Service Manual

MyLab 9 Family
350015200
www.esaote.com

Rev. 03
Jan 2018
350015200_03
INDEX

1 INTRODUCTION ..............................................................................................................1
1.1 Service Characteristics .............................................................................................2
1.1.1 Identifying the Boards .......................................................................................2
1.1.2 Fuses ................................................................................................................2
1.2 Equipment ................................................................................................................3
1.2.1 Disassembling Equipment .................................................................................3
1.2.2 Service Procedures ...........................................................................................3
1.2.3 USB Medium .....................................................................................................4
1.2.4 Safety Test Equipment ......................................................................................4
1.3 Warnings and Precautions ........................................................................................5
2 BLOCK DIAGRAMS .........................................................................................................6
2.1 General Block Diagram .............................................................................................7
2.2 Input Probe Board (IPB) ............................................................................................9
2.3 Digital Front End Board (DFB) ..................................................................................9
2.4 Digital Processing Board (DPB) ..............................................................................10
2.5 Host Processing Module (HPM) ..............................................................................10
2.6 Main Keyboard........................................................................................................11
2.7 Power Supply Group ...............................................................................................11
2.8 Main Bus Board (MBB) ...........................................................................................11
2.9 Enhanced ECG Board ............................................................................................11
2.10 Electric and Schematic Diagrams ...........................................................................12
3 UNIT DISASSEMBLY .....................................................................................................13
3.1 LCD Monitor ...........................................................................................................13
3.2 Control panel ..........................................................................................................14
3.3 PCB access ............................................................................................................16
3.3.1 Input board and power supply removal............................................................21
4 PARTS LIST ...................................................................................................................28
5 MAINTENANCE .............................................................................................................36
5.1 Battery Cell .............................................................................................................36
5.2 Check list ................................................................................................................36
5.2.1 Technical Check List .......................................................................................36
5.2.2 Maintenance Check List ..................................................................................37
5.3 Trouble shooting .....................................................................................................38
5.3.1 DFB position ...................................................................................................38
5.3.2 Hard Ware issues............................................................................................39
5.3.3 Error messages ...............................................................................................42
5.3.4 Log files ..........................................................................................................44
6 SERVICE INFORMATION ..............................................................................................46
6.1 Service menu ..........................................................................................................46
6.2 Software installation/update ....................................................................................47
6.3 Format procedure ...................................................................................................49
7 SAFETY TEST ...............................................................................................................53
7.1 Safety measurements according IEC60601-1 .........................................................53
7.1.1 MyLab safety test - Operating Procedures ......................................................55
7.2 Safety measurements according IEC 62353 ...........................................................59
7.2.1 Limits Table.....................................................................................................65

350015200_03
350015200_03
 1
Chapter

1 INTRODUCTION
This manual refers to all MyLab 9 Family ultrasound models, named in the following
chapters as MyLab 9 Family. The term “MyLab 9 Family”, 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 9 Family 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 350015200_03
1.1 Service Characteristics

1.1.1 Identifying the Boards

MyLab 9 Family Families 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 9 Family Families 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.

In the boards not equipped with flap this information is on labels affixed on the
printed circuit.

1.1.2 Fuses

WARNING
Do not replace the system fuses with types different from those specified.

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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, page 13.

Tool Dimension
Dynamometric Phillips electric screwdriver Large, medium and
small tips
Short Philips screwdriver Small tip
Slotted 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.

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 the cart USB
ports (not at the control panel).

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.

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1.2.3 USB Medium
To perform a complete check of the unit, it is suggested to always have an USB
medium. These tools allow the service technician to test the functioning of the USB
ports.
USB medium is also required to export Log files and perform a software upgrade.
For the software upgrade a 16GB USB 3.0 key is recommended to increase the
speed. This key must be connected in one of the cart USB ports (not at the control
panel).

1.2.4 Safety Test Equipment

The safety test have to 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 53 in this manual for detailed information on when to
perform the tests and how to carry it out.

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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.
 When the unit is in Standby mode (main switch on, but unit off), the AUX
connectors are supplied with a voltage.
 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)

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 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 9 Family unit.

