Kangaroo™ IRIS Console Manual
Contents
1. Kangaroo Console 20 Section V User Interface Features Section V User Interface Features On Screen Keyboard The on screen keyboard will be displayed when typing is necessary Use the keyboard to enter text such as a login name or to annotate images How to use the keyboard To enter text Tap a text field such as a login name or password Then tap on the letters on the keyboard to type Text will always be written in uppercase To edit text Tap the text field and use the arrow keys to navigate to the desired text location To enter numbers or secondary symbols Press and release the ALT key Tap the key s that contains the desired letter number or symbol displayed in the upper right corner of the key Press and release the ALT key again to return to main keyboard For example to enter a login name of 64USER press ALT then 6 4 then ALT again followed by U S E R Accept changes or cancel u m Tapping the check mark or x icons will either accept the entered text or cancel any changes and return to previous screen ALT lt i ALT key Arrow keys Return Enables alternate letter Moves cursor left Moves cursor to next symbol or number keys or right text field Table of Contents lw pepe pel pole neoeooeooe Bo Goou0eeae AA e pT X Delete text Deletes previously written text letter by letter X icon2. Feeding port Oral port ha cm marks Feeding eyelet Insufflation device single use device The insufflation device is included to aid in feeding tube placement Insufflation bulb Pressure relief valve Insufflation connector ON Table of Contents Kangaroo Console 4 Oral port Section I System Overview Interface cable The interface cable is a re usable cable that connects the console to the tube Connects to feeding tube 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 Table of Contents The interface cable has a push button used to capture images of the procedure Image capture button 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 Kangaroo Console 5 Section I System Overview Console and battery 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 Power On Off Touch screen Image capture The console has security features to help protect the information from being accessed by oth
3. Cancels any changes made and returns to previous screen Check mark icon Accepts changes made and advances to next screen Kangaroo Console 22 Section V User Interface Features Logging In and Automatic Log Out The console can only be used by approved individuals A login name and password is required New users Only an administrator can set up a new user account Note The original administrator login name is ADMINISTRATOR but other administrator accounts may be added Return users Using the on screen keyboard enter the login name and password Tap the check mark to confirm Login Password twee pel pole poocopanig Bo GUo00eee PLL Tpit Automatic log out After a certain period of inactivity where there is no user input to the console the console will automatically log the user out This inactivity time period is 5 minutes for operators and reviewers and 10 minutes for administrators The automatic log out will not occur during the procedure Table of Contents Wrong password for reviewer or operator account If a password is entered incorrectly the system allows a user to attempt to login up to five times After the fifth attempt the user s account is locked To unlock the account an administrator must reset the password from the settings menu Wrong password for administrator account If a password for an administrator account is entered i
4. 15 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 ot an image using the interface cable or the console 7 To capture an image using the interface cable e 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 11 11 11 PATIENT NAME UP TO THIRTY CHARACTERS 11 11 2011 PATIENT ID XXXX e 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 e Tapping on the camera icon on the display screen to freeze the image Once the image is frozen it can be saved or discarded e 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 e 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
5. power outlet COS BD gt eo ee C2 Co Left to right the symbols show 1 lt 10 2 10 25 3 26 50 4 51 75 5 76 100 6 charging 7 communication error 8 missing battery When the console battery has 10 capacity left a low battery warning screen will appear Tap the check mark and connect the console to an AC outlet using the removable power cord If the battery is very low a warning screen will appear and the console will shut off Plug the console in to charge the battery Storage requirements Store in environments of 0 C to 50 C and relative humidity of 15 to 85 non condensing Table of Contents Store the console away from direct sunlight heat sources and dust in particular do not expose the console to direct sunlight for long periods of time Remove battery from console to preserve longevity When using the mounting clamp the console must be removed from the pole prior to removing the battery Removing the battery The battery can be easily removed and replaced if necessary by the user When the console is not in use for extended periods of time removing the battery and storing separately can help maintain the battery s longevity Press the battery release button to pop one side of the battery out Then lift the battery off the console and place in proper storage Do not attempt to remove the battery while the console is attached to a pole
6. 3 V m 3 V m Where P is the maximum output power rating of the transmitter in watts W IEC 61000 4 3 80 MHz to 2 5 GHz according to the transmitter manufacturer and d is the recommended separation distances in meters m Field strengths from fixed RF transmitters as determined by an electronic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol gt NOTE 1 At 80 MHz and 800 MHz the higher frequency applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Kangaroo feeding tube with IRIS technology when used with the console as a system is used exceeds the applicable RF compliance level above the Kangaroo feeding tube with IRIS technology when used with the console as a system should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary
7. For detailed information on annotating images see the annotating images section Split view Viewing in split screen will show the captured image on the left and the live view from the camera on the right side lt Filename gt LIVE VIEW Zooming in out panning the image While touching the screen with two fingers slide the fingers away from each other to zoom in Pan the screen by touching with one finger and dragging along the screen Panning is only active when zoomed in To zoom out touch the screen with two fingers and slide them towards ee KAN U l Full screen view To switch to full screen view tap this icon Table of Contents Kangaroo Console 30 Section V User Interface Features Annotating Images A Annotating images X Tap on the annotate icon to bring up a icon tray with annotation options Tap the icons to add text lines or undo actions A reviewer can view the images and confirm that they have reviewed them Further annotation of images is not allowed after a still image is reviewed Note Annotation is not possible when image is zoomed in 11 11 11 PATIENT NAME UP TO THIRTY CHARACTERS 11 11 2011 PATIENT ID XXXX gt lt A V Draw a line on the image e Tap on the icon Then touch the screen where the line should start Touch the screen again at the point where the line should end Table of Contents Add text to the image
