_04537246001_N.indd 11 25.06.2021 16:20:4825.06.2021 16:20:4812

Consult your healthcare team on how to compensate for any missed insulin while you are disconnected from the insulin pump. Disconnecting the insulin pump

Hold the adhesive pad (C) in place.

Press the side wings (M) of the connector (L) together.

Remove the connector (L) from the cannula casing (H).

Push the disconnect cover (I) onto the cannula casing (H). Connecting the insulin pump

Hold the adhesive pad (C) in place.

Press the side wings of the disconnect cover (I) together.

Remove the disconnect cover (I) from the cannula casing (H).

Push the connector (L) onto the cannula casing (H). You must hear and feel the connector click into place.

Replacing the head set or transfer set

Disconnect the transfer set from the cannula casing (H); see section “Disconnecting the insulin pump”. Replacing the head set

in the section “Attaching the infusion set”. Replacing the transfer set

Connect the new transfer set to the insulin pump. Start with step

calls may be recorded for training purposes Some mobile operators may charge for calls to these numbers. [e-mail] www.accu-chek.co.uk www.accu-chek.ie pi_04537246001_N.indd 15pi_04537246001_N.indd 15 25.06.2021 16:20:4825.06.2021 16:20:48A