6 350015200_03
2.1 General Block Diagram
The probes are connected to the INPUT PROBE BOARD (IPB).
The board receives the HV pulses from the DIGITAL FRONT END BOARD (DFB).
Each DFB manages different channels and according the probe and preset selected,
they create the high voltage pulses necessary to the probe to create the US echo.
The US echo arriving from the probes, go to the Input Probe board that, without any
elaboration, sends the data to the two Digital Front End

7 350015200_03
The Input Probe Board, send to the DIGITAL PROCESSING BOARD (DPB) the
information about the probes connected to the unit.
In the two DFB the US echo pass through amplifiers and then are converted from
analogic to digital data. Then they go to the internal FPGAs for the image
reconstruction process.
The US data from the second DFB are sent to the first, where are mixed with the
internal ones. After this step the whole data are sent to the DPB.
The DPB receive all the US data and proceed with all the post processing
elaborations. As well from the US data creates the CFM and Doppler image (CW and
PW).The board has one interface to the ENHANCED ECG BOARD (EEB), to receive
the ECG signal to be displayed with the US image. The data go to the HOST
PROCESSING MODULE (HPM).
The DPB creates as well all the internal clocks necessary to the internal boards.
The DPB has as well one RF OUT, for the US unfiltered data.
The HPM receives the data and mix them to the overlay, then send all to the external
monitor.
It has a direct connection (by USB) to the QWERTY keyboard and touchscreen
group, to receive all the commands selected by the user and set the touch panel
according the modality enabled. As well send to the keyboard group all the audio
signals. In board there is an amplifier who drives the unit’s speakers.
In the Host Processing board, there is also the internal PC module, who manages the
internal HDDs (there are two, one SSD), network card, ram memories and USB
plugs. The PC module is able to receive from HDD all the SW necessary to the
various boards and, using one dedicated communication channel, send it to the
Digital Processing Board. This board sends the SW to the two Digital Front End, the
Input Probe and to the Switching Power Board.
The power supply section is composed by one insulation transformer for the auxiliary
plugs, one AC/DC module (who has inside one dedicated insulation transformer) that
receives the line voltage and then creates a 12Vdc. The 12Vdc is sent to the
SWITCHING POWER BOARD (SPB). This board sends the 12Vdc to the DPB, HPM;
and to the keyboard group. The SPB also creates different voltages for the DFB. The
Input Probe board is instead supplied by the DPB by one dedicated connection
(CBB).
The SPB manages the fans rack.
The Main Bus Board is a board on which are connected some of the internal boards
of the unit. It does not have active components on board but only connectors.

8 350015200_03
2.2 Input Probe Board (IPB)

The Input Probe board is the interface among the probes and the rest of the unit.
On board are assembled four connectors for electronic probes.
The board doesn’t perform any elaboration on the US data from the probes and on
the HV pulses, but simply passes/receives them from/to the two DFB.
In fact the HV pulses are already received at the high voltage level from the Digital
Front End and are directly sent to the right connector. This due to some relays which
proceed with the operation. The DPB controls these operations.
The information about the probe connected is sent to the DPB. From this board the
IPB receives all the settings and the information about the probe to enable.

2.3 Digital Front End Board (DFB)

The DFB is the responsible for the HV pulse generation and for the focalization of the
signals from the probes. In the unit there are two DFBs. No difference among them:
every board can be seated in every DFB position without trouble.
From the DPB board they receive all the focalization data and, according the probe
and the preset selected, they generate the high voltage pulses, starting from the low
signal pulse (also generated inside the DFB). The generated HV depends on the
image mode and is different for B mode and Doppler/CFM mode.
To perform this operation, the Power Supply Group sends in parallel to all the DFB
the high voltage to generate the pulses. When ready they are sent to the IPB and
then to the probe.
Every Digital Front End manages half portion of the image according the image
below:

The data from the probes directly returns to the Digital Front End. They are filtered
and amplified according the gain selected, then converted from analog to digital,
elaborated and sent out for the next steps.
The DFB 2 board does not send the data directly to the DPB, but the board number
two send the data to the number one who sum the two signals and send out the
result to the DPB
The position inside the MBB indicates if the board is the number one or two.
The sequence is IPB, DFB2 and DFB1.

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2.4 Digital Processing Board (DPB)

The DPB receives the US data (indicated as Data in the block diagram) from the DFB
1: The data receives different elaborations in case of BW image (2D and M-Mode) or
CFM, PW and CW.
The Data are filtered, demodulated and elaborated (also according some parameters
and filters set by the user) in the first internal block. After this step some post
processing elaborations are applied.
The internal Doppler demodulation circuit receive the elaborated Data from the first
block and generates the data that sent to the CFM and the PW Doppler elaboration
group create the CFM and PW Doppler image.
For CW Doppler, the CW elaboration group elaborates the Data arrived from the
DFB, before the elaboration done in the first block and creates the CW image.
All the US data (BW, CFM…) go to the PCiex group who send out them to the Host
Processing Module, where is created the whole US image and is added the overlay.
After, all is sent to the monitor.
On board, starting from two different clock generators, are created all the clocks
necessary for all the unit.
For the management of all the functions on board, there different DSPs in the control
group. This group communicates with the Digital Front End boards, the Input probe
(motor signals, temperature controls.), receive and send data with Host Processing
Board.
The board controls the Switching Power Board, part of the power supply group.
Correct generation of voltages are read from Switching Power Board on all the
boards in the rack, including the board itself. The board also generates all the supply
voltages for the IPB and sends them via the MBB.

