EndoFLIP® System Functional Lumen Imaging Probe EF
Contents
1. C EndoFLIP unit Humidity 10 to 95 relative humidity non condensing Atmospheric 500 to 1060 hPa pressure Note When not in use store the EndoFLIP system in clean sanitized plastic bag EndoFLIP System operates on DC input from AC DC power adapter P N EF 500 which operates on 90 264 VAC 47 63 Hz 80 VA rating EndoFLIP User Manual DD 41 Revision C 51 Back panel symbols Caution consult accompanying documents e USB port ae Direct current DC input Ol Video VGA output oooo Oooo Keyboard o000 Front panel symbols e USB port o Catheter electrical connector LTN Syringe thumb lock lt gt Syringe door Side panel symbols Caution consult accompanying documents 52 EndoFLIP User Manual DD 41 Revision C Main label underside of unit symbols Manufacturer Serial number Digits are of the form xxxxYYMMDD xx where YYMMDD represent the date of manufacture Part number Caution consult accompanying documents IPX 1 degree of water ingress protection provided by enclosure gt R 2 E EndoFLIP User Manual DD 41 Revision C 53 CE Mark and Notified Body Number product complies with requirements of the Medical Device Directive 93 42 EEC TUV Rheinland of North America is a Nationally Recognized Testing Laboratory NRTL A single mark cTUVus indicates compliance wi2. e 70 isopropyl alcohol Caution To avoid internal part corrosion do not use chlorine bleach on the touchscreen To minimize the risk of contamination between patients clean the catheter preparation area between each patient use Clean the stainless steel pre use checkout tube as per the hospital policy for the cleaning of operating room equipment The tube may be steam sterilized Only use a dry lint free non abrasive cloth to clean the external keyboard accessory 42 EndoFLIP User Manual DD 41 Revision C 5 2 Periodic maintenance This table summarizes periodic maintenance procedures for the EndoFLIP System Warning To ensure proper EndoFLIP System operation perform periodic maintenance at the specified intervals Part Interval Periodic maintenance procedure Air inlet filters Every 2 years or as needed Replace air inlet filter System exterior Before first use between patients and as needed Use recommended cleaners Do not allow liquid to penetrate the system 5 2 1 Air inlet filter Replace the Air Inlet Filter EF 110 Figure 30 every 2 years To remove the air inlet filter cover loosen its retaining screw on the underside of the device Ern Zan df Air inlet filter cover ND Air inlet filter cover Air inlet filter Figure 30 Air inlet filter EndoFLIP User Manual DD 41 Revision C 43 5 3 Service Full service and repair is avai
3. user defined comments Unavailable when comparing images and when the syringe pump is moving COMPARE Selects a previously saved image for comparison to the live image or compares two saved images Unavailable until an image has been saved CLEAR Clears the comparison of images and returns to the live image COMPARE SAVE CLIP Saves a continuous sequence of images similar to a video clip that can be replayed Unavailable when a clip is playing or the syringe pump is moving SELECT CLIP Selects a previously recorded clip from a list CLEAR CLIP Clears the screen during replay of a selected clip PRESSURE Zeroes the balloon pressure sensor Only available when there is less ZERO than 10ml of saline in the balloon and a catheter with an integrated pressure sensor is connected If there is less than 2 ml of saline in the balloon the system automatically inflates to 2 ml before the pressure zero ZOOM Zooms in or out on an image XS Up and Down Up and down arrows are used to display the upper or lower half of the Arrows image when in zoom view The arrows appear at the bottom left hand mn KM corner of the screen when the zoom is active Data Filter This Filter symbol is shown at the top of the screen if the data filter is r VI VV turned on The filter can be turned off on and configured by pressing the Menu button followed by the Filter Settings button EndoFLIP User Manual DD 41 Revision C 19 3 2 1 Mini
4. 3 minutes Once verified a message notifies you that the CATHETER IS READY FOR USE Touch CONTINUE If the catheter pre use check procedure detects a problem a message notifies you that the catheter may be faulty and should be replaced Remove the balloon from the pre use checkout tube and wipe down the catheter and balloon with isopropyl alcohol prior to deployment EndoFLIP User Manual DD 41 Revision C Notes The system automatically performs a pressure zero during the pre use checkout if the catheter contains a pressure sensor You can subsequently perform a pressure zero at any time if there is less than 10 ml in the balloon by touching the onscreen PRESSURE ZERO button If there is less than 2 ml in the balloon the system will inflate the balloon to 2 ml before performing the pressure zero It is recommended that the catheter is held horizontally and the pressure sensor is zeroed just before it is introduced into the patient If the syringe or catheter electrical connector are disconnected then reconnected a purge pop up window appears and you can perform another purge or touch CONTINUE to continue without purging It is not recommend to dis connect the catheter once it is purged 2 4 Configuring the unit The configuration menu Figure 10 allows you to Enter or change patient details e Select inflation settings and pressure alarm threshold if the connected catheter has an integrated pressure sensor e Set date t
5. 80 MHz field strengths should be less than 3 V m Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 60 EndoFLIP User Manual DD 41 Revision C Recommended separation distances between portable and mobile RF communications equipment and the EndoFLIP System IEC 60601 1 2 Frequency of 150 kHz to 150 kHz to 800 MHz to transmitter 80 MHz 800 MHz 2 5 GHz Equation d 1 2VP d 1 2VP d 2 3 VP Rated maximum output power of transmitter W Separation Separation Separation distance m distance m distance m For transmitters rated at a maximum output power not listed above the separation distance can be estimated using the equation in the corresponding column where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people EndoFLIP User Manual DD 41 Revision C 61 Warranty 62 Crospon warrants the EndoFLIP System to be free from defects in material and workmanship for a period of 12 months from the date of purchase provided that the unit is operated under conditions of normal use as described in this manual At its discretion Crospon will make replacements repairs or issue credits
6. Screen prompts user to stop or continue recording data User alert To continue recording the existing data must be archived or deleted If user stops recording no further live data is recorded and current data is not deleted Power loss occurred during procedure Unexpected power loss Inflation stops User alert Check patient Touch CONTINUE and inflate or deflate as required Check power source Pump Failure Faulty syringe pump Operation halts System error Check patient Manually retract syringe if needed remove catheter from patient Contact Service Syringe Not in Syringe not in place Syringe Check patient Place movement stops User alert Verify that syringe is correctly installed and the syringe door is closed Replace catheter if needed Contact Service EEPROM Format System has detected that Check patient Not Supported the type of catheter Replace the catheter connected to the unit is not supported by the unit User alert Contact Service Any message not shown in this table Faulty system operation Operation halts System error Check patient Manually retract syringe if needed remove catheter from patient Contact Service EndoFLIP User Manual DD 41 Revision C 31 4 EndoFLIP BaroStat Mode 4 1 Overview The BaroStat Mode on EndoFLIP allows a pre defined sequence of up to 10 balloon distensions to be carried ou
7. display an alarm window and sound an audible alarm System errors require the system to be turned off and on Continued operation is not allowed If an alarm occurs an alarm window appears on the screen Figure 21 CURRENT ALARMS SOFTWARE VERSION D 19 00 CURRENT ALARMS SOFTWARE VERSION D 19 00 TIME o DESCRIPTION EXTRA INFORMATION DESCRIPTION EXTRA INFORMATION TIME w 47 04 43 00 Syringe Not in Piace 13 34 54 ooo Received Negative Ack from FAB m a Z2 PE User alert System error user intervention required Condition must be corrected and to continue operation system turned off then back on Figure 21 Sample alarm messages EndoFLIP User Manual DD 41 Revision C 27 From the main screen touch VIEW ALARMS Figure 22 to view time stamped alarm messages that have occurred The window can display up to five of the most recent alarms PATIENT NAME PATIENT ID j Ea r VIEW ALARMS pm button Eya SYRINGE NOT IN PLACE Figure 22 VIEW ALARMS button 28 EndoFLIP User Manual DD 41 Revision C This table summarizes possible system alarms User Alerts or System Errors Follow the corrective actions in order until the problem is resolved Alarm message Description Corrective action Balloon Temperature is out of range System has detected a balloon temperature sensor out of range User alert Check patient Verify that catheter electrical connector is corr
