Professional Documents
Culture Documents
MyLabX5
MyLabX5VET
350032500
www.esaote.com
Rev. 03
Feb 2019
Copyright © Esaote S.p.A. All rights reserved. Reproduction in whole or in part is prohibited
without the written consent of the copyright owner.
Use of the information contained herein in any form and/or by any whatsoever is strictly
reserved for Esaote S.p.A. and its licensees.
Use of this manual by unauthorized is strictly prohibited.
INDEX
1 INTRODUCTION ................................................................................................... 1
1.1 Service Characteristics ................................................................................... 2
1.1.1 Identifying the Boards .............................................................................. 2
1.1.2 Fuses....................................................................................................... 2
1.2 Equipment ...................................................................................................... 2
1.2.1 Disassembling Equipment ....................................................................... 2
1.2.2 Service Procedures ................................................................................. 3
1.2.3 USB Medium and Re-Writable CD/DVD .................................................. 3
1.2.4 Upgrading File ......................................................................................... 3
1.2.5 Safety Test Equipment ............................................................................ 3
1.3 Warnings and Precautions.............................................................................. 4
1.4 Packaging ....................................................................................................... 4
1.4.1 System packaging ................................................................................... 5
1.4.2 PCB rack packaging ................................................................................ 6
2 BLOCK DIAGRAMS .............................................................................................. 7
2.1 General Block Diagram................................................................................... 8
2.2 Electric and Schematic Diagrams ................................................................. 11
3 UNIT DISASSEMBLY .......................................................................................... 12
3.1 LCD Section ................................................................................................. 13
3.2 Control Panel Section ................................................................................... 18
3.3 Chassis Section ............................................................................................ 19
3.4 Disassembly and assembly procedure PCB rack ......................................... 33
4 PARTS LIST ........................................................................................................ 50
5 MAINTENANCE................................................................................................... 54
5.1 Maintenance Procedures .............................................................................. 54
5.1.1 Battery Cell ............................................................................................ 54
5.1.2 Track ball ............................................................................................... 54
5.1.3 Fans ...................................................................................................... 55
5.1.4 LCD attachment..................................................................................... 55
5.1.5 Battery pack replacement ...................................................................... 56
5.2 Check list ...................................................................................................... 58
5.2.1 Technical Check List ............................................................................. 58
5.2.2 Maintenance Check List ........................................................................ 59
5.3 Cleanliness of product .................................................................................. 61
6 SERVICE INFORMATION ................................................................................... 62
6.1 Service menu................................................................................................ 62
6.1.1 Language settings ................................................................................. 63
6.1.2 Monitor field ........................................................................................... 63
6.1.3 Maintenance .......................................................................................... 63
6.1.4 Set AC filter frequency .......................................................................... 63
6.1.5 Show/hide frame rate on RT images ..................................................... 63
6.1.6 Show/hide system logo ......................................................................... 63
6.1.7 Enable/disable firewall ........................................................................... 63
6.1.8 Show/hide patient birthdate ................................................................... 63
6.1.9 Show/hide operator initials on header ................................................... 63
6.1.10 Enable/disable WiFi ............................................................................... 63
6.1.11 Screen saver time out ........................................................................... 64
6.2 Licenses ....................................................................................................... 64
6.3 Software installation ..................................................................................... 65
6.4 Formatting the Hard drive ............................................................................. 66
6.4.1 Saving unit settings ............................................................................... 67
6.4.2 Format procedure .................................................................................. 68
6.4.3 System reconfiguration .......................................................................... 71
6.5 Rack replacement......................................................................................... 72
6.6 Log Files ....................................................................................................... 73
6.6.1 Log Files Organization .......................................................................... 73
6.6.2 LogParser Executable ........................................................................... 73
6.6.3 User Session ......................................................................................... 75
6.7 Remote Service ............................................................................................ 77
7 SAFETY TEST..................................................................................................... 78
7.1 Safety measurements according IEC 62353 ................................................ 78
7.2 Safety measurements according IEC 60601-1 ............................................. 87
1
Chapter
1 INTRODUCTION
This manual refers to all MyLabX5 and MyLabX5VET ultrasound models, named in
the following chapters as MyLab. The term “MyLab”, used in this manual, refers to all
models. When the information refers to a dedicated model it will be specifically
indicated.
The manual is addressed to all the Service centers directly authorized by Esaote. All
the operations described in this manual are not critical from a safety point of view.
This manual describes the authorized operations.
WARNING
Perform only the operations describes in the manual. Any unauthorized modification
may introduce additional hazards.
Do not attempt to service MyLab unless this service manual has been consulted and
understood.
The Enter and context menu keys are respectively indicated as ENTER and UNDO
keys in this manual.
WARNING
In this manual WARNING identifies a risk for the patient and/or the operator.
CAUTION
The word CAUTION describes the precautions necessary for protecting the
equipment.
1 350032500_03
1.1 Service Characteristics
MyLab’s design is based on the use of modular, functionally isolated printed circuit
boards (PCBs) and subassemblies known as Field Replaceable Unit. This
modularization greatly simplifies on-site service and repair. In most cases, on-site
maintenance is accomplished by removing and replacing the PCBs or
subassemblies.
Most boards of MyLab are identified:
1.1.2 Fuses
WARNING
Do not replace the system fuses with types different from those specified.
1.2 Equipment
In this section the required tools to access the system internal parts are listed
together with the tools to activate the Service procedures and to perform a functional
test of the unit.
