Bone Waxbonewax

Waxocare is the brand name of surgical bone wax manufactured by Dolphin Sutures.

 

Bone wax is used to help mechanically control bleeding from bone surfaces during surgical procedures by providing hemostasis in bleeding bone. It controls bleeding of bone by blocking the holes and causing immediate bone hemostasis. Bone wax is used in procedures that involve cutting through bones like sternotomy, thoracic, neurosurgery, orthopedic, oral and maxillofacial surgeries.

 

Bone wax Composition: Bees wax, paraffin wax and iso propyl palmitate. Individually packed sterile bone wax is available in a form of bone wax stick with a weight of 2.5 gms and is sterilized by Gamma Radiation.

 

   Instructions for Use

 

  • Bone wax is available in custom pack sizes
  • Sterilized by Gamma Radiation
  • Bone wax is bio-chemically inert and partially resorbable
  • Waxocare bone wax effectively stops bleeding in bones
  • Waxocare bone wax exhibits minimal or no tissue reaction.
  • Waxocare bone wax is ideal for use in general orthopedics, craniomaxillofacial and cardio-thoracic surgery for sternal closure.

WAXOCARE®

NON-ABSORBABLE SURGICAL BONE WAX

 

DESCRIPTION

Bone Wax is a sterile mixture of beeswax, paraffin, and isopropyl palmitate, a wax-softening agent. It is opaque and has a waxy odor.

 

INTENDED USE

Bone Wax is indicated for use in the control of bleeding from bone surfaces.

 

PERFORMANCE

Bone Wax achieves local hemostasis of bone by acting as a mechanical (tamponade) barrier. It does not act biochemically and is nonabsorbable.

 

CONTRAINDICATIONS

Do not use Bone Wax where rapid osseous regeneration and fusion are desired. The use of this suture is contraindicated in patients with known sensitivities or allergies to bees wax, paraffin wax and iso propyl palmitate.

 

WARNINGS

  1. Do not subject Bone Wax to excessive heat. Bone Wax may inhibit osteogenesis and may act as a physical barrier to the reparative process.
  2. For single use only. Do not reuse, reprocess or re-sterilize. Reuse, reprocessing or re‐sterilization may compromise the structural integrity of the device and/ or lead to device failure which, in turn, may result in patient injury or illness.
  3. Reuse, reprocessing or re‐sterilization may also create a risk of contamination of the device and/or cause patient infection or cross‐infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another.
  4. Contamination of the device may lead to injury, illness or death of the patient.
  5. Do not manipulate with latex gloves as latex proteins deposited in the Bone Wax may precipitate an allergic reaction.

Do not use if package is opened or damaged. Discard open, unused Bone Wax.

 

PRECAUTIONS

Use Bone Wax sparingly. Remove excess Bone Wax from the operative site. Open the package just prior to use to minimize the possibility of contamination and excessive drying. Bone Wax melts at 620C – 64°C.

 

ADVERSE REACTIONS

Mild inflammatory reactions have been reported in tissues immediately adjacent to the site of implantation. Like all foreign bodies, Bone Wax may enhance an existing infection. Pollen granules imbedded in beeswax may elicit an allergic reaction.

 

DOSAGE ADMINISTRATION

Bone Wax is available sterile in individual foil envelopes, each containing 2.5 g, and packaged in an individually sealed overwrap packet.

Use bone wax immediately after removal from the package. Using aseptic technique, take 1 to 1.5 grams of bone wax, manipulate with the fingers to soften, and apply to bone surface.

 

STERILITY

Bone Wax are sterilized by gamma radiation. Do not re – sterilize. Do not use if package is opened or damaged! Discard opened unused bone wax.

 

STORAGE

Recommended storage condition 10oC - 35°C, away from moisture and direct heat. Do not use after expiry date.

 

DISPOSAL

Discard used bone wax contaminated with blood in the container meant infectious waste. Unused expired pouches should be incinerated.

 

 

  • Bone Wax is individually packed with a weight of 2.5 gms in a release paper
  • Individually packed bone wax is then packed in a tear-open or peel-open aluminum foil
  • Aluminum foils are further packed in a secondary medical grade paper pouch laminated with polyester laminated poly film
  • Sutures are further packed in small cartons made from premium 320 GSM Cyber XLPac in 12 suture pack
  • Boxes are further laminated in tamper proof film to protect it from dirt/dust
  • Further, the sutures are packed in an export worthy 7 ply master carton which can accommodate 100 boxes ( 70 x 30 x 30 cms) - weighing up to 9 to 10kg and 200 boxes ( 70 x 29 x 59 cms) - weighing up to 18kg