8. for equipment or parts that are found to be defective THE WARRANTY SET FORTH ABOVE IS THE SOLE AND EXCLUSIVE WARRANTY WITH RESPECT TO THE PRODUCT AND CROSPON DOES NOT MAKE AND HEREBY SPECIFICALLY DISCLAIMS ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABLITY OR IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE THE REPAIR REPLACEMENT OR CREDIT REMEDY SET FORTH ABOVE WILL BE THE SOLE REMEDY FOR BREACH OF WARRANTY IN NO EVENT SHALL CROSPON BE LIABLE FOR LOST PROFITS LOSS OF GOOD WILL OR INCIDENTAL OR CONSEQUENTIAL DAMAGES EVEN IF CROSPON HAS BEEN ADVISED OF THE POSSIBLITY OF SAME Exclusions This warranty does not apply to any unit or individual parts which have been repaired or altered in any way that in Crospon s judgment affect its ability or reliability or which has been subjected to misuse negligence abuse or accident Unauthorized service and or failure to perform periodic maintenance may void this warranty This warranty does not cover damage that may occur in shipment EndoFLIP User Manual DD 41 Revision C Manufacturer information Crospon Ltd Galway Business Park Dangan Galway Ireland Europe Phone 353 91 519880 Fax 353 91 519889 email info crospon com US Phone 1 855 CROSPON Fax 760 406 5644 email info crospon com EndoFLIP User Manual DD 41 Revision C 63 64 EndoFLIP User Manual DD 41 Revision C
9. is reached when a catheter with pressure sensing is being used e BaroStat mode can be used with any EndoFLIP catheter type 32 EndoFLIP User Manual DD 41 Revision C 4 3 How to enter and run BaroStat Mode From the main EndoFLIP screen select Menu to show the screen in Fig 23 below then select Configure BaroStat to select a BaroStat procedure or edit a procedure Once the procedure is selected it can be run by returning to this screen and selecting Go to BaroStat Mode ENDOFLIP CONFIGURATION MENU SOFTWARE VERSION E 21 00 CONFIGURE BALLOON INFLATE CHANGE USER PRESSURE PREFERENCES ALARM GOTO GOTO BAROSTAT NORMAL MODE MODE Figure 23 EndoFLIP Configuration Mode Menu screen EndoFLIP User Manual DD 41 Revision C 33 4 4 The Configure BaroStat Screens On selecting Configure BaroStat the screen below in Fig 24 is presented This is the first of two BaroStat Configuration screens available A button is provided at the bottom right of each BaroStat Configuration screen to toggle between the two screens 4 4 1 BaroStat Configuration screen 1 The first BaroStat Configuration screen is shown here Step Preview Windows Scrollto Showing 3 next of 10 Step 1 preview is selected window for editing TARGET VOLUME HOLD DURATION WAIT AFTER DEFLATE 5 10 10 Target Volume mi n secs n secs n and inflate rate adjust INFLATE RATE WAIT PATIENT INPUT DEFLATE 60 n Mo
10. manual are suitable for use in the patient environment Warning To avoid the risk of personal injury place the EndoFLIP Unit on a flat stable surface Do not attempt to lean on or use the EndoFLIP System for support EndoFLIP User Manual DD 41 Revision C 7 2 1 Connecting to power Warnings e The EndoFLIP System must be connected to a wall outlet or a single outlet extension only Do not use multiple outlet sockets e install all equipment according to applicable national wiring requirements e Connect the EndoFLIP System to power and turn the device on before installing the syringe to the system The EndoFLIP System comes with a power adapter that accepts mains AC power and provides DC power to the device Figure 5 DC power connector Power adapter Figure 5 EndoFLIP System power adapter EF 500 Note To remove mains power to the power adapter switch off power at the wall outlet if a switch is provided and disconnect the power cord at the outlet Note When not in use stow the power cord s in a safe manner 8 EndoFLIP User Manual DD 41 Revision C 2 2 Power on off O off Use the switch at the back of the device to turn it on I or off O At power on the device performs a power on self test POST for up to 30 seconds I on Before inserting the catheter assembly follow these steps 1 Turn the EndoFLIP System on and verify that two beeps sound indicating the audible ala
11. whether to archive or delete previous patient data Touch ARCHIVE AND CONTINUE a USB memory device must be connected to the USB connector port to complete this action and save the data to the USB memory device or DELETE AND CONTINUE You must enter new patient data Figure 9 if you selected NEW PATIENT or the catheter type has changed Enter patient data then touch SAVE DATA amp CONTINUE EndoFLIP User Manual DD 41 Revision C 11 11 12 12 Caution Use a unique ID for each patient Re entering the previously entered ID causes previous information to be overwritten when archiving patient data momon bs C552 NAME SEX MALE AGE COMMENTS PHYSICIAN SAVE DATA amp CONTINUE Figure 9 Patient data entry screen At the first catheter connection a prompt asks you to prepare for the pre use check catheter purge which removes air from the balloon Place the balloon tip first into the pre use checkout tube which holds the balloon in a vertical position Touch PURGE CATHETER to begin Note The pre use check is mandatory when the catheter is first connected to the EndoFLIP unit Following completion of the pre use check if the catheter needs to be disconnected and re connected for any reason e g moving the unit position you can choose to purge the catheter or continue to begin use without performing a purge The pre use check time is dependent on the type of catheter connected it typically takes
12. 00 to 2 5 Recommended separation distance 4 3 GHz d 1 2 VP d 1 2 P 80 MHz to 800 MHz d 2 3 VP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic 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 Cp EndoFLIP User Manual DD 41 Revision C 59 test Immunity test Compliance IEC 60601 1 2 level level Electromagnetic environment guidance 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 EndoFLIP System is used exceeds the applicable RF compliance level above the EndoFLIP System should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the EndoFLIP System Over the frequency range 150 kHz to
13. 80 0 mm IBARB ON PRES 19 7 mmHg ja i gE Graphic shows deflation status Figure 19 Display during deflation EndoFLIP User Manual DD 41 Revision C 25 3 4 When the procedure is complete When the procedure is complete deflate the balloon fully To confirm that the syringe plunger has returned to its original position check that the syringe plunger aligns with the arrow on the syringe Figure 20 Once the balloon is fully deflated carefully retract the catheter from the patient 1 26 Following removal of the catheter from the patient disconnect the catheter and syringe from the EndoFLIP unit and check the structural integrity of the catheter Dispose of the catheter and syringe per institutional guidelines for single use devices To export data to the EndoFLIP USB memory stick connect the memory stick to the USB connector and touch ARCHIVE DATA Do not remove the USB memory device until prompted to do so Use the on off switch on the back panel to turn off the system or connect a new catheter and enter new patient details as required the syringe Figure 20 Syringe plunger in original position EndoFLIP User Manual DD 41 Revision C 3 5 Alarms The EndoFLIP System has two types of alarms e User alerts low priority indicating that some intervention is required to continue no audible alarm Touch CONTINUE to return to main screen e System errors medium priority which
14. CROSPON EndoFLIP System Functional Lumen Imaging Probe EF 100 User Manual Copyright 2014 Crospon Ltd This document is the sole property of Crospon Ltd No part of this document may be copied or otherwise reproduced or stored in any electronic information retrieval system without the prior consent of Crospon Ltd EndoFLIP EsoFLIP and FLIP are registered trademarks of Crospon Ltd EndoFLIP User Manual DD 41 Revision C 1 Table of contents IMEFODUCEION S U DD DD 1 1 1 HOW ICWOLKS n oe ko n a e KO Aye Ere eren Ke W ee b ne eka 1 1 2 Intended use and contraindicati onS eee 2 1 3 Device features yiya ae ald kiren kilke Kiye kake ee Ean EIEEE Ked ee a eStas 3 1 4 WARMING n Hon yena died a ees cee KE S N kenza R K dka Ma nawe b y A xera KEKE KE rk 5 eleran e nu So ERA S5 Y E DA N SE Y Dn rn S5 Ra 7 2 1 CONNECTING tO POWEL cccececesesecececeseeeeeeececeeeeeeeeeceeeeeeeeeseeeeeseceeees 8 2 2 Power On Off NNN hick DR 9 2 3 Preparing the Catheter for USC ccccccccccessssscecececsessaeseeceeeseseeaes 10 2 4 Configuring the Un t llii kek k KEKE KAKA KA 13 Using the EndoFLIP System Normal MOde i E ekkkeke 16 3 1 Inflating the balloon uu keke kk kk k 16 3 2 Using EndoFLIP System tools M A kk kk 18 3 2 1 Minimum Diameter and Cross Sectional Area Display 20 3 2 2 SAVING a