8. January 2012 Version 1 23alpha Portugu s Last Reset HH MM Nederlands Language March 22 2012 English ADMINISTRATOR Deutsch Format Users JPG 23 Operators Current Time Format 3 Reviewers MM DD YYYY 3 Administrators Change password ma To change the account password tap on the key icon Use the keyboard to enter a new password then repeat the password in the second text field Tapping the check mark saves the changes Q New Password Verify Password x DOUCOOCUDOG DEnEEnEnig pooooninggg LL LO Table of Contents Kangaroo Console 32 Section V User Interface Features Administrator Settings Settings Administrators can make changes to the time date language image format user information and update the device The current settings for the console are shown on the screen The Device Version shown indicates the software version currently on the console Time and Date Device HH MM January 2012 Version 1 23alpha Last Reset HH MM La Ng uage March 22 2012 English ADMINISTRATOR Format Users JPG 23 Operators Current Time Format 3 Reviewers MM DD YYYY 3 Administrators K GRDA GQO Table of Contents A i O B B D a Change language Tapping on the language icon displays a screen giving optional language preferences Tap once on the preferred language then tap the check mark to save changes Change password To change the
9. Select the icon then tap on the screen where the text should be A list of anatomical marker labels will appear At the bottom of the list is an option to enter free text With free text a keyboard will appear Enter the text then press the check mark Confirmation will be required to save the changes Enter Annotation Text x v DOGOEGORoR HaoGEooeee BoOGUEOUraa 5 e E Review an image reviewer only Reviewing an image places a time stamp with the reviewer s login name and the time Note Once a reviewer confirms the review by tapping the checkmark no further annotations can be made Login ji Password poywlep etry yey pole DEoGEoOooee Bo Goooneae 50S oe Undo Undo up to twenty previous actions You can undo a review in order to continue making annotations Kangaroo Console 31 Section V User Interface Features Operator and Reviewer Settings Settings Change language Operators and reviewers can change the language preference and their Tapping on the language icon displays a screen giving optional language password from the settings menu preferences Tap once on the preferred language then tap the check mark to The current settings for the console are shown on the screen The Device save changes Version shown indicates the software version currently on the console y Francais Time and Date Device Espa ol HH MM
10. VI Additional Kangaroo Feeding Tube with IRIS Technology Information Definition of Symbols r Not made with natural rubber latex Keep Dry Not made with Di 2 ethylhexyl phthalate Dispose of as Electrical and Electronic Waste Identification of a substance that is not contained or present l we l Type BF protection against electrical shock within the product or packaging Single use only do not re use Class Il Equipment Federal USA law restricts this device Protected againstspiasnihg water to sale by or on the order of a physician NRTL test mark performed for compliance Safety Tested Caution consult accompanying documents NRTL test mark performed for compliance Type Tested Consult instructions for use C US C CE Mark Follow instructions for use 0123 Indicates that the specific device poses no known hazards in Catalog number a specified MR environment specific field strength spatial gradient RF pulse limitations and specific absorption rate Manufacturer Indicates the device would be unsafe in any MR environment Date of manufacture Store in temperatures between 0 C and 50 C 0 0 7 i a O a RONE NENE Authorized representative in the European Community Store in temperatures between 15 30 C 59 86 F Serial Number Table of Contents Kangaroo Console 41 Section VI Additional Kangaroo Feeding Tube with IRIS Technology Information Warranty Limited warranty Covidien llc warra
11. account password tap on the key icon Use the keyboard to enter a new password then repeat the password in the second text field Tapping the check mark saves the changes Format images Choose between exporting images as a bmp or jpg Change the date format to the preferred order Edit the way time is displayed during placement Device Erase patient data update the device software or reset the device back to factory settings Set or change date and time Use the touchscreen to select the time and date If English language is currently selected on the console select preferred time format 24 hours or 12 hours then tap the check mark to save changes User groups Add or change user passwords Encryption password Change password used to decrypt open patient images on a computer Passwords will be in all uppercase letters and are case sensitive Kangaroo Console 33 Section V User Interface Features Changing Date Time Formatting Language and Device Settings Set or change date and time Y Use the touch screen to select the time and date If English language is currently selected on the console select preferred time format 24 hours or 12 hours then tap the check mark to save changes Time A e lt HH MM gt Hours Ba Minutes B AM PM Rd 12 24 Date Format images Choose between exporting images as a bmp or jpg Change the date format to the preferred order Edit the way time
12. at 1 800 962 9888 or your local sales representative Table of Contents Kangaroo Console 45 Section VI Additional Kangaroo Feeding Tube with IRIS Technology Information Guidance and manufacturer s declaration electromagnetic emission The Kangaroo feeding tube with IRIS technology when used with the console as a system is intended for use in the electromagnetic environment specified below The customer or the user should assure that it is used in such an environment o Emissiontest O Compliance Electromagnetic environment guidance RF emissions The Kangaroo feeding tube with IRIS technology when used CISPR 11 with the console as a system uses RF energy only for its internal Group 1 i l E function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emission The Kangaroo feeding tube with IRIS technology when used with CISPR 11 class A the console as a system is suitable for use in all establishments other than domestic and those directly connected to a low voltage power supply network which supplies buildings used for domestic purposes Harmonic emissions Class A IEC 6100 3 2 Voltage fluctuations flicker emissions Complies IEC 6100 3 3 Table of Contents Kangaroo Console 46 Section VI Additional Kangaroo Feeding Tube with IRIS Technology Information Guidance and manufacturer s declaration electromagnetic immunity The Kangaroo fee