Tool Dimension
Dynamometric Phillips electric screwdriver Large, medium and
small tips
Short Philips screwdriver Small tip
Flat screwdriver Large and small tips
Box wrench
Allen screwdriver
Socket Wrench
Tweezer
Point pliers Small tip
The use of an electric screwdriver allows the access time to be minimized. Low
torques are recommended.
2 350032500_03
1.2.2 Service Procedures
The service procedures that require an interaction with the unit, can be activated
through the service key only. The service key must be inserted in one of USB ports.
The key must be inserted before switching on the unit, to be able to access to the
several service menus. If the procedure is not carried out properly, the system
doesn’t allow the access to the menu.
This symbol is used in this manual to indicate all the procedures that require
the use of the service key.
3 350032500_03
1.3 Warnings and Precautions
WARNINGS
It is forbidden to edit or delete files that belong to the software package. Doing so
may compromise the system safety.
PRECAUTIONS
A series of precautions that must be observed each time you perform an operation
on the system are emphasized below:
• The equipment must always be switched off before carrying out any service
operation. In the same way, all the probes and peripherals (for example
external monitor, printer, and video-recorder) must also be disconnected.
• Power off the equipment prior to perform any disassembling operation.
• An electrostatic discharge occurring through the contact with the operator, can
irreparably damage the electronic components on system boards that are
sensitive to electro-static discharges: it is therefore recommended that
precautions to prevent these discharges are taken each time a board has to
be removed/installed. In operational terms, this means:
o The machine must rest on an electro-static mat connected to earth.
o The service technician must also be connected to the same earth each
time he removes or installs the parts.
o The boards and components must always be moved in their special
electro-static containers.
o For the service on the field, use the specific kits including the anti-static
mat.
o The chapter entitled “system Parts List” details the sub-assemblies that
are to be considered sensitive to electro-static discharges (ESD).
When the board is ESD sensitive, you can find this symbol on the PCB master.
1.4 Packaging
Whenever the MyLab or PCB rack has to be shipped, the system or rack has to be
properly packed to prevent trauma damage.
NOTE:
The original packaging has to be stored should it be necessary to ship the system
Warranty will be void if the packing procedure is not followed.
4 350032500_03
1.4.1 System packaging
Procedure
• Disconnect and remove all probes and peripherals from the system.
• Remove the LCD Display and LCD attachment.
• Lower the control panel.Place the system on the palette.
• Rotate the wheels inwards (as shown in the figure below) and lock them using
the gray lever.
• Place the plastic bag and foam buffers (top and bottom).
• Place the carton box over the system.
• Place the carton cover on top.
• Close the box with three (3) layers of adhesive tape.
• Lock the carton box to the palette using two (2) strips and four (4) corner
protections.
CAUTION
The system could be damaged during transportation if the above rules are not
strictly followed.
5 350032500_03
1.4.2 PCB rack packaging
• Place the rack in the package with the probe locking devices facing up.
• Place the upper foam protection on the rack.
• Close the box.
6 350032500_03
2
Chapter
2 BLOCK DIAGRAMS
This chapter contains the block diagram descriptions for each board. The general
Block Diagram shows the relationships of each board having a unique function within
the overall unit.
In the block diagrams, the functions are gathered to permit an easy comprehension
of the block functioning, which indicates the correlative electronic boards.
Figure 1 shows the block diagram of the MyLab unit.
7 350032500_03
2.1 General Block Diagram
8 350032500_03
Probe Adapter Board
The Probe Adapter Board is the board for the connection of the echo probes: the
probes are physically connected to this board.
The board mounts n.3 (three) small connectors together with the switching logic to
enable the active connector.
The main function of the board is to switch among the three probe connectors
selecting the active one for the acquisition.
The board manages the transmission to the probe controlling the pulses to be
transmitted to the elements. The transmitters are individually controlled in terms of
enabling, delaying and pulse shape by a dedicated FPGA.
The board manages also the reception of the signals implementing the receiving
beam former.
The received signals are summed together, amplified, digitally converted and then
sent to the dedicated Rx FPGAs that implement the digital focalization.
CW Acquisition Section
This dedicated section manages the acquisition of the CW signals from their analogic
delay to their A/D conversion.
The FE implements the power supply function distributing the supply voltage within
both FE and BE boards so that all the other needed supply voltages can be
generated. It supplies also the high voltages for probe transmission and the standby
voltages for PC module.
9 350032500_03
Battery Bridge Board
The Battery Bridge board connects the two optional batteries to the Front End.
The bridge includes the power voltages, the SMB logic connections and the
monitoring thermal signals.
The BE board processes the RF signal through a FPGA and n.2 (two) DSPs. The
FPGA processes the RF signal and the Doppler data.
The first DSP controls the processes on the FPGA, the acquisition sequences and
processes both Doppler data and Physio signal. The second filters and mixes the
image data.
An AC/DC module converts the mains voltage to 19V. This voltage powers the
electronics and is sent to the Front End. There is also an AC/DC module that
generates the supply voltage for the main monitor.
10 350032500_03
Keyboard Group
The Keyboard Main board implements:
11 350032500_03
3
Chapter
3 UNIT DISASSEMBLY
The chapter describes the unit disassembly in such way that the major service parts
can be accessed.
In order to carry out all the all the removal procedures, all peripherals, probes and
power cables should be disconnected and removed.