15. Stat Mode kk kk kk KAKA KE KA 41 4 8 Resuming Re Running or Resetting a BaroStat Procedure 41 55 gt Maintenance s i yd xi ein k da Ek xerek Lal Ek derk AE ya bees dbentedtes 42 5 1 EI er se SR DO W ee Ken N n Der GOND Ye NI A Der ECO T 42 5 2 Periodic maintenance u Eek ek ek k k k kK KA KERA 43 SZT Ar inet filt e DD r rge 43 5 3 Sela e SON DD AAT T a 44 5 4 Parts list and accessories L E EEE Eek eke kk k EKA KARA 45 Appendix A Introduction to impedance planimetry u 46 A 1 Measurement method Eke kk kek k kk KAYA 46 Appendix B Specifications eke kk kkkk k keke k KA KAKE KA R KA 48 B 1 COMP NEAT E ER N a e Sen NNN 55 B 1 1 Electromagnetic e mi SS OS EE kk k k 56 iv EndoFLIP User Manual DD 41 Revision C 1 Introduction The EndoFLIP System uses a balloon catheter to display diameter estimates of the measurement area in real time The EndoFLIP System can measure and display diameter estimates at up to 16 points within the balloon The system can also measure and display balloon pressure Notes e The EndoFLIP System is intended for operation by trained medical personnel e This manual describes operation of Revision E system software which includes BaroStat Mode e This manual describes the operation of the EndoFLIP unit Refer to individual catheter manuals for specific i
16. and displayed when using a catheter containing a pressure sensor 1 2 Intended use and contraindications The following are the indications of use for the EndoFLIP system and catheters In the USA The EndoFLIP System is indicated for use in a clinical setting as a pressure and dimension measurement device and as an adjunct to other methods in the comprehensive evaluation of patients with symptoms consistent with esophageal sensory hypersensitivity It is also indicated for use as an adjunct to a bougie for measuring the size of a gastric sleeve created during bariatric surgery where it is suitable for diameter measurements for 22 to 60Fr sleeves It is also indicated for use to estimate the size of a stoma produced by a gastric band Note EndoFLIP is a measurement system It is not intended to perform a diagnostic test 2 EndoFLIP User Manual DD 41 Revision C Outside the USA The EndoFLIP System is used in a clinical setting to obtain an estimation of the dimensions and balloon pressure within the alimentary canal Contraindications The The EndoFLIP System is contraindicated where endoscopy is contraindicated EndoFLIP System is contraindicated for use in patients with actively bleeding varices in the esophagus 1 3 Device features USB connector Catheter connector Touchscreen Syringe lock Syringe door Air inlet filter Figure 3 EndoFLIP System front view Syring
17. at it is used in an electromagnetic environment as described below Immunity test EN 60601 test level Compliance level Electromagnetic environment guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood discharge ESD 8 kV air 8 kV air concrete or ceramic tile IEC 61000 4 2 If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast 2 kV for 2 kV for Mains power quality transient burst IEC 61000 4 4 power supply lines 1 kV for input output lines power supply lines 1 kV for input output lines should be that of a typical commercial and or hospital environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial and or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ux for 5 sec Mains power quality should be tha
18. at that electrode position The above shows that V is inversely proportional to Dest thus the diameter can be estimated based on the voltage reading If the conductive medium is contained in a flexible balloon and an array of voltage electrodes used the shape of the balloon can be reproduced based on the voltage readings This is the basis of the FLIP imaging technique 2 References 1 The functional lumen imaging probe FLIP for evaluation of the esophagogastric junction Am J Physiol 2007 Jan 292 1 G377 84 2 Functional oesophago gastric junction imaging 2006 May 14 12 18 2818 2824 World Journal of Gastroenterology 3 Do we really understand the role of the oesophagogastric junction in disease 2009 Jan 14 15 2 144 150 World Journal of Gastroenterology EndoFLIP User Manual DD 41 Revision C 47 Appendix B Specifications Operating modes New patient settings 48 Normal mode Impedance planimetry measurements can be made and displayed and the syringe pump can be controlled Configuration mode is accessible from Normal mode if the syringe pump is inactive Configuration mode Patient information can be entered or device settings can be adjusted Exiting Configuration mode returns the system to Normal mode BaroStat mode Allows a pre defined sequence of up to 10 balloon distensions to be carried out During each distension patient feedback of discomfort level can be acquired f
19. ch the two saved images you want to compare then touch OK to display the images Figure 16 or CANCEL to cancel the compare ee Dest NU v ML Figure 16 Comparing images EB 22 EndoFLIP User Manual DD 41 Revision C 3 2 4 Estimating volume To view an estimate of volume between two selected points press the diameter values in the Dest column at the top and bottom of the selected area Figure 17 To remove the volume display press the two selected points again Selected area of estimated volume is highlighted Estimated volume between selected points in units of ml PATIENT NAME PATIENT ID Top of selected area of selected area as ka ka Tm Figure 17 Estimating volume EndoFLIP User Manual DD 41 Revision C 23 3 2 5 Image Zoom Press to zoom out PATIENT NAME ce DATA John Doe PATIENTID Patient123 F 16336 nu PAUSE LIVE I COMPARE ON PRES 212 mnng 22 1 97 n n l ee purr ran Press arrows to move image up and down Press the zoom button to zoom in or out on an image Figure 18 24 Figure 18 Zooming in on an image EndoFLIP User Manual DD 41 Revision C 3 3 Deflating the balloon 1 Touch STOP to stop inflation if required 2 Once stopped touch DEFLATE to empty fluid from the balloon The screen shows the deflation status Figure 19 PATIENT NAME John Doe PATIENT ID Patient 23 gt ee mv 16 41 09
20. d Connector for an optional remote VGA display Display devices and adapters connected to the VGA display connector must meet the requirements of IEC 60601 1 and be located in the same room as the EndoFLIP System To connect a VGA cable remove the two screws to remove the dust cover and install the two hex nuts from the localisation kit Use only VGA cables with non conductive shells and thumbscrews with no exposed metal Retain the dust cover and screws to cover the VGA connector if the VGA cable is removed Connector for a USB memory device Connector for DC power adapter Only use adapters specified by Crospon Ltd Powers the unit On I and Off O EndoFLIP User Manual DD 41 Revision C 1 4 Warnings EndoFLIP User Manual DD 41 Revision C Federal law U S restricts this catheter to sale by or on the order of a physician To reduce the risk of electric shock always disconnect the device from AC power before opening the enclosure Do not use the device if any damage to the AC power cord such as frayed wires cracks or cut insulation is evident Do not use the device if the touchscreen is not functioning correctly or is not clearly readable Do not use this device if an error condition cannot be corrected The EndoFLIP System should be mounted on a flat stable surface When In use keep the catheter and power cord stowed or positioned in a safe manner in order to avoid a tripping or snagging hazard Do no
21. d here Balloon Dest and pressure values are shown similar to the normal mode EndoFLIP screen The balloon graphic is replaced by two graphs The upper graph displays Balloon Pressure and Volume versus time the PVG graph The lower graph shows the progression through the selected sequence called the Procedure Step Tracking graph PST PATIENT NAME PATIENT ID Balloon Dest Pressure Volume Values Graph Hold time counter Patient counts Severity down J Tension Procedure SS Sn 21 2 3 6 8 es Rest Pressure Step j z i 10 3 00 hPa Tracking Balloon Pressure Figure 27 Main Display in BaroStat mode EndoFLIP User Manual DD 41 Revision C 39 4 6 1 Pressure Volume Graph PVG The PVG displays current Balloon inflation volume in blue and current balloon Pressure in yellow versus time The Volume units are shown on the left and pressure unit on the right A vertical red line indicates the current readings and updates as it moves left to right 4 6 2 Procedure Step Tracking PST The PST displays an over view of the full sequence with balloon Target Volumes represented by the vertical blue lines The current step is shown in yellow This gives the user a view of where in the sequence the procedure is currently at When a Hold Time at the target volume is in progress a count down timer is presented to indicate the remaining time 4 6 3 Pa
