Mindray Zonare ZS3KP Elite User manual

ZS3KP Elite/ZS3 Elite/ZS4 Diagnostic
Ultrasound System
Service Manual

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©2023 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.
ZONARE, the ZONARE logo, ZS3KP Elite, ZS3 Elite, ZS4, ZS3 and z.onepro are all trademarks of Shenzhen Mindray
Bio-Medical Electronics Co., Ltd.. All other trademarks are the property of their respective holders.
The ZS3 Ultrasound Platform and products derived there from (for example, but not limited to, the ZS3KP Elite, ZS3
Elite, ZS4, ZS3 and the z.onepro with and without the SP UI option) is covered by one or more of the following
patents:
6,251,073; 6,569,102; 6,618,206; 6,663,567; 6,685,645; 6,733,455; 6,773,399; 6,866,631; 6,866,632; 6,896,658;
6,936,008; 6,980,419; 6,997,876; 7,022,075; 7,087,020; 7,226,416; 7,238,157; 7,352,570; 7,361,145; 7,510,529;
7,627,386; 7,382,309; 7,699,781; 8,002,705; 8,226,561; D461,814; D462,446; D467,002; D469,539; D469,877
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
Mindray Building, Keji 12th Road South, High-Tech Industrial Park, Nanshan,
Shenzhen, 518057, P.R.China
Shanghai international Holding Corp. GmbH(Europe)
Eiffestraβe 80, 20537 Hamburg, Germany
CAUTION: United States Federal Law restricts this device to sale by or on the order of a licensed physician or
licensed veterinarian.

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TABLE OF CONTENTS
1Introduction......................................................................................................................................... 7
Purpose.................................................................................................................................................... 8
Definitions/Acronyms ............................................................................................................................. 9
Documentation Conventions............................................................................................................... 10
Symbols.................................................................................................................................................. 10
2Safety.................................................................................................................................................. 12
Facility Needs........................................................................................................................................ 12
Notes When Returning or Transporting the System, Probes, and Repair Parts ........................ 13
Warning & Cautions ............................................................................................................................. 13
3System Specifications.................................................................................................................... 23
General System Specifications........................................................................................................... 23
Display.................................................................................................................................................... 28
Touch screen......................................................................................................................................... 28
Battery Pack Specifications................................................................................................................. 29
Standards and Compliance................................................................................................................. 34
4System Overview ............................................................................................................................. 36
Major System Assemblies................................................................................................................... 36
User Interface Overview ...................................................................................................................... 37
On-Screen “Dashboard” System Status ICONs .............................................................................. 41
Accessory Components....................................................................................................................... 42
Rear I/O Panel ...................................................................................................................................... 43
5System Uncrating & Installation Procedures........................................................................... 44
Product Shipment ................................................................................................................................. 44
Electrical Requirements....................................................................................................................... 44
Environmental and Space Requirements ......................................................................................... 44
Uncrating................................................................................................................................................ 44
Mechanical Inspection ......................................................................................................................... 48
System Installation ............................................................................................................................... 48
ZS4 System Verification ...................................................................................................................... 49
6Setup................................................................................................................................................... 52
System.................................................................................................................................................... 52
7Security .............................................................................................................................................. 58
Access Control ...................................................................................................................................... 58
Enabling Location Access Control ..................................................................................................... 59

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Enabling Account Access Control...................................................................................................... 60
System Login......................................................................................................................................... 60
Local Privilege Management............................................................................................................... 61
LDAP Privilege Management.............................................................................................................. 67
User Field Name................................................................................................................................... 69
Enable Barcode Login.......................................................................................................................... 69
Enable Encryption ................................................................................................................................ 70
8Patient Information Management ................................................................................................ 71
Patient Information ............................................................................................................................... 71
New Patient Information ...................................................................................................................... 72
Retrieve Patient Information ............................................................................................................... 77
9DICOM/HL7 ........................................................................................................................................ 83
DICOM Preset....................................................................................................................................... 84
Service Preset....................................................................................................................................... 86
DICOM Verifying................................................................................................................................. 100
DICOM Services ................................................................................................................................. 101
DICOM Media Storage....................................................................................................................... 107
10 Peripheral ........................................................................................................................................ 109
Print Service ........................................................................................................................................ 109
Barcode Reader Configuration ......................................................................................................... 110
Power Save ......................................................................................................................................... 112
11 Network ............................................................................................................................................ 114
Network Setup..................................................................................................................................... 114
FTP Setup............................................................................................................................................ 117
QPath/QView....................................................................................................................................... 118
VPN....................................................................................................................................................... 120
12 Functional Descriptions............................................................................................................... 123
System Capabilities............................................................................................................................ 123
Major FRUs.......................................................................................................................................... 123
13 System Diagrams .......................................................................................................................... 129
Power Block Diagram......................................................................................................................... 130
Cabling Diagram ................................................................................................................................. 131
System Block Diagram....................................................................................................................... 132
14 Peripherals & Accessories.......................................................................................................... 133
Black & White Printer ......................................................................................................................... 133

