Zimmer Sonido Smart User manual

Instructions for Use
SonidoSmart
EN

Ultrasound diagnostic system
Model
SonidoSmart
Dec. 2017
Instructions for use
For: SonidoSmart from
SN 1701001
Ident. no. EN 10102699TM 1217

CE mark
This product conforms to the essential requirements of the Medical Devices
Directive 93/42/EEC. Accessories without the CE mark are not guaranteed
to meet the essential requirements of the Medical Devices Directive.
These instructions for use refer to the device SonidoSmart ab SN 1701001. Please verify that you are
using the most up-to-date version of this document. If you need the latest edition, please contact your
distributor.
NOTE:
Important:
1. No part of this manual may be abridged, altered, copied or reprinted, in whole or in part, without the
prior written permission of Zimmer MedizinSysteme GmbH.
2. The contents of this manual are subject to change without prior notice and without legal obligation.
3. Before using the system, please read this manual carefully and completely. The instructions for use
constitute an integral part of the appliance. Please keep the instructions for use in an easily accessi-
ble place after reading. If you have any questions or doubts, please contact ZIMMER MEDIZINSYS-
TEME or your authorised service technician.

NOTE:
Important information
1. It is the operator’s responsibility to maintain and service the system after delivery.
2. The warranty does not cover the following items, even during the warranty period:
a) Damage or loss due to improper use or misuse of the system and probes, for example due to
dropping the probe, or if liquid or metal parts get into the system.
b) Damage caused by force majeure, such as fire, earthquakes, floods or lightning etc., dam-
age or loss caused by failure to meet the specified conditions for this system, such as inade-
quate power supply, improper installation or inappropriate environmental conditions.
d) Damage or loss caused by transportation not approved by ZIMMER MEDIZINSYSTEME.
e) Damage or loss due to use of the system outside the region in which the system was origi-
nally sold.
f) Damage or loss caused by the purchase of the system from a source other than ZIMMER
MEDIZINSYSTEME or one of its authorised dealers.
3. Do not make changes or modifications to the software or hardware of the system or probes.
4. The LCD display may have some dark or light dots; this is normal for the LCD display and does
not mean that the LCD screen is defective.
5. If the user has any questions or concerns while operating the system, or if anything is unclear,
please contact your ZIMMER MEDIZINSYSTEME-authorised service technician immediately.
Please describe the situation clearly in order to resolve the problem in good time.
Please do not operate the system until the problem has been resolved.
6. This system must not be used by persons other than fully trained medical personnel.
7. It is strictly prohibited to use the device for determining the sex of a fetus, except where this
is medically necessary. The device can only be sold to qualified medical facilities or doctors.
Users must fully understand and master the operating principle of the device before putting
it into operation. Users must have the qualifications and comply with local laws and regula-
tions, local rules of faith and practices, etc.
8. Should the system be modified or repaired by persons other than qualified ZIMMER
MEDIZINSYSTEME service technicians, ZIMMER MEDIZINSYSTEME will assume no lia-
bility for the system.
9. The purpose of this system is to provide physicians with data for clinical diagnosis. The di-
agnostic procedure is the responsibility of the physician. ZIMMER MEDIZINSYSTEME is
not liable for the results of diagnostic procedures.
10. These instructions for use contain warnings about possible foreseeable hazards, but the
user should always be aware of dangers that are not listed here. ZIMMER MEDIZINSYS-
TEME shall not be liable for damage or loss resulting from negligence or failure to observe
the precautions and instructions described in this manual.

