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REF: NS 01

USERS MANUAL

TABLE OF CONTENTS

1. PRODUCT DESCRIPTION ........................................................................................................................................4 1.1. Indications for use 1.2 The ECG Method for Catheter Guidance 1.3 Configuration 2. CONTRAINDICATIONS ...........................................................................................................................................5 3. WARNING AND PRECAUTIONS ............................................................................................................................5 4. WORKFLOW PROCEDURE .....................................................................................................................................7 4.1 System setup 4.2. Software application setup 4.3 Patient preparation and vein puncture 4.4 Connecting the Nautilus E/S Adaptor 4.5 Electrical vs. saline adaptors 4.6 Display ECG waveforms 4.7 Document the catheter tip location 4.8. Catheter Guidance 4.8.1. Upper superior vena cava 4.8.2. Lower third of superior vena cava 4.8.3. Cavo-atrial junction 4.8.4. Right atrium 4.8.5. Catheter tip placement verification 5. ERROR MESSAGES AND TROUBLESHOOTING ............................................................................................... 14 5.1 Electrodes not connected 5.2 ECG module not connected 5.3 Battery status 5.4 Printer error 6. CLEANING AND DISINFECTION ......................................................................................................................... 14 7. SERVICE .................................................................................................................................................................. 15 8. MAINTENANCE ...................................................................................................................................................... 15 9. TECHNICAL SPECIFICATIONS ............................................................................................................................ 15 10. RECYCLE INFORMATION .................................................................................................................................. 15 11. CONTACT INFORMATION.................................................................................................................................. 15

1. PRODUCT DESCRIPTION Nautilus is an endovascular guiding ECG system used in central venous catheterisation. 1.1 Indications for use Nautilus is indicated for guidance and positioning of central venous catheters such as peripherally inserted central catheter (PICCs), central venous catheter (CVCs), implantable ports (ports or implantable cameras) and hemodialysis catheters. The system provides real-time catheter tip location information and reflects the patients cardiac electrical activity. Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P wave as in atrial fibrillation, atrial flutter, severe tachycardia, and pacemaker driven rhythm, and in central venous catheterisation procedures performed through femoral or saphaneous vein access which change the presentation of the P wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location. 1.2 The ECG Method for Catheter Guidance Guiding the placement of central venous catheter using cardiac electric signals is an accepted clinical method as practiced in many health care institutions and as documented in many papers including: a. Electrocardiogram (EKG) Guided Peripherally Inserted Central Catheter Placement and Tip Position: Results of a Trial to Replace Radiological Confirmation, by Nancy Moureau et al. published in the Journal of the Association for Vascular Access in 2010, JAVA Vol. 15 No. 1 2010, pp. 9-15 b. The ECG method for positioning the tip of PICCs: results from two preliminary studies, by Mauro Pittiruti et al. published in the Journal of the Association for Vascular Access in 2008, JAVA Vol. 13 No. 4 2008, pp. 112-119 Figure 1 illustrates the different ECG waveforms at different locations in the venous system as currently accepted and documented by the clinical community.

Figure 1: Changes in ECG waveform depending on the location of the central venous system The basic principle of the ECG method is that the position of the tip inside the venous system can be detected by regarding the catheter itself (or a guide-wire inside the catheter) as an endovascular electrode which replaces the red or right shoulder electrode of the standard surface ECG. The system displays through the user interface graphic communication the waveforms of the hearts electric signals. These waveforms are generated at the tip of the central venous catheter and are captured in real time through the Electrical ECG Adaptor for endovascular guidance Nautilus E or the ECG Adaptor with saline solution for endovascular guidance Nautilus S. The Nautilus software processes data from the ECG data acquisition module and displays the waveforms that correspond to the endovascular electrocardiogram registered in the ECG module from the electrodes at skin level and transmitted through the Nautilus adaptor connected to the device for venous access. By observing the variations of the intravascular ECG waveform, the user can estimate the position of the catheter tip, as follows: When a maximum P wave is registered it means that the tip of the catheter is at the entrance in the atrium (at the cavoatrial junction) After this maximum, if the catheter is withdrawn the amplitude of the P wave decreases by half which corresponds to the catheter tip in the inferior third of the vena cava; If the catheter is continually withdrawn, the amplitude of the P wave decreases at values similar to those registered at skin level; this means that the catheter tip is at the superior side of the vena cava; If the catheter is placed too deep, the P wave decreases progressively until it becomes biphasic. This means that the catheter tip is inside the right atrium. If the advance of the catheter continues, the P wave becomes entirely negative. In such a situation, the catheter tip is in the inferior vena cava.

