DeRoyal Trach Tube Holder Instructions

June 4, 2024
DeRoyal

Trach Tube Holder
Instruction ManualDeRoyal Trach Tube Holder TRACH TUBE HOLDER

RX ONLY
SINGLE PATIENT USE
NON-STERILE
NOT MADE WITH NATURAL RUBBER LATEX
IMPORTANT INFORMATION
Please read all instructions, warnings, and precautions before use. Correct application is essential for proper functioning of the product.
Use only on the person it was provided to by a healthcare professional and only for the use it was intended.

INTENDED USE

The DeRoyal Trach Tube Holder is intended to be prescribed by a properly licensed practitioner to provide secure positioning and to minimize movement of the tracheostomy tube.
WARNINGS
Unnecessary movement of the trach tube can result in accidental dislodgement or displacement of the tube, tracheoesophageal fistula, tracheal stenosis, or airway granuloma.
PRECAUTIONS
This product is to be fitted initially by a physician (or properly licensed practitioner) who is familiar with the purpose for which it is intended. The physician or practitioner is responsible for providing wearing instructions and precautions to other healthcare practitioners or healthcare providers involved in the patient’s care as well as the patient.  Consult your physician (or properly licensed practitioner) immediately if you experience sensation changes, unusual reactions, swelling, or increased pain while using this product.
Follow the instructions of your physician (or properly licensed practitioner) for the length and duration of use. Be sure to follow your facility’s policies and guidelines for the frequency of patient monitoring.

INSTRUCTIONS FOR USE

  1. Measure the circumference of the patient’s neck to determine the appropriate size.
  2. Thread the hook and loop fastener through one side of the tracheostomy tube and secure it to the next strap.
  3. Bring the next strap behind the patient’s neck and thread the other hook and loop fastener through the other side of the tracheostomy tube and secure the strap.
  4. Visually check to ensure the patient’s circulation is not compromised.

Application videos are available on www.deroyal.com.

SIZING

Size Fastener Neck Circumference
Adult Wide Up to 23” (58 cm)
Adult Narrow Up to 20” (50 cm)
Pediatric Narrow Up to 10” (25 cm)
Bariatric Narrow Up to 30” (76 cm)

CLEANING AND/OR MAINTENANCE

To clean, hand wash with a mild fabric detergent in warm water. Do not bleach. Do not iron. Lay flat and open and allow to air dry. Inspect the product after washing to ensure it is intact. If the product is damaged, do not use it and replace it with a new one.
In addition to the competent authority in the country where the patient resides, serious incidents must be reported to DeRoyal Industries, Inc.

WARRANTY

DeRoyal products are warranted for one hundred twenty (120) days from the date of shipment from DeRoyal as to product quality and workmanship. DEROYAL’S WRITTEN WARRANTIES ARE GIVEN IN LIEU OF ANY IMPLIED WARRANTIES, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR  A PARTICULAR PURPOSE.

References

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