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6440 - ServiceManual MyLab 9 Fam - 05
6440 - ServiceManual MyLab 9 Fam - 05
MyLab 9 Family
350015200
www.esaote.com
Rev. 05
Feb 2019
350015200_05
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................................................................................... 8
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 ECG ASSY ................................................................................................... 11
2.10 Electric and Schematic Diagrams ................................................................. 11
3 UNIT DISASSEMBLY .......................................................................................... 12
3.1 LCD Monitor ................................................................................................. 12
3.2 Control panel ................................................................................................ 13
3.2.1 Control panel disassembly .................................................................... 15
3.3 PCB access .................................................................................................. 20
3.3.1 Input board and power supply removal.................................................. 25
4 PARTS LIST ........................................................................................................ 32
5 MAINTENANCE................................................................................................... 42
5.1 Battery Cell ................................................................................................... 42
5.2 Check list ...................................................................................................... 42
5.2.1 Technical Check List ............................................................................. 42
5.2.2 Maintenance Check List ........................................................................ 43
5.3 Cleanliness of product .................................................................................. 45
5.4 Trouble shooting ........................................................................................... 45
5.4.1 DFB position .......................................................................................... 45
5.4.2 Hard Ware issues .................................................................................. 46
5.4.3 Error messages ..................................................................................... 49
5.4.4 Log file error messages ......................................................................... 51
350015200_05
6 SERVICE INFORMATION ................................................................................... 53
6.1 Service menu................................................................................................ 53
6.3 Software installation/update.......................................................................... 56
6.4 Formatting the HDD/SSD ............................................................................. 58
6.5 Compatibility overview .................................................................................. 64
6.5.1 MyLab 9 Family V1, V2 PCB compatibility ............................................ 64
6.5.2 Control Panel compatibility .................................................................... 66
6.6 ID button ....................................................................................................... 66
6.7 Track ball dipswitch settings ......................................................................... 67
6.8 Log Files ....................................................................................................... 68
6.8.1 Log Files Organization .......................................................................... 68
6.8.2 LogParser Executable ........................................................................... 68
6.8.3 User Session ......................................................................................... 70
6.9 Remote Service ............................................................................................ 72
7 HARDWARE INSTALLATIONS AND UPGRADES ............................................ 73
7.1 8TB HDD ...................................................................................................... 73
7.2 24” LCD monitor BARCO ............................................................................. 79
7.3 UPS .............................................................................................................. 90
7.4 Virtual Navigator Drive Bay........................................................................... 97
7.5 ECG Module Assy ........................................................................................ 98
7.6 Basic to Cardio update ............................................................................... 103
8 SAFETY TEST................................................................................................... 104
8.1 Safety measurements according IEC 62353 .............................................. 104
8.1.1 Limits Table ......................................................................................... 111
8.2 Safety measurements according IEC60601-1 ............................................ 113
8.2.1 MyLab safety test - Operating Procedures .......................................... 114
350015200_05
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 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.
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.
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1.1 Service Characteristics
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:
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.
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.
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).
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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.
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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.
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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
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 ECG ASSY, to receive the ECG signal to be
displayed with the US image. The data go to the HOST PROCESSING MODULE
(HPM).
The DPB creates all the internal clocks necessary for 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.
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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.
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
(Video) 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.
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.
The amplified signal is sent to the keyboard group and from there to the speakers.
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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.
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.
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.
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
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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.
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3.2 Control panel
Remove the 4 M3x8 screws that secure the “control panel closing cover” and remove
the cover.
Use a short Philips screwdriver.
Remove the 7 screws that secure the Control Panel to the cart.
Note the length of the screws!
2 pcs M4 x 12 in the rear.
4 pcs M4 x 16 in the center.
1 pc M4 x 8 in the front.
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Remove the two screws that fix the Control Panel to the articulating arm.
Use a short Philips screwdriver
Lift the Control Panel and detach the cables connected to the Control Panel, to be
able to remove the Control panel.