2.5 Host Processing Module (HPM)

The Host Processing module is the interface between its internal PC group and the
rest of the unit.
This module receives from the DPB the US data (BW, CFM…). They are sent to the
video card on which are mixed to the overlay created to the PC part assembled on
board. The whole video frame is sent to the monitor.
At the start-up the DPB board checks the HW composition of the system and checks
if all the boards are connected. If all is ok every board starts to program itself using
the firmware present in some internal flash memories present in all the boards
The HPM, in case the firmware is not aligned with the main SW, acquire the
necessary firmware from the PC group that reads the SW present inside the HDD
and send it to the boards to upgrade, using internal serial buses.
The same channel is used for all the communications and checks during the live
activity or to upgrade the boards in case of new SW installation.
The PC group manages all the interfaces (USB, network, Wi-Fi) and the
communication with the keyboard group. It manages the display touch panel and set
it according the user selections. The LAN insulation transformer and connector are
located on this board as well.
The amplifier for the speakers, that are located in the upper group, is present on
board.
10 350015200_03
The amplified signal is sent to the keyboard group and from there to the speakers.

2.6 Main Keyboard

The group communicates with the PC module assembled in the HPM board by
dedicated USB cables, connected to 2 different HUB on the keyboard, to manage
several several USB resources: QWERTY, Touch Screen, Mouse, PIC keyboard, 2
user USB’;s, DVD and secondary display.
It receives all the data selected by the user and communicate with the Host
processing board in order to set the unit according the user’s selections.
On Board there are 2 USB hubs that manages the USB plugs present in the
keyboard group. The display link circuit manages the display touch panel and
communicates with the PC group.
On the keyboard group the connector is present on which is connected the supply
cable for the main monitor. The monitor is suppled at 12Vdc.

2.7 Power Supply Group

The group is composed by a board on which are assembled the auxiliary plugs, the
fuses holders and the insulation transformer who supply the auxiliary plugs. From this
group the line voltage is sent to the AC/DC module who converts the line voltage in a
12Vdc.
This voltage goes to the Switching Power Board (SPB) who is creating the different
voltages for the DFB (high voltage, +5…)
The SPB sends the 12 Vdc to the DPB, HPM, key board group.
Inside every board there is a circuit who creates the different voltages necessary for
the boards.The DPB supplies as well the IPB.

2.8 Main Bus Board (MBB)

The board is simply a passive board on which are connected some of the unit’s
boards. The boards connected are the two DFB, the DPB, the HPM and the SPB.

2.9 Enhanced ECG Board

The board acquires the ECG signal from the patient and elaborates it.
The signal is amplified, filtered converted and elaborated: Then is sent to the DPB, in
order to add it to the US data and show it on the main monitor.
All the ECG part is optical insulated from the rest of the unit.
The Physio input is not used, the patient has to be connected to the ECG input plug
using the dedicated Esaote cable

11 350015200_03
2.10 Electric and Schematic Diagrams

The diagrams are confidential and not enclosed in this manual.

12 350015200_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.

3.1 LCD Monitor

To remove the LCD monitor from the unit:

Detach the cables, coming from the articulating arm, from the monitor.
Remove the 4 M3x6 DIN912 Brnd HEX Socket Head Caps that fix the Plastic cover for
VESA fixing.

Remove the 4 screws that secure the monitor to the arm.

Note: Make sure that the monitor does not drop when removing the screws!

13 350015200_03
3.2 Control panel
Remove the 4 M3x8 screws that secure the control panel closing cover and remove
the cover.

Remove the 6 screw that secure the Control Panel to the cart.
Note the length of the screws!

14 350015200_03
Detach the cables connected to the Control panel, to be able to remove the Control
panel.

15 350015200_03
3.3 PCB access
The following PCB’s can be accessed:
1 SWITCHING POWER BOARD
2 CONTROL BUS BOARD
3 ANALOG BUS BOARD
4 DIGITAL PROCESSING BOARD assembly
5 DIGITAL FRONTEND BOARD Assembly
6 HOST PROCESSING MODULE

Remove the right cover, fixed with snap locks.

16 350015200_03
Remove the metal cover sheet from the PCB rack, fixed with 19 M3 x 8 screws.

After removing the metal cover sheet, the Switching power board can be removed

330000322 SWITCHING POWER BOARD

17 350015200_03
By removing the Control bus board it is possible to remove the Digital Processing
board.