1.3Configuration The Nautilus endovascular guidance system has the following components: - Notebook with an integrated ECG data acquisition module, with grounded medical grade power supply - 4 lead ECG cable - Nautilus software for processing and graphic presentation of ECG data. Nautilus is used together with its accessories: Nautilus E (ECG endovascular electric guiding adaptor) or Nautilus S (ECG adaptor with saline solution for endovascular guiding) for collecting and transmitting endovascular data to the ECG data acquisition module. Optionally a printer and a remote control can be added.

2.

CONTRAINDICATIONS

There are no specific contraindications related to the use of the Nautilus system.

3. WARNING AND PRECAUTIONS Warnings Warning Before using the Nautilus System for the first time, be sure to read and understand all of the information in this Users Manual. Warning The Nautilus System may be used only by medical personnel authorised for the catheter placement procedure, familiar with reading and interpreting ECG waveforms and trained by authorised personnel. Warning Failure to abide by the precautions detailed below causes the system and its use to be out of compliance with regulations and places the patient and the user at risk of injury or death. Warning The device must be connected to a properly installed power outlet with protectiveearth contacts only. If the installation does not provide a protective earth conductor, do not connect the device to the power line and operate it on battery power, if possible. Warning - It is forbidden to use this system during the time when surgical interventions of high frequency are carried out on the patient. Warning The battery must be installed for proper operation even if the the Nautilus system is plugged into AC power, Warning During operation, the medical chargers shall not be placed on the floor; it is recommended to use a mobile carrier with multiple sockets. Warning -Safety tests are performed at the time of manufacture to assure compliance with IEC 62353 standard. Perform these tests as part of your institutions maintenance program to assure compliance with the named standard. Warning - When using the Nautilus system with the Nautilus S and Nautilus E adaptors, always follow the instructions for use provided with these devices. Warning - The Nautilus System only works with a sinus rhythm of the heart. Warning - The Nautilus System Users Manual provides information about ECG waveforms and their correspondence with specific locations in the vasculature. In any situation in which the user cannot unambiguously identify ECG waveforms as described herein, the use of an additional and/or different method is required to confirm catheter tip location, e.g., chest X-ray or fluoroscopy as indicated by the institutional guidelines and clinical judgement. Warning - Place skin electrodes carefully at locations indicated by this Users Manual and ensure good skin-electrode contact. Failure to do so may cause unstable ECG waveforms and/or ECG waveforms which are not described in this Manual. In such a case, the use of an additional and/or different method may be required to confirm catheter tip location, e.g., chest X-ray or fluoroscopy as indicated by the institutional guidelines and clinical judgment. Warning - In patients where alterations of cardiac rhythm significantly change the presentation of the P wave as in atrial fibrillation, atrial flutter, severe tachycardia, and pacemaker driven rhythm, the use of an additional and/or different method is required to confirm catheter tip location, e.g., chest X-ray or fluoroscopy as indicated by the institutional guidelines and clinical judgment.
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Warning - In patients undergoing central venous catheterization using venous access through the saphenous or the femoral veins, the catheter tip will typically not reach the right atrium and the cavo atrial junction. In such a situation, the ECG waveforms described by this manual cannot be used for catheter guidance and placement and the use of an additional and/or different method is required to confirm catheter tip location, e.g., chest X-ray or fluoroscopy as indicated by the institutional guidelines and clinical judgment. Warning - In certain patients, unstable ECG waveforms may be detected because of the manipulation of the Nautilus E or Nautilus S by the user. Verify that the connection between the Adaptor and the central venous catheter and the connection between the Adaptor and the ECG cable are free from contact with any other material and refrain from touching the Adaptor and any of its connections. If the problem persists, the use of an additional and/or different method is required to confirm catheter tip location, e.g., chest X-ray or fluoroscopy as indicated by the