CORTRAK 2 Operators Manual with Service Guide

CORTRAK* 2 ENTERAL ACCESS SYSTEM OPERATOR’S GUIDE PROPRIETARY STATEMENT This manual contains proprietary information of Avanos Medical. It is intended solely for the information and use of parties operating and maintaining the equipment described herein. Such proprietary information may not be used, reproduced, or disclosed to any other parties for any other purpose without the expressed written permission of Avanos Medical.

LIABILITY DISCLAIMER The information in this document has been carefully examined and is believed to be entirely reliable. However, no responsibility is assumed for inaccuracies. Furthermore, Avanos Medical reserves the right to make changes to any products herein to improve readability, function, or design. Avanos Medical does not assume any liability arising out of the application or use of any product described herein; neither does it cover any license under its patent rights nor the rights of others.

FCC COMPLIANCE STATEMENT This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. Modifications not expressly approved by the manufacturer could void the user’s authority to operate the equipment under FCC rules. Copyrights © 2019 Avanos Medical, Inc. All rights reserved. The copyright in this manual and the CORTRAK*software system are owned by Avanos Medical, Inc. Copyright violators may be subject to civil and criminal liability. CORTRAK*contains third-party software components as acknowledged below. The third-party software components are provided under license by the respective copyright owners on terms and conditions provided by those parties. In accordance with license terms of some such third-party software components, Avanos Medical, Inc. will supply a copy of both original and modified versions of respective third-party software in digital form upon written request and payment of US $20 to cover the costs of copying and shipping. The CORTRAK*product: Utilizes software Copyright © 1993-2011 Jonathon Whellams. Operates on the QNX operating system, Copyright @ 2017 QNX Software Systems Limited, a subsidiary of BlackBerry. Has software written with the QT SDK, © 2018 The Qt Company Uses the 3D Rendering library Three.js, Copyright © 2010-2013 three.js authors (https://threejs.org/) Uses the Common Data Format (CDF) library, NASA Space Physics Data Facility & NASA/Goddard Space Flight Center

Patent Information This product is protected under United States patent: 7,976,518. Other U.S. and Foreign patents pending.

Trademark Information CORTRAK* is a Registered Trademark or Trademark of Avanos Medical, Inc., or its affiliates. © 2018 AVNS. All rights reserved.

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CONTENTS Introduction Indications For Use...7 Contraindications For Use...7 Scope...7 Accounts Mode...7 Anonymous Mode...7 Administrative Mode...8 Warnings...8 Cautions... 10 Contact Information...11 Labeling Symbol Definitions... 12

Initial Inspection Out Of Box Inspection... 14 Initial System Test... 14

Placement Basics Placements in Accounts Mode... 16 New Placement... 17 Placement History... 18 Log Out... 18 Placements in Anonymous Mode... 19 Placement Views...20 The Anterior View...20 The Depth Cross Sectional View...20 The Lateral View... 21 Starting the Placement...22 During the Placement...22 Ending the Placement...23 System Status Display...24

Placement Procedure Directions for Setup...25 Directions for Tube Insertion...26 Directions for Use and Handling of Transmitting Stylet...28

Administrative Mode Setting Administrator Account Name and Password...29 Accessing The Administrator Mode...30 Administrator Mode Features...30 Administrator Account Name and Password... 31 System Settings... 31 Operator Accounts...32 Import and Export of Operator Login Information...33

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File Management...35 Thermal Management...35 Maintenance...35 Touch Screen Alignment...36 Print Status Report...36 Software Upgrade...36 Initialize USB Flash Drive...36

File Management The File Management Screen...37 Tube Placement History Screen...38 Placement Review...39 Placement Printouts...39 Operator Upload of Placement Files... 41 Administrator Upload of Placement Files... 41

Indicator Tones Battery Status...43 Operating Temperature...45

Service Guide Cleaning Instructions...46 Annual Inspection...46 Battery Replacement...47 Monitor Mounting...48 Touch Screen Alignment...50 Battery Charging... 51 Fault Notifications...52 Technical Service Support...53 Troubleshooting - Refer to Operating and Trouble Shooting Tip Cards