In order to carry out all the removal procedures (with the exception of the battery
replacement), all connected probes, peripherals and cables must be disconnected.
The disassembling instructions are separately given for each part of the unit.
CAUTION
When the unit is equipped with the batteries, always remove them before
disassembling the internal parts of the unit. Short circuits could occur when
disassembling the unit with some tool.
See 5.1.5 Battery pack replacement, page 56.
12 350032500_03
3.1 LCD Section
This section describes the procedures to disassemble the LCD display and the LCD
attachment or articulated arm. The procedures refer to the unit with the wheels locked.
Removal Procedure
• Remove the two (2) small Phillips screws (shown in the below figure) fixing the
rear cover to the LCD display.
• Disconnect the video cable and the power cable from the LCD.
• Place the LCD horizontally and, holding it firmly, remove the four (4) medium
screws that fix the LCD to the articulated arm or LCD attachment.
CAUTION
Hold the LCD display tightly to prevent it from falling down.
13 350032500_03
Friction level of the LCD attachment
The weight of the 21 inch monitor (150000027) is more than the 19 inch monitors.
Therefore it could be necessary to increase the level of friction in the LCD attachment.
Top cover
• Tilt the monitor 45º and adjust the friction level until the monitor stays in
position. To adjust the friction level, slightly fasten the two allan screws as
indicated.
14 350032500_03
Friction level adjustment
Procedure
• Remove the LCD.
• Remove the four cross headed screws of the back cover and remove the cover.
Cover removal
• Remove the seven (7) socket head screws that fix the LCD attachment to the
system.
15 350032500_03
• Disconnect the Earth wire, DVI and Power supply cable of the LCD attachment
from the connectors inside the column of the unit. Inside the column there is a
faston to which the earth wire of the LCD attachment is connected to the unit
(see image for location).
Connectors
Articulated Arm
Procedure
Cover removal
• Loosen the seven (7) socket head screws that fix the articulating arm to the
system.
16 350032500_03
Articulating arm removal
• Disconnect the Earth wire, DVI and Power supply cable of the articulating arm
from the connectors inside the column of the unit. Inside the column there is a
faston to which the earth wire of the LCD attachment is connected to the unit
(see image for location).
Connectors
Connectors
• Finished.
17 350032500_03
3.2 Control Panel Section
This section describes the procedures to remove the keyboard unit and the side- rail.
The procedures refers to the unit in its working position with the wheels locked.
To remove the TGC, B/M, CFM and PW Encoders caps and Toggles no tool is
required.
• Remove the item by pulling it up.
Gel and Probes Holders can be removed by sliding the holder off the lateral support.
Keyboard Unit
Removal Procedure
• Remove the four (4) Phillips screws fixing the keyboard unit to the chassis. The
screws are placed on the lower side of the keyboard unit.
• Lift the keyboard unit.
• Detach the Ground cable and SCSI connector from the keyboard unit.
• Cut the cable ties.
• Remove the keyboard unit.
CAUTION
When assembling the keyboard unit pay attention not to bend the SCSI cable.
18 350032500_03
Side Rail
• Removal Procedure
• If necessary remove the holders.
• Remove the keyboard unit.
• Remove the four socket head screws to disassemble the side rail.
Side rail
19 350032500_03
Fuses
Removal Procedure
• The fuse supports are placed just besides the unit mains switch.
Fuses position
WARNING
Always replace the fuses with ones having the same characteristics (refer to
next section for further information).
20 350032500_03
Rear Panel (housing back)
Removal Procedure
• Remove the rear panel by pulling at the handles in such way that the rear panel
pivots on the bottom part.
Rear panel
Removal Procedure
• Remove the rear panel
• The side panels are locked with rubber locks. Slowly pull on the indicated
position and wait till the lock releases. Then carefully pull to release the other
locks
Side panels
21 350032500_03
• Remove the panel in such way that the panel pivots on the top.
Removal Procedure
• Slowly pull on the cable guides and remove the panel when
• the rubber locks have been released.
Removal Procedure
• Release the two (2) screws fixing the cover to the chassis.
22 350032500_03
• Remove the connector panel
23 350032500_03
Front Panel (housing front)
Removal Procedure
• Remove the rear panel
• Remove the side panels.
• Remove the front top panel.
• Remove the probe connector panel
• Remove the four (4), on each side two (2), medium Phillips screws fixing the
cover to the chassis (see the figure below).
Front panel
• Loosen the two (2) front socket head screws that secure the housing top panel,
in such way that the front panel can be taken out of the rubber locks.
• Remove the front panel carefully from the bottom panel.
24 350032500_03
Batteries
• Removal Procedure
• Remove the rear panel
• Remove the side panels.
• Remove the front top panel.
• Remove the probe connector panel
• Remove the front panel.
Battery panel
• Release the three (3) screws fixing the battery panel to the PCB rack.
• Remove the battery panel.
• Connect the power cable to the system.
• Connect the power cable to the mains.
• Check that the main switch, placed on the rear side, is set to ON. The system
must be OFF and powered.
• Remove the batteries, using the flaps to leverage the batteries.
CAUTION
The Power Supply group could be damaged if the above procedure is not
attended.
25 350032500_03
CAUTION
When the unit is equipped with the batteries, always remove them before
disassembling the internal parts of the unit. Short circuits could occur when
disassembling the unit with some tool.
Boards Rack
• Removal Procedure
• Remove the rear panel
• Remove the side panels.
• Remove the front top panel.
