Service Manual

MyLabX6
MyLabX7
MyLabX7VET
350032600
www.esaote.com

Rev. 03
Feb 2019
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.
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
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
 1
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.

CAUTION
The word CAUTION describes the precautions necessary for protecting the
equipment.

1 350032600_03
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
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
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
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.

CAUTION
The system could be damaged during transportation if the above rules are not
strictly followed.

5 350032600_03
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
 2
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
2.1 General Block Diagram

8 350032600_03
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
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
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
 3
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.

CAUTION
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
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

Removal Procedure
• 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.

CAUTION
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
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
Friction level adjustment

• Reassemble the arm.

Articulated Arm

Removal Procedure
• 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
 • 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
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

Removal Procedure
• 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.

• Remove the keyboard unit.

CAUTION
When assembling the keyboard unit pay attention not to bend the SCSI cable.

Keyboard unit lower cover

Removal Procedure
• 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
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
3.2.2 Side Rails

Removal Procedure Left Handle

• If necessary, remove the holders.
• Remove the keyboard unit.
• Remove the 2 Philips screws that fix the handle to the chassis.

Left Side Handle

• Remove the handle.

19 350032600_03
Removal Procedure Front/Right Handle
• If necessary, remove the holders.
• Remove the keyboard unit.
• 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
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

Removal Procedure
• 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

Removal Procedure
• 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
Rear cover

Removal Procedure
• 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

Removal Procedure
• Open the rear door.
• Remove the 6 screws that fix the cover to the chassis.
• Remove the cover

Probe connector cover

Removal Procedure
• Open the rear door.
• Remove the 6 screws that fix the cover to the chassis.
• Remove the cover

22 350032600_03
Front cover

Removal Procedure
• Remove the probe connector 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

Removal Procedure
• Remove the probe connector cover.
• Remove the front cover
• Remove the 2 Philips screws that fix the wheel cover to the chassis.

23 350032600_03
Right cover

Removal Procedure
• Remove the probe connector cover.
• Remove the front 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
Left cover

Removal Procedure
• Remove the probe connector cover.
• Remove the front 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
Batteries

Removal Procedure
• Remove the probe connector cover
• Remove the front 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.

CAUTION
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.

Removal Procedure
• 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
3.3.1 Chassis section, internal parts

CAUTION
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

Removal Procedure
• Remove the probe connector cover.
• Remove the front cover.
• 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
Removal Procedure
• 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
• 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
• 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
Boards Rack

Removal Procedure
• Remove the probe connector cover
• If the unit is equipped with batteries, remove the batteries.
• Remove the front cover.
• 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
 • 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
Removal Procedure
• 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.

CAUTION
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
Rack fans

Removal Procedure
• 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
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
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
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
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
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
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
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
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
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
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
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
e) Place the 8 pcs M3 x 8 screws to fix the Back End Board

46 350032600_03
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
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
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
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
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
 4
Chapter

4 PARTS LIST
Boards & Groups for: TRC a ESD b
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
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
Parts list for advanced service

TRC a ESD b

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

a Traceability by serial number (S/N)

b Electrostatic discharge
c Remind to carry out the safety tests whenever this part has been replaced

(see chapter 7 SAFETY TEST, page 79)

54 350032600_03
 5
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
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
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)

CAUTION
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.

CAUTION
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
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.

CAUTION
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
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:

Step Tool See section

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
3
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
5.2.2 Maintenance Check List

Physical check

Step Tool See section

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

Step Tool See section

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
Functional Check

Step Tool See section

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
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
 6
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
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
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
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
 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
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

• Start up with the service key connected, to start up in Windows mode

• Press the UNDO key and create a new folder.
• Open folder and select drive E:\Work
• Copy Archive and ConFSet folder to USB medium
• Delete New Folder

68 350032600_03
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
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
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
 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

• Start up with the service key connected, to start up in Windows mode
• Press the UNDO key and create a new folder.
• Copy Archive folder from USB medium
• Open folder and select drive E:\Work and paste the Archive folder
• Delete New Folder

72 350032600_03
 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

• Start up with the service key connected, to start up in Windows mode
• Press the UNDO key and create a new folder.
• Copy ConFSet folder from USB medium
• Open folder and select drive E:\Work and paste the ConFSet folder
• Delete New 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.