22. e only displayed if these conditions are met e The balloon must contain 10ml or more of solution e For Dist to be displayed Balloon pressure is greater than 5 mmHg e For Compliance to be displayed Balloon pressure is greater than 5 mmHg and the Minimum diameter Dmin is located at one of the center five Dests in the balloon 3 2 2 Saving an image Touch SAVE IMAGE to save the live or paused image Select whether to save the image with no comment use one of the pre defined comments 20ml Distension and 30ml Distension or with a user defined comment Figure 14 Selecting a user defined comment allows you to enter comments using the on screen keyboard USER DEFINED COMMENT 1 20ml Distension USER DEFINED COMMENT 2 30ml Distension USER DEFINED COMMENT 3 USER DEFINED COMMENT 4 USER DEFINED COMMENT 5 USER DEFINED COMMENT 6 USER DEFINED COMMENT 7 USER DEFINED COMMENT 8 USER DEFINED COMMENT 9 USER DEFINED COMMENT 10 USER DEFINED COMMENT 11 Figure 14 Saving an image EndoFLIP User Manual DD 41 Revision C 21 3 2 3 Comparing images Touch COMPARE to select one previously saved image for comparison with the live image or select two of the saved images for comparison with each other Figure 15 You can scroll through the saved images using the left and right arrow buttons Figure 15 Selecting saved images two saved images highlighted Select one image and touch OK to compare a saved image with the live image or tou
23. e supplied with conductive Fluid Catheter Assembly Element Description USB connector USB memory device connector for patient data storage Touchscreen High resolution touchscreen is the primary user interface Catheter Catheter connector allows the system to read geometric and connector pressure data where applicable from the catheter The catheter assembly includes a syringe and balloon catheter The syringe contains a conductive solution to inflate or deflate the balloon catheter according to user selected settings Syringe door and The syringe door and lock hold the syringe in position allowing the lock End system to detect that a syringe is installed oFLIP User Manual DD 41 Revision C Syringe backlight The backlight shows syringe contents and plunger position in low Air inlet filter light conditions Draws air into the system and out rear vents for internal cooling Do not block or obstruct Keyboard On Off 1 0 switch connector USB connector Communications DC power connector Element Communications connector Keyboard connector VGA display connector USB connector DC power connector On Off 1 0 switch VGA display connector connector Figure 4 EndoFLIP System back view Description Reserved for future use Do not remove the cover or connect any devices to this connector Connector for an optional external keyboard Only use keyboard s specified by Crospon Lt
24. ectly installed Deflate balloon as required Remove the catheter from the patient Replace catheter When a balloon temperature alarm is active all Dests are shown ina red background to indicate that the Dests are being calculated assuming a balloon temperature of 37 C Balloon Temperature Sensor Failure System has detected a balloon temperature sensor failure User alert Check patient Verify that catheter electrical connector is correctly installed Deflate balloon as required Replace catheter When a balloon temperature alarm is active all Dests are shown ina red background to indicate that the Dests are being calculated assuming a balloon temperature of 37 C Catheter EEPROM Failure EEPROM Write Failure System has detected a faulty catheter User alert Check patient Verify that catheter electrical connector is correctly installed disconnect and re connect the catheter connector Deflate balloon as required Replace catheter EndoFLIP User Manual DD 41 Revision C 29 Alarm message Description Corrective action Catheter not Electrical connector of Check patient connected catheter not connected Check that catheter is Syringe movement stops connected correctly User alert Verify that catheter electrical connector is correctly installed Replace catheter if needed Contact Service Enclosure Enclosure temperature If temperature is below lim
25. ependent Figure 11 Display during inflation Dashes in the Dest measurements indicate that Dest measurements are invalid Actual values are displayed when valid measurements are available Invalid Dest measurement EndoFLIP User Manual DD 41 Revision C 17 3 2 Using EndoFLIP System tools The display shows estimated diameter Dest and balloon pressure catheter dependent during inflation for clinical assessment Figure 12 Typically you might choose to perform several inflation procedures at various balloon volumes and save one or more images from every inflation procedure for comparison You can also choose to compare images from before during or following surgical procedures PATIENT NAME John Doe PATIENT ID Patient 23 2 re m 12 40 38 Dest mm BALLOON PRES 7 3 mmHg co Figure 12 System tools 18 EndoFLIP User Manual DD 41 Revision C System tool Description MENU Touching MENU displays the Configuration Menu Section 2 Unavailable while the syringe pump is moving ARCHIVE Saves data to a USB memory device Unavailable if a USB device is not DATA connected Up to 8 hours of measurement data can be stored for each patient PAUSE LIVE PAUSE LIVE pauses the live image for extended viewing RUN LIVE RUN LIVE cancels the pause and returns to the live image SAVE IMAGE Saves the current image Offers the option of saving the image with
26. g cables other than those supplied by Crospon may result in increased emission and or decreased immunity of the EndoFLIP System Guidance and manufacturer s declaration electromagnetic emissions EN 60601 1 2 2007 Third Edition The EndoF LIP System is suitable for use in the specified electromagnetic environment The customer and or the user of the EndoFLIP System should ensure that it is used in an electromagnetic environment as described below Electromagnetic environment Emissions test Compliance guidance RF emissions CISPR 11 Group 1 The EndoFLIP System uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The EndoFLIP System is suitable for use in all establishments other than RAE domestic and those directly connected Harmonic emissions Class A A to the public low voltage power supply EN 61000 3 2 3454 network that supplies buildings used for domestic purposes Voltage Complies fluctuations flicker emissions EN 61000 3 3 Guidance and manufacturer s declaration 60601 1 2 2007 Third Edition 56 electromagnetic immunity EN EndoFLIP User Manual DD 41 Revision C The EndoFLIP System is suitable for use in the specified electromagnetic environment The customer and or the user of the EndoFLIP System should ensure th
27. ime e Select user Preferences i e language units data filter settings e Enter BaroStat Configuration mode enter BaroStat mode enter Normal Mode To access the configuration menu touch MENU on the main screen Figure 2 Note MENU is not available during inflation or deflation EndoFLIP User Manual DD 41 Revision C 13 ENDOFLIP CONFIGURATION MENU SOFTWARE VERSION E 21 00 Figure 10 Configuration menu Note The patient details screen reverts to the main screen if there is no activity for 60 seconds and any unsaved entries are lost Note The version of software running on the EndoFLIP unit is displayed in the Configuration screen menu bar at the top of the screen as shown in Fig 10 Configuration Menu item Description NEW PATIENT Allows you to enter patient name ID male female procedure DETAILS details physician name and patient age using the onscreen keyboard At minimum a patient ID must be entered Once the Save Data and Continue button is pressed the screen prompts you to archive or delete previous patient data CHANGE Allows you to add to or change patient information except patient PATIENT ID DETAILS CONFIGURE Allows you to configure a sequence of up to 10 balloon distensions BAROSTAT see the BaroStat Chapter 14 EndoFLIP User Manual DD 41 Revision C GOTO Allows you to run a defined sequence of up to 10 balloon BAROSTAT distensio