13. green check mark Q Are you sure you completed the procedure 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 Table of Contents 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 dispo
14. 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 Kangaroo Console 2 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 Table of Contents Kangaroo Console 3 Section 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
15. 25 Section V User Interface Features Options for Viewing Patient Folders and Files Save to USB Export image s to USB flash drive Exported Patient folders and files Patient folders are auto titled with the procedure date feeding tube number patient name date of birth and patient identification Select a patient folder images are password protected to ensure to view by tapping twice on it All images are listed below the patient folder patient privacy Images can be viewed exported annotated or deleted Note Screens shown below show sample data as an example Ry Rename image By Rename a portion of the image E 20120101_SUDDEFAULTS_ NO NAME_NO DOB_NO ID a NO NAME_NO DOB_NO ID_112233_010 img Delete image s fi Delete one or more images from the NO NAME_NO DOB_NO ID_112233_009 img N patient folder e NO NAME_NO DOB_NO ID_112233_008 img Viewimade P NO NAME_NO DOB_NO ID_112233_007 img E View image in full screen a NO NAME_NO DOB_NO ID_112233_006 img AIC NMAAMAC AIM DAD NMA IM 119999 ANC inn Jiang Table of Contents Kangaroo Console 26 Section V User Interface Features Exporting Images to USB Flash Drive Save to USB Y Images can be exported to a USB flash drive and opened on Tap the USB icon A screen will pop up asking which USB port to save to Confirm and another computer tap the check mark Verify USB devices used with this equipment are free of soft
16. O ID_112233_009 img ir he NO NAME_NO DOB_NO ID_112233_006 img lt eiT The system will require confirmation before deleting Tap the check mark to confirm o NO NAME_NO DOB_NO ID_112233_008 img O NAME_NO DOB_NO ID_112233_007 img f j NO NAME_NO DOB_NO ID_112233_006 img MA NAMC NA DOD NAN IN 119999 NNE imaw Select the image to rename by tapping on it then tapping on the rename image icon A screen will pop up Using the text field enter the new name for the image Press the check mark when finished 4 Are you sure you want to delete v Previous Name lt NAME gt _ lt DOB gt _ lt ID gt _ lt TIME gt _ lt SEQ gt img New Name op whey aye pul pole DEoGooecee BoGoueo0nDEse PPL E Note Images can only have letters or numbers in the name symbols will not work Only one image can be renamed at a time Table of Contents Kangaroo Console 29 Section V User Interface Features Viewing Captured Images View image Procedure If not currently in the procedure process this icon will appear Tapping this icon opens the procedure screen When viewing a captured image there is an option to annotate view in split screen and return to the procedure live feed from camera and 11 11 11 PATIENT NAME UP TO THIRTY CHARACTERS 11 11 2011 PATIENT ID XXXX Annotate image Select an image to annotate by clicking the box to the left Then tap the annotation icon
17. Power console on and enter login name and password Connect console to interface cable Connect interface cable to pre placed Kangaroo feeding tube with IRIS technology 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 u If the information is incorrect tap the x to go back to the main menu screen Table of Contents Focus on procedure screen 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 11 11 11 PATIENT NAME UP TO THIRTY CHARACTERS 11 11 2011 PATIENT ID XXXX Kangaroo Console 17 Section IV Cleaning Charging and Storage Section IV Cleaning Charging and Storage General Console and Power Cord Cleaning Directions Cleaning should be performed as needed If any of the follow events occur do not use the console or power cord until it has been properly cleaned and serviced by personnel trained in servicing these devices e wetting of the console s power cord or leakage into the interior during cleaning e spillage of large amounts of liquids onto the console exterior or any spillage onto the power cord Cleaning of the console and cord must be p
18. T NAME gt _ lt DOB gt _ lt PATIENT ID gt lt DATE gt _ lt TUBE gt _ lt PATIENT NAME gt _ lt DOB gt _ lt PATIENT ID gt lt PATIENT NAME gt _ lt DOB gt _ lt PATIENT ID gt _ lt img gt filetype lt PATIENT NAME gt _ lt DOB gt _ lt PATIENT ID gt _ lt img gt filetype lt DATE gt _ lt TUBE gt _ lt PATIENT NAME gt _ lt DOB gt _ lt PATIENT ID gt lt DATE gt _ lt TUBE gt _ lt PATIENT NAME gt _ lt DOB gt _ lt PATIENT ID gt Please select the USB drive for export a lt gt Your Files are being exported 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 Kangaroo Console 16 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
19. al 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 Table of Contents 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 CORRECT PATHS sp Esophagus 2 Mid Esophagus acu Stomach Folds Y Pylorus Pyloric Sphincter O Duodenal Folds P K WRONG PATHS Vocal Cords Tracheal Cartilaginous Rinc gt a Bronchial Split a gt Kangaroo Console
20. assword 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 Kangaroo Console 11 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 2 Explain procedure to the conscious patient Prepare supplies oral tip syringe feeding tube water wipes and stethoscope Position console in a direct line of sight Console can be pole mounted propped on bedside table or handheld 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 If desired connect the power cord to the console To connect arrow on power adapter should be facing up same side as screen A 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 Table of Contents 5 Enter login password and patient i
21. atient 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 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 Kangaroo Console 7 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 The removable power adapter connects to the console to charge the battery back then lightly press it in To connect arrow on power adapter should be facing up same side as screen S S Q SON 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 N console Use a 3 8 16 bolt to fasten together NY NS 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 Ke gt L Table of Conten
22. autions 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 Instruct
23. be 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 Table of Contents 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 Semi Fowlers 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 drivin gas applications and conical connectors for limb ali inflation applications The feeding tube is specifically for the purpose
