MyLabFive ServiceManual Doc 41B40SM02
MyLabFive ServiceManual Doc 41B40SM02
Service Manual
Manufactured by:
1 INTRODUCTION
Display
• 15” LCD, TFT technology, color XVGA
Probe connectors
• 2 electronic probes (1 default, 1 optional (1 license enabled))
• 1 Doppler probe
Video I/O
• S-VGA
• RGB
• S-VHS
• Composites
Connectivity
• LAN RJ45
• 3 USB
• ECG input
• Foot switch
• Laser/Ink jet printers
• Complies with IHE integration profiles
Image Files
• Standard output file formats (BMP, JPEG, PNG, AVI)
• Native and Dicom formats
• Clips characteristics
• AVI Codec: Microsoft MPEG-4 V2
• Compression: JPEG lossy compression (about 70% of quality)
• Still frames / BMPs are stored at full resolution
Software
• Operating system: Unix and WIN XP Embedded
• Multi-lingual
Biometry
• Basic and advanced calculation, application dependent
• Annotations, bodymarks
Power cables
• Power cable with CEE socket
• Socket: 510 IEC 320/C13 type; 10A-250V
• Plug: VII (7) VII type; 10A-250V
• Conductors: 3
• Section: 1 mm2
• Length:2,5 m
• Power cable with NEMA socket
• Socket type and amperage: 510 IEC 320/C13 type; 13A-125V
• Plug type: NEMA 5-15; 13A-125V
• Conductors: 3
• Section: AWG 16
• Length: 3 m
Dimensions
• 170 (H) x 375 (W) x 460 (D) cm (with closed LCD)
• 440 (H) x 375 (W) x 500 (D) cm (with open LCD and extended handle)
Weight
• About 9 kg
Power Supply
• Voltage operative range:
• 100 ÷ 120V
• 200 ÷ 240 V
• Mains frequency: 50 ÷ 60 Hz
• Power consumption: ≤ 600 VA
Battery
• Duration > 300 charging cycles
• Battery life: three years
Operating requirements
• Temperature: 15÷35 ºC
• Humidity: 15÷95 % (not condensing)
• Pressure: 700÷1060 hPa
Storage requirements
• Temperature: -20 ÷ +60ºC
• Humidity: 5÷95 % (not condensing)
• Pressure: 70÷1060 hPa
Trolley
• Housings:
• Upper space about 33 (L) x 14.5 (H) x 38.5 (D) cm
• Lower space about: 33 (L) x 17 (H) x 41 (D) cm
• Dimensions: about 50 (L) x 90 (H) x 51 (D) cm
• Weight: about 31 kg
• Auxiliary power plugs: 4 insulated
Configuration Dimensions
• About 50 (L) x 99,5 (H) x 51 (D) cm
Configuration Weight
• About 45 kg
Power Supply
• Voltage operative range:
• 100 ÷ 115V
• 200 ÷ 240 V
• Mains frequency: 50 ÷ 60 Hz
• Power consumption: ≤ 600 VA
• Available power for peripheral units: up to 600 VA
• Fuses: 5A 250V T (200-240V); 10A 250V T (100-115V)
Dimensions
• 51 (L) x 84-106,6 (H) x 65,4 (D) cm
• about 24 kg
Dimensions
• 38 (L) x 69,5 (A) x 63,3 (D) cm
Weight
• about 5.8 kg
RGB printer
• Input: RGB SYNC
• RGB (analog): 0.7 Vp-p, 75 ohm
• SYNC : 5 Vp-p
• Connectors: standard BNC
• Safety standard: IEC 950 o EN60601-1
B/W printer
• Input: Video composite (1 Vp-p, 75 ohm)
• Connectors: standard BNC
• Safety standard: IEC 950 o EN60601-1
VTR
• I/O video: YC
• Y: 1 Vp-p, 75 ohm
• C: 0.3 Vp-p Color burst, 75 ohm
• Tape format: VHS, S-VHS
• Audio traces: 2
• Connectors:
• Video: 4 pin connector
• Audio: jack
• Safety standard: IEC 650 o EN60601-1
NOTE:
Specifications may change without prior notice.
2 INSTALLATION
Please refer to the Getting Started manual for more information on system
components and installation. This manual can be found on the user manual CD and
protected web.