28. imum radius in mm 4 7 Exiting BaroStat Mode BaroStat mode can be exited at any time by stopping the inflation or deflations and selecting Menu then Go to Normal Mode returning to the EndoFLIP configuration screen 4 8 Resuming Re Running or Resetting a BaroStat Procedure The BaroStat procedure is paused following patient input or if the STOP button is pressed To resume press the RESUME button which appears on the Main BaroStat screen To re run a completed BaroStat procedure press START on the Main BaroStat screen To reset a BaroStat procedure before it has completed press RESET in BaroStat Configuration screen 2 See section 4 4 2 Fig 25 to set the step tracking to the first step as selected in the Step Range Selection After saving and returning to the Main BaroStat Screen press RESET to return the syringe to the start position The patent sensitivity entries are cleared from the screen Press START to run the procedure EndoFLIP User Manual DD 41 Revision C 41 5 Maintenance This section describes maintenance of the EndoFLIP System including e Cleaning e Periodic maintenance Service e Parts list and accessories 5 1 Cleaning Clean the exterior of the EndoFLIP unit and preparation area before the first use between patients and as needed Use a soft lint free cloth moistened with any of these cleaners e Mild detergent or soapy water e 10 bleach solution 10 bleach 90 water
29. it Temperature above or below allowable operation automatically Alarm limits resumes when temperature is If below limit syringe within limit movement stops User alert Check ambient conditions If above limit operation Manually retract syringe if halts System error needed remove catheter from patient Contact Service Estimated System has detected that Check patient Diameter Values are Invalid Dest values are out of range User alert Verify that catheter is correctly installed Verify that there is fluid in the balloon and no large air bubbles Replace catheter if needed Contact Service Failed to export file Failed to delete file Failed to copy file Failed to load file System has detected a file operation failure when accessing a USB storage device User alert Check USB data key Check USB data key file capacity Disconnect USB key power cycle unit connect USB key and archive data again Contact Service High Pressure in Balloon Balloon pressure above set level for 2 seconds Inflation stops User alert Check patient Check that catheter is connected correctly Deflate balloon as required Adjust balloon pressure alarm or inflation settings as needed 30 EndoFLIP User Manual DD 41 Revision C Alarm message Description Corrective action Patient Data File is Full Live data file has reached maximum size Normal operation continues
30. lable from Crospon Ltd Galway Business Park Dangan Galway Ireland Phone 353 91 519880 Fax 353 91 519889 email info crospon com Or in the USA Crospon 701 Palomar Airport Road Carlsbad CA 92011 Phone 1 855 CROSPON Toll Free Fax 760 406 5644 Email info crospon com Web www endoflip com Or contact your local dealer 44 EndoFLIP User Manual DD 41 Revision C 5 4 Parts list and accessories The EndoFLIP System EF 100 is compatible with the following accessories Please contact your local Crospon Ltd representative before using other accessories Description Part number EndoFLIP Catheter 25mm 80mm measurement length with Pressure EF 325N Nasal Tip EndoFLIP Band Adjust Catheter 25mm 40mm measurement length BF 325 EndoFLIP Sleeve Catheter 20mm 160mm measurement length EF 620 EndoFLIP Catheter 25 mm 80mm measurement length EF 825 EndoFLIP USB memory stick EF 600 EndoFLIP External Keyboard EF 700 EndoFLIP Power Supply EF 500 Air Inlet Filter EF 110 EndoFLIP Pre Use Check Kit FRU LK 200 For the most up to date accessories list contact your local Crospon sales office EndoFLIP User Manual DD 41 Revision C 45 Appendix A Introduction to impedance planimetry Impedance planimetry IP is an established technique for performing measurements of cross sectional areas in the alimentary tract 1 2 3 The f
31. le on the onscreen keyboard Default setting alarm setting Patient ID Any alphanumeric character available on the onscreen keyboard Default setting PATIENT1234 Setting Description Balloon Range See catheter user manual inflate rate Resolution 20 mL min Balloon Range See catheter user manual inflate Resolution 1 mL volume Setting Description Balloon Range See catheter user manual pressure Resolution 1 mmHg Alarm See Balloon Pressure Accuracy accuracy Setting Description Hours Range 1 to 24 24 hour format Minutes Range 0 to 59 Day Range 1 to 31 Year Year Setting YYYY format Stores time stamped entries that identify error and device status at the time of occurrence Size and type 10 in LCD touchscreen Resolution 800 x 600 pixels Onscreen keyboard For entering alphanumeric data The device can accommodate external keyboard P N EF 700 EndoFLIP User Manual DD 41 Revision C VGA cable Physical Operating and storage conditions Electrical Maximum cable length 10 m 32 8 ft EndoFLIP System unit Dimensions 324 mm H x 365 mm W x 311 mm D 12 8 in H x 14 4 in W x 12 2 in D Weight 5 kg 11 Ib Operating conditions Temperature 20 to 40 C Humidity 15 to 95 relative humidity non condensing Atmospheric 700 to 1060 hPa pressure Storage conditions Temperature 20 to 50
32. mum Diameter and Cross Sectional Area Display If there is more than 10ml of saline in the balloon the main screen displays the minimum diameter Dmin and Cross Sectional Area CSA or Compliance and Distensibility Figure 13 if a catheter with a pressure sensor is connected PATIENT NAME Jn Doe PATIENTIO Parez oO MP van Minimum diameter and CSA or RES Ethan 2 Compliance and Distensibility display Touch to toggle between these j is displays Minimum 2 Distensibility N Dmin mm ist nhg Diameter 11 2 f and and CSA csamin mm2 THA Compliance Figure 13 Minimum diameter or compliance and distensibility display Pressing the Minimum diameter and CSA display will change the display to the Distensibility and Compliance display and vice versa Dmin or Frmin Minimum estimated diameter Dmin is displayed if selected diameter unit is mm Frmin is displayed if selected unit is French CSAmin Minimum cross sectional area Dist Distensibility defined as CSAmin divided by balloon distending pressure Note this requires a catheter configured with a pressure sensor Zone compliance defined as the volume of a region enclosed by two Dest readings above and below the minimum diameter divided by balloon distending pressure Note this requires a catheter configured with a pressure sensor 20 EndoFLIP User Manual DD 41 Revision C Note To ensure the imaged lumen is adequately distended the Dist and C numbers ar
33. n IMABE aiie taeae aaaea aknea aA aana aai aiia 21 3 2 3 Comparing imageS E u kk KEK KK KAKA 22 32 4 Estimating VOlU e moree lay nana EEA R y EET eed syne 23 32 54 WMABS ZOOM EEEE k rak A eke We yeee KEK yek rek ewewe k PERO e Aa kake Tea k 24 3 3 Deflating the ballon siinne isai ai 25 3 4 When the procedure is complete eke ekkk e 26 3 5 Alarm Saee t e Were dan e cs U seat a e EA Vek A tS 27 EndoFLIP BaroStat MOde E eee k rek k ke kek kk KAK 32 4 1 OV V OY 4 sas s n suriy n xara SEEE ean kak ESE kel kw K nh Vu p b U Akan V aw Y HEW w n Bn V 32 4 2 EndoFLIP BaroStat Mode Features hk lk lllije eee eke 32 EndoFLIP User Manual DD 41 Revision C iii 4 3 How to enter and run BaroStat Mode M j 33 4 4 The Configure BaroStat SCr rnS k h l li keke 34 4 4 1 BaroStat Configuration screen 1 eee 34 4 4 2 BaroStat Configuration screen 2 4 eke ekkkee 37 4 5 Running BaroStat MOd6e u ek kek k KAKA KAYA 39 4 6 Main BaroStat Ser l esei ee eieiei aidsin aee sieisen 39 4 6 1 Pressure Volume Graph PVG u eker k 40 4 6 2 Procedure Step Tracking PST uu keke 40 4 6 3 Patient Sensitivity Entry MA kk k kek 40 4 6 4 Stop Key Emergency Key Press k lhk kh ldl ek keke 40 4 6 5 Tension and Resting PF SSUFF A A AE E kk ke kk k 40 4 7 Exiting Baro
34. nflating the balloon Inflating the balloon allows the EndoFLIP System to visualize and measure the area of interest for clinical evaluation You can inflate the balloon in either of two ways e Use INFLATE DEFLATE and STOP to inflate the balloon to a particular volume or pressure up to the balloon volume and pressure alarm limits at the inflate rate set in the configuration menu e Use the configuration menu CONFIGURE BALLOON INFLATE to select the rate of balloon inflation and to set the balloon volume at which the unit will automatically stop inflation after pressing INFLATE on the main screen To begin inflation touch INFLATE at the main screen and the syringe driver starts to advance the syringe plunger and inflate the balloon The screen shows a graphic representation of the measurement area and syringe and balloon inflation status Figure 11 To stop inflation at any time touch STOP Once stopped you can touch INFLATE to resume inflation or DEFLATE to empty the balloon catheter 16 EndoFLIP User Manual DD 41 Revision C Recording icon image sequences being recorded Zoom Filter icon image filtering active PATIENT NAME John Doe PATIENT ID Patient123 l 08 43 46 for viewing RUN LIVE resumes live image Minimum Dest highlighted Dest at various points along the balloon Status window Fluid volume in STOP halts inflation syringe and balloon Pressure measured in balloon catheter d
