Home

ManoScan User Manual

1. i lk Figure 3 2 2 2 Main Display in Contour left and Line Trace right Modes To switch between the two different modes click the Display Mode button to the lower left While in Line Trace Mode the locations for display of line traces can be chosen from among the full 36 channels available by manipulation of the pointers 12 or 8 channels available for anorectal manometry system in the profile display as described in Section 3 2 2 2 At any point during viewing the Scroll Review button will hold the display while still recording data when recording is turned on Click the Scroll Review button again to return to real time display The Watch Window button brings up a small floating window that shows the contour map display This can be used to view the complete contour map while the Main Display is in line trace mode Figure 3 2 2 3 The window may be positioned anywhere on screen by dragging 1ts top and resized by dragging its lower right corner _ Atmosph _90 p t0seconds Je Figure 3 2 2 3 Main Display Area with Watch Window On esophageal data shown This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 23 Gl FEN IMAGING ManoScan M User Manual Expanding the scope of Gl If a pressure impedance probe is used t
2. a Refer to the ManoShield AR 3D instruction card b Make sure stopcock is in correct position c Add 1 cc of air to balloon to enable balloon compression during pressurization This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 54 GlyEN IMAGING ManoScan User Manual Expanding the scope of GI d Take note of balloon pressure profile during calibration if it builds then plummets well before the pressure drops on the body of the catheter there is an air leak between the balloon luer connection on the catheter and the A120 module e Tighten the luer connection on the distal tip of the probe be careful not to introduce twists in the sheath f No onscreen response from balloon sensor remove purple luer connection from back of A120 attach luer syringe lightly depress plunger and look for an increase in the balloon pressure signal on screen If pressure increases then replace luer connection with a new one 4 Should the inability to successfully pressure calibrate the catheter persists please contact your regional support representative 4 9 10 ManoScan Software Presentations 4 9 10 1 Display is not scrolling and or tuning is stuck at 0 1 Close acquisition program power cycle A120 for at least 10 seconds and then wait another 10 seconds after turning on A120 before launching software 2 Make sure another catheter is not plugged into t
3. swallow on command functionality You may create simulations by using the Save Selected function see 3 5 2 and saving selected data in ManoScan format in the Emulation folder The file extensions must be subsequently changed from mvs and mvsar to emb for Background files and eme for Event files This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 37 GlyEN IMAGING ManoScan User Manual Expanding the scope of GI 4 Maintenance Service Troubleshooting and Reference Information 4 1 Maintenance and Replacement No scheduled maintenance is required for the ManoScan system WARNING The modules and catheters of the ManoScan system do not include end user serviceable components and may pose a hazard during any attempts to troubleshoot or repair The ManoScan system shall only be serviced by Given Imaging trained service personnel WARNING No modification of this system or its components 1s allowed The ManoScan System excluding the high resolution catheters is warranted to be free from defects in material and workmanship under normal use for 2 years from the date of shipment The high resolution manometry catheter probes are limited use devices warranted to be free from defects in material and workmanship under normal use for 2 years or 200 uses whichever comes first from the date of initial shi
4. 1GB available hard disk 40GB or Greater Recommended for ManoScan V Use CD ROM Drive Minimum 24 bit color 1024x768 video adaptor USB 2 0 support Microsoft Windows XP SP3 32 bit only Microsoft Windows 7 32 and 64 bit Minimum Microsoft Word 2003 recommended Word 2007 or Word 2010 with Microsoft Save as PDF Add in e Adobe Reader Catheters Probes Reusable solid state tactile pressure sensing technology Standard Diameter 12 pressure sensitive segments circumferentially distributed on 4 2mm diameter ESO Catheter esophageal Regular or Extended Tip 36 channels 432 pressure points 10mm on center spacing ESO Z Catheter esophageal Impedance 36 channels 432 pressure points 10mm on center spacing 18 channels of impedance 20 mm on center spacing AR Catheter Regular anorectal 12 channels 144 pressure points 6mm on center spacing e AR Catheter Small anorectal 8 channels 96 pressure points 6mm on center spacing Small Diameter 36 channels with 16 pressure sensitive segments circumferentially distributed on 2 75mm diameter 576 total points ESO Catheter SD Regular Small diameter esophageal 10mm on center spacing ESO Catheter SD Small Small diameter esophageal 7 5mm on center spacing 3D Sensing ESO 3D Catheter 3D esophageal 128 individual pressure sensing channels 12 3D sensing rings evenly aligned axially in the LES region each consisti
5. The patient is then normally instructed to squeeze Press End after the maneuver is complete or allow the frame to auto close after the specified duration typically 20 30 seconds Additional squeeze measurements may be made by pressing the Start button or move to the next measurement type by pressing the Finish button Push Bear Down Frame s Press Start to begin the push bear down measurement The patient is normally instructed to push or bear down as in defecation Press End after the maneuver is complete or allow the frame to auto close after the specified duration typically 20 30 seconds Additional push bear down measurements may be made by pressing the Start button or move to the next measurement type by pressing the Finish button Balloon Inflation Frame s The user is prompted to indicate the next fill volume using the balloon volume controls on the lower right of the display screen and press Set Press Start to begin the balloon inflation measurement and inflate the balloon to the desired volume using air only do not fill with liquids Press the Sensation Urge or Discomfort annotation buttons as per patient response to the inflation Press End after the maneuver is complete or allow the frame to auto close after the specified duration typically 20 30 seconds Additional measurements may be made by repeating the process above for setting the fill volume pressing th
6. Australia amp New Zealand Given Imaging Pty Limited Unit 6A The Park 5 Talavera Road North Ryde NSW 2113 Australia Phone 61 2 9889 3944 Fax 61 2 9889 3955 supportAU givenimaging com Japan Given Imaging K K 2F KDX Kojimachi Bldg 3 3 Kojimachi Chiyoda ku Tokyo 102 0083 Japan Phone 81 3 5214 0588 supportUP givenimaging com Germany amp European Headquarters Authorized Representative in the EU Given Imaging GmbH Borsteler Chaussee 47 Hamburg 22453 Germany Phone 49 40 513 3000 Fax 49 40 4606 9611 supportEU givenimaging com France Given Imaging France S A S 22 Rue Guynemer 78600 Maison Laffitte Paris France Phone 33 0 1 34 93 80 00 Fax 33 0 1 34 93 80 11 supportF R givenimaging com Asia Given Imaging Asia Company Limited 211F Unit A Cheuk Nang Plaza 250 Hennessy Road Wanchai Hong Kong Phone 852 2989 0888 Fax 852 2989 0899 supportAP givenimaging com This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 58
7. Calibration If error persists Consult initial and final ambient pressures Factory Calibration Error probe element cal curve Error between reading and cal curve is Restart Calibration If error persists Consult gt 2 mmHg or gt 5 of reading whichever is Factory greater 4 9 2 Protocol Flow Logic The protocol will always start at the beginning Therefore if the initial steps in a procedure such as entering Patient Information and Probe Calibration are performed manually the protocol may be out of sync with the actual state of the clinical procedure This may be corrected by moving to the correct step in the protocol via the Go To gt gt button 4 9 3 Loss of power If there is a loss of electrical power first assure that the line source e g wall receptacle is providing proper voltage If proper power is confirmed to be entering the ManoScan system contact Given Imaging or your local representative for further instructions This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 51 GlyEN IMAGING ManoScan User Manual Expanding the scope of GI 4 9 4 HRM Catheter Calibration Error l Verify the pressure data acquisition A120 module is powered on USB connected and communicating Verify the catheter serial number selected in the software matches the catheter serial number connected to the module Ensure the intended use cathet
8. Chamber IE Housing Remove Tube Loosed approx 1 turn Pull tube down Calibration Reinstall Tube Tube Slide tube upward in Housing If tube does not seat firmly remove Seal Collar and thread Tube through internal o ring and replace Collar Tighten Collar Test Collar tightness by pulling down lightly on Tube Tube should not move Figure 3 1 1 2 ManoScan Calibration Chamber Disassembly for Cleaning This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 16 GlyEN IMAGING ManoScan User Manual Expanding the scope of GI 3 Using the System 3 1 Setup 3 1 1 Cleaning and Disinfecting The catheter is required to be disinfected per approved HLD process See Section 2 9 for instructions and precautions prior to each procedure 3 1 1 1 With ManoShield Disposable Sheath Due to sheath length limitations it is not recommended for use in proximal gut manometry gastric duodenal Install and remove per instructions provided with each type of sheath Ensure all the air between the catheter and the sheath has been properly removed with the squeegee to avoid excessively high pressures in the study at the distal portion of the catheter 3 1 2 Starting the Program The ManoScan software will open via the ManoScan Acquisition executable file or the program shortcut on the operating system desktop The current connected catheter can then
9. HIPAA compliant user experience This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 49 ManoScan User Manual GlyEN IMAGING Expanding the scope of Gl 4 8 ManoScan System Technical Specifications HARDWARE Workstation Data Acquisition Modules A120 ManoScan High Resolution Manometry A200 ManoScan ESO Z High Resolution Manometry A300 ManoScan 3D High Definition Manometry A400 ManoScan V High Resolution Video Manometry Portable cart With adjustable shelves and large lockable wheels 5 min dia and additional storage drawer Microsoft Windows platform PC Wi Fi LAN and color printer 600dpi min Flat panel color monitor with touch screen 17 min and articulating monitor arm keyboard and mouse control available as well Power Data acquisition and power conditioning unit rated at 90 to 230 VAC 50 60 Hz 40 VA Max Patient isolation transformer with available expansion power ports rated at 100 120 220 240 VAC 50 60 Hz 600 VA maximum e Workstation footprint 29 wide 27 deep 39 high to table top add 15 min to 24 max for overall height with adjustable 17 monitor Workstation weight approximately 310 to 325 pounds Recommended Computer Requirements e Minimum Intel Pentium IV 2 8 GHz Intel Core 2 DUO or Better Recommended Minimum 1GB RAM 2GB Recommended
10. and or biomed department Shut down PC and turn on PC again Boot back up in Safe Mode Run maintenance tasks on PC drives such as Check Disk and Defragment Remove uninstall any added non Given supplied hardware and software Save studies and reports on an external drive to avoid losing data Should the issue persist please contact your regional support representative This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 56 GlyEN ManoScan User Man ual Expanding the scope of Gl IMAGING 5 Spare Parts Seal Probe MVS ESO AR Seal Cal Tube MVS ESO AR AR 3D Probe Gasket Cal Rigid AR AR 3D This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 57 ManoScan User Manual GlyEN IMAGING Expanding the scope of Gl 6 Contacting Given Imaging On the Web www givenimaging com USA amp Headquarters of the Americas Given Imaging Inc 3950 Shackleford Road Suite 500 Duluth GA 30096 USA Phone 770 662 00870 Toll Free 1 800 GIVENGI Fax 770 662 0510 USA supportUS givenimaging com Latin America supportLA givenimaging com Canada Given Imaging Inc Canadian Office 2425 Matheson Blvd E 8th Floor Mississauga ON L4W 5K4 Canada Phone 905 361 2830 Toll Free 1866 98 GIVEN Fax 1 800 786 1967 supportCA givenimaging com
11. body This condition can be observed as a symmetric signature in the pressure profile and main displays as shown in Figure 3 3 5 1 If this occurs the probe should be withdrawn immediately to the point that the condition no longer exists Prolonged periods in the doubled back state can lead to premature failure of the probe see Section 2 8 for precautions 4 Provide a pressure neutral reading immediately after extubation A brief period at least 1 second should be provided in which the probe is in a pressure free state e g simply held in air by the ruled section without touching the sensor section This pressure neutral condition at or near body temperature will allow for more precise thermal compensation during subsequent data analysis This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 34 GlyEN IMAGING ManoScan User Manual Expanding the scope of Gl 60 5 mm Hu 25 Sens Chan Figure 3 3 5 1 Pressure signature of doubled back catheter condition 3 3 6 Saving a Data File Before closing or ending a Procedure the operator must specify the file to which recorded data will be saved To do so press End to end the procedure and allow for a new patient as instructed in the standard Protocols or select Close Save Current from the File menu or Close from the toolbar Enter the name of the Data file and click
12. facilitate catheter intubation such as standing The clinician may be positioned between the system and the patient to adequately intubate the patient The catheter should remain connected to the system to visually aid intubation by using the pressures presented in the acquisition software For the study the patient may remain in a seated position placed in a supine 15 to 30 degree angle position or in a lay flat position according to the procedure specified by the responsible physician Impedance data collection can be disabled prior to study execution and if impedance data collection is enabled impedance data visual presentation can be turned off and on during esophageal motility studies This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 29 GlyEN IMAGING ManoScan User Manual Expanding the scope of Gl 3D Esophageal Studies Studies should be performed identically to Esophageal Motility studies but care should be taken to locate the LES immediately in the center of the 3D section of the catheter see example below m w o a ra Y 0 0 50 0 Stomach Figure 3 2 4 1 Locating the LES in an ESO 3D Study Pharyngeal and Proximal Gut gastric duodenal Manometry Using 36 Channel Catheter and Associated Software Data collection may be via the Free Measurement protocol Trans nasal intubation patient and catheter positioning should be perform