11. ZIMMER MEDIZINSYSTEME shall not be liable for consequences arising from negligence
or failure to follow the instructions for use.
12. Before and after each ultrasound examination, please check the probe surface and the probe cable
and covering for abnormalities such as cracking, peeling and deformation. Please also check that
the lens is firmly mounted. Abnormally functioning probes can cause electric shock and injure the
patient. As soon as any abnormal functioning occurs, the device must no longer be used, and an au-
thorised service technician from ZIMMER MEDIZINSYSTEME must be contacted.
13. If the probe has been dropped or scratched by sharp parts, discontinue use immediately
and contact an authorised ZIMMER MEDIZINSYSTEME service technician to ensure the
safety and effectiveness of the device before use.
14. If any liquid or metal enters the system, please switch the system off immediately and stop
using it. Please contact an authorised ZIMMER MEDIZINSYSTEME service technician first
to make sure the device is working safely before using it again.
15. Please do not use solvents (such as paint thinners, benzene, or alcohol) or abrasive
cleansers for cleaning the system (including the monitor and probes, etc). These can cor-
rode the system and probes.
16. When the system or probe has exceeded its operational lifespan, please refer to the operat-
ing manual, section 9.4
17. Important data must be saved to external storage media. ZIMMER MEDIZINSYSTEME
shall not be liable for loss of data in the system memory caused by operator error or acci-
dents.
18. Please keep this operating manual near the system to ensure that users and service tech-
nicians can access it at all times.
Caution: It is strictly prohibited to use this device to determine the sex of a fetus, except where
absolutely necessary for medical purposes. The device can only be sold to qualified
medical facilities or doctors. Users must fully understand and master the functional
principles of the device before putting the system into operation. Users must have the
appropriate qualifications and comply with local laws and regulations, rules of faith and
practices, etc.
Caution: Users must read the operating manual carefully before putting the device into opera-
tion. By turning on the device, users signify that they have read the operating manual
and accept the precautions, warnings, and notes listed within it.

SONIDOSMART digital ultrasound
Contents
Chapter 1 Introduction........................................................................................................................................1
1.1 System overview ..............................................................................................................................1
1.1.1 Intended use/indications ........................................................................................................1
1.1.2 Contraindications ..................................................................................................................1
1.1.3 Contact information ...............................................................................................................1
Chapter 2 System safety ....................................................................................................................................2
2.1 Safety overview................................................................................................................................2
2.2 Electrical safety................................................................................................................................3
2.3 Label/icon........................................................................................................................................6
2.3.1 Warning symbols .................................................................................................................6
2.4 Devices in the patient environment.....................................................................................................7
2.5 Biological safety ...............................................................................................................................9
2.6 Scanning patients and training.........................................................................................................10
2.6.1 Guidelines for safe scanning ................................................................................................10
2.6.2 Understanding the MI/TI display ...........................................................................................11
2.6.3 Instructions for handling the battery ......................................................................................16
Chapter 3 System introduction ..........................................................................................................................17
3.1 Console overview...........................................................................................................................17
3.2 Dimensions....................................................................................................................................17
3.3 View..............................................................................................................................................17
3.4 Introduction to functions..................................................................................................................19
3.4.1 Image modes......................................................................................................................19
3.4.2 Accessories........................................................................................................................20
3.4.3 System configuration...........................................................................................................20
3.4.4 Scope of delivery ................................................................................................................21
3.4.5 Standard scope of delivery...................................................................................................21
3.4.6 Probes...............................................................................................................................21
3.4.7 Licences ............................................................................................................................21

SONIDOSMART digital ultrasound
3.5 Installation procedure......................................................................................................................21
3.5.1 Environmental conditions.....................................................................................................22
3.5.2 Turning the system on .........................................................................................................25
3.5.3 Probe installation ................................................................................................................25
3.5.4 Installation of accessories....................................................................................................26
4.1 Alphanumeric keyboard ..................................................................................................................27
4.2 Function keys/knobs.......................................................................................................................27
4.2.1 SWITCH.............................................................................................................................27
4.2.2 PATIENT............................................................................................................................27
4.2.3 PROBE ..............................................................................................................................27
4.2.4 SETUP ..............................................................................................................................28
4.2.5 END ..................................................................................................................................28
4.2.6 Body marker.......................................................................................................................28
4.2.7 COMMENTS ......................................................................................................................28
4.2.8 ARROWS...........................................................................................................................28
4.2.9 DEL ...................................................................................................................................29
4.2.10 Pressure ............................................................................................................................29
4.2.11 Archive ..............................................................................................................................29
4.2.12 Report................................................................................................................................29
4.2.13 Parameter control button......................................................................................................29
4.3 Central control unit .........................................................................................................................30
4.3.1 ENTER ..............................................................................................................................30
4.3.2 UPDATE ............................................................................................................................30
4.3.3 EXIT ..................................................................................................................................30
4.3.4 Cursor................................................................................................................................30
4.3.5 CHANGE ...........................................................................................................................30
4.3.6 Distance measurement (DIST) .............................................................................................31
4.3.7 Curve (TRACE)...................................................................................................................31
4.3.8 Calculate (CALC)................................................................................................................31

