Kangaroo Console with IRIS Technology User Manual May 2014

Table of Contents Section I: System Overview

Exporting Images to USB Flash Drive... 27

Safety and Cautions... 2

Opening Images from USB Flash Drive... 28

System Components... 3

Rename Images... 29 Delete Images... 29

Section II: Assembly and Initial Administrator Use Assembling System Parts... 9 Initial Use ... 10

Section III: Setting Up and Using the Kangaroo Feeding Tube with IRIS Technology for Placement Set Up and Use ... 13 Reconnecting ... 17

Section IV: Cleaning, Charging, and Storage General Console and Power Cord Cleaning Directions ... 19 Battery and Storage ... 20

Viewing Captured Images... 30 Annotating Images... 31 Operator and Reviewer Settings... 32 Administrator Settings... 33 Changing Date, Time, Formatting, Language, and Device Settings... 34 Adding and Editing Users... 35 Creating and Editing Encryption Password... 36 Icon Glossary... 37

Section VI: Additional Kangaroo Feeding Tube with IRIS Technology Information Order Information... 39 Troubleshooting... 40

Section V: User Interface Features On Screen Keyboard... 22 Logging In and Automatic Log-Out... 23 Main Menu... 24 Procedure... 25 Options for Viewing Patient Folders and Files... 26

Definition of Symbols... 41 Warranty... 42 Specifications... 43 MRI Safety Information... 43 Maintenance and Safety... 44 Electronic Specification Tables... 45-49

Section I: System Overview

Section I: System Overview Safety and Cautions Safety notice This section summarizes information basic to the safe operation of the equipment described in this manual. All safety precautions and operating instructions should be read and understood before installation, operation, maintenance, or repair of this device. Consult with Covidien-trained personnel before attempting to operate this equipment. Always follow product labeling and manufacturer’s recommendations. If in doubt as to how to proceed in any situation, contact your Covidien representative.

Note: For Enteral Feeding Only Description The Kangaroo™ feeding tube with IRIS technology is a single use device with a camera embedded in the distal end to aid in placement. The tube is made of radiopaque polyurethane material and features a Hydromer™* coated tip. The connectors are color coded to provide a visual indicator for enteral use only.

Indications The Kangaroo feeding tube with IRIS technology utilizes a video stream to aid a trained user during placement into the stomach or small bowel for the administration of nutrition, fluids, and medications by the naso-enteric route for patients aged 18 years and older who have an intact gastrointestinal tract, but are physically unable to manage nutritional intake through normal mastication and deglutition. A trained user, as defined per facility protocol or determined by clinical privileging, should read the Kangaroo Feeding Tube with IRIS Technology User Manual, Instructions for Use and review the training program provided. Facility protocol for insertion of any feeding tube should also be followed. Placement of the tip of the device into the small bowel should only be attempted by clinicians with expertise in small bowel placement. Prior to commencing administration, confirm correct tube placement per institutional protocol.

Actions • Acts as a conduit for food, fluids, and medications to a patient’s stomach or small bowel. • Avoid administration of light sensitive medications while the tube is connected to the interface cable.

Contraindications • Use caution with patients who have anomalies or diseases of the nose, throat, or esophagus. • The use of this product is contraindicated in patients with known sensitivities or allergies to its components.

Warnings • Coughing or any other symptom of respiratory distress would likely indicate that the device had been misplaced in the trachea. If this is suspected, remove the tube and guidewire and reinsert. • At any point during the procedure if continuous resistance is felt the device should be withdrawn and then reinserted. The operator should discontinue all attempts at placement after repetitive unsuccessful attempts (such as 5 or more) at device placement. • The presence of an endotracheal device tends to guide the feeding tube into the trachea. Should the feeding tube and guidewire (if guidewire is used) enter the tracheobrochial tree during tube placement, damage to the lung or esophagus could occur. If any resistance is felt during placement, remove the tube and guidewire and reinsert. Coughing or any other symptom of respiratory distress would likely indicate that the