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Color Printer ........................................................................................................................................ 140
Pedal Footswitch ................................................................................................................................ 141
Ultrasound Gel Warmer..................................................................................................................... 141
ZS4 Intracavity probe holder............................................................................................................. 149
15 Software Procedures .................................................................................................................... 154
Backup Operations............................................................................................................................. 154
Restore Operations ............................................................................................................................ 155
Diagnostic Panel Operations ............................................................................................................ 158
16 Care and Maintenance.................................................................................................................. 167
Overview .............................................................................................................................................. 167
Basic System Care............................................................................................................................. 168
Transducer Maintenance................................................................................................................... 170
System Check ..................................................................................................................................... 171
17 Preventative Maintenance Forms.............................................................................................. 178
18 System Troubleshooting ............................................................................................................. 183
Diagnostics .......................................................................................................................................... 183
Troubleshooting .................................................................................................................................. 187
System Status LED & Error Code Definitions ................................................................................ 196
How to Obtain MAC Address............................................................................................................ 206
19 Replacement Procedures ............................................................................................................ 209
Recommended Tools ......................................................................................................................... 209
ZS4 Module – Removal/Replacement............................................................................................. 210
Casters – Removal/Replacement .................................................................................................... 213
19” Display – Removal/Replacement .............................................................................................. 215
13.3” Touch Screen – Removal/Replacement ............................................................................... 218
Display Arm – Removal/Replacement............................................................................................. 221
Cart Battery – Removal/Replacement............................................................................................. 226
Power Module – Removal/Replacement......................................................................................... 231
User Interface – Removal/Replacement ......................................................................................... 235
Dock Board/SSD - Removal/Replacement..................................................................................... 239
Gas Spring – Removal/Replacement .............................................................................................. 244
20 Parts Catalog .................................................................................................................................. 248
System.................................................................................................................................................. 249
Display.................................................................................................................................................. 249
Accessories ......................................................................................................................................... 250

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User Interface...................................................................................................................................... 254
Module & Cart Electronics................................................................................................................. 255
Internal Cabling................................................................................................................................... 256
Power Module ..................................................................................................................................... 257
Miscellaneous Cart Items .................................................................................................................. 257
Peripherals........................................................................................................................................... 259
Options and Upgrading Package ..................................................................................................... 259
Revision History .................................................................................................................................. 278

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1 Introduction
Mindray Contact Information
Asia, Europe and ROW
Address
Mindray Building, Keji 12th Road South, High-tech
industrial park, Nanshan, Shenzhen 518057, P.R.China
E-mail
[e-mail]
Website
www.mindray.com
Telephone
[phone]
Fax
[phone]
United States and Canada
Address
Telephone
800 MacArthur Boulevard,
Mahwah, NJ 07430
1-800-288-2121, 1-201-995-8000
Technical Support
1-877-913-9663, 1-650-316-3199
Technical Support Email
Website
[e-mail]
www.mindraynorthamerica.com

