PILOT TLS TABLET Manual Ver 1.0 Jan 2018

PILOT TLS Tablet Manual, VER.1.0, 10 Jan 2018

INDEX

Technical features

page 3

Label symbols

page 4

Guidelines

page 5

Introduction

page 7

Connection to the patient

page 11

Icons description

page 12

PILOT TLS TABLET use

page 17

Atrial fibrillation

page 18

Differential navigation

page 18

Cleaning and maintenance

page 19

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PILOT TLS Tablet Manual, VER.1.0, 10 Jan 2018

TECHNICAL FEATURES Dimensions: 130mm x 80mm x 45mm Weight: 625g Operating temperature: +10°C / +40°C Power supply: 5Volt, +- 10%, 100mA Consumption: 500mW during acquisition Input: Protected for defibrillator discharge with insulation at: 4000Volts RMS dispersed current: best of class CF(<10µA) Amplification: 4 ranges that can be set by the user. Notch filter: can be set by the user: 50Hz, 60Hz or no filter EMG filter: can be set by the user yes/no Bandwidth: 0.05 to 70Hz QRS detection: 30 .. 300bpm +- 1%, +- 1 digit, Pacemaker: pacemaker detection +/-2mV to +/700mV, pulse amplitude from 0.5 to 2ms, (can be disabled) Outputs: RS232 asynchronous serial and CMOS level (0...5V) outputs, both outputs are completely isolated from the patient Serial protocol: Two-way package protocol: Connector to patient SV1: 1-C-IN 2-SHIELD Ground 3-LL-IN 4-RA-IN 5-LA-IN 6-SHIELD Connected to pin 2 7-RL-IN Input impedance: > 10MOhm CMRR: > 90dB at 50Hz or 60Hz Input range: ±5mV AC, ±300mV DC Complies with: IEC 60601-2-27 PILOT TLS TABLET must be disconnected before a defibrillator is used, in order to avoid interference. Restoration after fibrillation: <10sec for IEC 601-2-27 <10sec for AAMI EC13-1992

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PILOT TLS Tablet Manual, VER.1.0, 10 Jan 2018

Label Symbols

Keep in a dry place

Do not dispose of as normal household waste

Warning: refer to the user manual Read the manual before use

REF. Model/code Manufacturer

SN.

Applied part class CF protected against defibrillator shock

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Serial Number

PILOT TLS Tablet Manual, VER.1.0, 10 Jan 2018

GUIDELINES The instructions for use provided in this PILOT TLS TABLET manual must not in any way influence the medical protocol established for the patient's therapy and diagnostics. PILOT TLS TABLET must be used by qualified staff with adequate medical and technical training. PILOT TLS TABLET must not be used in the presence of flammable anaesthetic gases. PILOT TLS TABLET must not be used at the same time as other systems connected to the patient such as defibrillators, vital parameter monitors and ECG machines, as it could alter the diagnostic results of these appliances. PILOT TLS TABLET must be used taking care that the conductive parts of the electrodes do not come into contact with other conductive parts (metal, jewellery, etc.). Reductions in audio volume may jeopardise patient safety. Access to the device, to the internal circuits and to the corresponding components, its repair and maintenance must be performed by specialised, qualified technicians only. Qualification is certified by the manufacturer alone and based on adequate training in system features and operation. Connection to the mains power supply (+5Volt) and Front End connection must be performed using the connections provided by the manufacturer alone. Failure to comply with this guideline may jeopardise patient safety. Connecting the system to other appliances provided by third-party suppliers not specifically recommended or envisaged by the manufacturer BCS may jeopardise correct system operation and patient safety. Should it be necessary to connect PILOT TLS TABLET to another device, users should contact the manufacturer in order to obtain details on compatibility and keep PILOT TLS TABLET compliant with safety requisites.

WARNING: Do not connect PILOT TLS TABLET to the hospital or company network while running the software to avoid possible conflicts or slowdowns. Do not use PILOT TLS TABLET during the recharge of the battery of the Tablet.