The document numbers are as follows:
English 41B03ENxx
German 41B03DUxx
French 41B03FRxx
Spanish 41B03SPxx
Italian 41B03ITxx
With the exception of the probes, all connectors are located on the rear panel of the
console. The connectors are all clearly identified according to the type of peripheral
unit which they serve.
Rear panel
The table below lists the connectors and their intended use.
Ports indicated in italics are not currently in use
Connector Use
s
C1 ECG cable
C2 Video recorder
C3 B/W or RGB printer
C4 SVGA monitor
C5 Physiological signal
(breath, pressure or
CO2)
C6 LAN connection
C7, C8, C9 USB connections
C10 Footswitch input
The probe connectors are located on the right. The unit has two connectors: one
default and one optional (license enabled) for the electronic probes and one
connector for the Doppler probe.
2.1.2 Battery
The unit can be equipped with an internal battery pack, composed of two batteries,
working when no mains power is available.
Note
The battery pack is installed by ESAOTE personnel. This person will be responsible
for its installation and for ensuring that the system is working properly.
A fully charged battery ensures more then one hour of scanning.
Warning
When MyLab is equipped with its internal battery, do not leave the system exposed
to direct sunlight.
When the system is connected to the power mains and the main switch is on ON, the
battery is continuously charged, even if the unit is switched off. On the other hand,
the battery discharges whenever it is disconnected from the power mains.
Caution
The battery discharging time could be less when the battery pack is worn out.
When the charging level of the battery pack reaches the minimum threshold needed
for working, a flashing yellow frame surrounds the battery icon and the system emits
an intermittent beep. The residual operating time is displayed besides the battery
icon. Either connect the system to the mains power or switch the system off. The unit
automatically switches itself off when the residual operating time is expired.
Note:
Always check both LED’s, whenever the system has to be used disconnected from
the mains.
Charging Procedure
The best way of charging the battery is to connect the system to the power mains
keeping it off. In these conditions the charging cycle lasts around three and a half
hours (3.5 h).
During the charging procedure the battery led is orange: the procedure is completed
when the battery led turns green.
A battery, which has not been used for a month needs to be charged before working.
Warning
Charge and discharge the battery only when the environment temperature is
between 15°C and 30°C.
Note
When the battery is overheated, the status led is green since the pack is not under
charge.
When the battery reaches the maximum threshold of its working condition, a red
cross is displayed over the battery icon
When this occurs, disconnect the power cable and wait for about two hours before
connecting the power cable again, so that the battery cools down.
First Use
A new battery pack could be partially discharged: before using it for the first time,
perform one full charging procedure.
3 MAINTENANCE
3.1.1 Unit
Although the unit is produced with the utmost care and only the highest quality
components are used, maintenance will be necessary from time to time to ensure
trouble-free operation.
• Remove loose dust from the exterior with a soft cloth or a dry brush. A solution of
water with a mild detergent may be used. Avoid aggressive cleaners.
• Check the ventilation fans of the unit for proper operation.
• Remove dust from PCB’s and connectors. Consult paragraph Unit disassembly at
page 12 for disassembly instructions.
• Batteries
• Turn the system upside down (preferably on foam)
• Remove the battery panel by unlocking the panel from the lower cover.
• Remove the battery nearest to the unit rear side first by using the flap, then
remove the second battery.
Note:
The batteries are lithium-ion batteries and must be treated as special waste
according to the applicable local regulations.
Warning:
Do not expose the battery to high temperature. Keep the battery away from fire and
other hear sources.
Please refer to the Transducers and Consumables manual. This manual can be
found on the user manual CD and protected web.
The document numbers are as follows:
English 41B04ENxx
German 41B04DUxx
French 41B04FRxx
Spanish 41B04SPxx
Italian 41B04ITxx
Make sure that the mains cable is disconnected from the mains before opening the
system.
Remove the fan support, fixed with 2 screws to be able to remove the fan and
trackball. Detach the connectors first.
After removing the input board, the TRX1, TRX2, Control and Doppler board (from
top downwards) can be removed by pulling the PCB removers.
To be able to remove the video board and processor board, the 2 screws on the rear
of the unit that secure both boards have to be to remove first
Warning:
When re-assembling the power supply only use the same length screws to mount the
shielding. If longer screws are used components may be touched.
Detach the LCD cable from the mother board by means of a pair of tweezers.
4 EXPLANATIONS
The MyLabFive is built up with the following boards, each with its specific function:
• Input board
• TRX1 and TRX2 board
• Control board
• Doppler board
• Video board
• Processor board
• Connector board
• Power supply
• Keyboard and TGC
The received signals are amplified by the pre-amps and after that the MUX switched
the 96 inputs to 32 groups.