SONIDOSMART digital ultrasound
4.3.9 MENU................................................................................................................................31
4.3.10 Trackball ............................................................................................................................31
4.4 Image mode key.............................................................................................................................31
4.4.1 B.......................................................................................................................................31
4.4.2 B/B and 4B.........................................................................................................................31
4.4.3 M.......................................................................................................................................32
4.5 Image control.................................................................................................................................32
4.5.1 THI ....................................................................................................................................32
4.5.2 AIO....................................................................................................................................32
4.5.3 CINE..................................................................................................................................32
4.5.4 SAVE.................................................................................................................................32
4.5.5 Reverse left/right.................................................................................................................32
4.5.6 Invert up/down....................................................................................................................33
4.5.7 STC...................................................................................................................................33
4.5.8 GAIN .................................................................................................................................33
4.5.9 ANGLE/ZOOM knob............................................................................................................33
4.5.10 DEPTH/FOCUS knob ..........................................................................................................33
4.5.11 Info display with indication of the device status.......................................................................33
4.5.12 CONTROL LIGHT...............................................................................................................34
Chapter 5 Operating and examination mode.......................................................................................................35
5.1 Preparing the system for use...........................................................................................................35
5.1.1 Device inspection................................................................................................................35
5.1.2 Turning on..........................................................................................................................35
5.2 Selecting the examination mode ......................................................................................................35
5.2.1 Probe detection...................................................................................................................35
5.2.2 Mode selection ...................................................................................................................35
5.3 Inputting patient information ............................................................................................................36
5.4 Image editing interface....................................................................................................................37
5.5 Display mode.................................................................................................................................37

SONIDOSMART digital ultrasound
5.5.1 B mode ..............................................................................................................................37
5.5.2 B/B mode ...........................................................................................................................37
5.5.3 4B mode ............................................................................................................................37
5.5.4 B/M mode...........................................................................................................................38
5.5.5 M mode..............................................................................................................................38
5.5.6 PW mode...........................................................................................................................38
5.6 Image adjustment...........................................................................................................................39
5.6.1 Frequency..........................................................................................................................39
5.6.2 Dynamics ...........................................................................................................................39
5.6.3 i-image...............................................................................................................................39
5.6.4 Connection.........................................................................................................................39
5.6.5 PW ....................................................................................................................................40
5.6.6 M speed adjustment............................................................................................................40
5.6.7 GAIN .................................................................................................................................40
5.6.8 STC...................................................................................................................................40
5.6.9 Depth.................................................................................................................................40
5.6.10 Focus ................................................................................................................................40
5.6.11 Angle.................................................................................................................................40
5.6.12 ANGLE/ZOOM....................................................................................................................40
5.6.13 INVERT .............................................................................................................................40
5.6.14 THI ....................................................................................................................................41
5.6.15 AIO....................................................................................................................................41
5.7 B image menu adjustment...............................................................................................................41
5.7.1 Scan width .........................................................................................................................41
5.7.2 Focus point.........................................................................................................................41
5.7.3 Persistence ........................................................................................................................41
5.7.4 Line density........................................................................................................................41
5.7.5 Smoothing..........................................................................................................................42
5.7.6 Edge enhancement .............................................................................................................42