institutional guidelines and clinical judgment. Warning - In certain patients, no ECG waveforms may be detected because of very specific impedance mismatch between the patient and the ECG electrodes. Be sure to use the Instructions for Use provided by the manufacturer of the skin electrodes. Verify the connection between the patients skin and the electrodes, between the electrodes and ECG cable, and between the Nautilus Adaptor and the ECG cable. If the problem persists, the use of an additional and/or different method is required to confirm catheter tip location, e.g., chest X-ray or fluoroscopy as indicated by the institutional guidelines and clinical judgment. Warning - In neonates, unstable ECG waveforms may be detected because of patients movements or manipulation by the user. In such a situation, the use of an additional and/or different method is required to confirm catheter tip location, e.g., chest X-ray or fluoroscopy as indicated by the institutional guidelines and clinical judgment. Warning - The Nautilus System is not intended to diagnose or treat disease. Warning - Monitor catheter tip placement during insertion procedure and verify catheter tip location placement using your institutions guidelines. Warning - Do not place and/or use the Nautilus system in the presence of strong magnetic fields such as Magnetic Resonance Imaging (MRI) devices. The magnetic fields and the radio frequency fields (RF) associated with the MRI environment can interfere with the system. Consult the MRI manufacturer for more information. Warning - Always control, adjust and carry out procedures with the Nautilus system as they are specified in the Users Manual. Warning - The Nautilus software is preinstalled on the system; the user cannot modify, recompile and redistribute it on his behalf. Do not install any software on the Nautilus System unless instructed to do so by qualified Romedex International personnel and under the guidance of qualified Romedex International personnel. Failure to do so may result in patient and user harm and system damage. Warning - Do no install other software application on the system; these can affect the proper operation of the system by introducing delays, artifacts, interruptions or the impossibility to display ECG waveforms. Warning - The network connection (local or internet) of the Nautilus System has the inherent risks of such an operation, especially of the respective network does not observe a minimum safety level. Do not connect the Nautilus System to a network (local, internet) that has an unknown or insufficient security level! Warning - If you connect an external device to the Nautilus system (through USB), assure that: - The storage device does not contain viruses. - Do not execute the programs and applications that already exist on the storage device. - The respective storage device does not automatically install drivers and/or other applications, which through their execution, could consume the systems resources. Warning - The system, including all the optional components must be used only with the charger with grounding for medical use supplied by Romedex International together with the system. If the supply cable is replaced, a cable with the same characteristics as those from the technical specifications should be used. Warning - Do not use additional cables, extension cords or outlets with the Nautilus system. Warning - This device is not to be used in the presence of combustible or flammable gases. Warning - Do not remove system covers. To avoid electrical shock, use only the power cord supplied with the system and only connect to properly grounded wall outlets. Only Romedex International qualified personnel should service the system. Warning - Maximum care should be taken in checking that all connecting cables and connections, such as alligator clips, are electrically insulated and do not come into contact with other electrical cables or metal surfaces. Warning - The conductive parts of the ECG cable must not be in contact with other electrically conductive parts. Warning - Do not submerge the Nautilus system laptop or allow fluid to enter any of the connectors Warning - The optional printer must be chosen by the user according to the electrical safety and electromagnetic compatibility standards in effect, and in case of use, the printers power supply must be grounded medical grade type. Warning - Never connect an active device (supplied with power) to the electrical interfaces (for e.g. USB, external monitor, speakers) of the Nautilus System, if this device does not correspond to the electrical safety and electromagnetic compatibility standards in effect. This device must be powered on a grounded medical grade power supply. Warning - Only qualified personnel shall carry out service operations to the Nautilus System.

