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EMS-XL USER MANUAL

1. Chapter 9 Offline Utilities OVerView a an aan LETS evs BEE Re 9 1 Configuration Setup Utility 2 eee ee eee 9 1 Archive Utility xu secto pOY Eoi RUP is Er ES 9 5 Storing Patient D ta 2 olere er b em es merge 9 5 Restoring Patient Data lleeeeeeeeee eens 9 9 Locating Archived Case Studies lllllleelel eese 9 12 Configuring a Target scce 22 240 022 lie hM v RE vr 9 14 Index iv Mennen Medical Chapter 1 What You Should Know Intended Use of the EMS XL System The EMS XL is a computerized Cardiac Electrophysiological Measurement System designed for conducting regular or experimental electrophysiology EP studies The EMS XL System is intended to be used for performing computerized Cardiac Electrophysiological and Ablation procedures The EMS XL is intended for sale as a system for performing Cardiac EP clinical studies Using the EMS XL System Before commencing patient monitoring always perform the following routine checks 1 Check the system for signs of any mechanical damage 2 Check all external leads plug ins and accessories 3 Check all functions of the instrument needed to monitor the patient and ensure that the system is in proper working order Do not use the EMS XL System for any monitoring procedure on a patient if you identify features which demonstrate impaired functioning of the system Contact the hospital biomedical engineer or a Mennen Medical Ltd service e
2. Multiple Pages ECG 3x4 10 seconds of Holter Channel Active Only in Holter mode minute Holter Active Only in Holter mode e 2 channels Holter Active Only in Holter mode Close To close the popup menu EMS XL User s Guide 6 55 Working with Templates The EMS XL allows the user to compare waveforms with predefined templates To use this mode you first need to store template waveforms label the templates and then call any of the templates for comparison with the waveforms on the RT or NRT display Creating a Template You can create a 600 msec template by clicking the Save Template icon on the NRT screen ruler or the Save Template Tab Holter Save Template Ablator setup Snapshot set 4 gt r Template Comparison Save save Save Template 01 Rename Template 02 a Start I M Load Template Type Figure 6 1 Save Template Tab You can create a template storing 600 msec as follows Trigger RT Stored 600 msec from the Run Time screen Only when the RT is in Triggered mode Start Screen Stored 600 msec from the start of the Review NRT screen Start Marker Stored 600 msec from the location of the marker on the Review NRT screen 6 56 Mennen Medical Working with Templates Marker in Middle Stored 300 msec before and 300 msec after the location of the marker on the Review NRT screen The template receives a default label Template 01 or 02 etc Thi
3. Surface ECG Channels Used to add or remove Surface ECG channels displayed on the RT Monitor Also used to change a specific channel color as described below ECG channels All Spacing Sequence I I III aVR aVL aVF Vi v2 v3 v4 v5 V6 Figure 5 3 Surface ECG To change the Surface ECG channel display Click on any of the buttons in the three columns under Surface ECG to toggle between the add remove functions for a specific channel Click All to toggle between the add remove functions for all surface ECG channels Click on Spacing to cause the currently viewed ECG channels to be evenly repositioned on the RT Monitor Click Sequence to cause the currently viewed ECG channels to be repositioned numerically on the RT 5 8 Mennen Medical Building a Configuration monitor Note Channel identification label names may be edited for instructions see Channel Select Review Screen on page 5 11 To change a specific channel color 1 Doone of the following Right click a currently activated channel button A drop down palette of colors appears Choose a color Right click the Color column of the channel in the active channels list Multi set hd j 14 Channel Filter B U Gam CMor II 1 I 00 B 10 2 Hu 0 05 B 10 m 005 B 10 I R 005 B 10 5 aVL 005 B 10 6 aP 005 B 10 7 V1 005 B 75 8 605 PB 10 9 3 005 B 10 10 v4 005 B 10 1 005 B 10 12 v 005 B 10 1
4. Change the Color of a channel Perform Clipping of traces EMS XL User s Guide Set the channel to be the Stimulator Output for A or V stimulations To Access the Channel Settings controls 1 Right click or double click on any channel button refer to Figure 5 1 on page 5 5 The Channel Settings window opens i i Color Clipping 5 Stim emn 2 Proceed to the instructions for changing the required channel setting Label Invert Filter Color Gain and or Clipping see Channel Select Review Screen on page 5 11 To set the same Settings to multiple channels 1 Select the channels To select a range of channels Click in the first channel you want to include in the selection and then hold down Shift and click the last channel you want to include To add channels out of sequence to a selection Hold down Control and click the channel you want to add 2 Right click the selected channels to open the Setup dia log box 3 Proceed to the instructions for changing the required channel setting Label Invert Filter Color Gain and or Clipping see Channel Select Review Screen on page 5 11 Settings are applied to all selected chan nels 5 6 Mennen Medical Building a Configuration Channel Select Run Time Screen The left side of the RT Channel setup panel for RT screen window contains two groups of selection controls Surface ECG on the left and Intra ca
5. Close the panel Done before trying to activate any other function The Notes window is divided into three main areas enabling you to append pre defined Notes to the Case and or create new Notes as required Pre defined Notes enables selection of a ready made note from a list of Notes already defined in the system Notes contains a table with two columns Ref Time automatically displays the current time offset from the start of the Case Comments may be used for a pre defined or user defined note EMS XL User s Guide 6 49 Selected Note editable text field for editing a note Note For an explanation of the Notes window buttons refer to Table 6 1 below Table 6 1 Notes Buttons amp Functions Button Function e Appends a new note to the Case H Inserts a note in a specific location in the selected Notes list For example used to insert a note at the appropriate time when medication has been administered Insert Used to edit the contents of a Note clicking Change A Change accepts the edited text D Used to Delete a Note from the Case elete EE E Closes the Notes window Done 2 Select the required Note from the Pre defined Notes list and click Append to add it to the Notes list OR click and drag the required Note from the Pre defined Notes list to the Notes list Note A Note may be added at a specific location in the Notes List e g the
6. Controls Parameters i i i mies dk ORS Sets Chanel Settings Erna P Ret Tan Events and Stimuli Window Lev Rel Trigger Select Rel Pe FE gt a lee F AN Diy Pasties ITS IH An Fot TT ami d 3 Shortcut Screen p dE Sese seje m kelm oo lt p Surface ECG Surface Channel ECG Selection Channels Intra cardiac Channel Selection Intra Repositio pe Buttons Channels Zoom Control Channel 28 353 Clip Zoom 1 Control D q Ruler Time Scroll Event Scroll Backwards in Time Scroll Forwards in Time Event Time Figure 4 4 EMS XL Review Screen after Patient Registration As can be seen in Figure 4 4 the greater portion of the Review Screen comprises the Traces Display in the center the areas above and to the left of the Traces Display provide you with easy access to the various menus and buttons as described in the following sections 4 16 Mennen Medical Review Screen Designed for the execution of programmed stimulation protocols working with one or more extras and in conjunction with auto snapshot the Review Screen offers a triggered display at up to 300 mm sec focused around the last extra The last extra or with shorter intervals the last two stimuli is displayed and the screen refresh is triggered each time by the last extra A pair of electronic calipers is used to indicate the time of atrial or ventricular activation
7. To build a category 1 In the Channel set up panel press Categories see Fig ure 5 2 EMS XL User s Guide 5 19 The Config Setup window opens Config setup Choose category name x Add DU x r Config setup Choose configs Configs in categories aaa 12 lead ablation All leads zm baseline baseline CS BP Cryo Ablation Default Diagnostics kkkk Mennen my NEW_CONFIG RF Ablation Close 2 Choose a name for the Category you are building and enter to the text box at the top of the panel Click Add 3 Choose the configurations that will be under this cate gory and use the arrow to move the category from the available category list in the left pane to the right pane 4 Click Close Note Itis also possible to choose a category form the drop down list and edit its contents or to delete it Mennen Medical Setting Up Tachycardia Detection Setting Up Tachycardia Detection You can setup the the EMS XL to automatically detect onset of arrythmia according to your preferences Use the controls under the Tachy tab in the Review screen to set the system parameters for the detection and recognition of tachycardia Stimulator Pacing Display BP Tach y Alb Rate Detection 520 ee Minimum of cycles 5 m cycles s E d lp Cog Refractory Rate Detection Set the required Rate Detection value in msec A Heart Rate faster than this fo
8. 2 0 mA 2 0 msec AV Delay 59 mSec Sound On K Note For more details see Using the Stimulator on page 6 15 4 18 Mennen Medical Review Screen Stimulator Controls Function Click to access the Stimulator program See page 6 23 Stimulation panel Actual stimulation Click to access Stimulator Threshold setup i See page 6 21 Stimulation threshold Actual stimulation casn Click to access the Last Stimuli tab Slim Click to access A V coupling interval setup for stim ulation of both Atrium and Ventricle Click to access Stimulator pulse Atrium setup pa Click to access Stimulator pulse Ventricle setup EMS XL User s Guide 4 19 Table 4 2 Stimulator Tool Bar Buttons and Functions Button Function Click to jump to Auto Snapshot Setup Stimulator setup sub menu si Click to activate Sinus Node Recovery Time SNRT measurement This is a one time procedure testing the recovery of the sinus node For details see The SNRT Procedure on page 6 45 Review Screen Controls Toolbar Bal Abel Ser Table 4 3 Review Screen Tool Bar Buttons amp Func tions Button RA Controls trace thickness Function This button has 4 states Click once for thick trace lines on NRT click twice for thick lines on RT click 3 times for thick lines to appear on both screens click 4 times to return to regular tr
9. Click to re position the channels vertically and to re distribute them evenly on the screen Right click arranges channels in sequence with equal spacing Copy RT Click Copy RT to copy the Run Time Copy RT screen channel setup to the Review Screen 4 32 Mennen Medical Zoom Control Zoom 1 1 Heview Screen Use Zoom control combo box to select required zoom option Selections may be made from the following pre defined values 1 8 1 6 1 4 1 3 1 2 1 1 2 1 3 1 4 1 Note The selection list may not be edited the default value is 1 1 Note It is possible to change the zoom directly without entering properties of the channel by buttons UP and DOWN of the keyboard or by means of scroll button of the mouse If channel label is selected it s color is grey purple Channel Clip and Zoom Control Event Time Channel Clip amp Zoom Use Channel Clip and Zoom control to clip and zoom the view of a specific Surface ECG or Intra cardiac ECG channel Click to access the appropriate windows Use the slider to set the time for playback of a specific time The time from the start of the case is displayed in the window EMS XL User s Guide 4 33 Printing You can print from the Run Time Monitor screen see Printing from the Run Time Monitor Screen on page 6 51 and from the Review NRT screen see Printing from the Review Screen on page 6 53 Note Due to difference in pri
10. Picture gt From File and select the image file to insert The saved snapshot is inserted into the report To view all saved snapshots 1 Right click the Save shapshot to graphic file but ton to show window for reviewing all saved snapshots Lost pure 11 Date1 032009 1014 S 6 40 Mennen Medical Using the Stimulator To load a saved picture Figure 6 19 Load Picture window 1 Click Load Picture to open a directory for searching saved pictures Insert Text To insert text on the Review Screen 1 Click the Insert Text icon 7 A window opens at the top right corner of the Review screen 2 Using the mouse set the focus to the Text window 3 Use the keyboard to print the required text 4 Using the mouse place the cursor arrow at the required location of the text 5 CTRL right click the mouse to place the text on the screen Note To clear the text click the Insert Text icon again EMS XL User s Guide 6 41 Note To draw a line on the screen press Ctrl then click and drag to place the line where required Sinus Node Recovery Time SNRT Overview The Sinus Node Recovery Time SNRT is measured by driving the atrium with a stimulation rate greater than the spontaneous rate The procedure includes atrial driving for a user defined period SD default is 30 seconds and measuring the interval from the last atrial stimuli to the first sinus activity It is expe
11. above Set the required interval in msecs Set the location for the extra in this example Atrium Click to activate the Stimulator The Stop button becomes enabled EMS XL User s Guide 6 21 Click to stop the Stimulator stop The Go button becomes enabled Atrium Setup Use this panel to set the electrode that would be used for Atrial stimulation and to set the atrial stimulation pulse duration and current Stimulator Setup Stimulator Pacing Display BP Ta gt Ventricle Threshold Last Stim SNRT 4 gt Front ront 2 gt mA Figure 6 9 Attrium Setup Window Ventricle Setup Use this panel to set the electrode that would be used for Ventricular stimulation and to set the Ventricle stimulation pulse duration and current Stimulator Setup Stimulator Pacing Display BP Ta gt Figure 6 10 Ventricle setup Window WARNING For each new case the output electrodes for Atrium and Ventricle have to be set manu ally When a new case starts the stimulation output will always become Front 6 22 Mennen Medical Using the Stimulator Last Stim Stimulator Setup Stimulator Pacing Display BP Ta _4 Atrium Ventricle Threshold SNRT 4 Min Last Stim Bm mSec u Figure 6 11 Last Stim Setup Window Use this panel to set the minimal interval of an automatic stimulation To set the minimum automatic stimulation interval 1 Us
12. desktop of the workstation 2 Click the Archive tab 9 12 Mennen Medical Archive Utility i EMS XL Archive Elx File Help Store Restore Archive Configuration Filter LastName 0 FirstName Archive 2 05 2008 28 05 2006 Casel Patientid Study 12 05 2006 x 28 05 2006 x Voume Refresh Filter Clear Fiter Lastname Firstname Patientld Caseld Study date Archive date Volume Path File name Gazoz 32893789 73289_04_2 14 02 2006 27 02 2006 C tst 1Gazoz32893789 7 Gazoz 32893789 73289 04 14 02 2006 27 02 2006 tst Gazoz32893789 73 Add to restore list Delete 3 Select the field fields for filtering archived data 4 Click Refresh Filter The list displays study cases fitting the filter 5 Click Add to restore list to add the items to the restore window Note You can click Delete to delete the the archiving entry from the data base 6 You can now proceed to restore the selected cases 7 If the archived item is on a DVD you need to insert the DVD into the DVD drive EMS XL User s Guide 9 13 Configuring a Target You can configure the target archiving devices for the Archive utility You can configure up to 2 different archiving devices which can be network drives or DVD drives or one of each The DVD drives are used for burning DVD The default target is the DVD drive To configure a target 1 Double click the Archive utility S
13. ze Security 7987897 Date Of Birth 11 11 1961 Note There are four fields for which entering information is obligatory see below all other fields are optional Patient First Name Patient Last Name e Patient I D Case I D Note When entering the Case I D if a separator is required use underscore and not dash For example case 276 of year 2003 should be written as 276_2003 Activate the relevant radio buttons Weight Height and Sex 4 Under the Study Related Information select the required Study Type For example General Syncope VT WPW VF etc Study Related Patient Information Study Date Study Type 1704 2000 Gevcat sway x GeneralSudy yw Study Faculty ln ia Fellow p Technician Note The Study Date is automatically inserted on Start New Case EMS XL User s Guide 6 5 Enter additional information as required Faculty Fellow Technician Physician 5 Check that all details entered in the window are correct then click the StatNew button Case The patient is now registered in the system The timer starts The recording of Full Disclosure data onto the hard disk commences In the RT Monitor the newly registered Patient details are displayed in the Information panel center top of the screen refer to Figure 4 2 Note The Patient amp Study Information window remains open 6 Press Done Setting Up
14. 4 General Use of Accessories lesen 1 5 Environmental Specifications 0 0 0c eee eee eee 1 5 Where to Find Information 0 0 0 cece eee eee 1 7 Chapter 2 Warnings and Precautions Prescription Notice sr sicci li spo de va a aa 2 1 Biocompatibility llseseseeeeeeee e he 2 1 R di tion 2 ea ete pere n DARE MEE 2 1 Transducer Protection 0 0 ccc err 2 2 Explosion Hazard 02 ass sw ERE awe Mes mia DU au 2 2 Electrical Shock Hazards eee eee eee 2 3 CAUTIONS e e pede np hag deese he thin hans tav tpe EARS N 2 4 Safety Rating and Manufacturer Identification Label 2 5 Warning and Compliance Labels 0 0 cee eee eee 2 5 Chapter 3 Introduction OVerview srl Er os BOYS See Le BR SE quib wk 3 1 Introduction to Basic System Hardware Components 000 3 2 Amplifiers ic isha seed deckt lest lade pe xa Ip Ium dau ege 3 4 Connection Boxes 0 0 cece eee eect en en eee 3 5 EMS XL Special Features 2 0 0 0 eee cence cence 3 6 Comprehensive Full Disclosure 1 1 0 0 0 eee eee 3 6 Computerized Integrated Stimulator 0 0 0 0 cee eee eee 3 6 Continuous Case LOg eee cece eect ene a 3 6 Reports 5 sos RAE nto devon eur E E ade 3 6 Additional Features and Functions 0 0 cece eee eee eee 3 6 Offline Utilities nd u oh we an e tete due a hatte becas bun d 3 7 EMS XL Review Station Compleme
15. BP Ta 4 gt AV Delay Atrium Ventricle Threshold f gt Figure 6 6 Sound Setup tab Click the icon in this tab to turn the stimulation beep on off When the tab is turned on each stimuli will cause a auditory beep AV Delay Stimulator Setup Stimulator Pacing Display BP Ta4 gt Sound AV Delay Atrium Ventricle Threshold s4 gt Apply 86 see L Figure 6 7 Stimulator AV delaySetup Window Use this panel to set the interval delay between the atrial and ventricular stimulations that will be used during Dual chamber stimulation To set the interval for Dual Chamber stimulation 1 Use the spin box or the slider to set the required AV delay 2 Click Apply Note Dual chamber stimulation is produced by Choosing Both on the stimulator panel 6 20 Mennen Medical Using the Stimulator Threshold Configure Stimulator Setup Stimulator Pacing Disp gt Figure 6 8 Threshold Setup Window A Front V Front 2 ES mA K dT 6005 Q Atrium Use the mA editable field and the slider beneath it to control the value of current supplied during stimulation on the channel indicated in the corresponding static control A Atrium above Use the mA editable field and the slider beneath it to control the value of current supplied during stimulation on the channel indicated in the corresponding static control V Ventricle
16. EMS XL User s Guide 6 45 The system stores the last spontaneous RR interval Intrinsic Rate IR At the end of the train Automatic Snapshot is displayed on the NRT screen with a sweep speed of 150 mm sec The NRT magenta caliper is located on the last stimulation caliper is fixed The NRT green caliper is located on the first spontaneous spike after last stimulation caliper can be moved The interval between the calipers is displayed on screen SNRT measurement To allow you to correct the position you can change the NRT green caliper position by moving the mouse Popup dialog is displayed with IR SNRT and CSNRT values and you are requested to confirm the results by clicking the Accept Reject buttons SNRT Result 1 IR PacmgCL Beats SNRT CSNRT 999 800 37 1104 105 Accept Reject SNRT values greater than 1 500 msec and CSNRT values greater than 500 msec are displayed in red Note The calipers are removed after you accept or reject the values After clicking Accept or Reject the S1 period is decremented according to the field for the next 6 46 Mennen Medical Note You can run up to 10 SNRT cycles Using the Stimulator SNRT measurement The minimum period is the user defined value MSI In addition the S1 counter changes according to the user defined value for SD with the new CL You can now click Go again to start anew SNRT cycle 5 To exit SNRT m