The Variable Gain Amplifier and ADC circuit amplify the signals with the user
controlled gain curve and converts the signals into digital samples.
The digital samples are delayed, summed and filtered in the receive blocks RX1 and
RX2 and forms the 16 bit digital RF signal.
Also the TGC signals are generated which are used on the TRX1 and TRX2 boards.
The CFM Demodulation circuit extracts from the RF signal the phase and quadrature
components. The MTI filtering circuit extracts the high frequency components of the
signal that are associated with the moving targets. The Autocorrelation & CFM
parameters estimation circuit extracts the information concerning the speed, variance
and power of the color signal.
The PW demodulation & CW Digitizing circuit demodulates the Doppler signal and
digitizes the CW Doppler signal. The Doppler processing block receives the
demodulated signal and extracts the FFT spectrum and audio component.
The central processor manages the system, and communicates with the keyboard,
encoders and trackball.
The software located in this circuit contains the resident program and the AOD probe
management tables.
The CPU circuit also controls the Graphic memory which makes it possible to
superimpose the graphics on the ultrasound image.
The ETX board is a piggy back board that takes care of the digital archiving and
connectivity like LAN and USB.
Archiving images is done by reading the Image memory and ECG memory on the
video board.
The Video circuit generates the output signals for VGA and for the peripherals like
printers and VCR.
The image data, ECG and graphics are converted to RGB and the encoders and
DAC convert the signals in t the format of the involved peripheral.
The playback signal of the VCR is fed through the Video decoder into the image
memory.
The ECG circuit processes the physiological signals for presentation on the board.
The circuit filters the notch and extracts the ECG sync and sends the ECG signal to
the processor board for synchronization with the signal being acquired.
The interpolated image data from the control board is stored in the image memory.
When reviewing archived images, the data is coming from the processor board and
stored in the image memory to be processed by the video circuit.
Graphics are mixed with either ultrasound data or archived data in the image memory
as well.
5 Licenses
After start up press MENU and select SERVICE and then SETTINGS.
Now select the DEMO tab.
6 SERVICE INFORMATION
6.1 Configuration screen
To display the configuration screen press the MENU key and select SYSTEM
CONFIGURATION.
General
SYSTEM LICENSES:
GENERAL IMAGING
LICENSES:
CARDIAC
DOPPLER CW
Boards
INPUT [01]
CONTROL [13]
KEY [00]
KEY TGC [00]
PROCESSORS [42]
POWSUPPLY [12]
TRX1 [00]
TRX2 [00]
VIDEO [01]
DOPPLER [00]
The board tab shows the installed boards with their configuration index. (C.I.)
The configuration index indicates the hardware level of the board
DOC # 41B40SM01 27 Esaote Europe
Firmware
The Licenses tab shows the status of the demo licenses. With the aid of the service
key it is possible to activate or de-activate demo licenses.
The listed licenses can be activated by entering the license code, see 5.1 Installing
new licenses on page 26. When activated the involved license will be displayed in the
general tab.
See chapter 5.2 Demo licenses, page 26 for more information on how to activate or
de-activate the demo license.
The result is displayed in the configuration screen which is displayed during start up
or by pressing MENU and SYSTEM CONFIGURATION.
While performing the self test the unit checks whether new features (e.g. licenses)
are installed.
The fields causing the conflicts are displayed in red in the BOARDS tab in the
configuration screen.
Press CANCEL to proceed to the next screen.
The service menu will only be active when the unit has started up with the
service key connected.
The key provides access to the Service menu. The key can be pressed both in
real-time and in freeze state. The system displays this window:
Select the SERVICE option with the trackball and press ENTER to continue. The
system displays the following Service menu:
Setting Parameters:
• Position the trackball on the field to be changed and press to confirm.
• Use the alphanumeric keyboard to type in the characters.
• In the drop down menus, select the required option and press to confirm.
• Press OK to confirm.
Click OK to confirm.
Typically the support used to upgrade the unit is a DVD containing all necessary files.
To be able to update the units software, the external DVD drive, article code
97154411450, is required.
NOTE
The upgrading procedure will remove the drivers of all PC printers added by the
service. The PC printer driver CDs are necessary to install again the printers.
The upgrading procedure will cancel the network settings. Before starting the
upgrade, copy all the settings so that the network can be configured again.