Cautions Caution - Active electric motor driven equipment, such as pumps, may interfere with the display of the ECG waveforms. In any situation in which the user cannot unambiguously identify ECG waveforms as described herein, the use of an additional and/or different method is required to confirm catheter tip location, e.g., chest X-ray or fluoroscopy as indicated by the institutional guidelines and clinical judgment. Caution - Equipment such as CT scanners, X-rays and fluoroscopy systems, cauterisers and diathermy equipment, operating in close proximity may emit strong electromagnetic or radio frequency interference (RFI) which could interfere with the display of ECG waveforms by Nautilus system. In any situation in which the user cannot unambiguously identify ECG waveforms as described herein, the use of an additional and/or different method is required to confirm catheter tip location, e.g., chest X-ray or fluoroscopy as indicated by the institutional guidelines and clinical judgment. Caution - Electric equipment which requires direct contact with the patient may interfere with the display of ECG waveforms by Nautilus. Do not use electric cauterization, electric scalpels, and ablation equipment while using Nautilus. In any situation in which the user cannot unambiguously identify ECG waveforms as described herein, the use of an additional and/or different method is required to confirm catheter tip location, e.g., chest X-ray or fluoroscopy as indicated by the institutional guidelines and clinical judgment. 4. WORKFLOW PROCEDURE 4.1 System setup Find an appropriate location for the system. Ensure the Nautilus System is placed no more than 1,5 meters away from the patient outside the sterile field. Connect the system only to a socket with grounding contact. If the system works on the rechargeable battery pack (battery), check its state. A fully charged battery assures the operation for approximately two hours. Connect the ECG cable to the system. Start the Nautilus system by pushing the start button situated in the upper part of the keyboard. After start, as soon as the operating system on the laptop is completely loaded, the application is launched by double clicking on the Nautilus icon. The Nautilus interface is shown in figure 3.

Figure 3: Nautilus main interface 1.The toolbar of the application has the following control buttons for: a. Loading ECG files. b. Switch between data acquisition from board or display data from file c. Modify the application setting, send orders to the board d. Help.
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The following functions are available on the toolbar: a. open .ekg file: by pressing this button, the user can choose a previously saved .ekg file and can open it in the application to see the previously saved data; b. Switch work method: display waveforms received from the board or display saved waveforms in the .ekg file. By pressing this button, the user switches between the two work methods: display data from device or display data from the previously loaded .ekg file. c. Tools menu Settings - allows the modification of the application settings. d. Tools menu Commands allows the operator to send orders to the application.

The supported orders are displayed in the Command list. Depending on the selected command, a table is displayed under this list, which comprises the accepted parameters. The values of these parameters can be established in the right column. The command is sent automatically to the board when choosing or after modifying any parameter. For example, in the above image, the user has chosen the first command Set Amplification to board. It accepts a single parameter, the amplification level, that can be established from the list displayed in the right column of the table (Value). Accepted commands: Name Normal Mode Simulation Mode Set Amplification Description The board shall switch to normal where the exterior values are received, from the attached catheters. It shall switch to simulation, where values generated internally by the board are displayed and which simulate a real situation. It sets the amplification level of the board. The possible values of a single parameter are: 0, 1, 2 and 3 corresponding to signal amplification values of 32, 64, 128 respectively 256 for 1mV. Establish speed values when data shall be acquired. Possible values: 0,1, 2 and 7 corresponding to speeds of 50, 100, 150 and 300Hz. Calibrate command: Following this command, the board shall generate a row of 250 values of 1mV. Establishes the filter that shall be used: 0 shall not be used; 1 - 50Hz filter; 2 - 60Hz filter; Establishes the ECG signal filter method (averaging filter low pass): 0 without; 1 standard averaging; S maximum averaging. Establishes if a pacemaker is detected or not: 0 no; 1 yes.