Accessories Printer...54 USB Flash Drive Device...55 Stabilizer...55 Leveling Device...56 Protective Covers...56 Stylus...56

Specifications CORTRAK* 2 Enteral Access System Product Specifications... 57 EMC Considerations...58 Additional EMC Considerations... 61 Device Disposal... 61 Technical Service...62 Warranty...62

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INTRODUCTION The CORTRAK* 2 Enteral Access System (EAS) uses an electromagnetic sensing device to track the path of Avanos CORTRAK* 2 feeding tubes during a placement procedure. Refer to Figure 1. The CORTRAK* 2 consists of three major parts:

Figure 1. Proper Placement in the Digestive System • The CORTRAK* 2 Monitor contains an integrated Visual Display Terminal (VDT), a touch screen style user interface and an embedded computing system. An internal, rechargeable battery supplies the power. An External Power Supply/ Battery Charger will also provide power to the system while recharging the internal battery. • The CORTRAK* 2 Electromagnetic Transmitting Stylet with a small coil (Transmitter) located at the tip. This Transmitting Stylet is an integral part of the Avanos CORTRAK* 2 feeding tube inserted into a patient’s stomach or small bowel. A short interconnecting cable attaches the Transmitting Stylet to the CORTRAK* 2 Monitor. When placement is complete, the Transmitting Stylet is removed, leaving just the feeding tube. Refer to the Instructions for Use Insert packaged with the CORTRAK* 2 Feeding Tubes to either retain or dispose of Transmitting Stylet. The CORTRAK* 2 Electromagnetic Transmitting Stylet is part of the approved CORTRAK* 2 feeding tube assembly available from Avanos Medical. • The CORTRAK* 2 Receiver Unit (RU) is placed at the Xiphoid Process to track the position of the Transmitting Stylet during a placement. The RU is attached by a cable to the CORTRAK* 2 Monitor which then provides a graphical display of the Transmitting Stylet tip location and track relative to the RU. Refer to Figure 1 for a typical sample Placement Screen display. WARNING: The CORTRAK* 2 Monitor displays a representation of the Transmitting Stylet path relative to the Receiver Unit. This representation is NOT an image of the actual feeding tube position. Although this system has been designed and manufactured to exacting specifications, it is not intended to replace trained clinicians in the supervision of feeding tube placements. Clinical judgment should always take precedence. 6

INDICATIONS FOR USE 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 8FR or greater into the stomach or small bowel of patients requiring enteral feeding.

CONTRAINDICATIONS FOR USE DO NOT use the CORTRAK* 2 Enteral Access System for patients with implanted medical devices that may be affected by electromagnetic fields.

SCOPE The operator should carefully read this guide to fully understand the functionality of the CORTRAK* 2 and to ensure safe and proper operation. The CORTRAK* 2 can be configured for one of two principal operating modes, Accounts Mode and Anonymous Mode. A special Administrative Mode provides access to additional system features not required by the operator during placements.

Accounts Mode • Each qualified clinician is assigned an “Account” consisting of a unique login name and password which must be used to perform or review placements. • As a placement is performed, the CORTRAK* 2 Monitor displays the current Transmitting Stylet tip position and track relative to the CORTRAK* 2 Receiver Unit. The entire placement is recorded and may be replayed at a later time for review or critique. • An optional printer can be connected to the CORTRAK* 2 Monitor to print a graphical placement summary for the patient’s records. • The CORTRAK* 2 Monitor can save files to an external USB Flash Drive. These files may subsequently be reviewed on a PC for reference and training purposes. Refer to the Placement Basics section of this guide for further information on the Accounts Mode of operation.