35. nformation for each EndoFLIP catheter type 1 1 How it works The EndoFLIP System uses a technique called impedance planimetry to characterize the geometry of the measurement area The system injects a specially formulated conductive solution into a balloon catheter placed in the measurement area The balloon contains an array of electrodes that measure voltage The EndoFLIP System uses these voltages to estimate and display the diameter at up to 16 points along the measurement area Figure 1 See Appendix A Introduction to impedance planimetry for further details on the impedance planimetry technique The EndoFLIP System allows recording and snapshots of this data to be saved and commented for reference Catheter Tissue Balloon inflated with Estimated diameter Dest measured at each conductive solution electrode pair up to 16 measurements Figure 1 EndoFLIP System Image EndoFLIP User Manual DD 41 Revision C 1 The EndoFLIP system estimates the diameter Dest at up to 16 points along the measurement area and creates a real time geometric image of the area on the main screen Figure 2 PATIENT NAME John Doe PATIENTID Patiert123 w m nem D e un e Figure 2 Main screen The multi electrode balloon catheter acts as a functional lumen imaging probe FLIP that shows dynamic changes in the geometry of the measurement area in a real time image Pressure in the balloon is also measured
36. ns see the BaroStat Chapter MODE CONFIGURE Allows you to configure the set volume and rate of balloon inflation BALLOON during measurements INFLATE Note This option is available after a catheter is connected CHANGE Allows you to set the maximum balloon inflation pressure PRESSURE ALARM Note This option is available after a catheter with an integrated pressure sensor is connected CHANGE Allows you to set date and time DATE TIME USER Allows you to change the language and the display units for pressure PREFERENCES and estimated diameter Dest e Language English French Danish Dutch Finnish German Italian Norwegian Portuguese Spanish and Swedish e Pressure units mmHg cmH20 and hPa e Diameter units millimeters Dest or French Frest e Export Logs exports logs from the unit to a USB key if a USB key is attached used for technical support only FILTER Allows you to select data averaging filter settings SETTINGS e Weighted average Low Medium High e Standard average Average over 1 to 20 sec e Off No filtering GO TO Returns to main screen in Normal Mode NORMAL MODE EndoFLIP User Manual DD 41 Revision C 15 3 Using the EndoFLIP System Normal Mode This section describes how to use the EndoFLIP System including e Inflating the balloon e Using EndoFLIP System tools e Deflating the balloon e When the procedure is complete e Alarms For BaroStat Mode see the BaroStat chapter 3 1 I
37. ollowing is a brief technical description of the technique A 1 Measurement method Impedance planimetry uses AC voltage measurements made between receiver probes to estimate the extent of the diameter of the medium a conductive fluid between the probes This can be done provided the voltage drop across the medium is generated from a constant AC current source and the conductivity of the medium is constant and known for a given temperature Voltage probes separated by a fixed distance L connected via wires to a voltage meter vt Electric field lines Constant Current Source Walls of body lumen Conductive medium p 7 contained in a balloon constrained by a lumen 46 EndoFLIP User Manual DD 41 Revision C Considering the following V I R L Ao 2 L T Dest 2Y eo where R is resistance impedance a is the conductivity of the medium L is the distance between the voltage probes Ais the cylinder area and Dest is the cylinder diameter R can be calculated as the AC current I is known and is fixed and the AC voltage V is measured between the voltage probes If L is the fixed distance between the voltage probes and the medium conductivity o is known for a given temperature then Dest can be determined An estimate of the balloon diameter Dest at a given electrode position is derived from the measured area using the assumption that the balloon is symmetrical about its longitudinal axis
38. ps of 20ml min to a limit of 60ml min by default Further restrictions may be applied if the default rates are not supported by a connected catheter If a rate is not currently supported it is displayed in red and can only be adjusted downwards Valid rates are displayed in black 4 HOLD DURATION The hold duration is the length of time spent at the target volume for the current step The time is configurable from 1 to 60 seconds with a default delay of 10 seconds Step hold times are individually configurable 5 The WAIT PATIENT INPUT enable disable button The WAIT PATIENT INPUT option is a global setting for all steps and determines the types of inter step delay in use If the option is DISABLED the HOLD DURATION figure is used If the option is ENABLED then the system will wait at the target volume until the patient enters a sensitivity rating for that step If the Wait Patient Input option is enabled the hold duration option is not displayed and the current settings for that parameter are not shown on the preview graphs 6 The WAIT AFTER DEFLATE setting is the length of time that the system will pause after deflating from a target volume to Oml The time is configurable from 1 to 60 seconds with a default delay of 10 seconds and is individually configurable for each step 7 The DEFLATE enable disable button The DEFLATE enable disable option is a global setting for all steps If
39. rm system is functioning 2 After the 30 second POST an initialization screen Figure 6 appears 3 Touch CONTINUE to start syringe driver initialization Do not touch until the syringe driver stops moving DURING INITIALISATION ENSURE THE SYRINGE IS NOT INSERTED AND ALL STAFF ARE CLEAR OF THE UNIT WHEN READY PRESS CONTINUE SYRINGE NOT IN PLACE wot CONNECTED Figure 6 Syringe Driver initialization screen EndoFLIP User Manual DD 41 Revision C 2 3 Preparing the Catheter for use Warning Before use inspect the catheter assembly from end to end for breakage occlusions or debris Do not use if damage to the parts or packaging is evident or if any portion of the catheter packaging has been previously opened Do not use any part after its expiration date or if the expiration date cannot be verified 1 Remove the catheter assembly from its packaging as described in the catheter user manual 2 Insert the catheter electrical connector into the slot at the front of the unit with the green dot on the connector aligned with the green dot on the unit Note The catheter electrical connector must be connected before continuing 3 Depending on the catheter type the system may need to reinitialize the syringe driver position If so the initialization screen Figure 6 appears touch CONTINUE and do not touch the system until the syringe driver stops moving 4 Insert the syringe into the front of the sy
40. rocedure is running 7 Procedure list area When a USB key is connected the procedure list area will display an Export button to allow the current settings to be exported to a USB data key If the connected USB key already contains stored BaroStat procedures then they will be listed under the Procedures Available region of the list area If the Export key is selected the user will be presented with the procedure naming screen Fig 26 with the current procedure title displayed by default If a procedure is selected from this area an Import key will be presented If the user selects the Import button the settings in the imported file are applied to the current procedure settings The BaroStat Configuration screens will timeout and return to the configuration menu screen if there is no user interaction for 60 seconds BAROSTAT PROCEDURE NAME Ascending Method Of Limits _ i OK CANCEL Figure 26 Procedure naming screen for saving changes 38 EndoFLIP User Manual DD 41 Revision C 4 5 Running BaroStat Mode Once the BaroStat procedure has been selected or edited as required the sequence is started by returning to the main menu screen by pressing Save Changes on Settings Screen 1 or 2 above The BaroStat sequence is run from the configuration menu when the Go To BaroStat Mode option is selected 4 6 Main BaroStat Screen The screen shown when running a BaroStat procedure is describe
