PRODUCTS
Medical Devices
LOOPIX
Product classification: Medical device
Basic Information
Item Name
A medical clip
Item authorization numnber
No. 18-849
Purpose
This device is used to temporarily secure or hold medical devices (non-vascular catheter) other than human tissue.
Storage
Avoid direct sunlight and hot humid places
Detail Information
Precautions
Cautions for use
1) Familiarize with the instructions before use.
2) LOOPIX catheter anchor is prohibited for use with vascular catheters.
3) Unopened or undamaged contents are sterile.
4) This product is a disposable product. Regularly exchange the product based on the state of the exudates around the tube and the insertion period of the tube. Do not exceed 7 days.
5) This product is a disposable product and does not permit reuse. It is only available for one patient and is not reused or reprocessed. Reuse or reprocessing can damage the structure of the product and lead to product failure resulting in patient injury, disease, and death. In addition, it can lead to patient injury, disease and death by causing product contamination such as infection, cross infection, and infection of an infectious disease from one patient to anothe
6) Precautions for side effects and accidents caused by careless use
Sortation | Actions and precautions |
| Lock and unlock the hoop bands | Turn the rotating ring clockwise to activate hoop bands. While pressing the unlock button on both sides of the rotation ring, turn the rotating ring anticlockwise to deactivate the hoop bands. |
| Lock and unlock the catheter holder (ties) | Pull the heart-shaped ring of the ties to unhold the catheter. |
| Observation of the drainage | In case of poor drainage 1) Check the hoop bands and ties to adjust the degree of locking and unlocking according to the circumstances. 2) Adjust the catheter (drainage tube) position |
| Removal of the product | Either untie or cut the ties, then remove the product along the catheter (tube) while removing the adhesive band by deactivating the hoop bands. |
How to use
1. Preparations before use
1) Use alcohol to clean the area around the wound and keep the skin dry.
(If a disinfectant containing iodine is used, it must be deiodinized and the skin must be dry before use.)
2) Use this product while paying attention to the size of the tube.
2. Insructions
1) Remove the product from the packaging container.
2) Clean and dry the area to be applied to the skin.
3) Pass the catheter (drainage tube) through the specified hole in the rotating ring and remove the wrapping paper from the adhesive band to attach it completely to the skin.
4) Turn the rotating ring clockwise to activate the hoop bands so that the catheter is secured.
5) Secure the catheter tightly by using ties so that it does not move.
6) Ensure that the drainage tube is firmly fixed and that it has a smooth suction of exudates.
3. How to store and manage
1) Store at room temperature (10°C ~ 30°C).
2) Do not freeze or heat the product.
3) Avoid direct sunlight and hot humid places.
4) Do not reuse as this product is disposable.