The upgrading could remove the Dicom settings. Before proceeding with the
upgrade, copy the Dicom configuration (both server and printer) so that Dicom can
be configured again should it be necessary.
1. Connect the SERVICE KEY and external DVD Drive model 97154411450 and
switch on the unit.
2. Enter Real-Time.
3. Press ARCHIVE REV and verify if there are archived exams. If so, open the first
and last exams and annotate which images are archived and if the report exists (the
same check will be asked at the end of the upgrading).
4. Insert the update DVD.
5. Press MENU and select SERVICE MENU
6. Select the option “Firmware upgrades” using the trackball and the
ENTER key to confirm.
7. The system displays the window (right) allowing the selection of the
upgrade source drive. Choose the CD/DVD drive and press OK to
confirm.
8. The system shows a list of the files to be installed. All the files marked
with a cross will be loaded. Press OK to start the programming
procedure
9. The upgrade procedure is automatically executed: once
reprogramming has been started, a series of screens indicating the
progress of the upgrade procedure appears on the display.
10. When finished with upgrading the unit will reboot. During the initializing
of the unit a hourglass is displayed. The initializing may take up to 10
minutes.
NOTE
Repeat step 1 through 10 for a second time in case Control board with CI 13 is
installed.
11. Due to the fact that the Windows part is not yet updated, a configuration error is
displayed. Press ESC to ignore.
12. At the end of the upgrade procedure, the system displays the Start Exam window.
Switch off the unit now.
NOTE
If the upgrade procedure has not been carried out correctly, an error message will be
displayed to indicate which file has not been reprogrammed correctly. In this case,
the procedure must be repeated.
1. Leaving the upgrading DVD inserted, remove the service key and then switch on the
unit again.
NOTE
The service key must be removed in order to be sure that the upgrading procedure
ends successfully.
Processors Re-synchronization
1. Switch on again.
2. Wait for the Start End window. During this step (that could last some minutes) the
HD icon stays grey since the system is re-programming its devices. Press OK.
3. Press the key.
4. Select “General preset” option.
5. Once you have accessed to the preset menu, press OK to confirm.
6. Wait till the hourglass disappears and then switch the system off by pressing the
standby key.
7. Turn the unit on and enter Real-Time.
8. Press FREEZE and then POINTER. Verify that there is no purple shadow around
the displayed mouse cursor. If so, insert the upgrading DVD/CD and repeat the
Windows upgrade procedure
9. Press and verify the correspondence of the first and last exams. Should any
inconsistency be noted, run the “Recover archive” procedure (Hard Disk menu).
At the end of the upgrading procedure, insert again the service key to configure, if
necessary, the PC printer, the network and the DICOM server. Remind to save the
new configuration (“Save & Load Configuration” option of the Service menu) and to
print out the new System configuration screen.
NOTE
If the upgrading procedure is interrupted before it is completed, start again from the
beginning.
Backup
In ARCHIVE REV select the exams to backup.
To select more exams, just hold the shift key (alpha numeric keyboard) and select
the exams.
• Select COPY (lower left corner, software key) and select the destination for
the backup.
NOTE
The programmed Hard Disk is always delivered by Esaote with the last software
release installed. Please remind to install the last software release in the unit if not
already done.
Procedure
Once the Hard Disk has been replaced and the Processor board has been
reinstalled, set the following parameters:
This procedure can be activated only if the Service key is inserted before
switching on the unit.
Place the pointer on the desired option and press ENTER to confirm the selection.
Properties
See the Operator manuals for more details
The system displays the free disk space, the name and the IP address of the unit and
its AE Title. This option is always available (i.e. it does not require the Service key to
be shown).
Network Configuration
The Network Configuration can be modified only if the Service key is inserted
before switching on the unit.
Operations
Here all operations on the hard disk will be displayed (e.g. exporting, deleting etc.).
Operations can be aborted, retried, deleted or details concerning the operation can
be displayed.
to
Recover Archive
The system has been designed to preserve as much data integrity as possible. This
procedure allows rebuilding of the archive, if the hard disk is corrupted.
WARNING
Do not switch the unit off while this procedure is running. The Hard Disk could be
damaged.
In order to connect a unit to a network (LAN or wireless LAN), several settings must be
set accordingly. These settings involve windows settings as well as settings in the
resident program. Hereinafter follows a description of which settings should be set for
both LAN and wireless LAN. For LAN settings only the Network Configuration
section 6.9.2 is relevant. These procedures require a service key.