13. on or bent sharply during cleaning DO store the probe in a contamination free and protected manner e g using the provided storage case not coiled tighter than a 15 cm 6 in diameter The clinical procedure must be performed in accordance with an established protocol as prescribed by the responsible physician The anatomical depictions relative to the pressure signals provided in the software are rough approximations If the anatomical depictions are utilized the user is responsible for their proper positioning relative to the data Although electro cautery amp defibrillation equipment is unlikely to be used during manometry be advised that such use near the probe may damage the probe and or electronic circuits The motility probe and system are temperature compensated but not compensated for thermal shock A transient response of approximately one minute duration may be evident when a motility probe first experiences body temperature When giving a patient liquid to swallow minor thermal shock will be avoided by offering tepid near body temperature liquids To avoid excessive calibration shift and possible damage to the probe DO NOT manually apply pressure greater than 100 mmHg When determining whether probe sensors are operating observe the output signal while applying light pressure lt 100 mmHg DO NOT apply pressure This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging A
14. or the Tools menu The Smart Mouse data display is inherently more accurate than the vertical dashed lines showing time spacing The Smart Mouse values should always be used in obtaining precision data 3 5 1 1 Data Point Evaluation Pressure and position data at any point in the contour display are found by simply passing the cursor over the point when Smart Mouse is active Data point evaluation is also applicable to the 3D visualization window 3 5 1 2 Data Record Evaluation vertical time line By left clicking on the main display a red marker is anchored on the display showing the pressure and position data at the point 3 5 1 3 Data Across Records diagonal drag and delta time lines By left clicking on the main display and dragging between two points of interest data from two records are displayed In the trace display mode the time between the two points selected is displayed and a vertical line is drawn at each end of the drag line This is helpful for example in measuring the time between a swallow wave features seen on two separate channels In Contour display mode the pressure time and position at the start and endpoints of the drag line are displayed and the differences in these variables as well as the velocity e g for wave velocity measurement and maximum minimum and mean pressures within the enclosed areas are displayed This document contains proprietary information Source Given Imaging Copyright 2013 Given Imagi
15. passage of the instrument The use of the ManoScan system for anorectal manometry is contraindicated for patients with known anal stricture obstruction preventing insertion of the instrument 2 5 Adverse Events Potential adverse events associated with the use of this system and catheter insertion into the nasal passage may include discomfort nasal pain minor bleeding runny nose throat discomfort irregular heartbeat with dizziness and perforation In rare instances the catheter may be misdirected into the trachea causing coughing or choking the catheter may curl during intubation and catheter position may move during the procedure Potential adverse events associated with the use of this system and catheter insertion into the anorectum may include discomfort pain minor bleeding irregular heartbeat with dizziness and perforation In rare instances the catheter may curl during insertion and catheter position may move during the procedure Medical endoscopic or surgical intervention may be necessary to address any of these complications should they occur The system is not compatible for use in an MRI magnetic field This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GlyEN IMAGING ManoScan User Manual Expanding the scope of GI 2 6 Installation and Connections Initial ManoScan system installation is provided by trained and qualifie
16. started and via Edit after the information has first been entered The Patient Information screen contains certain mandatory fields as shown 1n Figure 3 2 1 1 A keyboard button in the lower right corner brings up an on screen keyboard so that information may be entered via the touch screen display Pressing the keyboard button closes the keyboard The Patient Information window includes pull down lists that automatically save information such as Physician name and Test Operator To delete an item from the list simply select the item and then click on the delete icon next to the list The patient information must be entered before data recording may begin Patient Information Study Information First Name N Date 12 14 2009 Middle Initial Physician Bi Last Name Referring Physician v Patient ID Test Operator v DOB Age Procedure Gender v Indications Height ft jm AN required data x an E v Show Preload Preload Patient Data File Figure 3 2 1 1 Patient Information Screen 3 2 1 1 Preloading Patient Data The program allows you to preload patient information to be later retrieved at the start of the procedure Any number of patients may be preloaded To enable this feature select Show Preload in the Patient Information screen Enter the patient data and select Save The data will be saved under the first and last name of the patient The previously saved information is loaded into the Patie
17. systems using both pressure calibration chambers as mentioned above the intended use catheter must be in the appropriate chamber and the provided plug must be inserted into the catheter insertion opening of the unoccupied chamber to ensure proper pressure calibration Do Not use a catheter probe to plug the not in use pressure calibration chamber ManoScan is the trademark name of the ManoScan system software This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 17 GlyEN IMAGING ManoScan User Manual Expanding the scope of GI For systems using both HRM and 3D type catheters in the same system setup prior to calibration or system setup ensure that the catheter s that are not currently in use are not plugged into the modules For Systems upgrading to the 3D esophageal catheter the calibration tube must be replaced to allow for the extra length of the 3D catheter such that it can be inserted to a depth of 52 55 cm The replacement tube will be provided with the purchase of the upgrade Hew Close Edit Info Calibration Channels Smart Mouse J Figure 3 1 3 1 Toolbar Pressing Calibration will bring up the Calibration Dialogue To start calibration click the Start button on the Calibration Screen The pump will turn on and the pressure display on the Calibration screen will show the output from the reference sensors
18. which independently measure the pressure in the chamber Once the maximum calibration pressure has been reached the pump will turn off and the chamber will return to atmospheric pressure as indicated by the sound of leaking air which is expected After an 8 second wait Calibration is finished and you can click the OK button to complete the process Pressing the Abort button during Calibration will stop the calibration process system will not be calibrated and the Calibration screen will remain open so that the process may be restarted Pressing the Cancel button will close the Calibration Screen without calibrating the system The calibration status of the probe Calibrated or Uncalibrated is shown in the status display near the top of the screen 3 1 4 Calibration Utilities Calibration utilities may be accessed via the Tools menu or Calibration dialog box 3 1 4 1 Calibrate In Vivo This control supports calibration of the probe relative to the elevated temperatures and aqueous environment of the body Before performing the In Vivo Calibration the probe must first be pressure calibrated see Section 3 1 3 A shallow basin of water set at 36 38 C is prepared by simply mixing hot and cold water and using a body thermometer The water should be thoroughly mixed for thermal uniformity and the catheter should be in a pressure free state e g lying on a flat surface both outside and inside the basin at the appropr
19. with the manometry readings to produce a more comprehensive study of the entire anatomy involved in the mechanism of swallowing The ManoScan modular system allows users to purchase a high resolution manometry system in the configuration that best meets their clinical needs In this manual the term ManoScan is used hereafter to refer to any configuration of the ManoScan modular system 1 1 Audience A thorough understanding of the technical principles clinical applications and risks associated with the ManoScan System is necessary before using this product Read the entire manual before using the system for the first time Make sure that only trained personnel familiar with all of the ManoScan System operating procedures use the system Manometric catheter placement requires skill and experience in esophageal and anorectal catheter intubations and insertions Use of the system is not recommended if the clinician lacks the required experience and proficiency 1 2 Purpose of the manual The purpose of this manual is to provide instruction on usage system setup troubleshooting and maintenance operations related to all the ManoScan system configurations This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved ManoScan User Manual GlyEN IMAGING Expanding the scope of Gl 2 Description Cleaning and Safety 2 1 Overview Various con
20. 3 Given Imaging All rights Reserved GlyEN IMAGING ManoScan User Manual Expanding the scope of Gl Manufacturer W MU es REF Reference number re order number catalog number MU Temperature limitation Type BF applied part Oo USB Data Connection This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved ManoScan User Manual USER ACCOUNTS e Windows User Accounts The ManoScan computer ships with a default administrative User Account ManosScan If separate User Accounts are desired they may be created However see important info on Read Write capability below e Read Write capability If User Accounts are created and denied administrative privileges ensure that each User Account has FULL READ WRITE ACCESS to the folder where our software resides C Program Files SSI The ManoScan and ManoView software requires read write capabilities to this folder to function properly DATA BACKUP amp PREVENTATIVE MAINTENANCE e Patient Files amp Custom Software Configurations It is highly recommended that each facility back up their patients and custom software configurations on a regular basis to a network archive drive and or external media such as CD ZIP drive tape etc The entire SSI folder C Program Files SSI can be archived as it contains all patient files custom configurations and program executables in it
21. C6 Figure 4 5 2 2 Electronic Interfaces to the A120 Module USB Type B data connection to PC Main Power Receptacle IEC 60320 C6 BEFORE CONNECTING Figure 4 5 2 3 Electronic Interfaces to the A200 Module This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved A4 IMAGING ManoScan User Manual Bending tie nno ojd GlgEN CONSULT BEFORE CONNECTING Figure 4 5 2 4 Electronic Interfaces to the A300 Module A in ManoScan CONSULT POWER REQUIREMENTS 12V 5A 65W Max CONNECTING DC Power Connector LED J Figure 4 5 2 5 Electronic Interfaces to the A400 Module 4 5 3 The ManoScan module front panel interfaces A400 pyn 4439 MSVnnnn A300 p n 3920 MSDnnnn MSD ILnnnn A200 p n 4189 MSZnnnn MSZ ILnnnn AR 3D p n 3885 AADnnnn A120 p n FGS 4374 MSM ILnnnn A100 p n 2550 MSMnnnn p n 1286 p n 2192 p n 2195 p n 800015 custom ESO SD Small guide wire tip AANnnnn APNnnnn p n 3886 EANnnnn Annn Pnnn Eg EPSnnnn Figure 4 5 3 1 ManoScan Module to HRM Catheter with device name part number and serial number formats This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 45 GlyEN IMAGING ManoScan User Manual Expanding the scope of Gl System or Electronics Modality Software Catheters Modular Enhancement ManoScan A120 HRM
22. E TROUBLESHOOTING AND REFERENCE INFORMATION ccssccssccssccssccssccssccsscessees 38 Bed MAINTENANCE AND REPLACEMENT a di GU Ea ENEE E AE Manta NEETA EENE ES EET O GNU 38 4 2 TRANSPORTATION STORAGE AND OPERATING RANGES ccecescscescecesceceecusescusnsceeeeeeeseusesseeessecesseeeseseueeseeseseeteeeueeseeeseeeess 38 4 3 MANOSCAN SYSTEM CART POWER ISOLATION STATION v sccecscesssscsssesesssesesesessececececececececucucacacacacacacacacasacacacavavavavavavavavans 38 AA ELECTROMAGNETIC COMPATIBILITY EMC au 31 aY Oe GOF YO CO SU GAD DLODI UO Gt A DNA DN DOS wn NF DARODD GURAD COLON a9 39 4 2 ELECTRONIC AND PRESSURE INTERFACES scacaicccssccurceudsectwenesteesadunenidawesenensestnadtveusedatiaduanesaasbacedsnetantdscutdantedensesdesuncentanitoeeyes 42 4 5 1 ManoScan SS CU ad TEE DDU EE UO AT A en T AT 42 4 5 2 ManoScan DT O E EE A O E E OEE 44 4 5 3 The ManoScan module front panel interfaces ei siscwnsuvscracasidsevescunvasendonvanseasueavesestvacusertdaussionsancsavanensseness 45 Bt DPERNTONOF ME a GA nn Gn SR ON UD OH OCR SN O ODS DYA ISO RNA 47 4 7 TECHNICAL CONNECTIVITY AND MAINTENANCE scccsvseceaccsecisaescaidedeccecnsgenveececcanecaeseauaidads dnennedecseiteaeatesieeeantiiedeanosmesemeaGeaceces 49 4 8 MANOSCAN SYSTEM TECHNICAL SPECIFICATIONS csececesesececscecevevscsvsesesvsesesusesesecececucececececucacacacacacacacacacacacacasavavavavavavavans 50 a TROUELE AOON eT UU ee esate cee ee GEUYN DEU NO EDN ED 51 4 9 1 ola go m
23. ESO ManoScan ESO ManoScan ESO Base pressure ManoView ESO EAN module ManoScan ESO SD Regular EAS ManoScan ESO SD Small EPS ManoScan AR ManoScan AR ManoView AR Regular AAN ManoScan AR Small APN ManoScan Z A200 HRM ESO Z_ ManoScan ESO ManoScan ESO Z Impedance ManoView ESO EAZ module ManoScan 3D A300 ManoScan ESO ManoScan ESO 3D 3D module ManoView ESO EAY ManoScan AR ManoScan AR 3D ManoView AR AAD ManoScan V A400 Augments all ManoScan ESO Video module modalities ManoView ESO ManoScan AR ManoView AR Figure 4 5 3 2 ManoScanTM System Modular Enhancements This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 46 GlgEN ManoScan User Manual Expanding the scope of Gl IMAGING 4 6 Definition of Symbols The symbols used in this manual and on the ManoScan system are defined in Table 4 1 Table 4 1 Symbols Used with the ManoScan System N Alternating Current A Attention see instructions for use Authorized representative in the European community Batch code RX o only By prescription only CE marking C Consult instructions for use Refer to instruction manual booklet eo Yoe a Lot number batch code This document contains proprietary information Source Given Imaging Copyright 201