17. No Yes selected in the lower left corner of the Review screen Parameter Setup and Command Menus The Parameter Setup and Command Menus are centrally located in the upper portion of the Review Screen Each group of commands can be identified by labelled tabs at the top of the screen Use the scroll arrows left and right to access the required tab the command groups and functions are described below Commands Commands ORS Settings Channel Settings Event sm Select Printer Grid Print RT Multiple pages Notes Speed RT screen 17 Exit Report Length 1 page Zec Note You can display the Commands menu directly by clicking the File icon on the Review screen shortcut toolbar see Review Screen Shortcut Toolbar on page 4 21 The three buttons on the left Patient Notes and Report are used to access the following windows Patient amp Study Information Notes and Report Generator respectively Use the Select Printer button in the center to access the Select Printer window to choose the printer you want to use Use the panel to set Print Speed mm sec and the number of pages to be printed 4 24 Mennen Medical Review Screen Click the Exit button to quit the EMS XL program and return to the Windows desktop See Registering a Patient on page 6 2 Adding On line Notes on page 6 48 Editing the EMS XL Report on page 6 60 Printing on page 6 51 QRS Settings C
18. Select list using the up and down arrows to choose a pre configured configuration Press Load Press CLOSE to close Channel set up panel To save a newly defined configuration setting to the system hard drive 1 Click the Channel set up open the Channel set up panel toolbar button to 2 In the textbox at the bottom of the pane type the cho sen name for the new configuration 5 18 Mennen Medical Building a Configuration Config Select Load A FLUTTER All BP A FLUTTERI baseline All leads baseline Save New Name aj Datei CLOSE Note Ifthe configuration name already exists in the system the Save button will be labeled Over write Use the Delete from the system ad button to delete a configuration setting Note Some file names may not be deleted in which case the Delete button is automatically disabled The currently selected configuration file name is displayed in an editable text field under the list control Editing the text in this field will create modify the file name when the Save Overwrite button is pressed A new configuration name appearing in the selected text field causes the Load and Delete buttons to be disabled Combining Configurations Under One Category It is possible to combine several configurations under a common Category name for instance the Category AVNRT will include a configuration for diagnosis and another configuration for ablation
19. Stimulator Auto Snapshot on page 5 26 EMS XL User s Guide 4 29 Events and Stimuli List Ref Time Event S181 S1S2 S2S3 S384 S485 a At the upper right corner of the Review Screen a window displays the Events and Stimuli List This provides a visual time referenced display of all events and stimuli during the case You can easily scroll through the list using the scroll bar or up down arrows e Double click a listed event to display the signals during the event on the Review screen Note that the left side of the scale at the bottom of Review screen is set to the time of the event 4 30 Mennen Medical Review Screen Left Panel Controls ECG and Intra cardiac Channel Selection Buttons These buttons control the channel set up of the Review screen Figure 4 5 ECG and Intracardiac Selection Buttons To Display turn ON a Channel Click on the required ECG Intra cardiac channel button or click ALL to display all channels To Remove turn OFF a Channel Click on the appropriate ECG Intra cardiac channel button one that appears pressed or click ALL to remove all channels EMS XL User s Guide 4 31 To change the color for the channel Right click the selected channel and select the new color Reposition Buttons Rasa Use Reposition buttons to control the Be view of the currently displayed ECG Intra Surface ECG and or Intra cardiac ALL ECG channels
20. Using the Stimulator Stimulation Synchronization Use this control to enable disable synchronization of stimulation with configured data toggles between Sync and No Sync Refer to QRS Settings on page 6 12 EST Use the Auto button to initiate stimulation whereby each time a complete protocol stimulation has finished the the last stimuli will be decremented incremented as specified in the field The new protocol will be executed after the delay in seconds specified in the D field Change the and D settings as required i H 5 EIE i 3 ae Use these controls or the keyboard shortcuts as follows di Go initiate stimulation in accordance with the current settings or press the lt G gt key b Ly 3 Stop abort stimulation or press the space bar Load access pop up menu and select required protocol from a list of pre defined stimulation protocols Save savea complete set of Pacing Protocol settings for future use Note Using the Save Protocol window you can define a unique name for the new set of Pacing Protocols The Stimulator Setup tab has nine sub groups Sound AV delay Atrium Ventricle Threshold Sensing Counter Auto Snapshot Last Stim and SNRT see Sinus Node Recovery Time SNRT on page 6 42 Each provides access to Stimulator control settings as described below EMS XL User s Guide Sound Stimulator Setup Stimulator Pacing Display
21. a DVD R W aCD R W ora magnetic optical disk MOD Computerized Integrated Stimulator Two channels of programmable stimulators with all basic modes of pacing are integrated into the display Also featured are automatic increment decrement functions with triggered displays Continuous Case Log The EMS XL provides a window showing stimulation and marker events to quickly locate a region of interest ROI Clicking the associated event evokes display of the marker in Full Disclosure context Reports The EMS XL provides an instantaneous laser printout of all displayed traces or 12 lead printing as selected of either the RT Monitor or the Review Screen Measured data and notes are automatically integrated into the fully editable Microsoft Word Report Additional Features and Functions The EMS XL System supports the following functions Programmable Stimulator pre defined or user defined 3 6 Mennen Medical System Specifications pacing protocols Burst pacing Autopace Stimulation protocols library can be customized and extended Playback of previous Case sessions Event handling for both user indicated events and system generated events enable quick zoom in on recorded information Holter enables minute by minute viewing of data in the Review Screen and jumping to event e Snapshot capture storage Bitmap format saved on the local hard disk or DVD magnetic optical disk Tachycardia
22. and the conduction time In combination with the automatic increment decrement mode of the stimulator you can easily observe the execution of the pace protocols Updating images is accomplished automatically at the end of stimulation or manually by clicking the Snapshot shortcut button described below When the Calipers are used to measure intervals the measured intervals are included in the final report When the mouse scrolls over a lead in NRT the waveform changes its color temporarily to orange This makes the selected lead stand out from all the rest and helps studying it EMS XL User s Guide 4 17 Upper Panel Controls Help The pi icon on top left of the Review screen provides basic EMS XL commands Pacing Session Window The Pacing Session window is located at the upper left corner of the Review Screen When the Stimulator is activated this window provides a useful view of the Pacing session and also indicates the current pacing protocol Stimulator Parameters The Stimulator Parameters are written in the 8 fields visible below the Pacing Session window Here the current Stimulator parameter settings are displayed showing the characteristics that have been defined via the Stimulator Setup commands The fields showing the output amperage and length are read only fields The A and V channel selectors are drop down lists for choosing the channel output A Front v 2 0 mA 2 0 mSec V Front v
23. as Ethylate 70 alcohol 70 isopropanol and Acetaldehyde at the following temperature 50 to 60 C 122 to 140 F Follow the sterilizer manufacturer s recommendation for required aeration times Disinfection Purpose To kill microbes and bacterial spores To avoid extended damage to the equipment disinfection is only recommended when stipulated as necessary in the Hospital Maintenance Schedule Disinfection facilities should be cleaned first CAUTION Do not use Ethylene Oxide EtO gas or formaldehyde to disinfect the equipment 8 4 Mennen Medical General Care and Maintenance Calibration and Preventive Maintenance Mennen Medical Ltd recommends that the EMS XL System be checked at least once a year by qualified Mennen Medical personnel to determine proper calibration of the unit The exterior of the unit should be checked periodically for any signs of damage or abuse Units or parts which show any signs of damage should be immediately referred to a qualified technician procedure on a patient if you identify features which Do not use the EMS XL for any monitoring A demonstrate impaired functioning of the system Contact the hospital biomedical engineer or a Mennen Medical service engineer Full performance checks including safety checks must be performed by qualified service personnel at least once a year and after every repair This should include the monitor as well as all vital sign modules
24. detection automatically detects onset of arrhythmia according to user defined preferences Ability to extract part or parts of a previous case using time reference points including all system and user events marked events and stimulator activities and save such data separately Archiving of Full Disclosure FD information to DVD SNRT sinus node recovery time automatically calculated Offline Utilities Configuration Setup utility for editing registry entries for EMS XL configuration Archive utility for storing and restoring patient files EMS XL Review Station Complementary Product Optional The EMS XL Review Station enables viewing and playing back patient data files created in EMS XL System Specifications See the following pages for system specifications EMS XL User s Guide 3 7 ay mennen 47 nedico A computerized cardiac electrophysiological measurement system intended for performing electrophysiological and ablation procedures HARDWARE AND PARAMETERS PC Personal Computer e CPU 2 4 GHz or Higher e Memory 512 MB or more e Graphics Card Matrox G450 Dual Head 1600x1200 e Network Built in Ethernet capability e Optical Drives DVD RW e Hard Drives 80 GB or more e Serial Ports 2 for 32 channels 3 for 64 channels e Display resolution 1600x1200 e Enclosure Tower or Desktop System e Dimensions for Tower Height 420 mm 16 5 inches Width 190 mm 7 5 inches Depth 430 m
25. find the required patient Name EMS XL User s Guide 7 3 Note Ifa patient has more than one Case a sign is displayed next to the listed patient name Click to expand the list 4 Click on the required Case ID to select it Playback 5 Click the ex button 6 Click Done to close the Patient amp Study Information window Allow a few seconds for the screens to be filled with the recorded data The RT Monitor will start displaying continuous waveforms starting from beginning of file the Review Screen will be filled with the first few seconds of data 7 Proceed to review the case using the tools and techniques previously described refer to the following Use the minutes bar left bottom of the NRT screen to select the required minute Use the scroll bar and arrows for fine tuning the time settings Using the Calipers for Interval Measurements on page 6 32 Note In Playback Mode you are not able to assign a location to the measurement or save the results in the Report Printing on page 6 51 Editing the EMS XL Report on page 6 60 Note While reviewing the Case you may jump to an Event via the Events and Stimuli List see page 4 50 or by simply scrolling through the data using the timer located at the lower left corner of the Review Screen 8 When done exit Playback as follows Mennen Medical Review Screen in Playback Click the iid shortcut icon the Patient amp
26. labelled Prl and Pr2 To change a specific channel color Right click on any channel button or right click on the Color column of the channel in the active channels list and select the required color from the pre defined colors The button background color changes in accordance with your selection Note Colors available for selection may be custom ized under the Channel Select Review Screen tab see page 5 11 Channel Select Review Screen Setting Up Surface ECG Channels ECG Ez I Figure 5 5 ECG Channel Selection Buttons To Display turn ON a Channel Click on the required ECG channel button or click ALL to display all channels EMS XL User s Guide 5 11 To Remove turn OFF a Channel Click on the appropriate ECG channel button one that appears pressed or click ALL to remove all channels Note Buttons for currently selected channels will have a pressed appearance inactive channel buttons appear normal Buttons toggle ON OFF To Change a Channel Color 1 Right Click on a currently activated channel button The button changes to a new color 2 Click again to scroll to the next color as pre defined in the system 3 Repeat Step 2 until the required color is selected The EMS XL System is supplied with a library of pre defined colors If required additional colors may be customized as described in Channel Select Review Screen on page 5 11 5 1
27. line before an existing Note by clicking Insert instead of Append 3 If preferred add free text to the Notes list by typing the required text in the Selected Notes text input field see Figure 6 1 and using the Append or Insert buttons as previously described 4 Repeat Step 2 or Step 3 to add any additional Notes to 6 50 Mennen Medical Printing the Case as required 5 Click Done to clear the Notes window Note All Notes added to a Case are saved in the Patient File together with the Case data They are automatically printed in the EMS XL Report You can print from the Run Time Monitor screen and from the Review NRT screen Note For details of the time range in milliseconds covered by one printed page under different printing speeds and page sizes see Screen Print Size Information on page 4 34 Printing from the Run Time Monitor Screen You can print from the Run Time Monitor RT screen Note Due to difference in printer paper size and display size the printed page does not include the same information as the display A red marker at the bottom of the display indicates the printer page end To print Surface ECG from the RT Screen 1 In the Run Time Monitor screen click the RT 12 Lead 2 button 2 From the popup menu that appears select one of the fol lowing 3x 4 Selected lead EMS XL User s Guide 6 51 Paper speed is 25mm sec Start time of print is 10 sec before us
28. on page 6 48 and print the RT and the NRT screens see Printing on page 6 51 You can also compare the Run Time waveforms with a pre defined template see Working with Templates on page 6 56 After ending the case you can cut part of a case and create a shorter case saving it as a new file see Saving Part of a Case on page 6 64 EMS XL User s Guide 6 1 Registering a Patient An EP study begins with patient registration After this the study procedures should be continued in the order given in the subsequent sections To register a patient 1 From the Command menus at the top of the Review Screen scroll to the Commands tab 2 Click Patient ORS Settings Channel Select Channel Select Printer Grid Print RT Multiple pages Speed RT screen Y 25 Exit sec Length l page v Note Alternatively click the fd shortcut icon instead of performing Step 1 and Step 2 above The Patient amp Study Information window opens as shown in Figure 6 1 The window has four main areas Patient General Information Study related Information Patient Tree Case Control Buttons 6 2 Mennen Medical Registering a Patient Patient amp Study Information Current Patient General Information Study Information Patients Registered in the System Case Control Buttons Figure 6 1 Patient and Study I
29. only Click Invert ON or OFF to mirror the channel polarity as required Changes the displayed polarity of the currently selected channel Note FD data is unaffected the default setting is OFF 5 14 Mennen Medical Building a Configuration Each channel has its own pre defined default High Pass Filter setting as supplied with the system However the setting may be changed if required Note By default 0 05 and 0 2 are unipo lar 40 and 80 are bipolar Channels 1 to 12 are Surface leads and are not effected by the Unipolar Bipolar switches Channels 13 to 24 and Channels 45 to 56 are switchable between Bipolar and Unipolar Channels 25 32 33 to 44 and 57 to 64 are Bipolar channels In Unipolar mode the black sockets will be used as reference The reference is the Wilson reference of the surface limb leads Filters Channels 25 to 32 33 to 44 and 57 to 64 have fixed High Pass filters of 40 Hz To change the Filter for the currently selected channel activate the appropriate radio button 0 05 0 2 40 or To change the polarity click the associated button Bipolar B or Unipolar U Buttons toggle between 1B and I Gain contains an editable text field used to edit the gain value 0 255 of the currently selected channel in the RT Monitor In addition a slider vertically positioned beneath the edit field points to a row of gain value marks on the right Moving the slider up
30. or down changes the value in the text field above Similarly any editing of text in the edit field will automatically change the slider to the position corresponding with the new value 0 at the bottom 255 at the top EMS XL User s Guide 5 15 Color provides the tools for color customization of colors Three movable sliders labeled R G and B red green blue are used to define the colors available for selection in the system To define a new color 1 Drag the R G and or B slider until the required color is displayed in the bar above 2 Click Set to save the color setting Note To change the color of a currently selected channel it is recommended to refer to the instructions for Channel Select Run Time Screen on page 5 7 Clipping is used to control the amount of clipping applied to the currently selected channel in the RT Monitor and to prevent overshooting of traces Note An overshooting trace i e one that overshoots to the neighboring trace may be clipped to prevent it from overwriting another channel The Clipping controls are two pairs of editable fields and sliders The pair on the top defines by percentage the clipping applied above the currently selected channel the pair below defines the clipping applied below the currently selected channel Radio buttons indicate whether clipping is enabled ON or disabled OFF for the currently selected channel Note By defaul
31. part of the system or to an individual module appear in the relevant section of the manual Radio frequency RF generates an electromagnetic field The intensity of the radiated field at any point in space is directly proportional to the source of the voltage and inversely proportional to the distance from the source In the case of Ablation the active electrode return plate and their cables act as transmitting antennas Electromagnetic fields radiate perpendicular to their associated cables Therefore susceptibility of the ECG cable to this RF is maximum when the ECG cable is parallel to the Ablation cable Separating or placing cables perpendicular to one another will minimize radiation coupling effects In summary radiation interference can be minimized by the following Using the lowest possible Ablation power setting Keeping ECG cables as far from Ablation cables as possible Keeping ECG cables at right angles to Ablation cables Transducer Protection Immunity requirements of IEC Collateral Standard 60601 1 2 for Electromagnetic Compatibility are met with the transducers recommended for use with the unit SAFETY WARNINGS THE USER OR THE PATIENT MAY BE IN DANGER A WARNING INDICATES A SITUATION IN WHICH OF INJURY OR DEATH Note This symbol is also used to signify a potential risk of permanent loss of data Explosion Hazard The equipment is not suitable for use in the presence of flammable anesthe
