ServiceManual-MyLabX6-X7-pdf

[Page 1] Service Manual MyLabX6 MyLabX7 MyLabX7VET 350032600 www.esaote.com Rev. 03 Feb 2019

[Page 2] Copyright © Esaote S.p.A. All rights reserved. Reproduction in whole or in part is prohibited without the written consent of the copyright owner. Use of the information contained herein in any form and/or by any whatsoever is strictly reserved for Esaote S.p.A. and its licensees. Use of this manual by unauthorized is strictly prohibited.

[Page 3] INDEX 1 INTRODUCTION ... 1 1.1 Service Characteristics 2 1.1.1 Identifying the Boards 2 1.1.2 Fuses 2 1.2 Equipment 2 1.2.1 Disassembling Equipment 2 1.2.2 Service Procedures 3 1.2.3 USB Medium and Re-Writable CD/DVD 3 1.2.4 Upgrading File 3 1.2.5 Safety Test Equipment 3 1.3 Warnings and Precautions 4 1.4 Packaging 4 1.4.1 System packaging 5 1.4.2 PCB rack packaging 6 2 BLOCK DIAGRAMS 7 2.1 General Block Diagram 8 2.2 Electric and Schematic Diagrams . 11 3 UNIT DISASSEMBLY 12 3.1 LCD Section . 13 3.2 Control Panel Section 17 3.2.1 Keyboard Unit 17 3.2.2 Side Rails 19 3.3 Chassis Section 21 3.3.1 Chassis section, internal parts 27 3.4 Disassembly and assembly procedure PCB rack 35 4 PARTS LIST 52 5 MAINTENANCE ... 55 5.1 Maintenance Procedures 55 5.1.1 Battery Cell 55 5.1.2 Track ball 55 5.1.3 Fans 56 5.1.4 LCD attachment 56 5.1.5 Battery pack replacement 57 5.2 Check list 59 5.2.1 Technical Check List 59 5.2.2 Maintenance Check List 60 5.3 Cleanliness of product 62

[Page 4] 6 SERVICE INFORMATION 63 6.1 Service menu 63 6.1.1 Language settings 64 6.1.2 Monitor field 64 6.1.3 Maintenance 64 6.1.4 Set AC filter frequency 64 6.1.5 Show/hide frame rate on RT images 64 6.1.6 Show/hide system logo 64 6.1.7 Enable/disable firewall 64 6.1.8 Show/hide patient birthdate ... 64 6.1.9 Show/hide operator initials on header 64 6.1.10 Enable/disable WiFi 64 6.1.11 Screen saver time out 65 6.2 Licenses 65 6.3 Software installation 66 6.4 Formatting the Hard drive 67 6.4.1 Saving unit settings 68 6.4.2 Format procedure 69 6.4.3 System reconfiguration 72 6.5 Rack replacement 73 6.6 Log Files 74 6.6.1 Log Files Organization 74 6.6.2 LogParser Executable 74 6.6.3 User Session 76 6.7 Remote Service 78 7 SAFETY TEST 79 7.1 Safety measurements according IEC 62353 79 7.2 Safety measurements according IEC 60601-1 88

[Page 5] Chapter 1 INTRODUCTION This manual refers to all MyLabX6, MyLabX7 and MyLabX7VET ultrasound models, named in the following chapters as MyLab. The term “MyLab”, used in this manual, refers to all models. When the information refers to a dedicated model it will be specifically indicated. The service manual is available in English only. The manual is addressed to all the Service centers directly authorized by Esaote. All the operations described in this manual are not critical from a safety point of view. This manual describes the authorized operations. WARNING Perform only the operations describes in the manual. Any unauthorized modification may introduce additional hazards. Do not attempt to service MyLab unless this service manual has been consulted and understood. The Enter and context menu keys are respectively indicated as ENTER and UNDO keys in this manual. The electronic diagrams are not enclosed in this manual. WARNING In this manual WARNING identifies a risk for the patient and/or the operator. The word CAUTION describes the precautions necessary for protecting the equipment. 1 350032600_03

[Page 6] 1.1 Service Characteristics 1.1.1 Identifying the Boards MyLab’s design is based on the use of modular, functionally isolated printed circuit boards (PCBs) and subassemblies known as Field Replaceable Unit. This modularization greatly simplifies on-site service and repair. In most cases, on-site maintenance is accomplished by removing and replacing the PCBs or subassemblies. Most boards of MyLab are identified: • By its Description and reference, which is always indicated on the label. • By the Serial Number (SN), indicated on the label. • By the Configuration Index (CI), indicated by two decimal figures on the label. The Configuration Index represents the HW level of the board. The Configuration Index is loaded in specific components mounted on each board. 1.1.2 Fuses WARNING Do not replace the system fuses with types different from those specified. 1.2 Equipment In this section the required tools to access the system internal parts are listed together with the tools to activate the Service procedures and to perform a functional test of the unit. 1.2.1 Disassembling Equipment The disassembling procedures are described in detail in Chapter 3, UNIT DISASSEMBLY on page 12. Tool Dimension Dynamometric Phillips electric screwdriver Large, medium and small tips Short Philips screwdriver Small tip Flat screwdriver Large and small tips Box wrench Allen screwdriver Socket Wrench Tweezer Point pliers Small tip The use of an electric screwdriver allows the access time to be minimized. Low torques are recommended. 2 350032600_03

[Page 7] 1.2.2 Service Procedures USB Service key P/N 140009500 The service procedures that require an interaction with the unit, can be activated through the service key only. The service key must be inserted in one of USB ports. The key must be inserted before switching on the unit, to be able to access to the several service menus. If the procedure is not carried out properly, the system doesn’t allow the access to the menu. This symbol is used in this manual to indicate all the procedures that require the use of the service key. 1.2.3 USB Medium and Re-Writable CD/DVD To perform a complete check of the unit, it is suggested to always have an USB medium and a re-writable CD/DVD. These tools allow the service technician to test the functioning of the USB ports and DVD burner. 1.2.4 Upgrading File It is suggested to always have the latest revision of the unit upgrading file, together with the pertaining upgrading instructions. These tools allow the service technician to install the software on the unit, should it be necessary. 1.2.5 Safety Test Equipment The safety test must be performed whenever the system composition has been changed, either by adding a new peripheral or by having replaced parts. Refer to chapter 7, SAFETY TEST page 79 in this manual for detailed information on when to perform the tests and how to carry it out. 3 350032600_03

[Page 8] 1.3 Warnings and Precautions WARNINGS It is forbidden to edit or delete files that belong to the software package. Doing so may compromise the system safety. PRECAUTIONS A series of precautions that must be observed each time you perform an operation on the system are emphasized below: • The equipment must always be switched off before carrying out any service operation. In the same way, all the probes and peripherals (for example external monitor, printer, and video-recorder) must also be disconnected. • Power off the equipment prior to perform any disassembling operation. • An electrostatic discharge occurring through the contact with the operator, can irreparably damage the electronic components on system boards that are sensitive to electro-static discharges: it is therefore recommended that precautions to prevent these discharges are taken each time a board has to be removed/installed. In operational terms, this means: o The machine must rest on an electro-static mat connected to earth. o The service technician must also be connected to the same earth each time he removes or installs the parts. o The boards and components must always be moved in their special electro-static containers. o For the service on the field, use the specific kits including the anti-static mat. o The chapter entitled “system Parts List” details the sub-assemblies that are to be considered sensitive to electro-static discharges (ESD). When the board is ESD sensitive, you can find this symbol on the PCB master. REFERENCE: IEC 61340-5-1 (2007) 1.4 Packaging Whenever the MyLab or PCB rack has to be shipped, the system or rack has to be properly packed to prevent trauma damage. NOTE: The original packaging has to be stored should it be necessary to ship the system. Warranty will be void if the packing procedure is not followed. 4 350032600_03

[Page 9] 1.4.1 System packaging Procedure • Disconnect and remove all probes and peripherals from the system. • Remove the LCD Display and LCD attachment and pack in original packing material. • Lower the control panel. Place the system on the palette. • Rotate the wheels inwards (as shown in the figure below) and lock them using the gray lever. • Place the plastic bag and foam buffers (top and bottom). • Place the carton box over the system. • Place the carton cover on top. • Close the box with three (3) layers of adhesive tape. • Lock the carton box to the palette using two (2) strips and four (4) corner protections. The system could be damaged during transportation if the above rules are not strictly followed. 5 350032600_03

[Page 10] 1.4.2 PCB rack packaging • Place the rack in the package with the probe locking devices facing up. • Place the upper foam protection on the rack. • Close the box. 6 350032600_03

[Page 11] Chapter 2 BLOCK DIAGRAMS This chapter contains the block diagram descriptions for each board. The general Block Diagram shows the relationships of each board having a unique function within the overall unit. In the block diagrams, the functions are gathered to permit an easy comprehension of the block functioning, which indicates the correlative electronic boards. Figure 1 shows the block diagram of the MyLab unit. 7 350032600_03

