Irrisept - Irrisept Antimicrobial Wound Lavage
Irrisept is jet lavage containing low concentration Chlorhexidine Gluconate (CHG) 0.05% in sterile water for irrigation. CHG acts as a preservative to help inhibit microbial growth in the solution.
The mechanical action of the Irrisept system removes particulate and debris. The unique bottle design allows users to control the delivery pressure of the solution through manual bottle compression. Grasping the bottle firmly, the user can control the direction and pressure needed to help remove particulate and debris.
Irrisept has successfully completed testing for cytotoxicity, skin irritation and sensitization/immune allergic response.
- Irrisept is FDA-cleared (K080779), Class II Medical Device and an unclassfied combination product
- Contents are wrapped in two sequential CSR wraps and sealed in a TYVEK® pouch, Model # ISEPT-450-USA
- (1) Irrisept (450mL bottle containing 0.05% CHG in sterile water, USP (99.95%))
- (1) Irriprobe applicator
Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.
Directions For Use:
- Grasp bottle top firmly and twist quickly in ONLY ONE direction, until seal cap snaps off.
- Attach applicator to bottle.
- Invert bottle. Using manual compression, direct stream into wound, ensuring complete coverage.
- Wait for approximately one minute, rinse with normal saline for irrigation. Discard any unused solution.
Warnings:
Do not use this product if the patient is allergic to chlorhexidine gluconate.
Discontinue use immediately if irritation, sensitization or allergic reaction occurs.
Cautions:
Do not use unless solution is clear and bottle twist seal is intact.
When using this product keep away from eyes and ear canals. If the solution inadvertently contacts these areas, rinse out promptly and thoroughly with water and/or normal saline.
Rx only.
Not for injection.
Single patient use only.
Do not use if the package is damaged.
Irrisept is intended for use by healthcare professionals only. Irrisept solution meets biocompatibility guidelines for ≤24 hours contact with breached or compromised surfaces (ISO 10993-1).
Features:
Not made with natural rubber latex
Single use, disposable
Self-contained, portable
Non-pyrogenic
The bottle and applicator are ethylene oxide-sterilized, whereas the solution is aseptically processed.