24. F FY snsoeanscensceascsseuqasunssnearaiseuies ASD GRO ENEI RNA RHY ONS RRNIOOSA RY EER ARF EDUDS 17 3 ETUD iau RE nae A AN NEDD USES EE EDGE CAEWYD SEDD EA CYSGU 17 3 1 1 Cleaning ana 8 b5 14 eCG FFF ie Y TYN RA RA HAF TE RHEN FA CF EFE FN EEF FFON RP 17 3 1 2 Staring the Progra assen SA CR GN 17 3 1 3 Go O OIT F _ _ RF RR FIRE YF FFATRI AFF HE re CA RR ONY FFA E NR RT ee 17 3 1 4 CDG UO UL HC aE dd YF A RD YT FF ceed a FAD NF 18 oa Ae 9 cote T A DYN NY FFY ee FRAN NF ee CAFFO ree YF EN FYN ere ere DT ANAW UY AN YF EN 19 3 1 6 SLEE E B EE a FF x RHEN A NWY OFN NF RD NE CT NF TYN 20 3 1 7 Saving and Loading Settings User PrefereNnCes cccccsseesseccescccseeeesecceececseeseecesetsuauuseeceeeeseaueeseeeessssaqaness 20 32 CONTROLS AND DATA DISPLAY dcr cs screens des pees FFA FFYN FFO HEFFER FFF WN FFF FYR EREE EE FF TA FEDR FFF Aa Aa 21 3 2 1 Patent mT OPTI EI O TYR ANAT EEE EN E EOE YN NN RWYF FN YEWD 21 3 2 2 nea Tune Data DISD Oi FU ENNE OE AECT O AEE ENNO OEA 22 3 2 3 Tace Mode HU DDEL Cle CLO ud TO YD OU E E E Y OU OND wena eee 28 3 2 4 Video Recording Specii CONES us ai YO GR NE RNA YU WY AA OFO ASID NE FYDDA 29 3 3 PERFORMING A PROCEDURE ue eie tencauscnececenncssnnuenetGanesasedanudambeeaoneae io OO o GTA Air EUOG GOL UG OEOD GROG GOR daa 29 3 3 1 USING the Protocol FUNCTION viceccinosnecesent codaneaunanasesvensinaviseeonesavadsnersensanedvtaqausicseiet6 EENET 31 3 3 2 M
25. GlgEN ManoScan User Manual Expanding the scope of Gl ManoScan User Manual Modular Cart System A120 A200 A300 and A400 DOC 1963 03 February 2013 This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GlyEN IMAGING ManoScan User Manual Expanding the scope of Gl COPYRIGHT Copyright 2013 Given Imaging Ltd TRADEMARKS GIVEN GIVEN amp Design PILLCAM PILLCAM amp Logo PILLCAM EXPRESS AGILE RAPID RAPID ACCESS BRAVO BRAVO PH SYSTEM DIGITRAPPER MANOSCAN MANOSHIELD MANOVIEW ACCUTRAC ACCUVIEW and POLYGRAF ID are Trademarks and or Registered Trademarks of Given Imaging Ltd its subsidiaries and or affiliates in the United States and or other countries All other company or product names are the trademarks or registered trademarks of their respective holders All rights not expressly granted are reserved U S Patent 7 476 204 Rx Only Given Imaging GmbH a EC Given Imaging Ec REP Borsteler Chaussee 47 D 22453 3950 Shackleford Road Suite 500 Duluth GA Hamburg Germany 30096 supportEU givenimaging com supportUS givenimaging com 0123 This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GlyEN IMAGING ManoScan User Manual Expanding the scope of GI L Table of Contents INTRODUCTION seas necinacsecasewusennsewnson ss ownnsensesa
26. Imaging probe without causing damage 2 DO NOT use ultrasonic or other agitation while washing the probe autoclave use ionizing radiation use hydrogen peroxide or glycerin containing products to clean or disinfect the probe 3 DO NOT clean the probe with strongly alkaline cleaning agents such as Parson s Soap or strongly oxidizing agents such as peracetic acid or Hydrogen Peroxide Disinfectants such as Endo Spor Sporox and the Steris Washer use Hydrogen Peroxide as a primary agent in their formulation and will damage the probe 4 DO NOT use synthetic detergents or petroleum based soaps as these may be absorbed by the silicone and subsequently leached out in prolonged use 5 DO NOT use silicone fluid or grease to lubricate the passage of the probe through the nares or anus as these materials may swell and weaken the tubing and consequently compromise the integrity of the outer section of the probe 6 DO NOT immerse the probe beyond the Do Not Immerse demarcation line near the proximal end of the probe the end with the electrical connectors and vent orifice Doing so can damage or destroy the probe 7 DO NOT pull on the outer sleeve of the catheter probe while cleaning This can cause bunching of the outer sleeve and potentially damage the probe 8 DO inspect for tears or damage in the exterior of the catheter The inspection should be done before immersion of the catheter in reprocessing solutions to minimize further dama
27. L aM mg T E E 4 N TT A RC RA RS Y NF ER HA TN RY CYFR FR HE RE RF YY 51 4 9 2 POOTO OW OIC TSH FFAN RAN FFWR FRY HEFY NYFFRYN EM FFY YF FFURF NYFFRYN EF YDA MENT YR 51 4 9 3 EOS O OW er e AU YE NON Cn ORA en NN EA 51 4 9 4 ARM Catheter Calibration EITOL si GRAFF NAU EREA DROED SANG EE OD DO A DAFN 52 4 9 5 Pressure stops building in calibration chamber does not reach 300 mmHg and pump continues to run 52 4 9 6 Error installing HRM catheter Access Code Invalid sssccccccneesecccnsesseececscseccsssuuseesessuunecesssaneessssaunsess 53 4 9 7 Start button in Calibration window is grayed Out cccsseecccsesccccseseccsaseccseusessausecssausecssuusessaussessauesesaaanes 53 4 9 8 Esophageal Pressure with Impedance EAZ catheter presentations ccccsccccceeseececceeeeesecceeseesesseeenees 53 4 9 9 3D Anorectal AAD catheter presentations sccccccccsseeeccccceeecscccueeecssccuceecssceueecsssuuceessssuueessssseuseesessenes 54 4 9 10 ManoScan Software Presentations cccccssseseccccnsesecccssnseccecscseessessussecsssuueecessaunsecesauunsessssaunseessaaaasees 55 4 9 11 ManoView ESO and AR Analysis Software Error Messages sssssccccseesececcnessecssaeseecessaensecessauseeessasens 22 4 9 12 Bide Sc CW ic O UN COD UL aa RE YO aU DC O DARO O ees 56 By SPARE PART Sisccssaxtseceawcsaacsssutannessksensvaontaensasisacsunsoansesstsasan EE ORAU GRAU Adn GON DRUSU AGY GUARD EE GRO OORO 57 CONTACTING GIVEN IMAGING cein
28. OK The operator may either use the default file name shown or overwrite it with another name The default consists of any combination of patient name patient ID number physician name and date as specified in the Patient File Naming control under the Setup menu The default may be changed via this control Portions or all of the data record may be subseguently saved 1n additional formats see 3 5 2 The file extension for a ManoScan study is mvs or mvsar for a ManoScan AR study If video recording has been performed at the same time an additional file with the mvd extension is created in the same folder The folder location of the mvs mvsar and the mvd files must be the same for the user to be able to perform video file review later 3 4 After a Procedure 3 4 1 Cleanup Steps After the procedure is finished the catheter should be disconnected cleaned and high level disinfected If the disposable sheath is used it should be appropriately disposed of in accordance with applicable biological waste protocols Be sure to turn off data recording after the procedure has ended The software can be shut down by selecting Exit from the File menu If the data had not already been saved the program will prompt you to save the file before exiting This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 35 GlyEN IMAGING ManoS
29. Probe Uses to Date To select a probe double click the probe line or highlight the desired probe and click on the Select button 3 1 5 2 Install Uninstall Probe The operator can install or uninstall a probe from either the Setup menu or the Select Probe screen The Install Uninstall Probe screen will be displayed showing all currently installed probes along with the following information a Probe Number b Probe Serial Number c Number of uses to date d Probe Service Code The operator can choose to uninstall a probe by selecting the appropriate probe or install a new probe by clicking Install NOTE Uninstalling a probe will remove the probe installation parameters from the ManoScan system The probe can only be reinstalled after receiving a new access code from Given Imaging After clicking on the Install button beside a blank probe number you will be prompted to enter the Probe Serial Number and a Key Code The Key Code will be provided by your sales representative or Given Imaging For further installation instructions please contact Given Imaging 3 1 6 Protocol Setup The protocols provide a display of instructions to the operator automatically open relevant windows within the program and mark the data at appropriate measurement times The desired protocol may be selected via the Protocol control in the Setup menu A given protocol may be selected as the default via selecting it and then using the Sa
30. R GLY SY OSOD SRG OR DWG E NA EE ET UON DOR NW SWN OUNEnRGRu 58 This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GlyEN IMAGING ManoScan User Manual Expanding the scope of GI 1 Introduction The ManoScan modular system is a high resolution manometry HRM system used for gastrointestinal GI manometry The base system includes a manometric catheter probe a ManoScan HRM module A120 module and software for data acquisition and analysis Various probe configurations are available depending on the application esophageal anorectal manometry size regular small and catheter diameter The probes measure circumferential pressure using solid state Sensors ManoScan 3D module supports 3D catheters and probes for esophageal and anorectal studies The 3D catheters and probes measure circumferential pressure using solid state sensors When used in combination with the ManoScan HRM module and software this module enables 3D imaging of the esophageal and anorectal anatomy ManoScan Z module adds impedance measurement capabilities to the ManoScan system This module supports the use of esophageal manometric catheters with impedance rings and provides additional clinical data from the same clinical procedure ManoScan V module adds video acquisition capabilities to the ManoScan system The video input from a camera or fluoroscopy system can be synced
31. Set button Additional annotations are provided by simply pressing the indicated buttons for Sensation Urge and Discomfort You may also input any general annotation you like and save previously entered annotations using the lt lt Other function described in the previous section Next Balloon Fill cc et e ilee Figure 3 3 4 1 Annotation Controls 3 3 5 Technique and Catheter Precautions The following points should be observed when handling the catheter probe during clinical data collection 1 Zero the Channels The catheter pressure channels may be zeroed one last time immediately before patient intubation This is accomplished by pressing the Zero Channels button in the Calibrate dialog box while the catheter is in a pressure neutral state such as hanging freely in the air 2 Handle the probe with the lightest possible pressure The probe should always be handled by applying the lightest possible pressure During patient intubation the real time display should be monitored and the pressures applied by the operator should be kept below 50 mmHg and never exceed 100 mmHg the actual pressures at the sensor can be considerably higher since they involve much higher localized values than those indicated This will help assure more stable readings during the study 3 Assure the probe does not become doubled back Care must be taken to assure the catheter is not doubled back on itself while in the
32. ains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 13 GlyEN IMAGING ManoScan User Manual Expanding the scope of Gl 2 9 Catheter Cleaning and High Level Disinfection Instructions The Centers for Disease Control CDC recommends the use of a probe cover or condom to reduce the level of microbial contamination when a probe cover is available 1 It is also recommended that all catheters and probes require cleaning and high level disinfection to be performed after each use or as otherwise permissible by region country institution guidelines and or standards where the product is being used 1 Centers for Disease Control CDC Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 William A Rutala Ph D M P H David J Weber M D M P H and the Healthcare Infection Control Practices Advisory Committee HICPAC The following information is supplied as a guide for cleaning and high level disinfecting Given Imaging motility catheters and probes taken from the Catheter Cleaning and High Level Disinfection Instructions provided with each catheter 2 10 Catheter Care Precautions 1 Given Imaging DOES NOT perform disinfection of gastrointestinal probes prior to shipment Proper disinfection of a probe is the responsibility of the clinician conducting the procedure The following recommendations are intended to aid in the cleaning or disinfection of a Given
33. al patient data for training purposes Educational support Simulation mode provides graphic high resolution playback of normal and pathological motility with anatomical background This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 50 GlyEN IMAGING ManoScan User Manual Expanding the scope of GI 4 9 Troubleshooting 4 9 1 Calibration Errors During the calibration process the software will check for the following error conditions If any are found an appropriate error message will be displayed with a Restart Calibration button Calibration error Check that catheter is The chamber does not reach 300 mmHg after properly sealed in calibration chamber and that 30 seconds based on reference sensor all hoses are secure then restart calibration readings Calibration error Check that the pump is off The chamber does not depressurize to within the bleed port is clear all hoses are straight and 2 mmHg of the initial reference sensor value then restart calibration within 30 seconds after the pump is stopped Calibration Error reference sensor Restart Difference between the two reference sensor Calibration If error persists consult the readings at zero nominal pressure is greater manufacturer than 2 mmHg or more than 3 whichever is greater Calibration Error probe element baseline Baseline non repeatability is gt 2 mmHg Restart
34. an ESO Acquisition and ManoView ESO Analysis Anorectal ManoScan AR Acquisition and ManoView AR Analysis Temporal display High resolution contour with instant switching to conventional line traces Real time display Pressure profile and color bar modes superimposed on anatomy of esophagus or anorectum Real Time 3D Display Free Rotating real time 3 Dimensional cylindrical pressure display with instant switching to Vector Volume and 2D Views e Interface Clinical procedure controls touch screen compatible All controls keyboard and mouse compatible Patient data review Replay movie and static scroll through file review modes Analysis tools available in each mode In procedure support Split screen allows review of data from earlier in recording while procedure is ongoing Analysis tools Built in functions provide quantitative measures of pressures velocities and event periods Graphical tools facilitate localization of sphincters and PIP Automated and manual analysis modes with user configurable and on the fly report formatting o Chicago Classification Scheme Support o 3D Only Asymmetry calculations and plots Operator support Automated clinical protocol that steps technician through setup calibration and data collection manual mode also available for investigational or other special uses Training support Emulation mode supports use of all system features using actu