SONIDOSMART digital ultrasound
5.7.7 Acoustic power ...................................................................................................................42
5.7.8 SRA...................................................................................................................................42
5.7.9 Utility software ....................................................................................................................42
5.7.10 Advance.............................................................................................................................42
5.8 PW image adjustment.....................................................................................................................44
5.8.1 Steering angle ....................................................................................................................44
5.8.2 Frequency..........................................................................................................................44
5.8.3 D 2D map...........................................................................................................................44
5.8.4 Enhance ............................................................................................................................44
5.8.5 D gamma ...........................................................................................................................44
5.8.6 Dynamics ...........................................................................................................................44
5.8.7 Pixel ratio ...........................................................................................................................44
5.8.8 Colour map.........................................................................................................................45
5.8.9 Audio.................................................................................................................................45
5.8.10 Acoustic power ...................................................................................................................45
5.8.11 Invert .................................................................................................................................45
5.8.12 Wall filter............................................................................................................................45
5.8.13 Velocity ..............................................................................................................................45
5.8.14 PRF...................................................................................................................................45
5.8.15 Baseline.............................................................................................................................45
5.9 Full-screen display (this feature must be activated in setup)................................................................46
5.10 Edit comments ...............................................................................................................................46
5.10.1 Overview............................................................................................................................46
5.10.2 Inputting characters.............................................................................................................46
5.10.3 Inputting comments from the character library........................................................................47
5.10.4 Editing quick comments.......................................................................................................47
5.10.5 Inputting quick comments ....................................................................................................47
5.10.6 Moving comments...............................................................................................................47
5.10.7Editing comments ...............................................................................................................47

SONIDOSMART digital ultrasound
5.10.8 Deleting comments .............................................................................................................47
5.11 Setting a body marker.....................................................................................................................48
5.11.1 General description .............................................................................................................48
5.11.2 Using body markers ............................................................................................................52
5.12 Set the direction of the arrow...........................................................................................................52
5.13 Image and cine configuration...........................................................................................................53
5.13.1 The principle of cine storage ................................................................................................53
5.13.2 Manual loop........................................................................................................................54
5.13.3 Automatic loop....................................................................................................................54
5.13.4 Saving and recalling images.................................................................................................54
5.13.5 Saving and retrieving cines ..................................................................................................54
5.13.6 Deleting images..................................................................................................................54
5.13.7 Sending images..................................................................................................................54
5.14 Browsing an image.........................................................................................................................54
5.15 Archive management......................................................................................................................56
5.16 Report...........................................................................................................................................57
5.17 DICOM..........................................................................................................................................58
5.17.1 DICOM Worklist..................................................................................................................58
5.17.2 DICOM storage...................................................................................................................58
5.17.3 DICOM printing...................................................................................................................59
Chapter 6 Measurements and calculations.........................................................................................................60
6.1 Keyboard for measurement .............................................................................................................60
6.1.1 Trackball ............................................................................................................................60
6.1.2 [ENTER] ............................................................................................................................60
6.1.3 [UPDATE] ..........................................................................................................................60
6.1.4 [DEL] .................................................................................................................................61
6.1.5 [Change] ............................................................................................................................61
6.1.6 [Exit] ..................................................................................................................................61
6.1.7 Parameter control button......................................................................................................61