24. caress sear sateen amcor gues Shea Sax taennctsinas doniatiooespeeoot acest 29 Viewing Captured IMAGES cccssesssseceeeeeeeeeeeessseeeeeeeeeesnees 30 Annotating IMages none emernr tren ne er mantener ner ne menace eer enemrere tre 31 Operator and Reviewer SettingS ccsscccceeeseesssesssseeeeeees 32 Administrator SQttingdS ccccccccssssssssseeeeeeeeseeeseessseeeeeeeesennaes 33 Changing Date Time Formatting Language and Device Settings ss sacanessecciancanidcaamenpsseccumssrnncuarotedeutiaegnceas 34 Adding and Editing USCIS xciesdectunrcncosrersixiacoiedeetnsacbsuanedusieiins 35 Creating and Editing Encryption Password 00cceeees 36 ICOM GOSS A E E E AEE A T E 37 Section VI Additional Kangaroo Feeding Tube with IRIS Technology Information Order Information ciijaimndacsiucusrinwes yavwiviewsGvndensndslaunsansemnuusincnedenns 39 WROUIDTESTIOOEING sctorriccesncn caacenaetennecabaaseinamensutetce qasteuadateannsoe 40 Definition OF Symbols wie yesecesocnsstalecocvanussduoninemaudentwahiemucciecen 41 VU s E nT Serre centr mtr etre errr ntr rare nr err 42 SDS CIC aL IO Iba oeer ase teexweacen 43 MRI Safety Information ccseeeeceeeeeeeseeeeeeeeeaseeeeeeesaaaeeeess 43 Maintenance and Satety cssscccececeeeeeeeeeeeseeeeeeeeeeeaeenaas 44 Electronic Specification Tables ccccccsssssceeeeessssseeeeeeees 45 49 Section I System Overview Section I System Overview Safety and C
25. cedures annotate remove patient information add or edit users update the software and reset the device to factory settings Table of Contents Edit user type password Select a pre existing user in the top left corner To change the user s password enter the new password and then verify it by entering it again Tap the check mark to save changes To change the user s control operator reviewer or administrator simply tap on the circle next to the desired option Tapping the check mark will save changes User hg New Password Verify Password ss operelor Reviewer Adminiseaver x v pDUGOGEGOUCGCOG neaoGeoeEces BoGuao0eee SPL tpi Add user Add a user by typing in the login name desired password and the user s control type operator reviewer or administrator Tapping the check mark will save changes Note Login names ADMINISTRATOR and MAINTAINER are in use those user names cannot be duplicated User New Password Verify Password sd Operator Reviewer Administrator EJ v pDHGOQDGOGODOCG DEOCOOADOD EPP EET a 006 Go 0 0 Kangaroo Console 35 Section V User Interface Features Creating and Editing Encryption Password Encryption password Select the encryption password icon to edit the password used to open patient images on a computer The password created will be needed to open any files exported from this console The same password wi
26. cking the log out icon ends the session Kangaroo Console 24 Section V User Interface Features Procedure Use the Procedure feature to launch the functional flow for entering patient information and procedure activities Patient and procedure information ae s lt Battery level indicator 11 11 11 PATIENT NAME UP TO THIRTY CHARACTERS 11 11 2011 PATIENT ID XXXX Live feed from feeding tube camera Icon tray BOOM Oo Zooming in out panning the image While touching the screen with two fingers slide the fingers away from each other to zoom in Pan the screen by touching with one finger and dragging along the screen To zoom out touch the screen with two fingers and slide them towards each other __ amt Table of Contents oe D Cancel Cancel procedure System will request cancellation confirmation Capture image Tap on the camera to capture an image from the live feed Patient folders Displays all patient folders Each folder contains images captured during the placement procedure Patient file Icon appears after capturing an image Tapping this icon opens patient s folder to show images Done Complete When placement is complete tapping on the check mark ends the placement procedure System will request completion confirmation Hide icon tray Hides icon tray Show icon tray Show icon tray on screen Kangaroo Console
27. d in water or other cleaning solution clean using a damp not wet cloth or sponge Directions for cleaning power cord e Unless soiling is observed the power cord should not be cleaned e Refer to general cleaning directions above before starting e f cleaning of the power cord is necessary unplug from outlet and wipe the exterior surfaces of the wall plug with a cloth dampened with isopropyl alcohol Avoid exposing power cord to excess moisture as this can lead to an electrical shock or fire hazard Kangaroo Console 19 Section IV Cleaning Charging and Storage Battery and Storage Charging Between uses the console with the battery should be plugged into AC power to keep it at full charge Charging stations and extra batteries are optional accessories When using a charging station refer to the instructions for use provided in the charging station packaging Battery The console has a replaceable rechargeable battery It is also recommended that the battery charge be topped off before battery only operation is utilized The battery pack will charge continuously whenever the device is plugged into a wall outlet including during normal use of the device with AC power Battery level indicator In the upper right corner of the screen is a battery icon This icon changes to reflect the amount of battery life remaining until recharging is needed The icon will also show when the console is connected to an AC
28. ding tube with IRIS technology when used with the console as a system is intended for use in the electromagnetic environment specified below The customer or the user should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnet environment guidance Electrostatic discharge ESD 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile If floors are IEC 61000 4 2 8 kV air 8 kV air covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst 2 kV for power supply lines 2 kV for power supply lines Mains power quality should be that of a typical commercial or IEC 61000 4 4 1kV for signal line 1kV for signal line hospital environment Surge 1 kV differential mode 1 kV differential mode Mains power quality should be that of a typical commercial or IEC 61000 4 5 hospital environment Voltage dips short interruptions and lt 5 U lt 5 U Mains power quality should be that of a typical commercial or voltage variations on power supply gt 95 dip in U for 0 5 cycle gt 95 dip in UT for 0 5 cycle hospital environment If the user of the Kangaroo feeding tube input lines with IRIS technology when used with the console as a system IEC 61000 4 1 1 40 U 40 U requires continued operation during power mains interruptions 60 dip in U for 5 cycles 60 dip in UT for 5 cycles it is recommended that it be powered fro
29. e 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 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 or