35. anding the scope of Gl IMAGING 7 ea meer Jo Liw tops CR gt anes A Comes 3 Network Connector Revove Seat omer EL Y Figure 4 5 1 2 ManoScan System Computer Interfaces This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 43 IMAGING GlgEN Expanding the scope of Gl ManoScan User Manual 4 5 2 ManoScan System Modules The electronic interfaces to the modules are shown in the Figures below WARNING To avoid risk of electric shock this eguipment must only be connected to a mains supply with protective earth Do not position the system in a way that would make it difficult to disconnect the system from the mains power supply Module Power Requirements A100 A 120 and A200 modules 90 230 Volts AC 50 60 Hz 40 VA Max A300 module is powered by the A120 module A400 module 12v 5A 65w Max USB Type B data connection to PC Manos can NO Model A100 POWER REQUIREMENTS 110 230 Volts Siero Scientific ieatruments inc les 4 CA 854 446 B4 2 Mode n UiA www siencini com Figure 4 5 2 1 Electronic Interfaces to the A100 Module USB Type B data connection to PC CONSULT Manoscan MANUAL EN Fare Model A120 CONNECTING POWER REQUIREMENTS 30 Volts 50 60 Hz 40 VA Max IP 20 Enclosure Sierra Scientific instruments Inc wow Sadie los Angeles CA Made n USA Main Power Receptacle IEC 60320
36. arking Catheter POSition ccccccccsescccssescccssesecsauseccsausecsaseeesauseessaueeesaensessaussessaueessaueessauseessaasessauassssges 33 3 3 3 Swallows and Other Events CSOPNAGCAL ssssseccccccnneeeseecesccccsesseeeesseeauuesseceseescsueeseeeesessauenseeeesessaaaeess 33 3 3 4 Balloon Fill and Other Annotations Anorectal ccccccccseeseccccceceecsccsueseccecsueceesescuceesessuueeesesseeeesessaeenses 34 33 5 Technique and Catheter Precautions ccsscccccsssecccssseccnsuseccseesecsaseessausesssuusessaunecesausecssuusessaussessausesssaages 34 3 3 6 wys NAY O DA O E ar AW YRR EEE ONIE NAF RR EFE FFO YFC Y EY WYR AOE 35 3A PRE i 818 RE ara aces ect oat cists nnn HF FFF FF HANNA HF FFR IF PFI HAWEN FFF REF NR FR HF ES HENRHYD 35 3 4 1 Ceanup SUCDS iei IA Cd BE HY NOFEL UWD GOF ARNO OODD ON UF 35 3 4 2 Reviewing Recorded DaLd uen FFF UF CEN GARFAN FF GE DEAL CFE elaine eee 36 gt i Me ec I CONTROLS yn YY Y RY EY I HE HN RA RY FN TH NN RF AF FFF WR YF 36 This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GlyEN IMAGING ManoScan User Manual Expanding the scope of GI 3 5 1 Analyzing Data using the Smart Mouse Function ccccsseecccccneeseececsnesseecssueseecessuueecssaauseecessaunsesessaansees 36 3 5 2 Bie ae e OLL OO P E A AR GR E NL E A E E 37 3 5 3 mua O MOTE a iu TEE E AT Y DO E EON E E E EEN EET 37 4 MAINTENANCE SERVIC
37. as asec ansassanaap wecewnaewes EE EEE 5 LL AUDENC a cee rence ces cre meee eee eee cere ce se ee ae ieee sagen ap eee a enero ween E T E 5 Le PURPOCE OF THE MANDAL see tencasseqeeaccccence ent EU GRO DDN GU YR OODD SCA DO TO DA EA AUD EANGU DS O DDd EG FD OUR 5 DESCRIPTION CLEANING AND SAFETY cs sisnonssessnv eens ssnsacusssusitsn use YRRU YMA YRRU YND SS UYS GN NOG UoUS nnd hyn E Hon LOU DON Onn NG DR 6 Lr sl NT FAAN EN FYR YN RI ee ee FD RE AFF RF ECH FA HAFAN ENTER HA HYN EEF DEFN 6 22 SV STEN CO ONES ccc ices cere ree cn EE cee FU FD ET DU 7 Deo ANID IC ATION OR l E aranne FEN HE FFF EF FFF FOTYFFYNTH FFF YE FI FFY FFR FN FA FYR HF FFY ONR PN TH I FAFN EE FERN PONY tee 8 Za CONTRAINDICATIONS OF USE GUDD GY Gw DUR Den Fn FOND UEN a a a A a a Ad NCF DNA Ow 8 T SEND ERE EVENT crear eee atic nets eens ete gree ace cee saree ces nee esa E AEE E EE 8 52 INSTAWATONAND CONNECTION Sie accencencesseniesaceuneceenssaie nU EDDAU O DDOI arane tensed aaea DOL y DDd 9 ea YVARNIN G HWFA FRAN HRN NN AF FN AE FANAU YA RA HA FRY YF A NF CHFAPANF FFA EU CHEI NU FE RA ANY FN EYN FE HN FF EFANS HAF FFAN FFCD EIN EF FFY 11 25 EF SL FEE AU TONS Sa Go UE OG Doa DUO AEF OS OCA O 12 2 9 CATHETER CLEANING AND HIGH LEVEL DISINFECTION NSTRUCTIONS 99 999 99YYnNY AER HE HER R RED HED R EE R EE REED R EEDD EEDD EDD EDN ED non 14 2 10 CATHETER CARE PRECAUTIONS O enis iG GYDA De RO UDA OE DDUON GORN SO DfES RAO EOG dn Gn O NUDD a 14 USING THE SY STEIL eiu ONN
38. ation Chamber and p n 2036 for AR 3D Calibration Chamber is tight around catheter to create good catheter seal give slight tug on catheter to see if it moves easily Seal knobs should be finger tight in order not to damage the catheter If two calibration chambers are connected to the A120 module make sure the unused one is sealed with the appropriate plug p n 150091 for the ESO Calibration Chamber and p n 150092 for the AR 3D Calibration Chamber Make sure Calibration Chamber Clamp Nut p n 1452 for ESO Calibration Chamber and p n 4280 for AR 3D Calibration Chamber is tight around calibration chamber tube p n 1455 to create a good seal Take off Calibration Chamber Seal knob and inspect small diameter gasket p n 1283 for ESO Calibration Chamber and p n 4278 for AR 3D Calibration Chamber Flip the This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 52 GlyEN IMAGING ManoScan User Manual Expanding the scope of GI gasket upside down to potentially enable a complete seal Replace the gasket if damaged Refer to Spare Parts Section Only for AAN APN catheters Make sure AR balloon fill locations are capped 6 Make sure all hoses connecting the calibration chambers to the A120 module are tight and the gaskets are making a good seal 7 If pressure still doesn t reach 300mmHg power cycle the system modules and computer and make sure that m
39. be selected in the catheter selection window for more information see section 3 1 5 3 1 3 Calibration The catheter must be calibrated prior to each clinical procedure The system must be powered on and running for at least five minutes before calibration is attempted Place the catheter in the Calibration Enclosure to a depth 42 45cm for the Normal Esophageal catheter 52 55 for the 3D esophageal catheter or 15 cm for the anorectal catheter Assure that the probe is at the correct depth before sealing Warning Catheter can be damaged if the seal knob is tightened directly over a sensor element Tighten the Seal Knob see Figure 3 1 1 2 finger tight Assure that the probe is properly positioned and click the Calibration button on the toolbar shown in Figure 3 1 3 1 The removable top seal knob on the pressure calibration chamber must have the step extension to enable proper gasket compression if both the regular and small diameter catheters are to be pressure calibrated on the same system The calibration chamber for the esophageal high resolution catheters including the pressure with impedance 3D esophageal and small diameter esophageal as well as regular and small high resolution anorectal is different from the calibration chamber used for the 3D anorectal probe If both types of catheters are being used with the same system setup care should be taken to use the appropriate seal grommet with the appropriate chamber For
40. c Discharge IEC 61000 4 2 1995 Al 1998 a oors should be wood concrete or Immunity A2 2000 Air discharge up to ceramic tile If floors are covered with 8kV Contact discharge up synthetic material the relative to 6kV humidity should be at least 30 This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 39 ManoScan User Manual GlyEN IMAGING Expanding the scope of Gl Guidance and manufacturer s declaration electromagnetic immunity The ManoScan system is intended for use in the electromagnetic environment specified below The TM ey A customer or the user of the ManoScan system should assure that it is used in such environment Immunity Test RF Radiated Fields Immunity Electrical Fast Transient Immunity Lightning Surge Immunity RF Common Mode Immunity Power Frequency Magnetic Field Immunity IEC 61000 4 3 2006 Portable and mobile RF Radiation Field Strength of communications equipment should be 3V m from 80 2500 MHz used no closer to any part of the M 1 80 AM 1 kHz anoScan system including cab es than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter See Note below table Interference may occur in the vicinity of equipment marked with the following symbol gt IEC 61000 4 4 2004 Corrigendu
41. can User Manual Expanding the scope of GI 3 4 2 Reviewing Recorded Data A previously saved data file can be loaded and replayed by selecting Review Patient File from the File menu The data may be played back via the Replay option or viewed as a static non moving record After finding the desired file select Open to display the data The display pressure reference atmospheric gastric or esophageal is set using the controls described in 3 2 2 3 the default is atmospheric 3 4 2 1 Replay The Emulation Replay function allows the data file to be reviewed in movie fashion Here the program emulates how these data would appear if it were being acquired in a clinical procedure Speed of the replay may be adjusted to multiples or fractions of normal speed 3 4 2 2 Static File Review The static File Review function immediately loads the entire patient record and allows it to be viewed using the scroll bar at the bottom of the main display The pressure profile is frozen at the state of the last record in the file unless the Smart Mouse tool left click see 3 5 1 2 is used in which case the pressure profile shows the data consistent with the red vertical guide line All data viewing functions are available in Static File Review 3 5 Other Tools and Controls 3 5 1 Analyzing Data using the Smart Mouse Function The Smart Mouse function provides on screen tools for examining patient data It is activated via the main toolbar
42. d Given Imaging personnel or product distribution representatives For portable systems training includes instructions on disassembly and setup Software installation instructions are provided on the software installation cases ManoScan A120 module Connections are provided on the front panel of the A120 for the high resolution probes The probe connections are color coded and keyed to prevent inadvertent swapping of the two connections The red dots on the catheter connectors are to be facing upwards at the 12 o clock position The main power to the system is supplied via the power cord located at the rear of the module A Universal Serial Bus USB port is provided on the rear of the module for interfacing with the PC Power is turned on and off via the power switch located on the front left side of the unit The module as a USB peripheral device should be turned on before powering up the computer Hose ports luer fittings are provided on the rear of the A120 module which enables connections to the calibration chamber assembly When using the A120 module along with the A300 module and 3D Anorectal probe follow the diagram in Figure 3 1 1 2 ManoScan Z A200 module The A200 Module adds an additional connector to support the impedance signal input from the high resolution manometry with impedance catheter The red dot on the impedance connector is to be facing upwards at the 12 o clock position The main power to the system is supplie
43. d cart system is supplied through an IEC 60601 1 compliant isolation station that is mounted in the cart This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GlyEN IMAGING ManoScan User Manual Expanding the scope of GI The A120 module configuration includes an electronic control box which serves as the interface for acquiring data from the probe and provides the logic for controlling the system The A200 module configuration includes an electronic control box which serves as the interface for acquiring impedance data from the probe and provides a means for direct communication with the host computer The A120 module configuration expands on this configuration by providing support for the A300 module expansion The A300 module configuration consists of an A300 electronic control box which serves as the interface for acquiring data from the probe and requires an A120 control box to provide the logic for controlling the system The A400 module configuration includes an electronic control box which consists of a video capture card and electronic circuitry to provide for communication with the host computer The software acquires and synchronizes as required the data from each of the control modules All power to the modules is supplied and regulated through an IEC 60601 1 compliant medical grade power supply that is incorporated within each of the independent modul
44. d via the power cord located at the rear of the module A Universal Serial Bus USB port is provided on the rear of the module for interfacing with the PC Power is turned on and off via the power switch located on the front left side of the unit The module as a USB peripheral device should be turned on before powering up the computer ManoScan 3D A300 module The A300 Module has two connectors to support the three dimensional pressure signals from the 3D probes The probe connections are color coded and keyed to prevent inadvertent swapping of the two connections The red dots on the catheter connectors are to be facing upwards at the 12 o clock position The additional hose port is for the AR 3D catheter balloon sensor as connected to an external pressure reference sensor housed in the A120 module Power is supplied to the A300 module by the A120 module which is turned on and off via the power switch located on the front left side of the A120 unit The main power to the system is supplied via the power cord located at the rear of the A120 module A Universal Serial Bus USB port 1s provided on the rear of the A120 module for interfacing with the PC The 3D pressure signal is relayed via the two hard wired cables from the A300 to the color coded connectors on the rear of the A120 module This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GlgEN IMAGING ManoScan U
45. e Start button and inflating the balloon To move to the next measurement type press the Finish button Optional Maneuvers This function is available to the clinician that would like to record maneuvers or measurements in addition to those listed above for example party balloon inflation Use the lt lt Other annotation control button to document the optional maneuvers This optional step may be skipped and the data collection concluded by pressing End End Remove the probe without touching the sensors Press End to terminate data recording clear the display save the recorded study and allow for a new patient This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 32 GI JEN IMAGING ManoScan M User Manual Expanding the scope of Gl 3 3 2 Marking Catheter Position When conducting an esophageal manometry procedure the operator should be sure to always update the catheter position with correct distance from nares nostril entrance as marked on the ruled section of the catheter probe This is done using the Catheter Position control shown in Figure 3 3 2 1 The arrows above and below increment or decrement the position by 0 5 cm A few moments after changing the position an annotation will appear on the main display at the time the catheter position last changed When using the Protocol function Standard EM protocol the control