• Remove the probe connector panel
• Remove the front panel.
• If the unit is equipped with batteries, remove the batteries.
• Detach, from the rear side, the cables that are connected to the Boards rack.
• Loosen the four (4) Phillips screws with spring that secure the boards rack (see
the figure below).
Boards rack
• From the front of the unit, tilt the bards rack to be able to detach the connectors
at the bottom side (see the figure below).
26 350032500_03
Boards rack
NOTE
When it is possible, copy both the “ConfSet” and the “Archive” folders (as explained in
the procedure below) before removing the hard disk. These folders allows to re-
configure the system as it is once the hard disk has been replaced.
27 350032500_03
Removal Procedure
• Remove the boards rack.
• The HD cover is placed on the upper side of the boards rack. Unscrew the four
(4) screws fixing the cover.
CAUTION
The probe connector sockets could be damaged if the rack is not placed on the
foam support.
• Unscrew the fifteen (15) screws fixing the rear cover to the rack.
• Unscrew the four (4) screws fixing the hard disk to the rack.
• Using the small slotted screwdriver, remove the hard disk.
Once the rear cover of the boards rack has been removed, you get access to the ID
Button (Hardware ID) and to the battery cell, which can be removed releasing the
spring.
NOTE
The ID Button is always coupled to the system S/N: make sure to install the rack with
its ID Button in the corresponding system S/N.
28 350032500_03
Burner (DVD slim line)
Removal Procedure
• Remove the rear panel
• Remove the side panels.
• Remove the front top panel.
• Remove the probe connector panel
• Remove the front panel.
• Remove the housing top panel unscrewing the four (4) head socket screws and
place the panel aside.
CAUTION
Pay attention to the Wi-Fi antenna when moving the upper panel.
• Unscrew the four (4) nuts fixing the burner to the chassis.
Burner
CAUTION
Pay attention not to drop the screws into the chassis.
29 350032500_03
Mains Entry
Removal Procedure
Remove the rear panel.
Remove four (4) screws fixing the housing back bottom panel to the chassis.
30 350032500_03
Mains entry connections
WARNING
It is mandatory to perform the safety test every time the mains entry has been
replaced. Safety test procedure is described in 7 SAFETY TEST page 78.
NOTE
The wheels marked with a yellow spot are part ESD Wheel 439017000. The ESD
wheels with brake have to be mounted on front side of the scanner
CAUTION
It is strongly recommended that this operation is performed by two persons.
Removal Procedure
NOTE
When replacing the rear wheel or rear wheel covers, the mains entry has to be
removed.
• Lock the wheels placed on the opposite side of the wheel to be removed.
• Tilt the unit.
• Remove the four (4) Phillips screws from the lower side of wheel base. The
center screw should not be removed
• Remove the wheel cover top.
• The wheel can be removed by removing the nut.
• If needed the wheel cover bottom can be removed by removing the center
Phillips screw.
31 350032500_03
Isolation Transformer
Removal Procedure
• Place the unit in horizontal position on the side bar and on the front wheels.
• Remove four (4) screws fixing the housing bottom panel to the chassis.
WARNING
It is mandatory to perform the safety test every time the isolation transformer
has been replaced.
Safety test procedure is described in 7 SAFETY TEST page 78.
32 350032500_03
3.4 Disassembly and assembly procedure PCB rack
Note:
This procedure may be performed only by engineers that passed the Esaote
Advanced Training level and must be performed in an ESD safe workshop.
Performing these actions without training may cause damage to the unit or parts.
REQUISITES
• Toolset
• External USB keyboard
• Kapton tape
• Sil pad 36x36 (4 pcs)
• Sil pad 20x20 (2 pcs)
Tip
Many screws are used and with different length. Do not collect screws in one cup.
Place screws sorted and in order of disassembly. This will help when reassembling the unit again.
Unit disassembly
1) Remove PCB rack as described in 3.3 Chassis Section, page 19.
33 350032500_03
c. Remove the cover carefully. Do not damage the levers.
34 350032500_03
e. Remove the 5 pcs M3 x 6 screws + washer that fix the Probe Adapter board.
35 350032500_03
3) Back side Cover
a) Remove the 15 pcs M3 x 6 screws to remove the Back side cover plate.
b) Remove the 13 pcs M3 x 6 screws that secure the board assembly to the chassis.
36 350032500_03
- 4 screws at fan side
37 350032500_03
- 2 screws at ECG side
38 350032500_03
d) Lead the connectors through the recess to avoid damage.
e) Remove the 2 pcs M3 x 8 screws that fix the Connection bridge board support.
Hold the Connection bridge board support to prevent it from damaging the
Back End board.
f) Remove the Kapton tape from the Back End Board Main LCD connector.
Disconnect the Main LCD, Keyboard LCD, Keyboard (lift lever to unlock), AUX
and WIFI cables from the Back End board.
Note: Mark the connectors for easy orientation.
39 350032500_03
h) Remove the Housing Side, fixed with 3 M3 x 16 + washer from the Board
assembly.
a) Loosen the two screws that secure the Bracket Lock Connectors and remove this
plastic support.
40 350032500_03
c) Remove the 2 pcs Plate for Front End PCB, each fixed with 7 pcs M2 x 14.
41 350032500_03
e) Remove the Sil pads from the frame. New ones have to be placed during re-
assembly.
42 350032500_03
b) Remove the 8 pcs M3 x 8 screws that fix the Back End Board
c) Remove the 5 pcs M2.5 x 6 that fix the Back End Board to the PC module.