Anonymous Mode • No operator login is required. • As a placement is performed, the CORTRAK* 2 Monitor displays the current Transmitting Stylet tip position and track relative to the CORTRAK* 2 Receiver Unit. The entire placement is temporarily held in memory (without patient information) for immediate review or critique but is not saved once exiting the placement session. • An optional printer can be connected to the CORTRAK* 2 Monitor to print a graphical placement summary (without patient information) for the patient’s records before exiting the placement screen. • Since no files are recorded, they may not be reviewed at a later date nor saved to an external USB Flash Drive. Refer to the Placement Basics section of this guide for further information on the Anonymous Mode of operation.

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Administrative Mode This privileged mode is accessed by a special operator, called the Administrator, to perform a number of management tasks which include choosing the principal operational mode, setting the time and date, aligning the touch screen, issuing accounts to qualified clinicians trained to use the CORTRAK* 2, and managing placement files resident in the memory of the CORTRAK* 2 Monitor. The Administrator should only grant new operator accounts to qualified clinicians who receive the appropriate prerequisite training and hands-on experience prior to clinical use of the CORTRAK* 2. Refer to the Administrative Mode section of this guide for further details on this mode.

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 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. • 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 does not prevent patient injury due to misplacement of a feeding tube into the trachea or lungs. • 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. • Misplacement of any feeding tube into the trachea or lungs may result in serious patient 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. • If lung placement is suspected, re-assess the patient and notify physician per institution protocol. • Tube position must be confirmed per institution protocol prior to flushing with water. • Clinicians must continuously observe and assess both the patients and the tracings on the CORTRAK* 2 Monitor while advancing the tube to ensure proper insertion of the tube down the nasoenteric pathway of the patient. 8

WARNINGS (Continued) • DO NOT use the CORTRAK* 2 with catheters other than Avanos CORTRAK* 2 feeding tubes that are compatible with this system. Potential complications with the CORTRAK* 2 are those normally associated with the risks of feeding tube placements (for example, lung intubations and pneumothorax). • Special care should be taken with the placement and securement of the CORTRAK* 2 Receiver Unit on burn patients and patients with other sensitive skin conditions. Clinical judgment should be used when treating these patients. • 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. • 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. • DO NOT begin patient feeding until the desired tube location is confirmed per institution protocol. Additional confirmatory techniques may be required, 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 • 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 this manual for additional guidance. Portable RF communications equipment (including RFID readers and peripherals such as antenna cables and external antennas) should be used no closer than 50 cm (20 inches) to any part of the CORTRAK* 2. • DO NOT clean the CORTRAK* 2 System while connected to External Power Supply. Failure to comply may result in electrical shock. • DO NOT disassemble the enclosures of the CORTRAK* 2 Monitor to reduce the risk of electric shock. The service panel may be removed as instructed in the service guide section of this manual for routine battery replacement. Refer all other servicing to qualified Avanos Medical service personnel.

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WARNINGS (CONTINUED) • 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: • the track does not follow the expected path • the Out of Range message • the Transmitting Stylet/Driver Fault notification • When attaching the CORTRAK* 2 Monitor to a standard IV pole, ensure that it is securely clamped in position and that the weight is properly distributed. The CORTRAK* 2 Monitor should be attached no higher than 5 feet from the floor when mounted on a 22” minimum diameter base IV pole with 5 legs minimum and 3” minimum diameter casters. • If the CORTRAK* 2 Monitor or Receiver Unit is dropped or appears to be damaged, the CORTRAK* 2 Enteral Access System should be taken out of service and inspected by qualified service personnel only and returned to Avanos Medical if repair is needed. • This device should be repaired only by Avanos Medical. Avanos Medical will assume no responsibility for incidents which may occur if the product was not repaired in accordance with procedures authorized by Avanos Medical. • Use of accessories, transducers and cables including USB devices other than those provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