Set Speed Calibrate Set Filter Set Acq Mode Pacemaker Detector

e. Help menu Displays the About window that shows the application version, as well as the firmware version installed. f. Help menu Demo displays a video clip that presents the functionalities available in the subsequent versions. 2. Main screen where the real-time ECG waveforms are displayed: the reference skin ECG waveform (lead III in Einthovens reference system) and the guiding ECG waveform at the tip of the catheter (lead II in Einthovens reference system). By clicking on this screen the user will switch to PAUSE mode; in this mode the application is not showing the actual
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waveforms received. Instead the image will freeze. This is shown by displaying PAUSED in place of pulse. Clicking again the application will resume and the data is displayed again. 3. Application logo and the current pulse value. 4. Information regarding the patients name, institution, catheter type and inserted length, which shall be displayed on the printed label. This information, together with the application version, is also saved in .ekg files. 5. Group of buttons that allow the modification of the data acquisition module from board. The SCALE buttons modify the board amplification; the SPEED buttons affect the acquisition speed. 6. Button group with the following functions: a. FREEZE freezes the waveforms displayed in screen 2, copying them in screen 7. Thus a reference image is created, that the operator can use to compare with the waveforms currently displayed in screen 2. b. PRINT shall automatically save the data and shall save a *.jpg file label on the disk to be subsequently printed. If an optional printer is attached, the PRINT function shall print the label at the optional printer. c. SAVE shall save the .ekg file with the data received up to that respective moment 7. Secondary reference screen, where the ECG wave forms shall be displayed still, for comparison. 8. Status indicator of laptop battery. 9. The scroll-bar type controls that allow the modifications of the position where the waveforms shall be displayed. 10. The status bar where information regarding the board operation module is displayed. 11. New Patient Button. 11.1 The following information can be input in the corresponding fields on the graphical user interface at any time: 1. Patient name 2. Institution name 3. Catheter type 4. Inserted length 11.2 When pressing the New Patient button the following events happen: 1. The field Patient name is set to the default string Patient 2. The field Institution name is left unchanged 3. The field Catheter type is cleared 4. The field Inserted length is cleared 5. The system memory, where ECG case data are stored, is cleared To power off the system: a. Close the Nautilus application b. Power down the Windows operating system on the laptop, by applying the Start-Shut Down sequence. 4.2. Software application setup The user has the possibility to modify the settings of the application through the Tools Settings menu. By accessing this system, a new window with two sections shall open. The window is shown in the images below:

In the Board section the user can modify the following parameters, specific to the device:
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Name ComPort DataBits Parity BaudRate StopBits IdentifyingString

Description Serial port to which the device is connected. Setting the serial port. Setting the serial port. Setting the serial port. Setting the serial port. Adjusted expression for identifying the string received from the Device following the identification command (I).

Default value automatically detected 8 2 115200 1 EG05000H\d+S\d +

Warning: the modification of the parameters can affect, if erroneous values are set, the proper operation of the device (display data with delay or not displaying data, failure in displaying waveforms and even the impossibility to use the application). The modification of any parameter in Board is reflected in the operation of the application only after its restart. The user is warned that if he wants these modifications to have immediate effect it is necessary to shut down and restart the application.

In the Main section the user can set the following parameters, specific to the software application: Name Scale factors: I, II, III Description Factors used to scale the waveforms corresponding to channels I, II, III. For example, channel II shall be displayed two times smaller (factor 0.5) compared to the data that arrive from board. The scroll speed for incrementing the chart positions of two consecutive value sets received from board. Frequency in milliseconds for displaying the data read in .ekg files Number of bytes that shall be read from the file at each time interval specified in the Playback speed. Number of values that shall be used for printing. The text that shall be displayed on the printed label, in the left of the waveform corresponding to the reference point from the Default value 0,5

Display speed Playback speed Playback bytes Print maximum number of values ACTUAL Text

1 1 3 400 SURFACE

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surface of the skin. REF Text Zero detection Value The text that shall be displayed on the printed label, in the left of the waveform corresponding to the intravascular reference point. Maximum value of the difference between two consecutive values for which we consider the reception of a series of 0 values. The number of 0 values that determine the transmission of the Wake-Up command. The folder used for saving the files generated by the application when pushing the SAVE button. INTRAVASCU LAR 3