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Purpose
This manual provides information to assist service personnel in performing
maintenance, and repair procedures that may be required to support ZS4 Ultrasound
System.
Only qualified personnel should perform ultrasound scanning of human subjects for
medical diagnostics.
This ultrasound system meets the acoustic output emission guidelines established by
the U.S. Food and Drug Administration (FDA). Acoustic output quantities have been
measured, and are displayed, in accordance with the standards listed under Guidance
Documents.
The ZS3 Ultrasound Platform and products derived there from (for example, but not
limited to, the ZS3 Elite, ZS3 KP Elite, ZS4 and Z.One Pro (with and without the SP UI
option) are used for ultrasound evaluation of the following applications:
The Ultrasound Systems are intended for use by a qualified physician for ultrasound
evaluation of Ophthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative
(abdominal, thoracic(cardiac), and vascular); Intra-operative (Neuro); Laparoscopic;
Pediatric; Small organ (thyroid, breast, testes, etc); Neonatal cephalic; Adult
Cephalic/Transcranial; Trans-rectal; Trans-vaginal; Trans-esoph.(non-Card);
Musculoskeletal(Conventional); Musculoskeletal(Superficial);Cardiac Adult; Cardiac
Pediatric; Trans-esoph. (Cardiac); Intra-cardiac; Peripheral vessel.
Note: The availability of application may be limited based on country or region of
use.
Users include ultrasound imaging technologists (sonographers), physicians, Physician’s
Assistants (PA), and nurses. This ultrasound system may be used in a hospital (imaging
laboratory, emergency room, patient bedside, and operating room), medical clinic,
physician’s office, or a mobile imaging center.
The ZS3 Elite Ultrasound Platform consists of two major components: 1) Cart; and, 2)
Transducer(s). The Cart contains the software driven imaging electronics and user
interfaces (touch screen, monitor, handles, etc.). It houses the microprocessor, memory,
amplifiers, and power supplies for the microprocessor. It sends electrical currents to and
receives electrical pulses from the compatible transducers. The Cart performs the
calculations involved in processing the data to produce the displayed ultrasound
images.

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Definitions/Acronyms
2D: Two dimensional (B-Mode, Color mode)
BMP: Bit MaP
C-Mode: Color Flow Mode (Doppler)
D-Mode:Doppler (Pulsed Wave) Mode
DICOM: Digital Imaging and COmmunication in Medicine
DSP: Digital Signal Processing
ESD: Electro Static Discharge
EV: Endo Vaginal
FPGA: Field Programmable Gate Array
FRU: Field Replaceable Unit
LCD: Liquid Crystal Display
LED: Light Emitting Diode
M: M-Mode (Motion Mode - Tissue)
NTSC: National Television Standards Committee (video standard)
PAL: Phase Alternation by Line (video standard)
PRF: Pulse Repetition Frequency
PW: Pulsed Wave Mode (Doppler)
Retrospective:Post-processing performed on frozen images from memory
DGC: Depth Gain Compensation
USB: Universal Serial Bus

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Documentation Conventions
The following alert conventions are used in this manual:
Symbols
The following symbols may be used in this manual or elsewhere in product labeling.
Symbol
Description
Information that may relate to safety of the patient, the operator, or the equipment
A type BF patient-applied part (B= body, F= floating applied part)
A type CF patient-applied part (C= cardiac, F= floating applied part)
Alternating current (AC)
Direct current (DC)
Date of manufacture
Manufacturer
Caution: ESD sensitive
Recyclable material
Waste Electrical & Electronic Equipment Standard
Applies to EU Member States only: this system should not be treated as household waste.
Mindray meets the WEEE Standard. For more information on returning or recycling this system, please
contact Shenzhen Mindray Bio-Medical Electronics Co. or the distributor from whom you purchased
the system.
Consult the Instructions for Use
Serial number
Authorized representative in the European Community

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Symbol
Description
Catalog number
Shipping & Storage: Fragile
Shipping & Storage: Keep dry
Shipping & Storage: Temperature limits
Shipping & Storage: This side UP
Shipping& Storage: Do not stack above this container
Shipping & Storage: Humidity limits
Shipping & Storage: Pressure limits
Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner (USA).
Protected against water immersion - Immersion for 30 minutes at a depth of 1 meter.
This product is provided with a CE marking in accordance with the regulations stated in the Regulation
(EU) 2017/745 of the European parliament. The number adjacent to the CE marking (0123) is the
number of the EU-notified body certified for meeting the requirements of the Regulation.
MR Unsafe – the system is not intended to be used within magnetic resonance (MR) environment.
Medical Device
Unique Device Identifier

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2 Safety
Facility Needs
Users should prepare for the materials needed in the site, so as to avoid confusion and complete the task
in time without any waste of manpower. Follow the checklist in pre-installation to ensure that the required
steps are performed.
Action
Yes
No
Schedule enough time for installation
Ensure that the operating environment meets the requirements
Ensure that you have adjusted the lighting environment to adapt to the
condition of the system
Ensure that the electrical supply conforms to the standard
requirements
Ensure that the EMI precautions are performed and all the sources
that might possibly cause unwanted interference are removed
The system is put in a site according to the requirements
Ensure that the network, if required, is ready for the system
Before installation, the users should:
Have the required material ready.
Prepare the site for the delivery of the system.
Note:
This equipment must be operated by skilled/trained clinical professionals.
Before delivering the system, ensure that the operating site is clean. Do not put the
system on a carpet that might attract dust and create static. In addition, the EMI
should also be taken into account during investigation.
It is important for the hospital or organization that employs this equipment to carry
out a reasonable service/maintenance plan. Neglect of this may result in machine
breakdown or personal injury.
Mindray's obligation or liability under this warranty does not include any
transportation or other charges or liability for direct, indirect or consequential
damages or delay resulting from the improper use or application of the product or
the use of parts or accessories not approved by Mindray or repairs by people other
than Mindray authorized personnel.

