Nautilus and Nautilus Plus Users Manual Reviewed Oct 2013

Fragile, handle with care Keep dry

Manufacturer

Defibrillation proof type CF applied part

Caution, follow user’s manual

Shall not be eliminated as unsorted municipal waste

Operating humidity

Storage humidity

Operating temperatures

Storage temperatures

Protection class I, protective earth

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TABLE OF CONTENTS

1. PRODUCT DESCRIPTION ... 4 1.1. Indications for use 1.2 Configuration 2. CONTRAINDICATIONS ... 4 3. WARNING AND PRECAUTIONS ... 4 4. WORKFLOW PROCEDURE ... 6 4.1 System setup 4.2 Patient preparation and vein puncture 4.3 Connecting the Nautilus E/S Adaptor 4.4 Display ECG waveforms 4.5 Document the catheter tip location 4.6. Catheter Guidance 4.6.1. Lower third of superior vena cava 4.6.2. Cavo-atrial junction 4.6.3. Right atrium 5. CLEANING AND DISINFECTION... 9 6. SERVICE ... 10 7. MAINTENANCE ... 10 8. TECHNICAL SPECIFICATIONS ... 10 9. RECYCLE INFORMATION ... 10 10. CONTACT INFORMATION ... 10

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1. PRODUCT DESCRIPTION NAUTILUS/NAUTILUS PLUS is an endovascular guiding ECG system used in central venous catheterisation. 1.1 Indications for use Nautilus/Nautilus Plus 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 patient’s 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 Configuration 1.2.1 Nautilus has the following components: - Netbook with an integrated ECG data acquisition module, with grounded medical grade power supply and grounded power cord - 4 lead ECG cable - Nautilus software for processing and graphic presentation of ECG data. 1.2.2 Nautilus Plus has the following components: - Nautilus system -Set of peripherals: - Thermal printer with medical grade power supply and grounded power cord - Presenter with laser pointer and wireless mouse - Carrying case - Self-adhesive label roll

Nautilus is used only 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. 2. CONTRAINDICATIONS There are no specific contraindications related to the use of the Nautilus/Nautilus Plus system. 3. WARNING AND PRECAUTIONS Warnings Warning – Before using the Nautilus/Nautilus Plus system for the first time, be sure to read and understand all of the information in this User’s Manual. Warning – Before using the Nautilus/Nautilus Plus system for the first time, be sure you read and understand all the instructions of the devices involved in the catheter placement procedure. Warning – Before using the Nautilus Plus system for the first time, be sure you read and understand the user's manuals for the set of peripherals. Warning – The Nautilus/Nautilus Plus 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 – Nautilus may be used only together with its accessories: the adaptors Nautilus E or Nautilus S for collecting and transmitting endovascular data to the ECG data acquisition module. 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. 4 [9.1.87] [Users manual-ed1rev6en.pdf] [Page 4 of 10]

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 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 or a spider box with a protective cover to prevent the accidental adding / removing of plugged-in devices. (SREN 60601-1 16.9.21) Warning -Safety tests are performed at the time of manufacture to assure compliance with SR EN 62353:2008 standard. Perform these tests as part of your institution’s maintenance program to assure compliance with the named standard. Warning - When using the system with the Nautilus S and Nautilus E adaptors, always follow the instructions for use provided with these devices. Warning - The system only works with a sinus rhythm of the heart. Warning - The Nautilus/Nautilus Plus User’s 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 User’s 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. 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 patient’s 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 patient’s 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/Nautilus Plus 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 institution’s guidelines. Warning - Do not place and/or use the 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/Nautilus Plus system as they are specified in the User’s 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/Nautilus Plus 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/Nautilus Plus 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 system to a network (local, internet) that has an unknown or insufficient security level! Warning - If you connect an external device to the 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. 5 [9.1.87] [Users manual-ed1rev6en.pdf] [Page 5 of 10]

