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Service Manual
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1 INTRODUCTION ................................................................................................... 1
1.1 The MyLab ........................................................................................................ 1
1.2 Configurations................................................................................................... 2
1.2.1 Arm-Held Configuration ............................................................................. 2
1.2.2 Desk Stand Operation................................................................................ 2
1.2.3 Mobile Configuration .................................................................................. 2
1.3 Warning and Precautions.................................................................................. 3
1.4 Specifications.................................................................................................... 3
1.4.1 MyLab ........................................................................................................ 3
1.4.2 Desk Stand ................................................................................................ 5
1.4.3 Mains Adapter............................................................................................ 5
1.4.4 Trolley Configuration.................................................................................. 6
1.4.5 Connectivity Option for Trolley ................................................................... 6
1.4.6 Battery Module Option for Trolley .............................................................. 7
1.4.7 Safety Standards ....................................................................................... 7
1.4.8 Probes ....................................................................................................... 8
2 Installation.............................................................................................................. 9
2.1 Identifying Connectors and Switches ................................................................ 9
2.2 Installing the System ....................................................................................... 13
2.2.1 MyLab ...................................................................................................... 13
2.2.2 Desk Stand .............................................................................................. 13
2.2.3 Trolley ...................................................................................................... 14
2.3 Revisions of the Deskstand and Rollstand...................................................... 16
2.4 Battery............................................................................................................. 18
2.5 Acclimation Time............................................................................................. 20
2.6 Setting Time and Date .................................................................................... 21
2.7 Setting the User Interface language................................................................ 22
2.8 Touch Screen Calibration................................................................................ 23
2.9 Tilt Sensor Calibration..................................................................................... 23
2.10 Display Orientation ....................................................................................... 24
2.11 MyLab Handle-Keys ..................................................................................... 24
2.12 Probe Keys ................................................................................................... 25
3 MAINTENANCE................................................................................................... 26
3.1 Planned Maintenance ..................................................................................... 26
3.2 Parts List ......................................................................................................... 27
4 Licenses............................................................................................................... 28
4.1 Activating Licenses. ........................................................................................ 28
5 SERVICE INFORMATION ................................................................................... 29
5.1 System Administration .................................................................................... 29
5.1.1 System Configuration............................................................................... 30
5.1.2 System Options........................................................................................ 31
5.1.3 Backup/Restore ....................................................................................... 32
5.2 Service Menu .................................................................................................. 33
5.2.1 Temperature/Fans Tab ............................................................................ 33
5.2.2 Battery Tab .............................................................................................. 34
1 INTRODUCTION
This service manual is intended for MyLabOne (all versions), MyLabOne Vet,
MyLabSat, MyLabSat Vet and MyLabTouch. These systems will be referred to
as MyLab.
The system has one small ZIF probe connector and is equipped with a battery able to
operate independently from mains connection. The battery is integrated in the handle of
the system and is very easy and fast to access.
The system, also in combination with the accessories, offers a great flexibility through
different ways of use:
A Roll-Stand for mobile use is available. This solution permits the MyLab to be
easily moved through any clinical sites and offers a comfortable and
dedicated support for the system.
A Desk Stand is available as option for MyLab, the system can be comfortable
used on tables or any carts in clinical sites. With the Desk Stand advanced
connectivity solutions are added to the whole configuration
MyLab can also be used as wall-mount system (or on an articulated arm) by
use of the VESA attachment present on the back of the system stand-alone or
on the back of the docking station of the Desk Stand.
The system can be used stand-alone allowing the user to easily carry the
system and bring ultrasound wherever it is needed. It can be easily moved
between roll stand, Desk Stand and wall mount by the simple click-in
mechanism.
The system can be operated both in portrait and landscape modes. Tilting the system
will automatically rotate the user interface that will be adjusted according to the
orientation of the system in any direction.
1.4 Specifications
1.4.1 MyLab
Display
12” TFT LCD Touch screen
Probe connectors
1 x ZIF probe connector
Connectors
2 x USB 2.0
Docking station connector
Power connector for DC adapter
Connectivity
Wireless connectivity for networks and wireless devices
LAN (optional, with Desk Stand and Trolley)
USB 2.01
1
The maximum current supplied by the USB ports of MyLab is 500mA. Peripherals
requiring more power and exceeding this limit can be connected to MyLab ONLY IF
powered by their own external power supply.