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device had been misplaced in the trachea. Misplacement of tubes into the lungs resulting in pneumothorax has been reported in neurologically impaired patients and those with endotracheal tubes in place. The operator should discontinue all attempts at placement after repetitive unsuccessful attempts (such as 5 or more) at device placement. • This device should only be inserted by a trained user. • The feeding tube is a disposable device intended for single use. Do not reuse. • Maintaining the patient in a High-Fowlers or SemiFowlers position may reduce regurgitation or aspiration. If using this position, do not lean patient forward. • The stylet must be removed prior to a patient MRI. • No modification of this equipment is allowed. • Do not use this device near flammable anesthetics or in oxygen rich environments. • There is a possibility of misconnection of the feeding tube connector and insufflation device connector with the following types of connectors: the sockets of anesthetic and respiratory equipment, conical oxygen tubing, connectors for breathing systems and driving gas applications, and conical connectors for limb cuff inflation applications. The feeding tube is specifically for the purpose of enteral feeding. The insufflation device is for use with the viewing system for connection with the feeding tube during placement, and is to be disconnected from the feeding tube after placement. Please avoid connection of these devices to devices of other applications and ensure that the tubing is appropriately connected in order to provide enteral nutrition to the patient. • Additional components or equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards. All configurations shall comply with the requirement for medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3Ed. of IEC 60601-1, respectively). If the operator connects additional components or equipment to the medical electrical equipment, the operator configures a medical system, and it is the operator’s responsibility that the system complies with the requirements for medical electrical systems. If in doubt, consult your local representative or the technical service department. • When light is emitted from tube tip, do not point directly at eye. • To minimize heat exposure of tissue, the Kangaroo feeding tube with IRIS technology should be disconnected from the interface cable after the placement is complete.

• The user should be aware of patients who have photosensitivity due to administered medications or other conditions since the device exposes internal tissues to light. • Do not autoclave. • Feeding tubes should be flushed frequently to prevent clogging. Suggested flushing schedule: a) before and after each feeding b) before and after administering medication c) once every four hours during continuous feeding or between intermittent feedings d) each time the feeding set is disconnected e) each time the feeding container is filled/changed f) each time the pump is stopped • Use only tap or sterile water to flush. Do not use solutions containing meat tenderizer to flush or open a clogged feeding tube. • Tube replacement may be considered at four (4) week intervals to ensure optimum tube patency. • Use a Kangaroo™ enteral feeding pump for accuracy and control of nutritional formula delivery. Infusion pumps that deliver in excess of 40 psi should not be used as excessive pressure is capable of causing tubes and pump sets to balloon and/or rupture. Consult pump manufacturer’s specifications and recommendations. • Administration of medications should be guided by hospital policy. Many liquid preparations contain Sorbitol™* which tends to interact with enteral formulas and clog the feeding tube. Thoroughly crush tablets, excluding enteric tablets which should never be crushed; however, always consult with your pharmacist regarding which tablets should be crushed for feeding tube administration. • The device generates light, the user should be aware of patients who have taken light sensitive medications or who may have photosensitivity. • Images from the camera going to the console may be lost or temporarily suspended during placement if performed near sources of electromagnetic energy such as RFID, diathermy equipment or hand-held metal detectors.

Adverse events Pneumothorax, intestinal perforation, and aspiration pneumonia have been reported during the use of this type of device.

Precautions • This device is not intended for diagnosis. Consult the appropriate service for diagnostic evaluation if there is concern regarding an image observed during placement.

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Section I: System Overview System Components The Kangaroo feeding tube with IRIS technology is supplied in a semi-ready-to-use state. Console with touch screen interface

Rechargeable battery

Mounting clamp

Interface cable

Kangaroo feeding tube with IRIS technology and stylet (packaged separately)

Insufflation device (packaged separately)

Detachable power adapter

Optional accessories (see section regarding optional accessories): Battery charging station, mounting cart, and carrying case.

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Section I: System Overview Kangaroo Feeding Tube with IRIS Technology and Stylet (single use devices): The Kangaroo feeding tube with IRIS technology and stylet is a single use device with a camera embedded in the distal end to aid in placement. The tube is made of radiopaque polyurethane material and features a Hydromer coated tip.