CAUTION
The rack has to be packaged in its original box to prevent its damage: refer to
1.4 Packaging for details.

73 350032600_03
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
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
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
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
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
 7
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
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
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
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
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
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

CAUTION
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
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
conductors, by means of the automatic equipment.

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, 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
automatic equipment, and check that the value indicated complies with the
indications given in the reference table for the single fault condition (SFC).
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
(SFC).
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
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
 TEST CERTIFICATE AND VERIFICATION ACCORDANCE WITH CEI EN 62353 STANDARD

SYSTEM DATA
UNIT UNDER TEST DESCRIPTION: □ EM System □ EM Device □ Peripheral

MODEL: _________________________ S/N: _______________________

US TRANSDUCER IS ACTIVE DURING TEST : YES □ NO □ ECG INPUT IS ACTIVE DURING TEST : YES □ NO □
ACTIVE US TRANSDUCER DATA : Model: ________________ S/N: __________________

TEST SUMMARY
TEST DESCRIPTION, REFERENCES AND NOTES
MEASURED VALUE TEST RESULT
WITH DIRECT METHOD LIMITS:
VISUAL CHECK RESULT:
( External visual check and label check )
--- □ OK □ Failed
PROTECTIVE CONDUCTOR IMPEDANCE (P.E.):
Detachable cable systems
Detachable cable devices Max_______ [mΩ] □ OK □ Failed
Test current: □
0,2A 1A □ □ 10A □ 25A
EQUIPMENT LEAKAGE CURRENT:
Class I 500 [µA]
Class II 100 [µA] Max_______ [µA] □ OK □ Failed
Class: I□ II □
PATIENT LEAKAGE CURRENT SFC, MAINS POWERED ,
(APPLIED PART LEAKAGE CURRENT)
AP: US TRANSDUCER :
BF Type 5000[µA] Max_______ [µA] □ OK □ Failed
CF Type 50[µA]

AP Type: □
BF CF □
PATIENT LEAKAGE CURRENT SFC, MAINS POWERED ,
(APPLIED PART LEAKAGE CURRENT)
AP: ECG INPUT:
BF Type 5000[µA] Max_______ [µA] □ OK □ Failed
CF Type 50[µA]

AP Type: BF□ CF □
FUNCTIONAL FINAL TEST RESULT :
--- □ OK □ Failed
P.E. CONNECTION IN CASE OF MAXIMUM MEASURED VALUE
□ POWER PLUG / US MACHINE FRAME □ OTHER: __________________________________________________________________________

□ POWER PLUG / CART FRAME

OVERALL ASSESSMENT
□ NO FUNCTIONAL DEFECTS OR DEFICIENCIES ABOUT SAFETY WERE FOUND.
□ THE DEVICE IS NOT COMPLIANT WITH THE SAFETY OR FUNCTIONAL REQUIREMENTS.
T HE REPAIR OR REPLACEMENT OF THE LACKING ELEMENTS IS REQUIRED .
RECOMMENDED FREQUENCY OF TEST: □ 12 MONTHS □ 24 MONTHS

MEASURING INSTRUMENTS AND AUDITOR

SAFETY TESTER DATA : Model: _______________ S/N: __________________

AUDITOR NAME: ______________________________

DATE: _______________ 24 SIGNATURE : ________________________

87 350032600_03
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
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
Measurement of Earth leakage current

CAUTION
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
the indications given in the reference table for the single fault condition
(SFC).
• 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

CAUTION
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)
1.2 Repeat the procedure simulating a break in the earth wire, 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 (SFC).
1.3 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
(SFC).
• 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, do not use the
equipment and send it to ESAOTE.

90 350032600_03
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).
1.2 Repeat the procedure simulating a break in the earth wire, 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 (SFC).
1.3 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
(SFC).
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
conductors, by means of the automatic equipment.

• 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
automatic equipment, and check that the value indicated complies with the
indications given in the reference table for the single fault condition (SFC).

• 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 (SFC).

• 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, 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.

WARNING: The defective patient cable or power cable must not be used

91 350032600_03
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).

1.2 Repeat the procedure simulating a break in the earth wire, 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 (SFC).

1.3 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
(SFC).

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, do not use the
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