43 350032500_03
d) Carefully remove the Back End Board from the frame. Take care about the
connectors that are connected to the PC module and that Sil pads are used.
e) Remove the Sil pads from the frame. New ones have to be placed during re-
assembly.
f) Detach the DVD cable from the Back End Board.
6) PC module + frame
a) Remove the 2 pcs M3 screws that fix the Bracket Lock connector and the 4 pcs
Stand-off M3 H=8 from the side of the frame. Install on the replacement
PC module + frame when applicable.
44 350032500_03
Re-installation
a) Swap ID Button and HDD between original and replacement board when
applicable.
b) Connect the DVD cable to the Back End Board.
c) Place the Back End Board on the frame. Align the holes for the screws. When in
correct position gently push the connectors on the PC module.
d) Place the 5 pcs M2.5 x 6 screws to lock the Back End Board to the PC Module.
45 350032500_03
f) Place Kapton tape as indicated
d) Place the 2 pcs Plate for Front End, each fixed with 7 pcs M2 x 14 screws.
46 350032500_03
e) Connect the Flat cable and place the Bracket Lock Connectors.
Lock with the 2 screws.
9) Housing Side
a) Place Housing Side and fix with 3 pcs M3 x 16 + washer.
47 350032500_03
10) Connection Bridge Board support
a) Connect DVD cable to Connection Bridge Board.
b) Connect the AUX, Keyboard, WIFI and Keyboard LCD cable.
c) Place the Connection Bridge Board support on the Housing side and fix
with 2 pcs M3 x 8 screws.
f) Place the 13 pcs M3 x 6 screws that secure the Board assembly to the chassis.
4 screws at HDD side
4 screws at fan side
2 screws at ECG side
3 screws at bottom side
g) Place the back side cover and fix with 15 pcs M3 x 6 screws.
h) Connect the fan cables
48 350032500_03
11) Probe Adapter Board
a) Place the Probe Adapter Board and fix with 5 pcs M3 x 6.
b) Connect the flat cable to the Probe Adapter Board.
c) Place the Cover Probe Adapter Board with 8 pcs M3 x 6 screws.
d) Place the Connector Support with 2 pcs M3 x 8 screws.
49 350032500_03
4
Chapter
4 PARTS LIST
Batteries
141004100 6400 KIT BATTERY
(Manufactured by: Inspired Energy (www.inspiredenergy.com), P/N 2044HD22)
LCD
150000028 19" High Resolution Wide Screen LCD S/N N
LCD Support
152005501 ARTICULATED ARM
319000300 MONITOR ARM COVER (TOP) 64XX
319000400 MONITOR ARM COVER (BOTTOM) 64XX
319000100 MONITOR PIVOT COVER (TOP) 64XX
152005401 LCD ATACHMENT
270007800 DVI cable articulating arm 6425
270000300 Power extension cable adapter (articulating arm)
50 350032500_03
Control panel covers and small parts
51 350032500_03
Chassis covers and parts
52 350032500_03
Parts list for advanced service
TRC a ESD b
VARIOUS
449024500 Sil-Pad 36x36
449024400 Sil-Pad 20x20
259028500 Connector cable PROBE ADAPTER ASSY-FRONT END BOARD
279001300 S-ATA cable
270000800 Keyboard LCD link cable
2200000155 jumper 50 way
279001600 DVI link cable
53 350032500_03
5
Chapter
5 MAINTENANCE
The unit contains a Lithium battery, located in the PCB rack located on the Back –End
Board.
It is strongly recommended to replace the battery cell every three (3) years. If the PCB
rack has to be stored, it will be necessary to first remove the battery.
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.
NOTE:
After replacing the Battery cell (see 3.3 Chassis Section, page 19), it is required to set
the Time and Date.
Connect an external USB keyboard and start up the unit.
The unit will ask to enter the Time and Date and will then fully start up.
Procedure:
• Apply light pressure and turn the locking ring clock wise, then lift and remove it.
• Remove the ball and clean.
• Clean the encoders with a brush. DO NOT use cleaning spray.
• Reassemble the track ball.
54 350032500_03
5.1.3 Fans
The fans need to be cleaned every 6 months (mandatory for Veterinary units) or once
a year, depending on the environment where the unit is used.
Procedure
• Remove the rack.
• Remove the rear cover of the rack to gain access to the fans.
• Spray compressed air on the fans, derationing the air from inside towards the
outside.
• Close the rack and install again.
Procedure
• Remove the top cover of the LCD attachment or articulated arm.
• Tilt the display 45° to the front.
• Use a 2.5 mm Hex key to adjust the friction. Use the same force on both Hex
bolts.
The friction is correctly adjusted when the display can be set in any position without
tilting.
55 350032500_03
5.1.5 Battery pack replacement
Batteries duration is higher than 300 charging cycles and their replacement is
recommended at least every three years.
CAUTION
Do not use different batteries from the ones specified above.
The battery is Lithium Ion (Li-Ion) battery, FCC approved; the cells, composing the
battery, are UL marked.
NOTE
The batteries must be treated as special waste according to the applicable local
regulations.
The batteries REF 141004100, provided by Esaote, are charged: the last recharging
operation is indicated in the recharging card. The batteries must be fully recharged
every six (6) months when they are kept on stock.
CAUTION
The Power Supply group could be damaged if the battery disassembling
procedure is not attended.