NOTE
It is necessary to have a working knowledge of networking environments. Prior to
starting the configuration procedure, determine characteristics of the network like the
addressing mode (fixed or DHCP), the default gateway IP address, if a DNS server is
present and so on. Thus it is suggested to contact the network administrator before
proceeding with the configuration.
• Select “No not this time” then select next. The following window will pop up.
• Select “include this location in the search” and select the drive and the path
for the drivers of the WiFi USB adapter (CD must be inserted). Then select
next. The following window will pop up.
• Select the wireless network of your choosing. It could be that a network key
is needed to be able to login on the network, if this is the case contact the
network administrator.
• In ARCHIVE REV Place the pointer on the Hard Disk icon and press
UNDO key. The system displays the following Hard Disk configuration menu:
The Network Configuration can be modified only if the Service key is inserted before
switching on the unit.
Some parameters such as: IP address, subnetmask and gateway can also be
configured with the “IP address configuration option” (see next section). For the “IP
address configuration option” the service key is not needed.
• Place the pointer on the “network configuration option” and press ENTER to
confirm the selection. Once activated, the equipment displays the Windows
XP Network configuration menu.
• Place the cursor on the “Internet Protocol (TCP/IP) option” and highlight it by
pressing ENTER.
• Place the cursor on “Properties” button and activate it by pressing ENTER.
The system displays the following TCP/IP configuration menu:
This menu allows selecting either a fixed IP address or a DHCP (Dynamic Host
Configuration Protocol) address and to set the DNS addresses, when necessary.
• Set the desired parameters and press OK to confirm. The network settings
will be operative at next start up.
Assumed that the Network Configuration is set as described in paragraph 6.9, this is
the procedure to set up a network drive, which can be used for archiving purposes. It is
suggested to contact the network administrator before proceeding with the
configuration.
• Press key.
• Select the “Network Directory” option.
• The system displays the following menu.
• Select ADD.
• Select connect drive. The system displays the following menu.
• Enter a description and the drive letter, which has just been mapped.
• Select ok.
• Also select ok in the network drives configuration menu.
• To activate the modifications, please start a new exam, press.
• Now in archive rev you will be able to export your data to your network
directory.
NOTE
Whenever changes have been made to existing network drives, these will not
work anymore after rebooting the system (error will be displayed). All network
drives have to be removed and reinstalled. The following procedure must be
followed.
This procedure can be activated only if the Service key is inserted before
switching on the unit.
Service personnel can customize the report, adding the centre logo, and can modify
measurement descriptions.
Report Configuration
Procedure
• Press key.
• Select the “Report Layout” option.
• Select “Header”.
• Select the desired application.
• The system displays the following menu
NOTE
The logo should be PNG, BMP or JPG format.
Measure Configuration
The measurements descriptions, abbreviations and labels of both Cardiac and
Vascular applications can be modified by the Service personnel.
Procedure
• Press key.
• Select “Application Measurement” option.
• Select the desired application.
• The system displays the application measurement menu. To modify the
description, place the cursor on the desired field and press ENTER.
• With the alphanumeric keyboard enter the new description.
CAUTION
It is possible to change only the descriptions but NOT the calculation combined to the
measure. Each measure is associated to a specific preset calculation (a velocity
measure can be freely named but it will always measure a velocity).
The mains input voltage can be selected by means of the 2 main input voltage
selectors, located on the socket panel.
NOTE
Both selectors should be placed in the same settings (either 120 or 240).
Disconnect the mains cable before changing the selectors.
Do not replace the system fuses with other types from the ones, specified by the
manufacturer.
WARNING
Replace only with the same or equivalent type. The Esaote supplier is: GP, Model
CR2032, 3V 210mA/h.
WARNING
Irritation, including caustic burns and injury may occur following exposure to a leaking
battery.
Procedure
For unit disassembly and gaining acces to the processor board see
chapter 3.2.
Replace the battery cell paying attention to cell orientation. The cell
positive side of the cell (indicated with +) must be placed upwards.
WARNING
Incorrect replacement of the battery can cause battery explosion.
Install the Processor board and Input boards again and close the unit.
Connect an external USB keyboard and switch the unit on.
Press Delete on the external keyboard and Press Alt + Ctrl + Archive Rev to
enter the System BIOS setup
The unit asks for a password, press enter on the USB extern Keyboard.