[Page 12] 2.1 General Block Diagram 8 350032600_03

[Page 13] Probe Adapter Board The Probe Adapter Board is the board for the connection of the echo probes: the probes are physically connected to this board. The board mounts 3 (three) small connectors and 1 large connector, together with the switching logic to enable the active connector. The main function of the board is to switch among the three probe connectors selecting the active one for the acquisition. Front End Board The Front End Board carries out some fundamental functions regarding probe managing and power supplying. Probe Transmission Section (Tx) The board manages the transmission to the probe controlling the pulses to be transmitted to the elements. The transmitters are individually controlled in terms of enabling, delaying and pulse shape by a dedicated FPGA. Probe Reception Section (Rx) The board manages also the reception of the signals implementing the receiving beam former. The received signals are summed together, amplified, digitally converted and then sent to the dedicated Rx FPGAs that implement the digital focalization. CW Acquisition Section This dedicated section manages the acquisition of the CW signals from their analogic delay to their A/D conversion. Power Supply Section The FE implements the power supply function distributing the supply voltage within both FE and BE boards so that all the other needed supply voltages can be generated. It supplies also the high voltages for probe transmission and the standby voltages for PC module. In this section a dedicated micro-controller manages the system start-up, shutdown, the batteries and their chargers. The micro-controller also monitors the internal temperature and controls the fans speed. 9 350032600_03

[Page 14] Battery Bridge Board The Battery Bridge board connects the two optional batteries to the Front End. The bridge includes the power voltages, the SMB logic connections and the monitoring thermal signals. Back End Board The board implements several functions. The BE board processes the RF signal through a FPGA and n.2 (two) DSPs. The FPGA processes the RF signal and the Doppler data. The first DSP controls the processes on the FPGA, the acquisition sequences and processes both Doppler data and Physio signal. The second filters and mixes the image data. The PC module is mounted on the BE board. The PC main functions are: • Processing CFM data • Managing of the cine memory, • Managing of the scan converter, • Generation of signals for the two LCD displays (main display and touchscreen display), • Managing of the user interface in terms of input from the keyboard and output to the displays. • Managing of the digital peripheral on the USB, • Managing of the LAN connection, • Managing of the audio signal for the speakers, • Control of the Hard disk mounted on this board, • Control of the DVD burner. A dedicated Wi-Fi module is accommodated on the board. This module is connected to the PC Module and to the Wi-Fi antennas. The BE Board also processes the ECG PHISYIO analog signal. Mains Power Group The group manages the connection to the mains power line. It sends and receives power to/from the insulating transformer. It mounts the power sockets for the peripheral devices. An AC/DC module converts the mains voltage to 19V. This voltage powers the electronics and is sent to the Front End. There is also an AC/DC module that generates the supply voltage for the main monitor. 10 350032600_03

[Page 15] Keyboard Group The Keyboard Main board implements: • the connection towards the main group of electronic boards • USB Hub for the USB connections • N.2 (two) external accessible USB connectors • the loudspeakers connection • N.1 (one) microcontroller for managing the control panel keys, the encoders, the TGC potentiometers, the touchscreen and the LED’s of the board keys. The Keyboard Main board manages: • the control panel keys • the gain encoders • the leds of the control panel keys • the six toggle encoders • the trackball keys • the trackball keys LED’s 2.2 Electric and Schematic Diagrams The diagrams are confidential and not enclosed in this manual. 11 350032600_03

[Page 16] Chapter 3 UNIT DISASSEMBLY The chapter describes the unit disassembly in such way that the major service parts can be accessed. In order to carry out all the all the removal procedures, all peripherals, probes and power cables should be disconnected and removed. Assembly Procedure is carried out in reverse of the removal procedure unless mentioned otherwise. In order to carry out all the removal procedures (with the exception of the battery replacement), all connected probes, peripherals and cables must be disconnected. The disassembling instructions are separately given for each part of the unit. When the unit is equipped with the batteries, always remove them before disassembling the internal parts of the unit. Short circuits could occur when disassembling the unit with some tool. See 5.1.5 Battery pack replacement , page 57 12 350032600_03

[Page 17] 3.1 LCD Section This section describes the procedures to disassemble the LCD display and the articulated arm. The procedures refer to the unit with the wheels locked. LCD Display • Remove the two (2) small Phillips screws (shown in the below figure) fixing the rear cover to the LCD display. LCD Rear Cover • Disconnect the video cable and the power cable from the LCD. • Place the LCD horizontally and, holding it firmly, remove the four (4) medium screws that fix the LCD to the articulated arm. Hold the LCD display tightly to prevent it from falling down. NOTE: For the 21” LCD screen an adapter plate is used between LCD and LCD attachment. Remember to mount this adapter when re-assembling the monitor. 13 350032600_03

[Page 18] Friction level of the LCD attachment The weight of the 21” monitor (150000027) is more than the 19 inch monitors. Therefore, it could be necessary to increase the level of friction in the LCD attachment. • Install the articulating arm or LCD attachment as described in the installation guide which is included in the box • Install the 21” monitor on the arm or attachment. • Test if the monitor stays in position when tilting the monitor 45º. If not please continue with next step. • Remove the top cover of the arm/attachment by removing the two screws. Top cover • Tilt the monitor 45º and adjust the friction level until the monitor stays in position. To adjust the friction level, slightly fasten the two Allan screws as indicated. 14 350032600_03

[Page 19] Friction level adjustment • Reassemble the arm. Articulated Arm • Remove the LCD. • Remove the four cross headed screws of the lower cover and remove the cover. Cover removal • Remove the top and lower covers of the arm closest to the system. • Remove the four (4) small Phillips screws placed on the lower side of the arm closest to the LCD. 15 350032600_03

[Page 20] • Remove the top and lower covers of the arm closest to the LCD. • Remove the two (2) small Phillips screws fixing the ground cable to the arm. One screw is placed close to the arm basis (shown in the below picture) and one screw is placed close to the LCD support. Caution Be careful to the screw close to the arm basis: if it falls down, it can go into the system chassis. It is strongly recommended to close the hole using a piece of paper or a piece of material. • Remove the cables from the arm. • Remove the four (4) Allen screws that fix the arm to the chassis. 16 350032600_03

[Page 21] 3.2 Control Panel Section This section describes the procedures to remove the keyboard unit and the side- rail. The procedures refers to the unit in its working position with the wheels locked. To remove the TGC, B/M, CFM and PW Encoders caps and Toggles no tool is required. • Remove the item by pulling it up. Gel and Probes Holders can be removed by sliding the holder off the lateral support. 3.2.1 Keyboard Unit • Remove the four (4) Phillips screws fixing the keyboard unit to the chassis. The screws are placed on the lower side of the keyboard unit. • Lift the keyboard unit. • Detach the Ground cable and SCSI connector from the keyboard unit. • Cut the cable ties. When assembling the keyboard unit pay attention not to bend the SCSI cable. Keyboard unit lower cover • Place the keyboard unit upside-down. • Remove the 12 medium Philips screws that fix the lower cover to the group. • Remove the cover 17 350032600_03

[Page 22] Left and Right Loudspeakers • Remove the 4 small Philips screws that the loudspeaklet to the group. • Disconnect respectively the P4 connector for the left loudspeaker and P3 for the right loudspeaker. Note: Remove the shielding when applicable. Do not damage the copper tape. • Remove the loudspeaker. Note: In case shielding is applicable, place correctly and apply the copper tape and Kapton tape Trackball • Remove the 2 small Philips screws that fix the trackball to the group • Disconnect connector P3 • Remove the trackball Alphanumeric keyboard Pull the alphanumeric keyboard completely out of the chassis. Remove the 8 Philips screws that fix the alphanumeric keyboard to the linear bearings on the sliding rail. Assembly procedure: • Loosen the 8 screws that fix the linear bearing to the alphanumeric keyboard. • Fix the linear bearing to the sliding rails. • Place the alphanumeric keyboard in closed position • Tighten the 8 screws in the indicated sequence below 18 350032600_03

[Page 23] 3.2.2 Side Rails Removal Procedure Left Handle • If necessary, remove the holders. • Remove the 2 Philips screws that fix the handle to the chassis. Left Side Handle • Remove the handle. 19 350032600_03

[Page 24] Removal Procedure Front/Right Handle • If necessary, remove the holders. • Remove the 6 medium Philips screws located on the lower side of the control panel. • Use a 12 mm wrench to remove the 2 hexagonal screws that fix the levers • Remove the levers. • Use a 8 mm wrench to release the 2 nuts that fix the cables to the chassis. • Remove the cables. • Remove the 6 medium Philips screws that fix the handle to the chassis. • Remove the handle. 20 350032600_03

[Page 25] 3.3 Chassis Section This section describes the procedures to access to all the covers, the boards rack and other components in the chassis section. The procedures refer to the unit in its working position with the wheels locked. Fuses • The fuses are placed just below the unit mains switch. • Use the screwdriver to remove one fuse support at a time. • If necessary, replace the fuse. WARNING Always replace the fuses with ones having the same characteristics (refer to next section for further information). Rear door • Open the rear door. • Remove the 3 Philips screws that fix the rear door to the chassis. Hold the door to prevent it from falling down. 21 350032600_03

[Page 26] Rear cover • Open/remove the rear door. • Remove the 4 medium Philips screws that fix the cover to the chassis. Hold the cover to prevent it from falling down. Rear panel • Then take out the rear panel. Rear wheel cover • Open the rear door. • Remove the 6 screws that fix the cover to the chassis. • Remove the cover Probe connector cover • Open the rear door. • Remove the 6 screws that fix the cover to the chassis. • Remove the cover 22 350032600_03

[Page 27] Front cover • Remove the 2 medium Philips screws that fix the cover to the chassis • Pull the cover upwards to remove. Right and left front wheel covers • Remove the front cover • Remove the 2 Philips screws that fix the wheel cover to the chassis. 23 350032600_03