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3.2.1 Control panel disassembly
Remove the 5 M3 x 8 screws to be able to remove the Control Panel Top cover
assembly.
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Remove the 15 M3 x 8 screws that secure the Control Panel Rear cover.
Note that 8 screws are located underneath the foam around the loudspeakers.
Carefully lift the cover and detach the DVD cable from the DVD drive, if not already
done.
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Keyboard assembly removal
Remove the four screws that fix the frame of the Base LCD Assy to the Keyboard
Assy.
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Carefully remove the Keyboard Assy from the Base LCD Assy.
Guide the flat cables from the encoders through the holes.
Remove the 4 screws that secure the Software Encoder Light board.
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ON/OFF Board Assembly removal
The screws are located underneath the foam. Carefully loosen the screws. They will
stay in the bracket.
Remove the 5 self-tapping screws that secure the ON/OFF Board Assembly to remove
the board.
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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
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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
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By removing the Control bus board, it is possible to remove the Digital Processing
board.
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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.
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Detach the cables connected to the PCB rack and remove the 4 M3 x 6 screws that
secure the Host Processing Module.
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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 and
DFB2
Remove the front panel assembly fixed with 6 pieces M4x12 HEX Socket Head Cap
and washer. 4 Pieces are located on the front and 2 are located on top.
Note: the probe cable holders remain attached to the front panel.
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Remove the Connectors Lighting Board, fixed with 4 pieces M4 x 6.
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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.
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Remove the M4x10 screw that fixates the PCB rack.
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Remove, from the front, the 5 screws M4 x 8 that screws.
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Slide the PCB rack out of the trolley.
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Detach the cable from the PCB rack.
Remove the AC/DC module by removing the 4 pcs M3 x 6 screws.
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4
Chapter
4 PARTS LIST
Parts are for MyLab 9 Family: 100644010 MyLab 9
100644000 MyLab 9 eXP
The unit version V1 or V2 can be recognized by means of the unit serial number.
For V2 systems the unit serial number starts at 20000.
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Common parts 250003500 CONTROL BUS BOARD
250003600 ANALOG BUS BOARD
330003066S MAIN BUS BOARD + UNIT'S RACK
330000467 Input Probe
250007900 Connectors Lighting Board
330000323 Host Processing Module
330001802 ECG ASSY
330001803S MAINS INLET ASSY
330001804 MAINS OUTLET ASSY
9103561000 DRIVE BAY ASSY
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 21.5” LCD Monitor
140037700 24” LCD monitor BARCO
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Upper Group
330000480
CONTROL PANEL
330001056
Keyboard Assy 6440
(without trackball)
330001811
Base LCD Assy 6440
450000003
TRACKBALL
270006300
TRACKBALL CABLE
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330001822S
On/Off board assy 6440
330001823S
Soft encoder light board
assy 6440
330000507
qwerty keyboard assy
509015300
DVD driver slim slot-in SATA
270004500
SPEAKER ASSEMBLY
WITH CABLE
330001019S
BACK CLOSING COVER
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330001147S
CONTROL PANEL REAR
COVER
330001696S
CONTROL PANEL LEFT
COVER ASSEMBLY
330001697S
CONTROL PANEL RIGHT
COVER ASSEMBLY
330001698S
CONTROL PANEL TOP
COVER ASSEMBLY
Platic Panels
330001815S
Left Cover Assy
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330001816S
Left Cover Assy
330001817S
Left Panel Assy
330001818S
Right Panel Assy
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330001819S
Front Panel Assy
330001948S
Top Cover Assy
330001820S
Side Door Assy
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330001900S
Console Assy
330001805S
Drawer Assy
430000025
Antistatic wheel
330000477S
Break’s footpedal
330000500S
Rear handle bottom cover
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330000499S
Rear handle top cover
330001250S
Power cable hook
330003065S
Rear handle buffalo horn
assy
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Various Parts
330001807
Fan assy
330000479
Articulated arm
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5
Chapter
5 MAINTENANCE
The unit contains a Lithium battery, located on the (Video) Host Processing Module . It
is strongly recommended to replace the battery cell every three (3) years. If the
(Video) Host Processing Module has to be stored, it will be necessary to first remove
the battery.