SONIDOSMART digital ultrasound
6.2 B mode general measurement methods ...........................................................................................61
6.2.1 Distance meas....................................................................................................................61
6.2.2 Ellipse................................................................................................................................61
6.2.3 Trace.................................................................................................................................62
6.2.4 Histogram...........................................................................................................................62
6.2.5 Cross-sectional diagram ......................................................................................................63
6.3 B quick measurement .....................................................................................................................63
6.4 Normal measurement and calculation in B mode ...............................................................................64
6.5 ABD measurement and calculation...................................................................................................66
6.6 Obstetrics measurement and calculation...........................................................................................67
6.6.1 Estimated date of delivery....................................................................................................70
6.6.2 Growth curves ....................................................................................................................70
6.7 Paediatric measurement .................................................................................................................71
6.7.1 HIP angle...........................................................................................................................71
6.8 GYN measurement and calculation ..................................................................................................71
6.9 Small parts measurement and calculation.........................................................................................74
6.10 B mode vessel measurement and calculation....................................................................................75
6.11 Urology measurement and calculation..............................................................................................75
6.12 Cardiac measurement and calculation..............................................................................................76
6.13 Normal measurement and calculation in M, B/M mode.......................................................................77
6.13.1 meas. ................................................................................................................................77
6.13.2 Time ..................................................................................................................................77
6.13.3 Heart rate...........................................................................................................................77
6.13.4 Velocity..............................................................................................................................78
6.14 General measurement in M mode ....................................................................................................78
6.15 M abdomen measurement...............................................................................................................79
6.16 Obstetrics measurements in M mode ...............................................................................................79
6.17 GYN measurement in M mode.........................................................................................................79
6.18 Cardiac measurement in M mode.....................................................................................................79

SONIDOSMART digital ultrasound
6.19 Urology M measurement.................................................................................................................81
6.20 Small parts M measurement............................................................................................................81
6.21 Paediatrics M measurement ............................................................................................................81
6.22 PW mode measurement methods ....................................................................................................81
6.22.1 Velocity..............................................................................................................................82
6.22.2 Time ..................................................................................................................................82
6.22.3 Heart rate...........................................................................................................................82
6.22.4 Auto trace ..........................................................................................................................82
6.22.5 Manual trace.......................................................................................................................82
6.23 PW quick measurement ..................................................................................................................82
6.24 PW general measurement...............................................................................................................83
6.25 PW abdomen measurement ............................................................................................................84
6.26 PW OB measurement.....................................................................................................................84
6.27 PW GYN measurement...................................................................................................................84
6.28 PW cardiology measurement...........................................................................................................85
6.29 PW vascular measurement..............................................................................................................88
6.30 PW urology measurement...............................................................................................................88
6.31 PW small parts measurement..........................................................................................................88
6.32 PW paediatrics adjustment..............................................................................................................88
Chapter 7 Presets............................................................................................................................................89
7.1 General setup ................................................................................................................................89
7.2 Measurement.................................................................................................................................91
7.2.1 General measurement setup ................................................................................................91
7.2.2 Measurement formula setup.................................................................................................92
7.3 Annotation .....................................................................................................................................99
7.3.1 Annotations library ..............................................................................................................99
7.3.1.1 Edit the annotation library ....................................................................................................99
7.3.2 Edit an annotation .............................................................................................................100
7.4 Body markers...............................................................................................................................101

SONIDOSMART digital ultrasound
7.4.1 Library of body markers .....................................................................................................101
7.4.1.1 Edit the body marker library................................................................................................101
7.4.2 Editing body markers.........................................................................................................102
7.4.3 Body marker options .........................................................................................................102
7.5 Examination mode........................................................................................................................102
7.5.1 Editing the examination mode ............................................................................................102
7.5.2 Examination mode selection...............................................................................................103
7.6 DICOM........................................................................................................................................105
7.6.1 Adding/editing the DICOM function .....................................................................................106
7.7 Network.......................................................................................................................................106
7.8 System........................................................................................................................................106
7.8.1 System information ...........................................................................................................106
7.8.2 Upgrading ........................................................................................................................107
7.8.3 Function setup..................................................................................................................107
7.8.4 Installation setup...............................................................................................................107
7.8.5 Video VGA .......................................................................................................................107
7.8.6 Image function..................................................................................................................107
7.8.7 System maintenance.........................................................................................................107
7.8.8 USB video printer option....................................................................................................107
Chapter 8 System maintenance ......................................................................................................................108
8.1 Cleaning the machine ...................................................................................................................108
8.2 Probe maintenance ......................................................................................................................108
8.3 Safety check ................................................................................................................................110
8.4 Checking for malfunctions .............................................................................................................111
8.5 Function test................................................................................................................................112
Chapter 9 Probes ..........................................................................................................................................113
9.1 General description ......................................................................................................................113
9.2 Care and maintenance..................................................................................................................113
9.2.1 Inspecting the probes ........................................................................................................113