Replacement procedure
1. Remove front cover to get access to the battery cover
(see 3 UNIT DISASSEMBLY)
2. Remove battery cover.
3. Connect unit to mains, mains switch ON but unit OFF
(ON/OFF button lit orange)
4. Replace/install batteries
5. Disconnect mains cable
6. Install covers and connect mains cable
Charging Procedure
The batteries can be charged either by installing them on the unit or by using the
charger manufactured by Inspired Energy:
56 350032500_03
Refer to the manufacturer “Instructions for use” manual to properly manage and
charge the batteries with the charger.
Refer to the “Getting Started” manual to charge the batteries using the unit.
CAUTION
Do not expose the battery to high temperature. Keep the battery away from fire
and other heat sources.
Do not charge the batteries near a heat surface such as fire or heater.
Avoid exposing the battery to excessive shock or vibration.
Do not immerse the battery in water or allow it to get wet.
Do not put the battery into a microwave.
Storage
Extended exposure to temperature above 45°C may degrade battery performance and
reduce battery life. Storage at low temperatures may affect initial battery performance.
57 350032500_03
5.2 Check list
This chapter proposes two different check lists. The first one (Technical Check List)
suggests a set of inspection steps to be performed each time service personnel modify
the HW/SW composition (for example a rack replacement or functional upgrade); the
other one (Maintenance Check List) suggests a check list intended for a general
equipment inspection like yearly maintenance.
Once any HW/SW change, modification or upgrade is finished and the unit is ready to
be closed, perform the following:
58 350032500_03
5.2.2 Maintenance Check List
Physical check
General Check
59 350032500_03
Functional Check
60 350032500_03
5.3 Cleanliness of product
In accordance to international standard ISO 13485 2016 3rd edition, products must be
delivered clean after installation or maintenance.
Please consider that your customer has purchased an excellent High-Quality
Ultrasound system with a modern design. The visual impression of the system is
equally important to your customer’s satisfaction
For that reason, the system must be delivered clean when installing a new system or
after performing maintenance to a system.
Clean the area of the system, dispose of empty cartons or other packing material.
61 350032500_03
6
Chapter
6 SERVICE INFORMATION
To activate the service menu, the unit must be started with the service key
connected.
The unit will start in Windows mode. Now double click the Workflow icon to start the
MyLab software.
Press MENU and select the SERVICE tab, then select the SERVICE button.
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.
62 350032500_03
6.1.1 Language settings
This field selects the default language that can be selected from the available ones in
the dropdown menu.
6.1.3 Maintenance
In the maintenance field the Service Reminder Message can be enabled.
When enabled, the unit will display a reminder for Maintenance after 2000 working
hours or 1 year, whichever comes first.
In the Main Timer Reset field, the timer can be reset to zero. This must be done every
service intervention.
63 350032500_03
6.1.11 Screen saver time out
This option allows to set the timeout (in minutes) after which the screensaver is
automatically activated
NOTE
If a too long timeout (higher than 2 hours) is set, sticking effect could be displayed
on the screen. Always reset this parameter at least to the factory default (that is 61
minutes) whenever it has been increased for Service purposes.
6.2 Licenses
When the system is initialized with the service key inserted, the “LICENCES”
option of the MENU key allows the operator to disable active licenses and to activate
or to reset a demo license.
Place the cursor on the “LICENCES” option and press ENTER to confirm. The system
displays the following window:
The time left for demo license is expressed in minutes. It is decremented every fifteen
(15) minutes
Demo License
Demo licenses last five hundreds (500) working hours before expiring.
Requisites
Preparation
1. Download the SW release file from ownCloud. (link via E-portal)
2. If required, the download can be checked for correctness with the program: Total
Commander.
Open the .ZIP file and open the x440 folder
Open the file SWPACK.MD5 with Total Commander and check for errors.
Continue when there are 0 errors.
3. Format the USB key to avoid virus infection
4. Open the .ZiP file and open folder x440.
5. Extract the folder SWPACK to the root of the USB pen drive. Do not change the
name of this folder or its content.
Installation procedure
1. With the service key inserted, turn on the system.
2. The system will start up in Windows mode.
3. Connect the USB pen drive that contains the Software pack to one of the USB
slots. To speed up the update, it is recommended to use the USB 3.0 slots on the
side of the unit.
4. With Windows File Explorer navigate to the USB pen drive and open it.
5. Open the SWPACK folder
6. Double click the SETUP.exe to start the update process.
7. A message will pop up to make sure the unit is connected to the mains. Click OK
to continue.
65 350032500_03
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.
The format procedure will erase the HDD completely, partition the disc and install the
software.
The procedure is done is several steps:
• Saving unit settings
• Format procedure
• System re-configuration
NOTE: before starting the Formatting of the Hard disk, make sure that all system
licenses are available. Without the Model license the procedure cannot be completed.
License codes can be found in the LOG files. See 6.6 Log Files, page 73
66 350032500_03
6.4.1 Saving unit settings
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.
67 350032500_03
6.4.2 Format procedure
Requisites
• USB memory drive, Min 32GB.
• USB keyboard
• Service Key P/N 140009500
Preparation
1. Download the file Format file (formatx4xx.iso) and program Rufus 2.9 from
ownCloud.
