Surgiphor™ Antimicrobial Irrigation System
Product description. Surgiphor™ Antimicrobial Irrigation System is an antimicrobial irrigation system containing 0.5% povidone iodine (PVP-I) in phosphate-buffered saline, potassium iodide and Vitamin E TPGS. PVP-I acts as a preservative to help inhibit microbial growth in the irrigation solution. Indication for use. Surgiphor™ Antimicrobial Irrigation System is intended to mechanically loosen and remove debris, and foreign materials, including microorganisms, from wounds. Contraindications: Surgiphor™ Antimicrobial Irrigation System should not be used in patients with known allergic reaction to any of the ingredients in the solutions. Surgiphor™ Antimicrobial Irrigation System should also not be combined with other irrigation or antiseptic solutions due to potential reactions and reduction in the effectiveness of the system. Not for use in neonates. Warnings. Do not use or mix with other cleansers, soaps, lotions, or ointments. Do not use for injection or infusion. Do not swallow. Do not use in eyes or ear canals. Discontinue use immediately if irritation or an allergic reaction occurs. Do not use if packaging is damaged or if seal integrity is compromised. Do not reuse Surgiphor™ solution after 24 hours. Precautions. Surgiphor™ solution may cause a temporary irritation and/or burning sensation on exposed skin in very rare cases. Surgiphor™ solution may cause allergic reactions such as rash or skin irritation in patients with iodine allergy. Anaphylaxis with the use of Surgiphor™ solution may occur in patients with severe iodine allergy. Federal law restricts this device to sale by or on the order of a licensed physician. Single patient use only. Not for at-home use. Please consult product insert for complete indications, contraindications, warnings, precautions, safety information and instructions for use.

Arista™ AH Absorbable Hemostatic Particles
Indications. Arista™ AH is indicated in surgical procedures (except neurological and ophthalmic) as an adjunctive hemostatic device to assist when control of capillary, venous, and arteriolar bleeding by pressure, ligature, and other conventional procedures are ineffective or impractical. Contraindications. Do not inject or place Arista™ AH into blood vessels as potential for embolization and death may exist. Warnings. Arista™ AH is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis. Once hemostasis is achieved, excess Arista™ AH should be removed from the site of application by irrigation and aspiration particularly when used in and around foramina of bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm. Arista™ AH swells to its maximum volume immediately upon contact with blood or other fluids. Dry, white Arista™ AH should be removed. The possibility of the product interfering with normal function and/or causing compression necrosis of surrounding tissues due to swelling is reduced by removal of excess dry material. Safety and effectiveness of Arista™ AH have not been clinically evaluated in children and pregnant women. Because there have been reports of decreased amylase activity in newborns up to 10 months, absorption rates of Arista™ AH in this population may be longer than 48 hours. Arista™ AH should be used with caution in the presence of infection or in contaminated areas of the body. If signs of infection or abscess develop where Arista™ AH has been applied, re-operation may be necessary in order to allow drainage. Safety and effectiveness in neurosurgical and ophthalmic procedures has not been established. Arista™ AH should not be used for controlling post-partum bleeding or menorrhagia. Precautions. When Arista™ AH is used in conjunction with autologous blood salvage circuits, carefully follow instructions in the Administration section of the IFU regarding proper filtration and cell washing. Arista™ AH is intended to be used in a dry state. Contact with saline or antibiotic solutions prior to achieving hemostasis will result in loss of hemostatic potential. Arista™ AH is not recommended for the primary treatment of coagulation disorders. No testing has been performed on the use of Arista™ AH on bone surfaces to which prosthetic materials are to be attached with adhesives and is therefore not recommended. Arista™ AH is supplied as a sterile product and cannot be resterilized. Unused, open containers of Arista™ AH should be discarded. Do not apply more than 50g of Arista™ AH in diabetic patients as it has been calculated that amounts in excess of 50g could affect the glucose load. In urological procedures, Arista™ AH should not be left in the renal pelvis or ureters to eliminate the potential foci for calculus formation. Adverse reactions. None of the adverse events that occurred in a randomized prospective, concurrently controlled clinical trial were judged by the Data Safety Monitoring Board to be related to the use of Arista™ AH. The most common recorded adverse events were pain related to surgery, anemia, nausea, lab values out of normal range, arrhythmia, constipation, respiratory dysfunction and hypotension – all reported in greater than 10% of the Arista™ AH treated patients. The details of this clinical trial’s adverse events can be reviewed in the IFU supplied with the product and are also available at www.bd.com. Caution: Federal (USA) law restricts this device to sale by or on order of a licensed physician or properly licensed practitioner.