Camera Stylet Feeding port Oral port

cm marks Port for interface cable Feeding eyelet

Insufflation device (single use device): The insufflation device is included to aid in feeding tube placement.

The insufflation device is connected to the feeding tube through the oral port. Insufflation bulb Insufflation connector

Pressure relief valve

Insufflation connector Oral port

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Section I: System Overview Interface cable: The interface cable is a re-usable cable that connects the console to the tube.

The interface cable has a push-button used to capture images of the procedure.

Connects to feeding tube Image capture button

Connects to console

Mounting clamp: The mounting clamp is used to attach the console to a pole, if desired. For detailed instructions, refer to the assembly section.

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Power adapter: The power adapter is supplied with five AC power cord options. Plug the power adapter into the console to charge the battery. It is important to choose the appropriate AC power cord for your region.

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Section I: System Overview Console and battery:

Kickstand:

The console has a full-color touch screen that displays a real time image as the feeding tube travels through the patient during the placement procedure. Images can be captured, stored, and annotated on the console.

The console can be used on a tabletop or mounted on a pole or cart. A built-in kickstand props the console up at an ideal viewing angle when on a flat surface.

Kickstand for use on flat surface

Power On/Off Touch screen Rechargeable battery:

A replaceable, rechargeable Li-Ion battery is included. The console recharges when the power adapter is plugged in to an AC outlet, or by using the battery charger (optional accessory). Image capture: The console has security features to help protect the information from being accessed by other people. The device requires a login name and password to use the system. Stored images can be exported as .bmp or .jpg files onto a USB flash drive and added to a patient’s file. Images are password-protected for security and privacy purposes. The USB ports are also used for software updates to the system.

Interface cable port Power cord connector

Ethernet port (non-functional)

Rubber console feet Rechargeable battery

Battery release button

USB ports Mounting clamp: The mounting clamp can be attached to the back of the console and is easily removable. For information on attaching, using, and removing the mounting clamp, see section regarding assembly.

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Section I: System Overview Console user interface:

System login:

Main menu:

The console has a color-display touch screen with step-by-step prompts to guide you through setup and operation.

After the initial set up, users will be prompted for a login name and password to access the system. First time users should receive their login information from an administrator. After logging in, the screen will show the main menu.

The main menu provides links to log out, settings, file management, and procedure initiation. Clicking any of these icons brings you to those screens.

On screen keyboard: An on screen keyboard will appear when typing is necessary. Use the keyboard to enter text, such as a login name, patient information, or to annotate images.

Procedure: To enter text:

Tap a text field (such as a login name or password) and then use the on screen keyboard to type.

To edit text:

Tap the text field and use the arrow keys to navigate to desired text location.

To enter numbers or secondary symbols:

Press the ALT key. Tap the key(s) that contains the desired number or symbol (displayed in the upper, right corner). When finished, press the ALT key again.

When finished typing, press the check mark icon return to the previous screen.

Use the procedure feature to launch the functional flow for entering patient information and procedure activities. Folders menu: The folders menu launches the data browser of patient folders. Each folder contains images captured during the procedure. Settings menu:

to save or the

to cancel and

The settings menu provides links to modify language, date/time, file formats, passwords, device options, and user settings. Log out: Clicking the log out icon ends the session.

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Section II: Assembly and Initial Administrator Use

Section II: Assembly and Initial Administrator Use Assembling System Parts Attach battery:

Connecting power adapter:

The battery provided is both removable and rechargeable. To place it into the console, align it with the space on the back, then lightly press it in.

The removable power adapter connects to the console to charge the battery. To connect, arrow on power adapter should be facing up (same side as screen).

Attach mounting clamp (optional): The console can be attached to a vertical pole using the mounting clamp, included with the system components.

To disconnect, grasp cord by the locking sleeve and pull away from console.

Attach the clamp to the console by aligning the hole on the pole clamp with the mounting hole on the back of the console. Use a 3/8” - 16 bolt to fasten together. Attach the mounting clamp to a pole by fitting it in between. Then, tighten the knob so that the clamp and console are securely attached.

