Lenis Needle-free Safety Syringe Device User Manual

Transcription

1 Lenis Needle-free Safety Syringe Device User Manual 1

2 Table of Contents Welcome.3 Lenis Kit Components.4 Instructions 5-9 Maintenance and Care..10 Troubleshooting. 11 Warranty.12 Precautions 13 Return Policy.14 Contact Lenis USA.15

3 Welcome The Lenis Needle-free Safety Syringe (NFSS) is a compact injection system that delivers liquid medications or supplements by creating a narrow precise fluid stream that penetrates the skin and eliminates the need for a needle. The fine as hair liquid jet stream is produced with high pressure spring power through a micro-orifice at the end of the Safety Syringe. This allows the medication to penetrate through the skin in a fraction of a second, delivering fluid into the body needle-free. The Lenis system is intended to deliver between ml of liquid medication for subcutaneous (Sub-Q) and intramuscular (IM) injections. Easy : Easy-to-administer, ergonomic design Safe: No needles = No needle-stick injuries Comfortable: Minimizes injection-associated fear and anxiety Cost-Effective: Durable, no external power source required, no sharp disposal Convenient: Small size, light weight, easy to store Please read manual carefully before using the device to ensure a thorough understanding of the user instruction for safe and effective use of the device. 3

4 Kit Contents 1 Injector ǀ 1 Loader ǀ 1 Sterile Adapter ǀ 5 Sterile Safety Syringes ǀ Instruction Manual Safety Cap (closed) Label Top of Injector Injector Reusable, guaranteed up to 10,000 uses. Reusable hardware Clean (not sterile) Safe to Autoclave for Sterile Adapter For the transfer of medication from vials to Safety Syringes. Disposable Sterile - May be reusable with multi-dose vials when maintaining sterility of cap and top and not breaking sterile tip to vial seal insertion. Head (sterile surface) Body Safety Cap (open) Trigger Button Spike (sterile surface inserted into vial) Cap Label Loader Open Barrel [side view] [front view] For priming/loading the Injector for injection. Reusable hardware Clean (not sterile) Safe to Autoclave for Sterile Lid Safety Syringe To hold and inject liquid medication. Increments of 0.01 ml, maximum 0.5 ml, one time/single use only. Disposable Sterile NOT reusable Plunger Body Head with Micro-orifice (injection point) Slide Lever Hinge Base Slide Plunger 4

5 Instructions: Preparation 1. Thoroughly wash your hands with soap and water. 2. Make sure to have all components of the Lenis Kit and two (2) antiseptic swabs ready 3. Select the site on the body for injection* and use one (1) antiseptic swab to thoroughly clean the area. Do before preparing the Injector to allow antiseptic to dissipate/dry. * * * The Lenis device is recommended to be applied where there are fewer blood vessels, follow the guidelines recommended by the drug being ministered and if to be Sub-Q or IM. Never inject directly over bones! Make sure to not inject over body hair. 5 ** If antiseptic/alcohol is not allowed to dissipate/air dry, the Lenis may inject and cause stinging (the same effect when using a standard, traditional hypodermic needle-syringe.)

6 Instructions: Preparing the Injector 1. Determine if the Injector is already pressure loaded. Looking into the open end barrel of the Injector: If the stainless steel head is positioned just below the screw threads (about 0.5 in), then the Injector is read to fire; otherwise, continue to step Open the loader lid fully, slightly greater than 90 degrees. Ready to Inject Needs Loading 4. Gently push down the length of the Injector firmly into place, and the Injector is lies flat against the bottom. 5. Firmly push down the loader cover until the lid is completely closed. 3. With the Injector handle facing upwards, install the Injector into the loader base by tilting the end of the Injector head first into the slide plunger. 6. Open the lid fully and gently remove the Injector from the base. The Injector is now primed and ready to use. 6 Warning Using the Injector without a Safety Syringe may result in damaging the device. Do not open cap and release trigger button without a Safety Syringe attached to the Injector, or dry fire the Injector upon removing from the loader.

7 Instructions: Preparing the Vial 1. Wipe the top of medicine vial with an antiseptic swab. 2. Remove the adaptor from the sterile packaging being careful to not touch the sterile tip avoiding cross contamination with fingers. 3. Insert the adaptor spike into the cleaned rubber head of the vial creating a firm seal. 4. Remove the cap from the adaptor head, keeping the bottom of cap sterile (place with top down on clean/sterile surface.) 5. Remove sterile Safety Syringe from package maintaining sterility of tip avoiding cross contamination with fingers. 7. Insert the Safety Syringe into the head of the adaptor and gently twist to form a seal - about three (3) turns. 7