[Page 28] Right cover • Remove the rear cover. • Remove the rear door. • Use a long screwdriver to loosen the 4 Philips screws on the rear side of the chassis, shown below • Remove the 2 Philips screws placed internally on the rear side, shown below • Tilt the cover to remove. 24 350032600_03

[Page 29] Left cover • Use a long screwdriver to loosen the 2 Philips screws placed internally on the front side. • Remove the rear cover. • Remove the rear door. • Loosen the 2 Philips screws on the rear side of the chassis, shown below • Remove the 2 Philips screws placed internally on the rear side, shown below • Tilt the cover to remove. 25 350032600_03

[Page 30] Batteries • Remove the probe connector cover • Remove both the front wheel covers. • Loosen the 3 screws that fix the battery panel to the chassis to remove the panel. • Connect the power cable to the system. • Connect the power cable to the mains. • Check that the main switch, placed on the rear side, is set to ON. The system must be OFF and powered. • Remove the batteries, using the flaps to leverage the batteries. The Power Supply group could be damaged if the above procedure is not attended. Wheels NOTE: It is strongly recommended to perform this action with 2 persons. • Remove the covers for the involved wheel • Lock the wheels on the opposite side of the wheel to be removed. • Tilt the unit. • Remove the nut to remove the wheel. 26 350032600_03

[Page 31] 3.3.1 Chassis section, internal parts When the unit is equipped with the batteries, always remove them before disassembling the internal parts of the unit. Short circuits could occur when disassembling the unit with some tool. DVD Burner • Remove the right cover. • Remove the upper panel by removing the 6 screws. CAUTION: Pay attention to the Wi-Fi antenna’s when moving the upper panel. • Remove the 4 screws that fix the burner to the chassis. CAUTION: Pay attention. Do not drop the screws into the chassis. • Slide the burner from the chassis. • Disconnect the cable. • Remove the 4 screws (2 on each side) that fix the sliders to the burner. Power supply section The power supply section is composed of 3 parts: 1. Main power board 2. 19V rack power supply 3. 12V Monitor power supply. 27 350032600_03

[Page 32] • Remove the rear cover • Remove the rear wheel cover • Remove the power cables coming from the mains power board. Remove the 4 screws that fix the bracket to the chassis. Remove the cable binder that fix the cables of the power supplies to the chassis. • Remove the power supplies • Remove the 6 screws that fix the Main power board cover. 28 350032600_03

[Page 33] • Remove the power cables from the board. Green/Yellow connected to GROUND Black connected to (N) White connected to (L) • Remove the cover • Remove the 4 screws that fix the left and right panel assemblies. 29 350032600_03

[Page 34] • Loosen the left assembly by opening the rivets of the 3 auxiliary outlets. • Loosen the right assembly by removing the 2 screws from the mains inlet and loosen the GROUND wire from the Earth plug. • Remove the left and right assemblies. • Remove the 4 screws that fix the power board. 30 350032600_03

[Page 35] Boards Rack • Remove the probe connector cover • If the unit is equipped with batteries, remove the batteries. • Remove the side covers. • Remove both the front wheel covers • Detach, from the left side, the cables that are connected to the Boards rack. • Remove the 2 screws on the left side • Remove the 2 screws on the front side. 31 350032600_03

[Page 36] • Remove the 2 screws on the right side. Hard Disk (HDD), ID button and Battery Cell NOTE When it is possible, copy both the “ConfSet” and the “Archive” folders (as explained in the procedure below) before removing the hard disk. These folders allows to re- configure the system as it is once the hard disk has been replaced. Procedure to Copy the Folders • Switch the unit on with the service key inserted. • Select the “Control Panel” option. • Using the trackball select the DATA (E:) disk in the “Address” field and press ENTER twice. • Using the trackball select the “work” folder and press ENTER twice. • Using the trackball select both the “ConfSet” and the “Archive” folders. • Copy the folders in an external medium. 32 350032600_03

[Page 37] • Remove the boards rack. • The HDD cover is placed on the upper side of the boards rack. Unscrew the four (4) screws fixing the cover. Hard disk cover screws • Place the rack upside down, laying it on the foam support. The probe connector sockets could be damaged if the rack is not placed on the foam support. • Unscrew the 15 screws that fix the rear cover to the rack. • Unscrew the 4 screws that fix the hard disk to the rack. • Use a small flat screwdriver to remove the hard disk. Once the rear cover of the boards rack has been removed, you get access to the ID Button (Hardware ID) and to the battery cell, which can be removed releasing the spring. NOTE The ID Button is always coupled to the system S/N: make sure to install the rack with its ID Button in the corresponding system S/N. 33 350032600_03

[Page 38] Rack fans • Remove the boards rack. • Remove the rear cover of the rack. • Place the rack upside down with the probe connector facing up. • Remove the battery cover, if not already done when removing the batteries. • Cut the cables ties of the fans. • Use a small flat screwdriver to disconnect the involved cable. • Use the small flat screwdriver to lift the 4 bolts that fix the fan to the rack 34 350032600_03

[Page 39] 3.4 Disassembly and assembly procedure PCB rack Note: This procedure may be performed only by engineers that passed the Esaote Advanced Training level and must be performed in an ESD safe workshop. Performing these actions without training may cause damage to the unit or parts. • REQUISITES Toolset External USB keyboard Kapton tape Sil pad 36x36 (5 pcs) Sil pad 20x20 (2 pcs) • ACTION Tip Many screws are used with different length. Do not collect screws in one cup. Place screws sorted in order of disassembly. This will help when reassembling the unit again. Note: The equipment’s ID button is installed on the Back End board. In case that the BE board is replaced, the ID button has to be swapped between the original and the replacement BE board. Remove PCB rack as described in the 3.3 Chassis Section , page 21 . Battery Bridge board Remove the battery cover 35 350032600_03

[Page 40] Remove the 9 screws as in red + 2 in yellow as shown Remove the Battery Bridge connector Remove the 3 screws in red to get the battery bridge P/N 9501490000 (not mandatory to be removed to access to boards assembly) 36 350032600_03

[Page 41] Probe adapter board Remove the 3 screws in red Remove the other 5 screws in red Detach the probe adapter link from the Probe adapter 37 350032600_03

[Page 42] Remove the 5 screws in red (with washer) to get the Probe Adapter board Back side Cover Remove the 12 pcs M3x6 screws with washer to remove the Back side Cover plate Detach the fan connectors 38 350032600_03

[Page 43] Remove the 14 pcs (13pcs M3x6 + 1 TSP) screws that secure the boards assembly to the chassis: 2 screws at ECG side (“B” is a TSP screw) 4 screws at fan side 4 screws at HDD side 4 screws at bottom side Carefully slide the Boards assembly out of the chassis Disconnect the battery bridge connector if necessary and lead the connectors through the recess to avoid damage 39 350032600_03

[Page 44] Connection bridge (not mandatory to be removed to access to Front End and Back End boards) Remove the 2 pcs connector screws + 2 pcs threaded nuts + 2 pcs golden nuts + washers Remove the 2 screws in red that fix Connection bridge board to the metallic support Remove the Kapton tape from the Main LCD connector; all the connectors can be extracted by gently pulling, except for the Keyboard (yellow circled one) where a lever has to be lifted to unlock. Pull up also the WiFi antennas connectors to detach them. Free the Back End board : Remove the Kapton tape from the Back End board Main LCD connector Disconnect the Main LCD, Keyboard LCD, Keyboard (lift lever to unlock), AUX and WIFI cables from the Back End board. Note: Mark the connectors for easy orientation. Disconnect the DVD cable 40 350032600_03

[Page 45] Remove the connectors panel, fixed with 3 pcs M3x16 + washer screws to access to the boards assembly Front End board Loosen the two screws that secure the Bracket Lock Connectors and remove the plastic support Disconnect the flat cable from the Front End board Remove the 2 pcs Plate for Front End PCB, each fixed with 7 pcs M2 x 14. 41 350032600_03

[Page 46] Remove the 9 pcs M3 x8 screws to remove the Front End Board. Remove the Sil pads from the frame. New ones have to be placed during re-assembly. 42 350032600_03

[Page 47] Back End board Remove the Kapton tape from the Back End Board Remove the 8 pcs M3 x 8 screws that fix the Back End Board Remove the 5 pcs M2.5 x 6 that fix the Back End Board to the PC module. 43 350032600_03

[Page 48] Carefully remove the Back End board from the frame. Take care about the connectors that are connected to the PC modules and to the Sil pads that are used Extract the ID button and the battery, to be re-installed in the replacement board. Remove the Sil pads from the frame. New ones have to be placed during re-assembly. Detach the DVD cable from the Back End board. It is possible to swap the HDD (if it is working correctly) between the old and new Back End board, to keep the licences and settings. NOTE The HDD can be replaced only with same model item. 44 350032600_03

[Page 49] RE-INSTALLATION Back-End board Place new Sil pads on the frame 2 pcs 36 x 36 2 pcs 20 x 20 a) Swap ID Button and battery between original and replacement board. DO NOT USE the housings on the other side of the Back End board OK b) Connect the DVD cable to the Back End Board. c) Place the Back End Board on the frame. Align the holes for the screws. When in correct position gently push the connectors on the PC module. d) Place the 5 pcs M2.5 x 6 screws to lock the Back End Board to the PC Module. 45 350032600_03

[Page 50] e) Place the 8 pcs M3 x 8 screws to fix the Back End Board 46 350032600_03