In the System BIOS setup go to Basic CMOS Configuration and check
the Date and Time.
In the System BIOS setup go to Advanced CMOS Configuration and
check if the option “Power Failure resume time ” is Always OFF.
In the System BIOS setup go to Chipset Configuration and check if the
option “Maximum CPU Frequency” is 1066 MHz.
In the System BIOS setup write to CMOS and Exit.
Disconnect the external USB keyboard.
The system will enter Real Time mode.
In Real Time mode press the MENU key.
Select GENERAL PRESET.
Set the data and time and press OK to confirm.
It is possible to install a Windows USB printer to print out reports and images.
NOTE
Before starting the installation procedure be sure to have the printer driver CD ready.
• Select “No, not this time” and click next. The following screen will pop up.
• Select “Include this location in search” and specify the path were the printer
driver resides or insert the driver CD and select “search removable media”.
Install the printer drivers only because all other printer related software could
interfere with the MyLab software. Click next. The following screen will pop
up.
• Select “Windows printer” and the model of the printer in the peripherals
menu. Set a print profile and click “ok”.
• In the figure above the network printer will be available under button.
Assumed that the Network Configuration is set as described in section 6.9, this is the
procedure to install a network printer. (i.e. the Service key is not required.).
• Enter the IP address of the Network printer and a port name; by default the
port name will be the IP address. Then select “Next”.
Malware Infection
Malware can enter into a computer system when executing a program with a viral
payload. Such a program could be either intentionally or accidentally executed.
Normally, a MyLab system does not allow to intentionally execute other software
NOTE
Esaote does not authorize any operation different from the ones described in the
Operator manual and in the Service manual. Any system malfunctioning caused by
unauthorized operations is considered as falling under the user’s or the technician’s
responsibility.
Antivirus
Esaote does not install an anti-virus program because it could affect the regular
operations of the system: to be really effective, antivirus software should be
configured in a way that heavily limits the system resources, especially regarding the
real-time ultrasound acquisition. Moreover any antivirus software is only effective if
continuously updated (daily basis). As explained above, any update should be
carefully validated by Esaote, to be sure it does not affect the regular operations of
the machine.
In case of serious doubts, it is possible to run an external antivirus program, with the sole
purpose of reporting if the MyLab system has been really attacked by a virus, without
changing its files in any way. We suggest using the Avira Antivir Rescue System. It is a
free product that allows you to burn a bootable CD-R that can be used to scan the MyLab
system.
To use the most recent Avira Antivir Rescue System CD-R please follow this
procedure.
8. Click on the British flag on the lower left to enable the English language:
9. By default, the Avira Antivir Rescue System is configured to examine all the files
on the unit, producing a report without changing anything. Please do not change
these settings, and just press “Start scanner”.
10. Scanning the whole unit could take from a few minutes to many hours, according
to the size of the image database. If the Avira Antivir Rescue System reports any
suspect file:
a. Reboot the machine, remove the Avira Antivir Rescue System CD and
execute a complete backup of the system (archive, settings, etc.).
b. Completely re-install the system software and BIOS using a BIOS CD and an
update DVD with the latest available MyLab software release The update files
are available on the helpdesk FTP site (ftp://gatekeeper2.pie.nl). For more info
see the Technical note regarding a software update, which is available on the
protected web.
Firewall
It is anyway advisable to close any possible access from the data network: for this
reason all unused network ports are closed in the MyLab system.
To minimize the exposition to the threats coming from the network, medical devices
based on a networked computer system, like the MyLab system, should be
connected only to a carefully managed data network, i.e. a network that is carefully
isolated from external networks through suitable firewalls and that is not used to
connect external devices (such as laptops coming from outside the department, etc.).
See for example, the USA Department of Veterans Affairs Medical Device Isolation
Architecture Guide, available at the HIMSS website:
http://www.himss.org/ASP/topics_FocusDynamic.asp?faid=101.
To ensure a complete protection of the MyLab system from any network attack,
Esaote suggests to use a complete agent less intrusion-prevention system: this is a
system that acts like a firewall protecting the network against malware from outside,
but also checks the internal network traffic, without require any additional software
installation in the MyLab system (see for example Trend Micro Network VirusWall
Enforcer or Firebox X Core Unified Threat Management products or SonicWALL TZ
products, or similar).
NOTE
It is suggested to contact the network administrator to know the network policy.
The Log and Shut Down files are useful tools and therefore should be sent to the
helpdesk in case of a problem.