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Section II: Assembly and Initial Administrator Use Initial Administrator Use When the console is powered on for the first time, or after being reset to factory settings, the administrator account needs to set up the console settings.

Choose language:

Administrator password:

Encryption password:

Choose the language for the console interface.

Create a password that will be used only for the system administrator account. Use the on screen keyboard to enter the password into the text fields. The password must be between 8 and 12 characters. Password can include uppercase letters, numbers, and symbols.

The password created will be needed to open any files exported from this console. The same password will be used for any files exported.

This administrator login name is “ADMINISTRATOR”. Other administrator accounts can be created in addition to this.

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Tap on the first text field to enter the desired password. Then, re-enter the password in the text field below. When satisfied, touch the check mark to save the changes. Note: The password is case-sensitive and will be in all upper-case.

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Section II: Assembly and Initial Administrator Use Initial Administrator Use When the console is powered on for the first time, or after being reset to factory settings, the administrator account needs to set up the console settings. A settings menu will appear once the language preference, administrator password and encryption password have been set. Settings menu: Tap on the icons at the bottom of the screen to make changes to the date/time, language, file format, device, and users. It is recommended that the current time and date is set prior to use. New user logins and passwords should be added at this point.

Back: Return to previous screen. Time and date: Set or change the time and date. Language: Change the preferred language. Format: Choose the preferred image type (.jpg or .bmp) for export. Edit the way the time and date are written on the patient files and images. Device: Erase patient data, update software, or reset console back to factory settings. Password: Change the login password. Passwords must be reset after 90 days. User groups: Create logins and passwords for operators and reviewers. Change login names and/or passwords for other users. Encryption password: Create password to decrypt and open exported files.

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Section III: Setting Up and Using the Kangaroo Feeding Tube with IRIS Technology for Placement

Section III: Setting Up and Using the Kangaroo Feeding Tube with IRIS Technology for Placement

Set Up and Use 1. Read all warnings and precautions prior to tube insertion.

5. Enter login, password, and patient information.

2. E xplain procedure to the conscious patient. Prepare supplies (oral tip syringe, feeding tube water, wipes, and stethoscope).

The system will request a login name and password. After typing, tap the check mark to proceed to the main menu.

Position console in a direct line of sight. Console can be pole mounted, propped on bedside table, or handheld.

Note: First time users need to have an administrator set up a login name and password prior to use.

CAUTION Do not place console on patient’s bed during procedure. Check battery life of console. If low, connect console to AC power outlet. 3. Plug in the power cable (if necessary).

The main menu will appear.

If desired, connect the power cord to the console. To connect, arrow on power adapter should be facing up (same side as screen).

Tap on the procedure icon to begin the placement procedure.

Follow the screen commands to enter the patient information. When complete, tap the check mark to proceed. 4. Power the console on. Press the power button. The system should start up shortly after and display a login screen. Note: After a period of inactivity (no user input to the console), the console will automatically log the user out. This log-out will not occur during a procedure.

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IEN

The system will ask for confirmation that the information is entered correctly. If yes, tap the check mark. If not, tap the red “x” to go back and re-enter the information.

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Section III: Setting Up and Using the Kangaroo Feeding Tube with IRIS Technology for Placement 6. Position patient and estimate feeding tube length.

8. Connect interface cable to console.

Position patient in accordance with facility protocol for feeding tube placement.

After entering patient information, the console will request a feeding tube to be attached.

To estimate insertion depth, use the tube to measure the distance from the tip of the patient’s nose to the earlobe and from the earlobe to the xiphoid process for gastric placement. Add approximately 10 (ten) inches (25 cm) for intestinal placement. Spontaneous transpyloric passage of the tip often occurs within 24 to 48 hours.

Start by connecting the larger end of the interface cable to the console.