250003500 CONTROL BUS BOARD (1 pcs)

250003600 ANALOG BUS BOARD (2 pcs)

330000324 DIGITAL PROCESSING BOARD assembly

18 350015200_03
By Removing the Control bus board and the 2 pcs Analog bus boards it is possible to
remove the 2 pcs Digital Front End boards.

330000325 DIGITAL FRONTEND BOARD Assembly

To be able to remove the Host Processing module, it is necessary to disconnect the

cables connected to this module
To do this, remove the left cover, fixed with snap locks.

19 350015200_03
Detach the cables connected to the PCB rack and remove the 4 M3 x 6 screws that
secure the Host Processing module.

Remove the Host Processing module.

330000323 HOST PROCESSING MODULE

20 350015200_03
3.3.1 Input board and power supply removal

Note: to be able to remove the Input board, it is required to remove both DFB1 anf
DFB2

Remove the front panel assembly fixed with 4 pieces M4x12 HEX Socket Head Cap
and washer.

Remove the Connectors Lighting Cable

21 350015200_03
Remove the Connectors Lighting Board, fixed with 4 pieces M4 x 6.

Remove the screw that fixes the Input Board, 11 pieces M3 x 8.

22 350015200_03
Remove the input board carefully.
Do not damage the probe connector locking levers.

To be able to remove the power supply it is necessary to remove the PCB rack from the
trolley.
To do this, remove the left cover which is fixed with snap locks. Front cover is also
removed.

Detach all cables from the PCB rack.

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Remove the M4x10 screw that fixates the PCB rack.

24 350015200_03
Remove, from the front, the 5 screws M4 x 8 that screws.

Remove the 330000941 - STRENGTHENING FRONT BULKHEAD

Remove at the right side the screw M4 x x8.

25 350015200_03
Slide the PCB rack out of the trolley.

Remove 9 pcs M3 x 6 screws to remove the shielding.

Note the internal cable.

Detach the cables from the AC/DC module.

26 350015200_03
Detach the cable from the PCB rack.
Remove the AC/DC module by removing the 4 pcs M3 x 6 screws.

27 350015200_03
 4
Chapter

4 PARTS LIST

BOARDS 250003500 CONTROL BUS BOARD

250003600 ANALOG BUS BOARD
330003066S MAIN BUS BOARD + UNIT'S RACK
330000467 Input Probe
250007900 Connectors Lighting Board
330000325 Digital Frontend Board
330000324 Digital Processing Board WITHOUT RF OUT
330002615 Digital Processing Board WITH RF OUT
330000322 SWITCHING POWER BOARD
330000323 Host Processing Module
330001802 ECG ASSY
530000005 AC/DC POWER SUPPLY
330001803S MAINS INLET ASSY
330001804 MAINS OUTLET ASSY
9103561000 ASSIEME DRIVE BAY
9103523000 Receiver for Virtual Navigator
9730630099 Transmitter for virtual Navigator
8109716000 Receiver Adapter spare (in combination with code 8109717000

8109717000 Small plate for receiver adapter (in combination with code
8109716000)
330000478 MONITOR

Upper Group

330000480
CONTROL PANEL

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330001056
Keyboard Assy 6440
(without trackball)

330001811
Base LCD Assy 6440

450000003
TRACKBALL

270006300
TRACKBALL CABLE

330001822S
On/Off board assy 6440

330001823S
Soft encoder light board
assy 6440

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330000507
qwerty keyboard assy

509015300
DVD driver slim slot-in SATA

270004500
SPEAKER ASSEMBLY
WITH CABLE

330001019S
BACK CLOSING COVER

330001147S
CONTROL PANEL REAR
COVER

330001696S
CONTROL PANEL LEFT
COVER ASSEMBLY

330001697S
CONTROL PANEL RIGHT
COVER ASSEMBLY

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330001698S
CONTROL PANEL TOP
COVER ASSEMBLY

Platic Panels

330001815S
Left Cover Assy

330001816S
Left Cover Assy

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330001817S
Left Panel Assy

330001818S
Right Panel Assy

330001819S
Front Panel Assy

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330001948S
Top Cover Assy

330001820S
Side Door Assy

330001900S
Console Assy

330001805S
Drawer Assy

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430000025
Antistatic wheel

330000477S
Break’s footpedal

330000500S
Rear handle bottom cover

330000499S
Rear handle top cover

330001250S
Power cable hook

330003065S
Rear handle buffalo horn
assy

34 350015200_03
Various Parts

330001807
Fan assy

330000479
Articulated arm

35 350015200_03
 5
Chapter

5 MAINTENANCE

5.1 Battery Cell

The unit contains a Lithium battery, located on the Host Processing Module. It is
strongly recommended to replace the battery cell every three (3) years. If the Host
Processing Module 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.