32. particularly useful when using the EMS XL Report feature EMS XL User s Guide 4 3 Click Help to see the basic EMS XL commands Click Open help file to open a PDF of the User Manual Note Close the Help panel before trying to activate any other function Mennen Medical Run Time Monitor Run Time Monitor The layout of the Run Time Monitor is designed to provide effortless viewing of waveforms in Real time Mode The greater portion of the Run Time Monitor comprises the Traces Display in the center Above this the screen is divided into three main areas see Figure 4 1 Heart Rate and BP Ablation windows left Information panel patient details date amp time center Traces Display controls and shortcut buttons right Heart Rate BP Ablation Traces Display Controls Window Window Information Panel 04 3 4 o Shortcut lt Buttons Traces Display 1 BEBERRIDINERR Paper 190 LL 4 Status Indicators Figure 4 1 EMS XL Run Time Monitor Initial Display at Start up EMS XL User s Guide 4 5 At this stage the display appears empty apart from flat traces and the actual date and time Since no patient is currently registered in the EMS XL system there is no monitoring of vital signs and therefore channel waveforms are not visible When a patient has been registered refer to Registering a Patient on page 6 2 wavefor
33. patients the template list is emptied at End Start case Comparing the Non Real Time Screen to a Template You can compare stored templates on the Non Real Time NRT Monitor screen To compare templates 1 In the NRT screen click the Save Template icon or Save Template Tab The Template Comparison window opens with a list of the current patient templates sorted alphabetically Holter Save Template Ablator setup Snapshot set 4 gt Template Comparison Save MO s 7 Delete Rename Template 02 aj Start Screen Load 6 58 Mennen Medical Working with Templates 2 Select a template from the list and click Load to load the template for comparison on the NRT screen Note Click the icon again to close the window Deleting and Over writing a Template To Delete a template In the NRT screen click the Save Template icon or Tab The Template Comparison window opens with a list of the current patient templates sorted alphabetically Select a template from the list and click the Delete button To Overwrite a template name 1 In the NRT screen click the Save Template icon or Tab The Template Comparison window opens with a list of the current patient templates sorted alphabetically Select the template from the list that you want to over write with a new template and click the Overwrite button EMS XL User s Guide 6 59 Ending the EP Stud
34. screen and labeled as SR CL A H HV ORS OT 3 SNRT measurement results Note You can insert the last saved snapshot into the report by pressing CTRL V See Save a Snapshot on page 4 15 3 When done click on any blank non active area on the Review Screen to hide the Report OR Click X at the top right corner of the Report template to close the file Note Note During Playback the report may be edited man ually but no additional information is entered automatically The report is automatically stored in D EP Patients Patient Name Case ID Report RTF It is possible to store the report as an RTF file under any other name The report can be retrieved via the Report Word panel or any Word panel or via Explorer EMS XL User s Guide 6 63 Ending a Case To end a Case 1 Check that all stages of the EP Study have been completed successfully i e all relevant data acquired 2 From the Patient and Study Information window click bud refer to Figure 6 1 on page 6 3 Full Disclosure recording stops and the patient s details are cleared from the RT Monitor 3 Click Done to exit 4 From the Commands menu at the top of the Review Screen click Exit to quit the EMS XL program ons Settings Channel Channel gt Select Printer Printer Select Printer St Print RT Multiple pages Speed us screen 2s 5 Length 1 pee Th
35. 0 50 60 or number of pages 1 2 3 4 pages Default 1 Page The User Defined print speed can be the same as the RT screen sweep or 25 50 100 150 200 250 300 mm sec Default The same as the NRT screen The Start time of the report is the NRT screen Sweep Begin time If Single Marker is selected the print starts on event marker time e ECG 3x4 10 seconds of Holter Channel This option is only available in Holter mode Printing speed for this option is 25 mm sec The Start time of the report is the NRT screen Sweep Begin time If Single Marker selected printing starts on event marker time 6 54 Mennen Medical Printing 1 minute Holter This option is only available in Holter mode Prints the entire 1 minute buffer of Holter selected channel surface or intracardiac channel Printing speed for this option is 25 mm sec The report includes 10 sec X 6 rows each row contains 1 channel waveforms 2 channels Holter This option is only available in Holter mode Print the entire 1 minute buffer of Holter selected channel user selected channel Surface intracardiac or pressure channel Default 2nd lead is V1 Printing speed for this option is 25 mm sec The report includes 10 sec X 6 rows each row contains 2 channel waveforms To print NRT displayed channels 1 In the Review Screen click the Printing button 2 From the popup menu that appears select one of the fol lowing Current View
36. 2 Mennen Medical Building a Configuration Setting Up Intra cardiac ECG Channels L4 5 6 Intra cardiac Channel Selection Buttons To Display turn ON a Channel Click on the required channel button or click ALL to display all channels To Remove turn OFF a Channel Click on the required channel button or click ALL to remove all channels Note Buttons for currently selected channels will have a pressed appearance inactive channel buttons appear normal Buttons toggle On OFF To Change a Channel Color 1 Right click on a currently activated channel button The button changes to a new color 2 Click again to scroll to the next color pre defined in the system 3 Repeat Step 2 until the required color is selected EMS XL User s Guide 5 13 Note Channel Settings Channel Settings Event Configure Stimulator Setuy gt Label The EMS XL System is supplied with a library of pre defined colors If required additional colors may be customized as described in Channel Select Review Screen on page 5 11 mess Invert c Figure 5 7 Channel Settings HBE Label Label contains an editable field to enable renaming of the currently selected Channel Identification Label Figure 5 1 on page 5 5 Click in the field and type the required name over the existing label name Note You can enter up to 5 characters
37. 3 HRAd 40 B 100 11 HRAp 10 B 100 13 HBF4 40 B 100 16 HBEp 10 B 100 Note The EMS XL System is supplied with a library of pre defined colors If required additional colors may be customized as described in Channel Select Review Screen on page 5 11 Intracardiac Channels You can add or remove intra cardiac ECG channels displayed on the RT Monitor You can also change a specific channel color EMS XL User s Guide 5 9 Intracardiac channels Spacing Sequence sms usas Fere o e l Figure 5 4 Intracardiac ECG To change the Intracardiac ECG channel display Click on any of the buttons in the four columns under Intracardiac to toggle between the add remove functions for a specific channel listed in those columns Click All to toggle between the add remove functions for all Intracardiac ECG channels Click Spacing to cause the currently viewed Intracardiac ECG channels to be evenly repositioned on the RT Monitor Click Sequence to cause the currently viewed Intra cardiac ECG channels to be repositioned numerically on the RT monitor Note Channel identification label names may be edited for instructions see Channel Select Review Screen on page 5 11 5 10 Mennen Medical Building a Configuration Note One or two Intra cardiac channels physical channels 26 and 26 only may be used for BP display if required By default these are
38. 4 35 4 36 Mennen Medical Chapter 5 Setting Up Monitoring Before starting Medical Procedures it is possible to set up certain parameters according to specific EP Lab requirements These parameters are saved from patient to patient and do not need to be changed after each procedure You can define the screen layout and channel settings and save the settings in a Configuration file The following sections detail the procedures involved in building a configuration and saving it Setting Up Traces Display on page 5 2 Channel Select Run Time Screen on page 5 7 Channel Select Review Screen on page 5 11 Setting Up Intra cardiac ECG Channels on page 5 13 Channel Settings on page 5 14 e Saving and Loading a Configuration on page 5 17 Additional setups are described in the following sections e Setting Up Tachycardia Detection on page 5 21 Setting Up the Holter Display Mode on page 5 22 Setting Up the Stimulator Auto Snapshot on page 5 26 Setting Up Ablation on page 5 28 EMS XL User s Guide Building a Configuration You can build a Configuration file that includes the screen layouts and channel settings If you save this file you can then load it and use it in future procedures Setting Up Traces Display Modifying the Traces Display Appearance There are three display controls located on the right of the RT Information panel Zoom and Notch are positioned one beneath the other and Sweep Speed is o
39. Caliper mode 1 Do one of the following Press the Caliper m icon Press the C keyboard key Click the mouse To set the calipers 1 Once the magenta caliper appears you can click on it and drag so that a Green caliper appears In this state the Elapsed Time location sec ms format of each caliper is displayed in it s corresponding color at the box above the Hour Minute box at bottom left of the NRT screen 2 Using the mouse you can move the Green caliper by EMS XL User s Guide 6 33 standing on the caliper this changes it s color to yel low and draging it to the required location The absolute delta time between the calipers is displayed beside the top of the green caliper 3 You can click the mouse anywhere on the screen to pro duce another Magenta caliper and pair 4 You can move a caliper pair with the mouse by clicking the mouse on the brown line between the pair of cali pers The absolute delta time between calipers is displayed in the blue box beside the green caliper Note Right clicking the Blue Box displays the interval rate in bpm beats per second Sue coE me e 4 Figure 6 16 Interval Rate display To Erase a pair of calipers from display right click the mouse on gray line between needed pair of calipers To exit Caliper mode 1 Do one of the following 6 34 Mennen Medical Using the Stimulator Press the Caliper icon Press
40. L Report Word format see next steps To Enter a Measurement to the Events list and EMS XL Final Report 1 Click the ll icon A Trace Properties bar opens 6 36 Mennen Medical Using the Stimulator 2 From the list of locations select the appropriate loca tion to which the measurement is to be associated for example QRS QT etc The measurement is written to the appropriate place in the Events list and EMS XL Report 3 When done click A to clear the screen or press C on the keyboard Ablation Events Ablation results are displayed on the RT screen inside the hemodynamic data window located at the top left of the screen The following information is displayed Temperature in Degrees Celsius acceptable range 15 80 Power in Watts acceptable range 1 150 Time in seconds acceptable range 1 240 Impedance in Ohms acceptable range 25 300 To start end an ablation event 1 Right click the hemodynamic data window The ablation menu is displayed Start Ablation End Ablation Show Hide Graph Ablation Close EMS XL User s Guide 6 37 2 Select Start Ablation End Ablation This will enter a manual event in the events list accordingly These lines are grayed out when an ablator is connected to the EMS XL system because the events will be entered to the Events list automatically after activating stopping the ablator A Start Ablation End Ablatio
41. Protection 2 2 EMS XL Application Login 4 1 Logout 4 35 Environmental specifications 1 5 EP Procedure documentation 6 48 EP Study 6 1 ending 6 60 EP study save partial 6 42 Event marking 6 28 H Hemodynamic Data 4 7 Holter 4 28 setting up 5 22 Information Panel 4 8 K Keyboard Shortcut Keys 4 3 Index 2 L Label compliance 2 5 safety 1 4 Loading 6 6 N Note adding 6 48 P Patient Data restoring 9 9 storing 9 5 Playback a case 7 3 Review screen 7 2 Run Time screen 7 1 Printing Print Size Information 4 34 Review screen 6 53 Q QRS Settings 4 25 6 12 R Radiation 2 1 Registering a Patient 6 2 Report editing 6 60 Review Screen Mennen Medical description 4 15 Printing 6 53 Shortcut toolbar 4 21 Run Time Monitor description 4 5 printing 6 51 shortcut toolbar 4 11 S Safety warnings 2 2 Save snapshot 6 39 Save Template 4 28 Setting Ablation 4 29 Snapshot loading 6 39 saving 6 39 SNRT 6 42 parameters 6 43 procedure 6 45 report 6 47 Sterilization 8 4 Stimulator atrium setup 6 22 F Key shortcuts 6 26 sound setup 6 20 Stimulation List 6 28 threshold setup 6 21 using Auto Snapshot 5 26 ventricle setup 6 22 Stimulator Setup 4 26 6 19 Surface ECG Channels setting up 5 11 System Horizon XVu User s Guide compliance 1 3 environmental specifications 1 5 1 Taces Display sweep speed 5 2 Tachy 4 28 Template comparing 6 57 creating 6 56 Text insertin
42. Sail icon on the desktop of the workstation The Configuration Setup window appears 9 2 Mennen Medical Configuration Setup Utility U EMS XL Configuration Panic Button 2 In the category pane select the category you want to edit The current entries appear in the list in the Value pane U EMS XL Configuration Atrial Fib Pacemaker Implant EMS XL User s Guide 9 3 3 Double click the category or click Edit to open the Edit window for the category To edit predefined notes 1 Display the EMS XL Configuration window 2 From the Category list select Notes The Notes window opens 3 Right click the note you want to edit The pop up menu enables you to Rename note Delete note Add a pre defined note Mennen Medical Archive Utility A Rename AIT Delete Add Termination Vf VT Conclusion Dual AV pathways in anterograde amp retrograde Normal Sinus Node function Typical sustained AV reentrant SVT Medication OK Cancel 4 Click OK Archive Utility The Archive utility enables DB management by storing and restoring patient files You can store files on a network drive or via a DVD burner After archiving you can locate the archiving media in order to enable restoring data Storing Patient Data You can store files on a network drive or via a DVD burner Setting up the storage target options is done in th
43. Select Target Directory window opens EMS XL User s Guide 9 7 EA Select Target Directory x Save in i lex Select Cancel 5 From the Save in drop down list select the target net work drive or DVD 6 Click Select to close the window 7 Inthe Archive tab Click Store The information is stored compressed for future Burn or archive opera tions The Burn window opens Note This could take a few minutes Note If target selected was a hard disk the information was compressed and stores in the final destination If target selected is a DVD drive the information is stored temporarily until pressing burn 9 8 Mennen Medical Archive Utility Note It is possible to store a case more than once in different media net work drives 51x gt Wait for burn Files Currently On e Sickey7898979 1 2 04 MB Delete 3 Files 230 47 MB Volume le Refresh Clear Log I7 Multi sessions disc Burn Erase disc Load disc Close 8 Click Burn The Burn process starts The log information appears in the Log pane Note If there isn t enough space in the media you can delete files 9 When the Burn operation finishes the media is ejected automatically Click Close to close the Burn window Restoring Patient Data The Restore operation enables restoring old cases from archives to the current online patient list After a Restore EMS XL User s Guide 9 9 ope
44. Study Information window re opens l E Click the en button The Patient Tree becomes active again enabling playback of another Case or registering another patient To Playback the case from a selected time 1 In the lower left corner of the Review screen use the slider to select the case time from which you want to start playback The selected time from case start is displayed in the window 2 Click the Playback button The RT Monitor will start displaying continuous waveforms starting from the selected time EMS XL User s Guide 7 5 Mennen Medical Chapter 8 Care and Maintenance General Care and Maintenance This section describes the routine EMS XL System Care and Maintenance procedures and provides recommendations for the frequency with which these should be performed Following the simple guidelines presented will help to maintain the system in proper working order and ensure safe and efficient operation General Cleaning Procedures Note In all cleaning and maintenance pro cedures the term Monitor refers to both the EMS XL Real Time RT Monitor and the EMS XL Review Screen Before cleaning the EMS XL System note all the Safety Warnings and precautions to be taken when performing cleaning or maintenance procedures Refer to the information in the front of this User s Guide The EMS XL System including the amplifier may be cleaned with most commonly used hospital cleaning s
45. TY mennen a EMS XL Electrophysiology System USER MANUAL mennen a medical DDE 965 001 Rev A August 2011 Ce 0473 Conformity according to the Council Directive 93 42 EEC concerning Medical Devices as amended by 2007 47 EC Manufacturer s Name ed Mennen Medical Ltd 4 Hayarden Street Yavne 81228 P O Box 102 Rehovot 76100 Israel Tel 972 8 9323333 Fax 972 8 9328510 European Representative Charter Kontron Limited Unit 18 Avant Business Centre 21 Denbigh Road Milton Keynes MK1 1DT England Tel 01908 646070 Fax 01908 646030 US Representative Mennen Medical Corp 950 Industrial Boulevard Southampton PA 18966 Phone 215 259 1020X1026 Toll Free 800 223 2201 Fax 215 675 6212 Publication No DDE 965 001 Ver 1 39 Revision Rev A August 2011 Copyright Mennen Medical Mennen Medical Ltd 2011 All RIGHTS RESERVED Registered trademarks are the intellectual property of their respective holders ii Mennen Medical Important Notice This document is delivered subject to the following conditions and restrictions The EMS XL User s Guide contains proprietary information of Mennen Medical Ltd This information is supplied solely for the purpose of assisting authorized users of Mennen Medical Ltd products The instructions presented in this guide should in no way supersede established medical protocol concerning patient care No part of the contents hereof may be used for any othe
46. The grounding and equipotential resistances of the EMS XL system including power cables must be tested at least every 3 months All checks which require the instrument to be opened must be made by qualified service personnel Safety and maintenance checks can also be made by Mennen Medical personnel Your local Mennen Medical Ltd agent will be glad to give you information about service contracts EMS XL User s Guide 8 5 Mennen Medical Overview Chapter 9 Offline Utilities This section describes the offline utilities that are part of the EMS XL System These utilities are automatically installed when you install EMS XL on a workstation Their icons appear on the desktop The following utilities are described Configuration Setup Utility on page 9 1 Archive Utility on page 9 5 Configuration Setup Utility The Configuration setup utility allows editing registry entries for EMS XL configuration The following categories are supported by this utility Hospital name Predefined notes Predefined events Study list EMS XL User s Guide 9 1 Technician list Fellow list Faculty list Ablation e Language Channels Panic buttons F11 and F12 You can define the the panic buttons F11 and F12 in two modes Burst F1 1 Burst A F12 Burst V Overdrive F112Overdrive A F12 Overdrive V To edita configuration category 1 Double click the Configuration Setup utility
47. V delay atrium ventricle Threshold Sensing Counter Auto Snapshot Last Stim and SNRT Each provides access to the Stimulator control settings See Using the Stimulator on page 6 15 Stimulator un Ev sil Stimulator Setup 5 Stimulator Pacing Display gt gt gt i 600 Atriur v ees _ Auto g Atriur Go Stop Stop Load ux TT Used for conducting all pacing amp stimulation protocols and provides tools for achieving precise control of the Stimulator Pacing settings There are five sets S1 S5 available The panel gives access to continuous single stimulation sync non sync stimuli automatic increment decrement stimulation and loading pre saved protocols at ease and in one screen See Using the Stimulator on page 6 15 Automatic Pacing on page 6 24 Display BP Stimulator Setup Stimulator Pacing Display BP on gt Eoo em p gra r m NH Zero pe Use the Display BP panel to set up the BP display Activate Deactivate Grid No grid Zero and to activate the display of the NIBP and SpO2 from the CFE in COmbo systems See Setting Up BP Display on page 6 8 EMS XL User s Guide 4 27 Tachycardia Rate Detection 520 msec Minimum of cycles 5 F cycles Refractory 5 m sec Lok Use the controls under the Tachy tab to set the system parameters for the detection and recognition of tachycardia See Setting Up Ta