41. rom a standard keyboard connected to the keyboard connector at the rear of the unit The Patient Discomfort level is displayed and recorded by the EndoFLIP system along with balloon dimensions balloon volume and balloon pressure when a catheter with pressure sensing is being used Setting Description Patient ID Range Any alphanumeric character available on the onscreen keyboard up to 16 characters Default setting PATIENT1234 Patient Range Any alphanumeric character available name on the onscreen keyboard up to 26 characters Default setting Patient sex Range Male Female Patient age Range 0 to 100 Comments Range Any alphanumeric character available on the onscreen keyboard up to 235 characters Physician Range Any alphanumeric character available name on the onscreen keyboard up to 26 characters EndoFLIP User Manual DD 41 Revision C Displayed data Data Description Normal mode ee Live image Measurement area graphic with estimated balloon diameter Dest at up to 16 points in the balloon Measurement length is catheter dependent Balloon pressure is displayed below the graphic if the catheter includes a pressure sensor Saved image Measurement area graphic and time of day in HH MM SS format with balloon pressure displayed below the graphic and volume of saline solution in balloon when image was saved above it Saved images can al
42. rospon Ltd Do not place fingers or hands near the syringe drive system when it is moving Service on this device should be performed only by a qualified service technician To ensure proper operation do not make unauthorized modifications to the device Transport set up and store the device so that it does not pose a tripping hazard Use proper technique for lifting the device Wipe the exterior of the device clean with a damp cloth and mild detergent solution before the first use between each patient use and as needed To minimize the risk of puncturing or damaging the device do not use sharp objects on the touchscreen This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide To minimize the risk of fire use this device in well ventilated areas away from flammable anesthetics To minimize the risks associated with excess inflation pressure observe the patient and all alarms during use and refer to the display to observe diameters and pressure during a procedure and while making settings or setting changes Verify that there are no leaks in the catheter during the purge cycle During operation check that the amount of fluid in the syringe matches the amount shown onscreen and verify that the syringe refills as indicated when the plunger aligns with the arrow on the syringe indicating that the balloon is empty before carefully removing the catheter from the patien
43. so be labeled with a user selected comment Up to 200 images can be saved Continuous live data For each patient the system saves up to 8 hours of continuous live data starting from first pump movement until a new patient is selected Dest Estimated balloon diameter Dest at up to 16 points in the balloon displayed in numeric and graphical form using the assumption that the balloon is symmetrical about its longitudinal axis at that electrode pair position Measurement length is catheter dependent Displayed at a resolution of 0 1mm or 0 1Fr Refer to catheter user manual for specific accuracy and range information Note indicates that a measurement is not available Balloon pressure Displayed in numeric form below the measurement area graphic Displayed at a resolution of 0 1mmHg Refer to catheter user manual for specific measurement range and accuracy information Note indicates that a measurement is not available Balloon volume Displayed at a resolution of 1ml with an accuracy of 1ml over a range 0 to 100ml EndoFLIP User Manual DD 41 Revision C 49 Displayed data Normal mode Balloon inflate settings Alarm settings Date and time settings Error log Display 50 Data Description Syringe Displayed at a resolution of 1ml with an volume accuracy of 1ml over a range 0 to 100ml Patient name Any alphanumeric character availab
44. stem with the syringe luer pointing away from the unit as shown Figure 7 Catheter electrical connector align green dots on connector and unit Syringe luer points away Syringe sa from unit connect catheter lock fill lumen Syringe door Figure 7 Installing the syringe and catheter assembly WARNING TO ENSURE PROPER OPERATION AND TO MINIMISE THE RISK OF PATIENT INJURY ONLY USE THE PRE FILLED SYRINGE SUPPLIED WITH THE CATHETER DIFFERENT CATHETER PART NUMBERS ARE SUPPLIED WITH DIFFERENT SOLUTION CONCENTRATIONS 10 EndoFLIP User Manual DD 41 Revision C 10 Slide the syringe door over the syringe shoulder and turn the syringe lock counter clockwise to secure the syringe Remove the luer cap from the syringe then connect the male luer of the catheter fill lumen to the syringe Verify that all connections between the syringe catheter and device are secure Verify that the onscreen balloon and syringe graphics show that the catheter electrical connector and syringe are in place Figure 8 Actual syringe volume depends on catheter type Figure 8 Onscreen syringe and catheter graphic If the catheter type is the same as previously connected a prompt asks whether to continue using current patient data Touch NEW PATIENT for a new patient or CONTINUE if you wish to use the new catheter and append the data record to the current patient If the catheter type has changed since the previous connection a prompt asks
45. t Replace the catheter if a Dest value remains consistently at a maximum or minimum compared to adjacent Dest values this can indicate a faulty catheter Do not use this device near magnetic resonance imaging MRI For accurate measurements high frequency devices such as electro surgery or diathermy cautery equipment should be deactivated Remove the catheter if the patient requires defibrillation Display devices and their adapters connected to the VGA connector of the EndoFLIP System must meet the requirements of IEC 60601 1 and be located in the same room where the EndoFLIP System is being used The EndoFLIP System must be connected to a wall outlet or a single outlet extension only Do not use multiple outlet sockets Install all equipment according to applicable national wiring requirements If used in conjunction with endoscopy equipment the leakage current from the EndoFLIP System catheter may be additive to the leakage current from the endoscope When using a catheter with integrated pressure sensor for optimal pressure measurements do not expose the balloon portion of the catheter to excessive light during operation EndoFLIP User Manual DD 41 Revision C 2 Getting started This section describes how to prepare the EndoFLIP System for use including e Connecting to AC power e Power on off e Preparing the catheter for use e Configuring the unit All components of the EndoFLIP System described in this
46. t During each distension patient feedback of discomfort level can be acquired from a standard keyboard connected to the keyboard connector at the rear of the unit The Patient Discomfort level is displayed and recorded by the EndoFLIP system along with balloon dimensions balloon volume and balloon pressure when a catheter with pressure sensing is being used 4 2 EndoFLIP BaroStat Mode Features e A pre defined sequence of up to 10 balloon distension steps e The user may change each distension s parameters as required target volume inflate rate time at target volume before the sequence begins using on screen set up controls from the Configure BaroStat menu located on the Configuration Mode screen e The user may choose to import a pre defined sequence from file USB key for ease of set up and consistency of protocols Protocol export is also possible to the USB key e The user may choose to deflate between distensions or not e The user can stop the distension at any time via the EndoFLIP screen The Patient can stop the distension at any time or immediately deflate the balloon via the patient keypad e Patient feedback of discomfort level can be acquired via a keyboard connected to the keyboard connector at the rear of the unit and is automatically recorded with Dest volume and pressure and a snapshot taken for each patient input e A user settable Pressure Alarm can be set to stop the distension if a pressure limit
47. t allow the air inlet at the side of the unit or ventilation ports at the rear to become covered or obstructed Use the EndoFLIP System only with the supplied power adapter part number EF 500 Do not use the device if any damage to the power adapter such as frayed wires cracks or cut insulation is evident The power adapter is not field serviceable Medical electrical equipment requires special precautions regarding electromagnetic compatibility EMC and must be installed and put into service according to the EMC information provided in this user manual see Appendix B Specifications Before using the EndoFLIP System on a patient allow the device to acclimate to conditions of use following transport or storage Do not insert the syringe into the EndoFLIP System before connecting power or powering on Use the EndoFLIP System on a patient when in Normal or BaroStat operating mode only Do not attach to the patient during power on self test POST or in service mode Maintain continuous observation of the patient during use In the unlikely event that the EndoFLIP System stops normal operation during a procedure use the back panel on off switch to turn the unit off remove the syringe from the unit and retract the syringe plunger manually to withdraw any remaining fluid from the balloon catheter The catheter can then be carefully removed from the patient Use the EndoFLIP System only with parts and accessories approved by C