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 board 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 Description

1 - Make note of any new board which have been replaced (REF
and C.I.).
2 Philips screwdriver Close the unit.
Straight Head
Screwdriver
Socket wrench
Box wrench

36 350015200_03
 3 Service key Switch the unit on with the service key inserted.
4 - If necessary set the boards C.I.
5 - When applicable, verify that the upgrade is working.
6 Printer Select the “Licenses” option (MENU key), print out all the
screens and place them in the pocket placed in the rear cover.
7 - Reboot the unit.
9 - Verify the unit functioning using the Maintenance Check List.

5.2.2 Maintenance Check List

Physical check

Step Tool Description

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.
7 Allen screwdriver Clean the trackball. *
Philips screwdriver
Straight Head
Screwdriver
8 - Check that the keyboard orientation works properly: the
keyboard must be both oriented and locked.
9 - Check that the keyboard can be lift up and down.
10 Check that the monitor can be moved easily.
11 - For all probes, check the external status (cable, housing,
connector and labeling). Refer to “Transducers and
Consumables” manual for further information.

* WARNING
Switch off the unit before trackball maintenance and do not look directly at the
transmitter light.
According to IEC60825-1 (Never look directly or stare into the beam/beam aperture
when on. Do not use optical viewing aids.)

General Check

Step Tool Description

1 - Press the MENU key and select the “Licenses” option.
2 (Printer) Compare the configuration prints located in the lower pocket
with the configuration screens. If necessary replace the prints.
3 Operator Manuals Check that the operator manuals are present and their
revisions are relevant to the installed software release.
4 - Check that the keyboards keys are lighted and functioning.
5 - If necessary, adjust the Monitor/LCD brightness and contrast.
6 Unit probes Verify that all transducers are correctly identified in each
connector.

37 350015200_03
Functional Check

Step Tool/Mode Description

1 B-Mode Verify that the mode keys (Gain, TGC, POWER ..) and all the
Soft keys controls work properly.
2 M-Mode Verify that the mode keys (Gain, TGC, POWER ..) and all the
Soft keys controls work properly.
3 CFM Verify that the mode keys (Gain, ROI cursor POWER ..) and all
the Soft keys controls work properly.
4 Doppler Verify that the mode keys (Gain, AUDIO, POWER ..) and all the
Soft keys controls work properly.
5 ECG Verify that the ECG controls (PHYSIO key) work properly.
6 Optional licenses Verify the basic operations of all optional licenses (CMM,
TVM, XStrain..)
7 Re-writable Save exams on CD/DVD support and then erase them.
CD/DVD
8 USB Pen Drive Save exams on the USB support. Repeat the operation for
both USB ports.

Peripherals Check

Step Tool/Part Description

1 Printer If a printer is connected to the system, verify:
- Printer cable and connection.
- Remote settings and its functioning.
- Print quality.
2 VTR If a VTR is connected to the system, verify:
- VTR cable and connection.
- Remote settings and its functioning.
- Play back quality and frame position (service
software keys)
- Audio quality.

5.3 Trouble shooting

This chapter describes the trouble shooting and indicates possible issues and
solutions

5.3.1 DFB position

The unit contains 2 identical Digital Front-end Boards (DFB 1 and DFB 2) and the
position on these boards can be interchanged. The function depends on the position.
For test purpose DFB 2 can be removed and the unit will run. Obviously no Ultrasound
data will be present in the area where this board is active.
By switching the boards in position 1, possibly a defective board can be determined.

Placing the DFB in position 2 only, will lock the unit!

38 350015200_03
5.3.2 Hard Ware issues

This chapter describes possible Hardware issues and the possible cause and action.

1) The unit does not switch on.

a. Check the internal cables, especially the cables between ASB board and
the AC/DC converter.
b. Replace the ASB board and if needed the AC/DC converter.
c. If the problem remains replace the SPB board

2) Unit does not start, but power LED is lit (Amber).

a. Can be an issue on SPB or HPB board

3) Application software does not boot due to wrong board configuration

a. In the log file, the HW configuration is indicated with the following starting
block:

Hardware configuration
I-Button: fd-1739e3e9-01
EnHwCode:0x1 Equipment HwCode: 0x7

If in this block the Equipment HwCode is not 0x7 as expected, there may
be connection problems of the MKB board (upper group) with the rack,
so check the related cables and connections, see picture below:

Then, immediately after this block of the log, the list of the system slots is
provided.