30. er where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Table of Contents Kangaroo Console 49 Rx ONLY Follow instructions for use Symbol appears blue on device MR Unsafe an item that is known to pose hazards in all MR environments MR Unsafe 32 F C 0 C Temperature Keep dry limitations E CoVIDIEN Manual No HP107561 COVIDIEN COVIDIEN with logo and Covidien logo are U S and internationally registered trademarks of Covidien AG Hydromer is a trademark of Hydromer Inc and is used under license are trademarks of their respective owner Other brands are trademarks of a Covidien company 2012 Covidien taal Covidien Ilc 15 Hampshire Street Mansfield MA 02048 USA Covidien Ireland Limited IDA Business amp Technology Park Tullamore www covidien com T 1 800 962 9888 REV 05 2014
31. er 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 Table of Contents Ethernet port non functional USB ports Kickstand 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 Rechargeable battery A replaceable rechargeable Li lon 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 Rubber console feet O Rechargeable battery Battery release W button 7 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 Kangaroo Console 6 Section I System Overview Console user interface The console has a color display touch screen with step by step prom
32. erformed as follows Use mild detergent for general cleaning If necessary the device may be cleaned with a 0 5 bleach mixture or Clorox germicidal wipes However repeated cleaning with this solution can damage the plastic device case Isopropyl alcohol applied with a damp not wet cotton swab may be used for cleaning difficult to reach areas however it should be used sparingly because repeated cleaning may damage the case Do not use strong cleaners such as Spray Nine Phisohex Hibiclens or Vesta Syde because damage to the device housing can result Directions for cleaning console e Refer to general cleaning directions above before starting e Clean outside surface with a damp not wet cloth or sponge and keep console in upright position as much as possible e Avoid excess moisture near mounting clamp area e Do not allow cleaning solution to enter the vertical vents in the housing underneath the handle Table of Contents Failure to follow the cleaning procedures described herein could result in hazard to users As with any AC powered electrical device care must be taken to prevent liquid from entering the console to avoid electrical shock hazard fire hazard or damage to electrical components Disconnect console from AC power source before cleaning After cleaning do not connect to AC power source until console and power cord are thoroughly dry Do not immerse console or power cor
33. ey COvIDIEN User Manual Kangaroo Console For use with Kangaroo Feeding Tubes with IRIS Technology Table of Contents Section I System Overview Safety and CAUTIONS wssviriscsssvarinassssncwosvardsenasnadtownawsansbovarssndesenns 2 System CON OCIS echacinet sacte cen cascee nes ictsimteradicescacvadeeauesastenaecenen 3 Section Il Assembly and Initial Administrator Use Assembling System Parts siissitices eesti ssasanndectunncddeuauerssatedsaleceewlewest 9 PNT SS ea E E esas 10 Section Ill Setting Up and Using the Kangaroo Feeding Tube with IRIS Technology for Placement BEG Wail USE sensasi sate E 13 Reconnecting nssiicccccectnocnesazeqanssesescsaxsanneguencnasssedncrnedeudeneasncenees 17 Section IV Cleaning Charging and Storage General Console and Power Cord Cleaning Directions 19 Battery and Storage scsiciesaisqsidcouseranuievasabatidonstsdereienaceauvdensaelat 20 Section V User Interface Features On Screen Keyboard c ccccsssecccceeeeseeeecceeeeeeeeeecssaeeeeeeeseeas 22 Logging In and Automatic LOg OUt cccccceeeeeeesesseeeees 23 Mai MEN er E E s 24 Proce II E caup ane re EEEE E EEA E E E E E E A 25 Options for Viewing Patient Folders and Files 0 26 Exporting Images to USB Flash Drive ccccccceeeeeeeeseeeeees 27 Opening Images from USB Flash Drive ccccceeeeeeeeeeeees 28 Rename VV AC CS a E dn ee edabdinastiertenee scenes 29 Delete VA SS
34. gy Non clinical testing demonstrated that the Kangaroo feeding tube with IRIS technology is MR Conditional A patient with this device can be scanned safely immediately following positioning of this feeding tube under the following MR Scan Conditions e The stylet must be removed from the Kangaroo feeding tube with IRIS technology prior to permitting the patient to enter the MR system room to undergo an MRI examination e Static magnetic field of 1 5 or 3 0 Tesla e Maximum spatial gradient magnetic field of 3 700 gauss cm 37 T m e Maximum MR system reported whole body averaged specific absorption rate SAR of lt 2 W kg Normal Operating Mode MRI related heating Under MR Scan Conditions defined above the Kangaroo feeding tube with IRIS technology is expected to produce a maximum temperature increase of 1 5 C after 15 minutes of continuous scanning These temperature changes will not pose a hazard to a human subject under the conditions indicated above Artifact Information MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the Kangaroo feeding tube with IRIS technology Therefore optimization of MR imaging parameters to compensate for the presence of this device may be necessary The maximum artifact size i e as seen on the gradient echo pulse sequence extends approximately 10 mm relative to the size and shape of this device Applied par
35. ions 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 e Acts as a conduit for food fluids and medications to a patient s stomach or small bowel e Avoid administration of light sensitive medications while the tube is connected to the interface cable Contraindications e Use caution with patients who have anomalies or diseases of the nose throat or esophagus e The use of this product is contraindicated in patients with known sensitivities or allergies to its components Warnings e 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 e 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 e 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 tu
36. is displayed during placement S Export Format On Screen Display Format JPG BMP Time Elapsed Current Time Date Format J MM DD YYYY vp mm vvvy YYYY MMDD Change language Tapping on the language icon displays a screen giving optional language preferences Tap once on the preferred language then tap the check mark to save changes Fran ais Espa ol Portugu s Nederlands Deutsch Device Tap on the Erase Patient Data block to permanently remove all stored patient information and captured images recommended if sending console for maintenance The Software Update upgrades the device to the latest version Tapping Master Reset removes all data and restores to factory settings s Erase Patient Data Removes all patient date Software Update Upgrades the Device Software C Master Reset Removes all Patient Data and User set options including passwords Table of Contents Kangaroo Console 34 Section V User Interface Features Adding and Editing Users User groups Select the user groups icon to add a user or edit a user s information Operator Can access the system to perform procedures and annotate Reviewer Can access the system to perform procedures annotate and review any images edited by operators Administrator Can access any part of the system perform pro
