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The "Carilex" VT · 200-i NX suction therapy unit is indicated on use with patients with the following wounds: - · Traumatic - Dehisced wounds - Partial thickness burns - · Chronic wounds including pressure ulcers, diabetic foot ulcers and venous leg ulcers - Acute wounds - · Flaps and grafts The device is not intended for home use. Wound irrigation/Instillation function is not intended for use in a homecare setting.

Carilex VT 200-i NX is a powered, portable suction device with battery backup that provides localized negative pressure wound therapy when used with the VT Dressing kits to remove body fluids, irrigation fluids, infectious material and tissue debris from the wound. Carilex VT 200-i NX have shown that they may help promote the healing of several different kind of wounds via fluid removal. When in use, the vacuum air suction pump in the control unit suck the air from the wound through the connecting hose and dressing to create a negative pressure environment of the wound. The suction of the pump will help remove excess fluids from the wound. VT Dressing kits will be placed onto the wound by healthcare professional and a tube will be connected from the wound to the canister on the pump. After the dressing and tube are correctly applied and connected, turn on the VT · 200 i NX device and set to the pressure setting that is prescribed by healthcare provider. The canister will then collect the excess fluid. This device is not intended for home use. Carilex VT-200-i NX is an updated version of Carilex VT-100/VT-200 (K173407) via engineering change, and its software and hardware modifications are made to add instill function. The instillation mode is a modified continuous mode, where wound irrigation solution is simultaneously infused during negative pressure suction to assist in wound cleaning and removal of infectious substances. There has been no change to the operating principle, mechanism of action or fundamental scientific technology of the predicate device. The Carilex VT-200-i NX is developed with technology and components that are almost identical to Carilex VT·100/ VT·200. Carilex VT-200-i NX use the same collection canisters as predicate, VT-100, and VT-200 that are supplied non-sterile, single-use with a volume capacity of 300 ml or 1000ml. The canister is permanently sealed to minimize the potential of users coming into contact with exudates. Two tubes with two connector attached to its distal end is attached to the canister, and this connector which can be provided with or without lock feature attaches to the corresponding tubing included in the Carilex VT Dressing Kits.

Carilex VT • 100/VT • 200 is indicated for patients who would benefit from wound management via the application of negative pressure for removal of fluids and excess exudate, infectious material, and tissue debris which may promote wound healing. The VT · 100/VT · 200 suction therapy unit is indicated on use with patients with the following wounds: Traumatic, Dehisced wounds, Partial-thickness burns, Chronic wounds including pressure ulcers, diabetic foot ulcers and venous leg ulcers, Acute wounds, Flaps and grafts.

Carilex VT • 100 and VT • 200 are suction pumps with collection canisters for negative pressure wound therapy. The VT · 100 and VT · 200 are modified from their precursor VOLTERA Powered Suction Pump, S1001-3 Series (K112853). The pump is connected to the wound dressing via a tube connected to a disposable canister. The devices provide negative pressure wound therapy to the wound at a range of pressure settings and removes exudates from the wound site to the disposable canister. The devices can operate either by a mains power supply or internal battery. The VT • 200 is developed with technology and components that are almost identical to VT • 100, but for marketing differentiation it is designed with a new outer case which contains extra room to allow incorporation with different types of air compressors in the future.

Carilex VT Dressing Kits is intended to be used with the Carilex VT device (S1 series) to manage wounds through removal of fluids, and the NPWT system is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of fluids, excess exudates, infectious material, and tissue debris. The Carilex VT Dressing Kits is indicated for use for patients with the following wounds: - Traumatic - Dehisced wounds - Partial-thickness burns - Chronic wounds including pressure ulcers, diabetic foot ulcers and venous leg ulcers - Acute wounds - Flaps and grafts

Carilex VT Dressing Kits is the wound dressing to be used with the Carilex VT suction pumps for negative pressure wound therapy. This single-use dressing is manufactured using a reticulated flexible polyether and polyurethane hydrophobic material, housed in a medical grade peel pouch, and sterilized by Ethylene Oxide. The Carilex VT Dressing Kits is available in three sizes; 1) small 2) medium and 3) large

Carilex VT·One/VT·One 60days is indicated for patients who benefit from removal of fluids and excess exudates, infectious material, and tissue debris, which may promote wound healing. The VT-One/VT-One 60days suction therapy unit is indicated on use with patients with the following wounds: Traumatic, Dehisced wounds, Partial thickness burns, Chronic wounds including pressure ulcers, diabetic foot ulcers, and venous leg ulcers, Acute wounds, Flaps and grafts.

Carilex VT One and VT One 60days are suction pumps with collection canisters for negative pressure wound therapy. Carilex VT.One 60days are modified from its precursor VOLTERA Powered Suction Pump, S1001-3 Series (K112853), and they are smaller, portable and lighter in weight. The pump is connected to the wound dressing via a tube connected to a disposable canister. The device provides negative pressure wound therapy to the wound at a range of pressure settings and removes exudates from the wound site to the disposable canister. The device can operate either by a mains power supply or internal battery. The intended use, performance, and technology for Carilex VT·One and VT·One 60days are mostly identical. However, the VT·One 60days is programmed to stop working after 60 days of use and will not re-start after this time. This feature makes VT One 60days a single patient use NPWT pump that has a lifetime of 60 days; while VT-One is a durable medical device with a minimum lifetime of 3 years.