Note: The Kangaroo feeding tube with IRIS technology tip is marked with an arrow on the tube near the feeding eyelets. The tip housing camera has optimal flexibility to bend in two directions, either towards or away from this arrow. Camera housing cm marks Flexibility direction arrow

9. Connect interface cable to feeding tube.

7. Activate Hydromer coating. Use water to activate the Hydromer coating on the Kangaroo feeding tube with IRIS technology. Submerge tip for about 5 seconds to activate the Hydromer coating.

A screen on the console will request that a feeding tube be attached. Connect the smaller end of the interface cable to the feeding tube. Once the feeding tube and interface cable are connected to the console, a live feed from the camera will display on the screen.

CAUTION Allow enough slack so that there is no stress on the tube or console. Strain on the tube or console could cause droppage, breakage, or discomfort to the patient.

CAUTION If applying lubricant, do not put lubricant on or near the camera-side of the feeding tube. The camera vision may become blocked or blurred.

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Avoid applying additional lubricant to tip

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Section III: Setting Up and Using the Kangaroo Feeding Tube with IRIS Technology for Placement 10. Choose the most patent nare. Choose the most patent nare and insert the feeding tube with the stylet. Direct the feeding tube posteriorly, aiming the tip parallel to the nasal septum and superior surface of the hard palate. Advance the tube to the nasopharynx, allowing the tip to seek its own passage. Once in place, do not manipulate or pull the stylet back and forth within the feeding tube. When the tube has reached the oropharnyx, encourage the patient to swallow. Giving sips of cool or room temperature water may assist the passage of the tube.

WARNING Images of anatomical markers are for reference only. Refer to Kangaroo feeding tube with IRIS technology system training. Only a trained professional should use the system.

11. Using the insufflation device. The insufflation device is for use during placement of the Kangaroo feeding tube with IRIS technology to assist in the identification of anatomical landmarks. Slight distension of the anatomy around the camera’s viewing area can aid the visualization of the esophagus and the gastro-intestinal surfaces. Air may be needed for improved viewing of anatomical landmarks when tube tip insertion has progressed beyond the 25-35 cm mark. Additional air may be needed when advanced beyond the esophagogastric (E-G) junction. The volume of air needed for visualization will vary due to the amount of air expelled naturally by the patient during the procedure as well as the distribution of air in the GI tract. Do not administer more air than is necessary for visualization. However, it should be expected that excess air will be expelled naturally from the patient during and after insufflation. To use the insufflation device, insert the insufflation connector into the oral port of the Kangaroo feeding tube with IRIS technology. The feeding port should be closed off during tube insertion, either by maintaining the stylet hub in the feeding port or by placing the tethered cap into the feeding port. At the discretion of the clinician, air can be delivered through the feeding tube during the placement by manually squeezing the insufflation bulb, which provides approximately 30mL per hand squeeze. Monitor the patient’s level of tolerance and visual signs of abdominal distention. At any time, the clinician may press the black button on the insufflation device to release excess air. At the end of the placement, the insufflation device should be disconnected from the feeding tube and the oral port should be closed. 12. Using console for placement. While inserting the Kangaroo feeding tube with IRIS technology, utilize the console screen to correctly identify anatomical markers during placement (see path images at right).

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Section III: Setting Up and Using the Kangaroo Feeding Tube with IRIS Technology for Placement 13. Capture images. The system offers two ways to capture or an image: using the interface cable or the console. To capture an image using the interface cable: • Press the button on the interface cable once to freeze the image during procedure – Once the image is frozen, it can be saved or discarded. • To save the image, click the button on the interface cable once. An hourglass will appear on the screen while the system is saving the image. – To discard the image, click the button on the interface cable twice. Once the image has been discarded, the live feed will reappear on the console. To capture an image using the console: • Tapping on the camera icon on the display screen to freeze the image. – Once the image is frozen, it can be saved or discarded. • Tapping the screen once while the image is frozen will cause the Cancel and Complete icons to appear. – Tap on the Done/Complete icon to save the image. An hourglass will appear on the screen while the system is saving the image. • Tap on the Cancel icon to discard the image. Once the image has been discarded, the live feed will reappear on the console. 14. Ending procedure. When the procedure is complete and the feeding tube has been placed properly, tap the green check mark. 11:11:11 PATIENT-NAME-UP-TO-THIRTY-CHARACTERS 11-11-2011 PATIENT-ID-XXXX