48. t modified itui088 baro 15 29 November 23 201 proc 2 ui baro 15 35 November 23 201 itbs07 001 baro 18 34 December 02 201 Pump Test Exported baro 11 05 December 05 201 y li lt gt Figure 25 The second BaroStat Configuration screen USB data key connected Description of BaroStat Configuration screen 2 1 PROCEDURE TITLE The name of the current procedure in use is listed in this display area The default is Ascending Method of Limits 2 CURRENT STEP number This displays the step currently in use or the next step to run in the case of a procedure that has not yet started or has been reset 3 RESET button The reset button resets the current step setting to the starting step for the current procedure 4 STEP RANGE SELECTION This setting allows the user to define the starting and ending step number inclusive for the current procedure The step number changes in increments of 1 and the starting and ending step may be the same indicating that the procedure only contains one step EndoFLIP User Manual DD 41 Revision C 37 5 RESTING PATIENT PRESSURE The resting patient pressure allows the clinician to enter a baseline resting pressure for the current patient The pressure may be positive or negative 6 PRESSURE SCALE setting The pressure scale setting may be one of 50 100 or 150 units of pressure and refers to the limit of the pressure reading that may be viewed on the Pressure Volume graph when the p
49. t of a typical commercial and or hospital environment If the EndoFLIP System user requires continued operation during power mains interruptions it is recommended that the EndoFLIP System be powered from an uninterruptible power supply or a battery EndoFLIP User Manual DD 41 Revision C 57 EN 60601 Compliance Electromagnetic Immunity test test level level environment guidance Power frequency 3 A m 3 A m Power frequency 50 60 Hz magnetic field IEC 61000 4 8 magnetic fields should be at levels characteristic of a typical location in a typical commercial and or hospital environment Note Uris the AC mains voltage prior to application of the test level 58 EndoFLIP User Manual DD 41 Revision C The EndoFLIP System is suitable for use in the specified electromagnetic environment The customer and or the user of the EndoFLIP System should ensure that it is used in an electromagnetic environment as described below IEC 60601 1 2 Immunity test Compliance test level level Electromagnetic environment guidance Conducted 3 Vrms 3Vrms Portable and mobile RF communications RF 150 kHz equipment should be used no closer to IEC 61000 to 80 any part of the EndoFLIP System 4 6 MHz including cables than the recommended separation distance calculated from the Radiated 3 V m 3V m equation appropriate for the frequency RF 80 MHz of the transmitter IEC 610
50. th electrical safety regulations for U S and Canadian markets Type BF applied part complying with IEC 60601 1 Compliant with Waste Electrical and Electronic Equipment WEEE Directive 2002 96 EC Technical Note The EF 500 Power Supply provides two means of operator protection Earth continuity testing should not be performed on the connectors to the rear of the EndoFLIP system 54 EndoFLIP User Manual DD 41 Revision C B 1 Compliance International standards IEC 60601 1 Classification WEEE ROHS Recycling Directive e IEC 60601 1 2005 Third Edition Medical Electrical Equipment Part 1 General Requirements for Safety plus corr 1 2006 and corr 2 2007 to the standard and U S and Canadian deviations e EN 60601 1 2 2007 Third Edition Medical Electrical Equipment Electromagnetic Compatibility Requirements and Tests e IEC 60601 2 18 2009 Third Edition Medical Electrical Equipment Particular requirements for the safety of endoscopic equipment Class Type BF drip proof equipment continuous operation WASTE ELECTRICAL AND ELECTRONIC EQUIPMENT AND RESTRICTION OF THE USE OF CERTAIN HAZARDOUS SUBSTANCES IN ELECTRICAL AND ELECTRONIC Equipment WEEE ROHS RECYCLING DIRECTIVES If you are subject to the WEEE ROHS directives contact Crospon Ltd regarding recycling this product EndoFLIP User Manual DD 41 Revision C 55 B 1 1 Electromagnetic emissions Warning Usin
51. this option is enabled the EndoFLIP User Manual DD 41 Revision C 35 36 10 balloon will be deflated after reaching each target volume and then the system will pause for the time indicated by the WAIT AFTER DEFLATE setting If the option is disabled the balloon will not deflate after each step and will move immediately to the target volume for the next step If the DEFLATE option is disabled then WAIT AFTER DEFLATE is not shown and the preview graphs do not display the step wait times SAVE CHANGES button The save button only appears after procedural changes have been made and requests that the user enter a procedure name for any changes made as shown on the BaroStat procedure naming screen in Fig 25 The current procedure name may be reused and is presented by default When the procedure name is accepted the changes made are saved to file and the active procedure is updated CANCEL button This button cancels any changes to the current procedure and returns to the configuration menu screen Settings page toggle This button toggles between the available settings screens for BaroStat mode EndoFLIP User Manual DD 41 Revision C 4 4 2 BaroStat Configuration screen 2 The second BaroStat Configuration screen is shown here PROCEDURE TITLE ASCENDING METHOD OF LIMITS CURRENT STEP 1 STEP RANGE SELECTION 1 10 RESTING PATIENT PRESSURE 0 mmHg PRESSURE SCALE 100 Procedures Available Las
52. tient Sensitivity Entry During a BaroStat procedure the user or patient is normally expected to enter a patient sensitivity rating using a keypad when the target volume is reached Depending on the step setting the user will have a defined time period to enter a value or will be required to enter a value before the procedure can progress The user can enter a sensitivity rating at any time and the procedure will pause and display the rating over the step on the PST graph Key presses in the range 1 9 will trigger an automatic snapshot of the data at the time when the key was pressed This information will be stored as a standard snapshot and the data is presented in the normal EndoFLIP mode balloon image when the snapshot is recalled 4 6 4 Stop Key Emergency Key Press Using the keypad the patient has the option to stop the inflation by pressing space bar or once or to perform an emergency deflation by pressing space bar or twice within 1 second The user can also stop the procedure and deflate at any time using the on screen Inflate Deflate Stop controls 4 6 5 Tension and Resting Pressure The resting pressure Presting entered during BaroStat configuration is displayed in the status window 40 EndoFLIP User Manual DD 41 Revision C Wall Tension is also displayed and is determined as Tension P Presting r where P is pressure in mmHg Prestingis the resting Pressure and r is the current min
53. ve to on O settings screen 2 Hold Duration Hold Duration setting for time setting for time at target volume after deflate Fig 24 BaroStat Configuration screen 1 Description of BaroStat Configuration screen 1 1 Step preview windows Any of the 10 available steps can be edited by selecting the step by touching the step window of interest The selected step is highlighted when selected Arrows are provided to the left and right of the preview images to scroll through the steps available Each preview displays e The step number represented e g 1 10 e The target volume for the current step in ml 34 EndoFLIP User Manual DD 41 Revision C e The hold time at target volume for the current step if WAIT PATIENT INPUT is Disabled e The time to wait after a deflation for the current step if DEFLATE is Enabled 2 TARGET VOLUME adjustment This displays the current target volume for a highlighted step The volume can be adjusted up down in steps of 1ml The default volume limit is 50ml until a connected catheter determines the actual volume limit based on the catheter type If a step volume target exceeds that allowed by a connected catheter then the target volume figure is displayed in red and can only be adjusted downwards Valid volume targets are displayed in black 3 INFLATE RATE adjustment Displays the current inflation rate for a highlighted step The inflation rate can be adjusted up down in ste
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