Sansulin Rapid Patient Counseling Information

Instructions for Use: Introduction: Read this manual completely and follow the directions carefully before using the SANSULIN Rapid Dispopen, even if the patient have used a similar injection pen device before.
Important Information: Always attach a new needle before each use.
Do not select a dose and/or press the injection button without a needle attached.
Always perform the functional test before each injection (see step 2).
This pen is only for the patient's use. Do not share it with anyone else.
Never use SANSULIN Rapid Dispopen if it is damaged or if the patient is not sure that it is working properly.
Technical Characteristics: SANSULIN Rapid Dispopen can deliver doses between 10 μL (microliter) and 600 μL in 10 μL increments.
Step 1: Attach Pen Needle: 1.1 Pull off the pen cap.
1.2 Pull off the protective foil on the pen needle.
1.3 Put on the pen needle onto the SANSULIN Rapid Dispopen, keeping it straight. (screw or push on, depending on the needle type).
1.4 Pull off the outer pen needle cap and keep for use after the injection.
1.5 Pull off the inner pern needle cap and dispose of it.
Step 2: Priming/Functional Test: Important: Prior to the first injection, the SANSULIN Rapid Dispopen must be primed in order to remove air bubbles from the cartridge for accurate dosing and/or to ensure that the needle is not clogged.
2.1 Select a dose of 2 units turning the dose knob clockwise (2 clicks).
If necessary the selected dose can be corrected by turning the dose knob counter-clockwise.
2.2 Hold the pen in an upright position (pen needle pointing up). Tap slightly with a finger on the cartridge holder to allow potential air bubbles within the cartridge to rise up.
Note: Air bubbles are not always present. Nevertheless this step should be performed to check drug flow through the pen needle prior to each injection.
2.3 Press the push button all the way until a hard stop is felt to discharge the dose. Number '0' is visible in the display window and aligns with the dose indicator.
2.4 Check whether a droplet of liquid shows at the tip of the pen needle. If no drops appear repeat step 2.1 - 2.4 (Priming/functional Test) until a drop appears.
Important: In case no drops emerge after 5 attempts, replace the pen needle (see step 6) and repeat the functional test (see step 2.1 - 2.4).
Step 3: Setting the Dose: 3.1 Turn the dose knob clockwise until the prescribed dose aligns with the dose indicator in the display window. If necessary the dose can be corrected by turning the dose knob counter-clockwise.
Important: Make sure not to press the push button while dialing the dose to avoid loss of drug.
Notes: A dose larger than the amount of drug remaining in the pen cannot be dialed.
If the dose is larger than the remaining drug volume in the cartridge a new pen should be used for the remaining dose.
Step 4: Injection: Read steps 4.1 and 5.1 first before proceeding with the injection.
4.1 Hold the pen so that the display window is visible during the injection. Insert the pen needle into the skin and press the push button all the way in until a hard stop.
is felt and the number '0' is visible in the display window and aligns with the dose indicator.
Note: Use the injection technique recommended by the doctor or healthcare professional.
Step 5: Holding After Injection: 5.1 When the complete dose has been delivered, keep the push button pressed for another 10 seconds. Then slowly remove the pen from the injection site at a 90° angle.
Important: Do not tilt the pen during injection and removal from skin to avoid pen needle damage.
Note: Holding ensures a complete discharge of the drug dose.
Step 6: Disposal of Pen Needle: 6.1 Replace the outer pen needle cap carefully.
6.2 Unscrew the pen needle counter-clockwise and dispose of the pen needle safely.
Step 7: Pen Cap Mounting: 7.1 Firmly attach the pen cap to the pen for protection between injections.
Maintenance: Protect the SANSULIN Rapid Dispopen from dust and dirt.
The patient can clean the outside of the SANSULIN Rapid Dispopen by wiping it with a damp cloth.
Do not soak, wash or lubricate the pen as this may damage it.
The SANSULIN Rapid Dispopen is designed to work accurately and safely. It should be handle with care.
Avoid situation where SANSULIN Rapid Dispopen might be damaged. If the patient is concerned that the SANSULIN Rapid Dispopen may be damaged, use a new one.