COMBITUBE®

Prompt establishment of an airway is a primary goal in CPR of nonbreathing and unconscious patient.

INDICATONS: The Esophageal Tracheal COMBITUBE® is a new airway designed for emergency or difficult intubation providing sufficient ventilation whether the airway is placed into the esophagus or into the trachea. Most effective for use in patients over 5 ft. (152CM). These recommendations are based upon patients with typical anatomy. Individual patient anatomy may vary sufficiently to warrant using a different size COMBITUBE®. Proper sizing and use should be in accordance with accepted medical techniques and expert clinical judgment.

NOTE: This device is intended for use by speciallytrained medical and paramedical personnel. It is not intended for use by untrained or lay persons. Proper instructions and practice are required prior to use on patients. An intubation manikin should be used for training and practice. Proficiency in correctly placing the COMBITUBE® should be evaluated periodically.

CAUTION: Federal law in U.S.A. restricts this device to sale by or on the order of a licensed practitioner

DIRECTIONS:

1. Begin artificial respiration or CPR, incorporating usual precautions to verify an open airway.

2. Prior to insertion, test cuff integrity by inflating each cuff with the prescribed volume of air. Inflate the proximal pharyngeal cuff (blue pilot balloon) with 100 ml of air. Inflate the distal white esophageal cuff (white pilot balloon) with 15 ml of air.

3. Lubricate tube with water soluble lubricant to facilitate insertion.

4. A fluid deflector is provided to direct stomach contents away from personnel. Attach the fluid deflector to the clear connecting lumen marked No. 2.

5. In the supine patient, lift the tongue and jaw upward with one hand (See illustration A)

CAUTION: When facial trauma has resulted in sharp, broken teeth or dentures, remove dentures and exercise extreme caution when passing the COMBITUBE® into the mouth to prevent the cuff from tearing.

6. With the other hand, hold the COMBITUBE® so that it curves in the same direction as the natural curvature of the pharynx. Maintain a midline position of the COMBITUBE® as demonstrated in illustration A. Insert the tip into the mouth, advance in a downward curved movement until the teeth or alveolar ridges lie between the two printed bands.

CAUTION: DO NOT FORCE THE COMBITUBE®. If the tube does not advance easily, redirect it or withdraw and reinsert.

7. Inflate #1 Blue pilot balloon with 100ml of air using the 140ml blue colored coded syringe supplied. The large latex cuff will fill and may cause the COMBITUBE® to move slightly from the patient's mouth. This is to be expected. (See illustration B)

8. Inflate #2 White pilot balloon with 15ml of air using the 20ml syringe supplied.

9. Begin ventilation through the longer blue connecting tube labeled No.1. If auscultation of breath sounds is positive and auscultation of gastric insufflation is negative, continue ventilation. (See illustration C) (If possible confirm by observing chest expansion.) Under this condition, the second connecting tube may be used for the removal of gastric fluids with the suction catheter provided in the kit.

10. If auscultation of breath sounds is negative, and gastric insufflation is negative, the COMBITUBE® may have been advanced too far into the pharynx. Deflate the No.1 pilot balloon/cuff, move the COMBITUBE® approximately 23 cm out of the patient's mouth. Reinflate the No.1 pilot balloon/cuff with 100ml of air. If auscultation of breath sounds is positive and auscultation of gastric insufflation is negative, continue ventilation.

11. If auscultation of breath sounds is negative, and gastric insufflation is positive, immediately begin ventilation through the shorter clear connecting tube labeled No.2. (See illustration D) Confirm tracheal ventilation by auscultation of breath sounds and absence of gastric insufflation.

CONTRAINDICATIONS:

1. Patients under 5 feet tall, 152cm

2. Responsive patients with an intact gag reflex

3. Patients with known esophageal disease

4. Patients who have ingested caustic substances

NOTE: Single patient use. Device is not to be cleaned and reused.

KENDALL SHERIDAN
HEALTHCARE PRODUCTS COMPANY
ROUTE 40, ARGYLE, NY 128099684

(The above information is taken from the manufacturer's instruction sheet that comes with the COMBITUBE®.)