Automatic Medical Injector Spasilin

For self-administration of intramuscular and subcutaneous injections using single-use standard syringes with a volume of 3 ml and 5 ml.

1. Ensure that the required cartridge (3 ml or 5 ml) is installed in the injector. Replace the cartridge in the injector if necessary.
2. Wipe the outer surfaces of the injector and needle cap remover with an alcohol wipe.
3. Insert the filled syringe into the injector.
4. Close the injector with the lid.
5. Insert the needle cap remover until it clicks.
6. Wipe the end of the injector that will contact the injection site with an alcohol wipe, without removing the needle cap remover.
7. Remove the protective cap from the needle using the cap remover, avoiding contact with the injector using your fingers.
8. Clean the injection site with at least two wipes or balls soaked in antiseptic solution.
9. Press the injector against the intended injection site at a right angle from the side of the safety guard.
10. Press the trigger button. The trigger button will not activate if the injector is not pressed firmly against the injection site.
11. After pressing the trigger button, the needle insertion mechanism will activate (first click). Then, the medication will be administered for approximately 12 seconds. Following this, the needle extraction mechanism will activate (second click). The injection is complete.
12. Press a wipe or ball soaked in antiseptic solution against the injection site. Without removing your hand, gently massage the site of medication administration.
13. Open the injector casing, remove the syringe, and place the protective cap on the needle. Dispose of all used disposable materials according to their safety class.
14. After each procedure, rinse the injector with warm running water. After that, dry the injector by leaving it in open air for a couple of hours until completely dry. The injector is ready for the next procedure.

Material composition:
Left housing, right housing, removable: ABS white
Damping disc, ratchet axis, damping cover, ratchet gear, holder, pusher, lifter, 3 cc cartridge, plug, button, fuse, fuse holder: ABS natural
Housing cover, 5 cc cartridge: SAN plastic
Self-tapping screws DIN 7982 2.2x16 A2, large springs ST 13100, small springs ST 13097, tiny springs 0.4x4x5 5X7: Stainless steel
Damping lubricant: silicone oil

It is not recommended to use the injector for administering oil-based medications, as it cannot ensure the specific technique required for oil-based drug administration, namely: before administering an oil-based medication, it is necessary to ensure that the needle has not entered a blood vessel.

Before using the device, carefully read the user manual and keep it for future reference.
The manual contains all the necessary information on how to handle and care for the device.
Strictly follow the instructions for proper use of the device!
Precautions
Before use, thoroughly wash your hands and disinfect the device with an alcohol wipe.
The device is intended for use only with syringes of 3ml and 5ml volumes that meet the requirements of GOST ISO 7886-1-2011 and are registered in accordance with the established procedure with Roszdravnadzor.
Avoid drops and strong impacts.
Do not use the Injector if it has external damage or is functioning abnormally.
After each use, the Injector must be rinsed with warm (not hot) running water.
Important information.
1. If the injector is cocked into working condition, the trigger button is protected from accidental pressing by a safety mechanism. The safety mechanism releases the trigger button when pressed against the injection site. The safety mechanism also prevents the trigger button from being pressed if the lift is not fully cocked.
2. When working with the device, it is important to properly prepare the device for use: a) for subcutaneous injection, the syringe lift should be cocked not to the stop, but to the indicator line for subcutaneous injection, marked inside the body (see Fig. 1), reaching the line is accompanied by a characteristic (first) click; b) for intramuscular injection, the syringe lift should be cocked to the stop (second click).
3. Do not discard the needle cap after removal. After the injection, the cap should be placed back on the needle and then the syringe with the needle should be disposed of in a trash bin. Ensure that no one can be injured by the needles. This is dangerous, as the tip of the needle may contain remnants of medication and biological materials from sick individuals.
4. Try to use standard disposable syringes of the SFM brand, 3ml with a 23G (0.63x32mm) needle and 5ml with a 22G (0.7x40mm) needle.
5. When performing an intramuscular injection, it is necessary to consider the body mass index (BMI) * and follow these recommendations:

• For patients with normal (18.5 ≤ BMI < 25) or excess body weight (25 ≤ BMI < 29.9), intramuscular injections can be performed in commonly accepted body areas (buttock, thigh);• For patients with obesity (BMI ≥ 30) or if the patient's body weight is below normal (BMI < 18.5), it is necessary to consult with the attending physician regarding the possibility of using the injector and selecting the injection site.• BMI - body mass index (World Health Organization classification)• It is not recommended to use the injector for administering oil-based medications, as it cannot ensure the special technique required for administering oil-based medications, namely: before administering an oil-based medication, it is necessary to ensure that the needle has not entered a blood vessel.• Due to the fact that some injectable solutions have aggressive or sticky properties that may affect the plastic parts of the device, the injector must be rinsed with warm running water after each use (especially if drops of medication get on the parts). Care and disinfection. To avoid dirt and dust getting on the device, it should be stored in a tightly closed plastic case or cardboard box (packaging). The injector does not require special maintenance. Before the first use of the injector, the surface should be wiped with a slightly damp cloth. Before performing the injection, all external and accessible internal surfaces of the injector should be disinfected with an alcohol solution or alcohol wipe. After the injection, the device should be rinsed with warm running water or fully immersed in warm water, possibly with the addition of 0.5% detergent (in case of heavy contamination), dried by leaving it in the air for a couple of hours, and stored in a plastic case or cardboard box. Storage and operating conditions Store the device in household conditions in consumer packaging-case at a temperature not exceeding 30°C in a dry place, protected from direct sunlight and out of reach of children, away from heating appliances. The injector should be operated at temperatures from +10°C to +40°C with a relative humidity of no more than 80%, without deterioration of quality and loss of functional properties.