2. Create bootable USB memory drive.
a) Connect USB memory drive to PC
b) Run the program rufus.exe. NOTE: DO NOT update when asked.
c) Set the Rufus fields as indicated below:
1) Select
USB drive
5) Enter
Volume label
“WinPE”
4) un-check
6) Start
Process
68 350032500_03
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 ESC on the keyboard, while starting up.
Password: Fireball
Select: Boot menu; Boot Type Order; select USB at first position
Save and exit with YES.
69 350032500_03
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
70 350032500_03
h. Enter system license and optional licenses:
a. Press the MENU key and select the License key.
b. Select the MODEL tab and enter the System license in the appropriate
field.
c. Type the unit serial number in the serial number field.
d. Press VERIFY and then SAFE.
e. Restart and enter all optional licenses.
f. Press Verify and then SAFE.
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:
71 350032500_03
2. Settings installation
• Depending on how the settings had been saved, follow the corresponding
procedure:
NOTE
When the settings are not saved nor exported, the settings must be set manually.
NOTE:
When ready, set the startup priority back to HDD/SSD.
Whenever the rack has been replaced, both the ID button and, when possible, the
hard disk have to be installed.
NOTE
All the system’s licenses are correlated to the ID button.
Procedure
• Remove the ID button from the fault rack
• Install the ID button on the new rack.
• Remove the hard disk from the faulty rack.
• Install the hard disk on the new rack.
• Install the rack and close the system.
CAUTION
The rack must be packaged in its original box to prevent its damage: refer to 1.4
Packaging for details.
72 350032500_03
6.6 Log Files
The log file has to be saved soon after the problem occurs or, at the latest, at the next
start up. The file has a FIFO structure with a limited memory availability: When the log
file memory is full, the oldest events registered in the file are eliminated to free space
for the recent ones.
For this reason the log file has to be saved as soon as possible.
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
73 350032500_03
The utility is organized in four main areas.
TextLog Folder
The TextLog folder, containing the log files, is displayed in the upper left area
(indicated by the number “1” in the above figure). Place the cursor on the “+” symbol
displayed beside the name and press ENTER to display its contents.
This folder contains the list of all entries done on the system that is the list of all times
the unit has been switched on. Each entry is so listed:
The first date and time indicate when the unit has been turned on; the second date
and time when the unit has been turned off.
When an entry is selected, the areas “2” and “3” show the logged information related
to this entry.
In the left bottom area (“2”) the following system information is listed:
• model name
• installed licences and the corresponding licence numbers
• installed build
• the ID button number
• hardware characteristics
In the main area (“3”) the list of the operations logged for the selected entry is
displayed.
The three buttons displayed at the bottom of the area “3” allow to change the zoom
factor (buttons “-” and “+”) and to refresh the log of the operations.
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.
74 350032500_03
6.6.3 User Session
Whenever the log has to be analyzed, the simplest way is to follow the procedure:
• Expand the TextLog folder.
• Select the entry to be analyzed.
• Select in the right combo box the UserSession option.
The logged operations are displayed in chronological order, showing the operations
done by the user.
The main phases of the exam are clearly indicated by data delimiters, like:
When an error occurs the delimiters allow to identify in which phase happens.
75 350032500_03
Logged Errors
The errors are reported in the upper right list, as shown in the figure below.
The error log group displays all the errors occurred in the system.
76 350032500_03
6.7 Remote Service
The “Remote Service” option of the MENU key allows the Service personnel to access
to MyLab in remote. When the Remote Service is active, the Service personnel can
remotely interact with the user and with the system looking at its screen and at its
disks.
Pre Conditions
The access to the Remote Service is possible only when:
• MyLab system is connected to the network (refer to the user manuals for further
information)
• the Service personnel has a PC connected to the network
• the Service personnel has an Esaote account for Remote Service
• the Service personnel has an account to work with the LogMeIn Rescue
application (either via Web or locally)
NOTE:
Contact the Esaote Service department for accounts and further information on
Remote Service
To activate the Remote Service session, the Service personnel has to provide the
customer with two PIN numbers. The PINs can be used one time only.
NOTE:
The “Clinical and System Configuration” section of the Advanced Operations manual
has a dedicated chapter on Remote Service, to guide the user to the activation.
77 350032500_03
7
Chapter
7 SAFETY TEST
Every MyLab unit complies with EN60601-1 (IEC 60601-1) standard.
The MyLab units are Class I Type B and BF (Ultrasound probe) and CF (ECG)
applied parts.
It is mandatory to perform Safety Tests every time new peripherals are powered
through the cart or you had to replace any of the following parts:
• Boards Rack
• Power Supply
• Mains entry
• Mains cable
• Isolation transformer
• Probe adapter board
Anyway we suggest repeating the safety tests every two years. If the system is used
in the Intensive or Coronary Care, we suggest repeating the safety tests once a year.
WARNING
Whenever the measured values exceed the reference ones (see the following
table) don’t use the unit and send it to ESAOTE
Applicability
The standard IEC 62353 ed. 2 is applicable for Recurrent test and test after repair of
medical electrical equipment.
78 350032500_03
Electrical Safety Test on MyLab devices
Aim of this Technical Note is to highlight the importance of the Electrical Safety Tests
and provide the necessary instruction to properly execute them.
Electrical Safety Tests certify that the risks of electric shocks for patient and operator
are minimized.
The verification of electrical safety is an extremely important step for recurrent test
and test after repair of medical electrical equipment and during the installation
process. The results of the electrical safety verification must be annotated in the
“TEST CERTIFICATE AND VERIFICATION FORM”.