46. e done It is advisable to crop out as much of irrelevant portion of video window as possible This will ensure that the software captures the video data at the highest possible frame rate Video recording can be switched On Off using the 9 icon but only after the pressure data recording has started Blue markers at the top of the Main Display indicate that video has been recorded at corresponding time instances Once the recording is started the region of interest can only be changed after the recorded video data is cleared by clicking Setup Video 3 3 Performing a Procedure Procedures may be performed by simply following the guided Protocol instructions and corresponding user interface buttons which open the appropriate control boxes automatically The Standard Esophageal Motility Std Esoph Motility protocol must be used to enable certain automatic features of the data analysis program for esophageal motility study Esophageal Motility Data collection may be via the Standard EM protocol or via the Free Measurement protocol Trans nasal intubation should be performed according to a procedure approved by the responsible physician Trans oral intubation is not recommended Standard patient positioning during catheter trans nasal intubation may have the patient in a sitting position in close proximity to the system within the length of the catheter being used and connected to the system Alternative patient positioning may be necessary to
47. e of the following measures Reorient or relocate the receiving device Increase the separation between the equipment Connect the equipment into an outlet on a circuit different from that to which the other device s are connected Consult the manufacturer or field service technician for help This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 41 GlyEN IMAGING ManoScan User Manual Expanding the scope of Gl 4 5 Electronic and Pressure Interfaces 4 5 1 ManoScan System PC Typical interfaces to the ManoScan System PC are shown in the Figures below The connector layout may vary depending on the PC model Please consult the provided PC documentation for specific connector layouts If the device is connected to a general network during procedure it should have isolation PC Power Requirements Power Supply Wattage 240W AC Input Voltage Range 90 264VAC AC Input Current low AC high AC range 4 0A 2 0A AC Input Freguency low AC high AC range 47Hz 63Hz PC Back Panel Connectors BACK PANEL CONNECTORS 1 Mouse Connector 7 Keyboard Connector ewe Comener 7 Secme Diao Comes amer AI LA Lu o Figure 4 5 1 1 ManoScanTM System Computer Interfaces This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 42 GlgEN ManoScan User Manual Exp
48. e system standard IEC 60601 1 1 If in doubt consult the technical services department or your local representative 4 When the disposable sheath is used it must be secured to the probe to prevent accidental aspiration The clinician must ensure both the catheter and the sheath are removed from the patient upon extubation While not likely it is possible for the sheath to slip off of the catheter during removal 5 The disposable sheath should not be used for proximal gut studies or pressure with impedance studies 6 DO NOT immerse the probe in liquids beyond the Do Not Immerse label on the probe Immersion of the connectors or vent tube located at the Y near the proximal end of the probe can damage or destroy the probe 7 This system contains a type BF applied part It is not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 17 GlyEN IMAGING ManoScan User Manual Expanding the scope of Gl 2 8 Safety amp Precautions l 2 The ManoScan probe must be calibrated prior to each use TAKE CARE to handle the manometric catheter probe and ManoShield in such a way as to avoid even minor nicks and cuts The probe can be damaged by excessive gripping bending or pulling Hold the catheter with the same force you would use to h
49. ector One IEC 320 with dual fuse block Fuses 6 3 Amps 230 VAC Output Voltage 115 120 230 240 VAC IEC 320 15 Amp Output Current 5 2 Amps 2 6 Amps Output Voltage Selections 115 or 230 VAC Outlet Connectors Six IEC 320 15 Amp connectors 4 4 Electromagnetic Compatibility EMC Guidance and manufacturer s declaration electronic emissions The ManoScan system is intended for use in the electromagnetic environment specified below The customer or the user of the ManoScan system should assure that it is used in such environment Conducted Emissions Group 1 Class A EN55011 2007 0 15 MHz 30 00 MHz Radiated Emissions Group 1 Class A EN55011 2007 30 0 MHZ 1000 MHz The ManoScan system is suitable for use in all establishments other than Power Line Harmonics EN61000 3 2 2006 Up to 40 domestic and those directly connected Harmonic to the public low voltage power supply net work that supplies Power Line Flicker EN61000 3 3 1995 A2 2005 buildings used for domestic purposes Less than or equal to 4 Maximum Relative Voltage Change Value of D T less than or egual to 390 for more than 200 ms Guidance and manufacturer s declaration electromagnetic immunity The ManoScan system is intended for use in the electromagnetic environment specified below The customer or the user of the ManoScan system should assure that it is used in such environment Electrostati
50. ed according to a procedure approved by the responsible physician Anorectal Manometry Using Anorectal Catheter and Associated Software Data collection may be via the Standard Anorectal Manometry protocol Probe introduction and positioning should be performed according to a procedure approved by the responsible physician Standard patient positioning during catheter insertion may have the patient on a flat surface such as a bed in a left lateral position with knees and hip flexed in close proximity to the system within the length of the catheter being used and connected to the system Alternative patient positioning may be necessary to facilitate catheter insertion such as squatting The clinician may be positioned between the system and the patient to adequately insert the catheter in the patient The catheter should remain connected to the system to visually aid insertion by using the pressures presented in the acquisition software For the study the patient may remain on the flat surface in a left lateral position with knees and hip flexed according to the procedure specified by the responsible physician The probe should be inserted to an appropriate depth so that the anal sphincter is positioned in the center of the contiguous sensor section of the array If using the AR 3D probe the alignment bump on the handle must be kept at the same reference angle to the patient throughout the procedure Care must be taken not to allow the catheter t
51. ement frame Press End after the swallow is complete or allow the frame to auto close after the specified duration typically 20 30 seconds d End After 10 swallows additional swallows may be completed as described above or you may press Finish to end the swallow sequence After finishing press End to clear the display save the record and allow for a new patient 3 3 1 2 Free Measurement Protocol This protocol allows the operator to perform general testing according to a physician approved procedure The protocol facilitates the entry of patient data calibration recording and subsequent closing saving of the data file It does not prompt for specific measurement activities This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 31 GlyEN IMAGING ManoScan User Manual Expanding the scope of Gl 3 3 1 3 Standard Anorectal Manometry Protocol The Standard Anorectal Manometry protocol follows the sequence below a Start Press the blue bordered Start button and follow the on screen instructions to Enter Patient Information perform Calibration and intubate patient Resting Pressure Frame s After patient acclimation press Start to begin the measurement frame The measurement frame will close automatically after the specified duration typically 20 30 seconds Squeeze Frame s Press Start to begin the squeeze measurement
52. ent contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 25 ManoScan User Manual 3 2 2 3 Pressure Profile Display Modes Anorectal Program Gl EN IMAGING Expanding the scope of GI For the anorectal program the same options of data display are available as for the esophageal program Toward the top of the display are shown one small probe or two for regular probe channels of the sensors near the tip of the probe which may be used to measure balloon or rectal pressure as appropriate Anatomical markers are available to adjust the positions of the upper and lower boundaries of the anal sphincter When the anatomy is displayed these adjust the location of the depiction of the anal canal It is the user s responsibility to assure that these markers are positioned properly relative to the pressure data if they are to be used for analysis The anorectal pressure profile in various display modes is shown in Figure 3 2 2 7 12 12 4 11 M q 1i 10 J 9 5 47 6 4 5 4 a 4 3 Z a a4 l Fressure Profile Snach 0 co co Mode Anatom Mode Line Trace Anatomy Off Pressure Profile Sns Ch Mode Color Map Anatomy Off Mode Line Trace Pressure Profile Sns Ch Col Mode Anatomy On Pressure Profile Sns Ch Mode Color Map Anatomy On Figure 3 2 2 7 Available Pressure Profile Displays Ano
53. er is the only catheter connected Do not have a catheter connected to the A120 and the A300 modules at the same time Verify catheter is correctly inserted and completely sealed in the pressure calibration chamber ensure no sensors are pinched in pressure calibration chamber gasket a Esophageal catheter insertion to the gt CAL lt mark on the ruled tubing b Anorectal catheter insertion balloon fill tube is almost touching the top of the chamber twist knob If a ManoShield is used verify that ManoShield is applied correctly and has been applied for less than 20 minutes Refer to esophageal ManoShield Instruction card a A properly applied ManoShield may be applying constrictive pressure on the sensor s identified in the calibration error message make an additional attempt to pressure calibrate the catheter by pressing Start again in the Calibration window If different sensors fail each time tune catheter calibration utilities tune system and try again a Whenever a tuning is performed the catheter should be hanging in the calibration chamber with no pressure exerted on the sensors Should the inability to successfully pressure calibrate the catheter persists please contact your regional support representative 4 9 5 Pressure stops building in calibration chamber does not reach 300 mmHg and pump continues to run l Make sure Calibration Chamber Catheter Seal knob p n 4256 for the ESO Calibr
54. erage of the data relative to the current time The current values of the Atmospheric Gastric and Esophageal pressures relative to the selected reference pressure are also shown in the lower left region 2 When reviewing previously saved patient data files in a static mode the 30 second average is taken relative to the time associated with the current pressure profile view In that case the pressure profile displays the data associated with the last record in the file or to the red vertical line obtained by clicking on the main display when Smart Mouse is active This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 27 GlyEN IMAGING ManoScan User Manual Expanding the scope of GI 3 2 2 6 Scale Controls The scales of the various displays can be changed by clicking on the appropriate button as listed in Table 3 1 Use the slider to set the new scale value and then click outside of the slider to hide it Figure 3 2 2 9 By selecting All for the Line Trace scale control all traces are scaled accordingly Table 3 1 Location of Scale Controls Figure 3 2 2 9 Scale Adjustment Slider Line Trace Limits 3 2 3 Trace Mode Channel Selection Trace Channel Selection may be done by either manipulating the markers on the pressure profile plot or selecting the channels on the Trace Display Channel Control screen via the Channels button 3 2 3 1 Channels Bu
55. es 2 2 System Components WARNING To avoid risk of electric shock this equipment must only be connected to a mains supply with protective earth A complete ManoScan modular cart system consists of the following items e Manometric Catheter Probe e A120 Module e Computer e External computer peripherals keyboard mouse etc e Touch screen display monitor e Calibration chamber e Power isolation station e Software All components are integrated into the supplied cart for easy mobility A complete ManoScan modular system consists of the following items e Manometric Catheter Probe e A120 Module e Calibration chamber e Software In the Modular System configuration the modules will interface with an external Personal Computer PC supplied by the user customer The user customer shall ensure that the PC is in compliance with the governing safety standards and meets medical grade power isolation requirements This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved GlyEN IMAGING ManoScan User Manual Expanding the scope of GI The ManoScan Z configuration will include an A200 module a motility pressure catheter with impedance and software This configuration can be easily added to either the modular cart system or the modular system as desired by the customer The ManoScan 3D configuration will include an A300 module a high def
56. figurations of probes are available The specifications of the probes are listed in Table 2 1 Table 2 1 Specification of High Resolution Manometry HRM and 3D Manometry Catheters Probe Type Number of Sensors 36 Spacing between Diameter sensors ManoScan ESO Catheter with 36 Extended Tip EAN ManoScan ESO Catheter SD Small EPS ManoScan ESO Catheter SD Regular EAS Pressure 36 Impedance 1 channels and 19 rings ManoScan ESO Z Catheter EAZ 128 Including 32 ManoScan ESO 3D Catheter EAY HRM Sensors and 96 3D Sensors ManoScan AR Catheter Small APN ManoScan AR Catheter Regular 12 including AAN 2 balloon sensors 257 including ManoScan AR 3D Probe AAD 1 balloon reference sensor Pressure 10mm Impedance 20mm Proximal to Distal 10mm Between HRM Sensors 7 5mm Between 3D Sensors Circumferential within 3D sensor area 1 5mm 4mm Circumferential The system is supplied as either an integrated cart system basic ManoScan a portable system integrated with a laptop PC or as a stand alone module that connects to a host PC The ManoScan cart system includes an A120 Module with options of accompanying A200 Module and or A400 Module or ManoScan A120 with options of accompanying A200 Module and or A300 Module and or A400 Module together with a computer with software program for control of the system All power to the integrate