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Notes When Returning or Transporting the
System, Probes, and Repair Parts
When returning or transporting the ultrasound system in the original packaging, ensure
that:
The ultrasound system should be adjusted to its lowest height and the monitor
should be folded in the down position.
The control panel should be placed in the center and locked.
Note:
When you return the system, ensure that the system is fully decontaminated, and
human fluids or blood are removed from the system, parts or probes. This is to protect
those who transports, receives or opens this package.
The US Department of Transportation (DOT) has ruled that “items that were saturated
and/or dripping with human blood that are now caked with dried blood; or which were
used or intended for use in patient care” are “regulated medical waste” for transportation
purpose and must be transported as a hazardous material.
Warning & Cautions
It is not possible to anticipate every condition and situation in which ultrasound system
will be used. The following cautions represent typical situations that require special
attention. User knowledge and experience with a specific application and environment
must also be taken into consideration to help ensure the safety of personnel and
equipment.
Safety Standards
All MINDRAY/ZONARE instruments, cables, and diagnostic ultrasound imaging
transducers have been designed to meet the essential requirements contained in
93/42/EEC (Medical Device Directive), and all appropriate requirements contained
within IEC 60601-1, AAMI STD ES 60601-1, CSA STD C22.2 NO. 60601-1 (Medical
electrical equipment - Part 1: General requirements for basic safety and essential
performance), IEC 60601 (Medical electrical equipment - Part 2-37: Particular
requirements for the safety of ultrasonic medical diagnostic and monitoring equipment),
IEC 60601-1-2(Medical electrical equipment - Part 1-2: General requirements for basic
safety and essential performance Collateral Standard: Electromagnetic Compatibility),
and JIS-T-1501 (General Methods of Measuring the Performance of Ultrasonic Pulse-
Echo Diagnostic Equipment), including limits for current leakage and isolation from a
primary power line. Testing for compliance with the essential requirements of the
Medical Device Directive has been performed.
The following is a comprehensive list of the Precautions associated with the use of ZS3
Elite Ultrasound System and compatible transducers.

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Precautions
Precautions - Electrical
Be aware of the potential hazards associated with the environment where the
ultrasound systems will be used. The systems and/or the external equipment can be
damaged if signal levels are not appropriate. If peripheral equipment not specifically
authorized by Mindray is to be connected to the system, it must meet all applicable
electrical safety standards that apply to the system to maintain safety integrity. Any
equipment not supplied by Mindray must be approved.
Accessory equipment (analog or digital) connected to the ultrasound system must
comply with the relevant IEC standards (e.g., IEC 60950 information technology
equipment safety standard and IEC 60601-1 medical equipment standard).
Furthermore, all configurations must comply with the standard IEC 60601-1. It is the
responsibility of the individual that connects additional equipment to the signal input
or output ports and configures a medical system to verify that the system complies
with the requirements of IEC 60601-1. If there are any questions regarding these
requirements, please consult your sales representative.
If using relevant IEC standards compliant equipment that was not provided by
MINDRAY/ZONARE, it is required that total leakage currents be tested and
validated to be below the IEC 60601-1 limits in chapter 21.
The use of non-Mindray approved cables and accessories may result in increased
radiated emissions as well as decreased immunity to external signal fields.
Use of non-Mindray-approved equipment may result in an unsafe condition, impair
operation of the ultrasound system, impair diagnostic capabilities, and void your
warranty or service contract coverage.
If an external video monitor is connected to the ZS3 Elite system, it is necessary to
ensure that an RF ferrite is clamped to the cable as close to the ZS3 Elite system as
possible. Use a ferrite such as Fair- Rite Products Corp. 0431167281 (or an
equivalent).
To reduce the risk of electric shock, DO NOT connect the ZS3 Elite system input or
output connections to equipment that is not properly connected to an Earth ground.
To achieve proper grounding reliability, the ultrasound system power cord must be
fully inserted into a receptacle marked “hospital grade.” Do not remove the
grounding wire. If there is any question of power outlet or power cord integrity, do
not proceed. Obtain qualified assistance.
To maintain proper grounding reliability, use only Mindray-recommended
peripherals and accessories. Use of non-specified peripherals and accessories
could result in risk of electrical shock or injury.
If the ZS3 Elite System has been moved between environments with extremes of
temperature and/or humidity, allow the ZS3 Elite System to rest for at least 30
minutes in a controlled environment before using.
To reduce the risk of electric shock, do not connect the ZS3 Elite input or output
connections to equipment that is not properly connected to an Earth ground.
The potential equalization terminal, located by the AC Mains connection, is
connected to the system chassis. It can be connected to corresponding terminals on
other equipment to eliminate potential differences. Do NOT use it for additional
protective grounding.