WARNING
Irritation, including caustic burns and injury may occur following exposure to a
leaking battery.
If the battery is incorrectly installed it may explode. Replace only with the same
or equivalent type.
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.
Once any HW/SW change, modification or upgrade is finished and the unit is ready to
be closed, perform the following:
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Socket wrench
Box wrench
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.
Physical check
* 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
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Functional Check
Peripherals Check
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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.
Clean the area of the system, dispose of empty cartons or other packing material.
This chapter describes the trouble shooting and indicates possible issues and
solutions
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.
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5.4.2 Hard Ware issues
This chapter describes possible Hardware issues and the possible cause and action.
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.
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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 (Video) Host Processing Module
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
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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
9) ECG/Physio
a. This may happen typically at run-time because ECG ASSY is not correctly
connected to the backplane, the MBB board.
Check ECG ASSY cabling and connection with MBB.
b. If still no result, substitute ECG ASSY board.
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5.4.3 Error messages
It is possible that during operation the following error message are displayed in a pop
up menu:
-
-
- 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.
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"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.
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"Error in Power supply (11)" Please contact Service department. The application will
close in (sec) xx.
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
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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.
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7
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.
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.
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6.1.1 Language settings
This field selects the default language that can be selected from the available ones in
the dropdown menu.
6.1.3 Maintenance
In the maintenance field the Service Maintenance 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
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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
Demo License
Demo licenses last five hundred (500) working hours before expiring.
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.
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9. The following message is shown.
At this point the USB pen drive can be disconnected.
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.
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6.4 Formatting the HDD/SSD
The format procedure will erase the HDD/SSD completely, partition the disc and install
the software.
This procedure can be performed to solve unit issues with corrupt files on the
HDD/SSD and must be performed when installing a new HDD/SSD.
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.
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Log Files, page 68.
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.
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6.4.2 Format procedure
REQUISITES
• USB memory drive, Min 32GB.
• USB keyboard (only in case unit keyboard does not work)
• Service Key P/N 140009500
PREPERATION
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”
4) un-check
6) Start
Process
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3. A warning will be displayed:
Click OK to continue.
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 DEL on the keyboard, while starting up.
Password: Fireball
Select: Boot menu; Boot Type Order; select USB at first position
Save and exit with YES.
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c. The Model selection 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
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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.
Requisites:
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:
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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.
NOTE:
When ready, set the startup priority back to HDD/SSD when applicable.
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6.5 Compatibility overview
This section gives a compatibility overview between the dedicated PCB’s for
MyLab 9 Family version V1 and version V2
The unit version V1, V2 or V2.1 can be recognized by means of the unit serial number.
For V2 systems the unit serial number starts at 20000.
NOTE:
PCB’s dedicated for V1 systems, may not be used in MyLab 9 Family V2 units.
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PCB overview MyLab 9 V2 version
(unit serial number ≥ 20000)
Downwards
V2 V2
Board Compatible
version version Remark
description for V1 unit?
board P/N
(Note 1)
330003675 Only replacing both
DFB II Yes
C.I. 12 boards (Note 2)
Front End
DFB II no 330003782
No
CW C.I. 20
DPB II 330003781
Back End Yes
C.I. 51
Power 330003593
SPB II Yes
supply C.I. 30
AC/DC Only installing also a
AC/DC 530000090
POWER Yes new SPB II P/N
supply C.I. 00
SUPPLY 330003593
Note 1
SW Release F080103 or higher is required for installation of the compatible V2 boards
on a V1 system
Note 2
Any system is equipped with 2 Front end board.
The two FE boards installed in the system must be of the same version.