Software
Operating system: Windows XP Embedded
Multi-lingual
Software/Firmware upgrades are performed by DVD
Biometry
Basic and advanced measurements and calculations, general and application-
dependent.
Annotations, Body marks
Peripherals
Via USB connection, e.g. Thermal/Inkjet printers, memory sticks etc.
Dimensions
115 (H) x 340 (W) x 315 (D) mm
Weight
Approximately of 6.0 kg for full configuration
Probe: approx. 0.5kg
DC Power Jack
Contact rating: 7.5A max. @ 20V DC
Battery
Li-ion 14.4V
Life expectancy: min. 300 charge/discharge cycles
Operating requirements
Temperature: 1535C
Humidity: 1595 % (without condensation)
Pressure: 7001060 hPa
Storage requirements
Temperature: -20 +60C
Humidity: 595 % (without condensation)
Pressure: 7001060 hPa
Connectors
3 x USB 2.0
LAN RJ45
Footswitch
DVI-I
Audio line-out
Microphone
Docking station connector
Power connector for DC adapter
Dimensions
290 (H) x 250 (W) x 280 (D) mm
Weight
Approximately of 3.8 kg
DC Power Jack
Contact rating: 7.5A max. @ 20V DC
Operating requirements
Temperature: 1535C
Humidity: 1595 % (not condensing)
Pressure: 7001060 hPa
Storage requirements
Temperature: -20 +60C
Humidity: 595 % (not condensing)
Pressure: 7001060 hPa
Specifications
Voltage operative range: 100 240 Vac
Mains frequency: 47 63 Hz
Power consumption: 1.4-0.6A
0utput 120W max.
19V DC, 6.32A max.
Operating requirements
Temperature: 1535C
Humidity: 1595 % (not condensing)
Pressure: 7001060 hPa
Connectors
Docking connector
Dimensions
Work surface height: approx. min. 1010 mm – Max. 1310 mm (H)
Max. height with MyLab installed: approx. min. 1260 mm– Max. 1560 mm (H)
Base dimensions: approx. 500 (L) x 470 (W) mm
Printer tray: approx. 390 (L) x 280 (W) x 470 (H) mm
Work surface: approx. 300 (L) x 410 (W) x 980 (H) mm
Weight
Approximately 22 kg
Power Supply
Voltage operative range: 100 240 Vac
Mains frequency: 47 63 Hz
Output voltage 19V
0utput 200W max.
Fuses:
200 – 240 V => 250 V / T 5 A
100 – 120 V => 250 V / T 10 A
Battery
12V
38 Ah
Weight 15 kg
Optional Mains Entry for Trolley
Human
Probe ID Modes TEI
Vet
Probe ID Modes TEI
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.
The document numbers are as follows:
English 81Bx3ENxx
German 81Bx3DUxx
French 81Bx3FRxx
Spanish 81Bx3SPxx
Italian 81Bx3ITxx
System
All the controls and ports are located on the exterior of the console and can be clearly
identified. Their description is provided hereinafter:
Desk Stand
The MyLab can be used upon a Desk Stand. This makes it possible to create a
stable work environment if the MyLab is used on a desk.
C11
C14
C15
C15 a
C16
C17
System Connection
If the MyLab unit is not used in arm held position make sure that the MyLab is placed on a
stable and horizontal work surface. Make sure that all four feet of the MyLab are in contact
with the work surface. If the system is meant to work on mains power, please use the DC
adapter.
CAUTION
Do not switch off the machine before the initialization has finished.
Probes Connection
The probe connector is located at the right bottom side of the system. The MyLab is
equipped with 1 Zero Insertion Force (ZIF) probe connector.
The probes should be connected to the ZIF-connector. Make sure that the ZIF
connector handle is in an open position, align the pins of the two connectors and
carefully fit the probe connector. To secure it, lock the handle
Marker on scanner
The trolley is supplied assembled except for the probe holders and Probe cable
holder (arm).
Probe holders
Slide the probe holders onto the edge of the working surface, starting from the corner
of the table.