57. ge of the catheter to parts not designed for fluid exposure 9 DO Reference the Catheter Cleaning and High Level Disinfection Instructions provided with each catheter This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 14 GlyEN IMAGING ManoScan User Manual Expanding the scope of GI 10 DO Reference the ManoShield Instructions for Use 11 The ruled tubing and Y connector section of the probe may be cleaned with an Antiseptic Towelette or Germicidal Disposable Cloth Adhere to the manufacturer s guidelines when using Antiseptic or Germicidal towelette or cloth Given Imaging recommends the following cleaning cloths and or towelettes 11 1 PDI Sani Cloth Plus germicidal disposable cloth 11 2 Benzalkonium antiseptic BZK towelettes 11 3 PDI Super Sani Cloth Plus Germicidal Wipes 11 4 Accel PREVentionTM surface disinfectant applied to sterile wipe cloth or gauze This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 15 GlyEN IMAGING Expanding the scope of Gl ManoScan User Manual ED sea Grommet Seal Knob Tube Seal Collar Calibration Chamber Housin Calibration g Tube Figure 3 1 1 1 ManoScan AR 3D Calibration Chamber Disassembly for cleaning Tube Seal Collar Seal Knob Seal T 7 Grommet Calibration
58. he A120 while the AR 3D catheter is connected to the A300 module 3 Should the issue persist please contact your regional support representative 4 9 10 2 ManoScan opens in Simulation Mode 1 Verify USB cable connections between modules and PC with corresponding device driver detection in the Windows OS Device Manager 2 Verify Windows user account is an Administrator account Default ManoScan PC user login is an Admin account Or ensure user account logins have read write capability enabled to the C Program Files SSI folder or there may be issues writing to program file directory and saving studies 3 Should the issue persist please contact your regional support representative 4 9 11 ManoView ESO and AR Analysis Software Error Messages 4 9 11 1 Invalid class string Error Message when generating report 1 Verify Microsoft Office Word is installed on PC ManoView ESO and AR Analysis Software require Microsoft Office Word to generate reports 2 Microsoft Office Word software must be registered trial versions and viewers are not supported 4 9 11 2 Server threw an exception Error Message when generating report 1 Ensure Microsoft Office Word is not open and running in the background if it 1s close it via the Task Manager Task Manager gt Processes gt Winword exe End process 2 Ensure Microsoft Office Word can launch without errors or messages a new Word document page is displayed T
59. he user has the option to display hide impedance data on main display by toggling Show Z Hide Z button located on the lower left side of the application The impedance data is superimposed and synchronized in time with the pressure data An example of pressure impedance contour plot is shown in Figure 3 2 2 4 The impedance traces have the similar layout as that of pressure traces and can be viewed by toggling Display Mode button Figure 3 2 2 4 Contour plot of pressure impedance data displayed in Main Display If 3D type catheters are being used ESO 3D or AR 3D a 3D view button will be available in the bottom left corner of the screen When toggled it will cycle through different 3D visualization modes allowing for detailed real time 3D visualization The view will cycle through configurations of the 3D window shown in Figure 3 2 2 5 Figure 3 2 2 5 3D View Window showing 3D Visualizations available in ManoScan This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 2 4 GlgEN IMAGING ManoScan M User Manual Expanding the scope of Gl 3 2 2 2 Pressure Profile Display Modes Esophageal Program The Pressure Profile display normally shows the current real time pressure values which can be viewed as a smooth curve or as a color map Toggle between the two by clicking the Mode button under the pressure profile An approximate anatomical map is
60. his document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 55 GlyEN IMAGING ManoScan User Manual Expanding the scope of GI 3 Ifthere is a pane that says word has recovered the following document it will hang up 5 6 7 report generation close that pane then close the report template and reopen Microsoft Office Word to ensure it no longer presents Delete any report rtf files They may be found in the C Program Files SSI ManoView Temp folders Ensure all the report templates launch without errors Report templates can be found in the C Program Files SSI ManoView Setup folders Should the issue persist please contact your regional support representative 4 9 11 3 Exception Occurred Error Message when generating report l 3 Verify Microsoft Office Word is installed on PC ManoView ESO and AR Analysis Software require Microsoft Office Word to generate reports Close application and re open it by running the executable as administrator right click on the exe file and select Run as administrator Should the issue persist please contact your regional support representative 4 9 11 4 External Exception EEFFACE Error Message when analyzing manometry study l Please contact your regional support representative 4 9 12 Blue screen when starting Computer l a en ae oe Contact your facility s IT
61. iate times Follow the on screen instructions to complete this process In Vivo calibration should be performed at least once a week Important Notes on In Vivo Calibration 1 Probe must be at room temperature at the beginning of the procedure If the probe has been handled or immersed in warm water it should be left in room ambient temperature for at least 5 minutes before In Vivo Calibration 2 Probe should have no applied pressure prior to immersion and after immersion Assure the probe is lying flat with no kinks or external objects touching it 3 Assure that water is well mixed for thermal uniformity Do not immerse probe until instructed to do so This will lead to erroneous calibration This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 18 GlyEN IMAGING ManoScan User Manual Expanding the scope of GI 5 Do not use more than 4 cm water depth to avoid water pressure induced errors 6 Do not apply protective ManoShield sheaths for or during in vivo calibration with the exception of the AR 3D catheter which will have the sheath applied during in vivo calibration 7 For the 3D esophageal catheter for best results after inserting the catheter in the warm water allow the catheter to stabilize for approximately one minute prior to pressing Next 3 1 4 2 Apply In Vivo Compensation Apply In Vivo Compensation applies the the
62. inition motility pressure catheter and software This configuration can be easily added to either the modular cart system or the modular system The ManoScan V configuration will include an A400 module a motility pressure catheter and software This configuration can be easily added to either the modular cart system or the modular system as desired by the customer 2 3 Indications of Use The ManoScan system obtains a high resolution and or three dimensional mapping of pressure levels within the tubular organs of the human gastrointestinal tract and optionally pressure with impedance levels within the tubular organs of the human upper gastrointestinal tract Specifically this includes the pharynx esophagus proximal gut stomach duodenum anus and rectum It is used in a medical clinical setting to acquire the pressure and impedance levels and store the corresponding data for visualization and analysis The real time data as well as the analysis information can then be viewed by a physician for diagnostic and analytical purposes 2 4 Contraindications of Use The use of the ManoScan system for pharyngeal esophageal motility study and proximal gut gastric duodenal manometry is contraindicated for the following a patients with an inability to tolerate nasal intubation b patients with significant bleeding disorders for whom nasal intubation is contraindicated and c patients with a known esophageal obstruction preventing
63. ll rights Reserved 12 GlyEN IMAGING ManoScan User Manual Expanding the scope of GI 16 17 18 19 20 21 22 25 24 with a fingernail or sharp object which may create high localized stress When applying uniform pressures such as via an air pressure chamber do not apply pressures greater than 300 mm Hg Regular and Small Diameter Esophageal Catheters To avoid applying clamping pressure on a sensor element that could permanently damage it assure that these esophageal catheters are inserted to the labeled depth of 42 cm no more than 45 cm into the calibration chamber 3D Esophageal Catheter To avoid applying clamping pressure on a sensor element that could permanently damage it assure that the 3D esophageal catheters are inserted to a minimum depth of 52cm no more than 55 cm into the calibration chamber High resolution anorectal probes To avoid applying clamping pressure on a sensor element that could permanently damage it assure that the anorectal catheters are inserted into the calibration chamber to just below the balloon fill tubes Avoid severe buckling bending of all catheters no more than a 5cm radius Cleaning of the cart modules catheter case and tray and calibration chamber external may be accomplished using the referenced above process note 11 If a disposable sheath is used the probe should be cleaned and high level disinfected prior to each subsequent use Reference the Ca
64. m 1 2006 Level I Power line pulses of 2kV direct I O line pulses of 1 Mains power quality should be kV that of a typical commercial or hospital environment IEC 61000 4 5 2005 Power line surges of 2k V common 1kV differential mode IEC 61000 4 Portable and mobile RF 6 2003 A1 2004 A2 2006 communications eguipment should be Level I 150 kHz 80 MHz used no closer to any part of the ManoScan system including cables 3 Vrms 1 kHz 80 amplitude Pn nL Y E than the recommended separation modulated distance calculated from the eguation applicable to the freguency of the transmitter See Note 1 below table Interference may occur in the vicinity of eguipment marked with the following symbol o IEC 61000 4 8 1993 Power frequency magnetic fields A1 2000 Level I Helmholtz should be at levels characteristic of a coil 50 Hz and 60 Hz to typical location in a typical 3 amps rms per meter commercial or hospital environment This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 40 GlyEN IMAGING ManoScan User Manual Expanding the scope of GI Guidance and manufacturer s declaration electromagnetic immunity The ManoScan system is intended for use in the electromagnetic environment specified below The customer or the user of the ManoScan system should assure that it is used in such environmen
65. n the A200 module USB cable Open the software and check for the impedance signal c Or power cycle both computer and modules making sure to turn on modules before computer Open the software and check for the impedance signal 5 Verify presence of Z signal by placing the catheter in a basin with tap water or saline solution after a successful pressure calibration and prior to patient intubation This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 53 GlyEN IMAGING ManoScan User Manual Expanding the scope of Gl 6 Note The impedance data will not appear if ManoShieldTM is used and or if the No button to display pressure only is chosen after an EAZ catheter selection 7 Should the inability to successfully display an impedance signal persist please contact your regional support representative 4 9 8 2 No Impedance Signal on some channels 1 Not all channels show an impedance signal purple color when placing the catheter in a basin full of saline solution 2 Should the inability to successfully display an impedance signal persist please contact your regional support representative 4 9 9 3D Anorectal AAD catheter presentations 4 9 9 1 Pressure doesn t build to 300 mmHg 1 The AR 3D and standard HRM catheter pressure calibration chamber orange and green connector hosing must be securely T connected plumbed together and attached t
66. ng All rights Reserved 36 GlyEN IMAGING ManoScan User Manual Expanding the scope of GI 3 5 1 4 Data Across 3D Records By left clicking on the 3D Lay Flat Visualization display and dragging between two points of interest time dependent data across multiple sensors is displayed The pressure and position at the start and endpoints of the drag line are displayed the differences in these variables as well as maximum minimum and mean pressures within the enclosed areas are displayed 3 5 2 Save Selected In addition to the normal saving of the recorded data a selected portion may be saved for subsequent review and analysis This may be accomplished both during initial data acquisition and subsequent review of saved patient files The desired data are selected by drawing a rectangular area in the Main Display while in Contour mode using the smart mouse diagonal drag function see 3 5 1 3 If no data is selected the data displayed on the main screen is saved You may then choose Save Selected under the File menu and select from one of the following three available data file formats 1 Text file The range of data are saved as a tab delimited text table where the rows are the data records for each sample time the first column contains the sample times and the subsequent columns contain the pressure values mmHg for each sensor in the range selected from distal to proximal and pressure values of the two reference sensors If the im
67. ng of 8 sensors circumferentially distributed along the radius giving 96 individual sensing points at 7 5mm on center spacing and 1 6mm 45 deg spacing between adjacent radial sensors 32 Standard Diameter sensors at 10mm on center spacing giving 384 additional pressure points covering the remainder of the esophagus 4 2mm diameter AR 3D Probe 3D anorectal 256 individual pressure sensing channels 16 3D sensing rings evenly aligned axially each consisting of 16 sensors circumferentially distributed along the radius 4mm spacing between adjacent sensor rings 2mm 22 5 deg spacing between adjacent radial sensors 10 75mm Diameter sensing length 7cm Catheter Probe Accessories ManoShield ESO latex free disposable sanitary sheath ManoShield ESO SD latex free disposable sanitary sheath ManoShield AR latex free disposable sanitary sheath ManoShield AR 3D latex free disposable sanitary sheath Anorectal balloons latex free 150cc 400cc amp 600cc Performance Frequency response Capability gt 100Hz system response limited by catheter scan rate shown below Minimum Scan rate 37Hz Regular EM 66Hz Regular AR 77Hz Small AR 10Hz AR 3D 20Hz ESO 3D Output resolution 0 1mmHg Sensor channel uniformity 10 lt 1 mmHg at 0 50 mmHg 10 lt 2 mmHg at 51 300 mmHg Sensor non linearity calibration residual 2 mmHg 0 100 mmHg 2 of reading 100 300 mmHg mean SOFTWARE Esophageal ManoSc
