CORTRAK 2 Instructions for Use

1.0 Universal Connector

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2.0 ANTI-IV* Connector

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3.0 ENFit® Connector

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Explanation of Graphical Symbols Length

Diameter Not made with natural rubber latex BPA

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Product is NOT made with BPA

Rx Only

Do not use if package damaged

Single Patient Use Product is not made with DEHP as a plasticizer Caution

Contains Consult instructions for use

AVANOS* CORTRAK* 2 NASOGASTRIC / NASOINTESTINAL FEEDING TUBE With Electromagnetic Transmitting Stylet Rx Only: Federal Law (USA) restricts this device to sale by or on the order of a physician.

Indications for Use This tube and transmitting stylet have been designed for use with the CORTRAK* 2 Enteral Access System. The tube is intended for use in patients who require intermittent or continuous tube feedings via the NG or NE route. The Avanos* CORTRAK* 2 Enteral Access System (EAS*) utilizes tube tracking technology to assist, in conjunction with institution protocols, qualified clinicians in guiding placement of Avanos Medical CORTRAK* 2 feeding tubes of 8 Fr or greater into the stomach or small bowel of patients requiring enteral feeding.

Warnings:

• Qualified clinicians (clinicians) must first be credentialed by their institution to place enteral feeding tubes. A qualified clinician, as defined by institution protocol or determined by clinical credentialing, must read and follow the CORTRAK*2 Enteral Access System (EAS*) Operator’s Manual and the Instructions for Use included with the CORTRAK* 2 feeding tube prior to tube insertion. • Only qualified clinicians trained according to Avanos CORTRAK* 2 training should use the CORTRAK* 2 as an aid in the placement of compatible Avanos CORTRAK* 2 Feeding Tubes. Clinical personnel must receive appropriate training combined with hands-on experience prior to clinical use of the CORTRAK*2. • Institution protocols must always supersede the use of the CORTRAK*2. Clinical judgment must always take precedence. • The CORTRAK* 2 does not replace qualified clinicians in the supervision of feeding tube placements and does not replace the need for vigilant clinical assessment during the feeding tube insertion procedure. • The CORTRAK* 2 Enteral Access System does not prevent patient injury due to misplacement of a feeding tube into the trachea or lungs. • Only clinical personnel qualified by their institution in small bowel placement should attempt to place the tip of an Avanos CORTRAK* 2 Feeding Tube into the small bowel of a patient. • Inserting the transmitting stylet while the tube is indwelling should be performed by a clinician who is qualified by their institution to reposition feeding tubes or to advance them into the jejunum when clinically necessary. • Misplacement of the feeding tube into trachea or lungs may result in serious injury (e.g. perforation, pneumothorax, aspiration pneumonia) or death. • Particular care should be taken if any type of endotracheal device is in place, as it may tend to guide feeding tube into trachea. • Withdraw the tube immediately if the patient demonstrates any signs of respiratory irritation or distress during tube placement procedure, including coughing or shortness of breath, as this may indicate passage of tube into trachea. • Withdraw the tube immediately if any resistance is encountered during the placement, as this may indicate passage of the tube into the trachea.

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• If lung placement is suspected, re-assess the patient and notify physician per institution protocol. • Tube position must be confirmed prior to flushing with water. The CORTRAK* 2 Monitor displays a representation of the Transmitting Stylet tip path relative to the CORTRAK* 2 Receiver Unit. This representation is NOT an image of the actual feeding tube position. Clinicians must continuously observe and assess both the patients and the tracings on the Monitor while advancing the tube to ensure proper insertion of the tube down the nasoenteric pathway of the patient. Failure to follow instructions when setting up CORTRAK* 2 equipment including the Receiver Unit can lead to injuries and/or death. The transmitting stylet tip position and track displayed on the CORTRAK* 2 Monitor is affected by many variables including Receiver Unit (RU) positioning on the patient, patient size and build, anatomical variances, and movement of the Receiver Unit relative to the patient. DO NOT move the CORTRAK* 2 Receiver Unit from the patient once it is correctly placed and secured at the Xiphoid Process. Movement of the RU relative to the patient will alter the alignment and the relationship of the track displayed on the CORTRAK* 2 Monitor. Use extreme caution in patients who are combative or who move excessively during placement as the displayed track is impacted by movement between the receiver unit and the patient. The RU should be secured on the patient. Comply with Institution protocol to determine the final location of a feeding tube tip. Neither CORTRAK* 2 trace nor feeding tube centimeter markings should be used as a sole method of confirmation. Clinical observation and institution protocols must be part of successful feeding tube placement. If the CORTRAK* 2 image is not displaying the expected path (Fig. 6, 7 and 8) as observed by a qualified clinician of if there is uncertainty of the tube’s distal location after facility placement verification methods have been performed, additional confirmation methods should be considered (e.g. X-ray and/or pH). Do NOT begin patient feeding until the desired tube location is confirmed per hospital protocol. Additional confirmatory techniques may be indicated, particularly for the following patient populations: • Patients with any variation in normal gastrointestinal anatomy • Patients with any known history of gastrointestinal surgery • Patients with an altered state of consciousness • Patients who are intubated • Patients who cannot provide visual or physiological feedback to the clinician during tube placement, e.g. patient is unconscious or missing the gag reflex • Patients who are combative or move excessively during placement If unable to advance the Transmitting Stylet into the feeding tube during insertion or if resistance is met, stop the procedure and discontinue using the CORTRAK* 2. Always confirm feeding tube placement according to institution protocol. 3

