Orthopedic surgery pulsed lavage system

wound debridement

Overview
AC version: the Mölnlycke pulsed lavage operates with an AC adaptor. Battery version: the device includes a built‑in, easily removable battery pack for disposal. Both versions are supplied as single‑use devices intended to minimise contamination in surgical and wound care settings.

Intended use
Disposable pulsed lavage system for irrigation and cleaning of wounds and surgical sites in orthopaedic procedures, trauma and general wound care. Available in AC adaptor and built‑in battery variants.

Key features

• Sterile if package intact
• Single‑use handpiece; AC version with reusable AC adaptor
• Built‑in removable battery pack (battery version)
• Short fan spray tip with splash shield and long femoral canal tip
• Integrated suction and irrigation
• Cleaning rod to clear potential occlusions in femoral tips
• Ergonomic handpiece design
• DEHP‑free materials
• Supplied singly packaged or included in Mölnlycke procedure trays

Variants / product references

• REF 9750000-01 — consumer pack (1) GTIN 06973181645565; dispenser box (1) GTIN 16973181645562; transport carton (5) GTIN 36973181645566
• REF 9750000-00 — consumer pack (1) GTIN 7323190161072; dispenser box (1) GTIN 7323190157167; transport carton (5) GTIN 7323190157150
• Other variants: REF 9750003 (battery kit with 3 m suction/irrigation tubes), REF 9751004 (131 mm coaxial canal brush tip), REF 9751007 (hip revision tip)

Precautions

• DO NOT submerge the instrument in liquid.
• DO NOT drop or strike the instrument.
• Store in a cool, dry place.
• No modification of the equipment is permitted.
• Do not mix with used or other types of batteries.
• Dispose of single‑use components immediately after use following local regulations.
• Ensure safe disposal in accordance with applicable national and international waste directives.
• Sale restricted to or on the order of a physician under applicable law.

Warnings

• Failure to follow warnings may cause injury to user or patient.
• Wear appropriate personal protective equipment (fluid‑proof gown, gloves, mask or face shield, hair cover) to avoid infectious splash.
• Cover patient lines, ports and wounds not being treated.
• Follow standard aseptic practices to minimise contamination.
• Sterile only if package is unopened and undamaged.
• Single‑use only — DO NOT re‑sterilize.
• Do not use a damaged or malfunctioning instrument.
• Improper technique may damage the wound bed.

Regulatory & specifications

• Commercial name: Pulsed Lavage (Mölnlycke)
• Product type: disposable single‑use pulsed lavage system
• Versions: AC adaptor version and built‑in battery version
• Intended applications: orthopaedic surgery, trauma and general wound care
• Regulatory class: MDD Class IIa
• Notified body: BSi 2797
• IFU (Instructions for Use) available; example internal ref PD-779232_2
• Manufacturer listed in product file: Dongguan Kaiser Technology Co., Ltd.