Maximum zero values Photo location

1000 C:\Data

Example: if between two consecutive values there is a difference smaller or equal to 3 (value for Zero detection Value) than a meter is incremented. If this meter reaches the 1000 value (Maximum zero values), than the Wake-Up command is sent, after which the board shall restore its activity. The respective meter is reset when the difference between the two consecutive values is greater or equal to 3. After the modification of any parameter, the user shall click Save. The executed modifications have immediate effect and are kept after the shutdown of the application, so that the latest values, those established by the user, are loaded during a new work session. 4.3 Patient preparation and vein puncture Connect the ECG cable to the patient: 1. Before preparing the sterile field, take the ECG cable supplied with the Nautilus System and wipe the cable down according to hospitals guideline. 2. Locate three ECG snap electrode patches (available on the market) and place one on the patients lower left abdomen, one on the patients lower right abdomen, and one on the patients left shoulder or arm according to the ECG electrodes instructions for use. 3. Connect the green clip connector of the provided ECG cable to the electrode snap on the patients left lower abdomen 4. Connect the black clip connector of the provided ECG cable to the electrode snap on the patients right lower abdomen 5. Connect the yellow clip connector of the provided ECG cable to the electrode snap on the patients left shoulder or arm. 6. Leave the red clip connector of the provided ECG cable in a reachable location for the connection with the sterile adaptor during the procedure. With the Nautilus System running, the reference skin ECG waveform should be at this time visible and stable. It should be possible to unambiguously identify the ECG waveform elements, e.g., the P-wave and the R-wave, as represented in this Users Manual. If this is not the case, do not attempt to use Nautilus for catheter guidance and positioning and use another method for catheter tip location verification as indicated by the institutional guidelines, e.g., chest X-ray or fluoroscopy. Prepare the patient for central venous catheterisation according to the institutions guidelines. Perform vein puncture and venous access per institutions guidelines, if applicable under ultrasound imaging guidance. 4.4 Connecting the Nautilus E/S Adaptor In order to obtain ECG waveforms at the tip of the central venous catheter, the non-sterile red clip connector of the provided ECG cable must be connected to the sterile central venous catheter. This connection is achieved using the Nautilus E or Nautilus S adaptor. Please refer to the Instructions for Use of these adaptors for details. When using the Nautilus E adaptor, connect the alligator clip end to the proximal end of the stylet or guide-wire which is packaged with your venous access device or pre-inserted in one of the lumens of your venous access device. Connect the red clip connector of the provided ECG cable to the plug end of the sterile Nautilus E Adaptor. When using the Nautilus S adaptor connect the adaptor piece between the luer connector of the central venous catheter and then connect the red clip connector of the provided ECG cable to the plug end of the adaptor. 4.5 Electrical vs. saline adaptors The choice between using the Nautilus E adaptor or the Nautilus S adaptor is a matter of user preference and workflow optimization and is potentially subject to institutional guidelines. Please refer also to the Instructions for Use of the respective adaptors. Typical situations for using the Nautilus E adaptor are: 1. Placement of open-ended PICCs with pre-inserted stylets and luer-locks which allow for stylet position control
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2. 3.

Implantable ports using open vein access with over-the-guide-wire catheter placement Any central venous catheter inserted over a guide-wire with centimetre markings