[Page 51] f) Place Kapton tape as indicated Connect the Main LCD, Keyboard LCD. Keyboard (lock the lever), AUX and WIFI cables from the Connection bridge board. Place the Kapton tape on the Back End board Main LCD connector Front End board Place new Sil pads on the frame (3 pcs 36x36) Place the Front End board on the frame. Align the holes for the screws. When in correct position gently push the location where the connector to the Back End board is located Place the 9 pcs M3x8 screws to fix the Front End board Place the 2 pcs Plate for Front End, each fixed with 7 pcs M2x14 screws 47 350032600_03

[Page 52] Connect the flat cable and place the Bracket Lock Connectors Lock with the two screws Connectors panel Place the Connectors panel taking care that the DVD cable is on the BE board side Fix the panel with 3 pcs M3x16 screws + washers. 48 350032600_03

[Page 53] Connection Bridge board Place the 2 pcs connector screws + 2 pcs threaded nuts + 2 pcs golden nuts + washers Place the 2 screws in red that fix the Connection bridge board to the metallic support Connect the DVD cable to the Connection bridge board Connect the Main LCD cable and apply Kapton tape Connect Keyboard LCD, Keyboard (yellow circled, locking the lever), AUX and WIFI cables to the Back End board. 49 350032600_03

[Page 54] Carefully slide the Boards assembly into the chassis. Connect the battery bridge connector and lead the connectors through the recess to avoid damage. Place the 14 pcs (13pcs M3x6 + 1 TSP) screws that secure the boards assembly to the chassis : 2 screws at ECG side (“B” is a TSP screw) 4 screws at fan side 4 screws at HDD side 4 screws at bottom side 50 350032600_03

[Page 55] Insert the fan connectors Place the 12 pcs M3x6 screws with washer to fix the Back side Cover plate Probe Adapter board Place the Probe Adapter board and fix it with 5 pcs screws with washer Connect the flat cable to the Probe Adapter board Place the Probe Adapter board cover and fix it with 8 pcs M3x6 screws Battery bridge board Place the 3 screws to fix the battery bridge board Insert the Battery Bridge connector Battery housing Place the 11 pcs screws that fix the battery housing Place the battery cover Install the PCB rack in the unit. First start up Connect the internal USB keyboard and switch on the unit The unit will ask to enter Time and Date in the BIOS by pressing F2 Enter Time and Date (in DD/MM/YYYY format) 51 350032600_03

[Page 56] Chapter 4 PARTS LIST a b Boards & Groups for: TRC ESD 101640006 MyLabX6 101640007 MyLabX7 101640008 MyLabX7VET 220003600 BOARDS RACK ASSY 6400 V3 c S/N N 530000062 SWITCHING POWER ADAPTER 100-240Vac 12Vdc c S/N N 530000063 SWITCHING POWER ADAPTER 100-240Vac 19Vdc c S/N N 8750031200 INSULATION TRANSFORMER 600VA c S/N N Common Spare parts 259014600 MyLab7 PROBE ADAPTER c S/N Y 229000900 FAN ASSY 64XX N 229001000 LOUDSPEAKER ASSY 64XX N 229002903 KEYBOARD UNIT 6400 V3 S/N N 229003000 QWERTY UNIT 6400 S/N N 229022200 KEYBOARD EXTENTION GROUP 6400 S/N Y 9501479100 6400 V3 KEYBOARD MAIN S/N Y 279001701 SCSI-III CABLE 64xx N 439000800 WHEEL D=120 Swivel with Brake N 449014900 FUSE CARTRIDGE 5A 250V 5x20mm TIME-LAG N 449015100 FUSE CARTRIDGE 10A 250V 5x20mm TIME-LAG N 459005400 TRACKBALL USB/PS2 2" S/N N 509015400 DVD DRIVER Slim SLOT-IN SATA S/N N 9501446000 PCBA KB Encoder panel 62XX S/N N 9501494000 6400 TRACKBALL SWITCHES S/N Y 9730650146 HDD 500GB SATA 2 1/2" N Batteries 141004100 6400 KIT BATTERY N (Manufactured by: Inspired Energy (www.inspiredenergy.com), P/N 2044HD22) LCD 150000027 21'' LCD monitor S/N N Articulating arm 229003300 ARM ASSEMBLY 64XX 319000100 MONITOR PIVOT COVER (TOP) 64XX 319000200 MONITOR ARM 319000300 MONITOR ARM COVER (TOP) 64XX 319000400 MONITOR ARM COVER (BOTTOM) 64XX 52 350032600_03

[Page 57] Control panel covers 313949 Cable Guide 314086 PROBE HOLDER STERILE APPLICATION 314215 Gel Holder 224001200 CA PROBE HOLDER 224001300 PA PROBE HOLDER 319000900 FRONT/RIGHT HANDLE 64XX 319001000 LEFT HANDLE 64XX 319001200 BOTTOM KEYBOARD COVER 64XX 310001300 USB SIDE MASK GRAY 319001900 LIGHT GUIDE 64XX 310001600 ENCODER KNOB "SMALL" GRAY 8109900000 ENCODER KNOB (LARGE) 62XX 310001800 ENCODER BUTTON (LARGE) "PW" GRAY 310001900 ENCODER BUTTON (LARGE) "CFM" GRAY 310002000 ENCODER BUTTON (LARGE) "B/M" GRAY 8109904000 RUBBER RING FOR ENCODER KNOB LARGE - 62X 8200047000 TGC SLIDE KNOB 62XX 310002300 RUBBER KEYPAD "A" GRAY (On/Off) 310001100 RUBBER KEYPAD "B" GRAY (Archive/End Exam) 319001820 RUBBER KEYPAD "C" GRAY (Freeze) 319001830 RUBBER KEYPAD "D" (gain slider) Chassis covers 224000603 ASSEMBLY LEFT SIDE PANEL 6400 GRAY 224000703 ASSEMBLY RIGHT SIDE PANEL 6400 GRAY 229022000 REAR DOOR 6400 330002685 HAND REST 64XX GRAY 319002500 REAR COVER 64XX 310002700 MAT FOR TOP PANEL 6400 GRAY 319003000 FRONT PANEL 64XX 310002600 PROBES PANEL 6400 GRAY 319003200 BASE COVER 6400 319003300 FRONT BASE COVER LEFT 319003400 REAR BASE COVER 319006600 FRONT BASE COVER RIGHT 319009400 LATERAL PANEL LABEL 64XX 330003487 MyLabX6 US System Logo Label 330003488 MyLabX7 US System Logo Label 330003499 MyLabX7VET US System Logo Label 53 350032600_03

[Page 58] Parts list for advanced service a b TRC ESD 330003989 PROCESSOR BOARD SPARE X5-X6-X7 c S/N Y 220004300 FRONT END BOARD c S/N Y 250019900 6400/642X/74X0 BACK END Board V3 c S/N Y 500000174 Internal WIFI Board c Y (the one connected to the BACK END board) 9501488000 Connection Bridge c Y 9501490000 Battery Bridge c Y VARIOUS 449024500 Sil-Pad 36x36 449024400 Sil-Pad 20x20 259028500 Connector cable PROBE ADAPTER ASSY-FRONT END BOARD 279001300 S-ATA cable 270000800 Keyboard LCD link cable 2200000155 jumper 50 way 279001600 DVI link cable Traceability by serial number (S/N) Electrostatic discharge Remind to carry out the safety tests whenever this part has been replaced (see chapter 7 SAFETY TEST , page 79 ) 54 350032600_03

[Page 59] Chapter 5 MAINTENANCE 5.1 Maintenance Procedures 5.1.1 Battery Cell The unit contains a Lithium battery, located in the PCB rack located on the Back –End Board. It is strongly recommended to replace the battery cell every three (3) years. If the PCB rack has to be stored, it will be necessary to first remove the battery. The Esaote supplier is 3V 210 mA/h GP Model CR 2032. Avoid contact with a leaking battery as the contents are harmful. WARNING Irritation, including caustic burns and injury may occur following exposure to a leaking battery. Do not expose the battery to high temperature. Dispose batteries according to local regulation. If the battery is incorrectly installed it may explode. Replace only with the same or equivalent type. NOTE: After replacing the Battery cell (see 3.3 Chassis Section , page 21 ), it is required to set the Time and Date. The unit will ask to enter the Time and Date and will then fully start up. 5.1.2 Track ball The track ball needs to be cleaned at least once a year. Procedure: • Apply light pressure and turn the locking ring clock wise, then lift and remove it. • Remove the ball and clean. • Clean the encoders with a brush. DO NOT use cleaning spray. • Reassemble the track ball. 55 350032600_03

[Page 60] 5.1.3 Fans The fans need to be cleaned every 6 months (mandatory for Veterinary units) or once a year, depending on the environment where the unit is used. Procedure • Remove the rack. • Remove the rear cover of the rack to gain access to the fans. • Spray compressed air on the fans, derationing the air from inside towards the outside. • Close the rack and install again. 5.1.4 LCD attachment Over time it may be necessary to adjust the friction of the LCD attachment to prevent the display from tilting. Procedure • Remove the top cover of the LCD attachment or articulated arm. • Tilt the display 45° to the front. • Use a 2.5 mm Hex key to adjust the friction. Use the same force on both Hex bolts. The friction is correctly adjusted when the display can be set in any position without tilting. 56 350032600_03