CAUTIONS: Caution: In the U.S., use of the CORTRAK* 2 Enteral Access System is restricted by federal law (USA) to sale or use by, on the order of, or under the supervision of a physician or other licensed health care professional. Caution: NEVER use the CORTRAK* 2 and IV pole/CORTRAK* Stand as a patient support device. Caution: Changes or modifications not expressly approved by Avanos Medical could void the user’s authority to operate the equipment. Caution: DO NOT use hard or sharp objects on the CORTRAK* 2 Monitor display screen. Use the touch screen stylus provided in the accessory kit for enhanced touch screen response. Caution: DO NOT lay the CORTRAK* 2 Monitor face down on any surface which could scratch or damage the display screen. Caution: To prevent system overheating, operate the CORTRAK* 2 Monitor in an upright manner and ensure that the vents are always unobstructed. Caution: The CORTRAK* 2 may interact with some ECG monitoring equipment. Proper set-up of the ECG monitor should eliminate any difficulties. Consult the ECG monitor instruction manual for more information. Caution: DO NOT allow fluid or residue to remain on the CORTRAK* 2 Monitor or Receiver Unit. Wipe off spills immediately. Caution: DO NOT steam sterilize, Ethylene Oxide sterilize, or immerse the CORTRAK* 2 Enteral Access System components.

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Caution: Ensure proper maintenance of the CORTRAK* 2 by following the cleaning schedule and methods defined in the Service Guide section of this guide. Caution: Refer all service and repair to Avanos Medical personnel. Caution: When disposing of the CORTRAK* 2, the replaceable lithium ion batteries specified for use with the CORTRAK* 2, and/or any other electronic accessories specified for use with the CORTRAK* 2, adhere to local and institution regulations and guidelines.

ADVERSE EVENTS Placement and use of any feeding tube may result in patient discomfort. Use or misuse of any feeding tube may lead to infrequently occurring events including pneumothorax, aspiration, aspiration pneumonia, airway obstruction, nasal erosion, sinusitis, esophagitis, esophagotracheal fistula, gastric erosion, GI perforation, pulmonary and/or other infections, tissue irritation or necrosis, allergic reaction, contamination, delay in diagnosis, delay or misdose of medication or nutrition, related complications leading to the need for additional medical procedures, or death.

NOTIFICATION TO USERS: Please immediately report any serious incident that may have occurred due to this medical device to the manufacturer or its Authorized Representative and to your National Authority.

CONTACT INFORMATION For more information about the Avanos Medical CORTRAK* 2 Enteral Access System, contact us at: Avanos Medical, Inc. 5405 Windward Parkway Alpharetta, GA 30004 Call: 1-844-428-2667

EU Authorized Rep EC REP Avanos Medical Belgium BVBA Leonardo Da Vincilaan 1 1930 Zaventum, Belgium www.avanosmedicaldevices.com

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LABELING SYMBOL DEFINITIONS Classifications in accordance with UL/IEC 60601-1, The Standard for Medical Electrical Equipment Part 1: General Requirements for Safety: • Type of Protection Against Electrical Shock: Class I Equipment / Internally (Battery) Powered Equipment • Degree of Protection Against Electrical Shock: Type BF Applied Part • Degree of Protection Against Ingress: • IP20 – Monitor Unit • IP21 – Receiver Unit • Continuous operation • Equipment not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide.

IP20

Protected for Spillage Inaccessible to objects larger than 12.5mm Not protected from vertically falling water Not Protected for ingress of water

IP21

Protected for Spillage Inaccessible to objects larger than 12.5mm Protected from vertically falling water Protected for ingress of water Attention, consult accompanying documents. This product is classified by Underwriters Laboratories Inc. with respect to electric shock, fire, and mechanical hazards only in accordance with UL 60601-1, CAN/CSA C22.2 No. 601.1 and IEC 60601-1. Type BF Applied Part Power Button Rocker Switch (| = ON) Interconnect Cable/Stylet Connector Receiver Unit Connector USB Connector for connection of Authorized USB Printer or USB Flash Drive DC (Direct Current) Input European Union Conformity Marking Caution, consult accompanying documents

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Do not dispose through standard waste disposal Catalogue Number Serial Number Date of Manufacture Manufacturer

i

Informational pop-up dialog Toggle Button

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INITIAL INSPECTION The Avanos Medical CORTRAK* 2 Enteral Access System was thoroughly tested and inspected at the factory prior to shipment. It has been found to comply with all electrical and mechanical specifications. Abusive handling during shipment may cause visible or hidden damage. If any damage is observed, and this damage is related to shipping, notify the carrier’s agent immediately. Do not return the damaged equipment to Avanos Medical without prior authorization.