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PILOT TLS Tablet Manual, VER.1.0, 10 Jan 2018

CONFORMITY PILOT TLS TABLET is a medical device designed and built in compliance with the safety requisites required of electrical appliances. PILOT TLS TABLET: medical device, class IIa Complies with: Directive 93/42/EEC (Legislative Decree 46/97 and subsequent amendments) DIRECTIVE 93/42/EEC, of 14 June 1993 and subsequent amendments. LEGISLATIVE DECREE no. 46 of 24 February 1997, and subsequent amendments. Standards UNI EN ISO 9001:2008 - SisUNI CEI EN ISO 13485:2012 - UNI CEI EN ISO 14971:2012 - CEI EN 60601-1:2007 - CEI EN 606011-2:2010 - CEI EN 60601-1-6:2011 - ISO CEI EN 62366-1:2008 PILOT TLS TABLET is protected against the effects of defibrillation, but needs to be restarted after defibrillator use. This class CF appliance has been designed to guarantee protection against electric discharge. PILOT TLS TABLET is a detector of electrocardiographic signals that does not have any active connections with the patient; its detection electrodes must be positioned as illustrated in the following pages. PILOT TLS TABLET is not an electrocardiogram machine and cannot, therefore, be used as an ECG monitor. PILOT TLS TABLET has not be used at the same time as electrosurgery instruments. PILOT TLS TABLET must be used with accessories approved by BCS Srl only; do not reuse disposable accessories even after they have been resterilised. For the patient connection always use the ECG cable provided with PILOT TLS. Do not use damaged accessories and electrodes, to avoid compromising the operation of PILOT TLS TABLET.

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PILOT TLS Tablet Manual, VER.1.0, 10 Jan 2018

INTRODUCTION PILOT TLS TABLET has been built as an aid to be used by those implanting central venous catheters and haemodialysis catheters. The intracavitary ECG method is based on evaluation of the P wave, which is highest at the sinoatrial node. PILOT TLS TABLET displays the height of the P wave in real time, acquiring the ECG signal through the catheter used as an electrode. The operator will therefore be able to find the position of the catheter related to the maximum height of the P wave.

Fig. 1

Fig. 2

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PILOT TLS Tablet Manual, VER.1.0, 10 Jan 2018

With PILOT TLS TABLET the catheter is used as an intracavitary electrode, replacing the yellow (left shoulder) and giving the advantage of continuously and simultaneously being able to observe the superficial ECG (second lead). PILOT TLS TABLET is also able to detect biphasic P wave. In this case the central band will become orange. PILOT TLS TABLET recognises every single QRS, calculates the isoelectric line of the complex and uses it to calculate the height of the P wave.

Fig. 3

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PILOT TLS Tablet Manual, VER.1.0, 10 Jan 2018

In a single panel, PILOT TLS TABLET provides the user with the superficial tracing, the intracavitary tracing and the height of the P wave. It also shows the maximum P wave achieved for the complexes displayed to date, clearly highlighting the isoelectric line and any biphasicity of the P wave (fig. 4).

Fig. 4

The unique features of PILOT TLS TABLET are:

1. Measurements in millivolt of the height of the P wave with definition from 0.062mV to 2. 3. 4. 5. 6.

0.008mV per digit (default setting 0.031mV); Displaying of the complex's isoelectric line; Detection of biphasic P wave; Suitable for AFIB patients; Possibility of recording procedures; Possibility to determine the exact position of the Sinoatrial node.

The device's memory capacity is almost unlimited and is only conditioned by the tablet's settings and the external memory devices available.

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PILOT TLS Tablet Manual, VER.1.0, 10 Jan 2018

PILOT TLS is a data acquisition interface powered directly from the USB socket at +5 volts with an absorption of approximately 100 mA and is connected to a tablet. PILOT TLS TABLET is an application that has been developed on a Windows platform, framework 3.5 and later versions, but can also be used on MAC by using ORACLE's VirtualBox VM virtual machine or the Wine application. Do not use a USB cable longer than the one provided. Should it be necessary to use a longer cable, an amplified cable should be used.