68. ng the Given Imaging equipment warranty e Saving Patients to Network Drives If desired patients may be saved to network drives with no issues However it is important to note that SSI s software still reads writes data to the local machine during report generation INTERNET CONNECTIVITY e Internet Connectivity The ManoScan M computer does not need Internet connectivity to perform procedures and analyze data properly If desired the computer may be connected to the Internet without voiding the Given Imaging equipment warranty e Website Restrictions If Internet connectivity is permitted only to connect to certain websites ensure the following websites are viewable o www Givenimaging com Given Imaging Website o www logmein123 com Remote Assistance tool Optional See specifics below REMOTE ASSISTANCE e Remote Assistance LogMeln Rescue is the web based remote assistance tool used by Given Imaging to aid in troubleshooting and technical support The ability to utilize this tool is not required to perform procedures and analyze data properly e HIPAA Compliance LogMeln Rescue satisfies all requirements of HIPAA The document Meeting HIPAA Compliance Rules with LogMeln Rescue is available upon request e VPN client software Specific facility VPNs are not supported by Given Imaging for troubleshooting or technical support remote assistance as LogMeln Rescue provides a secure encrypted easy to use and
69. nt Information screen by simply selecting the name and then Load This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 21 GlyEN IMAGING ManoScan User Manual Expanding the scope of Gl 3 2 2 Real Time Data Display Real time pressures and impedance if available are viewed on two different display areas the Main Display which shows the pressure or pressure impedance history and the Profile Display which shows the current pressure or pressure impedance distribution see Figure 3 2 2 1 D cpsaesus 8 2 sa ll E m as aan o Jes EF a B s SH s BH BH o BE Main Display in Contour mode Pressure Profile in Line Trace mode Main Display in Contour mode Pressure Profile in Color Map mode Figure 3 2 2 1 Pressure Display Areas Shown in Various Modes esophageal and anorectal programs This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 22 GlyEN IMAGING ManoScan User Manual Expanding the scope of Gl 3 2 2 1 Main Display Modes The ManoScan system offers the unique capability of viewing data from all high resolution sensor channels simultaneously as a contour map in real time as seen on the left of Figure 3 2 2 2 or as line tracings selectable for any location along the sensors as seen on the right Bocnsesasua
70. o excessively bend or move during this procedure Balloon inflation may only be performed with air and not liquid to prevent catheter damage Instructed patient expulsion of the HRM and 3D catheter probes is not recommended Anorectal Manometry Using 36 Channel Catheter and Associated Software Anorectal Manometry may be performed using the 36 channel system Data collection may be via the Free Measurement protocol or by simply using the controls manually Probe introduction patient and catheter This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 30 GlyEN IMAGING ManoScan User Manual Expanding the scope of GI positioning should be performed according to a procedure approved by the responsible physician The probe should be inserted to a depth of 10 15 cm Care must be taken not to allow the catheter to excessively bend during this procedure see 2 8 item 3 At the physician s option a small balloon catheter may be introduced alongside the manometric probe such that balloon inflation is detected in the distal pressure sensors 3 3 1 Using the Protocol Function The protocol function provides a display of instructions to the operator and automatically opens relevant windows within the program It also marks specific time periods called measurement frames in the record during which relevant data are being collected These frames are necessary for subsequent a
71. o the A120 module The AR 3D pressure calibration chamber will not work by itself 2 Make sure both pressure calibration chamber knobs are tight around the catheter and the plug and the balloon fill hoses are securely connected between the probe and the modules Check the 3 way stop cock to ensure the syringe connection point is closed off and there is free passage of pressure between the probe and module 3 Ensure the ManoShield AR 3D collar is snapped in place on the probe to make a good seal with the AR 3D pressure calibration chamber Refer to the ManoShield AR 3D instruction card 4 If pressure still doesn t reach 300mmHg power cycle the system modules and computer and make sure that modules are USB connected and powered on before the computer is done booting up otherwise synchronization communication issues may exist between the modules and the computer Attempt calibration again 5 Should the inability to successfully pressure calibrate the catheter persists please contact your regional support representative 4 9 9 2 AR 3D Catheter does not calibrate 1 If different sensors fail on multiple calibration attempts Verify there are no twists or wrinkles in sheath and re Tune the probe 2 If all sensors in a row or column fail verify that the cables linking the A300 and the A120 are very tight this requires a flat head screw driver 3 lf Element B error message is displayed Balloon sensor calibration error
72. odules are USB connected and powered on before the computer is done booting up otherwise synchronization communication issues may exist between the modules and the computer Attempt calibration again 8 Should the inability to successfully pressure calibrate the catheter persists please contact your regional support representative 4 9 6 Error installing HRM catheter Access Code Invalid 1 Re enter the catheter serial number and Key Code and press Install 2 Should the inability to successfully install the catheter persists please contact your regional support representative 4 9 7 Start button in calibration window is grayed out 1 The pressure reference sensors offset and gain values in the respective Acquisition software installation GLOBAL CFG file need to be adjusted 2 Please contact your regional support representative 4 9 8 Esophageal Pressure with Impedance EAZ catheter presentations 4 9 8 1 No Impedance Signal on all channels 1 Ensure the A200 is powered on and the impedance connector is attached 2 Open the ManoScan Acquisition software and ensure an EAZ catheter is selected and the Yes button to display both pressure and impedance is chosen USB communication data light on the A200 module is ON or flickering 4 If the USB communication data light on the A200 module is OFF the computer is not detecting A200 a Close the ManoScan Acquisition software b Unplug and then plug back i
73. og component video The video input can be of non standard high resolution and frequency typically from fluoroscopy equipment b BNC Supports monochrome or gray scale analog video The video must be of standard television specifications PAL or NTSC c S Video Supports monochrome or gray scale analog composite video The video must be of standard television specifications PAL or NTSC typically from endoscopy equipment ManoScan V can also be used to acquire video from USB based devices e g webcams The A400 module is not required for such acquisition if the USB input is directly connected to the computer the appropriate video input device can be selected within the software 2 Warnings 1 Ensure all personnel responsible for operating the ManoScan system are properly trained prior to use 2 Please follow the on screen instructions and those in Section 3 3 to calibrate probe and verify its proper function before each clinical use 3 All accessory equipment connected to the analog and digital interfaces must be certified to the respective IEC standards i e IEC 60950 for data processing equipment and IEC 60601 1 for medical equipment Furthermore all configurations shall comply with the system standard IEC 60601 1 1 Any person that connects additional equipment to the signal input part or signal output part configures a medical system and is therefore responsible that the system complies with the requirements of th
74. old a fragile object The probe should never be bent in a radius less than 2 0 cm nor pulled with a force greater than 1 N equivalent to 0 1 kg or 0 2 lb Tight bending can also occur during clinical data collection if the probe becomes doubled back on itself This condition is readily recognized via the real time display and rectified by withdrawing the catheter See 3 3 5 Failures of the probe due to excessive force or tight bending are not covered under warranty DO NOT use any probe that has cuts or openings in the probe body 5 DO NOT disconnect the probe from the module by pulling on either the cable or the probe Grasp 10 11 l ET 14 lO the probe only by its connectors when making connections DO NOT keep the catheter in a detergent or disinfection solution for prolonged periods The catheter should remain in such solutions no more than 125 of the time recommended by the disinfection manufacture to complete the disinfection process Prolonged disinfection soakings may permanently discolor the outer covering and make it tacky to the touch DO NOT manipulate the probe using any endoscopic instruments Such devices have great potential for rupturing the outer catheter sleeve DO NOT damage or scratch the external gold impedance sensor rings as found in the ManoScan ESO Z impedance catheter DO handle the probe gently and assure that no objects are inadvertently placed on it and that it is not pulled
75. pedance data is also recorded it 1s saved after the after the last pressure data column The files are saved with a txt extension 2 3D data points file The range of data is saved as the time sensor number and pressure mmHg for each sample These data may then be opened using commercial 3D plotting programs e g to generate 3D mesh plots The files are saved with a p3d extension 3 Patient examination file The data for the time duration of the diagonal drag area are saved in a format that may be subsequently viewed in the ManoView software either data acguisition or analysis The files are saved in the applicable program with an mvs or mvsar extension 3 5 3 Simulation Mode A simulator is provided that allows the replay of patient data in an interactive fashion for demonstration and tutorial purposes This is accessed via the Tools menu under Simulation Mode The simulation control allows for selection of Background and Event data The Background plays in a loop i e it restarts automatically after ending while the Event plays only once per command If a Background file is playing when an event is commanded the Event if selected will begin at the end of the current Background and the Background will resume after the end of the Event By using one respiratory cycle as the Background and a swallow sequence as the Event high resolution pressure movies of esophageal motility may be shown with
76. pment The seal grommets O rings gaskets of the Calibration Chambers may be subject to wear after prolonged use Replacement parts are provided with the system and are available from your regional sales representative or Given Imaging Support Representative 4 2 Transportation Storage and Operating Ranges The ManoScan system must be transported and stored in conditions that fall within the following Temperature Transportation Storage 40 C to 65 C Catheters Operating 10 C to 40 C Modules Operating 10 C to 35 C Relative Humidity Transportation Storage 10 to 93 RH Operating 20 to 80 RH Altitude Transportation Storage 15 2m to 10668m 50ft to 35 000ft Operating 15 2m to 3048m 50ft to 10 000ft 4 3 ManoScan System Cart Power Isolation Station WARNING To avoid risk of electric shock this eguipment must only be connected to a mains supply with protective earth Do not position the system in a way that would make it difficult to disconnect the system from the mains power supply The ManoScan System Cart power isolation station specifications Power 600 VA Input Voltage 115 120 230 240 VAC 50 60 Hz This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 38 GlyEN IMAGING ManoScan User Manual Expanding the scope of GI Input Current 5 2 Amps 2 6 Amps Input Voltage Configuration 115 or 230 VAC Input Conn
77. rectal Program This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 26 GI JEN IMAGING ManoScan M User Manual Expanding the scope of Gl 3 2 2 4 Pressure Impedance Profile Display Esophageal Program In addition to the profile features discussed in Section 3 2 2 2 above an impedance trace and a bolus depiction of impedance data is also displayed in this mode An example of peristaltic wave contraction and bolus movement as viewed in pressure impedance profile view is shown in Figure 3 2 2 8 18 5 Wi rynx A he 00 Stomach 1500 0 51 0 06 Figure 3 2 2 8 Bolus movement in a normal swallow as viewed in pressure impedance profile display 3 2 2 5 Display Pressure Reference The display pressure reference is available for the esophageal program and 1s set using the control at the lower left of the main display The value is set according to the current 30 second average of the desired reference atmospheric gastric or esophageal at the time the control box is closed This reference is for display purposes only and does not affect the recorded data By selecting the Gastric control below the pressure profile the Gastric and Esophageal position pointers are displayed These may be moved vertically to select the position at which the gastric and esophageal reference pressures are taken The baseline pressures are calculated from a 30 second av
78. rmal compensation established during Calibrate In Vivo This should generally be applied whenever the catheter is in the body and removed whenever the catheter is out of the body for accurate viewing of the real time data The compensation is saved with all recorded data however and automatically applied when the data is later reviewed so there is no effect on the recorded data whether the compensation is turned on or off during data acquisition When using the automatic protocol function see 3 1 6 In Vivo Compensation is automatically applied and removed at the appropriate times 3 1 4 3 Tune System Tune System identifies characteristics of a particular catheter so that its performance may be optimized This process may be undertaken if the pressure calibration is not successful or if instructed to do so by Given Imaging personnel The catheter should be placed in the calibration tube in the Same way as when performing a normal pressure calibration see 3 1 3 Select Tune System and you will see some changes in the real time display as the system goes through this process of approximately 90 second duration The probe should then be calibrated immediately following the tuning process Once tuning is performed the system keeps track of the proper tuning and other parameters for each catheter see 3 1 5 1 3 1 4 4 Mask Interpolate Mask Interpolate allows the system to ignore or mask the data of one or more pressure and or impedance
