NEGATIVE PRESURE WOUND THERAPY PROGRAM

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1 NEGATIVE PRESURE WOUND THERAPY PROGRAM /

2 TABLE OF CONTENTS To place an order: 1. Please visit our website 2. Please to 3. Please call / For product support, please call our Nursing Hotline at USTOM, 5184 CALDWELL MILL RD.. SUITE , HOOVER, AL 35244

3 extricare 2400 Negative Pressure Wound Therapy (NPWT) System The FDA-cleared and Medicare-reimbursable extricare 2400 Negative Pressure Wound Therapy (NPWT) pump features portability for patients. The lightweight, battery-powered device works with anatomically fitted dressings to generate negative pressure around a patient s wound. The negative pressure works to remove wound exudates, infectious material, and tissue debris from the wound bed and bring blood to the wound, which may promote faster healing. NOTE: FOR PRESCRIPTION USE ONLY ey Features: Lightweight & Portable Weighs only 8.6 oz. (competitors as high as 20 lbs. or more). A carrying case is available so patients can be mobile during the wound healing process. Rechargeable Battery 30 hours of continuous battery life. Battery is rechargeable. Anatomically Fitted Dressings Various sizes of dressings that contour to all parts of the body and create tight seals. Variety of shapes available for the legs, feet, sacrum, and more. Quick & Easy Application The easy-to-use extricare pump and associated dressings decrease wound preparation time to approximately 15 minutes (competitors as long as 45 minutes). This allows wound care professionals to create tight seals quickly. LB Rev D

4 Device Specifications: Weight: 8.6 oz. Mobility: Portable, Carrying pouch included Battery Type: Lithium (rechargeable) Vacuum Modes: Continuous or intermittent Dimensions: Length: 3.35 (8.5 cm) Height: 5.67 (14.4 cm) Width: 1.46 (3.7 cm) Input: V 50/60 Hz 0.4 A Operating Conditions: Temperature: +5 C 40 C Humidity: 15% 85% non-condensing Pressure Options: 60mmHg 140mmHg Fuse: 1.5 A Charging Time: < 3.5 hours Barometric Pressure Range: 800 hpa 1060 hpa Storage Temperature: -10 C +45 C Altitude Range: < 2000 m Ingress Protection: IPX0 Protection Against Electric Shock: CLASS II Patient Protection: Type B Precautions & Warnings Extra precaution and care should be taken when using Negative Pressure Wound Therapy in the following conditions: Bleeding and hemorrhage Hemostasis, anticoagulants, and platelet aggregation inhibitors Friable vessels and infected blood vessels Vascular anastomosis Infected wounds Osteomyelitis Exposed organs, vessels, nerves, tendons, and ligaments Sharp edges (bone fragments) Dressing being retained in wound Use in MRI environment Use in hyperbaric chamber environment Contraindications The use of the extricare 2400 pump is contraindicated in the presence of: Necrotic tissue with eschar present Untreated osteomyelitis Non-enteric and unexplored Malignancy in the wound Exposed vasculature Exposed nerves Exposed anastomotic site Exposed bone or tendons Patient size and weight Use near vagus nerve (bradycardia) Patients with spinal cord injury Protection of periwound skin Circumferential dressing application Intermittent versus continuous pressure Transmission of infectious agents

5 extricare 3600 Negative Pressure Wound Therapy (NPWT) System The extricare 3600 Negative Pressure Wound Therapy (NPWT) device is a high capacity and high flow pump designed for use in hospitals, wound care centers, and other medical facilities. The extricare 3600 NPWT pump is a portable, battery powered pump which may promote wound healing through the drainage and removal of wound exudates, infectious material, and tissue debris from the wound bed using continuous and/or intermittent negative pressure. Indications for Use The extricare 3600 Negative Pressure Wound Therapy System is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudate, infectious materials, and tissue debris from the wound bed. The extricare 3600 Negative Pressure Wound Therapy System is indicated for the following wound types: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. ey Features: Long-Lasting Battery: 24 Hours Rotatable Back Mount for Securing to Hospital Bed Rails, IV Poles, etc. LCD Screen, Intuitive User Interface, and Easy Pressure Setting (40-200mmHg) Continuous Mode or Intermittent Mode Alarms: Leakage, Canister Full, Canister Installation Error, High Voltage, Low Battery, Blockage LB Rev A