Mixed configurations between DFB, DFB II and DFB II no CW on the 2 slots of the
system are not allowed
It is not possible to mix 330003675 and 330003782 (CW/no CW option)
It is not possible to mix DFB P/N 330000325 and DFB II P/N 330003675
Both DFB P/N 330000325 and DFB II P/N 330003675 manage the CW
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6.5.2 Control Panel compatibility
Control panels with the letters “EL” (e.g. xxELxxxxx) in the serial number require
software release F080101 for proper functioning. The unit will lock otherwise.
Serial number label location:
When required the unit can be started with the service key connected to enter Windows
mode and load the software.
6.6 ID button
The ID button is a cell that contains the system ID number on which all the unit’s
licenses are based. The ID number is always linked to the unit serial number.
For that reason, it is required to change the ID button when the Host Processing
Module has to be replaced to make sure that the original ID button is installed in the
system.
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6.7 Track ball dipswitch settings
For correct functioning of the track, switch 1 and 2 must be set to ON.
Switch 3, 4, 5, 6, 7 and 8 must be set to OFF
SWI_1
1 2 3 4 5 6 7 8
ON ON OFF OFF OFF OFF OFF OFF
* 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.)
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6.8 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 must be saved as soon as possible.
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
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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:
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 licenses 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.
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.
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6.8.3 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:
When an error occurs the delimiters allow to identify in which phase happens.
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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.
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6.9 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.
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7
Chapter
7 HARDWARE INSTALLATIONS
AND UPGRADES
This section describes the procedure to install an external USB 8TB HDD, with its own
power supply.
The procedure foresees a hardware installation and a software installation.
HW installation:
PROCEDURE
Remove the upper cover and the belts to fix the peripherals.
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Remove the left lateral panel
Attach the Velcro on the HDD and on the plastic part (left side of the image).
Attach the double side tape on the power supply and attach it on the metallic panel
positioned as described in the image below.(right part of the image).
When placing the Power Supply on the plastic, the installation will not fit and the cover
cannot be closed correctly.
.
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Pass the USB and the power supply extension cable in the hole.
Place the USB cable connector in front of one of the free USB3 ports. DO NOT
connect yet!
Connect the PS cable in one of the aux plugs
Fix again the belts and assemble the covers.
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SW INSTALLATION:
Procedure
Switch on the unit with the Service key inserted
Connect the USB HDD connector to the USB3 plug and double click the
“PrepareinternalDisk” icon to start the program. To install you must press “PREPARE”
and the tool will format the disk and will assign the first letter available.
Then label “EXTENDED ARCHIVE” will be assigned to this drive.
The tool is programmed to format only the external devices with size over 4TB; it
doesnot consider the pen drive or the internal disks. When the procedure ends, the
following message is shown.
In case a failure message should appear, remove other USB connected devices
(except for the Service key) and press again “PREPARE”.
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With SW Release F0801XX or higher it is possible to manage more USB destinations.
When enabling the “autosave” option in the Saving Options Menu and selecting the
USB drive in the USB section in the NATIVE field, the drive will act as the internal
archive of the unit.
This drive is not affected when running the Esaote Format procedure, therefore it is
possible to use it to store the unit settings, to restore them very quickly after format.
Pressing RIGHT CLICK on the Network Icon in ARCHIVE REVIEW mode, will activate
a pop-up menu of the available USB drives.
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The same from the “BROWSE” icon:
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7.2 24” LCD monitor BARCO
This section describes the installation of 24” LCD monitor BARCO P/N 140037700.
Software Release F0801XX or higher is required.
DESCRIPTION
HW installation of the 24” LCD monitor P/N 140037700 on the equipment.
Set up:
to set the correct monitor profile in the unit
to change the LUMINANCE (i.e. brightness) value from 100 (producer setting) to the
suggested one according to the room’s brightness. All the other parameters are
already set by the manufacturer. In case they are inadvertently changed, they can be
re-set using the “FACTORY RESET” option.
In case that the monitor arrives with its Power supply and desk support, they must be
removed.
Here the video adapter, power supply adapter and mechanical adapter
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PROCEDURE
In case the unit is already equipped with LCD display, remove it (see service manual),
otherwise go on with the instructions below.