Socket in base
The same DC adapter that is used for The MyLab in normal operation is also used to
power The MyLab if the system is mounted on the trolley. Open the
cover on the base of the trolley, place the DC adapter in the middle and mount the
bracket that is used to hold the adapter into position. Then connect the DC adapter
cable to the socket inside the base. Finally connect the mains cable to the adapter.
WARNING
Don’t park the system on a slope. Don’t use the brakes to park the system on a slope.
Deskstands and Rollstands with disabled USB ports have a certain revision
letter.
Deskstand: Revision B. The Deskstand label is marked: R. B
Rollstand: Revision D. The Rollstand label is marked: R. D
MyLab units with revision 04 can be removed from the Deskstand or Rollstand
during operation (hot docking) without the risk that the unit crashes.
Deskstand
Unit Unit
Rev <04 Rev 04
2.4 Battery
When no mains power is available, the MyLab can operate on its internal battery pack. A
fully charged double battery pack allows about 3 hours of operation time.
CAUTION
When the MyLab is equipped with its internal battery pack, do not leave the system
exposed to direct sunlight to avoid overheating of the battery.
WARNING
The battery pack will self-discharge over time, the maximum charge retention of a fully
charged battery pack is ninety (90) days. Make sure that a fully charged battery pack will
be re-charged each 3 months. A partially charged battery pack needs to be re-charged
earlier. A Li-Ion battery will be destroyed if it is fully depleted. The battery pack capacity
will decrease over time, because of aging of the battery pack.
WARNING
Stop immediately using MyLab and disconnect the mains power if the system functions in
an abnormal manner, produces unusual sounds or smell or overheats. In any of these
cases please contact your Esaote representative
WARNING
Do NOT open or alter batteries.
WARNING
If the battery is incorrectly installed it may explode. Replace only with same type.
MyLab automatically switches off when the minimum charge for proper operation is
reached. The following warning message will then appear:
The charge icon is located next to the battery icon. If it is visible, MyLab is
connected to the mains power and the battery pack is being charged.
Charging Procedure
The battery pack is always recharged if the scanner is connected to the mains power
independently from the fact that the system is on or off. The most efficient way to charge
the battery pack is to connect the system to the mains power without switching the unit on.
A battery, which has not been used for some time, needs to be recharged before
operation.
CAUTION
Charge the MyLab only with the provided mains adapter.
Manufacturer/Model:
Protek Power
Model: PMP 120F-13-2
Class II
WARNING Charge and discharge the battery only when the environmental temperature is
between 15°C and 30°C.
First Use
A new battery pack could be partially discharged if it is used for the first time, therefore
recharge a new battery pack.
Select the SYSTEM SETUP touch screen key and select the DISPLAY touch screen key.
On the GENERAL tab the time, date and language can be set.
NOTE!
To be sure settings are being saved properly; the unit must not be turned off within 5
seconds of changing a setting.
NOTE
It is important to make use of the touch screen stylus for accurate calibration.
Use the touch screen stylus to point out the calibration marks on the screen and follow the
procedure according to the system. When the procedure is finished, the system returns to
the initial screen.
When performing the calibration of the touch screen it could be the case that the last
part of the calibration (the verification part) is difficult to complete. This can be caused
by a calibration that is not executed accurate enough.
To avoid this an USB mouse can be connected to the unit. If connected the mouse
pointer will be visible. In this way the location on the screen that is touched with the
stylus is visable (i.e. the mouse pointer will move to the location that is touched).This
procedure should ease the verification part of the touch screen calibration.
The buttons can be programmed by holding down a button on the handle and press
any user interface key on the screen simultaneously. The programmed key will get
The buttons can be programmed by holding down a button on the probe and press any
control panel key on the screen simultaneously. The programmed key is indicated with
a mark that is linked to the corresponding button on the probe.
3 MAINTENANCE
WARNING
Turn off the system before any cleaning operation. Liquid, also spray, may cause electrical
shock.
To clean the system, use a soft cloth slightly dampened with water. If necessary, apply a
small amount of ammonia- and alcohol-free, not abrasive detergent onto a clean, soft cloth
and then wipe the surface. Switch the system off and rub the outside with the cloth.
When dust and dirt accumulates in the system vents, remove the substance with a low-
powered vacuum cleaner.
WARNING
Make sure that the detergent has completely evaporated before turning on the equipment.