SONIDOSMART digital ultrasound
9.2.2 Cleaning and disinfection...................................................................................................114
9.3 Probe operating instructions..........................................................................................................121
9.3.1 Scanning the patient..........................................................................................................121
9.3.2 Operating the transvaginal probe........................................................................................122
9.3.3 Cleaning and disinfecting TV and TR probes .......................................................................122
9.3.4 Thermal and probe tip angle monitoring...............................................................................123
9.4 Service responsibility ....................................................................................................................124
Appendix A: Acoustic output report table.......................................................................................................126
Appendix B: EMC guidelines and manufacturer's declaration ..........................................................................151
Appendix C: Summary of measurement results .............................................................................................155
Appendix D Display accuracy and acoustic measurement uncertainties ...........................................................156
Appendix E: Maximum surface temperature for the transducer........................................................................157

1
Chapter 1 Introduction
This manual contains necessary information for safe operation of the system. Please read all the instructions contained
in this operating manual carefully before putting the system into operation. Always store the operating manual near the
device and regularly review the procedures for operation and the safety precautions.
1.1 System overview
1.1.1 Intended use/indications
The device is a general-purpose diagnostic ultrasonic instrument intended for use by qualified physicians to evaluate
fetuses/for obstetrics; for abdominal (GYN & Urology); paediatrics; small parts (breast, testes, thyroid) examinations; for
cardiac examinations (paediatrics); peripheral vessels, musculoskeletal, conventional, superficial and transvaginal exam-
inations.
1.1.2 Contraindications
The system is NOT intended for ophthalmic use or any examinations that cause the acoustic beam to pass through the
eye.
1.1.3 Contact information
For additional information or assistance, please contact your local distributor or the appropriate support resource as
specified below:
The ZIMMER MEDIZINSYSTEME website www.Zimmer.de
Service support Zimmer MedizinSysteme GmbH
Junkersstrasse 9
89231 Neu-Ulm
Germany
Tel.: [phone]
E-mail: [e-mail]
Manufacturer Zimmer MedizinSysteme GmbH
Junkersstrasse 9
89231 Neu-Ulm
Germany
Tel.: [phone]
E-mail: [e-mail]

2
Chapter 2 System safety
2.1 Safety overview
This section deals with measures for ensuring the safety of users and patients. In order to ensure the safety of users and
patients, please read the corresponding information in this chapter before putting the system into operation. Failure to
observe the warnings or breach of the relevant regulations can lead to injuries, or even the loss of life, to users
or patients.
Users must observe the following precautions:
This system is of Type BF and complies with the applicable EN and IEC standards.
This system may not be modified in any way. Necessary changes to the device may only be carried out by the manufac-
turer or by its appointed representatives.
This system was fully calibrated at the factory. Do not adjust any fixed adjustable parts.
In the event of a malfunction, turn off the system immediately and inform the manufacturer or its designated agent.
The system's power cable should only be connected to an earthed protective power socket. Do not under any circum-
stances remove the earthing cable.
Only connect this system to electronic or mechanical devices that comply with the EN60601-1 standard. Check the
leakage current and other safety parameters of the entire system to avoid possible damage and risks caused by leak-
age currents and their overburdening.
The system does not have any special protective measures for the event that it is combined with high-frequency devices.
The operator should use extreme caution with these types of devices, as a matter of principle.
The system may only be installed by persons authorised by the manufacturer. Do not attempt to install the system your-
self.
Maintenance be only be performed by an authorised service technician.
The system may be used only by a qualified operator, or under qualified supervision.
Do not use this system in the vicinity of inflammable substances, otherwise an explosion may occur. Do not continu-
ously scan the same part of a patient's body or expose the patient to extensive scanning. This could harm the patient.
When using the system for ultrasound testing, use only appropriate ultrasound gel that complies with the system specifi-
cations.
Do not unplug the probe from the system when it is in active operation. Always go to the examination screen when
you need to remove the probe.
To prevent injury to the arms or the neck region, the operator should not stay in the same position for too long during the
examination.
Do not place any liquids on top of the device.