Check the length of the Video and power supply cables (from the arm to the
connector).They must be around 300mm for the video and 330mm for the supply (if
shorter it’s necessary to remove the plastic covers from the arm and move a bit the
cables to reach the desired length.
Install the plastic clip code 420000266 on the adapter using the screw cod.
06061014077 of the kit.
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Fix the adapter to the arm using the shorter screws cod. 06021010633 with 4 washer
(one each screw).
Connect the adapter cables and fix with the video ones using their screws and nuts
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Fix the power supply cable to the mechanical adapter using the clip. The cable must
be a bit angled, as in the image
.
Position also the video cable as shown below and connect the monitor using the
remaining screws 0600000253 and washers of the kit.
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The arrows indicate where to place the screws
Connect the supply cable and video one on the upper part of the monitor
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Block the supply cable in the hook and the video cable with a tie
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Close the connector’s area with the monitor cover
Apply the back cover, removed from the previous monitor who covers the adapter area
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If the arm is not able to hold the weight of the monitor, it’s necessary to regulate it, by
the allen screw present in the arm, close the support
NOTICE When the 24” LCD Monitor P/N 140037700 is connected, the
“Disable monitor auto detection” field must be checked.
Brightness settings must be set manually in the Monitor menu
according to the values indicated in the section “Procedure to
set the Brightness”.
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MyLab 9 Settings
Switch on the unit with the Service key and press MENU – SERVICE.
In case that an error message “UNKNOWN MONITOR CONNECTED” is shown, press
ok.
NOTE
If you connect the monitor without the service key, the unit will turn off, because not correctly set.
Disable the “AUTO DETECTION” and set the correct monitor profile:
“ML9_BARCO24_WUXGA”
The monitor resolution is 1920x1200 / 60Hz. The machine must set itself the correct
resolution.
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Procedure to set the Brightness (called LUMINANCE):
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Press MENU to enable the modification and change the value to one of the ones
shown in the table below, according to the room’s brightness, using the “-“ key. Press
again MENU to confirm the value and exit
Medium/Dark room: 62
Dark room: 44
Bright room: 84
Press the MENU key to access to the internal MENU -> ADJUSTMENTS –> SETTING
–> FACTORY RESET
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Press MENU key and select YES; then confirm with MENU key
This operation will reset all the monitor parameters and the BRIGHTNESS
(LUMINANCE) will return to 100. So it will be necessary to set it again to the required
value.
7.3 UPS
MyLab 9 Family can be equipped with an optional UPS that provides emergency
power when the mains power fails.
The model is Ametek Powervar Security II series UPM model ABCE602-22MED.
NOTE:
When installing 140037400 INTEGRATED MEDICAL UPS KIT, there is still space for
EXTERNAL HD (8TB) model 140037800 plus a small printer. The available power is
100VA MAX.
A system powered by the UPS has limited power available for peripherals, it is only
100VA (400VA when powered from mains).
100VA are available for any accessory combination, with the restriction that overall
power consumption on insulator transformer is below this value.
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330003886, UPS Support 330003823, UPS CARTER
ACTION
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Remove the 2 Alan screws in the front and place the hexagonal Male/Female spacers
(M4 x 10) with washer.
Position the UPS support on the main chassis and secure the UPS support with two
screws on the Hexagonal spacers.
Secure the UPS Support on the rear side of the unit with two pieces 330003885 rear
bracket.
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NOTE:
Check for correct installation of the UPS support, by trying to move the support.
Position the two belts through the dedicated slots of the UPS support.
Place the UPS on the UPS support. (mains plug of the UPS on the same side as unit
mains plugs)
Secure the UPS with the two belts.
Remove 3 screws from the UPS rear panel and place the UPS carter. Secure the UPS
carter with the 3 screws.
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Place the "REFER TO INSTRUCTION MANUAL" label on the indicated position.
Open the panel on the left rear side of the unit.
Remove the indicated screw.
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Place the Plate Support Assy and fix with the screw.
NOTE:
In case a printer or other peripheral is connected, remove the Protection Plate from
the Plate Support Assy. Non-used sockets must be covered.