6 Device Specifications: Weight: 2.87 lbs (1.3 kg) Mobility: Portable Battery Type: Lithium (rechargeable) Vacuum Modes: Continuous or intermittent Dimensions: Length: 6.7 (17cm) Depth: 4.3 (11cm) Height: 5.1 (13cm) Input: V 50/60 Hz 1.5 A Operating Conditions: Temperature: +5 C 40 C Humidity: 15% 93% Pressure Options: 40mmHg 200mmHg Charging Time: < 5 hours Barometric Pressure Range: 800 hpa 1060 hpa Storage Temperature: -25 C C Altitude Range: < 2000 m Ingress Protection: IP21 Protection Against Electric Shock: CLASS II Patient Protection: Type BF Precautions & Warnings Extra precaution and care should be taken when using Negative Pressure Wound Therapy in the following conditions: Bleeding/Hemorrhaging Hemostasis, anticoagulants, and platelet aggregation inhibitors Friable blood vessels or infected vascular anastomosis Exposed bones, vessels, ligaments or tendons Sharp edges (bone fragments) - tion environment Infected wounds and osteomyelitis Patient size and weight Spinal cord injury Enteric Fistulas Circumferential Dressing application Use near the vagus nerve (Bradycardia) Protection of the periwound skin Intermittent versus continuous mode Contraindications The use of the extricare 3600 pump is contraindicated in the presence of: Exposed vessels, organs, or nerves. Anastomotic sites. Exposed arteries or veins in a wound. Fistulas, unexplored or non-enteric. Untreated osteomyelitis. Malignancy in the wound. Excess amount of necrotic tissue with eschar. Wounds which are too large or too deep to be accommodated by the dressing. Inability to be followed by a medical professional or to keep scheduled appointments. Allergy to urethane dressings and adhesives. Use of topical products which must be applied more frequently than the dressing change schedule allows.

7 extricare Negative Pressure Wound Therapy (NPWT) System Dressings The extricare NPWT system incorporates the use of extricare pump models with Devon Medical s proprietary NPWT dressings. These dressings utilize a wound pad enclosed in mesh under an adhesive film that can be applied directly to the wound bed. A drainage tube connects each dressing with a canister that is connected to the pump. The canister collects exudates and bodily fluid that is removed from the wound bed. Application of the dressing is very quick and easy, allowing wound care professionals to decrease application time. Dressings are available in various shapes and sizes and designed for use with wounds on all parts of the body. extricare Bandages Type of Dressing Dressing Size Dressing Pad Size Mini Oval EC2400-MN 120 mm x 130 mm (4.7 x 5.1 ) 50 mm x 60 mm (2.0 x 2.3 ) Small Oval EC2400-SO 160 mm x 180 mm (6.3 x7.1 ) 80 mm x 100 mm (3.1 x 3.9 ) Large Oval EC2400-LO 192 mm x 270 mm (7.6 x 10.6 ) 77 mm x 152 mm (3.0 x 6.0 ) Extra Large Oval EC2400-IM 140 mm x 310 mm (5.5 x 12.2 ) 72 mm x 220 mm (2.8 x 8.7 ) Sacral EC2400-S 245 mm x 225 mm (9.6 x 8.9 ) 140 mm x 125 mm (5.5 x 5.0 ) Foot EC2400-F 350 mm x 280 mm (13.8 x 11.0 ) 320 mm x 100 mm (12.6 x 3.9 ) LB Rev G

8 Indications for Use The extricare NPWT foam kit is intended to be used in conjunction with the extricare 3600 NPWT pump. The extricare 3600 Negative Pressure Wound Therapy System is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudate, infectious materials, and tissue debris from the wound bed. The extricare 3600 Negative Pressure Wound Therapy System is indicated for the following wound types: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. Contraindications The extricare NPWT System should NOT be used in the following conditions: Exposed vessels, organs, or nerves. Anastomotic sites. Exposed arteries or veins in a wound. Fistulas, unexplored or non-enteric. Untreated osteomyelitis. Malignancy in the wound. Excess amount of necrotic tissue with eschar. Wounds which are too large or too deep to be accommodated by the dressing. Inability to be followed by a medical professional or to keep scheduled appointments. Allergy to urethane dressings and adhesives. Use of topical products which must be applied more frequently than the dressing change schedule allows.

9 extricare Negative Pressure Wound Therapy (NPWT) System Foam Dressings The extricare 3600 NPWT system incorporates use of the extricare foam kits or the extricare bandages. These dressings utilize a foam pad under an adhesive film that can be applied directly to the wound bed. A drainage tube connects each dressing with a canister that is connected to the pump. The canister collects exudates and bodily fluid that is removed from the wound bed. The extricare Negative Pressure Wound Therapy Foam Dressing is intended to be changed at a minimum of every 72 hours. Application of the foam dressing is very quick and easy, allowing wound care professionals and caregivers to decrease application time. Foam dressings are available in various shapes and sizes and designed for use with wounds on all parts of the body. extricare Foam Dressings Type of Dressing Dressing Size Foam Pad Size EC-FOAM-S Small Foam Dressing 10cm x 7.5cm x 3cm EC-FOAM-L Large Foam Dressing 25cm x 16cm x 3cm

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