39 350015200_03
 For a correct configuration, all slots must have Error Code 0x0, like in the
following example:

Slot:[0]
Error Code:[0x0]
….
Slot:[1]
Error Code:[0x0]
….
….
….
….
Slot:[8]
Error Code:[0x0]
….
If Error Code is not 0x0, there is a problem with the corresponding board.

Slot 0 DPB
Slot 1 DFB1
Slot 2 DFB2
Slot 3 SPARE
Slot 4 Keyboard
Slot 5 Power Supply
Slot 6 Input Probe Board
Slot 7 Main Bus Board
Slot 8 Host Processing Module

Try to repositioning the boards in their slots, because there may be

contact problems.

4) Application software crashes at start up with Algol device not found problem
a. An error log is created (file .err) with the text string “Algol device not
found”
Could be an issue on the DPB board
b. Try to reposition the DPB board and the PC module on the HPM board

5) The probe connector do not switch

a. There may be a connection problem between IPB board and DPB board.
b. Reposition the CBB board, the physical bridge board that joins IPB with
DPB.

6) Probes are not recognized on one or more connectors

a. Check the physical status of the probe connector pins on IPB board,
especially if this happens only on one of the four available connectors.
b. If it happens on all four connectors, then try repositioning the CBB board.
c. It still no result, try substituting IPB board and then DPB board.

40 350015200_03
7) Noisy channels in ultrasound image

a. Most likely the DFB board. Try to place the boards one by one in
position 1 to determine the defective board.
b. In a linear probe image like the one depicted above, where the ESAOTE
red logo is on the upper-left corner, the first half on the left would be
for DFB1, the second half on the right would be for DFB2; in the specific
case of the image above, DFB2 would be the board to be substituted

8) Missing channels in Ultrasound image

a. probe with missing/broken/damaged elements
b. IPB board, relays not switching properly
c. IPB board, probe connectors pins broken/damaged
d. DFB boards, not working properly in TX/RX
For case a), try to substitute the probe with a good working probe (same
model).
For case c), visually inspect the probe connector pins physical status and their
soldering to the PCB.

9) ECG/Physio
a. This may happen typically at run-time because EEB board is not correctly
connected to the backplane, the MBB board.
Check EEB cabling and connection with MBB.
b. If still no result, substitute EEB board.

41 350015200_03
5.3.3 Error messages

It is possible that during operation the following error message are displayed in a pop
up menu:

"Error with over temperature (#5)" Please contact Service department.

An OK confirmation from the user is requested to close the warning message.

- Corrective action: verify fan functioning, cleaning and fan cable

- See corrective action for “Error with fan (#6)”

“Error with fan (#6)” Please contact Service department.

An OK confirmation from the user is required to close the warning message.

- Corrective action: verify fan and fan cable

- There may be a disconnection of the fans assembly from the FPB board (see
picture of the fans assy below), or a disconnection of the FPB board from the
MBB board.
-

-
-
- Alternatively, the problem may be more subtle and depend on a HW issue on
the SPB board, which controls the fans rotation.
- Check the fan assembly connections and then, if still no result, check FPB and
MBB board connectors and finally try substituting the SPB board.
42 350015200_03
"Error with internal voltage (#7)" Please contact Service department.

An error log is created (file .ERR), even if this issue is not strictly blocking.
The causes may be several.
If the log puts in evidence the “+5V_AFE” internal voltage (search for such string), the
problem can be on the DFB boards. Replace the first one and then the other DFB
board.
If instead the log puts in evidence the “+1V2_DFB” internal voltage (search for such
string), the problem can be on the SPB board. Replace the SPB board.

"Wrong Impulse Voltage (#8)" Please contact Service department.

An OK confirmation from the user is requested to close the warning message.

- Corrective action: replace Switching Power Board or Digital Processing Board

-

- An error log file is created (file.ERR).

- Most likely there is a problem on the SPB board, especially at the High Voltage
section. Replace the SPB board.

43 350015200_03
"Error in Power supply (11)" Please contact Service department. The application will
close in (sec) xx.

- An error log file is created (file.ERR).

- Can be a problem on SP Board

5.3.4 Log files

This section describes error messages that may appear in the log files and the
possible solution or action.

