INSTRUCTIONS FOR USE

Instructions for Use

**Please Note: These documents may be revised from time to time, so please refer to this Web page for the most current version at the time of the procedure.

NFIS IFU 2023 Rev I

NFIS IFU (Other Languages)

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Product FAQs

1. Why can’t I push down on the NFIS Device trigger button?

Ensure your thumb is covering the entire surface of the trigger button for better leverage. Practice injecting in the injection test foam to get comfortable with the amount of pressure needed to press the trigger button successfully. If the issue persists, please contact to customer service team.

2. Does the injection device make a sound?

When injecting a medication, the device will make an audible click sound when the trigger button is pressed.

3. What are the Vial Adapters for?

The Vial Adapters are used to transfer the liquid drug / biologic from the medication vial into the cartridge of the Needle Free Injection System. Since NFIS Device does not use a needle to remove the drug / biologic from the vial, a Vial Adapter is needed to transfer the drug / biologic into the cartridge.

4. What are the Pre-filled Syringe Adapters for?

The pre-filled Syringe Adapters are used to transfer the liquid drug/ biologic from the pre-filled syringe into the cartridge of the Needle Free Injection System.

5. How many times can the Vial Adapter be used?

The Vial Adapter is a disposable product intended to be used for one type of medication either a single dose or a multi-dose.

6. How many times can the Pre-filled Syringe Adapters be used?

The Pre-filled Syringe Adapter is single use only.

7. What are the minimum and maximum quantities per application?

Minimum of 0.1 ml and a maximum of 0.5 ml of a liquid drug / biologic can be administered at one time.

8. Can the IntegriMedical Needle Free Cartridge be used again?

No, the cartridge is intended too be single use only.

9. What is the warranty?

The NFIS shall be covered under a warranty of 2 years from the date of purchase. The warranty shall cover any defects in material or workmanship under normal use. During the warranty period lntegriMedical will repair or replace the NFIS Device and/or the components. A handling and service fee may apply. To obtain warranty service, send an email with your NFIS Serial Number to customerservice@integrimedical.com

Injection Process FAQs

1. What is the best position for injecting?

The administrator of the injection must choose the appropriate position. However, must assure placement of NFIS Device at 90° & follow all the steps to perform injection.

2. Should I rotate my injection site?

Yes, the injection site should be rotated as directed by the physicians / healthcare professionals.

3. Do you bleed after receiving an injection?

Bleeding does not usually occur. Similar to needle injections, needle free injection system might cause some damage to the outer layer of skin. In rare instances, this might cause a pin-sized drop of blood to appear at the needle free injection site.

4. Why is some liquid on my skin after the injection is complete?

When this occurs, it is because not all the medication has been administered. Residual medicine on the skin is caused by the device not being placed firmly enough on the skin and/or not being placed at 90°. Press the NFIS Device firmly onto the injection site, until the skin is clearly sealed with the injection device. Hold the NFIS Device in place for 5 – 7 seconds to allow the medication to penetrate the skin completely.

Storage, Cleaning & Disposal FAQs

1. How do I clean the IntegriMedical Needle Free Injection System?

To prevent the cross contamination, the reusable NFIS Device & Loader should be disinfected with alcohol wipes outside of the device.

2. How do I store the device?

Store the NFIS Device in the provided storage kit-box.

3. How do I dispose of the Cartridge, Vial Adapters, and Pre-filled Syringe Adapters?

Dispose of the Cartridge, Vial Adapters, Pre-filed Syringe Adapters according to your local requirements /WHO Guidelines / Instructions from manufacturer.

4. What temperature should the system be stored at?

The NIFS kit shall be ideally stored at temperatures between 15°C (59°F) -30°C (86°F)