3
NOTE:
The system has a built-in screensaver to prevent damage to the display. It is not recommended to continually turn the
unit on and off. To dispose of this product properly, please contact your local service department.
2.2 Electrical safety
Type of device protection against electric shock
CLASS I DEVICE, where protection against electric shock is based not solely on BASE ISOLATION; the device also has
protective earthing. This additional safety precaution prevents exposed metal parts from becoming LIVE should there be
an insulation failure.
Degree of protection against electric shock
Type BF applied part (for probes marked with the BF symbol)
TYPE BF APPLIED PART, providing a specified degree of protection against electric shock, in particular with regard to
the permitted leakage current.
BF: Insulation against earth; max. patient leakage current: under normal conditions < 100 μA,
in the event of the first failure < 500 μA
Degree of protection against harmful ingress of water
The parts of the probe that are likely to come in contact with the user or the patient meet the requirements for protection
against dripping water (IPX1). The parts of the probe that are intended for immersion in the course of normal use meet
the requirements for protection against temporary submersion (IPX7). The IP classification of the device is that for ordi-
nary devices (no protection, IPX0).
Safety level for use in oxygen-enriched environments, inflammable anaesthetics or other inflammable or com-
bustion-promoting substances
The device is not suitable for use in oxygen-enriched environments, inflammable anaesthetics or other inflammable or
combustion-promoting substances.

4
Operating mode
Continuous operation
For maximum safety, follow these guidelines at all times:
Proper earthing of the system is crucial in order to avoid electric shock. To ensure proper earthing, use a power cable
with a protective conductor and only connect this to an earthed power socket. Do not remove or disconnect the earthing
wire. Do not remove the system's protective covers. These covers protect against dangerous electrical voltage. The
housing parts must always be left in place when the system is in operation. The replacement of all internal replacement
parts may only be performed by trained service technicians. Do not operate this system in the vicinity of inflammable
gases or anaesthetics. All peripheral devices (unless certified for medical purposes) that are connected to the system
must be connected to a power socket via an optional isolation transformer.
Notes on the installation of the product
Distance and effects of fixed radio communication devices: The field strengths of fixed transmitters, such as base sta-
tions for radios (mobile/cordless telephones) and mobile devices, radio devices, amateur radio, AM and FM radio trans-
missions and TV broadcasting stations cannot be predicted theoretically with any accuracy. In order to assess the elec-
tromagnetic environment with regard to the fixed transmitters, an investigation into the electromagnetic radiation on site
should be considered. If the measured field strength at the location where the ultrasound system is used exceeds the
permitted EMC level, the ultrasound system must be monitored to see if it operates normally. If abnormal operation is
observed, additional measures, such as reorienting or repositioning the ultrasound system or using an examination room
that is shielded from RF, may be necessary.
Use either the supplied power cable, or one provided by ZIMMER MEDIZINSYSTEME. Products that are equipped with
a plug for power supply must be inserted in a fixed socket that has been fitted with a protective conductor. Never use an
adapter or converter to connect to a power source (e.g. a converter from three to two pins). Place the device as far away
as possible from other electronic devices.
Ensure that you use only the cable supplied or intended by ZIMMER MEDIZINSYSTEME. Connect the cable and, while
doing so, adhere strictly to the installation procedures (e.g., lay the power cable so that it is separated from the signal
cables).
Install the main equipment and other peripheral devices in accordance with the installation procedures described in this
operating manual.

5
Notice on the ban against modification by the user
The user should under no circumstances modify this product.
User modifications may lead to inferior electrical safety. Modification of the product includes changes to:
-Cables (length, material, wiring, etc.)
-System configuration/
-components
User modifications can lead to deterioration of the EMC properties.
Modification of the product includes changes to:
-Cables (length, material, wiring, etc.)
-System installation/layout
-System configuration/components
-Attachment of the device components (open/close lid, screwing on the cover)