Not detected.

Brand Spasilen - medical devices and consumables

AUTOMATIC MEDICAL INJECTOR SPASILEN - a device for self-administering intramuscular and subcutaneous injections using disposable syringes of 3 and 5 ml volume.

Spasilen Auto-Injector:
-Automatic
-Reusable
-Mechanical
-Uses disposable syringes of 5 and 3 ml volume
-Cocked into working condition by hand
-Equipped with a safety mechanism to prevent accidental discharge. Includes a trigger button
-Accessories include interchangeable cartridges for 3 and 5 ml syringes
-The cap remover allows for the removal of the protective cap from the needle of the disposable syringe without compromising sterility
-Has settings for needle insertion "intramuscular" and "subcutaneous"

Area and conditions of use.
The device is a reusable non-sterile tool for performing intramuscular and subcutaneous injections at home and in medical institutions. It allows for self-injection without special professional skills. It alleviates painful and unpleasant sensations. Ensures proper injection administration.

The Spasilen auto-injector is designed to significantly reduce discomfort from injections and make the process more comfortable for both adults and children.
The manufacturers have made the device so simple and convenient that you can use it independently without involving others.
Spasilen has registration certificate No. RZN 2021/13631 from Roszdravnadzor.
The device is reusable for performing intramuscular and subcutaneous injections at home and in medical institutions.
The product features a compact body made of polymer material with an ergonomic shape and a cover.
Inside the body are spring mechanisms that facilitate automatic injection administration.
On the side surface of the body is a trigger button that activates the injection mechanisms.
On the end of the product's body, near the needle exit hole, is a safety button that prevents the device from activating when the trigger button is accidentally pressed.
To install syringes in the injector body, there are interchangeable cartridges for 3 ml and 5 ml syringes.
The cartridge with the syringe is secured on the cartridge holder located inside the device body.
A cap remover is provided for removing the cap from the syringe needle.
The automatic medical injector "Spasilen" is supplied in a box made of coated cardboard, ensuring safe transportation and storage of the product.

Principle of operation.
The principle of the automatic injector's operation is based on the action of spring mechanisms that provide the reciprocating motion of the syringe.
The spring mechanisms are activated by pressing the trigger button.
One press of the trigger button replaces several sequential actions that need to be performed during a standard injection:
1) inserting the needle;
2) moving the piston and administering the medication;
3) withdrawing the needle.
Functional characteristics.
The automatic medical injector "Spasilen" allows for self-injection without external assistance, as well as for injecting loved ones, addressing the issue of distance from medical facilities.
The device helps reduce emotional and physical reactions to the injection procedure.
Using the device relieves the patient of nervous tension during the injection and allows for self-administration without external help when injectable medications are prescribed by a treating physician and professional medical assistance is unavailable.
The needle enters the injection site at a precise 90° angle quickly, painlessly, to the required depth.

TECHNICAL SPECIFICATIONS
The product body is white, smooth, glossy, without cracks, stains, chips, or burrs.
The trigger button and safety button are of uniform blue color.
The body cover is transparent, blue, easily removable, and fits tightly.
The trigger button operates smoothly, without effort, and without sticking.
The materials used for manufacturing the product are lightweight, non-toxic, have high strength and durability in operating conditions, and are resistant to disinfection treatments.
The weight of the assembled injector is 245.0 g
Dimensions of the injector are 198 mm * 53 mm * 42 mm
The residual volume of medication in the syringe is no more than 0.07 ml.
Working length of the needle for intramuscular injection - 26 mm ±2
Working length of the needle for subcutaneous injection - 13 mm ±2
The product ensures uniform administration of the medication over 12 ±3 seconds.
Sterilization
The medical device does not require sterilization.
Technical maintenance and repair
The product does not require special technical maintenance during operation.
Repair of the product is not provided.

Automatic Medical Injector Spasilen - a device for self-administering intramuscular and subcutaneous injections with single-use syringes of 3 and 5 ml. Spasilen is designed to significantly reduce discomfort from injections and make the process more comfortable for both adults and children:

- Allows for self-administration of intramuscular injections at home
- Does not require professional skills
- Ensures proper injection technique
- Helps alleviate children's fear of injections
- Minimizes pain from injections and unpleasant sensations
- Reduces psychological fear of injections
- Fully automatic.

The automatic medical injector "Spasilen" is a reliable assistant in providing qualified medical care at home.