OUT OF BOX INSPECTION 1. Carefully inspect the shipping carton. Make a record of any damage caused by mishandling. 2. Ensure the following items are in the carton: CORTRAK* 2 Enteral Access System •

One Operator’s Manual with Service Guide

•

One CORTRAK* 2 Monitor (Monitor)

•

One CORTRAK* 2 Receiver Unit (RU)

•

One Interconnect Cable

•

One External Power Supply

•

One Power Cord

CORTRAK* 2 Enteral Access System Accessory Kit •

One USB Flash Drive Device

•

One Stabilizer - to help secure the RU in position

•

One Stylus - for use with touch screen alignment

•

One Leveling Device

CORTRAK* 2 Replacement Battery CORTRAK* 2 Replacement Receiver Unit Note: Retain the packing materials in case the CORTRAK* 2 needs to be returned for repair. To order additional packing materials, call +1-844-428-2667. 3. Provide the Operator’s Manual with Service Guide to the appropriate clinical staff. In addition, copies of this manual should be added to the documentation library maintained in the equipment servicing or biomedical engineering area per institution protocol. 4. Inspect the CORTRAK* 2 Receiver Unit housing and the CORTRAK* 2 Monitor housing and display for any signs of defects, damage, or hazards that might affect the performance. This completes the initial inspection. Continue to the Initial System Test which follows.

INITIAL SYSTEM TEST 1. Set the unit in an upright position on a flat surface or attach the CORTRAK* 2 to the Stand by sliding the CORTRAK* 2 Monitor onto the Stand Adaptor Head on the top of the Stand. 2. Toggle the rocker switch to the ON (|) position. The rocker switch is located on the bottom panel of the CORTRAK* 2 Monitor. The rocker switch is only intended for use during shipping or in the rare condition that the CORTRAK* 2 Monitor might become unresponsive. Do not use the rocker switch as the standard method of Power on and Power off. 14

3. Connect the External Power Supply and wait for the LED on the Power Button to flash or show green. 4. Press (and hold for approximately 5 seconds), the Power ON/OFF button on the CORTRAK* 2 Monitor. 5. After a series of initialization screens, the Language Selection screen will appear. Press the flag corresponding to the desired language.

Figure 2. Language Selection Screen 6. The Welcome screen will then appear. Press “Shutdown” and confirm shutdown at the prompt. Refer to Figure 3. 7. After a series of shutdown screens, power will turn OFF automatically. Note: The External Power Supply should be connected for a period of six hours to charge the internal battery before putting the system into use. 8. Go to the Administrative Mode section of this guide to set up the System Features.

Figure 3. Welcome Screen

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PLACEMENT BASICS During the initial set up, an administrator configures the CORTRAK* 2 Monitor for either an Accounts Mode or an Anonymous Mode of operation. For the Accounts Mode, the Administrator also enters operator login names and passwords. The Administrator should only grant new operator accounts to qualified clinicians who receive the appropriate prerequisite training and hands-on experience prior to clinical use of the CORTRAK* 2. This section provides an overview of these two operating modes. When ready to perform a CORTRAK* 2 feeding tube placement, refer to the Placement Procedure section of the guide. For details about the CORTRAK* 2 features available only to the Administrator, refer to the Administrative Mode section of this guide.

PLACEMENTS IN ACCOUNTS MODE In the Accounts Mode, the Operator Login screen is displayed. Refer to Figure 4. The Operator Login screen initially has a “System Status” button where the “Login” button is currently shown. Only after entering the first character in either the Login or Password fields will the “Login” button be present.