CAUTION
Do not use any type of ammonia-, alcohol- or benzene-based cleaners on the case.
To clean the LCD screen, use a soft dry cloth, lightly rubbing the display surface.
CAUTION
Do not use detergents or other liquids directly on the screen. Immediately dry any drops of
water that may fall on the screen as they could stain the screen.
The probe and gel holders are easily removed from their location for cleaning and can be
washed in a mild soap solution. Make sure they are completely dry prior to replacing them.
For cleaning of probes please refer to the Transducers and Consumables manual. This
manual can be found on the user manual CD.
The document numbers are as follows:
English 81Bx4ENxx
German 81Bx4DUxx
French 81Bx4FRxx
Spanish 81Bx4SPxx
Italian 81Bx4ITxx
4 LICENSES
This tab summarizes the status of the available licenses (active, inactive or demo).
The user can activate licenses by selecting them and entering the relative license
code. License codes are generated according to the System ID of the system. If a
demo license has been activated, this shows the time left. In order to enter a new
license, perform the following steps:
Select the option to be enabled in the Options list.
Enter the license code in the New License field.
Press SUBMIT.
If the number is correct, the status will change into a positive check and the license
becomes instantly functional. Please consider that the system is case sensitive.
Note!
On the SYSTEM OPTIONS tab licenses can only be activated. Deactivation of licenses or
managing of demo licenses is done on the license tab of the SERVICE tab (as
described further along in this manual).
5 SERVICE INFORMATION
On the MENU screen select the MISCELLANEOUS touch screen key and choose the
SYSTEM ADMINISTRATION touch screen key.
This tab provides information about the system Hardware, Software and
Firmware configuration. Whenever consulting the help desk, please mention the
System version number.
CAUTION
The INSTALL DEFAULT SETTINGS key will restore all settings to factory settings with loss of
all user modifications.
This tab summarizes the status of the licenses and demo licenses. Licenses can be
activated by selecting them and entering the relative license code. See chapter 4.1
CAUTION
The system is equipped with several USB ports. Insert only one USB medium in either
of the ports during data archiving or exporting.
Backup
The type of settings that can be saved are listed in the page and can be selectively
activated for the backup operation.
Connect the USB medium to the system and press the BACKUP key to start the backup
procedure. Please wait until the procedure is finished. When the procedure is finished
touch the OK key to continue. If the external drive has not enough storage capacity for
the backup, the following warning will pop up: “Backup failed: Data does not fit on
destination drive”.
NOTE
Make a backup of the settings on regular bases.
The SERVICE TAB will only be active when the service key is inserted. It is not
necessary to restart the unit.
When the service key is inserted the SERVICE TAB will become visible. The SERVICE
TAB has several sub tabs:
Temperature tab
Fans tab
Battery tab
Tilt sensor tab
Log tab
System Tab
Licenses tab
MyLibrary
This tab shows the actual temperature and the temperature history of several printed
circuit boards. The actual temperatures shown above can be considered as normal
condition.
Acceptable temperature = Normal Condition +10˚C.
DOC # 81B40SM04 33 Esaote Europe
This tab also shows the actual speed of the 5 fans and the history. The speed of the
fans is depending on the temperature inside the unit. When the temperature
increases, the fans will speed up. When the temperature has been decreased the
fans will slow down.
On this tab the tilt sensor of the unit can be tested. If the unit is tilted in a specific
direction the red dot also should move in that direction.
This tab shows the most recent log file. The Log files are useful tools and therefore
should be sent to the helpdesk in case of a problem. The log files have to be saved
On this Tab the display method of the frequency in B-Mode and M-mode can be set.
Either Numeric or Text can be selected.
On the license tab also the demo licenses can be managed. Demo licenses can be
activated or deactivated separately. Each demo license has duration of 500 hours. If
the 500 hours of one of demo license has expired, the demo license can be extended
5 times. This extension will reset all demo licenses to 500 hours.
To extend the demo license select RESET DEMO TIMERS. The following screen will pop
up.
To extend the demo license a demo license number is required. To obtain this
number contact our sales department and supply them with the SYSTEM ID of the
unit and inform them which demo license number is needed (demo license number 1,
2, 3, 4 or 5).