• Severe injury (i.e. perforation) is possible during insertion of the transmitting stylet while the tube is indwelling. • Never use the transmitting stylet to unclog or unblock a feeding tube. • Never use a transmitting stylet in a feeding tube other than the transmitting stylet originally provided with the patient’s feeding tube as they are uniquely matched to ensure proper fit. • Vigorous syringe force should not be used to irrigate, administer liquids or unblock the tube. • Stop insertion and withdraw the tube when the CORTRAK* 2 Monitor is not displaying the expected path (Fig. 6, 7 and 8) as observed by a qualified clinician. DO NOT use the CORTRAK* 2 as an aid during a tube placement if NO SIGNAL or an unexpected or unusual tracing is visible on the CORTRAK*2 Monitor. • The Transmitting Stylet must be handled with care at all times and discarded if the transmitting wires break. Damage to the Transmitting Stylet may impact the CORTRAK* 2 tracing. If the Transmitting Stylet has broken wires at any point, you may see any of the following after the Energizing Stylet message: 1. the Transmitting Stylet/Driver Fault notification 2. the track does not follow the expected path 3. the Out of Range message • DO NOT use the CORTRAK* 2 near equipment which radiates radiofrequency energy in the frequency band of 20-300 kHz. The CORTRAK* 2 tracing may be influenced by electromagnetic interference from other electrical equipment (such as electro-surgical/cauterizing equipment, RFID devices, two-way radios, Left Ventricular Assist Devices), and other CORTRAK* 2 equipment operating in the immediate proximity. Refer to EMC Considerations Section of the CORTRAK* 2 Operator’s Manual and Service Guide for additional guidance. • DO NOT use the CORTRAK* 2 as an aid during a tube placement if NO SIGNAL or an unexpected or unusual tracing is visible on the CORTRAK* 2 Monitor.

Adverse Events Placement and use of any feeding tube may result in patient discomfort. Infrequently occurring factors as a result of use or misuse of any feeding tube may include pneumothorax, GI perforation, aspiration, airway obstruction, tissue irritation or necrosis, allergic reaction, contamination, delay in diagnosis, delay or misdose of medication or nutrition and related complications or the need for additional medical procedures.

Features • Polyurethane Tube • Length, French Size, centimeter markings, and CORTRAK printed on tube • Radiopaque tube and tip • Pre-inserted braided stainless steel stylet with electromagnetic transmitting coil for use with the CORTRAK* 2 • Distinctive YELLOW* tube design • Anti-clog exit port • Y-access side port • Water-activated lubricant on tip and internal lumen of tube • Available with ENFit®, ANTI-IV*, and Universal connectors • MRI Safe (with stylet removed, MRI: ≤ 3 Tesla) 4

Illustrations (page 2) 1.0 Universal Connector 2.0 ANTI-IV* Connector 3.0 ENFit® Connector 1 Feed Port 2 Auxiliary Port 3 Administration Set 4 Irrigation Syringe Adaptor