[Page 61] 5.1.5 Battery pack replacement Batteries duration is higher than 300 charging cycles and their replacement is recommended at least every three years. The batteries installed in the unit are manufactured by: Manufacturer Model Qty Inspired Energy NL2044HD22 2 (www.inspiredenergy.com) Do not use different batteries from the ones specified above. The battery is Lithium Ion (Li-Ion) battery, FCC approved; the cells, composing the battery, are UL marked. NOTE The batteries must be treated as special waste according to the applicable local regulations. The batteries REF 141004100, provided by Esaote, are charged: the last recharging operation is indicated in the recharging card. The batteries must be fully recharged every six (6) months when they are kept on stock. The Power Supply group could be damaged if the battery disassembling procedure is not attended. Replacement procedure 1. Remove front cover to get access to the battery cover (see 3 UNIT DISASSEMBLY ) 2. Remove battery cover. 3. Connect unit to mains, mains switch ON but unit OFF (ON/OFF button lit orange) 4. Replace/install batteries 5. Disconnect mains cable 6. Install covers and connect mains cable Charging Procedure The batteries can be charged either by installing them on the unit or by using the charger manufactured by Inspired Energy: Manufacturer Charger Model Inspired Energy CH5000A/E/U (one battery a time) (www.inspiredenergy.com) CH5555A/E/U (four battery a time) 57 350032600_03

[Page 62] Refer to the manufacturer “Instructions for use” manual to properly manage and charge the batteries with the charger. Refer to the “Getting Started” manual to charge the batteries using the unit. Do not expose the battery to high temperature. Keep the battery away from fire and other heat sources. Do not charge the batteries near a heat surface such as fire or heater. Avoid exposing the battery to excessive shock or vibration. Do not immerse the battery in water or allow it to get wet. Do not put the battery into a microwave. Storage The battery should be stored at a recommended temperature range <21°C in a cool, dry, well-ventilated facility, free from corrosive gas or vapor. Extended exposure to temperature above 45°C may degrade battery performance and reduce battery life. Storage at low temperatures may affect initial battery performance. Storage Temperature Limits: -20°C to 60°C,  80%RH 58 350032600_03

[Page 63] 5.2 Check list This chapter proposes two different check lists. The first one (Technical Check List) suggests a set of inspection steps to be performed each time service personnel modify the HW/SW composition (for example a rack replacement or functional upgrade); the other one (Maintenance Check List) suggests a check list intended for a general equipment inspection like yearly maintenance. 5.2.1 Technical Check List The Service key is required Once any HW/SW change, modification or upgrade is finished and the unit is ready to be closed, perform the following: 1 If the power supply, mains entry, isolation 7 SAFETY TEST transformer or the rack has been replaced, perform the safety test 2 Close the unit. 3 UNIT DISASSEMBLY Switch on the unit with the service key inserted. 4 If the HDD has been replaced, perform 6.4 Formatting the Hard Format. Reconfigure system and settings. drive , page 67 5 When applicable, verify that the upgrade is working. 6 Verify the unit functioning using the Maintenance Check List. 59 350032600_03

[Page 64] 5.2.2 Maintenance Check List Physical check 1 Check the unit for any external damage. 2 Check the wheels and the brakes functioning. 3 Check that the unit labels (S/N, Reference and Certification) are present. 4 Check the power cable status (no cut, plug condition) and connection. 5 Check the connectors in the rear panel (no loosing connector). 6 If installed, check the ECG cable status. “Transducers and Consumables” manual 7 Clean the trackball 5.1.2 Track ball 8 Check that the control panel orientation works properly: the keyboard must be both oriented and locked. 9 Check that the control panel can be lift up and down. 10 Check that the LCD monitor can be moved 5.1.4 LCD attachment easily and can maintain its position. If required, adjust the friction. 11 If necessary clean the system and LCD “Getting Started” manual 12 For all probes, check the external status “Transducers and (cable, housing, connector and labeling. Consumables” manual 13 If necessary clean the probes. “Transducers and Consumables” manual General Check 1 Switch on the unit. 2 Check that the operator manuals are present and their revisions are relevant to the installed software release. 3 Check that he control panel keys are lit and functioning. 4 Check the touch screen functionality. 5 Verify that all transducers are correctly identified in each connector. 60 350032600_03

[Page 65] Functional Check 1 Switch on the unit. 2 Verify that the B-mode controls work properly “Advanced Operations” manual, section “Image Optimization and Annotation” 3 Verify that the M-mode controls work properly “Advanced Operations” manual, section “Image Optimization and Annotation” 4 Verify that the Doppler-mode controls work “Advanced Operations” properly manual, section “Image Optimization and Annotation” 5 Verify that the ECG-mode controls work “Advanced Operations” properly manual, section “Image Optimization and Annotation” 6 Verify the basic operation of all optional Advanced operations and licenses optional manual 7 Save exams on CD/DVD and verify that the burner works properly 8 Save exams on USB medium and verify that they are saved properly 9 If necessary make a backup of all clinical and system settings and store them. 10 If necessary make a backup of the archive. 11 Check the functionality of connected peripherals. 61 350032600_03

[Page 66] 5.3 Cleanliness of product In accordance to international standard ISO 13485 2016 3rd edition, products must be delivered clean after installation or maintenance. Please consider that your customer has purchased an excellent High-Quality Ultrasound system with a modern design. The visual impression of the system is equally important to your customer’s satisfaction For that reason, the system must be delivered clean when installing a new system or after performing maintenance to a system. After system installation or maintenance use a mild cleaner to: • Clean any fingerprints off the LCD and Touch Screen • Clean any fingerprints off the system, trolley or roll stand. • Clean any fingerprints off the probes Clean the area of the system, dispose of empty cartons or other packing material. For more information on cleaning and maintenance refer to: User manual: GETTING STARTED, section Maintenance PROBES CONSUMABLES 62 350032600_03

[Page 67] Chapter 6 SERVICE INFORMATION 6.1 Service menu To activate the service menu, the unit must be started with the service key connected. The unit will start in Windows mode. Now double click the Workflow icon to start the MyLab software. Press MENU and select the SERVICE tab, then select the SERVICE button. Note: The screen layout may vary, depending on Software version. The system displays the service menu with the following options: • Language settings • Monitor field • Maintenance • Set AC filter frequency • Show/hide frame rate on RT images • Show/hide system logo • Enable/disable firewall • Show/hide patient birthdate • Show/hide operator initials on header • Enable/disable WiFi • Screen saver time out Pressing SAVE will save and activate the settings. CANCEL will exit the menu without saving. 63 350032600_03

[Page 68] 6.1.1 Language settings This field selects the default language that can be selected from the available ones in the dropdown menu. 6.1.2 Monitor field In the MONITOR field, the monitor can be selected when the Disable Monitor Auto Detection box is checked. A recognizable monitor will be detected when this box is not active and can then be controlled via the Touch screen. 6.1.3 Maintenance In the maintenance field the Service Reminder Message can be enabled. When enabled, the unit will display a reminder for Maintenance after 2000 working hours or 1 year, whichever comes first. In the Main Timer Reset field, the timer can be reset to zero. This must be done every service intervention. 6.1.4 Set AC filter frequency According to the mains frequency used in the country, the AC filter for the ECG signal must be selected. This is the filter that removes the mains frequency interference from the ECG signal. 6.1.5 Show/hide frame rate on RT images When enabled, the frame rate is displayed on the bottom right side of the image. 6.1.6 Show/hide system logo This option will show or hide the system logo 6.1.7 Enable/disable firewall When checked, the firewall installed in the system is active. 6.1.8 Show/hide patient birthdate When enabled, the patient birthdate is displayed in the heading area of the screen and of the report instead of the patient age. 6.1.9 Show/hide operator initials on header When enabled, the operator initials are displayed in the heading area of the screen and of the report. 6.1.10 Enable/disable WiFi This option allows to enable/disable the Wi-Fi capability. 64 350032600_03

[Page 69] 6.1.11 Screen saver time out This option allows to set the timeout (in minutes) after which the screensaver is automatically activated NOTE If a too long timeout (higher than 2 hours) is set, sticking effect could be displayed on the screen. Always reset this parameter at least to the factory default (that is 61 minutes) whenever it has been increased for Service purposes. 6.2 Licenses When the system is initialized with the service key inserted, the “LICENCES” option of the MENU key allows the operator to disable active licenses and to activate or to reset a demo license. Place the cursor on the “LICENCES” option and press ENTER to confirm. The system displays the following window: The time left for demo license is expressed in minutes. It is decremented every fifteen (15) minutes Disabling Active License Both “applications” and “options” licenses can be disabled. To de-activate a license, position the cursor on the corresponding box and uncheck it by pressing ENTER. Press SAVE to confirm. Demo License Demo licenses last five hundreds (500) working hours before expiring. Reset Demo license On the “Reset Demo” tab a special reset demo license can be entered. This will reset all Demo licenses back to 500 hours. 65 350032600_03

[Page 70] Model The model tab shows the system model and the system license is entered here. The system license has to be entered after a unit format. The serial number can be entered in the serial number field. 6.3 Software installation Requisites - USB memory drive (USB 3.0 recommended). - Service Key P/N 140009500 Preparation 1. Download the SW release file from ownCloud. (link via E-portal) 2. If required, the download can be checked for correctness with the program: Total Commander. Open the .ZIP file and open the x440 folder Open the file SWPACK.MD5 with Total Commander and check for errors. Continue when there are 0 errors. 3. Format the USB key to avoid virus infection 4. Open the .ZiP file and open folder x440. 5. Extract the folder SWPACK to the root of the USB pen drive. Do not change the name of this folder or its content. Installation procedure 1. With the service key inserted, turn on the system. 2. The system will start up in Windows mode. 3. Connect the USB pen drive that contains the Software pack to one of the USB slots. To speed up the update, it is recommended to use the USB 3.0 slots on the side of the unit. 4. With Windows File Explorer navigate to the USB pen drive and open it. 5. Open the SWPACK folder 6. Double click the SETUP.exe to start the update process. 7. A message will pop up to make sure the unit is connected to the mains. Click OK to continue. 8. Follow on-screen instructions. 66 350032600_03