All MyLab units comply with the requirements of EN60601-1 (IEC 60601-1) Medical
Electrical Equipment standard. All MyLab systems are Class I, using applied parts
being Type B and BF (ultrasound probes) and CF (ECG, when available).
It is mandatory to perform Electrical Safety Tests in all the following cases:
1. every time the transducer is dropped;
2. every time a new peripheral is powered through the unit/cart;
3. every time you had to replace any of the following parts related to:
a Mains Power: ASB board, AC/DC converter, mains and/or power boards,
mains cables, insulation transformer.
b Activities that involve substitution or temporary disconnection of ground
able and/or metal parts being part of Protective earth (PE) protection
c (Enhanced) ECG Board/back-end board, ECG cable
d Power Supply Plug
4. repeat the safety test when replacing the parts indicated in the service manual
5. when a used MyLab is installed by Esaote to a different customer /clinical site
It is mandatory to perform the Electrical Safety Tests every two years, once a year in
the Intensive or Coronary Care.
In case local/hospital directives are more restrictive, it is mandatory to comply with
their directives.
Whenever the measured values exceed the reference ones indicated in Limits table
on page Error! Bookmark not defined.:
DO NOT USE the unit and contact Esaote Technical Assistance.
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.
79 350032500_03
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.
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.
80 350032500_03
Test set-up procedure
Power the automatic testing equipment through mains supply and the equipment
under test through the automatic equipment, as shown in the figure on the next page.
Rigel 62353+
81 350032500_03
Note: Probe placed in container with 0.9 saline solution.
The ECG cable must be connected to the MyLab ECG connector (if present) and the
Applied Parts terminals in the automatic equipment (see above).
Set the automatic equipment according to its user manual in order to perform a Class
I, Type CF equipment test.
82 350032500_03
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.
83 350032500_03
Measurement of the Patient Leakage Current
(ECG cable when ECG is available)
• Insert the ECG cable leads in the applied parts terminals in the automatic
equipment.
• When testing ME EQUIPMENT with multiple Applied Parts, connect them
each in turn and comply with the applicable limits in Table 2. Applied Parts not
part of the measurement shall be floating.
1. Activate the procedure simulating the application of the mains voltage, by
means of the automatic equipment, to the plugs on the patient cable and
check that the value indicated complies with the indication given in the
reference table for the single fault condition (SFC).
• Repeat the above measurement procedures inverting the polarity of the power
conductors, by means of the automatic equipment.
If any of the measured values are higher than the value in the table, do not use the
equipment and replace the ECG patient cable. Repeat the procedure with the new
cable and if the values continue to be higher, contact Esaote Technical Assistance.
• 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.
84 350032500_03
7.1.1 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.
85 350032500_03
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
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.
88 350032500_03
Measurement of Earth leakage current
CAUTION
In all the conditions in which it is necessary power on the MyLab system press
the pause key immediately after the power on button in order to avoid the
Windows start up. This operation is very important in order to avoid data loss
and hard disk damages.
• Activate the procedure for measuring the earth leakage current on the automatic
equipment:
1.1 Check that the value indicated complies with the indications given in the
reference table for normal condition (NC).
1.2 Repeat the procedure simulating a break in a power conductor, by means
of the automatic equipment, and check that the value indicated complies with
the indications given in the reference table for the single fault condition
(SFC).
• Repeat the above measurement procedures inverting the polarity of the power
conductors, by means of the automatic equipment
If any measured value is higher than the value in the table, do not use the equipment
and replace the power cable. Repeat the procedure with the new cable and if the
values continue to be higher, send the equipment to ESAOTE.
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.
89 350032500_03
Measurement the Patient Leakage Current (ECG cable)
• Insert the ECG cable leads in the applied parts terminals in the automatic
equipment.
1.1 Activate the procedure for measuring the Patient leakage current on the
automatic equipment and check that the value indicated complies with the
indications given in the reference table for the normal condition (NC).
1.2 Repeat the procedure simulating a break in the earth wire, by means of the
automatic equipment, and check that the value indicated complies with the
indications given in the reference table for the single fault condition (SFC).
1.3 Repeat the procedure simulating a break in a power conductor, by means of
the automatic equipment, and check that the value indicated complies with
the indications given in the reference table for the single fault condition
(SFC).
1.4 Repeat the procedure simulating the application of the mains voltage, by
means of the automatic equipment, to the plugs on the patient cable and
check that the value indicated complies with the indication given in the
reference table for the single fault condition (SFC).
• Repeat the above measurement procedures inverting the polarity of the power
conductors, by means of the automatic equipment.
• If any of the measured values are higher than the value in the table, do not use
the equipment and replace the ECG patient cable. Repeat the procedure with the
new cable and if the values continue to be higher, send the equipment to
ESAOTE.
• 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
90 350032500_03
Probe safety tests
For any probe in use with the unit, repeat the procedure for measuring the Patient
Leakage Current test (without application of mains voltage on applied part), wrapping
the probe enclosure with the metal foil and connecting the test lead to it. The test
must be performed in any Real Time mode application. The probe must be
connected to the unit
1.1 Activate the procedure for measuring the Patient leakage current on the
automatic equipment and check that the value indicated complies with the
indications given in the reference table for the normal condition (NC).
1.2 Repeat the procedure simulating a break in the earth wire, by means of the
automatic equipment, and check that the value indicated complies with the
indications given in the reference table for the single fault condition (SFC).
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.
91 350032500_03