Deroyal Umbilical Clamp Cutter

More Information

• DO NOT REUSE
• RX ONLY
• IMPORTANT INFORMATION
  Please read all instructions, warnings, and precautions before use.
  Correct application is essential for proper functioning of product.
• INTENDED USE
  The DeRoyal Umbilical Cord Clamp is intended to occlude the blood vessels in the umbilical cord of a newborn infant as the cord dries and shrinks after birth. The DeRoyal Umbilical Cord Clamp Cutter is intended to cut the umbilical cord clamp off the newborn.
• WARNINGS
  - This device must be applied by a healthcare professional who is familiar with its use. Improper use could cause severe injury.
  - Do not use if packaging is damaged, as product may no longer be sterile.
  - Take care in handling the device as it has sharp edges that could cause scratches, lacerations or glove perforations.
  - Dispose all items in accordance with institutional protocol.
• PRECAUTIONS
  - This device is for single use only. It is not intended for disinfection and subsequent re-use, which may result in device failure or create the risk of contamination.
  - This device has not been evaluated for reprocessing or re-sterilization. Reprocessing or re-sterilization may damage the device, rendering it unusable or may lead to device failure, which could result in patient illness, injury or death.
• DIRECTIONS
  - Visually examine the package for damage before opening. Replace clamp if the package or the device is damaged.
  - Open packaging using proper sterile technique.
  - Visually inspect the clamp and clamp cutter for damage. Replace if device is damaged.
  - Place the umbilical cord in the center of the clamp. Avoid placing the cord too close to the latch or hinge. Improper placement could result in injury to the patient.
  - Press the cord clamp until it clicks, indicating the clamp is securely closed.
  - Cut the umbilical cord in accordance with the current standard of care, but in no instance closer than ½ inch (13 mm) from the clamp. Cutting too close to the clamp could cause the clamp to slip off the cord.
  - Remove the cord clamp in accordance with the current standard of care.
  - If necessary to remove, cut the clamp at the hinge area with the clamp cutter until completely severed.