Attach 330004264, 6440 AUX RATING LABEL 200-240V on the indicated position on
top of the old label. In case the Plate Support Assy covers the label, place the label on
the Plate Support Assy.
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Place the 4 screw caps on the 4 socket head screws that secure the UPS support.
Connect the mains socket of UPS to the main socket of the unit, by means of
Power Cord C14 DA to C19, 0.6 m, 14AWG.
Connect the mains socket of the UPS to the wall socket by means of
Power Cord CEE 7/7 C13, 2.5 m.
Please refer to the Ametek Powervar Security II series UPM model ABCE602-22MED
user’s manual for first time testing and operation.
NOTE:
Perform safety measurements after installation.
See section 8 SAFETY TEST, page 104.
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7.4 Virtual Navigator Drive Bay
This section describes the installation of the Drive bay, required for the Virtual
Navigator option.
Remove the cover on the rear of the unit, secured with 2 socket head screws.
Connect the Power connector, USB type B and the GND cable to the Drive Bay.
Place the Drive bay in the unit and secure with the 2 socket head screws.
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Activate the Virtual Navigator licenses
• Turn on unit
• Press the MENU key and select LICENSES.
• Select VN licenses in the Options tab and enter provided license code.
• Select VERIFY and then SAVE.
NOTE:
Perform safety measurements after installation.
See section 8 SAFETY TEST, page 104.
• Cover removal
Remove the front panel assembly fixed with 6 pieces M4x12 HEX Socket Head Cap
and washer. 4 Pieces are located on the front and 2 are located on top.
Note: the probe cable holders remain attached to the front panel.
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Remove the Right Cover assy.
9 PCS
2 PCS M4 x 30
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Remove Left Cover assy
8 PCS M4x12
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• Top Cover Assy removal
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Connect the other end of the ECG cable to the ECG connector on the PCB rack.
Place the Ferrite Split on the indicated position on the ECG cable.
Remove the ECG cover panel from the Front Panel Assy.
Reinstall covers
NOTE:
Perform safety measurements after installation.
See section 8 SAFETY TEST, page 104.
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7.6 Basic to Cardio update
For MyLab 9 Fam version V2 (unit serial number starts at 20000) it possible to
upgrade a BASIC version to a CARDIO version by means of 330004452 BASIC TO
CARDIO Upgrade KIT.
Install ECG Module Assy as described in 7.5 ECG Module Assy, page 98.
Remove 2 pieces 330003782 DFB II, no CW. See 3 UNIT DISASSEMBLY, page 12
for unit disassembly.
Attach 330004351 CV label to the Control panel, above the Esaote MyLab 9 system
label.
Use the Positioning template to position the label correctly.
330004351 CV label
NOTE:
Perform safety measurements after installation.
See section 8 SAFETY TEST, page 104.
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8
Chapter
8 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
• ECG ASSY, 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
Applicability
The standard IEC 62353 ed. 2 is applicable for Recurrent test and test after repair of
medical electrical equipment.
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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 111:
DO NOT USE the unit and contact Esaote Technical Assistance.
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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
The list of the parameters to be checked is indicated inside the related service
manual, so please check them according the unit under control.
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.
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Tools
Tool Dimension
RIGEL 62353+ 270 x 110 x 75 mm
Metal foil maximum size 20 x 20 cm
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.
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+
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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.
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Test procedure
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.
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.
• 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.
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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.
• 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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8.1.1 Limits Table
---
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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TEST CERTIFICATE AND VERIFICATION ACCORDANCE WITH CEI EN 62353 STANDARD
SYSTEM DATA
UNIT UNDER TEST DESCRIPTION: □ EM System □ EM Device □ Peripheral
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: __________________________________________________________________________
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8.2 Safety measurements according IEC60601-1
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
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.
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.
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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.
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.
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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.
If any of the measured values are higher than the value in the table, do not use the
equipment and send it to ESAOTE.
• 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.
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• 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.
• 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 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
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).
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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.
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