[Page 71] 9. The following message is shown. At this point the USB pen drive can be disconnected. 10. Click “OK, continue” to continue. 11. After several automatic reboots, the unit will end in Windows 10 desktop mode. 12. Double click the WORKFLOW icon to start the MyLab software and finish the Firmware installation. NOTE: Do not open the MONITOR icon. This may cause malfunction of the unit and is used for production purpose only. 13. Remove the USB pen drive, if not already done, and remove the Service key. 14. Shut down the system and start up again. 6.4 Formatting the Hard drive The format procedure will erase the HDD completely, partition the disc and install the software. The procedure is done is several steps: • Saving unit settings • Format procedure • System re-configuration NOTE : before starting the Formatting of the Hard disk, make sure that all system licenses are available. Without the Model license the procedure cannot be completed. License codes can be found in the LOG files. See 6.6 Log Files , page 74 . 67 350032600_03

[Page 72] 6.4.1 Saving unit settings NOTE: DO NOT transfer these settings to another system. Save Settings through the Export Procedure • Press the MENU key. • Select the “Import/Export” option. • Export the desired settings. Save Archive through its Menu • Press the ARCHIVE key. • Select the desired exams and export them in native format to the external medium. NOTE: in case the MyLab software is not running, it might be possible to copy the folders with the settings and Archive in the Windows environment when starting up with the service key connected. Copy Configuration and Archive folder • Open folder and select drive E:\Work • Copy Archive and ConFSet folder to USB medium 68 350032600_03

[Page 73] 6.4.2 Format procedure Requisites • USB memory drive, Min 32GB. • USB keyboard • Service Key P/N 140009500 Preparation 1. Download the file Format file (formatx4xx.iso) and program Rufus 2.9 from ownCloud. 2. Create bootable USB memory drive. a) Connect USB memory drive to PC b) Run the program rufus.exe. NOTE: DO NOT update when asked. c) Set the Rufus fields as indicated below: 1) Select USB drive 5) Enter Volume label “WinPE” 2) Press to see 3) Select the all the options [build].iso file 4) un-check 6) Start Process Click START to continue. 69 350032600_03

[Page 74] 3. A warning will be displayed: Click OK to continue. 4. When DONE, click CLOSE 5. A bootable USB memory drive, with HDD image is created. 6. Unit installation a) Connect the bootable USB memory drive and Service key to the MyLab unit. b) Start up the unit Note: In case the unit will not boot from the USB memory drive, the BIOS setting must be adapted: DO NOT change any other setting. Press ESC on the keyboard, while starting up. Password: Fireball Select: Boot menu; Boot Type Order; select USB at first position Save and exit with YES. 70 350032600_03

[Page 75] c. The Model selection screen is displayed Select model 6400 for MyLabX6/X7 d. Click OK after the operation is completed e. Click EXIT and then the following screen is displayed: f. Remove the bootable USB memory drive and restart with the Service key inserted. g. Double click the WORKFLOW icon to start the MyLab software 71 350032600_03

[Page 76] h. Enter system license and optional licenses: a. Press the MENU key and select the License key. b. Select the MODEL tab and enter the System license in the appropriate field. c. Type the unit serial number in the serial number field. d. Press VERIFY and then SAFE. e. Restart and enter all optional licenses. f. Press Verify and then SAFE. 6.4.3 System reconfiguration Requisites • Service key P/N 140009500 • Medium containing the copy of the “Archive” and “ConfSet” folders of the original settings or as an alternative a copy of the clinical and system settings obtained via the “import/export” option in the MENU. • All system licenses 1. System reconfiguration • Switch the unit on with the service key inserted. • Double click the Workflow icon to start the MyLab software and press the MENU key. • If necessary, select “GENERAL SET UP” option and set the local time. • Select the “LICENCES” option and: o First enter the model and system serial number (MODEL tab). Press VERIFY and then SAVE. o Then insert all the license codes. Press VERIFY and then SAVE. • If necessary, install the printer. (Refer to the Getting Started manual) • If necessary, set the printer configuration (“PRINTERS” option). • If required, re-store the archive. Depending on how the archive had been saved, follow the corresponding procedure: Archive Saved through its Menu • Press the ARCHIVE key. • Select the external medium containing the archive. • Select the desired exams and export them from the external medium in native format into the local archive. Archive Saved by Copying the “Archive” Folder • Copy Archive folder from USB medium • Open folder and select drive E:\Work and paste the Archive folder 72 350032600_03

[Page 77] 2. Settings installation • Depending on how the settings had been saved, follow the corresponding procedure: NOTE When the settings are not saved nor exported, the settings must be set manually. Settings Saved through the Export Procedure • Press the MENU key. • Select the “Import/Export” option. • Import the desired settings. Settings Saved by Copying the “ConfSet” Folder • Copy ConFSet folder from USB medium • Open folder and select drive E:\Work and paste the ConFSet folder NOTE: When ready, set the startup priority back to HDD/SSD. 6.5 Rack replacement Whenever the rack has been replaced, both the ID button and, when possible, the hard disk have to be installed. NOTE All the system’s licenses are correlated to the ID button. Procedure • Remove the ID button from the fault rack • Install the ID button on the new rack. • Remove the hard disk from the faulty rack. • Install the hard disk on the new rack. • Install the rack and close the system. The rack has to be packaged in its original box to prevent its damage: refer to 1.4 Packaging for details. 73 350032600_03

[Page 78] 6.6 Log Files The log file has to be saved soon after the problem occurs or, at the latest, at the next start up. The file has a FIFO structure with a limited memory availability: When the log file memory is full, the oldest events registered in the file are eliminated to free space for the recent ones. For this reason the log file has to be saved as soon as possible. 6.6.1 Log Files Organization The zip of log files (and the “Logs” folder) contains the following file and folders: • LogParser executable file that allows to analyze the log contents. • TextLog folder that contains the list of the entries done on the system. • LogInstallMS folder that traces the updates done on the system. • Dump folder. 6.6.2 LogParser Executable This file allows the technician to look at the log files for a first error analysis. To launch the executable, place the cursor on it and press the ENTER key twice. This utility can be run both directly in the system and in any PC having the following operating systems: • Windows XP Home • Windows XP Professional • Windows Vista • Windows 7 • Windows 10 LogParser 74 350032600_03

[Page 79] The utility is organized in four main areas. TextLog Folder The TextLog folder, containing the log files, is displayed in the upper left area (indicated by the number “1” in the above figure). Place the cursor on the “+” symbol displayed beside the name and press ENTER to display its contents. This folder contains the list of all entries done on the system that is the list of all times the unit has been switched on. Each entry is so listed: date[yyyy-mm-dd] time [hh:mm:ss] - date[yyyy-mm-dd] time [hh:mm:ss] The first date and time indicate when the unit has been turned on; the second date and time when the unit has been turned off. When an entry is selected, the areas “2” and “3” show the logged information related to this entry. In the left bottom area (“2”) the following system information is listed: • model name • installed licences and the corresponding licence numbers • installed build • the ID button number • hardware characteristics In the main area (“3”) the list of the operations logged for the selected entry is displayed. The three buttons displayed at the bottom of the area “3” allow to change the zoom factor (buttons “-” and “+”) and to refresh the log of the operations. Each logged operation is listed in this format: date time [Software component][log group] logged operation Criteria for displaying the logs Displaying criteria can be selected from the upper left and right lists. The upper left list contains all the system software components; the upper right list contains logic log groups with which the list of logged operations can be organized for an easiest analysis. Place the cursor on the desired element of one of the lists to display the related logs. It is possible to do a double selection that is selecting both the software component and the logic log group. In this case the system displays all logged operations satisfying both criteria. 75 350032600_03

[Page 80] 6.6.3 User Session Whenever the log has to be analyzed, the simplest way is to follow the procedure: • Expand the TextLog folder. • Select the entry to be analyzed. • Select in the right combo box the UserSession option. The logged operations are displayed in chronological order, showing the operations done by the user. The main phases of the exam are clearly indicated by data delimiters, like: • ---StartExam.xml--- and ---EndExam.xml--- between which all exam operations are listed. • ---RT.xml--- that marks the operations done in real time and in freeze. • ---WorksheetComponent.xml--- and ---ReportViewer.xml--- that respectively indicate when the WORKSHEET and the REPORT buttons have been pressed. When an error occurs the delimiters allow to identify in which phase happens. 76 350032600_03

[Page 81] Logged Errors The errors are reported in the upper right list, as shown in the figure below. The error log group displays all the errors occurred in the system. 77 350032600_03