37. ive Accessories for Kangaroo Feeding Tube with IRIS Technology Kangaroo Console Kangaroo Replacement Stylets for use with Kangaroo Feeding Tube with IRIS Technology Item Code Order Information Item Code Product Descriptor Size Order Information 386100 468036 8 Fr Ch 2 7 mm Replacement Stylet 36 91 cm Kangaroo Feeding Tube with IRIS Technology 468043 8 Fr Ch 2 7 mm Replacement Stylet 43 109 cm 468055 8 Fr Ch 2 7 mm Replacement Stylet 55 140 cm 460036 10 Fr Ch 3 3 mm Replacement Stylet 36 91 cm 8 Fr Ch 2 7 mm x 36 91 cm 8 Fr Ch 2 7 mm x 43 109 cm 460855 8 Fr Ch 2 7 mm x 55 140 cm 5 each case 461036 10 Fr Ch 3 3 mm x 36 91 cm 461043 10 Fr Ch 3 3 mm x 43 109 cm 461055 10 Fr Ch 3 3 mm x 55 140 cm 5 each case 10 Fr Ch 3 3 mm Replacement Stylet 10 Fr Ch 3 3 mm Replacement Stylet 12 Fr Ch 4 0 mm Replacement Stylet 12 Fr Ch 4 0 mm Replacement Stylet 461236 12 Fr Ch 4 0 mm x 36 91 cm 12 Fr Ch 4 0 mm Replacement Stylet 461243 12 Fr Ch 4 0 mm x 43 109 cm 461255 12 Fr Ch 4 0 mm x 55 140 cm Kangaroo System Accessories for use with Kangaroo Feeding Tube with IRIS Technology Table of Contents Kangaroo Console 39 Section VI Additional Kangaroo Feeding Tube with IRIS Technology Information Troubleshooting Console screen Read all warnings and precautions prior to tube insertion stops working Explain procedure to the conscious
38. ll be used for any files exported THE SAME PASSWORD MUST BE USED TO DECRYPT THE FILES FOR FUTURE VIEWING E m Encryption Password Re Enter Password x ud otwPepeTepy el ole ppononaning pponopnggg 905 Ge oS 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 Table of Contents Kangaroo Console 36 Section V User Interface Features Icon Glossary Table of Contents Dgo CD BO o Bpo B Cancel Take picture File Done Complete Hide icon tray Show icon tray Add text Annotate image Return to previous screen Delete Device Encryption password DO Deon gA gS Full screen view Language Draw line Log out Password Procedure Reset console Review image Save to USB flash drive Set time Settings SOUR 3 3 Re Undo action Update software User groups User Wait Split view View image Erase patient data Folders Format Rename Kangaroo Console 37 Section VI Additional Kangaroo Feeding Tube with IRIS Technology Information Section VI Additional Kangaroo Feeding Tube with IRIS Technology Information Order information To purchase any of these accessories contact your Covidien customer service representat
39. luoroscopic confirmation Warning 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 Once the tube position has been confirmed the stylet is then removed by gentle traction Tape the tube securely avoiding pressure on the nares Disconnect the feeding tube from the interface cable prior to feedings Enteral feedings may begin by filling the enteral feeding bag purging the tubing of air and connecting it to the feeding tube No live feed from Check connections on both sides of the interface cable Ensure that everything is plugged in correctly and securely camera Advance the feeding tube forward or backward a few inches If feeding tube tip is estimated to be in the stomach or small bowel try insufflation then flush tube with water using syringe If feeding tube is estimated to be located prior to the stomach or small bowel remove wipe and try again If problem still persists adhere to blind placement procedure Battery dies Confirm all components are securely and properly connected during placement Connect power adapter to console and AC outlet Console is Press and hold the power button for 10 seconds The console will shut down Wait 30 seconds then press the power button to turn it back on not functioning If problem persists check battery level Table of Contents Kangaroo Console 40 Section
40. m an uninterruptable power supply or battery 70 U 70 U 30 dip in U for 25 cycles 30 dip in UT for 25 cycles lt 5 U lt 5 U gt 95 dip i in U for 5 sec gt 95 dip i in UT for 5 sec Power frequency 50 60Hz magnetic 3A min 3A min Mains power quality should be that of a typical commercial or field hospital environment IEC 61000 4 8 NOTE U is the a c mains voltage prior to application of the test level Table of Contents Kangaroo Console 47 Section VI Additional Kangaroo Feeding Tube with IRIS Technology Information Guidance and manufacturer s declaration electromagnetic immunity The Kangaroo feeding tube with IRIS technology when used with the console as a system is intended for use in the electromagnetic environment specified below The customer or the user should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnet environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the Kangaroo feeding tube with IRIS technology when used with the console as a system including cables than the recommended separation distance calculated from the equation applicable to the frequency transmitter Recommended separation distance d 3 5 V1 P Conducted RF 3 Vrms 3 Vrms IEC 61000 4 6 150 kHz to 80 MHz d 3 5 E1 JP 80 MHz to 800 MHz d 7 0 E1 VP 800 MHz to 2 5 GHz Radiated RF
41. ncorrectly the system will allow up to five attempts After the fifth try the console is reset to factory settings All patient and user information will be lost The system could not validate username or password Make sure your username is correct and type your password again Invalid credentials You have X more attempts before this account will be locked out The User is locked out The system could not validate username or password Make sure your username is correct and type your password again Invalid credentials You have X more attempts before the console will be reset The Console is going to be reset to factory defaults Kangaroo Console 23 Section V User Interface Features 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 Table of Contents Battery level indicator a Live feed from nasogastric tube camera i o D Procedure Use the procedure feature to launch the functional flow for entering patient information and procedure activities Settings menu The settings menu provides links to modify language date time file formats passwords device options and user settings Folders menu The folders menu launches the data browser of patient folders Each folder contains images captured during the procedure Log out Cli
42. nformation Login The system will request a login name and password After ord typing tap the check mark to proceed to the main menu olwle peepee pole pATsfoTeictutyykyy zyxfciv payne olo ly l fJEJE EE IE Note First time users need to have an administrator set up a login name and password prior to use The main menu will appear Tap on the procedure icon to begin the placement procedure Follow the screen commands to enter the patient Patient Name information When complete tap the check mark gt N Patientoos patienti to proceed DUGDUUUTOG DEDDCO0DCUDS BoEUoO00ese Pty fpf Is this your patient The system will ask for confirmation that the Q OS PATEN information is entered correctly If yes tap the check mark If not tap the red x to go back and re enter the information Kangaroo Console 13 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 To estimate insertion depth use the tube to measure the distance from the tip of the be attached patient s nose to the earlobe and from the earlobe to the xiphoid process for gastric Start by connecting the larger end of the inte