Enter the demo license number on the RESET DEMO TIMERS screen and select RESET
TIMERS. On the LICENSE tab the demo licenses will be reset to 500. This can be
checked under “TIME LEFT”. After entering the demo license code there will be 500
hours of time left.
After extending the demo license, activate the specific demo licenses on the LICENSE
tab. If a demo license is activated it is indicated with a checkmark. If all needed demo
licenses have been activated leave the LICENSE tab, for instance by selecting the
USER tab.
To check if the demo licenses are active, access the SYSTEM OPTIONS tab. To access
this tab select: the SETTINGS tab and the MENU touch screen key. On the SETTINGS
screen select SYSTEM ADMINISTRATION. On the SYSTEM ADMINISTRATION screen select the
SYSTEM OPTIONS tab. The activated demo licenses are indicated with a green
checkmark.
For this procedure one of the supported external dvd/cd-rom drives has to
be used: Sony USB DVD-burner DRX-S70-U/W or Sony USB DVD-burner
DRX-S77-U/W.
To upgrade the system, the system must boot from the Upgrade DVD.
Make sure the system is off.
Connect the external power supply, the external DVD drive and the USB
keyboard to the system.
Place the Upgrade DVD in the drive.
Turn the system on.
When the system boots with the DVD, press any key on the USB keyboard when
the system prompts: “Press any key to boot from CD or DVD”.
A series of checks are performed to determine if the system is indeed a
MyLab, a touch screen is present, check the system board version, PC
module version, if the system is running on external power and if a service key
is present.
When prompted for the service key, the keyboard can be removed from the USB
port to make place for the service key. It’s also possible to connect all USB
devices at once by using a deskstand or rollstand with activated USB ports (see
Technical note 81A35X101) or a separate USB hub.
If all checks are OK, an Upgrade button is unlocked on screen. When pressed,
the system will load the new system version image onto the C: drive of the
MyLab unit.
If the upgrade has completed, a reboot button is shown. Please first disconnect
the external DVD drive from the unit before pressing this button to finish the
installation.
After reboot, a second upgrade phase will start. During this phase, the system
version image is ‘resealed’ and the flash memory is programmed. After
programming the flash memory, the system will automatically power down.
The installation is ready now. If the unit is turned on it will start with the new
system version.
Note!
INSTALL DEFAULTS will erase all presets, network, dicom and printer settings.
Before executing “install defaults” be sure to backup the presets, network and dicom
settings and make sure that the printer driver CD’s are available for installation after
the update.
Recommendations:
If no user presets were defined prior the software update, we recommend to
execute INSTALL DEFAULTS to obtain the latest default presets for the
specific unit.
If user presets were defined prior the software update, don’t execute INSTALL
DEFAULTS before saving the user presets to an external drive because
otherwise the user presets will be lost.
5.4 Archiving
5.4.1 Archive Menu
Hard Network DICOM Archival
Disk The archival system icons, such as hard drive (More/less
than 20% of free space), network and Dicom, are shown at
top right of the screen. An icon is shown with an exclamation
mark whenever there are management problems involving
the specific archival system. By pressing an icon a pop up
menu will appear.
Bluetooth Wireless
connection
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.
Wireless network
Be sure that the Wireless connection adapter is enabled. Check that there is no red
cross in the Wireless connection icon (upper right hand corner of the screen). If there
is a cross in the icon, enable the Wireless connection adapter by selecting the
Wireless connection touch screen icon. The following menu will pop up.
Enable the Wireless connection adapter by touching the ENABLE key. The red cross
on the icon will disappear.
Enter the Network Configuration menu by selecting the SETTINGS tab and the MENU
button. In the Network Configuration menu select the NETWORK DRIVE touch screen
key. The following screen appears.
This screen manages the network drives. Drives can be added, deleted or edited.
To add a network drive select ADD. The following menu will pop up.
Enter the Dicom menu by selecting the SETTINGS tab and the MENU button. In the
PERIPHERALS menu select the DICOM touch screen key. The Dicom screen has several
tabs. On this tabs the connection to the Dicom network can be configured. For a
detailed description on dicom see the system configuration section of the Advance
operations of the user manual.
Operations
On this screen all running and completed operations concerning the USB drive are
displayed.
NOTE Whenever there is a failed operation status, the DETAIL key will be activated.
This function provides more information according to the type of failure.