48. a Procedure Loading the System Setup for the Study The setup procedure is required to configure the EMS XL System with a setup appropriate for the specific study Note Some studies may require more channels and others basic studies will require less channels System setups can be loaded using either the Configuration command or simply tailored manually for the particular case To load the system setup for the study 1 Do one of the following 6 6 Mennen Medical Setting Up a Procedure Press the Configuration toolbar button and choose a Configuration or Category sub config from the menu that opens 12 lead All leads my AAAQ gt Dr Levi baseline Diagnostics RF Ablation toolbar button to Load Over Write Dei Click the Channel set up open the Channel set up panel Config Select aseline CS Diagnostics my Cryo Ablation kkkk NEW_CC Default CLOSE Click or scroll through the Config Select list using the up and down arrows to choose a pre configured configuration Press Load Press CLOSE to close Channel set up panel EMS XL User s Guide 6 7 Note Note Setting Up BP Display If the required setting is not available for selec tion configure the system parameters as required see Chapter 5 Setting Up Monitor ing If you wish to name and save the newly defined configuration setting to the system hard drive f
49. a case is not being recorded to file Mennen Medical Review Screen Review Screen When the Review Screen is activated at system start up refer to Starting the EMS XL Application on page 4 1 it initially opens displaying still traces as shown in the example below Event SISI SIS2 S253 5384 54S 00 00 25 943 Pause R E Hoc Sove Tenpbie Abbtor semp Suapebot set L4 gt Ref Tune ee Post stan snapshot Repeat snapshot Ablation time Stinmlstion time 7 ON OFF 7 ONOFF Seconds 1 Seconds STIM Intras iA css IHRAp 084 D 1 2 BEE Pu RVd Ja Rp P2 csd 6 Cs 8 csi Mp1 C82 Mp2 auf ecd Repesinon ECG Intra AL Copy RT Zoom i Figure 4 3 Review Screen Initial Display at Start up Note The Review Screen is subject to the registration of a patient if no patient is currently registered the screen will show blank traces Once a patient has been registered the Review Screen display will appear as shown in the example in 4 4 EMS XL User s Guide The Review Screen is dedicated to the measurement and uninterrupted manipulation of data and provides a view of waveforms based on the Full Disclosure FD data This enables you to focus on events control stimulation protocols perform measurements and study various relationships of the cardiac complex Stimulator ae Setup and i f i Command Menus Stimulator Pacing Session Window
50. a lint free cloth a paper towel may damage the screen 4 Clean patient cables and all exposed surfaces with mild soap solution only For example use a fine hair cloth moistened in mild soap liquid or cleaning agent containing 70 ethanol Note Using alcohol or any type of con centrated cleaning solution may impair patient cable flexibility 5 Remove any adhesive used to attach the cable to the patient To remove adhesive residue use a plaster remover solution made up of one third alcohol two thirds water Alternatively use a commercially available tape remover such as Scholl Double Seal Tape Remover Note Do not use strong solvents for example acetone pure alcohol ammonia etc These will damage the cable CAUTION Do not autoclave patient leads transducer components or other sensors Autoclaving permanently damages these instruments If you need to sterilize accessories Mennen Medical Ltd recommends Ethylene Oxide EtO gas sterilization CAUTION Check the amplifier frame cables and BP sensor carefully after cleaning the system Do not use equipment or accessories that are worn or damaged EMS XL User s Guide Sterilization Purpose To kill and remove pathogenic microbes To avoid extended damage to the equipment sterilization is only recommended when stipulated as necessary in the Hospital Maintenance Schedule Recommended sterilization material Use an ethylene oxide mixture such
51. ace line thickness This feature allows for a clearer view of traces when snapshots are presented on slides i Saves a snapshot of the Review Screen to file Used to take a snapshot ofthe currently displayed traces and save it in various image formats default format is JPEG Click to open Insert Text window Used to type text on the display 4 20 Mennen Medical Review Screen Table 4 3 Review Screen Tool Bar Buttons amp Func tions Button amp Function Saves a partial Case to file Enables you to cut part of a case and create a shorter case saving it as a new file For example cut 2 hours from a 5 hour study Click to open Stimulation List window Event Click to open Event List window Review Screen Shortcut Toolbar The Review Screen Shortcut Toolbar is located below the Command Menus and Events and Stimuli List refer to Figure 4 4 It contains a row of buttons that provide quick access to frequently used functions as shown in Table 4 4 amp 8 a Ed Hh zs d e mlo amp Note During playback and when no case is selected some of the icons will be dimmed this means that the function is unavailable EMS XL User s Guide 4 21 Table 4 4 Review Screen Shortcut Toolbar No Button Function Playback case THEY Toggle between Holter and Study Normal view Yes Yes EH Holter
52. across the Traces Display from left to right Increasing the Sweep Speed will influence the Traces Display by making the waveforms move faster decreasing the speed will make them move slower There are six Sweep Speed control buttons positioned horizontally in one row and labeled in mm sec incrementing from left to right as follows Sweep Speed 25 50 100 150 200 300 Each of the six buttons provides exclusive selectivity The button corresponding to the currently selected sweep speed appears as pressed all others appear normal and are ready for selection Note The default Sweep Speed is 100 mm Sec In Trigger Mode only any changes made to the Sweep Speed will have an effect on the positioning of the vertical line displayed on the RT Monitor Notch The function of the Notch control is to enable or disable the 50Hz Notch Filter on the EP Box amplifiers The Notch control has two buttons On and Off Note The default value is ON However this may be overwritten by loading any other configuration For details refer to Loading the System Setup for the Study on page 6 6 4 10 Mennen Medical Run Time Monitor Run Time Monitor Shortcut Toolbar Below the Sweep Speed controls and to the right of the patient information panel upper right corner of the Run Time Monitor there is a Shortcut Toolbar containing a row of buttons These provide quick access to various frequently used funct
53. al General Use of Accessories Use only Mennen Medical approved accessories with the EMS XL System This includes but is not limited to those accessories approved for use with the Vital Signs Modules ECG and IBP Do not use a damaged accessory Always refer to the instructions for use included with each accessory A disposable single patient accessory should not be sterilized or cleaned for re use Use care when installing accessories such as adapters and cables Do not use force Do not cause tension in cables when connecting them to the vital signs modules Environmental Specifications Operation Mode of Operation Continuous use during EP study Humidity 1096 9396 non condensing Temperature 5 C to 35 C 41 F 95 F Environmental Conditions for Transport and Storage Temperature 15 C to68 C 5 F 158 F Relative Humidity 10 93 non condensing Atmospheric Pres 700hPa to 1060hPa sure For easy reference a table showing the Environmental Conditions and Situations to be Avoided is provided on the next page EMS XL User s Guide 1 5 Table 1 1 Environmental Conditions and Situations to be Avoided Do not operate EMS XL System equipment in these environmental conditions Always adhere to the safety instructions Locations where sudden impact or vibration may occur Avoid damp locations Do not operate the equipment with wet hands Lo
54. bles you to control the automatic snapshot settings in use when the Stimulator is activated see Setting Up the Stimulator Auto Snapshot on page 5 26 Although stimuli can be performed via the dedicated Stimulator menu see Stimulator Controls on page 4 19 it is recommended to use the keyboard short cut keys Best results are achieved by a combination of the following keys lt G gt Start stimulation protocol Spacebar Stop stimulation protocol lt A gt Automatic pacing 4 Decrement extra stimuli Increment extra stimuli lt B gt Big numbers view Note An example of stimulation technique is shown in the procedure below The following basic pacing protocol will be used and the pacing parameters set accordingly S1 8 600 Atrium S2 1 380 Atrium In this example there is a drive train of eight 600 msec time intervals at the atrium followed by one extra premature beat of 380 msec at the atrium Precise control of the Stimulator Pacing settings is achieved using the tools provided under the Stimulator Pacing Tab 6 16 Mennen Medical Using the Stimulator Configure Stimulator Setup Stimulator Pacing Dis 4 gt Figure 6 5 Stimulator Pacing Setup tab S1 S2 Use the vertical scroll bar and arrows to scroll through the extra stimuli controls S1 through S5 Use the arrows to set the number of control to set the number of extra stimuli to be executed Scroll to the requir
55. by doing one of the following Event Speed 50 mm Secv Click Now to mark an event at the current time of activation Click Marker to mark at any previous time during the procedure by setting the marker caliper at the point of interest Click Start Screen Middle screen to mark at the corresponding place on the NRT screen 3 Click ENTER The Event is added to the Events List together with a timestamp and the selected category This enables jumping to the event by double clicking it in the Events and Stimuli List window at the top right corner of the Review Screen see Events and Stimuli List on page 4 30 Note All new events entered during the current case are added to the Evenets list At END CASE the list returns to the default EMS XL User s Guide 6 29 Deleting or Renaming an Event Event List The Event tab displays the list of events listed alphabetically that can be used to collect events marked during the procedure or new events that were entered by the user diring the current procedure Event Stimulator Setup Stimulator Pacing Display 4 m Mark Event By Category You cn scroll through the list using the up and down arrows To delete an event 1 Select the event in the Event and Stimuli List and click Delete To rename an event 1 To rename an event select the event on the Event and Stimuli List type the new name in the text boxand click Relab
56. cations exposed to chemicals or explosive gases Locations with large temperature fluctuations Operational range 5 35 C humidity 10 93 Do not allow dust or metal debris to penetrate the monitors Locations where moisture level may increase considerably room is inadequately ventilated Do not plug in the mains power cable until all installation procedures are completed Damage can be caused to the equipment Locations exposed to direct sunlight Do not pull directly on the mains power cable Always hold the plug when pulling the cable out of the wall socket Locations near electrical heating apparatus Do not dis assemble the equipment This should be done by authorized personnel only otherwise Mennen Medical Ltd will not be obligated to provide technical service 1 6 Mennen Medical Where to Find Information This guide contains the following additional chapters Chapter 2 Warnings and Precautions includes detailed warnings and precautions you should adhere to Chapter 3 Introduction describes the main features and the hardware of the EMS XL system Chapter 4 Getting Started describes the Run Time and Review screens and provides a short description of their funcutionalities In addition it describes logging in and out of the application Chapter 5 Setting Up Monitoring describes how you can setup the run time display as well as other param
57. chycardia Detection on page 5 21 Holter Holter Chan 2 II Enables choosing the channel which will be shown in Holter mode See Setting Up the Holter Display Mode on page 5 22 Save Template Display BP Tachy Holter Save Template Ablator 4 gt r Template comparison save Over Write a i pn Rename Template OL stat Screen Load Enables saving a section of the recording as a template for future comparison to the real time recording See Creating a Template on page 6 56 4 28 Mennen Medical Review Screen Ablator Setup Tachy Holter Save Template Snaps 4 gt Ablator STOCKERT Y COMport 2 v The EMS XL has interface ability for connectivity to a Generator See Setting Up Ablation on page 5 28 for a list of Generators that have this ability Use this window to select the abalator and the COM port to connect to See Ablation Events on page 6 37 Snapshot Setup Enables changing the settings of the snapshots that are taken automatically after each stimulation Post stim snapshot tab and setting the ability for automatic repeat snapshots taken during stimulation and or ablation repeat snapshot tab Holter Save Template Ablator setup Snapshot set 4 Post stim snapshot Repeat snapshot Post stim Location Sweep Speed Delay after Snapshot mm stimulation sec fon ont 10 sof zoo 3 See Setting Up the
58. cted that as the stimulation interval becomes shorter the recovery time becomes longer The procedure is repeated at shorter and shorter stimulation Cycle Length CL i e at increasing rates At the end of the SNRT procedure a table that relates SNRT to stimulation interval is created Corrected SNRT CSNRT SNRT IR is the difference between the recovery time and the spontaneous beat to beat interval prior to the atrial driving Normal range values for SNRT are up to 1 500 msec Normal range values for CSNRT are up to 500 msec The EMS XL provides a semi automatic SNRT procedure 6 42 Mennen Medical Using the Stimulator Terminology Table 6 1 SNRT Terminology Label Description Formula SNRT Sinus Node Recovery Time IR Intrinsic Rate stimulation SD Stimulation duration CSNRT Corrected CNSRT SNRT IR SNRT MSI Minimum stimulation interval CL Stimulation Cycle Length SNRT Parameters SNRT Dialog panel allows the user to define the SNRT parameters SD Stimulation Duration during SNRT procedure in seconds 10 60 seconds range in steps of 10 sec default 30 sec MSI Minimum Stimulation Interval in msec 200 1 000 ms range in steps of 100 msec default 400 msec To set SNRT Parameters 1 From the Command menus at the top of the Review EMS XL User s Guide 6 43 Screen see Figure 2 5 on page 18 use the Left Right arrows no to scro
59. d display of all stimulations during the case Choose Markers to see a visual time referenced display of all non stimulation events during the case You can easily scroll through the list using the left right arrows The event and time stamp appear in the window beneath the Event Scroll button Scroll Markers E Speed 300 mm Sec Event Category Defdg At 00 00 20 022 Figure 6 15 Event and Time Stamp Using the Calipers for Interval Measurements This section describes the technique for using the pairs of interactive calipers specially designed for easy operation when performing interval measurements Note The calipers may be used at any time in the Review Screen but can only be used in Trigger Mode on the RT Monitor Intervals can be measured by 6 32 Mennen Medical Using the Stimulator Up to 10 pairs of Magenta Green cursors One Magenta cursor and several green cursors with intervals measured between the Magenta to each Green cursor As a general rule the cursors are activated by Mouse click Click mouse and drag Activates and fixes a pair of Green amp Magenta cursors marking the Start and End of an interval Right click Activates and fixes Green cursor marks End of interval It is possible to lock and move a pair of calipers by clicking on connection line between cursors In order to delete a pair of calipers right click on a connection line between cursors To Activate
60. e EMS XL User s Guide 9 5 Configuration tab To store patient data 1 Double click the Archive utility az icon on the desktop of the workstation The Archive window appears File Help Storm Restore Archive Configuration 31959 2000 Alon Yitzhak 6298801 31959_2001 08 05 2008 10 30 Alon Yitzhak 298801 31958 70011 Bl US 2005 10 31 Alon Yitzhak 6298801 31959_20012 08 05 2006 10 36 Alon Yitzhak 5238801 31959 70013 00 05 2006 10 47 Alon Yitehak 6298801 Save Partial 00 05 2006 10 42 54 06 54 05 zAmz 2005 10 47 54 06 54 06a 22 03 2006 12 18 54 06 54 0520 22 03 2006 12 1 54 06 54 05 MM 24 02 2006 10 47 22 03 2006 u Store Burn _ 1 patient files waiting for CD burn 2 Click Add Patients The Select Patient window opens enabling selecting patients for archiving 9 6 Mennen Medical Archive Utility if Select Patient x Patients View C All C Archived Not Archived Alon6298801 Om Demo Patient amp Orazio54 06 SickeyPatuent Testpat87987979 ok Cancel Note You can filter the list to display All Patients patients already archived or patients not yet archived default value Note You can select all the patient files or expand the folder and select specific case s 3 Select the cases for archiving and click OK The selected cases are displayed in the Patient list 4 Click Select Target to select the storage target The
61. e and two invasive BP channels In addition pacing protocols are integrated into the display and recording system Designed by EP professionals the EMS XL may be used for performing computerized EP and ablation procedures and is suitable for a variety of clinical applications Ranging from simple EP diagnostic investigations to complex cardiac procedures The compact amplifier combines signal acquisition and cardiac stimulation capabilities Inherent flexibility of the system and easy to use stimulation protocols enables the EP specialist to view measure and focus on events of cardiac electrophysiological activity which occur either naturally or are induced via external stimulation EMS XL User s Guide 3 1 Introduction to Basic System Hardware Components The EMS XL system operates on a Windows XP platform Two 20 color monitors are mounted side by side on a central console The dedicated Run Time RT Monitor on the left displays up to 32 or 64 traces of continuous data in real time the Review Screen on the right displays still trace images Run Time Monitor Review Screen Figure 3 1 Typical EMS XL System Configuration During an EP study acquired information is presented in graphic on line displays waveforms traces text format reports lists as well as hard copy printouts waveforms There are two options of the EMS XL 32 and 64 channels For the 32 channel option the system is supplied with on
62. e master amplifier one patient box and a 10 lead surface ECG patient cable For 64 channel option the system is supplied with one Mennen Medical Introduction to Basic System Hardware Components master amplifier and one expansion amplifier with 4 patient boxes and a 10 lead ECG cable Channel Allocation Each of the channels has gain control and an Invert switch The BP channels have a zero mode and calibration factor The EMS XL has 64 channels with the following characteristics Master Amplifier Channels Box Mode Filter Note 1to12 ECG 12L Selectable 13 to 24 A1 12 Mono or Selectable Stimulator Bipolar Output 25 Bipolar 40 Hz Fixed 26 BP cable BP No gain controls 27 Bipolar 40 Hz Fixed No gain 28 BP cable BP controls 29 32 Bipolar 40 Hz Fixed Expansion Amplifier Channels Box Mode Filter Note 33 to 44 B 1 12 Bipolar 40 Hz Fixed 45 to 56 C 1 12 Mono or Selectable Bipolar 57 to 64 D 1 8 Bipolar 40 Hz Fixed EMS XL User s Guide 3 3 Amplifiers Z y gg DE Amplifier 1 This amplifier is integral to the system and includes a built in stimulator and the connections seen in Figure 3 2 Figure 3 2 Amplifier Connections Front connections Outputs of the Atrial and Ventricular stimulation Used for service and not required for clinical use stimulation 1 12 surface ECG leads 60 BPM switch for stimulator te
63. e Windows desktop is displayed Saving Part of a Case After ending the EP study it is possible to save a part of a case You can save up to 25 sections of an event into one file In addition you can use the Auto Save option to create a new file that will contain all the events stimulations in the case study including 30 seond pre event and 30 second post event recordings 6 64 Mennen Medical Ending the EP Study To save part of a case ER 1 Click the Save Partial icon hs in playback mode A window opens enabling you to select the Start and End times Save Partial Auto partial 00 00 00 02 27 02 Start 02 27 02 Adi End 00 00 00 Delete ub Save Save _ Clear 2 Use the Hour Minute scroll bar located at the bottom corner of the NRT screen see Figure 4 4 to the required Start Time and click Start 3 Use the Hour Minute scroll bar located at the bottom corner of the NRT screen see Figure 4 4 to the required EndTime and click End 4 Click Add to add another segment and repeat 5 When you finish selecting the segments click Save to display the Save partial Case Patient Information panel 6 Type a name for the saved partial file or modify the default name default name is the original case file with an underscore after it for example if the original case number is 557 Partial Case no is 557_ You can add to this name for example 557_partl or change the name altogether Note Ifyou