Directions For Set-up

1. Position the patient in accordance with facility protocol for feeding tube placement. 2. Place the Monitor on the CORTRAK* 2 Stand, an IV pole, bed rail or table in a position that permits easy viewing of the display during the feeding tube placement procedure. 3. Position the equipment sufficiently close to the patient so the length of the Transmitting Stylet will allow proper feeding tube placement. 4. Ensure the Interconnect Cable and the Receiver are attached to the Monitor. 5. Turn on the Monitor by pressing and holding the power ON/OFF button for approximately 5 seconds until it remains green. 6. Enter the operator login credentials on the Monitor when prompted. 7. Select the menu button on the Monitor to start a new placement. 8. Enter the patient information on the Monitor when prompted and then continue onto the Placement Screen. 9. When the Placement Screen displays, Fig. 1 do NOT press “Start” or the orange button on the Receiver at this time, but continue through the following steps. 10. Palpate the lower sternum and follow it to the xiphoid process. Place the apex or front foot of the Receiver at the Xiphoid Process and align the vertical line marked on the Receiver with the midsagittal line of the patient. It is important that the Receiver be reasonably level relative to the patient’s spine. (Fig. 1) 11. Secure Receiver to patient with tape.

Directions For Tube Insertion 12. Remove tube with stylet from package and inspect tube integrity. 13. Secure stylet connector to feeding port of feeding tube and close side access port. 14. Connect the Transmitting Stylet to the Interconnect Cable by lining up the arrows. 15. Measure length of tube to be inserted per facility protocol. 16. Activate lubricant on guide tube tip/bolus by immersing in water or lubricate with water-soluble lubricant if desired. If more than several minutes elapse before tube insertion is attempted, additional dipping of the tube tip may be required.

17. Determine preferred nostril for insertion. Provide cooperative patient with glass of water and straw. 18. Insert the feeding tube (with Transmitting Stylet) approximately 5-10 cm into the patient’s nostril. Direct tube posteriorly, aiming tip parallel to nasal septum and superior surface of hard palate. Advance tube to nasopharynx, allowing tip to seek its own passage. 19. Press “Start” on the Monitor or the orange button on the Receiver to begin the placement procedure. As the feeding tube and Transmitting Stylet are advanced into the patient, the display will transition from “Out of Range” to showing the relative position of the tube tip (Fig. 2-3).

Fig. 2 Out of Range Message

Fig. 3 Start of Placement

20. If path of the tube on the display shows a severe curve to the right or left relative to the patient’s mid-line and above the horizontal axis, (Fig. 4-5) immediately pull back the feeding tube to the patient’s pharynx and adjust placement to show a straight line towards the horizontal axis. Use printed centimeter markings on the feeding tube to aid in placement.

Fig. 4 Example Left Mainstem

Fig. 5 Example Right Mainstem

21. Refer to the display to aid proper placement while slowly advancing the tube towards the stomach or small bowel. Advance the tip of the tube across the greater curvature of the stomach (Fig. 6) watching the track as it travels to the mid-line. For stomach placement, proceed to step 20. 22. For small bowel placement, continue advancing the tube. Some manipulation of the proximal end of the tube may be needed to encourage the passage across the midline. Refer to the display until advancement across the midline and into the duodenum occurs (Fig. 7). The tip passing the midline axis on the display suggests passage into the duodenum. An increase in depth under the Receiver, as indicated on the Depth Cross Section or Lateral View would be a further indication of duodenal placement. The tube track traversing back across the midline (Fig. 8), suggests placement of the feeding tube in the small bowel. 23. When the desired tube tip position has been achieved, press “END” on the Monitor or the orange button on the Receiver. 24. When desired position is obtained, secure tube per institution protocol. 25. Confirm tube position per institution protocol.

Fig. 6 Example Gastric Placement

Fig. 7 Example Duodenal Placement

Fig. 8 Example Jejunal Placement

Electromagnetic Transmitting Stylet Removal 1. Activate internal lubricant before Transmitting Stylet is removed by flushing tube through Med/Flushing side port with 10 ml of water. 2. Disconnect Transmitting Stylet from Interconnect Cable. Holding the feeding tube, slowly remove the Transmitting Stylet from the feeding tube. 3. If desired, rinse Transmitting Stylet in warm water or cleanse with 70% isopropyl alcohol and retain in enclosed Transmitting Stylet Retention Bag or similar aerated container and record patient information. 4. Attach administration set connector to the feeding tube connector per institution protocol. 5. Begin feeding per physician’s order and usual institution protocol