Minimum hardware requisites: • Processor X5-Z8350 1.92 GHz or similar • Quad core • 4 threads • HD 32GB Operating systems: • Windows 7 SP1 • Windows 8.1 (x86 and x64) • Windows 10 (x86 and x64)

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PILOT TLS Tablet Manual, VER.1.0, 10 Jan 2018

CONNECTIONS TO THE PATIENT Connect the electrodes as shown in fig. 5:

Fig.5

Once the electrodes have been connected as shown in figure 6, the patient's ECG tracings will appear in the PILOT TLS TABLET window (fig. 6).

Fig.6 The red tracing at the top represents superficial DII. Removing the yellow lead from the patient and connecting it to the catheter, the lower tracing will appear representing the intracavitary signal.

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PILOT TLS Tablet Manual, VER.1.0, 10 Jan 2018

ICONS DESCRIPTION

Left side screen icons:

Patient: opens the window below (fig. 7).

Fig. 7

Yellow fields are mandatory. The system will automatically generate a folder named with Surname_Name_procedure date in the directory C:PILOTTLS. In this folder you will also find screenshots (Immages folder). Raw data will be stored in the data folder. No Name option will start the procedure without filling the patient information. Every screenshot will be saved in the C:PILOTTLSNo Name folder. Recording button is not activated.

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PILOT TLS Tablet Manual, VER.1.0, 10 Jan 2018

Freeze: allows the user to “freeze” the image. Once it has been selected, the icon will become green and the system will ask for internal and external length of the catheter. If you are placing a port, system will ask only for internal length. Click again to resume the acquisition.

Print: creates, saves (in the folder C:PILOT/TLS/Surname_Name_procedure date/Immages) and shows the preview window the screenshot of the current display. To print the image, just press the print button in the print preview window. This function can be used without freezing the image.

AFIB: activates F waves calculation using peak-to-peak method (see page 19).

Files: will open a window with the stored patient folders. The trace raw data is stored into the data folder in the patient folders (C:PILOT/TLS/Surname_Name_procedure date/data). Here you can select the file to replay.

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PILOT TLS Tablet Manual, VER.1.0, 10 Jan 2018

Settings: enables the menu (fig. 8) of threshold parameters, amplification and noise. In the brackets are indicated the default values. Select the checkbox next to the chosen parameter and use the arrows below to increase/decrease the value. Press Store to confirm; configuration will be saved only for admitted patients without affecting default. Patient Simulator: enables an ECG simulation to test the device and for training. QRS and P: indicate the slope value to be exceeded for detection of the corresponding wave. Biphasic: indicates to what extent the initial P wave tracing has to drop below the isoelectric line in order to be identified as biphasic. Biphase Repetition: indicates how many times the biphasicity condition has to be repeated to make the central green band turning orange. Isoelectric: indicates how many points have to be aligned in the T-P segment to identify the value of the isoelectric line. ECG Gain: determines the amplification of the input signal changing the resolution of the trace: 0.5 halves the signal received; 1 the signal as it is received; 2 doubles the signal received; 4 quadruples the signal received.

Fig. 8

Noise: removes the noise in the tracing. The higher the value, the clearer the tracing, but affects the displayed P wave height value and other waves. Screen Time: defines the duration in seconds of one screen; the higher the value the more complexes shown in a single screen, but they will appear narrower and it will decrease the resolution of the complexes. Set Zero defines the position of the electrical zero. The value 0 coincides with the central zero for the tracings. Selecting the down arrow, the zero moves downwards and viceversa. It does not modify the P wave height value being a graphical display adjustment.

Parameters: opens internal parameters configuration menu of the ECG board. This function is locked with a password it is not to be used by customer. 14

PILOT TLS Tablet Manual, VER.1.0, 10 Jan 2018

Right side screen icons:

Rec: stores raw data in the C:PILOTTLSSurname_Name_ procedure datedata directory. NOTE: This function is only for admitted patient.