Log files can be extracted to USB by pressing the MENU key, then select the
SYSTEM INFO button and select EXPORT LOG FILES

Keywords Defect description Suggested action

(log checking)
HW WARNING , Application may not start or may start IPD processing block on DPB board
IPD_TIMEOUT_ERR, with slow/ disturbed acquisition in fails during boot operation.
BOOT B-Mode modality Restart or check DPB.
HW WARNING, Application may not start or may start CFM processing block on DPB board
CFM_TIMEOUT_ERR, with slow/disturbed acquisition in CFM fails during boot operation.
BOOT modality Restart or check DPB.
HW WARNING, Application may not start or may start PW processing block on DPB board
PW_TIMEOUT_ERR, with slow/disturbed acquisition in PW fails during boot operation
BOOT, Doppler modality Restart or check DPB.
HW WARNING, Application may crash suddenly IPD processing block on DPB board
IPD_TIMEOUT_ERR, (SYSTEM INTERNAL ERROR pop- fails during normal acquisition.
RUNTIME up on screen) or may proceed with Check DPB.
slow/disturbed acquisition in B-Mode.
HW WARNING, Application may crash suddenly CFM processing block on DPB board
CFM_TIMEOUT_ERR, (SYSTEM INTERNAL ERROR pop- fails during normal acquisition.
RUNTIME up on screen) or may proceed with Check DPB.
slow/disturbed acquisition in CFM
modality
HW WARNING, Application may crash suddenly RT Bus problem.
FIFO_TX_RTB_BUSY, (SYSTEM INTERNAL ERROR pop- Check DPB and DFB.
RUNTIME up on screen)
HW WARNING, Application may crash suddenly RT Bus problem.
UNEXPECTED_ACK, (SYSTEM INTERNAL ERROR pop- Check DPB and DFB.
RUNTIME up on screen) or may proceed with
slow/disturbed acquisition in all
conditions
HW WARNING, Application may crash suddenly UART problem (SPB-DPB
UARTPS_TX_ERROR (SYSTEM INTERNAL ERROR pop- communication)
up on screen) or may proceed with Check DPB and SPB.
slow/disturbed acquisition in all
conditions
HW WARNING , Application may crash suddenly UART problem (SPB-DPB
UARTPS_RX_ERROR (SYSTEM INTERNAL ERROR pop- communication).

44 350015200_03
 up on screen) or may proceed with Check DPB and SPB.
slow/disturbed acquisition in all
conditions
HW WARNING, Application may crash suddenly RT Bus problem.
TOO_FEW_DATA, (SYSTEM INTERNAL ERROR pop- Check DPB and DFB.
FORMAT up on screen)
HW WARNING, Application may crash suddenly RT Bus problem.
TOO_MUCH_DATA, (SYSTEM INTERNAL ERROR pop- Check DPB and DFB.
FORMAT up on screen)
HW WARNING, Application may crash suddenly PW DSP problem. (Overlab).
E_OVERLAB, RUNTIME (SYSTEM INTERNAL ERROR pop- Check DPB.
up on screen) or may proceed with
slow/disturbed acquisition in PW/CW
Doppler modality
HW WARNING, Application may crash suddenly PW DSP problem. (Overlab ECG).
E_OVERLABECG, (SYSTEM INTERNAL ERROR pop- Check DPB.
RUNTIME up on screen) or may proceed with
slow/disturbed acquisition in PW/CW
Doppler modality
HW WARNING, Application may crash suddenly PW DSP problem. (Overlab
E_OVERLABPHYSIO, (SYSTEM INTERNAL ERROR pop- PHYSIO).
RUNTIME up on screen) or may proceed with Check DPB.
slow/disturbed acquisition in PW/CW
Doppler modality
HW WARNING, Application may crash suddenly PW DSP problem. (UnderRun).
E_UNDERRUN, (SYSTEM INTERNAL ERROR pop- Check DPB.
RUNTIME up on screen) or may proceed with
slow/disturbed acquisition in PW/CW
Doppler modality
HW WARNING, Application may crash suddenly PW DSP problem. (UnderRun ECG).
E_UNDERRUNECG, (SYSTEM INTERNAL ERROR pop- Check DPB.
RUNTIME up on screen) or may proceed with
slow/disturbed acquisition in PW/CW
Doppler modality
HW WARNING, Application may crash suddenly PW DSP problem. (SoF EoF).
E_SOF_EOF, RUNTIME (SYSTEM INTERNAL ERROR pop- Check DPB.
up on screen) or may proceed with
slow/disturbed acquisition in PW/CW
Doppler modality
ERROR #6, SERVICE Application stops displaying a pop-up SPB board problem/FAN assembly
DEPARTMENT, POWER on screen without crashing. The problem
SUPPLY ALARM application waits for an user
interaction (press OK on the pop-up
multiple times until pop-up
disappears)
ERROR #7, SERVICE Application stops displaying a pop-up SPB board problem. (Voltage Alarm)
DEPARTMENT, POWER on screen without crashing. The
SUPPLY ALARM application waits for an user
interaction (press OK on the pop-up
until pop-up disappears)
ERROR #8, SERVICE Application stops displaying a pop-up SPB board problem. (Voltage Alarm)
DEPARTMENT, POWER on screen without crashing. The
SUPPLY ALARM application waits for an user
interaction (press OK on the pop-up
until pop-up disappears)
ERROR #11, SERVICE Application stops displaying a pop-up SPB board problem. (Voltage Alarm)
DEPARTMENT, POWER on screen without crashing. The
SUPPLY ALARM application waits for some seconds
and then shuts down
ERROR #5, SERVICE Application stops displaying a pop-up Over temperature problem on rack
DEPARTMENT POWER on screen without crashing. The boards.
SUPPLY ALARM application waits for some seconds Check DFB, DPB, SPB and HPM
and then shuts down
ERROR #4, SERVICE Application stops displaying a pop-up Over temperature problem on
DEPARTMENT, POWER on screen without crashing. The batteries.
SUPPLY ALARM application waits for some seconds Check battery pack or SPB.
and then shuts down
Error initializing the unit Touch screen not active Error initializing the unit Touchscreen
Touchscreen Input Device Input Device.
Check Main Keyboard Board and
HPM
Problem with Burner Disk not working Check disk and DVD burner.
manager initialization.