The log files have to be saved soon after the problem occurs or, the latest, at the
next start up. The files have a FIFO structure with a limited memory availability: when
the log file memory is full, the oldest events registered in the files are eliminated to
free space for the recent ones. For this reason the log files have to be saved as soon
as possible. For detailed information on how to save the log files see section 6.8.
Dam Folder
The Dam folder traces the communication between the processors installed
in the unit. The folder contains the following files and folders:
• Dam Service_0.txt, that traces the communication protocol between the
processors. The system model and S/N, the installed software, the installed
licences are logged in this file
• Dam Service.bck, that contains the information on the far operations
• DamShutDown_0.txt, that traces the unit shut downs.
• DamPrintFiles, folder, which contains temporary files for printing operations.
• DamTargetFiles, folder, which contains temporary files for saved
clips/images of the current exam.
• Panoramic, folder, which contains temporary files for saved Panoramic
(VPan tool) images of the current exam.
• ThreeD, folder, that contains temporary files for saved 3D/4D clips/images of
the current exam.
Dinamo Folder
The Dinamo folder traces the DICOM conversion process of the exams. The folder
contains:
• Dinamo-Dicom Service_0.txt, file where the failed operations are traced.
Each Dicom operation is identified by an UID number. Any error, when
present, after a certain UID number can indicate which operation fails.
• QueueSerial.xml, file where the Dicom operations are queued
• Log folder, that traces the used Dicom libraries.
SetUp Folder
This folder logs the setups of a software upgrade.
ThreeDLogs
The folder traces the main operations done in the 3D/4D environment.
Upgrade Folder
This folder logs the processes that automatically run at the first start up after an
upgrade.
7 Safety test
Every MyLab Five unit complies with EN60601-1 (IEC 60601-1) standard. The
MyLab Five is Class I Type B and BF (Ultrasound probe).
We strongly recommend performing Safety Tests every time new peripherals are
powered through the unit or that the unit is opened to perform service.
It is recommended to perform the safety tests every two years. If the system is used
in the Intensive or Coronary Care, it is recommended to perform the safety tests once
a year.
Local directives may be different but are mandatory to comply to.
WARNING
If the measured values exceed the reference values, indicated in the following table,
don’t use the unit. Contact the manufacturer.
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
Requisites:
• Earth leakage tester, such as BIOTEK 01 Pro.
• Metal foil, maximum size 20 x 20 cm.
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. or
equivalent equipment.
• Power the automatic testing equipment through mains supply and the equipment
under test through the automatic equipment.
• Set the automatic equipment according to its user manual in order to perform a
Class I, Type CF equipment test.
If the measured value is higher than the value in the table, do not use the equipment
and contact the manufacturer.
• Activate the procedure for measuring the earth 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 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, contact the manufacturer.
If any of the measured values are higher than the value in the table, do not use the
equipment and contact the manufacturer.
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), immerse
the probe in a saline solution connecting the test lead to a metal plate in the solution.
(Saline = 1000gr water + 50gr salt).
Please refer to the Transducers and Consumables manual for maximum immerse
depth of the probes . This manual can be found on the user manual CD.
The document numbers are as follows:
English 41B04ENxx
German 41B04DUxx
French 41B04FRxx
Spanish 41B04SPxx
Italian 41B04ITxx
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).
• 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
probe and contact the manufacturer.
WARNING
Any break in the probe case or in the probe cable can cause an electrical hazard.
Do not use the probe and contact the manufacturer.
8 ESD
Electro static discharges are not always noticed by men, because ESD is:
• sensed at 3.500 Volt
• audible at 4.500 Volt
• visible at 5.000 Volt
Components and integrated circuits are more sensitive as men and might be damaged
by lower voltage discharges.
To be sure that there is no potential difference between body, boards and work
surface, the work surface should be made of electrostatic dissipative rubber.
The work surface should be connected to a central ground point.
The engineer, handling the boards should also be connected to the central ground
point, either through wrist strap or heal strap (and conductive floor).
To enable ESD field safe service an ESD field service kit has to be used when
handling boards.
This ESD field service kit should be connected to a central ground point and the
service engineer should be connected to the ESD field service kit through a wrist
strap.
Handle boards only on this ESD field service kit and pack in ESD safe packing
material.
ESD safe
Field service kit
All precautions against ESD damage are described in the CECC 00015/I regulations,
composed by the CECC (Cenelec electronic Components
Committee).