43. nts to the original purchaser Customer that this product will be free of defects in materials and workmanship under normal use for one 1 year from the date of original purchase from Covidien or its authorized distributor If this product does not operate as warranted above during the applicable warranty period Covidien may at its option and expense replace the defective part or product with a comparable part or product repair the defective part or product or if neither replacement nor repair is reasonably available refund to Customer the purchase price for the defective part or product Dated proof of original purchase will be required Covidien does not assume any liability for loss arising from unauthorized repair misuse neglect or accident Table of Contents Kangaroo Console 42 Section VI Additional Kangaroo Feeding Tube with IRIS Technology Information Specifications Console dimensions 29 5 x 21 6 x 4 cm 11 6 x 8 5 x 1 57 in Console weight mass 4 95 Ib 2 24 kg Console power Use AC adapter for wall outlet usage Console operates on 15 VDC 40 W Use only Kangaroo feeding tube with IRIS technology console AC adapter AC power adapter The power supply is a part of the ME equipment It is rated for continuous use Input Voltage 100 240 VAC Input Frequency 50 60 Hz Console battery New fully charged Lithium lon Battery Pack delivers approximately four hours of service before needing
44. nts 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
45. 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 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 The user should be aware of patie
46. patient Prepare supplies oral tip syringe feeding tube water wipes and stethoscope during procedure a e Position patient in accordance with facility protocol for feeding tube placement 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 Passage of the feeding tube through the nasal passage into the stomach can be facilitated by using a stylet Activate the Hydromer coating on the tip of the tube by submerging the weight assembly in water for at least 5 seconds Choose the most patent nare and insert the feeding tube with the stylet if the stylet is used Once in place do not manipulate or pull the stylet back and forth within the feeding tube When the tube has reached the oropharynx encourage the patient to swallow Giving sips of cool or room temperature water may assist the passage of the tube Confirm 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 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 f
47. pts to guide you through setup and operation 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 olwPe pepe eT pole neocon Bo Goo0u0eee 06 e 0 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 Press the ALT key Tap the key s that contains the desired numbers or number or symbol displayed in the upper right corner When secondary finished press the ALT key again symbols When finished typing press the check mark icon v to save or the Ed to cancel and return to the previous screen Table of Contents System login 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 Login Password pE GEE el ole DEDEE0D0NE poooopnnggg EPL ID 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 R xt 3 Procedure Use the procedure feature to launch the functional flow for entering p
48. rface cable to the console placement Add approximately 10 ten inches 25 cm for intestinal placement Spontaneous transpyloric passage of the tip often occurs within 24 to 48 hours 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 Ay Camera Q housing Wf cm marks ffa a 4 Flexibility direction arrow 9 Connect interface cable to feeding tube 7 Activate Hydromer coating A screen on the console will request that a feeding tube be attached Connect the Use water to activate the Hydromer coating on the Kangaroo feeding tube with IRIS smaller end of the interface cable to the feeding tube Once the feeding tube and technology Submerge tip for about 5 seconds to activate the Hydromer coating interface cable are connected to the console a live feed from the camera will display on the screen Avoid applying additional lubricant to tip 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 Table of Contents Kangaroo Console 14 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 tub
49. roo Console 44 Section VI Additional Kangaroo Feeding Tube with IRIS Technology Information Specifications Electrical Safety The Kangaroo feeding tube with IRIS technology has been built and tested according IEC 60601 3ED 2005 ANSI AAMI ES 60601 1 2005 CAN CSA C22 2 No 60601 1 08 IEC 60601 1 6 2010 IEC 60601 1 2 Ed 3 0 2007 Standards The Kangaroo feeding tube with IRIS technology when used with the console as a system is intended for use in the electromagnetic environment specified below The user should assure that it is used in such an environment Electromagnetic Conformity Declaration RF emissions CISPR 11 2010 See guidance comments for emissions tests in the tables on the following a ee DO S Votiage Fluctuations ficker emisions ENevo0D 33200 OOOO Geos PS Radiated Disturbance Immunity EN60601 1 2 2007 IEC 61000 4 3 2010 See guidance comments for immunity tests in the tables on the following pages conducted Disturbance mmunty eneoeoi 1 22007 T Power reuency Magnetic Feld nmunity N6o6o 0T022007 1Ec 61000 48200 complies O OOO Votiage Dips andSags immunity No6o 0T022007 lEC610004 112011 complies O OSS lecicel Fst harsien Bursts Inmunty EN606010102 2007 eC 61000 44201 complies OO OOO lecrostatic Discharge immunity EN606010102 2007 EC 61000 422008 OO fompi OO OOS Surge imnity EN6O6OT 1 2 2007 ec 61000 42005 OOOO Gos SOSCSCSCSCSCSCSCSS For any questions please contact Covidien Customer Service
50. rs decoders Use whichever the facility protocol states Instructions for WinZip are shown here as an example First start by opening WinZip Note If the file is opened from WinZip without being extracted it has not been decrypted You will have to reenter the encryption password to open it again later Select the file then click the Extract icon Next choose the directory for the extracted folder Then click the Extract button Enter the password making sure to only use uppercase letters The images should then be decrypted and able to be opened Table of Contents Kangaroo Console 28 Section V User Interface Features Rename Image Delete Image s FQ Renaming an image Delete image s By Captured images are automatically titled with the patient s name date of Select one or more images to delete by tapping on the boxes to the left birth identification number and an image number The image numbers Then tap the delete icon are created sequentially as they are captured When renaming an image only the portion with the image number can be changed lt 020120101 _SUDDEFAULTS_NO NAME_NO DOB_NO ID o NO NAME_ NO DOB_NO ID_112233_010 img p o0 NO NAME_NO DOB_NO ID_112233_009 img s 020120101 _SUDDEFAULTS_NO NAME_NO DOB_NO ID a j NO NAME_NO DOB_NO ID_112233_008 img o NO NAME_NO DOB_NO ID_112233_010 img NO NAME_NO DOB_NO ID_112283_007 img o NO NAME_NO DOB_N