8 Instruction: Filling the Safety Syringe 1. Keep the bottle upside down. Pull the Safety Syringe plunger drawing out the amount of fluid for the medication dosage needed. (If there is too much vacuum resistance as the vial becomes less full of medicine, insert a small amount of air to counter, maintaining sterility of ends.) 3. Screw the plunger side of the Safety Syringe into the head of the Injector; About three (3) turns until snug, do not force/try to over rotate. 2. One the required amount is in the syringe*, tap to make sure there are no air bubbles. Remove the Safety Syringe from the adapter and verify all air bubbles have been removed by gently flicking the side of the Safety Syringe and then using the plunger slowing pushing any air out. *The very tip of the plunger needs to be aligned with the increment line of desired dosage volume. 4. Put the adapter cap back on the vial, if a multi-dose vial, maintaining sterility of the cap and adaptor head. (Store vials as directed by the medication labels and facility medication protocols. 5. The system is now ready to Inject medication. 8 Warning Do not inject with any air bubbles as the Lenis uses 4,000 psi, any air bubbles may break the Safety Syringe.

9 Instructions: Injecting using Lenis 1. Push the head of the Safety Syringe firmly against the skin and hold at a 90 angle to create a seal, avoiding fluid leaking Keep the Safety Syringe firmly against the skin for five (5) seconds. 4. Remove the device and place a swab with slight pressure over the injection site for a few seconds. 2. Flip open the Injector protective cap at the top to expose the trigger button and press down the trigger to inject the medication/fluid. You will hear a small click noise when the trigger has been activated. 5. Unscrew the one time only use Safety Syringe from the Injector and dispose in a trash bin no biohazard container is needed. 6. You may store the Injector back in the loader in-between uses. For further information and instructional videos, please visit the website: 9 Warning Do not dry fire the Injector directly against a person s skin as it may cause damage to the tissue because no medication/fluid is pushed into it.

10 Maintenance and Care The Lenis Injector and Loader are reusable components, therefore, it is important to maintain these parts of the system appropriately to ensure dose accuracy and life cycle of the devices. Injector and Pressure Lever may be cleaned and disinfected regularly by wiping the exterior surfaces using 70% Isopropyl Alcohol. When using in a sterile environment, the Injector and Loader are safe to autoclave Store the Lenis at room temperature. 10

11 Trouble shooting 1) No pressure in the main unit. Engage pressurization 3 to 4 times using the loader. If this does not work contact the seller directly. 2) Excessive residual medicine on the skin after injection. Make sure there is no body hair on the injection site as it will block and prevent a full seal between the micro-orifice on the Safety Syringe and the skin. Press Safety Syringe more firmly against the skin making sure the Safety Syringe is at 90 angle. Do not pinch the skin. Keep the Safety Syringe against the skin for 5 seconds after completing the injection. For any inquiries on the product, contact Lenis USA directly. 3) Unable to withdraw medication into Safety Syringe. The hole in the hollow needle of the adapter may be against the rubber septum of the vial. Turn adapter on vial 45 and try again. 11

12 Warranty FREE OF CHARGE WARRANTY SERVICE We provide warranty service free of charge for defective products caused during the manufacturing process or occurred under normal dosage conditions for a period of 60 days from the date of purchase. WARRANTY IS VOID IF The warranty period has ended (Over 60 days from the date of purchase). The user has not complied with the directions or cautions on using the product. Problem caused by negligence on the part of the person using the product. Problem caused by disassembling or rebuilding the unit or a repair by an unauthorized person. Any other problem caused by Act of God. 12

13 Precautions Please read manual carefully before using the device to ensure a thorough understanding of the user instruction for safety and proper usage. Make sure to always inject/release the Injector unit with a Safety Syringe. Using the Injector unit without the Safety Syringe - a dry fire - may result in damaging the device or a person s skin. Do not use excessive force when using the system as it may damage the product. Do not use if the Safety Syringe or adapter packages are open or passed expiry date. Do not hold loaded Injector with Safety Syringe close to or against the eyes, ears bones or other sensitive parts/none tissue areas of the body. Keep all medication and injection devices out of reach of children. Make sure to press the Lenis against your skin at a 90-degree angle. If the Lenis is not pressed against the skin at a straight angle, you run the risk of a wet/incomplete injection. The Safety Syringes are sterile and for single use only. They must be disposed of after each injection because they will no longer have sterile tips. For best results, an injection volume between ml is recommended. 13

14 Return Policy If you are unsatisfied with the product, please contact us within 30 days of the purchase date to arrange a refund of your ordered item(s) and we will provide a refund for the product. The item s online purchase receipt and original packaging are required for all exchanges or refunds. Refunds will be issued in the same method of payment as the original payment (e.g., credit card purchases will be credited to the original credit card account). Our return policy lasts 30 days, starting on the date of purchase. Shipping charges for any items returned are not assumed by Lenis. 14

15 Contact Us Lenis Medical Ltd. Manufacturer 8755 Ash Street, Suite 1 Vancouver, BC, V6P 6TS Lenis USA 1046 E. University Dr. Mesa, AZ (866) Version 2.0 Last Updated 10/15/2018, Revisit 1/1/2019