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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.

N-FIS IFU 2023 Rev I

Latest version of the Instructions for Use document

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N-FIS IFU 2023 Rev I

N-FIS IFU (Other Languages)

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N-FIS IFU 2023 Rev I

N-FIS IFU (Other Languages)

Finnish
Norwegian
Swedish
Greek
Czech
Hungarian

Frequently Asked Questions

Find answers to common questions about our products and services

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 our customer service team.

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

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 N-FIS 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.

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.

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

The Pre-filled Syringe Adapter is single use only.

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

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

The N-FIS 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 IntegriMedical will repair or replace the N-FIS Device and/or the components. A handling and service fee may apply. To obtain warranty service, send an email with your N-FIS Serial Number to customerservice@integrimedical.com

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

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

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.

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 N-FIS Device firmly onto the injection site, until the skin is clearly sealed with the injection device. Hold the N-FIS Device in place for 5 – 7 seconds to allow the medication to penetrate the skin completely.

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

Store the N-FIS Device in the provided storage kit-box.

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

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

Clinical Trials

Needle Free Injection

Vs Hypodermic Needles

Investigate Safety, tolerability and acceptability evaluation of N-FIS

Immunogenicity Performance – Covid 19 Booster Dose

Performance comparison between needle-free and Hypodermic injections

Safety, Tolerability & Acceptability – Covid 19 Dose in Children

Pain assessment in children using intramuscular vaccines

Product FAQs

1. Why can’t I push down on the N-FIS 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 N-FIS 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 N-FIS 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 N-FIS Device and/or the components. A handling and service fee may apply. To obtain warranty service, send an email with your N-FIS 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 N-FIS 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 N-FIS Device firmly onto the injection site, until the skin is clearly sealed with the injection device. Hold the N-FIS 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 N-FIS Device & Loader should be disinfected with alcohol wipes outside of the device.

2. How do I store the device?

Store the N-FIS 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 N-FIS kit shall be ideally stored at temperatures between 15°C (59°F) -30°C (86°F)

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