64. e special protection against electric shocks particularly regarding leakage current and is defibrillator proof For descriptions and locations of the symbols used on the modules of the EMS XL System see Label Locations amp Symbol Descriptions on page 1 4 EMS XL User s Guide Label Locations amp Symbol Descriptions The following provides a short description of the meaning of various labels and symbols that appear on the EMS XL System and identifies their location on the equipment Symbol Description Location Attention consult accompanying documents Service to be performed by qualified technician consult Service Manual before removing cover Isolation Transformer and front and rear panels on Amplifier ON power from mains power supply Power switch Isolation Transformer front panel OFF power disconnected from mains power supply Power switch Isolation Transformer front panel Defibrillation Proof Amplifier front panel next to all ECG related connectors o Type CF Applied Part Earth Isolation Transformer rear panel AC Output Isolation Transformer rear panel 220 240V 10A 473 oO CE Approval by Notified Body Manufacturer Identification Label Iso lation Transformer rear panel Date of Manufacture Manufacturer Identification Label Iso lation Transformer rear panel 1 4 Mennen Medic
65. e the spin box or the slider to set the required mini mal interval Performing Stimulation To perform stimulation 1 From the Command menus at the top of the Review Screen scroll to the Stimulator Pacing tab Configure Stimulator Setup Stimulator Pacing DA 600 Atriun a Auto 380 Atriun 7 _ Go Z 10 0 E None v Stop 0 E None Load Normal _Save_ 2 Use the up down arrows to select the required pacing parameters for S1 and S2 as per the example dT S1 8 600 Atrium S2 1 380 Atrium The selected parameters are visible in the appropriate fields as above EMS XL User s Guide 6 23 Automatic Pacing Note Instead of performing Steps I and 2 a set of pacing protocols may be loaded from a pre defined list as follows Click the xad button or press the lt F3 gt key to access the Protocols List see below Select and load the required protocol set by clicking the appropriate name in the list 1000A cont Overdrive 1000V cont 30X600A 4003803604 400380360V 400380A 400380V 500380360A 500380A 500380V 6003803604 600380360V 600380A 600380V 600A cont 600Cont 600V cont Acute A Acute V Basic Ensure that the pacing catheter is located at the correct site then press lt G gt to start the stimuli protocol To decrement the Extra stimuli in this example S2 simply use the down arrow this will decre
66. ea displays SpO2 and NIBP measurements if measured from the patient If the patient is connected to both an Invasive Pressure line and a NIBP cuff only the IBP reading will show EMS XL User s Guide Ablation Data Information Panel Ablation results are displayed on the RT screen inside the hemodynamic data window located at the top left of the screen The following information is displayed Temperature in Degrees Celsius acceptable range 15 80 Power in Watts acceptable range 1 150 Time in seconds acceptable range 1 240 mpedance in Ohms acceptable range 25 300 Patient Details To the right of the BP window patient details are displayed in an information panel in the center of the screen in the following format First Name Last Name Case ID GONEN N 28491 Note Patient details are only displayed here when a case is started or when Play back Mode is activated in the Review Screen In all other situations these fields appear empty Mennen Medical Run Time Monitor Date and Time Below the patient details the information panel displays the actual time and current date on the left and the elapsed time since the start of the case on the right Time amp Date Elapsed 08 49 20 17 04 2000 00 053 D Note During Playback the elapsed time is relative to the recorded elapsed time Note however that since the playback is at a different speed than real time it is di
67. ed number or type to edit the number currently displayed S1 is usually referred to as the drive train When it is used in conjunction with extra stimuli it is usually given a value of between 6 and 10 fol lowed by 1 2 3 or 4 extras For example 8 600 Atrium 1 360 Atrium In this example there is a drive train of eight 600 msec time intervals at the atrium followed by one extra premature beat of 360 msec at the atrium 600 Set the required duration between pulses 380 0 0 n a a Scroll with the arrows to the required number Note Values range between 0 and 9999 msec EMS XL User s Guide 6 17 Location of Stimulation Use this control to select the required location for the stimulation Choose one of the following None Atrium Ventricle Both If Both is selected the interval between the ventricular and Atrial stimulation will be as set by the A V delay Sensing If Sensing is selected the stimulator will sense the heart beat for a given number of beats and then continue to 2 No stimuli will be given for the number of pulses written in the Left most column For example in the following setup the stimulation will start with Sensing of 8 beats and then 1 atrial stimulation 380 ms from the last beat Type of Stimulation Cont Set the type of stimulation toggles between Cont continuous and Single 6 18 Mennen Medical Stimulator Setup
68. el When you click the Event List m icon the Events Selected window appears with a list of all available event sub sets categories in the left pane and selected categories in the right pane The bottom pane lists all the events from the selected sub sets categories that were listed during the case You can use the left arrow to de select a subset of Events When you de select a category all the events of 6 30 Mennen Medical Using the Stimulator this sub set will be erased from the list in the bottom pane Events Select Ablation CM ISNRT 624 msec Tachy 60 bpm VF VT SNRT 624 msec Tachy 60 bpm Tachy 60 bpm Figure 6 13 Events Table Window To view the signal during a selected event select the line of the event in the bottom pane and click View Selected Events Select EMS XL User s Guide 6 31 Figure 6 14 Events Select Window This displays the signals during the event on the Review screen Note that the left side of the scale at the bottom of Review screen is set to the time of the event Events Markers and Stimuli List in the Review Screen At the upper right corner of the Review Screen a window displays the Events Markers and Stimuli List see Figure 4 4 You can scroll through the events or stimulations one at a time by using the Scroll button the Scroll Event button is a single button that toggles between functions Choose Stimuli to see a visual time reference
69. er click time The default Rhythm lead is Lead II It is possible to select a different Rhythm lead by selecting one of the Surface ECG channels on the RT display Lined 12 X 10 seconds Paper speed is 25mm sec Start time of report is 10 sec before user click time 12 Lead consecutively from top to bottom Lead I to Lead V6 Close To close the popup menu Printing RT Displayed Channels You can print RT waveforms according to the definitions in the Print panel To print RT displayed channels In the Run Time Monitor screen click the Print RT Displayed Channels button The default of the RT printing is one page printed at a paper speed equal to the RT sweep speed In the Print panel you can select printing length by Time 10 20 30 40 50 60 seconds or by the Number of Pages 1 2 3 4 The print speed can be set to Same as RT screen or 25 50 100 150 200 250 300 mm sec Note The print panel is located in the Commands tab on the NRT screen Click the Print RT Displayed Channels button or lt F8 gt keyboard key to start and stop multi page printing 6 52 Mennen Medical Printing While printing is in progress the current page number is displayed on the bottom line of the RT screen The start time of the first printed page is the time of the last page before the user Click time Page number and elapsed time are displayed on each printed page Note RT Printing is functional in both Sweep and T
70. eters that can constitute a Configuration which you can save choose to load for an EP study Chapter 6 Performing the EP Study describes the steps involved in performing an EP study and how to perform them Chapter 7 Case Playback describes the Case Playback function which enables off line review of a closed EP Study Chapter 8 Care and Maintenance describes the routine care and maintenance procedures and provides recommendations for the frequency with which they should be performed Chapter 9 Offline Utilities describes the available offline utilities Configuration Setup Utilitiy and Archive Utility EMS XL User s Guide 1 7 Mennen Medical Chapter 2 Warnings and Precautions Prescription Notice Biocompatibility Radiation Federal United States law restricts the sale and use of this instrument to qualified medical personnel only In addition the user should be properly trained in the use of the system The instructions for use presented in this guide should in no way supersede established medical protocol concerning patient care All materials used in the patient cables and applied parts have been tested for biocompatibility by the OEM manufacturer s and are in compliance with the applicable standards on biocompatibility The following information contains general warnings and cautions for the user before initial use of the system Specific warnings and cautions pertaining to the operation of
71. eview Screen Initial Display at Start up on page 2 15 The Run Time Monitor layout menus and tools are described in the next section see Run Time Monitor on page 4 5 An overview of the Review Screen layout menus and tools is provided in Review Screen on page 4 15 For a list of keyboard shortcuts see Table 4 1 on page 4 3 Note For details on using the Run Time Monitor and Review Screen during an EP study see Chapter 6 Performing the EP Study Mennen Medical Starting the EMS XL Application Keyboard Shortcut Keys Table 4 1 Keyboard Shortcut Keys and Functions Key Function lt F1 gt Help Screen lt F2 gt Configuration Menu lt F3 gt Pacing Protocol list lt F4 gt Note Dialog lt F5 gt Sweep Speed of Real Time screen lt F6 gt Zoom all Real Time channels lt F7 gt Freeze Real Time Screen lt F8 gt Print all Real Time Screen lt F9 gt Cont A 600 Stimulation CTRL lt F9 gt Cont 600V lt F10 gt Basic A CTRL lt F10 gt Basic V lt F11 gt Burst A lt F12 gt Burst V lt G gt Start Stimulation lt SPACE gt Stop Stimulation lt A gt Start Automatic Pacing lt C gt Display and cancel Caliper lt S gt Snapshot lt M gt Mark event lt T gt Timer lt B gt Toggle Big Numbers view for Stim window In addition to the keyboard shortcuts you can use the following buttons Click x to refresh the view This is
72. fferent than the actual elapsed time Traces Display Setup Panel There are three display controls located on the right of the Information panel Zoom and Notch are positioned one beneath the other and Sweep Speed is on the right Zoom Sweep Speed ET ef offi of of imf Notch Note When the stimulator panel is on the Review screen the Zoom and Notch area will be used to display the stimulation parameters Zoom Using the Zoom control you can see the overall picture at a glance or Zoom in to view the waveforms in greater detail in much the same way that you would use a zoom lens on a camera This is particularly useful for viewing events or special regions of interest Zoom The Zoom display control has a combo 11 box and is used to increase or decrease the display zoom factor Possible selections of a Zoom factor may be made from a drop down list of the following pre defined values 1 1 1 2 1 4 1 8 or 2 1 EMS XL User s Guide 4 9 Note The selection list may not be edited and the default value is 1 1 This may be overwritten however by loading any other configuration For details refer to Loading the System Setup for the Study on page 6 6 Note When selecting a Zoom factor only the display of the waveforms in the RT Monitor will be affected The recorded FD data will remain unchanged Sweep Speed Sweep Speed is the rate in mm Sec at which the waveforms are seen to move
73. figuration changes that were done during the study will be shown on the RT screen Changes of configuration that were done by Config button Manual change of appearance disappearance of leads Label change of lead Changes of lead positions Run Time Screen in Playback During Playback the Run Time screen plays with all the changes that were done during the recording The Run Time screen changes automatically according to changes done during recording EMS XL User s Guide 7 1 During playback you cannot perform manual changes to the Run Time screen or to the channel set up Pressing the PLAY button on the NRT screen during playback sets the RT screen to the same time as the NRT screen The configuration of the screen is the original recorded configuration Review Screen in Playback You can manually display hide a lead during playback You can change the position label zoom and color of the lead Pressing COPY RT copies the configuration shown on the RT screen at time of playback to the NRT screen This will overwrite any manual changes done to the NRT screen Double clicking an event in the event list displays the event in the Review screen with the configuration used during the recording of that specific event This overwrites any manual changes done to the Review screen Movement in time ruler and minute steps on the left bottom of the Review screen show on the Review screen with the configurat
74. g 6 41 Traced Display paper speed 4 14 Traces Display 4 12 appearance 5 2 setting up 5 2 setup panel 4 9 W Warnings safety 2 2 Index 3
75. ined The labels of these files can not be deleted of modified Note F11 F12 keys and Stimulation mode combo box not active during Playback Caution The G key will not start stimulation and the space key will not stop stimulation if panels that use the keyboard are open For Example Patient Notes Report EMS XL User s Guide 6 27 Stimulation List When you click the List Stim icon Ll a panel with a list of all stimulations performed during the examination appears To view the signal during a selected stimulation select the Stimulation line and click on View Selected This will display the signals during the stimulation on the Review screen Note that the left side of the scale at the bottom of Review screen is set to the time of the stimulation m Stimulation Event List Ref Time Protocol sisi s s2 00 04 32 968 _ 88 9 00 04 42 020 _ 600 00 04 57 114 600 Jooo e 00 05 13 660 123 70 00 05 22 690 400380360V 400 00 05 30 252 _ 600 00 05 54 406 ABC 600 00 07 01 903 99 600 00 12 43 604 30X600A 600 00 12 58 637 30X600A 600 00 13 19 702 30X600A 600 oooococo SOS SO SSS ISO View Selected Figure 6 12 Stimulation List Window Marking an Event To mark an event 1 Click Event and select the appropriate event category from the list 6 28 Mennen Medical Using the Stimulator Speed 50 mm Sec 2 Open the drop down list next to Event and mark the event
76. ing Holter mode e Template comparison e Interface availability for various ablators RF Generators MAESTRO 3000 EPT 1000 Boston Scientific IBI 1500T Irvine Biomedical Inc STOCKERT Biosense Webster ATAKR II Medtronic HAT 300 Smart Osypka e Connectivity to Horizon Xvu Hemodynamic System combo DGE 965 000 Rev A 07 2011 EMS XL Specification AMPLIFIER Two options 32 channels 64 channels ECG 32 channel amplifier 12 Surface ECG 18 Intracardiac ECG 12 Unipolar Bipolar 6 Bipolar 64 channel amplifier 12 Surface ECG 50 Intracardiac ECG 24 Unipolar Bipolar 26 Bipolar e Defibrillation protection in the cable e Input Dynamic Range 5 mV peak to peak AAMI EC11 par 3 2 3 e Baseline Correction 300 mV AAMI EC11 par 3 2 3 e Input DC Offset 530 mV e Notch Filtering 50 Hz 60 Hz e High pass filter 0 05 0 2 40 80 Hz e Low pass filter 500 Hz e Sample Resolution 12bit e Sample Rate 1000 sample sec e Gain 0 1 to 25 6 mV cm e Beat detection from any chosen lead e Heart rate counting beat by beat e Common Mode Rejection 120 dB minimum e Noise 30 uV e Input Impedance 2 5 megaQ e Baseline Recovery lt 8 sec e Ablation RF Filtering 100 W e Saturation Recovery 1sec Invasive Blood Pressure e Channels 2 e Input Sensitivity 5 uV V mmHg transducers e Pressure Range 50 to 300 mmHg e Zero Range 150 mmHg e Total Dynamic Range 200 to 450 mmHg e Transducer Excitati
77. ing of NIBP every X minutes EMS XL User s Guide QRS Settings Start Stop Starts or Stops NIBP cuff inflation for a NIBP measurement Each NIBP and SPO2 measurement is entered in the Events list with a time stamp Ref Time Event 8181 S182 S283 S384 S4 00 Figure 6 2 Measurement with time stamp Commands QRS Settings Channel Select Channel 4 ENS Trigger Select On Slope i RefPer 100 a r Adjust Adjust QRS Min Len 10 I Parameters se sS Chan 2 I RA s 1 I l5 z er ge mn 16 HBEp 17 RV d Figure 6 3 QRS Setting Window Mennen Medical Setting Up a Procedure Channel Settings Use the combo box to select from a list of Surface and Intra cardiac channels 1 32 or 1 64 optional named according to the current configuration The selected channel is used for HR calculation and QRS detection and is the default Stimulator trigger source Note The Stimulator can be used on Channels 13 24 only i e the first 12 Intra cardiac channels The selected channel will be used in synchroni zation procedures in the system Lead II will be used as a default Lev Ref Level Reference Use the combo box to select the appropriate Level reference For low voltage levels i e patients with a low QRS adjusting the Level reference to a lower value may be required For
78. ion used during the recording Movement with the ruler in the Review does not change the configuration that was determined manually on the screen until it reaches a point where the configuration changes on the RT done during recording and then it too changes accordingly on the Review You can use the Snapshot feature during playback Mennen Medical Review Screen in Playback You can enter events and notes during playback During Playback you may use the Calipers to measure events In addition the EMS XL Report is also active and can be edited and printed if required During playback you can also select a specific time from the case recording and playback the case from that time onward In Playback Mode a few EMS XL features are disabled rendering the following functions unavailable Printing from the RT Monitor Using the Stimulator Inserting Measurement Results with assigned location in the EMS XL Report To Playback a Case Click the shortcut icon OR From the Command menus at the top of the Review Screen scroll to the Commands tab 2 Click Patient ons Settings Channel Select Channel gt Select Printer Grid Print RT Multiple pages speed RT screen 25 Exit Length l page x sec Notes Report The Patient amp Study Information window opens refer to Figure 6 1 on page 6 3 3 Under the Patient Tree scroll the list of Patient Files and
79. ions and are explained in Table 4 1 Table 4 1 Run Time Monitor Shortcut Buttons and Functions Button Function Provides a comparison between a template and E the Run Time screen o See Comparing the Run Time Screen to a Tem Tima Note Keyboard lt T gt performs the same function plate on page 6 57 n Save changes done online to the chosen screen Tes configuration Write Start Stop and Reset Timer displayed on lower bar ofthe RT screen Sweep Toggle between Sweep and Triggered Activates Calibration Pulse 1mV Cal Pulse Freeze Ar 12L Used to Freeze the display Button toggles between Freeze Unfreeze Or use keyboard shortcut press lt FI gt key Displays 12 lead ECG EMS XL User s Guide 4 11 Traces Display Table 4 1 Run Time Monitor Shortcut Buttons and Functions Button Function 2 Activates 12 lead printout Activates displayed channels printout Activates Calipers used for performing interval measurements In Run Time Monitor only available in Trigger Mode The waveforms visible in different portions of the Traces Display are as follows Surface ECG channels Intra cardiac channels BP channels Surface ECG Channels In Figure 4 2 traces from five surface ECG leads may be seen at the top of the Traces Display Each waveform is labelled on the right with an associated channel Up
80. layed to the right of this line represents the last most recently updated beat Caution Some of the software keys in the EMS XL do not show the active Status but the Response to the activation of the key Status Bar and Indicators The Status Bar located beneath the Traces Display and extending the full width of the Run Time Monitor displays indicators showing general system information and application modes as described below from left to right EMS XL User s Guide 4 13 Disk Space Disk ENENNEZ This window indicates how much free space is still available on the system hard drive during recording Warning Do not allow the disk to be full Delete files when you reach 85 Note When the disc reaches 85 it will not be possible to start a new case unless files are deleted When the disc reaches 8596 during a case a warning panel that allows file delete will be presented If the disc reaches 90 a warning panel will appear every 5 minutes When the disc reaches 9296 the case will be terminated Paper Speed Shows the currently selected printer paper speed setting mm sec Paper 100 Recording Playback Pause This indicator shows the current system status and will display one of the following Playback a recorded case is being played back Note if the indicator appears grayed out Playback mode is currently inactive Recording a case is being recorded Recording Pause
