INTENDED USE Kerecis® VET™ is indicated for the management of wounds including: • Par;al and full-thickness wounds • Trauma;c wounds (abrasions, lacera;ons, skin tears) • Superficial and par;al thickness burns CAUTION Federal law restricts this device to sale by or on the order of veterinarian. CONTRAINDICATIONS Contraindicated for fish allergies. PRECAUTIONS • Remove most of necro;c ;ssue prior to device applica;on. • Remove exudate and control bleeding prior to device applica;on. • Do not reuse or re-sterilize. • Discard unused por;ons of device. • Do not use aNer printed expira;on date. • Sterile if package is unopened and undamaged. • Do not use device if package seal has been broken or if handling hascaused damage or contamina;on. • Do not use in case of known fish allergies. POTENTIAL COMPLICATIONS The following complica;ons are possible. If any of these condi;ons occur, the device should be removed. • Infec;on • Chronic inflamma;on (Ini;al applica;on of wound dressings may be associated with transient, mild, localized inflamma;on) • Allergic reac;on • Excessive redness, pain, swelling, or blistering STORAGE This device should be stored in a clean, dry loca;on at room temperature. STERILIZATION This device has been sterilized using ethylene oxide. SUGGESTED INSTRUCTIONS FOR USE The following recommenda;ons are designed to serve only as a general guideline. They are not intended to supersede ins;tu;onal protocols or professional clinical judgment concerning animal care. Always handle the product in an asep;c manner. First Applica;on 1. When applying the product for the first ;me, clean the wound bed by removing necro;c ;ssue to obtain a fresh ;ssue surface. Irrigate to remove debris and exudates. The sheet can be applied to lightly bleeding wound bed. 2. Remove the product from the pouch using asep;c technique. 3. Cut the sheet roughly to the size of the area to be covered and pre-hydrate in sterile saline. 4. Apply sheet directly into the wound, making sure that the sheet does not overlap the wound edges. 5. Overlap sheet edges slightly to assure coverage of the en;re wound. 6. Apply an appropriate secondary, non-adherent wound dressing to maintain a moist wound environment. Follow-Up Applica;ons ANer star;ng treatment, the wound should be checked regularly to ensure that the cover dressing is maintaining a sufficient moist wound environment and if a re-applica;on of the product is needed. 1. Inspect wound every two days. The dura;on between inspec;ons may be extended up to seven days as healing progresses. 2. Insert a new sheet into the wound if the previously applied sheet has been absorbed and is no longer visible. 3. Change the cover dressing as needed to maintain a moist, clean wound area. As wound healing occurs, redness and swelling of wound edges will decrease and the level of exudate will be reduced. These are signs of wound healing and are oNen seen before epitheliza;on is obvious. Make sure to use an appropriate type of cover wound dressing at all ;mes to maintain a moist, clean wound area. Should you suspect any adverse reac;on from this product please report it to the e-mail adversereac;[email protected] leaving a phone number and e-mail address. Adverse reac;ons might also be subject to mandatory repor;ng to the authori;es. Please submit the data on the package or pouch i.e. “lot number” and “use before” date. SYMBOLS FROM PRODUCT LABEL KEEP AWAY FROM SUNLIGHT KEEP DRY DOES NOT CONTAIN OR HAVE THE PRESENCE OF NATURAL RUBBER LATEX UPPER LIMIT OF TEMPERATURE, 77˚F, 25˚C CONSULT INSTRUCTION FOR USE DO NOT USE IF PACKAGE IS DAMAGED DO NOT REUSE STERILIZED WITH ETHYLENE OXIDE FOR VETERINARY USE ONLY MANUFACTURER Kerecis Limited KM-19-0170.4©2024Kerecis.AllRightsReserved. J1540 Series – Kerecis®VET™ INSTRUCTIONS FOR USE ACCELULLAR FISH SKIN FOR VETERINARY USE For more information, visit www.jorvet.com or email: [email protected] Jorgensen Laboratories, LLC Loveland, CO 80538 800.525.5614 [email protected] www.JorVet.com