Pause: suspends only registration.

Stop: ends the registration and dismiss patient.

Navigation: activates the navigation tool (see page19).

Sound: activates the beep for QRS recognition. Press twice on the button that will first become green and then will turn grey to deactivate sound.

Cm: use this button to insert the catheter depth it to the screenshot saved.

, before pressing

, to relate

In the lower right corner there is the status indicator. It notifies if the device is acquiring the tracing (Live), if it is playing a stored procedure (from File) and if simulation mode has been activated (Simulation).

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PILOT TLS Tablet Manual, VER.1.0, 10 Jan 2018

Central band icons:

Zoom adjustment. Doesn’t affect P wave height values.

Instant P wave value.

Heart Rate.

Below this button there is a grey band. This band will become orange if a persistent biphasicity is detected.

Hidden keys: Clicking on the lower tracing a dotted line on the detected P waves will be displayed. Clicking on the upper tracing a dashed line on the detected R waves will be displayed.

Light grey means that the button is disabled, green activated, grey enabled.

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PILOT TLS Tablet Manual, VER.1.0, 10 Jan 2018

PILOT TLS TABLET USE

ICON STATUS INDICATOR Dark Grey: enabled Light Grey: disabled Green: activated

PROCEDURE DESCRIPTION 1. Turn on the device 2. Run Pilot TLS Tablet software clicking on the shortcut on the desktop

or on the

icon in the application list of Windows Start menu 3. Connect the interface to the Tablet USB port. The indicator

in the lower right

part of the display will show the port used and confirms the interface detection 4. Random traces (noise) will appear on the screen until the leads will be connected to the patient 5. Connect the leads to the patient as shown in figure 5 (page 7)

6. Press

to insert patient ID, yellow fields are required

7. Prepare for catheter insertion (sterile field, ultrasound exam, venipuncture, etc) 8. Insert the catheter following the superficial measurement. Then remove the yellow lead (left shoulder) from the patient and connect it to the catheter using VYGOCARD connection or similar. 9. After the connection, the intracavitary trace will appear the in lower part of the display 10. Wait for trace stability and make sure that the complex has been detected by the software (“beep” at the QRS). To highlight the QRS detection it is possible to activate a special marker (dashed line) clicking on the upper trace. Check if P wave is visible and if it increases/decreases with the catheter movements. If P wave is not visible use the Navigation tool (see page 19)

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PILOT TLS Tablet Manual, VER.1.0, 10 Jan 2018

11. Once P wave and QRS are detected start to analyse P wave height values. It is advised to take a mental average of the values 12. P wave height values are calculated only if QRS (beep) and isoelectric line (green line) have been detected 13. Advance the catheter and analyse P wave height value in the new position 14. Repeat the P wave height evaluation in next catheter position chosen to find the maximum (advance if P wave height value is increasing, move backward if it is decreasing). After that, highest P wave value for the current patient will be identified 15. In order to render the procedure more precise, or if it is required in the patient information, it is possible to save different screenshots related to each catheter position. Click under label and insert catheter depth then press to save the screenshot. To print the image, just press the print button in the print preview window

16. Once the catheter has been placed, proceed with the final print: press to freeze the trace. The software will ask for catheter depth (internal cm) and for external centimetres, if the device is not a PORT. Press to save the screenshot. To print the image, just press the print button in the print preview window

17. Press

to end eventual recording and to dismiss patient.

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PILOT TLS Tablet Manual, VER.1.0, 10 Jan 2018

ATRIAL FIBRILLATION Atrial fibrillation (AFIB) is an abnormal heart rhythm. A typical ECG in an AFIB patient has no P wave, presenting typical F waves between two QRS. PILOT TLS AFIB tool is useful with patient with atrial fibrillation. NOTE PILOT TLS TABLET Atrial fibrillation algorithm consists of a measurement of the peak-to-peak (pp) amplitude of the F waves between two QRS. Software will measure the p-p amplitude and will display the number in the box beside F. This measurement method has been applied to more than hundred AFIB patients, where the accurate positioning of the catheter tip was confirmed through the X-ray method (Carina method). This measurement is also subject to another study validating the positioning by a TransEsophageal Echocardiogram (TEE). Consequently it is recommended to use it with care.