81. ll to the Stimulator Setup tab Configure Stimulator Sctup Stimulator Pacmg Dis 4 gt Auto Snapshot Last Stim SNRT SNRT Duration Min Interval po a Sec 400 ieee 2 In the SNRT tab use the Up Down arrows LLJ to set the stimulation duration 3 Use the Up Down arrows LLJ to set the minimum interval for the SNRT procedure 4 Click Apply 6 44 Mennen Medical Using the Stimulator The SNRT Procedure After setting up the parameters you can start the SNRT procedure You are permitted up to 10 SNRT cycles SNRT mode is active only after selecting a patient SNRT is not available in Burst mode The Auto button in the Stimulation panel is not active in SNRT mode Note SNRT procedure uses only S1 stimulation Do not use 2 83 To start the SNRT Procedure 1 Click the SNRT icon The stimulation dialog panel is displayed with the SNRT stimulation protocol The default protocol shows CL S1 period 800 msec and S1 counter SD 1000 CL Note The default SNRT stimulation protocol file can be modified but not deleted Default attributes are Single Sync S1237X600 msec SD 30 sec Atrium Delta 50msec 2 You can now manually set the first S1 period usually it is set to Spontaneous interval minus 50 msec The S1 counter is then set automatically to provide the preset SD duration No of Beats SD 1000 CL 3 Press lt G gt or click Go to start stimulation series
82. location cannot be modified by dragging the channel labels You need to return to Study Display mode in order to modify trace locations Note Calipers activities in the WF area are the same as in Study Display mode in the Review NRT screen Holter Area Description The Holter area displays 1 minute of single channel WF data of a specific channel defined in the Holter window The one minute Holter display start at the beginning of the minute selected on the Review screen bottom left of the screen This waveform is displayed in 25 mm sec divided into 12 lines each showing 5 seconds of a single channel WF data Two red markers and on the Holter area show the selected Holter range The selected range width depends on the WF Area sweep speed see Figure 2 11 The distance between the brackets is equal to the length of the WF area that is for example About 12 seconds in 25 mm sec About 6 seconds in 50 mm sec About 3 seconds in 100 mm sec Any change of the selected area presents the EMS XL User s Guide 5 23 corresponding multi lead waveforms in the WF Area Stimulation Events are shown on both the Holter and the WF area by magenta markers on the Holter waveform and on the top of the WF area Holter Area Navigation You can move the selected range by setting the Start End or Middle position of the range You can also use the navigation buttons to move the range back or forward in steps to an
83. m 16 9 inches e Dimensions for Desktop Height 150 mm 5 9 inches Width 380 mm 15 0 inches Depth 460 mm 18 1 inches Laser Printer e Parallel HP3005 or an equivalent Displays e 2 local displays TFT LCD 20 each e 2 remote displays Optional System Configurations e Console or Cart e EMS Console Dimensions with external computer Width 1050 mm 41 3 inches Width 1180 mm 46 4 inches with display Height 1300 mm 51 2 inches with display Depth 820 mm 32 3 inches e Cart Dimensions including displays Height 1550 mm 61 0 inches Closed Position Width 800 mm 31 5 inches Closed Position Depth 700 mm 27 5 inches Open Position Width 1150 mm 45 3 inches Open Position Depth 600 mm 23 6 inches System Power Requirement e 100 120 VAC 12A 50 60 Hz e 230 240 VAC 6A 50 Hz Environmental Operating Conditions e Temperature 5 C to 35 C 41 F to 95 F e Humidity 10 to 93 percent noncondensing Environmental Storage Conditions e Temperature 15 C to 68 C 5 F to 158 F e Humidity 10 to 93 percent noncondensing SOFTWARE e Operating System Platform Windows XP Pro e GUI C MFC Visual Studio 2003 e Video Board Driver DIRECT X7 e MS Word 2007 FEATURES e Built in stimulator e Multiple display configurations e User definable waveform color e Caliper measurements e Event marking e Complete full disclosure playback e Snapshot storage e Versatile customized automatic report
84. ment S2 by 10 press lt G gt again Repeat Step 4 until the required results are achieved To stop pacing press the space bar When using auto stimulation the Stimulator gives continuous stimuli according to values stated in S1 S5 but in each cycle the interval of the last extra stimuli is incremented decremented automatically For example 6 24 Mennen Medical Using the Stimulator The increment decrement is according to what is specified in the Stimulator Setup tab Configure Stimulator Setup Stimulator Pacing Disp 4 gt enn E Fic Default READY Tree SET S18 600 S2 1 380 S1 8 600 S2 1370 S1 8 600 S2 1 360 etc Pacing will automatically stop at the value stated in the Last Stim tab of the Stimulator Set up Values under this value can only be accessed manually The lowest stimulation allowed is 70msec To perform auto stimulation 1 Press the lt A gt key to start the auto stimulation process Process and will decrement the last extra continuously until it reaches the value stated in Last Stim tab EMS XL User s Guide 6 25 F Key Shortcut to Stimulator Setup F9 F10 F11 and F12 serve as shortcuts to user defined stimulation protocols The following table lists the shortcut keys F Ke Stimulation Sequence Mennen y Protocol labels default F9 Cont A 600 Continuous Atrial stimula tion at 600 mSec lt Ctrl gt F9 C
85. mode Click to display one minute of single only lead Default lead Il at 25 mm min See Setting Up Study E BP Display on page 6 8 for details Study Cancels the Holter view returning the study to normal view Provides a comparison between a template and Yes Yes 7 the Run Time screen on the right side of the NRT s screen See Comparing the Run Time Screen to a Template on page 6 57 Opening a patient file See Registering a Patient on page 6 2 Add online Notes See Adding On line Notes on page 6 48 Reports generator See Editing the EMS XL Report on page 6 60 Yes Yes Exiting EMS XL application See Exiting the EMS XL Application on page 4 35 Setup printing See Printing from the Run Time Monitor Screen on page 6 51 Click to add Notes to a Case Note Or use keyboard shortcut press F3 key No Yes See Adding On line Notes on page 6 48 Opens the QRS settings Tab to set the Heart Rate gc source channel and settings See QRS Settings on Yes No QRS page 4 25 Click to access Channel Select commands For aL details see Channel Select Run Time Screen on Yes Yes page 5 7 4 22 Mennen Medical Table 4 4 Review Screen Shortcut Toolbar Review Screen Button Ra Function Click to access the Mark commands menu For details see Marking an Event on page 6 28 No case No Playback Yes Click t
86. ms and additional information can be seen as shown in the example in Figure 4 2 below During stimulation and stimulation setting the Zoom and Notch areas are used to display the stimulation parameters Heart Rate Blood Pressure Patient Details Ablation Actual Time and Current Date Playback Time and Date F EP Study Time Elapsed Zum Bw Shortcut Toolbars Surface ECG Channels Intra Cardiac Channels qe BEBNEREGSENES l Status Indicators Figure 4 2 EMS XL Run Time Monitor Run Time Display 4 6 Mennen Medical Run Time Monitor Hemodynamic Data Patient hemodynamic data is visible in the Heart Rate HR and BP windows located at the top left of the screen The heart rate beats per minute is displayed in large green figures the smaller figure in red underneath is labeled RR and represents the RR Interval distance in mSec between R to R peaks Note The flashing asterisk on the left indicates sensing of the heart rate HR To the right of the HR a dynamically updated view of the patient s blood pressure is visible in the BP window Pressure values are shown in the following order Systolic Diastolic Mean Note If the BP display setting has not been enabled from the Review Screen BP values will not be visible in the Run Time Monitor and the area will appear blank For details refer to Setting Up BP Display on page 6 8 Note In Mennen Combo systems this ar
87. n with other medical equipment which also meets this requirement To avoid interference problems affecting the Monitor do not use Monitor in the presence of equipment which does not conform to these specifications Note The term Monitor refers to both the EMS XL RT Monitor Run Time and the EMS XL Review Screen Do not apply pressurized air to any outlet or tubing connected to the monitor Pressure may destroy sensitive elements Do not store the system outside the specified temperature range 20 C to 65 C 4 F to 149 F Leave space for circulation of air to prevent the system from overheating Do not subject critical components of the system to excessive heat bending or magnetic fields To prevent any liquid from entering the casing of the display screen do not tilt the display more than 45 degrees backwards or 15 degrees forwards and ensure that the display screen is not exposed to knocking and bumping Mennen Medical Dispose of the entire device or parts of it in accordance with local environmental and waste disposal regulations Safety Rating and Manufacturer Identification Label A Safety Rating and Manufacturer Identification label for the EMS XL System is located on the right side of the isolation transformer rear panel MENNEN MEDICAL LTD Cart Assy EMS OPT VOLTAGE V 220 240 P N 965 101 010 REV H FREQUENCY Hz 50 S N EP0189 CURRENT A 8MAX Warning Disconnec
88. n event is displayed in orange in the Events list in the review screen During an ablation events results are displayed automatically in the hemodynamic data window Note You can select Show Hide Ablation to display hide ablation data 3 Select Show Hide Graph Ablation to show hide data in graph form Double clicking on events of Start Ablation from the event list on the NRT screen dis plays previous graphs of ablations The graphs appear on the NRT screen 6 38 Mennen Medical Save a Snapshot Using the Stimulator You can print the graphs by pressing Print graph button The ablation graph printout contains patient s first name last name and number of ablation from the event list 4 Press BIG for Big numbers display of ablation data Press Graph to return to graphic display OR OW Using this icon A displays a Save As window in which you can browse to a folder name the image file name and select the format of the NRT snapshot image to be saved in the computer default format is JPEG This also enters an event of the Screen shot into the Events list and enter the screenshot into the final report Ref Time Event s1s1 s s2 283 384 S4S5 00 13 02 044 ScreenShot 00 1 Figure 6 18 ScreenShot Event EMS XL User s Guide 6 39 To insert the saved picture into a report 1 Open the report 2 Set the Cursor at the end of the report 3 Select Insert gt
89. n the right Zoom Sweep Speed Notch Note When the stimulator panel is used on the Review screen the Zoom and Notch area will be used to display the stimulation parameters lcs ew Sweep Speed Zoom Using the Zoom control you can see the overall picture at a glance or Zoom in to view the waveforms in greater detail in much the same way that you would use a zoom lens on a camera This is particularly useful for viewing events or special regions of interest Zoom The Zoom display control has a combo 11 box and is used to increase or decrease the display zoom factor Possible selections of a Zoom factor may be made from a Mennen Medical Building a Configuration drop down list of the following pre defined values 1 1 1 2 1 4 1 8 or 2 1 Note The selection list may not be edited and the default value is 1 1 This may be overwritten however by loading any other configuration For details refer to Saving and Loading a Con figuration on page 5 17 Note When selecting a Zoom factor only the display of the waveforms in the RT Monitor will be affected The recorded FD data will remain unchanged Sweep Speed Sweep Speed is the rate in mm sec at which the waveforms are seen to move across the Traces Display from left to right Increasing the Sweep Speed will influence the Traces Display by making the waveforms move faster decreasing the speed will make them move slo
90. nformation Window Note For an explanation of the Case Control buttons refer to Table 6 1 Click Done to close the panel before trying to activate any other function EMS XL User s Guide Table 6 1 Case Control Buttons amp Functions Button Playback Case Function Starts playback of a closed Case from a previously registered Patient File after End Case enables re opening Case for playback See Chapter 7 Case Playback Starts recording data from a newly registered Start New Case patient End Ends closes the current Case Case both in Real time and Playback modes Continue Case Resumes recording of a closed case from a previously registered Patient File Notes 1 The system adds a pause between the case parts 2 Continue Case is only enabled for 24 hours after closing the case Used to Delete a Case from a Patient File Delete P This function is irreversible All data in the currently selected Case will be removed from the hard drive Make sure the correct Patient File and Case is selected before clicking the Delete button Used to close the Patient and Study Information Done window 6 4 Mennen Medical Registering a Patient 3 Enter the appropriate details in the Patient General Information data input fields as shown below Patient General ea r First Name Patient Last Name Asheton 000000 Patient LD Feiern ID Case LD
91. ngineer Notes For recommended EMS XL System cleaning procedures see General Cleaning Procedures on page 8 1 For information on Calibration and Preventive Maintenance on page 8 5 Replacement of the CPU Battery Whenever the EMS XL System is disconnected from the mains power supply the CPU battery provides the back up power to the system set up In the event that the system is disconnected from the mains power supply for an accumulated period of 2 months 1440 hours or more or if it is only intermittently attached to the power supply the CPU battery should be replaced 1 2 Mennen Medical Compliance The EMS XL System is designed to comply with amongst others the following international safety requirements for medical electrical equipment IEC 60601 1 IEC 60601 1 2 IEC 60601 2 27 AAMI voluntary performance standards ES1 EC 11 The European Directive of 93 42 EEC classifies the EMS XL as a Class IIb device The system is designed to have special protection against electric shocks and is defibrillator proof The ECG application is classified as Type CF equipment for direct cardiac application The EMS XL provides protection against the effects of defibrillation and electrosurgery If the correct electrodes are used and applied in accordance with the manufacturer s instructions the screen display will recover within 10 seconds of defibrillation Type CF equipment is designed to hav
92. nly Displaying the QRS Parameters on the RT screen Click the Adjust button to display the QRS parameters on the RT screen The ECG channel used for QRS detection is displayed between two brown border lines Below the ECG is the detected channel displayed as derivative of the QRS detection channel A special green marker appears on the signal when QRS is detected Red line marking the level reference Use the Up down Rev Lev arrows to adjust the level reference see above White line marks the minimum length in milliseconds Use the Up down Min Len arrows to adjust the minimum length see above light blue line marks the time of the refractory period in miliseconds Use the Up down Ref Per arrows to adjust 6 14 Mennen Medical Using the Stimulator the refractory period see above 159 e m Refractory QRS Channel Period Level Reference Detector Signal Minimum Length he Recording Tam Figure 6 4 Stimulation of RT Screen Using the Stimulator The system includes 8 pre defined stimulation protocols e Default prg Stimulation loaded during startup Cont A 600 prg F9 Cont V 600 prg CTRL F9 Basic A prg F10 Basic V prg CTRL F10 SNRT prg Loaded during SNRT Procedure Burst A prg Loaded during Burst Procedure Burst V prg Loaded during Burst Procedure EMS XL User s Guide 6 15 Stimulator Pacing The Auto Snapshot feature ena
93. ntary Product Optional 3 7 System Specifications 0 0 eee eee eens 3 7 Chapter 4 Getting Started Starting the EMS XL Application 0 0 0 00 eee eee 4 1 Keyboard Shortcut Keys 0 0 eect e 4 3 DE Dre dept beds tc aR taste lade rest scd as EEE se Sy ordering 4 4 Run Time Monitor i ouem ceteras OR dee Ari ek na a 4 5 Traces Display sic ib eem iw Len Sa eh dt ed Dash ne 4 12 REVIEW SCE GI c sss areata ADR UEXE UA HERE AREER ie BA ee Aes 4 15 Upper Panel Eontrolss 4 Soo re era en 4 18 Parameter Setup and Command Menus 2 2222 0 00 s eee eee ee aes 4 24 Left Panel Control Sir ie USE PEDE CREE Re REL as ea 4 31 ii Mennen Medical PRINS UD 4 34 Exiting the EMS XL Application 00 0 0 cece eee eee ee 4 35 Chapter 5 Setting Up Monitoring Building a Configuration lesse 5 2 Setting Up Traces Display III 5 2 Channel Select Run Time Screen 0 0 0 cee eee eee eee eee 5 7 Channel Select Review Screen 0 0 0 e ccc eee ee 5 11 Setting Up Intra cardiac ECG Channels 0 0 0 eee eee eee 5 13 Channel Settings u 8 er hee ee LE a pc age 5 14 Saving and Loading a Configuration 0 0 02 cece eee eee 5 17 Setting Up Tachycardia Detection eee 5 21 Setting Up the Holter Display Mode 0 0 cece cee eee 5 22 Setting Up the Stimulator Auto Snapshot 0 0 0 02 ee eee eee 5 26 Setting Up the Repeat Auto Snap
94. nter paper size and display size the printed page does not include the same information as the display A red marker at the bottom of the display indicates the printer page end Screen Print Size Information Table 4 6 gives the time range in milliseconds covered by one printed page under different printing speeds and page sizes It also presents the percetage of the NRT screens in Study and Holter modes covered by different page sizes Table 4 6 Screen Print Size Information ada A4 Page Letter Page 25 11 200 10 400 50 5 600 5 000 100 2 800 2 500 150 1 900 1 700 200 1 400 1 300 250 1 100 1 000 300 950 850 from NRT Study screen 10 63 from NRT Holter screen 100 90 4 34 Mennen Medical Exiting the EMS XL Application Exiting the EMS XL Application Before exiting the program you need to close the patient case see Ending a Case on page 6 64 To exit EMS XL In the Commands menu at the top of the Review Screen click Exit Note You can display the Commands menu directly by clicking the File d icon on the Review screen shortcut toolbar see page 21 ORS Settings Channel Select Channel d Select Printer Gnd Patient Print RT Multiple pages Notes Speed RT screen Y 25 Exit Report Length n page x 3 The Windows desktop is displayed EMS XL User s Guide
95. o access the Config commands menu Note Or use keyboard shortcut press lt F4 gt key For details see Loading the System Setup for the Study on page 6 6 and Saving and Loading a Configu ration on page 5 17 Yes Yes Click to copy snapshot of the current display of the patient s waveform status in the RT Monitor to the Review Screen Note Or use keyboard shortcut press lt S gt key No No Click to activate Calipers for performing interval measurements See Using the Calipers for Interval Measurements on page 6 32 Yes Yes ASS AH Click to activate Traces Location bar used to associ ate a measurement with a location See Using the Calipers for Interval Measurements on page 6 32 Yes Yes Click to activate 12 lead printout No Yes Click to activate displayed channels printout No Yes Click to access BP Display commands See Setting Up BP Display on page 6 8 Yes Yes Note Available in Run Time Mode only Click to stop saving Full Disclosure data to the system hard disk The FD button changes color and becomes a red stop sign Click again to resume saving FD data to the hard disk No No EMS XL User s Guide 4 23 Table 4 4 Review Screen Shortcut Toolbar Button Function as Playback case Note Available in Playback Mode only Click to start playback of the event case from a time
96. o the Channel Select Run Time Screen instructions on page 5 7 Note The channel display hide commands for the RT Monitor can only be executed from the Channel Select window accessed from the Review Screen To Reposition a channel 1 Click on any channel button see Figure 5 1 and hold down while dragging the button up or down 2 Release the mouse button the channel and its corresponding button remains in the new position 5 4 Mennen Medical Building a Configuration Channel Button Channel Identification Label may be edited Physical Channel Number relates to patient connection board may not be changed Figure 5 1 Channel Buttons and Labels Note Itis possible to arrange the channels with equal spacing or in sequence See Channel Select Run Time Screen on page 5 7 for details Each channel has pre defined settings as supplied with the system However right click access to the Channel Settings controls enables you to make any of the following changes to the currently selected channel as required Change the Name of a channel identifier label Invert the displayed polarity of a channel Change High Pass Filter Change Polarity Bipolar to Unipolar or vice versa Set the Gain Note It is possible to change the gain without enter ing Channel Setting Click with the mouse on the channel and use the mouse scroller up down or keyboard keys up down to change the gain