79. s lower folder hierarchies e Disk Cleanup Once a month This utility looks for old temporary files that can be removed and are taking up space Start gt All Programs gt Accessories gt System Tools gt Disk Cleanup e Disk Defragmenter Once a month This utility reorganizes the files on the hard drive in a more efficient way SO accessing them is quicker Start gt All Programs gt Accessories gt System Tools gt Disk Defragmenter THIRD PARTY SOFTWARE PROGRAMS e Virus Scan Software If Virus Protection Software is desired it may be installed to the ManoScan computer without voiding the Given Imaging equipment warranty However this software must be procured and maintained by each facility Given Imaging claims no responsibility for these software installations o Scan Times f Virus Protection is desired and installed ensure that Virus Definition updates and full system scans DO NOT occur during ManoScan procedures e Other 3 Party Software Some 3 Party software programs may void SSiI s equipment warranty Please consult Given Imaging Technical Support before installation of 3 Party software GlyEN IMAGING Expanding the scope of GI 4 7 Technical Connectivity and Maintenance INTRANET CONNECTIVITY e Intranet Connectivity The ManoScan M computer does not need Intranet connectivity to perform procedures and analyze data properly If desired the computer may be connected to an Intranet without voidi
80. sensors The adjacent sensor data are used to linearly interpolate across the masked sensor and its data are not seen on screen or in the stored file This creates a virtual channel and the system otherwise behaves as normal This function is useful to eliminate data from a non functioning sensor in One or more non essential locations The location of the masked pressure channel is indicated by the following symbol in the Pressure Profile display The location of the masked impedance channel is indicated by the same symbol but colored purple 3 1 5 Probe Setup The Select Probe screen will display during startup when more than one probe is installed on the system You must assure that the probe serial number as indicated on the body of the probe matches the selected probe in the computer program If the probe is changed between procedures the new probe must be selected using the Select Probe Screen via the Setup menu This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 19 GlyEN IMAGING ManoScan User Manual Expanding the scope of GI 3 1 5 1 Select Probe The ManoScan system has the ability to support an unlimited number of probes Each of the installed probes will be listed on the Select Probe screen Setup menu along with the following information for each a Probe Number According to the order installed b Probe Serial Number c Number of
81. ser Manual Bodley io nno efl Figure 3 1 1 1 Connections and Interface Features of the ManoScan Modules from bottom to the top ManoScan A120 Module ManoScan Z A200 Module ManoScan 3D A300 Module and the ManoScan V A400 Module When using the A120 module along with the A300 module and 3D Anorectal probe follow the special Air Hose Connections diagram in Figure 3 1 1 2 Connect White Luers with White Jumper To Colored Luers on 3D Anal Rectal Calibration Chamber To Colored Luers on Secure all T MVS Calibration Chamber Joints Figure 3 1 1 2 Air Hose Connections on A120 A300 Combination when using the 3D Anorectal Probe This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 10 GlyEN IMAGING ManoScan User Manual Expanding the scope of GI ManoScan V A400 module The A400 module should be connected to the computer and power turned on before switching on the computer The connections from A400 module to the computer is made using the custom extender cable supplied with the system A400 module provides for three types of video input connectors any one of which can be used at a time to feed video data from an external video source such as fluoroscopy or endoscopy eguipment The three types of connectors and the corresponding input video format supported by them are a DVI Supports color monochrome or gray scale anal
82. shown by clicking the Anatom button after the UES and LES markers have been adjusted This feature projects an anatomical depiction based on the positions of the landmark indicators that the user positions by examination of the on screen data The various possible configurations of the pressure profile are shown in Figure 3 2 2 6 and Figure 3 2 2 7 The position indicators for the Upper Esophageal Sphincter UES Lower Esophageal Sphincter LES and Pressure Inversion Point PIP and upper and lower margins of the LES can be adjusted by dragging their markers on the Pressure Profile display This is most useful when the Main Display is in contour mode where horizontal lines facilitate localization of the anatomical landmarks After adjusting the position of the LES UES and PIP markers their respective positions are noted as annotations on the main display relative to their position from nares based on the current Catheter Position setting It is the user s responsibility to assure that these markers are positioned properly relative to the pressure data if they are to be used for analysis Pharynx 40 Fr Harez EEN _FrNares Fr Nares ca Mode cot poten lenis ca maon Mode Line Trace Mode Color Map Mode Line Trace Mode Color Map Fr Hares ol EEN gd sosse Anatomy Off Anatomy Off Anatomy On Anatomy On Figure 3 2 2 6 Available Pressure Profile Displays esophageal program This docum
83. t Voltage Dips and Short IEC 61000 4 11 2004 Level I Mains power quality should be that of Interruptions Voltage Dips of gt 9590 3090 a typical commercial or hospital and 60 Interruptions of gt 95 environment If the user of the ManoScan system requires continued operation during power mains interruptions it is recommended that the ManoScan system be powered from an un interruptible power supply or a battery Note 1 Recommended Separation Distances a 0 15 80 MHz D 3 5VP b 80 800 MHz D 1 2XP c 8 2 5 GHz D 2 3 VP Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacture and D is the recommended separation distance in meter m This equipment has been tested and found to comply with the limits for medical devices to the EN 60601 1 2 These limits are designed to provide reasonable protection against harmful interference in a typical medical installation However there is no guarantee that interference will not occur in a particular installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to other devices in the vicinity If this equipment does cause harmful interference to other devices which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or mor
84. theter Cleaning and High Level Disinfection Instructions for use included with each catheter or probe The calibration tube seal knob seal ring and any other reusable calibration accessories should be cleaned a minimum of once per month in a laboratory dishwasher with water temperature not exceeding 180 F 82 C see Figure 3 1 1 1 and Figure 3 1 1 2 The clear tube should be dried internally with a clean non scratching cloth to prevent water spotting If the calibration chamber is contaminated via introduction of a non disinfected probe or other means the tube and seal knob should be disinfected using the same guidelines as described above for the probe The seal grommet typically white in color or translucent see Figure 3 1 1 1 and Figure 3 1 1 2 should be replaced Although the probe does not come into contact with the calibration housing during normal use it is recommended that the calibration housing be disinfected using topical spray should inadvertent contamination be suspected Care must be taken to minimize the amount of spray introduced so as to keep the clear pressure tubing dry Do not soak or clean the calibration tube gasket and seal knob grommet with any Cidex product The deterioration of the gasket material is likely when in contact with these disinfecting solutions Heated water not exceeding 180 F and a mild soap solution should be sufficient Unauthorized software must not be added to the system This document cont
85. tton Esophageal Program Press the Channels tool bar button to display the Trace Display Channel Control dialog You can then select channels to be displayed in either Free Selection mode or the Landmark Reference mode by simply clicking the corresponding button To setup the way the channels are displayed in either mode select that mode and then select Setup For Free Selection setup all available sensor channels will appear and you may simply check which ones you wish to be displayed For Landmark Reference mode esophageal program only you may select multiple channels at specified distances from the LES and UES Anorectal Program Press the Channels tool bar button to setup the way the trace channels are displayed Simply check which ones you wish to be displayed including the balloon rectal pressure sensor channels and these will be displayed in the Pressure Profile 3 2 3 2 Manipulating Channels via the Pressure Profile The channels for trace display may be selected by graphically manipulating the channel pointers in the pressure profile display When the main display is in contour mode vertical movement of a channel in the Pressure Profile causes a horizontal guideline to appear in the main display to assist in positioning the channel location relative to the contour data In Free Selection mode move the chevron shaped pointers up and down to select the position of a given channel This document contains proprietary information Source Gi
86. utomatic data analysis and report generation and are not provided during manual data collection they may be added later however using the ManoView analysis program Simply press the blue bordered button in the upper right area of the screen and follow the on screen instructions to step through the protocol sequence You may navigate backward and forward through the protocol using the Go To button There are currently two standard protocols available In the descriptions below the term Frame is used as a shorthand for Measurement Frame 3 3 1 1 Standard EM Protocol The Standard Esophageal Motility protocol follows the sequence below a Start Press the blue bordered Start button and follow the on screen instructions to Enter Patient Information perform Calibration intubate patient and record catheter position b Landmark ID and Sphincter Pressure Measurement Frame After patient acclimation press Start to begin the measurement frame The measurement frame will close automatically after the specified duration typically 20 30 seconds c Swallow Frames Press Start to begin the first of 10 swallow measurements During this period a measurement frame will be drawn for each swallow event Provide the physician recommended amount typically 10 ml of room temperature water or other liquid such as saline solution for ESO Z studies or food and ask the patient to swallow shortly after the start of the measur
87. ve Settings function described in 3 1 7 The protocol function is described in 3 3 1 3 1 7 Saving and Loading Settings User preferences The settings of the current display may be saved and later reloaded so that the program will display the data in the current configuration Among the parameters that are remembered and reloaded are maximum and minimum scale values time base settings current protocol display modes channels selected and channel mode Free Selection v Landmark Reference and channel position unit selection You may save these under a desired name via Save Settings in the Setup menu The settings are reloaded and the program immediately assumes the corresponding display configuration using Load Settings If the current configuration is saved as Default the full file name becomes Default cft the program will start in this state the next time This allows you to This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 20 GlyEN IMAGING ManoScan User Manual Expanding the scope of GI customize the start up viewing configuration and have other viewing configurations for specific needs 3 2 Controls and Data Display 3 2 1 Patient Information Before starting a procedure patient information should be entered The Patient Information screen is accessed via New on the Toolbar File menu or when a procedure is
88. ven Imaging Copyright 2013 Given Imaging All rights Reserved 28 GlyEN IMAGING ManoScan User Manual Expanding the scope of GI In Landmark Reference mode esophageal program only the channels are held in fixed position relative to the LES and UES as set in the Channels control When the LES or UES pointers are moved in the pressure profile the channels move with them thus the channels at fixed distance from the anatomical landmarks are easily found by positioning the landmark pointers with the main display in contour mode 3 2 4 Video Recording Specific Controls The video recording specific controls are only available for ManoScan V system ManoScan V allows multiple video inputs to be connected any one of which can be selected from the Video Device option available under Setup Menu Other options say to change video display size may be available from the Setup Video control depending on the video device connected The video window can be opened by clicking the Video button located below the Main Display Zoom icons can be used to change the size of the video display The user may set the region of interest on the display by either dragging the borders of the video window or by using zoom controls followed by clicking the Crop icon 4 The cropped out region will not be recorded upon the starting of data recording The Uncrop button may be used if readjustment of the region of interest is to b
89. will automatically display the approximate catheter position when the up or down arrows are first contacted after entering the patient information This reduces the amount of time required to enter the actual position Catheter Position ia Figure 3 3 2 1 Catheter Position Control esophageal program 3 3 3 Swallows and Other Events esophageal You can quickly mark the occurrence of Wet Swallows Dry Swallows and Gag by pressing the annotation buttons on the right side of the screen Figure 3 3 3 1 Wet Sul Dry 5 HH lag lt lt Other H Figure 3 3 3 1 Annotation Controls Clicking the Other button allows you to record the occurrence of other events by entering their name into the dialog box that appears Figure 3 3 3 2 A pull down list function allows you to reuse annotations so that they do not need to be typed in each time Chest Pain z Ok Figure 3 3 3 2 Other Annotation Control 3 For Anorectal studies there is no need to enter the catheter position This document contains proprietary information Source Given Imaging Copyright 2013 Given Imaging All rights Reserved 33 GlyEN IMAGING ManoScan User Manual Expanding the scope of GI 3 3 4 Balloon Fill and Other Annotations Anorectal In order to annotate the record with the balloon volume in anorectal studies select the desired volume using the up down arrows in the control shown in Figure 3 3 4 1 and press the

ManoScan User Manual

Contents

Download Pdf Manuals

Related Search

Related Contents