45 350015200_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.
Preferably to the USB port at the side of the unit.
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.

The system language can be set in this menu.

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.

The AC line frequency can be set and several other function can be enabled or
disabled as well as the screen saver time out time.

46 350015200_03
6.2 Software installation/update

REQUISITES
• USB memory drive (USB 3.0 recommended).
• Service Key P/N 140009500

PREPERATION
1. Download the file MyLab9_[version]_6440.zip from ownCloud.
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. There are no batteries in MyLab 9 Family.

8. Follow on-screen instructions.

47 350015200_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.

48 350015200_03
6.3 Format procedure

The format procedure will erase both the HDD and SSD completely and partition both
discs.
After the format procedure, the MyLab software should be installed as described in the
previous section.

REQUISITES
• USB memory drive (USB 3.0 recommended, Min 16GB).

PREPERATION
1. Download the file Format.iso from ownCloud.
2. Create bootable USB memory drive.
a) Connect USB memory drive to PC
b) Run “DISKPART” on PC with administrator rights

c) List the volumes by entering “list volume”

49 350015200_03
d) Select the USB memory drive by entering “select volume [# of USB drive]”

e) Enter “clean” to clean the USB memory drive

f) Enter “create partition primary”.

50 350015200_03
g) Enter “Select partition 1”.

h) Enter “active”

i) Format by entering “format fs=NTFS quick”

j) Enter “assign”

51 350015200_03
3. Extract the Format.iso file (right click and select extract file” or “mount”) to the
root of the USB pen drive
4. Connect the USB pen drive that contains the Format pack to one of the USB
slots on the side of the unit.
5. Start the unit.

The unit will start up with the following screen

Menu Options START

Menu
----------------
1. Format and Install OS from image (scratch install)
2. Upgrade BIOS
H. Help me!
A. About
Q. Quit (reboot)

Your choice [1, 2, h, a, q]?

Press “1” to start the Format.

When ready remove the USB memory drive and restart the unit.

Install the software pack as described in 6.2 Software installation/update, page 47.

NOTE:
In case the unit does not start up from the USB: check the BOOT Option
Priorities in the BIOS
DO NOT CHANGE ANY OTHER BIOS SETTING

1) Start the unit and press DEL on the keyboard.

2) Enter the BIOS password: [Fireball] and press [enter]
3) Connect the USB memory drive to the unit.
4) Select the BOOT tab by means of the arrow keys.
5) Select “Hard Drive BBS Priorities” by means of the arrow keys.
6) Move, by means of the arrow keys the USB memory drive to “Boot Option #1”.
7) Press [F4] to save and exit.
8) The unit will reboot and the format procedure will start

52 350015200_03
 7
Chapter

7 SAFETY TEST
Every MyLab 9 Family unit complies with EN60601-1 (IEC 60601-1) standard.
The MyLab 9 Family 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:
• Power Supply Group: ASB, AC/DC, mains cables
• Activities that involve substitution or temporary disconnection of ground cable
for PE protection
• Enhanced ECG Board, ECG cable
• Power Supply Plug

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

7.1 Safety measurements according IEC60601-1

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.

53 350015200_03
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

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.

54 350015200_03
7.1.1 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.

55 350015200_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.

56 350015200_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

57 350015200_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.

58 350015200_03
7.2 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

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 65:
DO NOT USE the unit and contact Esaote Technical Assistance.

59 350015200_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

60 350015200_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

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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.

62 350015200_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 9 Family Rear screw on monitor – inlet 44 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.

63 350015200_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.

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7.2.1 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.

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 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: SIGNATURE :

66 350015200_03