Typical situations for using the Nautilus S adaptor are: 1. Any post-procedural tip location verification of any central venous catheter type. 2. Placement of closed-end PICCs 3. Placement of central venous catheters using the modified Seldinger technique (MST) which do not have pre-inserted stylets, e.g., tunneled catheters 4. Any central venous catheter inserted over a guide-wire without centimetre markings, e.g., CVCs. 5. Haemodialysis catheters which may require tip location verification for both ends: the long distal end in the right atrium and the short distal end at the cavo-atrial junction. 4.6 Display ECG waveforms As soon as a Nautilus adaptor is connected to the catheter and to the ECG cable, the guiding ECG waveform is displayed (Figure 3). The waveforms on the bottom in Figure 3 on both left and right hand side display windows represent the electric signal detected at the tip of the central venous catheter. The red markers show the peak of the R in the ECG waveforms. P wave changes should be followed on the yellow bottom waveform on the left of the red marker. The right hand side window in Figure 3 is labelled Reference. The reference window allows for saving the ECG waveforms at a desired location for further comparison. Clicking on the Freeze button below the Reference window or using the left arrow key on the keyboard freezes the display, such that the frozen ECG waveform can be used as a reference. The scroll speed of the ECG waveform can be selected by using the buttons SPEED + and SPEED -; The amplitude scale for the ECG waveform can be manually selected by using the SCALE + and SCALE buttons (5 in Fig 3) or the up/down arrow keys on the keyboard. 4.7 Document the catheter tip location The ECG waveforms can be recorded real-time during the procedure by clicking on the SAVE button or PRINT (6 in Fig 3). The ECG waveforms are recorded in a file. The file name is automatically generated by the computer if a patient ID is not input. If a patient ID is input the file name is generated based on the patient ID. The file can be copied to a USB memory stick or memory card as a removable storage device. Clicking the PRINT button sends a screen shot to the printer if attached and save the screen shot in a file in .jpg format. The file name is assigned automatically if no patient ID is input and a name is assigned based on the patient ID if a patient ID is input. The alphanumeric information input by the user and the ECG waveforms displayed in the Reference window are printed using the print layout illustrated in Figure 4. The ECG waveforms from the skin electrodes and the ECG waveforms from the tip of the catheter are displayed in the upper, respectively inferior side. The patient name, institution name, catheter type and length, are displayed as they were inputted in the corresponding fields of the graphical user interface. Moreover, the date and time for generating the image are displayed automatically. The following information can be inputted in the corresponding fields on the graphical user interface at any time: 1. Patient name 2. Institution name 3. Catheter type 4. Inserted length

Figure 4: Print format To copy any file from the Nautilus laptop to a removable storage medium, exit the Nautilus application and use the Windows operating system to copy the desired file to the desired location. 4.8. Catheter Guidance
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Check the presence of a P wave in the surface ECG, then watch the changes of the P wave in the intracavitary ECG while the catheter progresses onto the heart and assess the position of the tip of the catheter. 4.8.1 Upper superior vena cava When the P-wave has normal dimensions, similar to those of the P-wave on the surface or trans-parietal ECG, this indicates that the tip of the catheter is in the upper part of the superior vena cava.

Fig. 5 ECG waveform at the tip of the catheter in the upper SVC 4.8.2 Lower third of the superior vena cava When the height of the P-wave is approximately half of the maximum P-wave height reached at the cavo-atrial junction (see Section 4.8.3), it means that the tip of the catheter is in the lower third of the superior vena cava, just above the cavo-atrial junction.

Fig. 6 ECG waveform at the tip of the catheter in the lower third of the SVC 4.8.3 Cavo-atrial junction When the P-wave is fully peaked or at the highest amplitude, and no negative segment before the standard positive P-wave is visible, the tip is at the caval atrial junction (SVC/RA). This waveform indicates that the catheter tip is at the entrance of the atrium (ie close to the crista terminalis, at the cavo atrial junction).

Fig. 7 ECG waveform at the tip of the catheter at the CAJ 4.8.4 Right atrium When the P-wave progressively decreases and a small negative incision before the standard positive P-wave shows up, it is the first sign that the catheter tip has entered the right atrium. When the P-wave becomes biphasic (expands beyond the baseline up and down), the catheters tip is in the low right atrium/high right ventricle. This is known as an atrial spike.

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Fig. 8 ECG waveform at the tip of the catheter in the RA