Figure 4. Operator Login Screen Note: Use the “Alt” key to change the keypad character set between the standard English and an alternate keypad containing punctuation and European characters. Refer to Figure 5.

Figure 5. Alternate Keyboard

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Once a valid login name and password are entered and “Login” is pressed, the Placement Selection screen appears. Refer to Figure 6. The operator may select either “New Placement” to begin a new procedure, “Placement History” to review a previously completed procedure, or “Log Out” to return to the Operator Login Screen.

Figure 6. Placement Selection

New Placement When “New Placement” is selected, the Patient Information screen is displayed. Refer to Figure 7. The operator must enter the Patient’s First Name, Last Name, and ID number. An entry must be made in each of these fields. Use the “Alt” key to change the keypad character set between the standard English and an alternate keypad containing punctuation and European characters. Refer to Figure 5.

Figure 7. Patient Information Screen Pressing “Next” causes the Placement screen to appear. Figure 8 shows an Accounts Mode Placement Screen prior to starting the placement.

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Figure 8. Placement Screen (Accounts Mode) If the operator’s name or the patient’s name is too long to fit into the available space, the CORTRAK* 2 Monitor will abbreviate to the first initial and last name; if it is still too long, the last name is automatically truncated.

Placement History Refer to Figure 9. When “Placement History” is selected, the Tube Placement History Screen displays a list of all placements performed by the operator currently logged into the system. (If the administrator is logged in, all placements are listed for all operators.) Refer to the File Management section of this guide for additional information about previously recorded placement files.

Figure 9. Tube Placement History Screen

Log Out Pressing “Log Out” on the Placement Selection Screen returns the operator to the Operator Login Screen.

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PLACEMENTS IN ANONYMOUS MODE In the Anonymous Mode the operator sees a Placement Selection screen similar to the one shown in Figure 6. However, in this mode, placements are not recorded. Therefore, the “Placement History” feature is replaced by the “System Status” feature. Press “New Placement” to proceed to the Placement screen. There is no entry of operator or patient information in Anonymous Mode. Figure 10 shows an Anonymous Mode Placement screen prior to starting the placement.

Figure 10. Placement Screen Display (Anonymous Mode)

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PLACEMENT VIEWS During the placement procedure, the operator is presented with a selection of 2-dimensional views of the Transmitting Stylet tip location and deployment path relative to the CORTRAK* 2 Receiver Unit (RU). The system provides a means for the operator to toggle both the major and minor displays such that a combination of the Anterior View and either Depth Cross-Section or Lateral View display simultaneously, thereby providing a complete presentation of the procedural data in all 3 dimensions. WARNING: The CORTRAK* 2 Monitor displays a representation of the Transmitting Stylet tip path relative to the Receiver Unit. This representation is NOT an image of the actual feeding tube position.

The Anterior View includes: • A vertical reference line representing a mid-sagittal line of the patient (for properly positioned RU). • A horizontal reference line representing a vertical cross-section of the patient’s diaphragm, wherein the vertical reference line and horizontal reference line intersect at a point representative of the patient’s Xiphoid Process (for properly positioned RU). Refer to Figure 11.

The Depth Cross Sectional View includes: • A vertical reference line representing the patient’s mid-sagittal line (for properly positioned RU). • A horizontal reference line representing the anterior plane of the patient, wherein the front foot of the RU rests on the patient’s Xiphoid Process. Refer to Figure 11.

Figure 11. Anterior and Depth Cross Section View (Default Placement Screen, Accounts Mode)

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The Lateral View includes: • A vertical reference line representing a vertical cross-section of the patient’s diaphragm, wherein the vertical reference line and horizontal reference line intersect at a point representative of the patient’s Xiphoid Process (for properly positioned RU). • A horizontal reference line representing the anterior plane of the patient, wherein the RU rests on the patient’s Xiphoid Process. Refer to Figures 12 and 13.

Figure 12. Lateral View, Minor Screen, Anterior View Major Screen

Figure 13. Lateral View Major Screen, Anterior View Minor Screen

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