[Page 82] 6.7 Remote Service The “Remote Service” option of the MENU key allows the Service personnel to access to MyLab in remote. When the Remote Service is active, the Service personnel can remotely interact with the user and with the system looking at its screen and at its disks. Pre Conditions The access to the Remote Service is possible only when: • MyLab system is connected to the network (refer to the user manuals for further information) • the Service personnel has a PC connected to the network • the Service personnel has an Esaote account for Remote Service • the Service personnel has an account to work with the LogMeIn Rescue application (either via Web or locally) NOTE: Contact the Esaote Service department for accounts and further information on Remote Service To activate the Remote Service session, the Service personnel has to provide the customer with two PIN numbers. The PINs can be used one time only. NOTE: The “Clinical and System Configuration” section of the Advanced Operations manual has a dedicated chapter on Remote Service, to guide the user to the activation. 78 350032600_03

[Page 83] Chapter 7 SAFETY TEST Every MyLab unit complies with EN60601-1 (IEC 60601-1) standard. The MyLab units are Class I Type B and BF (Ultrasound probe) and CF (ECG) applied parts. It is mandatory to perform Safety Tests every time new peripherals are powered through the cart or you had to replace any of the following parts: • Boards Rack • Power Supply • Mains entry • Mains cable • Isolation transformer • Probe adapter board Anyway we suggest repeating the safety tests every two years. If the system is used in the Intensive or Coronary Care, we suggest repeating the safety tests once a year. WARNING Whenever the measured values exceed the reference ones (see the following table) don’t use the unit and send it to ESAOTE The parameters to be tested are the following: • Impedance of Protective Earth Connection • Earth Leakage Current • Enclosure Leakage Current • Touch Current • Patient Leakage Current • Total Patient Leakage Current • Patient Auxiliary Current 7.1 Safety measurements according IEC 62353 For measurements of this standard, only use measurement equipment complying with IEC 62353 Annex C.1 Applicability The standard IEC 62353 ed. 2 is applicable for Recurrent test and test after repair of medical electrical equipment. All MAINTENANCE, INSPECTION, SERVICING, and REPAIR done in accordance with MANUFACTURER's instructions maintain the conformity to the standard used for the design of the equipment. Electrical Safety Test on MyLab devices 79 350032600_03

[Page 84] Aim of this Technical Note is to highlight the importance of the Electrical Safety Tests and provide the necessary instruction to properly execute them. Electrical Safety Tests certify that the risks of electric shocks for patient and operator are minimized. The verification of electrical safety is an extremely important step for recurrent test and test after repair of medical electrical equipment and during the installation process. The results of the electrical safety verification must be annotated in the “TEST CERTIFICATE AND VERIFICATION FORM”. All MyLab units comply with the requirements of EN60601-1 (IEC 60601-1) Medical Electrical Equipment standard. All MyLab systems are Class I, using applied parts being Type B and BF (ultrasound probes) and CF (ECG, when available). It is mandatory to perform Electrical Safety Tests in all the following cases: 1. every time the transducer is dropped; 2. every time a new peripheral is powered through the unit/cart; 3. every time you had to replace any of the following parts related to: a Mains Power: ASB board, AC/DC converter, mains and/or power boards, mains cables, insulation transformer. b Activities that involve substitution or temporary disconnection of ground able and/or metal parts being part of Protective earth (PE) protection c (Enhanced) ECG Board/back-end board, ECG cable d Power Supply Plug 4. repeat the safety test when replacing the parts indicated in the service manual 5. when a used MyLab is installed by Esaote to a different customer /clinical site It is mandatory to perform the Electrical Safety Tests every two years, once a year in the Intensive or Coronary Care. In case local/hospital directives are more restrictive, it is mandatory to comply with their directives. Whenever the measured values exceed the reference ones indicated in Limits table on page Error! Bookmark not defined. : DO NOT USE the unit and contact Esaote Technical Assistance. 80 350032600_03

[Page 85] The parameters to be tested are the following: • Protective Conductor Impedance (P.E.) • Equipment Leakage Current • Applied Part Leakage Current This section defines safety Parameters and their range according to EN62353 standard and describes the Electrical Safety Tests to be carried out on the equipment. Definitions 1) Protective Conductor Impedance (P.E.) The impedance between the Protective Earth (PE) terminal of the mains input connector and any accessible metal part Protectively Earthed 2) Equipment Leakage Current. NOTE: IEC 62353 also identifies total current flowing from Main Parts to earth 3) Patient Leakage Current The current that flows through the Patient, from the applied parts (ECG and US probe) and the Earth The list of the parameters to be checked is indicated inside the related service manual, so please check them according the unit under control. MyLab safety test - Operating Procedures Regularly perform the Electrical Safety Tests to ensure that IEC 62353 Type CF leakage limits are not exceeded. You can perform this procedure with any commercially available safety analyzer that is designed for hospital use. NOTE Rigel 62353 doesn’t perform IEC 60601 tests, it is designed for IEC 62353 tests: All MAINTENANCE, INSPECTION, SERVICING, and REPAIR done in accordance with MANUFACTURER's instructions maintain the conformity to the standard used for the design of the equipment. NOTE The test must be carried out by skilled personnel using equipment compliant with the reference standard indicated. Esaote prescribes the use of the automatic RIGEL 62353+ equipment. Tools Tool Dimension RIGEL 62353+ 270 x 110 x 75 mm Metal foil maximum size 20 x 20 cm 81 350032600_03

[Page 86] The procedure described below refers to the RIGEL 62353+ measurement device. NOTE Before proceeding with the safety test, be sure of the test equipment calibration. Test set-up procedure Power the automatic testing equipment through mains supply and the equipment under test through the automatic equipment, as shown in the figure on the next page. Rigel 62353+ 1) Alpha Numeric keyboard, Up / Down and Left / Right cursor control. 2) 4 Programmable soft keys below display 3) Larger Green and Red key 4) Full graphic Monochrone LCD, blue with white backlit, 1/4 VGA 5) EUT socket to meet local requirements 6) IEC input socket (IEC lead test) 7) Custom detachable mains cable inlet 8) 2 way Applied Part adapter box 9) 4mm Earth bond probe socket (Black) 10) 4 mm Earth bond Auxiliary socket (Green) 11) RS232 connection 82 350032600_03

[Page 87] Note: Probe placed in container with 0.9 saline solution. The ECG cable must be connected to the MyLab ECG connector (if present) and the Applied Parts terminals in the automatic equipment (see above). Set the automatic equipment according to its user manual in order to perform a Class I, Type CF equipment test. 83 350032600_03

[Page 88] Test procedure Measurement of the Protective Conductor Impedance (P.E.) 1) • Connect the test lead to MyLab equipotential node. Connect the test lead to the farthest protectively earthed metal point. • Activate the procedure for measuring the Impedance of Protective Earth on the automatic equipment. • Check that the value indicated complies with the indications given in the reference table for normal condition (NC). Please see below for worst case reference points and reference values. EUT Location Measured value in CB report MyLab Screw on monitor code 150000027 40 mΩ If the measured value is higher than the value indicated above, do not use the equipment and contact Esaote Technical Assistance. If the measured value shows more than 50% difference than the value, check test setup. Measurement of the Equipment Leakage Current In all the conditions in which it is necessary power on the MyLab system press the pause key immediately after the power on button in order to avoid the Widows start up. This operation is very important in order to avoid data loss and hard disk damages. Measuring of Leakage currents In CLASS I ME EQUIPMENT, like MyLab systems of Esaote, a leakage current measurement may only be performed after the protective conductor impedance testing has been passed. • Activate the procedure for measuring the Equipment leakage current on the automatic equipment: 1. Check that the value indicated complies with the indications given in the reference table for normal condition (NC). 2. Repeat the above measurement procedures inverting the polarity of the power conductors, by means of the automatic equipment If any measured value is higher than the value in the table, do not use the equipment and replace the power cable. Repeat the procedure with the new cable and if the values continue to be higher, contact Esaote Technical Assistance. 84 350032600_03

[Page 89] Measurement of the Patient Leakage Current (ECG cable when ECG is available) • Insert the ECG cable leads in the applied parts terminals in the automatic equipment. • When testing ME EQUIPMENT with multiple Applied Parts, connect them each in turn and comply with the applicable limits in Table 2. Applied Parts not part of the measurement shall be floating. 1. Activate the procedure simulating the application of the mains voltage, by means of the automatic equipment, to the plugs on the patient cable and check that the value indicated complies with the indication given in the reference table for the single fault condition (SFC). • Repeat the above measurement procedures inverting the polarity of the power equipment and replace the ECG patient cable. Repeat the procedure with the new cable and if the values continue to be higher, contact Esaote Technical Assistance. Probe safety tests For any probe in use with the unit, repeat the procedure for measuring the Patient Leakage Current test (without application of mains voltage on applied part), wrapping the probe enclosure with the metal foil and connecting the test lead to it. The test must be performed in any Real Time mode application. The probe must be connected to the unit • Activate the procedure for measuring the Patient leakage current on the automatic equipment and check that the value indicated complies with the indications given in the reference table for the normal condition (NC). 1. Repeat the procedure simulating a break in the earth wire, by means of the 2. Repeat the procedure simulating a break in a power conductor, by means of the automatic equipment, and check that the value indicated complies with the indications given in the reference table for the single fault condition 3. Repeat the above measurement procedures inverting the polarity of the power conductors, by means of the automatic equipment. If any of the measured values are higher than the value in the table below, do not use the probe and contact Esaote Technical Assistance. 85 350032600_03