Electromagnetic Transmitting Stylet Insertion Inserting the transmitting stylet while the tube is indwelling should be performed by a clinician who is qualified by their institution to reposition feeding tubes or to advance them into the jejunum when clinically necessary. Always confirm feeding tube placement according to institution protocol. 1. You must only use the Transmitting Stylet provided in the original package of the indwelling feeding tube. Confirm the indwelling feeding tube has “CORTRAK” printed directly below the Y-connector prior to insertion. 2. Do not use Transmitting Stylet if it is bent or unraveled. 3. Wear protective gloves during the insertion procedure of the Transmitting Stylet as bare hands may affect the signal. 4. Ensure the Interconnect Cable and the Receiver are attached to the Monitor. 5. Place front foot of Receiver on the patient at the xiphoid process as instructed per the initial feeding tube insertion procedure. 6. Connect the feeding tube Transmitting Stylet to the Interconnect Cable. 7. Lubricate original Transmitting Stylet with watersoluble lubricant. 8. Insert the Transmitting Stylet 5-10 cm into the straight arm (feeding port) of the feeding tube, and press START on the Monitor or Receiver. 9. Slowly insert the Transmitting Stylet into the feeding tube. 10. Watch the display for indication of tube position. If lung placement is suspected, withdraw the feeding tube AND Transmitting Stylet. Assess patient per institution protocol prior to further feeding tube insertion. 11. If no indication of lung placement is noted, continue to advance the Transmitting Stylet until the mating connector reaches the straight arm port of the feeding tube. 12. End the placement on the Monitor or Receiver, note tube tip position, and slowly withdraw the Transmitting Stylet. If the feeding tube tip location is not consistent

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with desired position per physician order, then follow institution protocol to resolve placement of feeding tube. Always confirm final feeding tube placement per institution protocol prior to feeding. 13. If desired, cleanse the Transmitting Stylet in warm water or 70% isopropyl alcohol and retain in the Retention Bag or similar aerated container and label with patient identification. Note: If the Transmitting Stylet has broken wires at any point, you may see any of the following on the Monitor display after the Energizing Stylet message: 1. the Transmitting Stylet/Driver Fault notification 2. the track does not follow the expected path or 3. the Out of Range message To insert previously placed feeding tube with Transmitting Stylet: 1. Do not use Transmitting Stylet if it is bent or unraveled. 2. Flush feeding tube with clear warm water to confirm patency. 3. Prior to reinsertion, lubricate original Transmitting Stylet with water-soluble lubricant and insert into the straight arm port of the feeding tube. 4. Seat the Transmitting Stylet into the straight arm port of the feeding tube. 5. Connect the Transmitting Stylet to the Interconnect Cable. 6. Follow the directions for feeding tube insertion in the “Directions for Insertion” section.

Tube Maintenance 1. Follow your institution/facility/hospital protocol or clinician’s order. 2. It is recommended the tube be irrigated every 4 hours with up to 20 ml of water before and after medication administration or when feeding formula is interrupted. 3. The feeding tube should be monitored, regularly assessed, and replaced when clinically indicated based on functionality and patient condition.

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Disposal 1. To remove tube, gently withdraw through nostril. 2. Discard per facility protocol. 3. The entire product may be incinerated.

Interconnectability to Non-Enteral Medical Devices The ENFit® connectors were designed to meet ISO 80369-3 requirements. However, the design of the ENFit® connector cannot overcome all chances of misconnection. The following connector types are potential misconnections for the ENFit® connector (feeding/medication access port) of this enteral feeding tube: • Suction ports on Endotracheal • Suction Systems • Respiratory circuit filtration connectors • Oxygen inlet connectors for Resuscitation Devices • Baxter IV Solution Bag ports (such as NaCl, Ringers Solution, etc.) • Sample ports on drainage bags • Peritoneal Dialysis connectors • Cones & sockets of ISO 5356-1:2004 and ISO 5356-2:2004 • Temperature sensor connectors and mating ports of ISO 8185:2007 • Oxygen nipples as defined in EN 13544-2:2002

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*Registered Trademark or Trademark of Avanos Medical, Inc., or its affiliates. COLOR YELLOW* is a Registered Trademark or Trademark of Avanos Medical, Inc., or its affiliates. © 2018 AVNS. All rights reserved. 2022-06-06 15-M1-300-03 / 50001140