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Unless a battery is present, do not connect or disconnect the system’s power cord
or its accessories (e.g., a printer) without turning OFF the system power first. This
may damage the system and its accessories or cause electric shock.
DO NOT touch or allow patients to touch the Signal I/O ports if in contact with the
patient; otherwise, electric shock and patient injury may result.
Mindray ultrasound system is manufactured in compliance with existing
electromagnetic immunity (EMI) and electromagnetic compatibility (EMC)
requirements. Operating the systems in the presence of external electromagnetic
fields can degrade the quality of the ultrasound image. High-frequency devices,
such as electro-surgical devices, can produce image artifacts. If required, a review
of the local electromagnetic environment may be required to minimize the sources
of external noise generators.
Electrostatic discharge (ESD), or static shock, is a naturally occurring phenomenon.
ESD is common in low humidity, which can be caused by heating or air conditioning.
ESD shock occurs when electrical energy is discharged from one body, to a
differently charged body. To lessen the occurrence of ESD, use antistatic spray on
carpets and flooring, and antistatic mats.
To minimize potential ESD damage and electrical contact contamination, avoid
touching the metal contacts for the transducer connections, at both the ZS3 Elite
port and the transducer connector.
The ultrasound system contains no operator-serviceable components within the
enclosures. To avoid electrical shock, do not remove any covers other than the
module cover. As with any other electrical equipment, always use caution when
operating this device. For service issues, contact Mindray Technical Support.
Failure to follow these restrictions may void your warranty or service contract
coverage.
The module cover may be removed to remove and replace the module, in its
entirety, or to perform preventative maintenance such as cleaning filters.
Do not disassemble a transducer to avoid the possibility of electric shock.
No modification of the system is permitted. Modifying the system may subject the
operator or patient to hazardous conditions.
The ultrasound system and transducers represent a potential explosion hazard if
used in the presence of flammable anesthetics, flammable gases, or an oxygen rich
environment
Precautions – System Usage
Inspect the transducer and ZS3 Elite System before each use. Inspect the
transducer face, housing, cable, connectors, and cases. Do not use the unit or
transducer if damage is detected and contact Mindray Technical Support for
assistance.
If the system is powered off improperly during operation, it may result in data
damage of the system hard disk or system failure.
Do not block airflow to any ventilation holes on the system.
Carefully review the manufacturer’s directions for any component used with the
ultrasound system. Mindray assumes no liability with respect to single-use devices
that are reused, reprocessed, or re-sterilized and makes no warranties, expressed
or implied (including the warranties of merchantability or fitness for a particular use),
with respect to such devices.