WARNING
Do not switch the unit off while executing this procedure. The hard disk could be
permanently damaged.
Select the Burner icon (upper right hand corner of the screen). The following menu
will pop up:
Operations
On this screen all running and completed operations concerning the Burner are
displayed.
NOTE
Whenever there is a failed operation status, the DETAIL key will be activated. This
function provides more information according to the type of failure.
Erase Device
This option is used to delete stored data on rewritable CDs. Insert the rewritable CD,
select ERASE DEVICE to begin the procedure.
WARNING
Do not switch the unit off while executing this procedure. The hard disk could be
permanently damaged.
On the Bluetooth screen the desired wireless keyboard and/or mouse can be
connected or disconnected. To refresh the device list please select the REFRESH touch
screen key.
NOTE
Be sure that the specific wireless adapter is enabled whenever a wireless connection
to a network or a connection to a device should be established.
For this procedure one of the supported external dvd/cd-rom drives has to be
used: Sony USB DVD-burner DRX-S70-U/W or Sony USB DVD-burner DRX-
S77-U/W.
NOTE
Before starting the installation procedure be sure to have the printer driver CD ready.
Now connect the printer to the unit. If there is no driver available for this
specific printer, the printer will appear in the device manager list marked
with an acclamation mark.
In the popup menu select “No not this time”. Click next.
In the popup menu select the location were the printer driver (*.inf) resides.
Note!
Some printer manufacturers supply a driver CD/DVD without separate “*.inf” driver
files. If this is the case either the driver CD/DVD is compiled to start automatically
(autorun) or there is an executable on the CD/DVD. If this is the case run the printer
driver installer. When the installer asks for the type of installation, be sure to select
the type where you can select the features to be installed. Only install the features
that are necessary. Unnecessary features could interfere with scanner operations.
On this screen select the installed printer. The other options on this screen will
be explained in the following chapter.
For this procedure one of the supported external dvd/cd-rom drives has to be
used: Sony USB DVD-burner DRX-S70-U/W or Sony USB DVD-burner
DRX-S77-U/W.
Select “create a new port” and make the selection “Standard TCP/IP Port”.
Then select “Next”.
On this screen select the installed printer. The other options on this screen
will be explained in the following chapter.
To enter the DIGITAL PRINTER screen select the SETTINGS tab and the MENU button on
the start screen. On the next screen select the PERIPHERALS touch screen key and
choose DIGITAL PRINTER. The next screen will pop up.
Field Action
Printer This pull-down menu lists the digital printers that can be
connected to the MyLab.
Printer Type Sets the printer to use sheets or rolls for paper input.
Print Key Selection Enables the print key for the digital printer to be visible on
the screen.
Images Per Sheet Sets the number of pictures that should be printed on one
page. The images are sized properly accordingly.
BW - Color Sets the printer to print in color or BW.
Orientation Sets the orientation of the page (portrait or landscape).
White Background Sets the printer to print the parts of the pictures outside
the ultrasound image in white.
Include Header Includes Physician Name and/or Hospital Name to print
out.
Include Footer Includes Patient Name and/or Date to print out.
The format archive icon gradually becomes blue as images are sent to the printer.
The figure displays the print format set on 3x2 and three images
(colored in blue) are sent to the printer. Printing takes place when
the icon is completely filled.
The printing function is also available off line, i.e. when the printer is not physically
connected to the system. In this case, printouts are temporarily stored on the hard disk.
Printing is automatically activated once the printer is connected.
Force Print
To print before formatting is complete, press the FORCE PRINT key to start printing.
Reset Page
The option cancels all images sent to the printer for this format: the image counter
will be automatically reset.
6 SAFETY TEST
Every unit complies with EN60601-1 (IEC 60601-1) standard. MyLab is classified as
Class II, with applied parts of type BF (probes).
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.
NOTE! When performing the safety tests always insert a charged battery into the
unit. Because then the unit will not be damged by an incomplete boot sequence.
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
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 II, Type BF equipment test.
If any of the measured values are higher than the value in the table, do not use the
equipment and contact the manufacturer.
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 81Bx4ENxx
German 81Bx4DUxx
French 81Bx4FRxx
Spanish 81Bx4SPxx
Italian 81Bx4ITxx
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 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.
7 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.
ESD safe
Field service kit