The dressing should not be placed over infected wounds. This device is not intended to treat Surgical Site Infections (SSl's) or other percutaneous device-related infections. This device has not been studied in a randomized clinical study to determine its effectiveness in preventing such infections.
Active bleeding at wound sites should be stabilized before applying the dressing.
Do not stretch the dressing before applying it to the skin. Dressings applied under tension can cause trauma to the skin.
To ensure good adhesion and to help prevent skin irritation, remove detergent residues and allow all skin preparations and protectants to dry completely before applying the dressing to the skin.
Caution: Federal (USA) law restricts this device to sale by or on the order of a licensed healthcare practitioner.
For proper use, clinicians should be trained in the use of this device.
- ReliaTect® Post-Op Dressing with CHG SHOULD NOT BE USED AS A REPLACEMENT FOR SUTURES AND OTHER PRIMARY WOUND CLOSURE METHODS.
- ReliaTect® Post-Op Dressing with CHG SHOULD NOT BE USED ON THIRD DEGREE BURNS.
- DO NOT USE ReliaTect® Post-Op Dressing with CHG ON PREMATURE INFANTS OR INFANTS YOUNGER THAN 2 MONTHS OF AGE. USE OF THIS PRODUCT ON PREMATURE INFANTS MAY RESULT IN HYPERSENSITIVITY REACTIONS OR NECROSIS OF THE SKIN.
- ReliaTect® Post-Op Dressing with CHG SHOULD NOT BE USED AS A PRIMARY MEANS TO FIX ARTERIAL CATHETERS OR ARTERIAL CANNULAE.
- FOR EXTERNAL USE ONLY. DO NOT ALLOW CONTACT OF THIS DEVICE WITH EARS, EYES, MOUTH OR MUCOUS MEMBRANES.
- DO NOT USE THIS DEVICE ON PATIENTS WITH A KNOWN HYPERSENSITIVITY TO CHLORHEXIDINE GLUCONATE. ADVERSE REACTIONS SUCH AS IRRITATIONS, SENSITIZATION AND GENERALIZED ALLERGIC REACTIONS HAVE BEEN REPORTED WITH THE USE OF CHLORHEXIDINE GLUCONATE.
- IF ALLERGIC REACTIONS OCCUR, DISCONTINUE USE IMMEDIATELY AND, IF SEVERE, CONTACT A PHYSICIAN.
- STOP USING THE ReliaTect® Post-Op Dressing with CHG IF THE PATIENT EXPERIENCES SYMPTOMS SUCH AS: WHEEZING OR DIFFICULTY BREATHING, SWELLING FACE, HIVES THAT CAN QUICKLY PROGRESS TO MORE SERIOUS SYMPTOMS, SEVERE RASH OR SHOCK (WHICH IS A LIFE THREATENING CONDITION THAT OCCURS WHEN THE BODY IS NOT GETTING ENOUGH BLOOD FLOW). THESE SYMPTOMS ARE ASSOCIATED WITH AN ALLERGIC REACTION TO CHG.
- Patients must be questioned about any prior allergic reactions to a medical device containing Chlorhexidine Gluconate. ALTERNATIVES MUST BE CONSIDERED UNDER SUCH CIRCUMSTANCES.
- Literature searches found hypersensitivity reactions associated with the topical use of chlorhexidine gluconate have been reported in several countries. Caution should be used when using chlorhexidine containing preparations, and the patient should be observed for the possibility of hypersensitivity reactions.
- Do not use on immune compromised patients or patients with underlying skin pathology which compromises the epidermal barrier. Use of this product may result in erosive contact dermatitis.
- INTENDED FOR SINGLE PATIENT USE ONLY.
- DO NOT REUSE. AS WITH ALL ADHESIVE-BASED PRODUCTS, ADHESIVE EFFECTIVENESS AND FUNCTIONALITY CAN DECLINE AFTER THE FIRST USE AND THE PRODUCT WILL NOT PERFORM AS SPECIFIED. REUSE MAY LEAD TO INFECTION OR OTHER ILLNESS/INJURY.
- STORE IN A COOL DRY PLACE. KEEP AWAY FROM DIRECT SUNLIGHT. DO NOT STORE ABOVE 25°C/77°F. DO NOT USE IF PACKAGING IS DAMAGED. DO NOT RESTERILIZE.