DIFFERENTIAL NAVIGATION

activates the differential navigation tool. This analysis consists of a differential calculation between the superficial and the intracavitary traces. This function verifies whether the catheter has taken the right path inside the superior vena cava (SVC) or if it has entered other vessels such as the jugular vein. When this function is activated, in the lower part of the screen the system will display the differential tracing and not the intracavitary trace. If the central band becomes red, it will indicate that catheter is not in the SVC. If the central band becomes green, it will indicate that catheter is in the SVC. Use Navigation if, once catheter has been placed following the superficial measurement, P wave is not visible in the intracavitary trace (lower) and it is visible in the superficial trace (upper). • •

If P wave is not visible do standard manoeuvres (check with ultrasound if the catheter is in the jugular vein, pull back the catheter etc) until you see the central band becoming green Then disable Navigation and go back to the point 11 of the procedure description

It is not possible to analyse P wave height and its eventual biphasicity in Navigation mode because, while in Navigation mode, the analysed trace (N, navigation) is the result of the difference of the intracavitary trace (A) minus the superficial lead II signal (DII). So the analysis is made on the new signal N=A-DII and, if P wave height value in the intracavitary trace is null or very low (as in the jugular vein for example), we will have a false indication of total biphasicity; so it is not possible to relate the biphasicity indication obtained in navigation mode with catheter position in the atrium. Navigation can be used with AFIB patients because the indication comes from R wave analysis that if it is negative means certainly that catheter is not in SVC. 19

PILOT TLS Tablet Manual, VER.1.0, 10 Jan 2018

CLEANING AND MAINTENANCE This section describes the routine maintenance and cleaning procedures to be performed on PILOT TLS TABLET and provides advice regarding the frequency at which they should be carried out. Following these simple instructions will help maintain efficiency and guarantee the correct operation of the system. General cleaning procedure At least once a day, disconnect PILOT TLS from the tablet and wipe the case using a cloth. At least once a month, clean the electrode connection cable. Tablet and the connection cables can be cleaned using normal hospital cleaning products and detergents. Maintenance and troubleshooting The preventative maintenance operations to be performed are those typical of any tablet. They therefore consist in checking settings, updating the operating system and making sure the hard disk is never completely full. The system is fitted with a simulator built into the interface. This makes it possible to establish whether the system is operating correctly, with the exception of the input stage. It can be enabled using the Simulation key in the Settings menu (fig. 8). In the event of a malfunction, perform the following checks: • make sure the tablet is switched on; • make sure the USB cable is connected to the tablet; • make sure that the Windows “control panel” shows a "USB Serial Port (COMX)", where X is a number that varies from one tablet to the next. If it does not appear, disconnect and reconnect PILOT TLS USB cable. If it still does not appear, contact the Assistance Service; • start PILOT TLS TABLET and check that the same COM number appears in the bottom right-hand corner of the box; • click the Settings icon, enable the Simulation and press OK. A test ECG will appear on the display; this makes it possible to check that communication between the acquisition interface and the tablet is working correctly; • close then reopen PILOT TLS TABLET and wait for it to connect to the tablet (the COM used will appear in the bottom right-hand corner); • if there is still no patient signal, check the electrodes are positioned correctly; • take an external ECG simulator and connect the PILOT TLS terminals to the simulator; • if there is still no signal, contact the Assistance Service; • in the event of excessive noise in the tracing, disconnect the patient cable (socket in the middle of PILOT TLS) and check whether the noise disappears. Check the status of the electrodes and the connection to the patient. If the problem persists, call the Assistance Service;

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