The respective storage device does not automatically install drivers and/or other applications, which through their execution, could consume the system’s resources. Warning - The system, including the peripherals must be used only with the chargers 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 – Only use the components and peripherals supplied by Romedex International for Nautilus and Nautilus Plus (ECG cable, grounded medical power supply and power cord for netbook, printer, grounded medical power supply and power cord for printer, netbook battery, presenter) Warning - Do not use additional cables, extension cords or outlets with the Nautilus/Nautilus Plus 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/Nautilus Plus system netbook or allow fluid to enter any of the connectors Warning - Never connect an active device (supplied with power) to the electrical interfaces (for e.g. USB, external monitor, speakers) of the Nautilus/Nautilus Plus 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/Nautilus Plus 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 has direct contact with the patient may interfere with the display of ECG waveforms by Nautilus/Nautilus Plus. Do not use electric cauterization, electric scalpels, and ablation equipment while using Nautilus/Nautilus Plus. 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/Nautilus Plus 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 thermal printer only to the electrical socket with grounding contact (for Nautilus Plus). Connect the USB A/B cable between the printer and netbook in any of the free USB ports. (for Nautilus Plus) Connect the receiver of the presenter in any of the free USB ports of the netbook. Start the presenter from the ON/OFF button placed on the side. (for Nautilus Plus). 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 netbook is completely loaded, the application is launched by double clicking on the Nautilus icon. The Nautilus interface is shown in figure 2.

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Figure 2: 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. Help. 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. Help menu – Displays the About window that shows the application version, as well as the firmware version installed. d. 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 Einthoven’s reference system) and the guiding ECG waveform at the tip of the catheter (lead II in Einthoven’s reference system). By clicking on this screen the user will switch to “PAUSE” mode; in this mode the application is not showing the actual 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 “patient’s 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. 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 netbook 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. 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 To power off the system: a. Close the Nautilus application b. Power down the Windows operating system on the netbook, by applying the Start-Shut Down sequence. c. Shut-down the presenter (for Nautilus Plus). 7 [9.1.87] [Users manual-ed1rev6en.pdf] [Page 7 of 10]

4.2 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 hospital’s guideline. 2. Locate three ECG snap electrode patches (available on the market) and place one on the patient’s lower left abdomen, one on the patient’s lower right abdomen, and one on the patient’s 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 patient’s left lower abdomen 4. Connect the black clip connector of the provided ECG cable to the electrode snap on the patient’s right lower abdomen 5. Connect the yellow clip connector of the provided ECG cable to the electrode snap on the patient’s 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/Nautilus Plus 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 User’s 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 institution’s guidelines. Perform vein puncture and venous access per institution’s guidelines, if applicable under ultrasound imaging guidance. 4.3 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. 4.4 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 2). The waveforms on the bottom in Figure 2 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 2 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. 4.5 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 2). 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 3. 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.

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Figure 3: Print format

To copy any file from the Nautilus netbook to a removable storage medium, exit the Nautilus application and use the Windows operating system to copy the desired file to the desired location. 4.6. Catheter Guidance 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.

Fig. 4 Catheter Guidance

4.6.1 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, it means that the tip of the catheter is in the lower third of the superior vena cava, just above the cavo-atrial junction (1, Fig 4). 4.6.2 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; 2, Fig 4). 4.6.3 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 catheter’s tip is in the low right atrium/high right ventricle. This is known as an atrial spike (3, Fig 4). 5. CLEANING AND DISINFECTION To clean the Nautilus/Nautilus Plus system: 1. Turn off the system 2. Dampen a nonabrasive cloth with either mild soap and water or Sodium Hypochlorite 1% solution. 3. Gently wipe the dampened cloth over the exterior surfaces of the the system’s components. Warning! Do not submerge the system’s components in water and do not allow fluids to enter the components. 9 [9.1.87] [Users manual-ed1rev6en.pdf] [Page 9 of 10]

6. 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. 7. MAINTENANCE Safety tests are performed at the time of manufacture to assure compliance with SR EN 62353:2008. Perform these tests according of your institution’s 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. 8. TECHNICAL SPECIFICATIONS  Netbook with Processor: CPU Intel Atom N450 (1.66GHz, 512KB L2 cache); Display: 10.1’’ LCD, 1024x600 resolution; Entry voltage: 100-240V~1,5A, 50-60Hz; Power consumption less than 40 W  Module ECG 4-electrodes, full patient isolation, defibrillation protected, integrated in netbook  Nautilus data acquisition application running under Windows XP/7 operating system  Nautilus grounded medical grade power supply, AFM60US18; grounded power cord, IEC 3G 1,0 mm2  ECG cable 4 leads, 2,7m  Thermal printer, DYMO type  Grounded medical grade power supply for the printer Dymo, type AFM60US24; grounded power cord, H05VV-F - 3G 0.75 mm2 type  Presenter (with laser pointer and wireless mouse function), M961AT III type

9. 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 the system 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 User’s manual latest review: October 2013

Romedex International SRL 74 Fundeni Str, Bucharest, Romania Tel: +40.212.550.385 Fax: +40.318.179.962 Email: [email protected]

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