51. se 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 REFERENCE_LIBRARY lt DATE gt _ lt TUBE gt _ lt PATIEN
52. such as reorienting or relocating the Kangaroo feeding tube with IRIS technology when used with the console as a system b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Table of Contents Kangaroo Console 48 Section VI Additional Kangaroo Feeding Tube with IRIS Technology Information Recommended separation distances between portable and mobile RF communications equipment and the Kangaroo feeding tube with IRIS technology when used with the console as a system The Kangaroo feeding tube with IRIS technology when used with the console as a system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Kangaroo feeding tube with IRIS technology when used with the console as a system as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum output power 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz of transmitter W d 3 5 V1 VP d V35 IEI 4P d 7 0 E1 yP For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitt
53. t definition Per IEC 60601 1 3rd Edition the applied part of this system is the Kangaroo feeding tube with IRIS technology Kangaroo Console 43 Section VI Additional Kangaroo Feeding Tube with IRIS Technology Information Pulse Sequence T1 SE T1 SE GRE GRE Signal Void Size 14 108 mm 1 095 mm 12 655 mm 1 916 mm Plane Orientation Parallel Perpendicular Parallel Perpendicular USB ports The USB ports will support only USB flash drive and USB hard drives Do not plug any other device into the USB ports Covers on console and tube Close the covers on the console ports for the tube USB and Ethernet when they are not in use to protect the console from spills and splashes Note the Ethernet port is currently not enabled Close the electronic port on the feeding tube when it is not being used with the interface cable and console Maintenance and safety Do not open the console housing as there are no user serviceable parts inside Opening may affect function of device and voids the warranty To replace battery see Section IV The console must be periodically tested to assure proper functioning and safety The recommended service interval is at least once per year To arrange for Covidien Factory Service in the US call 1 800 448 0190 In Canada please contact 1 877 664 8926 Outside of the US and Canada please contact your local Customer Service for more information Table of Contents Kanga
54. to be recharged Rated Voltage 11 IV DC Rated Capacity 3 7Ah 41 0Wh Console image output format Bitmap BMP uncompressed or JPEG JPG compressed file format 800 x 600 pixel resolution Operating temperature humidity and altitude 10 C 40 C 15 85 R H non condensing Operating altitude for this system is 2000M or less Storage and transport temperature and humidity 0 C 50 C 15 85 R H non condensing Type of protection against electrical shock Class II Internally powered Equipment Degree of protection against electrical shock Type BF Please ensure device is plugged into an easily accessible outlet in case of emergency Table of Contents Degree of protection against ingress of fluids IPX4 in a typical use configuration with all console port covers closed except for the power cable and interface cable covers both being open with those cables plugged in See page 8 for cover information MRI Safety Information MRI Information Console with power accessories interface cable stylet mounting clamp and carrying case MR Unsafe MR Conditional Kangaroo feeding tube with IRIS technology The Kangaroo feeding tube with IRIS technology was determined to be MR Conditional Do not bring MR Unsafe items into the MRI scan room This includes all components and accessories of the Kangaroo system console interface cables stylet etc other than the Kangaroo feeding tube with IRIS technolo
55. ts Kangaroo Console 9 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 The password created will be needed to open any files administrator account Use the on screen keyboard to exported from this console The same password will be enter the password into the text fields The password used for any files exported must be between 8 and 12 characters Password can Tap on the first text field to enter the desired password include uppercase letters numbers and symbols Then re enter the password in the text field below This administrator login name is ADMINISTRATOR When satisfied touch the check mark to save Other administrator accounts can be created in the changes addition to this Note The password is case sensitive and will be in all upper case THE SAME PASSWORD MUST BE USED TO DECRYPT THE FILES FOR FUTURE VIEWING J 5x __ _ pp New Password m Encryption Password oe Fran ais a Verify Password Re Enter Password Espanol Portugu s x v 1x Nederlands Deutsch Qpwhe per yr py pul o e o
56. ware viruses and other Please select the USB drive for export malicious software Start by plugging the USB flash drive into the port on the side of the console Q RY be LA For privacy purposes a password has been created by an administrator The password will be required to view the images on another computer Note Passwords are in full upper case When using a computer be sure to use p upper case letters After the files are exported disconnect the USB flash drive 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 Images can only be exported from one patient aly Your Files are being exported folder at a time B 20120101_SUDDEFAULTS_NO NAME_NO DOB_NO ID NO NAME_NO DOB_NO ID_112233_010 img a NO NAME_NO DOB_NO ID_112233_009 img a NO NAME_NO DOB_NO ID_112233_008 img __ NO NAME_NO DOB_NO ID_112233_007 img NO NAME_NO DOB_NO ID_112233_006 img lt e dE Table of Contents Kangaroo Console 27 Section V User Interface Features Opening Images from USB Flash Drive Opening on a computer Images exported from the console can be opened on a computer and saved into a patient folder The console will encrypt all files using a Zip file format before exporting them onto a USB drive To open the images on a computer the correct password must be entered Extracting and decoding files There are multiple Zip encode
57. ywy ep ett py pul iyo pe DEOEGbOo008 EAT BoGuo00eEs g Bacuo00eee A4 bt ee py Table of Contents Kangaroo Console 10 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 tk Time and Date Device HH MM January 2012 Version 1 23alpha Last Reset HH MM La Ng uage March 22 2012 English ADMINISTRATOR Format Users JPG 23 Operators Current Time Format 3 Reviewers MM DD YYYY 3 Administrators Table of Contents NRBAQ 0 05305 a B 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 p
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