4.8.5. Catheter tip placement verification The ECG waveforms can be clearly localised based on the specific positioning of the tip catheter in the vascular system. In any situation in which the user cannot unambiguously identify ECG waveforms as described in Section 4.8.1.-4.8.4, the use of an additional and/or different method is required to confirm catheter tip location, e.g., chest X-ray or fluoroscopy as indicated by the institutional guidelines and clinical judgment. According to institutional guidelines and in accordance with clinical judgment, in indicated patients, and under the conditions described by this Users Manual, Nautilus may be used in conjunction with ultrasound-guided vein puncture or open vein access to replace chest X-ray and fluoroscopy for intra- and post-procedural central venous catheter tip location confirmation. Using the Nautilus guidance system, central venous catheter tip location can be documented for the patients chart either on paper or electronically. Using Nautilus, the location of the central venous catheter tip can be determined and documented as required by the different types of central venous catheters and by different institutional guidelines, for example: 1. When the tip of a PICC catheter must be placed in the lower third of the superior vena cava, the ECG waveforms illustrated in Figure 6 must be detected and documented at the tip of the PICC catheter. 2. When during intra-procedural catheter insertion or, at later times, during periodical post-procedural catheter tip verification, the long end of a haemodialysis catheter must be placed in the right atrium while its short end must be placed at the cavo-atrial junction, then the ECG waveform in Figure 8 must be detected and documented at the long tip and, respectively, the ECG waveform in Figure 7 must be detected and documented at the short tip of the haemodialysis catheter. 3. When the tip of a central venous catheter (CVC) or of an implantable port must be placed at the cavo-atrial junction, then an ECG waveform like the one in Figure 7 must be detected and documented at the tip of the catheter. 5. ERROR MESSAGES AND TROUBLESHOOTING 5.1 Electrodes not connected If Nautilus does not detect any connection of electrodes to the patient, the waveforms shall not be displayed. In such a case, verify that the skin electrodes are attached to the patients skin, that the ECG cable clips are attached to the snap nipple on the electrodes and that the Nautilus Adaptor is connected to the red clip of the ECG cable. Verify that the ECG cable is attached to the laptop. If the error situation persists, you may replace the ECG skin electrodes with new ones. 5.2 ECG module not connected If Nautilus does not detect the presence of an ECG module, the ECG wave forms are not displayed. In this case, contact the nearest sale representative or distribution office of Romedex International. 5.3 Battery status The battery status is displayed in the upper right corner of the Nautilus graphical user interface. (8 of Figure 3). 5.4 Printer error A printer error message is displayed when printing if the printer is not connected or if it is out of paper. Check the printer connection and paper status and try again. 6. CLEANING AND DISINFECTION To clean the Nautilus system: 1. Turn off the system
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2. 3.

Dampen a nonabrasive cloth with either warm water or rubbing alcohol. Gently wipe the dampened cloth over the exterior surfaces of the laptop.

Warning! Do not submerge the Nautilus laptop or allow fluid to enter any of the connectors.

7. SERVICE Only the Romedex International personnel is authorised to carry out service operations. For service information please contact the nearest sale representative or distribution office of Romedex International. 8. MAINTENANCE Safety tests are performed at the time of manufacture to assure compliance with SR EN 62353:2008. Perform these tests as part of your institutions maintenance program to assure compliance with the named standard. The tests which we recommend to be performed every two years are: 5.2 / SR EN 62353:2008 - visual inspection 5.3.2 / SR EN 62353:2008 - measuring of protective earth resistance 5.3.3.3 / SR EN 62353:2008 - measurement of applied part leakage current 5.3.4 / SR EN 62353:2008 measurement of insulation resistance. 9. TECHNICAL SPECIFICATIONS 1. Netbook, 100-240V, 50/60 Hz, with a power consumption less than 40W 2. Module ECG 4-electrodes, full patient isolation, defibrillation protected, integrated in netbook 3. Nautilus data acquisition application running under Windows operating system. 4. Medical grade charger with grounding, AFM60US18 5. Supply cable with grounding, IEC 3G 1,0 mm2 6. ECG cable with 4 derivations, 2,7m Accessories: 1. Nautilus E - ECG endovascular electric guiding adaptor 2. Nautilus S ECG adaptor with saline solution for endovascular guiding 10. RECYCLE INFORMATION The component parts of the system shall not be eliminated as unsorted municipal waste, but they shall be collected selectively, according the local and institutional regulations. In order to return Nautilus for recycling, when it cannot be used anymore, please contact the nearest sale representative or distribution office of Romedex International in the country where the purchase was made.

If you have any questions or comments regarding the use of this product please contact us. For additional information and training materials, please go to the Romedex International web site: www.romedex.com.
Users manual latest review: June 2012

Romedex International SRL 74 Fundeni Str, Bucharest, Romania Tel: +40.212.550.385 Fax: +40.318.179.962 Email: info@romedex.com

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