97. ode click the SNRT icon SNRT Table in a Report The following table is presented in the report with each line representing one SNRT test cycle Table 6 2 Sinus Node Recovery Time Corrected IR Intrinsic Pacing CL Number of SNRT SNRT Rate msec msec beats msec CSNRT msec 953 700 60 1143 190 1010 650 93 1160 150 Normal range for SNRT is up to 1 500 msec Normal range for CSNRT is up to 500 msec Abnormal SNRT values are displayed with a red background In the report abnormal SNRT values are marked by a star EMS XL User s Guide 6 47 Procedure Documentation Adding On line Notes Note On line notes may be added at any time during a Case To add a note 1 From the Commands menu at the top of the Review Screen click Notes Note You can display the Commands menu directly by clicking the File d icon on the Review screen shortcut toolbar see page 4 21 Or Click the Ly icon Or Press lt F3 gt on the keyboard 6 48 Mennen Medical Using the Stimulator The Notes window opens Predefmed Notes Anliythiusa Summary Conclusion Dual AV pathways ir Ref Time Comments 00 08 58 202 Dual AV pathways m anterograde amp ical sustained AN Medication Adenosme Amiodarone Atenolo Mexiletine Procamannde Propanolol Quumdaie Tunolol Verapamil Selected Note Esmolol Figure 6 1 Notes Window Note
98. of ablators generators Connection to ablators enables seeing the ablation data on the EMS XL screen during the ablation as well as a graph of the data and printing this data It is possible to change the ablator and COM port from the application The ablators that connect to the EMS XL are MAESTRO 3000 Boston Scientific BI 1500T Irvine Biomedical Inc STOCKERT Biosense Webster EPT 1000 Boston Scientific ATAKR II Medtronic HAT 300 Smart OSYPKA To set up ablation 1 Click the Ablation setup tab Tachy Holter Save Template Ablator setup Snaps 4 gt Ablator STOCKERT v COM port 2 v 2 Choose the COM port to which the ablator is con nected 5 28 Mennen Medical Setting Up Ablation 3 Choose the type of abaltor generator connected 4 Click Apply EMS XL User s Guide 5 29 5 30 Mennen Medical Chapter 6 Performing the EP Study EP Study Overview Performing an EP Study consists of the following Registering a patient see Registering a Patient on page 6 2 Setting up the EP study parameters You can start by loading a saved configuration or start a new setup see Setting Up a Procedure on page 6 6 Using the Stimulator and selecting the required pacing protocols see Performing Stimulation on page 6 23 Performing the study Ending the case see Ending the EP Study on page 6 60 In addition you can add notes see Adding On line Notes
99. of the Run Time Monitor screen and its functionalities Review Screen on page 4 15 A description of the Review screen and its functionalities Printing on page 4 34 Printing information Starting the EMS XL Application The system is supplied ready for use therefore no special set up or installation procedures are required Note In some situations a user password may be necessary to start the program for example when the EMS XL system is networked to a hospital information system For user access contact your system administrator You need to check if your system has 32 or 64 channels One or Two Amplifiers Note Make sure that the program you are using is for 32 or 64 channels accordingly EMS XL User s Guide 4 1 To check the number of amplifiers 1 Right click the EMS XL Icon 2 Select Properties 3 Set the Target to D EPVersions EmsOseRT_V1_1 37 exe XX Where 1 37 serves as an example of the software version and the value of XX is set according to the number of amplifiers If the system has one amplifier XX 32 if two XX 64 To Start the EMS XL Program Double click on the EMS XL program icon p on the Run Time Monitor desktop the monitor standing on the left The EMS XL program starts running the Run Time Monitor opens with an initial display showing scrolling waveforms see 4 1 and the Review Screen opens displaying still traces as shown in the example in Figure 4 3 R
100. olutions and detergents EMS XL User s Guide 8 1 General Cleaning Purpose To remove dirt and most microbes At least once per month clean and wipe off the frame of the amplifier and the monitors using a soft wet cloth moistened with lukewarm water and cleaning solution CAUTION A Do not use caustic detergents oxides hypochlorite lacquer thinners ammonia or acetone based cleaning solutions These may damage the system Most cleaning agents must be diluted before use Take care to follow the manufacturer s directions for dilution Note In the event that harmful unautho rized materials are used for clean ing the damaged or contaminated equipment will be serviced at a cost regardless of the warranty period Cleaning the EMS XL System and Accessories To clean the EMS XL and accessories 1 Before cleaning the monitor or the BP sensor switch the monitor OFF and disconnect it from the power supply Clean the OEM sensors according to the instructions provided by the manufacturer CAUTION A Do not sterilize the BP sensor by irradiation steam or ethylene oxide EtO 2 Dust the EMS XL regularly Clean with a lint free cloth or sponge dampened with cleaning solution Abrasive scouring powders and pads should be avoided to prevent damage to the system 8 2 Mennen Medical A General Care and Maintenance 3 Clean the display screen with a non abrasive anti static glass cleaner Use
101. ommands ORS Settings Channel Settings Event 4 gt Lev Ref Trigger Select RefPer 100 Min Len 10 Chan 2 11 This panel enables setting the channel from which the HR will be measured Use the Chan combo box to select the HR source from a list of Surface and Intra cardiac channels 1 32 or 1 64 optional named according to the current configuration Use the other combo boxes to adjust the HR detection See QRS Settings on page 6 12 EMS XL User s Guide 4 25 Channel Settings ORS Settings Channel Settings Event Stimulator S 4 Filter Gain Color Clippins C 0 05 ull 255 2022 mij Invert amp 40 B cl ajom so 21 Use to set up various channel parameters of the RT waveforms See Channel Select Review Screen on page 5 11 Event Event Stimulator Setup Stimulator Pacing Display 4 gt Mark Event By Category Now Wenck Marker Relabel CM gi zl Delete Displays a list of Category names that are used to mark events during the procedure You can scroll through the list using the 4 up and down arrows See Marking an Event on page 6 28 Stimulator Setup Stimulator Setup Stimulator Pacing Display BP Ta 4 2 Atrium Ventricle Threshold Last Stim SNRT 4 gt E Front BA 2 o E 4 26 Mennen Medical Review Screen The Stimulator Setup tab has nine sub groups Sound A
102. on 5 VDC with separate excitation driver for each channel e Zero Accuracy 0 2 mmHg e Zero Drift Less than 0 2 mmHg in 24 hours at constant temperature e Blood Pressure Accuracy 2 mmHg or 296 whichever is greater exclusive of transducer e Blood Pressure Linearity Within 1 across entire range e Common Mode Rejection 100 dB minimum e Digital Sample Rate 480 Hz e Sample Resolution 24 bit e Frequency Response Operator Selectable DC to 12 Hz e Calculated Values Systolic Diastolic and Mean pressures STIMULATOR e Built in e Dual channel output Basic 4 extra stimuli e Programmable pacing controls e Automatic or manual increment and decrement e Auto snapshot after stimulation e SNRT protocol e Pulse Width 0 1 9 9 msec e Pulse Range 0 25 5 mA 40 V e Pulse Interval 70 9999 msec REGULATORY APPROVALS e EN 60601 1 e EN 60601 1 1 e EN 60601 1 2 e Degree of protection against electrical shock ECG IECG and IBP Type CF e CE Mark 0473 e FDA Approval K071348 We follow every beat of your heart 2009 Mennen Medical Ltd All rights reserved Specification subject to be changed without notice Chapter 4 Getting Started This chapter describes the procedure for starting the EMS XL application Starting the EMS XL Application on page 4 1 and exiting the application Exiting the EMS XL Application on page 4 35 It also includes the following Run Time Monitor on page 4 5 A description
103. ont V 600 Continuous Ventricular stim ulation at 600 mSec F10 Basic A 8 x 600 1x 380 A lt Ctrl gt F10 Basic V 8 x 600 1 x 380 V F11 Burst A If defined in the Offline Configuration Utility as Burst See below F12 Burst V If defined in the Offline Configuration Utility as Burst See below Burst Mode The EMS XL has 3 modes of stimulation dialog Normal Burst A Burst V Normal mode is the default mode when starting a new case Burst modes are indicated by a red background on the 6 26 Mennen Medical Using the Stimulator Stimulator Pacing panel Note Ifthe Panic buttons F11 and F12 were config ured as Burst in the Configuration Offline Util ity then F11 toggles between Burst A and Normal modes F12 toggles between Burst V and Normal modes The first time Burst mode is used in a case receives the Mennen default parameters Changes made to stimulation parameters while in Burst mode are stored as updated Burst parameters Returning from Burst A or Burst V to Normal mode sets the stimulation protocol to the last normal setting prior to activation of the Burst Using the mouse switching between modes is done by opening the combo box with 5 options Normal Exit Burst A or Burst V modes Burst A Enter Burst A mode Burst V Enter Burst V mode Burst Defaults The stimulation files Burst A and Burst V are used as defaults on the start of a new case The content of these files is user def
104. or future use click save Print Baseline With the appropriate system setup selected click the amp icon on the Run Time Monitor display to print a 12 lead print Out The 12 lead printout called baseline printout is recommended as it provides a reference of the basic status of the ECG prior to the interven tion You need to prepare the system for BP display by activating the BP channels To activate the BP channels 1 Add PRI 26 and PR2 28 to the screen 2 Use the Display BP panel to Activate Deactivate BP display Grid No Grid Zero Activate Deactivate CFE connection Stimulator Setup Stimulator Pacing Display BP Ta 4 gt Scal Vr CER 25 50 50 100 125 250 CFE Calibration eas BE Auto fs x F000 1 000 NoGrid ex ET The Display BP tab is used to configure the two BP channels Pr1 and Pr2 Once they have been configured they are permanently displayed in the lower portion of the RT Monitor Figure 4 1 below the intra cardiac channels Mennen Medical Setting Up a Procedure The tab is also used to display the parameters received from the CFE in a Combo system The parameters received from the CFE are the NIBP readings and SpO2 readings They are displayed in the BP window of the RT screen Scale The grid scale ranges from zero to one of five maximum values 25 50 100 125 or 250 pi 5 so J 100 125 250 Choose the req
105. other line or to the beginning or end of a page To set the selected Holter area 1 Do one of the following Set the Start position Select the Start position of the brackets D in Holter area and click the mouse Set the End position Select the End position of the brackets b in Holter area and right click the mouse Set the position of the middle of the range Select a middle position of the brackets in the Holter area and while holding down Ctrl click or right click the mouse To move the selected Holter area 1 Use the navigation buttons at the bottom of the Holter area in the Review screen see Figure 2 11 1 Move the brackets to previous next data in Holter area Each step is about 1 12 of the WF area duration Click the mouse to move one step forward or backward 1 second if WF area speed is 25 mm sec Right click the mouse to move 2 steps forward or 5 24 Mennen Medical Setting Up the Holter Display Mode backward 2 seconds if WF area speed is 25 mm sec EN Move to previous next line in Holter area Click the mouse to move one page forward or backward Start of new brackets at the end of the previous brackets about 11 5 seconds with WF area speed of 25 mm sec Right click the mouse to move move 1 line forward or backward 5 seconds with WF area speed of 25 mm sec Note New 30 seconds are loaded automatically when the brackets cross the limit of the Holter dis
106. patients with a tall T wave level it may be necessary to increase the Level reference The default is 20 an arbitrary factor without units Ref Per Refractory Period Use the combo box to select the required Refractory Period For patients with a tall T wave level this is useful to block the T wave in order to to prevent falsely identifying it as a QRS and triggering on it Once a QRS is detected the system will start searching for another QRS only after the refractory period has passed The default is 100 msec Min Len Minimum Length Use the combo box to select the required Minimum Length To prevent false detection of the T wave as QRS the minimum length width of a complex may be set The default value is 10 msec EMS XL User s Guide 6 13 Trigger Select On contains two mutually exclusive radio buttons labeled R and S These indicate whether synchronization will be on the R peaks high points or S troughs low points of the QRS Note This subgroup is used for surface ECG channels only Slope contains two mutually exclusive radio buttons labeled and These synchronize on the ECG with various slope shapes Note Relevant for surface ECG channels only Spike contains two mutually exclusive radio buttons labeled and The Spike is used to detect fast deflection in the intra cardiac signal Use the or to set the required level Note Relevant for Intra cardiac ECG leads o
107. pecified for Syncope study Send Data to HL7 sends data to HL7 server optional mode available in some models Save Report in XML format saves report in special XML format File is saved in special XML format Note It is possible to build reports specified for the end user using XML Format EMS XL User s Guide 6 61 Report nf Microsoft Word Eile Edit View Insert Format Tools Table Window Help iDngz2i 3 3 53 4 7 D X E F IC S ACH CA ER AO o O i 44 Normal 14 pt Bc Times New Roman 14 s z u E amp 2 D amurg 5 My ALL Demographic data Patient Name test Date 06 05 2008 10 04 ID 4554656677 Case ID 566878998 Sex M Age 31 Sinus node recovery time Intrinsic Pacing Number Corrected Rate ms CL ms Of beats SNRT indicate a value that exceeds normal range Intervals Notes Events Stimulations sazm Draw Lz AutShepes U WOOF AG Ro ru rA cm o cc B Page 1 Sec 1 1 1 At 8 2 Ln 40 Coli REC TRK EXT OVR Engkh U s U Figure 6 2 EMS XL Report Template Note Close the panel before trying to activate any other function 6 62 Mennen Medical Ending the EP Study 2 Add information to the report as required by clicking and typing text where appropriate Note The following data is inserted into the report automatically Patient name Patient ID and Case ID 2 Labeled Intervals measured by the cursor on the review
108. played minute To change to Study Display mode Holter mode 1 Click the Study Display mode button to change from Holter mode to Study Display mode 2 Click the Holter mode button a to change from Study Display mode to Holter mode Changing from one mode to another keeps the same time location and view Note If calipers are active they are removed when changing from one mode to another EMS XL User s Guide 5 25 Setting Up the Stimulator Auto Snap shot Holter Save Template Ablator setup Snapshot set 4 gt Post stim snapshot Repeat snapshot Post stim Location Sweep Speed Delay after Snapshot mm stimulation sec The Post stim Snapshot tab enables you to control the automatic snapshot settings in use when the Stimulator is activated This feature is particularly useful for measuring refractoriness where the Review Screen is triggered by the last stimuli The triggered display is continuously refreshed by the last extra premature stimulus A pair calipers is used to indicate the time of Atrial or Ventricular activation as well as the conduction time In combination with the automatic increment decrement mode of the Stimulator you may easily observe the execution of the pace protocols The RT Monitor running display monitors the patient and gives information about the capture of the stimuli the triggered portion represents the conduction time differences in full time resolution Rm U
109. r example 120 BPM will be considered by the system as being tachycardia When this occurs an event named Tachycardia will be added to the Events and Stimuli List seen at the upper right corner of the Review Screen refer to the next page Minimum Cycles Set the number of beats that should sustain before the rate is considered as being tachycardia Refractory Use this control to set the length of the pause secs to be counted by the system after arrhythmic tachycardia has ceased before the next arrhythmia is considered as being tachycardia EMS XL User s Guide 5 21 Setting Up the Holter Display Mode The Holter Display mode enables minute by minute viewing of data in the Review NRT Inte 14 15 14 15 00 28 12 802 MAMMA NA 1 7 Mihi d ddddddddd TEN IM vvv WWW WWW FII WM MN J li 4 oO 2H 00 27 45 679 The Holter Display mode divides the Review screen NRT screen into 2 areas Holter area about 30 of original NRT screen at right side and Waveform WF Area about 70 96 of original NRT screen at left side that displays WF channels in the same way as during StudyDisplay mode 5 22 Mennen Medical Setting Up the Holter Display Mode The Waveform WF Area The WF Area is the same as in Study Display mode in the Review NRT screen with two exceptions There is no navigation scroll bar Navigation is done in the Holter area Trace
110. r purposes disclosed to any person or firm or reproduced by any means without the express prior written permission of Mennen Medical Ltd The text and drawings herein are for the purposes of illustration and reference only The specifications on which they are based are subject to change without notice Trademarks EMS XL is a registered trademark of Mennen Medical Ltd Other company and brand product and service names are for identification purposes only and may be trademarks or registered trademarks of their respective holders Data is subject to change without notice Responsibility of Manufacturer Mennen Medical Ltd considers itself responsible for the effects on safety reliability and performance of the equipment only if Repairs are carried out by authorized Mennen Medical personnel only Electrical installation of the room in which the system is installed complies with all aspects of the relevant internationally recognized electrical safety standards as well as specific hospital requirements The equipment is used in accordance with instructions for use EMS XL User s Guide iii Mennen Medical EMS XL User s Guide Table of Contents Chapter 1 What You Should Know Intended Use of the EMS XL System eee 1 1 Using the EMS XL System llle 1 1 Replacement of the CPU Battery llle 1 2 Compliance e e n E Ba Sheps VET eds 1 3 Label Locations amp Symbol Descriptions 00 eene 1
111. ration EMS XL can playback the archived case To restore a case 1 Double click the Archive utility 20E icon on the desktop of the workstation 2 Click the Restore tab 3 In the Restore tab click Add The Add Restore Item window opens 9 10 Mennen Medical Archive Utility Ki Add Restore items x Get From E ex Add Close In the Get From drop down list select the archiving target from which to restore The items available for restoring appear in the window Select the items you want restored and click Add The window closes You can now restore or delete the case study case studies Note Use multi selection to restore more than one case study Select the cases marked in green meaning they are archived that you want restored and click Restore When restoration is finished cases are available for playback in EMS XL EMS XL User s Guide Locating Archived Case Studies The Archive utility creates a database for storing references to all case studies stores by the Archive utility It is possible to search the database for archived cases through the following fields Last name First name Case ID Patient ID Selected range of case study dates Selected range of case study arciving dates To locate a study case for restoring 1 Double click the Archive utility Simi icon on the