[Page 90] 7.1.1 Limits Table LIMITS CEI EN 62353 SAFETY EARTH CONDUCTOR MAX Single unit with separable cable ≤0,3Ω EM system with multiple socket and separable cable ≤0,5Ω DISTRIBUTION CURVE DIRECT METHOD MEASUREMENT CONDITIONS TYPE TYPE TYPE B BF CF ME Classe I 500 μA 500 μA 500 μA ME Classe II 100 μA 100 μA 100 μA --- Mains on Applied part for Class I and 2 5000 μA 50 μA WARNING Any break in the probe case or in the probe cable can cause an electrical hazard. Do not use the probe and contact Esaote Technical Assistance. 86 350032600_03

[Page 91] TEST CERTIFICATE AND VERIFICATION ACCORDANCE WITH CEI EN 62353 STANDARD SYSTEM DATA UNIT UNDER TEST DESCRIPTION: □ EM System □ EM Device □ Peripheral M ODEL : _________________________ S/N: _______________________ US T RANSDUCER IS ACTIVE DURING TEST : YES □ NO □ ECG I NPUT IS ACTIVE DURING TEST : YES □ NO □ A CTIVE US T RANSDUCER DATA : Model: ________________ S/N: __________________ TEST SUMMARY TEST DESCRIPTION, REFERENCES AND NOTES MEASURED VALUE TEST RESULT WITH DIRECT METHOD LIMITS: V ISUAL C HECK R ESULT : --- □ OK □ Failed ( External visual check and label check ) P ROTECTIVE C ONDUCTOR I MPEDANCE (P.E.): Detachable cable systems Detachable cable devices Max _______ [mΩ] □ OK □ Failed Test current: □ 0,2A □ 1A □ 10A □ 25A E QUIPMENT L EAKAGE C URRENT : Class I 500 [μA] Class II 100 [μA] Max _______ [μA] □ OK □ Failed Class: □ I □ II P ATIENT L EAKAGE C URRENT SFC, M AINS POWERED , (A PPLIED P ART L EAKAGE C URRENT ) AP: US T RANSDUCER : Max _______ [μA] BF Type 5000[μA] □ OK □ Failed CF Type 50[μA] AP Type: □ BF □ CF P ATIENT L EAKAGE C URRENT SFC, M AINS POWERED , (A PPLIED P ART L EAKAGE C URRENT ) AP: ECG I NPUT : Max _______ [μA] BF Type 5000[μA] □ OK □ Failed CF Type 50[μA] AP Type: □ BF □ CF F UNCTIONAL F INAL T EST R ESULT : --- □ OK □ Failed P.E. CONNECTION IN CASE OF MAXIMUM MEASURED VALUE □ POWER PLUG / US MACHINE FRAME □ OTHER: __________________________________________________________________________ □ POWER PLUG / CART FRAME OVERALL ASSESSMENT □ N O FUNCTIONAL DEFECTS OR DEFICIENCIES ABOUT SAFETY WERE FOUND . □ T HE DEVICE IS NOT COMPLIANT WITH THE SAFETY OR FUNCTIONAL REQUIREMENTS . T HE REPAIR OR REPLACEMENT OF THE LACKING ELEMENTS IS REQUIRED . R ECOMMENDED FREQUENCY OF TEST : □ 12 MONTHS □ 24 MONTHS MEASURING INSTRUMENTS AND AUDITOR S AFETY TESTER DATA : Model: _______________ S/N: __________________ A UDITOR NAME : ______________________________ D ATE : _______________ 24 S IGNATURE : ________________________ 87 350032600_03

[Page 92] 7.2 Safety measurements according IEC 60601-1 The parameters to be tested are the following: • Impedance of Protective Earth Connection • Earth Leakage Current • Enclosure Leakage Current • Patient Leakage Current • Patient Auxiliary Current This chapter defines safety Parameters and their range according to EN60601-1 standard and describes the safety tests to be carried out on the equipment. Definitions 1) Impedance of Protective Earth Connection The impedance between the Protective Earth (PE) terminal of the mains input connector and any accessible metal part. 2) Earth Leakage Current The current that flows from the mains terminals (P=Phase, N=Neutral) to the Protective Earth (PE) through the insulation. 3) Enclosure Leakage Current The current that flows between the enclosure and the Protective Earth (PE) terminal. 4) Patient Leakage Current The current that flows through the applied parts (ECG and US probe) towards the Protective Earth (PE). 5) Patient Auxiliary Current The current that flows between two different applied parts (for instance between two ECG electrodes). The table below provides the user with a list of the parameters to be checked, the maximum values and references to the IEC 60601-1 standard (1988), II Edition. Parameter Max Value N.C. Max Value S.F.C. EN 60601-1 Impedance of protective 0.2  - 18.f earth connection (with Mains Power cable) Earth leakage current 0.5 mA 1 mA 19.4.f Enclosure leakage 0.1 mA 0.5 mA 19.4.g current Patient leakage current CF 0.01 mA ac CF 0.05 mA ac 19.4.h B/BF 0.1 mA ac B/BF 0.5 mA ac Patient leakage current - CF 0.05 mA 19.4 h (mains on applied part) BF 0.5 mA Patient auxiliary current CF 0.01 mA CF 0.05mA 19.4.j B/BF 0.1 mA B/BF 0.5 mA N.C. Normal Condition S.F.C. Single Fault Condition 88 350032600_03

[Page 93] Note The test must be carried out by skilled personnel using equipment compliant with the reference standard indicated. ESAOTE recommends the use of the automatic BIO- TEK 601-PRO equipment manufactured by BIO-TEK Instruments INC. (www.biomedequip.com) or equivalent equipment. MyLab safety test - Operating Procedures Tool Dimension BIOTEK 601 Pro or equivalent - Metal foil maximum size 20 x 10 cm Note Before proceeding with the safety test, be sure of the equipment calibration. Procedure • Power the automatic testing equipment through mains supply and the equipment under test through the automatic equipment, as shown below. • The ECG cable must be connected to the unit’s ECG connector (if present) and the applied parts terminals in the automatic equipment (see Fig.1). • Set the automatic equipment according to its user manual in order to perform a Class I, Type CF equipment test. Measurement of the Impedance of Protective Earth connection • Connect the test lead to unit’s equipotential node. • Activate the procedure for measuring the Impedance of Protective Earth on the automatic equipment. • Check that the value indicated complies with the indications given in the reference table for normal condition (NC). If the measured value is higher than the value in the table, do not use the equipment and send to ESAOTE. 89 350032600_03

[Page 94] Measurement of Earth leakage current In all the conditions in which it is necessary power on the MyLab system press the pause key immediately after the power on button in order to avoid the Windows start up. This operation is very important in order to avoid data loss and hard disk damages. • Activate the procedure for measuring the earth leakage current on the automatic equipment: 1.1 Check that the value indicated complies with the indications given in the reference table for normal condition (NC). 1.2 Repeat the procedure simulating a break in a power conductor, by means of the automatic equipment, and check that the value indicated complies with • Repeat the above measurement procedures inverting the polarity of the power conductors, by means of the automatic equipment If any measured value is higher than the value in the table, do not use the equipment and replace the power cable. Repeat the procedure with the new cable and if the values continue to be higher, send the equipment to ESAOTE. Measurement the Enclosure Leakage Current In all the conditions in which it is necessary power on the MyLab system press the pause key immediately after the power on button in order to avoid the Windows start up. This operation is very important in order to avoid data loss and hard disk damages. • Connect the test lead to the metal foil. 1.1 Place the metal foil in close contact with the unit and activate the procedure for measuring the enclosure leakage current on the automatic equipment; varying the foil position, check that the value indicated complies with the indications given in the reference table for the normal condition (NC) • Repeat the above measurement procedures inverting the polarity of the power equipment and send it to ESAOTE. 90 350032600_03

[Page 95] Measurement the Patient Leakage Current (ECG cable) • Insert the ECG cable leads in the applied parts terminals in the automatic equipment. 1.1 Activate the procedure for measuring the Patient leakage current on the automatic equipment and check that the value indicated complies with the indications given in the reference table for the normal condition (NC). 1.4 Repeat the procedure simulating the application of the mains voltage, by means of the automatic equipment, to the plugs on the patient cable and check that the value indicated complies with the indication given in the reference table for the single fault condition (SFC). • Repeat the above measurement procedures inverting the polarity of the power • If any of the measured values are higher than the value in the table, do not use the equipment and replace the ECG patient cable. Repeat the procedure with the new cable and if the values continue to be higher, send the equipment to ESAOTE. Measurement the Patient Auxiliary Current • Activate the procedure for measuring the patient auxiliary current on the automatic equipment and check that the value indicated complies with the indications given in the reference table for the normal condition (NC). • Repeat the procedure simulating a break in the earth wire, by means of the • Repeat the procedure simulating a break in a power conductor, by means of the • Repeat the above measurement procedures inverting the polarity of the power equipment and replace the ECG patient cable. Repeat the procedure with the new cable and if the values continue to be higher, send the equipment to ESAOTE. WARNING: The defective patient cable or power cable must not be used 91 350032600_03

[Page 96] Probe safety tests For any probe in use with the unit, repeat the procedure for measuring the Patient Leakage Current test (without application of mains voltage on applied part), wrapping the probe enclosure with the metal foil and connecting the test lead to it. The test must be performed in any Real Time mode application. The probe must be connected to the unit 1.1 Activate the procedure for measuring the Patient leakage current on the automatic equipment and check that the value indicated complies with the indications given in the reference table for the normal condition (NC). Repeat the above measurement procedures inverting the polarity of the power probe and send it to ESAOTE. WARNING Any break in the probe case or in the probe cable can cause an electrical hazard. Do not use the probe and send it back to ESAOTE for repair. 92 350032600_03