11:11:11 PATIENT-NAME-UP-TO-THIRTY-CHARACTERS 11-11-2011 PATIENT-ID-XXXX

A window will pop up requesting confirmation that the procedure is complete. If so, tap the green check mark again. Disconnect the interface cable from the feeding tube and cover the electronic port. Should the operator forget to end the procedure the system will automatically shut down after 120 minutes of the tube being powered on. 15. MR Information Card.

The MR information card provided within the instructions supplied with the Kangaroo feeding tube with IRIS technology is to be filled out and removed. The card is to be carried by the patient. 16. Confirm placement. Confirm feeding tube position per institutional protocol. Supportive confirmation includes auscultation of the upper left quadrant during injection of air using a syringe and aspiration of gastric contents. If stylet is used, placement confirmation may be confirmed with a stylet secured within the tube. These tubes are equipped with a radiopaque material for facilitating radiological (X-ray or fluoroscopic) confirmation. If there is uncertainty of the tube’s distal location after institutional placement verification methods have been performed, confirmation by X-ray should be considered. Stylet must be removed before commencement of enteral nutrition delivery.Safely dispose of all supplies according to the policy of your facility. The interface cable is re-usable, do not dispose.

CAUTION Disconnect the feeding tube from the interface cable prior to feedings. 17. View captured images. In the main menu, tap the folder menu icon. The folder menu will appear, displaying patient folders. Patient folders are named using their name, date of birth, and ID number. The patient folder holds all images captured during the procedure. Double tap the desired patient folder to view a list of images stored within. Double tapping on one of the images will display it on the screen. 18. Export images to USB. Images can be exported to a USB flash drive and opened on another computer. Plug the USB flash drive into the port on the side of the console. Then, tap the box on the left of the image(s) to be exported. Tapping the box at the left of the folder selects all images. Tap the USB icon. A pop-up screen will ask which USB port the USB flash drive is plugged into. Confirm the appropriate drive and press the check mark. If only one USB is connected, the console will highlight that option. For privacy purposes, a password has been created by an administrator. The password will be required in order to view the images on computer. Note: Passwords are in full upper-case. When using a computer, be sure to use all upper-case letters. After the files are exported, disconnect the USB flash drive. Use WinZip™* or 7-Zip to open the files. It is considered best practice to decrypt and open the files as soon as possible so that a password is no CAUTION longer required. Passwords are case-sensitive. Use upper-case letters when entering the password on the computer. Verify USB devices used with this equipment are free of software viruses and other malicious software.

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Section III: Setting Up and Using the Kangaroo Feeding Tube with IRIS Technology for Placement Reconnecting Reconnecting the console and interface cable to the Kangaroo Feeding Tube with IRIS Technology: A console used to place a feeding tube will retain the memory of which patient is associated to that tube. By re-connecting to the same feeding tube, the console will recognize it and ask for confirmation that the patient data is correct. Note: Only the console used during the placement procedure will recognize the feeding tube and associated patient information. If a different console is connected to a pre-placed tube, entering the patient’s information is required. Power on and reconnect:

Focus on procedure screen:

Power console on and enter login name and password.

The console will display the procedure screen with a live-feed from the camera on the end of the enteral feeding tube. Refer to parts section to order stylets.

Connect console to interface cable. Connect interface cable to pre-placed Kangaroo feeding tube with IRIS technology.

11:11:11

PATIENT-NAME-UP-TO-THIRTY-CHARACTERS 11-11-2011 PATIENT-ID-XXXX

You have just connected a feeding tube placed on the following patient: PATIENTNAME - DOB - PATIENTID. Is this your patient?

Confirm patient information: A screen will pop up with the recognized patient information. Tap the check mark to confirm the information is correct. If the information is incorrect, tap the “x” to go back to the main menu screen.

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Section IV: Cleaning, Charging, and Storage