112. rdiac ECG on the right The right side of the RT Channel setup panel for RT screen window contains the list of the Active RT channels with fields that enable changing the Label Filter Polarity Gain and Color of the channels RT Channel setup panel for RT screen m x Spacing Sequence Multi set x x 0 FT All All Id Channel Filter B U Gain Color ECG channels Intracardiac channels 1 I 005 B 10 All Spacing Sequence 2 I 005 B 10 Spacing Sequence ou 9 03 1B 2 _Spacina u Sequence Parad HRAp RB An 4 a R 005 B 1 ENEN E 5 aL 0 05 B 1 wR wt ew 6 aVF 0 05 B 10 m m a 12 3 4 5 6 7 8 VI 0 05 P 75 vw ws vw 8 v 005 B 10 9 NB 005 B 10 BP channels 10 V4 005 B 10 11 v5 0 05 B 10 12 V6 005 B 10 13 HRAd 40 B 100 14 HRAp 40 B 100 15 HBEd 40 B 100 16 HBEp 40 B 100 17 RV d 40 B 50 mu 18 RVp 4 B s Uni Bip convert Config Select Load P Diagnostics my Over Cryo Ablation kkkk NEW CC Write Default alzi Delete CLOSE Figure 5 2 Channel Setup Panel e Click SPACING to cause the currently viewed ECG or EMS XL User s Guide 5 7 ICECG channels to be evenly repositioned on the RT Monitor Click SEQUENCE to cause the ECG channels or ICECG to be displayed in numeric order Click SPACING ALL or SEQUENCE ALL to cause all channels to displayed evenly spaced or in numeric order
113. rigger modes However it uses the FD to prepare a signal for printing thus it is not activated if FD is set to Off Printing from the Review Screen You can print from the Review screen during a case and during playback in both Study and Holter display To print Surface ECG from the NRT Screen 1 In the Review screen click the printing button EA 2 2 From the popup menu select one of the following e 3x 4 Selected lead Lined 12 X 10 seconds Close To close the popup menu Printing NRT Displayed Channels You can print RT waveforms according to the definitions in the Print panel The following printing options are available Current View Prints current signals displayed on the NRT screen on one page The printing speed matches the NRT sweep speed Start EMS XL User s Guide 6 53 time of the printing is the Begin time of the NRT screen sweep Printing includes Calipers Caliper measurement Text Graphics Elements The Waveforms trace thickness is according to the current NRT view Multiple Pages This option opens a special dialog window where you can select speed report time grid for printing the current signals displayed on NRT on multiple pages The dialog screen displays the number of pages and the total report time Each report page includes the page number Waveforms trace thickness according to current NRT view The User Defined report length can be given in seconds 10 20 30 4
114. s label can be changed by the user using the keyboard To create a template 1 In the Save Template select the template type from the dropdown list see Figure 6 1 2 Click Save Comparing the Run Time Screen to a Template You can compare stored templates to the Run Time Monitor screen To compare templates 1 In the RT screen click the Comp icon El The Template Comparison window opens with a list of the current patient templates sorted alphabetically Template Comparison Template 01 Sie Por ds Tin Super Pos ond Color Trig Toad Set 1 Note Click the icon again to close the window 2 Click Side Pos to activate the side position area in the RT screen 600 msec at the right end of the screen 3 Click Super Position to activate superposition of the 600 msec template on the live triggered waveforms in the RT screen active only in Trigger mode EMS XL User s Guide 6 57 4 Click Color to paint all superimposed tem plate chan nels with the same color If unselected each channel has its own original color active only in Trigger mode 5 Select the template for comparison from the list and click Load to load the template Notes The last selected template label is displayed at the bottom of the RT screen near timer view This label is removed during End Start case During End Start case the Template Comparison window closes automatically Since templates are related to
115. se this control to set Automatic Snapshot Snapshot ON or OFF oa ott 5 26 Mennen Medical Setting Up the Repeat Auto Snapshot are Sets the position of the last stimulus mm mm ets the sweep spee Sweep Speed S es PSP d 2s repo nf 2f 1o seo 35 Sets the delay after stimulation the Delay afle stimulation number of secs required to delay the 0 autosnapshot after capturing og When all the above mentioned settings are correct click OK Setting Up the Repeat Auto Snapshot Holter Save Template Ablator setup Snapshot set 4 Post stim snapshot Repeat snapshot Free time Ablation time Stimulation time i M ON OFF v ON OFF F 5 Seconds 2 Seconds 1 Seconds The Repeat Snapshot tab enables you to set up auto snapshots shown on the NRT screen every X seconds during the ablation and or stimulation and or free time For automatic snapshots during the study Check Free Time and enter the interval at which automatic snaphots are taken during the study For automatic during any ablation event Check Ablation and enter the interval at which automatic snaphots are taken during any ablation event For automatic during any stimulation event Check Stimulation and enter the interval at which automatic EMS XL User s Guide 5 27 snaphots are taken during any stimulation event Setting Up Ablation The EMS XL has the ability to connect to a number
116. shot 20 0 cece cee eens 5 27 Setting Up Ablation 02 2 0 eer 4 2222 cence eee eee hh 5 28 Chapter 6 Performing the EP Study EP Study Overview ce b Aor ae rn ee a EU uie 6 1 Registering Patient elio DID EISE VI Euge ed bie O eani bes 6 2 Setting Up a Procedure 2 iiis bleibe Rb Se cede aa d 6 6 Loading the System Setup for the Study 2 2 0 0 0 cece eee eee eee 6 6 Using th Stimulator 1 ith eA ede a Bee a BA ote a Een 6 15 Markins an Event u u seele aunt ask 6 28 Sinus Node Recovery Time SNRT sseeeeeee eee 6 42 Procedure Documentation llle 6 48 Printing i 4 Bos aden enh ee ern aa Sd tay a a es on ets 6 51 Working with Templates 00 eee eee III 6 56 Ending the BP Study dr RERUM wie a ore ag 6 60 Saving and Storing the EP Study 0 0 0 0 cee eee eee 6 60 Editing the EMS XL Report 0 0 0 eee eee eee nee 6 60 EMS XL User s Guide iii Ending a Case eu ves wade s e ae tanta kin ayia ee ba ses 6 64 saving Partof a Case ee See ee a MR 6 64 Chapter 7 Case Playback Overview a IHR ee ee ee 3 bw 7 1 Run Time Screen in Playback 2 222202 eee eee 7 1 Review Screen in Playback 0 0 eee ene eee 7 2 Chapter 8 Care and Maintenance General Care and Maintenance 0 0 0 ccc cece eee eens 8 1 General Cleaning Procedures 0 0 0 0 cece eee eee eee eee 8 1 Calibration and Preventive Maintenance 0 0 00 ce ees 8 5
117. sting LED indicator blinks when HR is detected 13 24 ICECG leads 2 IBP channels 27 32 ICECG leads Mennen Medical Introduction to Basic System Hardware Components Amplifier 2 for 64 lead Option This amplifier is an additional that includes 3 connectors to Intracardiac ECG leads This amplifier is used for the 64 lead option only Figure 3 3 Additional Amplifier Connectors Connection Boxes The Connection boxes enable connecting the Intracardiac leads to the amplifier s Each Connections box includes 12 plugs for Intracardiac leads and a cable to connect between the box and the amplifier The 32 channel option requires 1 2 connection boxes The 64 channel option requires up to 5 connection boxes Figure 3 4 Connection Box and cable EMS XL User s Guide EMS XL Special Features Comprehensive Full Disclosure All sampled data is recorded during an EP study Full Disclosure FD This enables viewing of the information while the procedure is in progress or during replay of the session in Playback Mode Patient data is written to the hard disk throughout the case Note For standard 32 channel systems up to 16 hours per patient may be recorded On EMS XL Systems with the 64 channel option up to 8 hours per patient may be recorded During the case snapshots may be saved as bitmap or JPEG images for future presentation At the end of the case all recorded study data may be archived to
118. t the channel clipping is set to OFF and 0 is displayed in the editable fields 0 means no clipping 100 means full clip ping 5 16 Mennen Medical Building a Configuration To activate channel clipping 1 Activate the ON radio button 2 Click and drag the upper or lower slider as appropriate to the required position The percentage of clipping to be applied to the channel above or below is shown in the corresponding field Saving and Loading a Configuration The Channel set up shortcut in the Review screen toolbar opens a window for Config Select that displays text items listed alphabetically which are configuration file names used to Load or Save entire screen layouts and channel settings Config Select il Tee aseline CS i P Diagnostics y Over Cryo Ablation kkkk CC Write pda To open a defined configuration setting 1 Doone of the following Press the Configuration toolbar button and choose a Configuration or Category sub config from the menu that opens aaa 12 lead All leads my AAAQ gt Dr Levi gt IPs baseline Diagnostics RF Ablation EMS XL User s Guide 5 17 toolbar button to Click the Channel set up open the Channel set up panel Config Select Load Over Write Delete Iennen P Diagnostics my Cryo Ablation kkkk NEW_CC Default CLOSE Click or scroll through the Config
119. t supply before servicing Avertissement Couper l alimentation avant le depannage Achtung Vor Wartungsarbeiteen netzstecker ziehen 4 Hayarden Street Yavne P O Box 102 Rehovot 76100 Israel N ce mn As shown in the above example the label includes the following warnings and compliance information dentification information Part Number P N Serial Number S N and model name Electrical power information Voltage Current and Frequency Warnings Disconnect supply before servicing Warning and Compliance Labels The EMS XL System is fitted with warning and compliance labels located as follows EMS XL User s Guide Isolation Transformer CAUTION Electrical Shock Hazard Do not remove the cover Monitor Note The term Monitor refers to both the EMS XL Run Time RT Monitor and the EMS XL Review Screen Complies with DHHS radiation performance standards 2 CFR subchapter J Complies with Part 15 of FCC rules Place of manufacture Mennen Medical Overview Chapter 3 Introduction The EMS XL is an advanced Electrophysiology Measurement System designed for use by cardiac specialists as a diagnostic aid when conducting electrophysiology EP studies on patients in a clinical situation This dual monitor system has 32 channels or 64 optional and features an integrated two channel programmable stimulator continuous Full Disclosure waveform storag
120. tate desktop of the workstation icon on the 2 Click the Configuration tab 3 In the Configuration tab click Edit The window opens ETTITETUESUO 2x m J 312 Floppy A m Local Disk C m New Volume D amp gt CD RW Drive E amp amp Control Panel m c Shared Documents a EP3 s Documents oren A 4 Select the target drive and click OK 9 14 Mennen Medical Archive Utility The window closes and the target drive is selected 5 Click Apply to save the current configuration Note It is recommended that you define a special network drive as the disk archive target This operation can be done once from Windows XP OS Windows Explorer gt Tools gt Map Network drive EMS XL User s Guide Mennen Medical A Ablation Data 4 8 Ablation Event 6 37 Ablator Generator set up 5 28 Accessories use of 1 5 Archive configure target 9 14 locating cases 9 12 Archiving 9 5 B Biocompatibility 2 1 BP Display Setting Up 6 8 Index C Calibration and Preventive Mainte nance 8 5 Calipers using for interval measurments 6 32 Care and Maintenance 8 1 8 5 Case ending 6 64 playing back 7 3 Cautions 2 4 Channel Select 4 26 5 7 Channel Settings 4 26 5 4 5 14 Cleaning 8 1 Cleaning Procedures disinfection 8 4 sterilization 8 4 Configuration 6 6 Configuration Setup Utility 9 1 CPU Battery 1 2 D Disinfection 8 4 Display BP 4 27 E Electrode
121. the lt C gt keyboard key Jump to new minute Manual snapshot Modify NRT speed Exit from Holter display mode Start End case or playback To mark an Event by caliper 1 The current caliper time is taken 2 This time is displayed in magenta or green at the bot tom left of NRT screen sec ms format Note The Elapsed Time box bottom left shows the active caliper elapsed time It will adapt the active caliper color Magenta for the first marker and Green for the second marker When no cali pers is active the box shows the NRT screen start time in Yellow To perform interval measurements using the calipers 1 Click the Calipers icon to activate the calipers The magenta colored vertical line is the reference point for the measurement The second caliper green measures the interval between the calipers in msec EMS XL User s Guide 6 35 Interval Measurement msecs First Caliper Second Caliper Figure 6 17 Interval Measurement using Calipers 2 Move the green line second caliper to the left or right of the magenta line by moving the mouse as required When this line is in the appropriate position for the required measurement i e relative to the first caliper click on it to fix it in position see Figure 6 17 Note The interval measurement value displayed on the icon adjacent to the calipers see Figure 6 17 can be entered to the Events list and stored in the EMS X
122. tic mixture with air or with Oxygen or Nitrous Oxide 2 2 Mennen Medical Electrical Shock Hazards A To eliminate the risk of electrical shock always adhere to the precautions shown below e Do not touch the patient bed or instrument during defibrillation e Before cleaning the monitor switch the monitor OFF and disconnect it from the power supply and electrical outlet After cleaning or if liquid has accidentally entered the interior of the monitor make sure that every part of the monitor is dry before reconnecting it the power supply See Chapter 8 Care and Maintenance for more information on cleaning the monitor e Access to any internal part of the EMS XL System and or the performance of any service procedures should only be carried out by a qualified technician fully trained in the operation of the system For continued protection against fire hazard fuses should be replaced only with those of the same type and rating Disconnect the power supply before servicing Risk of Permanent Loss of Data To eliminate the risk of permanent loss of data always adhere to the procedure instructions provided in this manual EMS XL User s Guide CAUTIONS A A CAUTION INDICATES A SITUATION IN WHICH THE UNIT OR DEVICES CONNECTED TO IT MAY BE DAMAGED OR MALFUNCTION The EMS XL System is designed to conform to Electromagnetic Compatibility EMC standard IEC 60601 1 2 and will operate accurately in conjunctio
123. to 12 channels 1 through 12 may be displayed here as required Intra cardiac Channels The next three rows of traces beneath those of surface ECG refer to Figure 4 2 show waveforms input from the intra cardiac channels Up to 20 or optional 52 intra cardiac channels 13 and onwards may be displayed here However one or two of these channels may be used for the display of BP signals if required Mennen Medical Run Time Monitor BP Channels Below the intra cardiac waveform signals there may be one or two BP channels displayed Note If you choose not to display BP channels the lower portion of the screen is used to display Intra cardiac signals The total number of channels displayed in the Run Time Monitor reflects the currently selected settings These may be changed from the Run Time Monitor using the tools provided in the Review screen see Setting Up Surface ECG Channels on page 5 11 and Zoom Control on page 4 33 Note The settings may also be changed by loading a pre defined or customized configuration setup See Loading the System Setup for the Study on page 6 6 STIM The word STIM is visible in green letters at the top right corner of the Traces Display This is associated with anything displayed adjacent to and on the left of this and provides a visual indication of Stimulator Spikes When in Trigger Mode a single vertical white line is visible on the Traces Display Allinformation disp
124. uired grid scale by clicking the appropriate button Calibration Factor The Calibration Factor is a numeric field provided to enable calibration of the EP box amplifier Calibration Factor Note The default is 1 000 BP Channel Display When the BP channel display is disabled No BP the BP grid and scale are automatically removed from the RT Monitor display Grid Display The Grid button toggles between No Grid and Grid Click No Grid to hide display of the BP grid click Grid to show the grid EMS XL User s Guide No Grid Grid Note The default setting is No Grid Mennen Medical Setting Up a Procedure Zero Zero is used to indicate that the current values received by the two BP channels should be regarded as the zero values see note below Zero Note This button should only be used when the trans ducer has been opened to the atmosphere Note Channels are zeroed one at a time Before click ing Zero each BP channel has to be defined from the RT Monitor right click on the channel button to define the channel identification label refer to Channel Select Review Screen on page 5 11 CFE CFE activates display of NIBP and SpO2 parameters taken from the CFE to the BP display window of the RT screen Figure 6 1 BP dispaly in RT window Note This option is active only in COMBO systems combined Horizon XVu and EMS XL Auto Enables selecting automatic measur
125. wer There are six Sweep Speed control buttons positioned horizontally in one row and labeled in mm sec incrementing from left to right as follows Sweep Speed ee I 1 Each of the six buttons provides exclusive selectivity The button corresponding to the currently selected sweep speed appears as pressed all others appear normal and are ready for selection Note The default Sweep Speed is 100 mm Sec In Trigger Mode only any changes made to the Sweep Speed will have an effect on the posi tioning of the vertical line displayed on the RT Monitor Notch The function of the Notch control is to enable or disable EMS XL User s Guide 5 3 the 50Hz Notch Filter on the EP Box amplifiers The Notch control has two buttons ON and OFF Notch fon om Note The default value is ON However this may be overwritten by loading any other configuration For details refer to Saving and Loading a Con figuration on page 5 17 Changing Channel Settings In addition to modifying the general appearance of the Traces Display you can also change the number of channels displayed by adding or removing a channel from the display reposition a channel make changes to the channel settings and select the channel for stimulation output Note When a channel is selected it becomes grey in color to indicate that it is the currently selected channel To add or remove a channel from the Run Time display Refer t
126. wish to save more than one part of the same case it is recommended to add a suffix after the underscore for each of the saved parts Example Case ID 137 EMS XL User s Guide 6 65 The partial case is automatically marked as 137_ This is a new Case ID and can be stored as such or you can change the file name to any new name It is however recommended to add a suffix to each part such as 137_A 137_B etc This will enable you to recognize the parts as belonging to the same case 7 Click Save Part Notes The required part of the case is saved to the new file The waveforms and the list of stimulations and events for the saved part are also saved You can now delete the original file to save disk space To auto save events stimulations of a case Sx 1 Click the Save Partial icon ej in playback mode 2 In the window that opens click Auto Save The Save partial Case Patient Information panel appears 3 Type a name for the saved partial file or modify the default name and click Save Part 6 66 Mennen Medical Overview Chapter 7 Case Playback The EMS XL Case Playback function enables off line review of a closed EP Study The recorded data in a Patient File may be re opened and the entire Case or portions of the Case may be played back analyzed and printed Note The Case Playback feature is enabled only after End Case has been indicated During playback the following types of con
127. y Saving and Storing the EP Study During recording all Full Disclosure data is automatically saved to the Patient File on the system hard disk Note Itis possible to copy data directly via Windows Explorer There are two ways in which waveform data may be stored DVD R W CDR W non erasable Editing the EMS XL Report Note On line notes may be added at any time during a Case To edit a report 1 From the Commands menu at the top of the Review Screen click Report Note You can display the Commands menu directly by clicking the File Fad icon on the Review screen shortcut toolbar see page 4 21 Commands QRS Settings Channel Select Channel 4 Select Printer Grid Patient Print RT Multiple pages Speed RT screen 2 5 Ext Length l page A menu with the following options appears 6 60 Mennen Medical Ending the EP Study SHEN WARREN Build ALL Build EPS SYNCOPE Send data to HL7 Save report in XML format Close e Open Old Report this report includes report previously saved All information added since last report built is NOT included in report Build All The Reports Generator opens displaying the EMS XL Report template Microsoft Word rich text format rtf By default the patient information from current case is already entered in the template see the example in Figure 6 2 Build EPS Syncope builds specific report with details s

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