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Use of peripherals or other equipment not provided by Mindray may result in system
damage or degraded performance. Carefully review the labeling of any such
equipment before connecting to the ultrasound system.
Use-time from the optional ZS3 Elite battery pack will vary depending on the system
usage and battery conditioning. Ensure the battery is adequately charged before
starting a procedure without AC main power.
The optional cart battery is not a user serviceable item. Contact Mindray Technical
Support group for assistance with the ZPAK battery.
Do not expose the device to a magnetic resonance (MR) environment.
When the wireless LAN function is turned on, the ultrasound system may suffer
interference from other equipment, even if that equipment complies with CISPR
EMISSION requirements.
The system is not intended for use in conjunction with high frequency (HF) surgical
equipment (tissue ablation devices). Do not use transducers connected to the
ultrasound system on patients while HF surgical devices are in use.
Avoid rolling the carts wheels over cables. Use of cable hooks is recommended to
minimize chance of damage to cables.
Do not spill liquids on the system or transducers.
Use of a non-compatible USB thumb drive may result in file corruption or long file
transfer times.
Please confirm proper operation of any thumb drive prior to attempting to use for
clinical data.
Make sure the ZS3 Elite System has fully completed upgrades, importing/exporting,
or collecting log data to the USB thumb drive before removing it from the ZS3 Elite
System. Failure to do so may result in loss of data.
There are many types of system use and system error messages that might be
displayed during the use of the ZS3 Elite Ultrasound System. If a message is
encountered that is not self- explanatory, contact Mindray Technical Support for
assistance.
To dispose of the system or any part, contact Mindray Technical Support or local
Sales Representative. Mindray is not responsible for any system content or
accessories that have been discarded improperly.
Precautions – Transducer Usage
Transducers are individually licensed according to the system configuration. Only
the following transducers are available without an advanced feature configuration:
C4-1, C6-2, C6-1, C9-3, C9- 3sp, C8-3 3D, C10-3, C12-4lp, C18-5, E9-3 3D, E9-3,
E9-4, L8-3, L10-5, L14-5w, L14-5sp, L20-5, L30-8, P4-1c, P7-3c, P8-3TEE, P8-
3mTEE
The A2CW and A5CW transducers are enabled if the system is configured with
either the Echocardiography or the Advanced Vascular Imaging option. Attempting
to use any other transducers will result in an error message.
Compatible transducers have a specific range of acceptable application use. Users
are advised to restrict each transducer’s use to those applications. Excessive
bending, twisting, pulling, dragging, or compression of transducer cables may cause
failure or intermittent operation of the system.
If a transducer has not been approved and/or licensed for use on a system or if a
licensed transducer is not properly connected, the corresponding transducer
identification data will not display on the LCD Display and imaging will be disabled.

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The ultrasound system and/or transducer could be damaged if an unapproved
transducer is connected.
Only use water-soluble acoustic coupling gel that is compliant with the relevant local
regulations. Other coupling gels can cause transducer damage.
Do not touch exposed metal of transducer connector.
Always examine transducers for damage, such as cracks, splitting, holes, or fluid
leaks. If damage is evident, discontinue use of the transducer and contact Mindray
Technical Support.
Bent, broken, or missing pins on the transducer connector may cause poor image
quality, including possible mirror image artifact. Be sure to check pins before
connecting transducer to the ultrasound system. If pins are bent, broken, or missing,
do not use the transducer and call Mindray Technical Support.
The transducer must be removed from patient contact before application of a high-
voltage defibrillation.
Before beginning to image a new patient, be sure to conclude any in-progress
patient exam. Failure to do so will result in any subsequent storing of images being
mistakenly written to the previous patient exam directory.
Improper setting of imaging controls may obscure low-level signals and other
diagnostically valuable information in the display. The factory default settings were
preselected as appropriate for most imaging circumstances. Improper user
configuration of custom presets may seriously degrade image quality.
Any image sets stored on the system that are not identified by patient name and
number will be stored with a unique number based on the system ID.
Validate that measured and calculated results shown in Calc Package reports
reflect the clinical observations.
Long-term exposure to ultrasound should be minimized. Although there have been
no confirmed adverse effects produced by diagnostic levels of ultrasound,
unnecessary patient exposure to ultrasound energy should be avoided, especially in
the Doppler mode.
Avoid unnecessarily scanning a fetus for an extended period of time.
In normal diagnostic ultrasound mode, there is no danger of a temperature burn;
however, avoid keeping the transducer on the same region of the patient for an
unnecessarily long period of time.
If not transferring studies to an external archive, routinely back up patient exams to
avoid data loss and do not delete patient exams from the system until the ability to
view exams is verified.
Total Recall data (TRI) should not be relied on for primary storage of diagnostic
data. Use of Total Recall data across software versions is not guaranteed.
Auto-Trace is intended to serve as an adjunct to the diagnostic process in
evaluating blood flow during Doppler examinations. When using the Auto-Trace
feature, evaluate the results to verify accuracy before committing the values to the
Report Package.
Damage to the system may cause poor image quality, including possible imaging
artifacts sometimes referred to as ‘halo’ or ‘headlight’ artifacts. Regularly inspect the
system for damage and know how to recognize imaging artifacts.
Precautions – Disinfection

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Improper cleaning or disinfection of patient applied parts may cause permanent
damage.
Using a non-recommended cleaning or disinfectant solution, incorrect solution
strength, or immersing the transducer deeper or longer than indicated can damage
the transducer. Damages linked to the use of disapproved chemicals are not
covered under product warranty or service contract.
To avoid electrical shock, always disconnect the transducer from the ultrasound
system cleaning. Do not immerse the transducer past the specified
cleaning/disinfection level, as specified in Transducer Cleaning and Disinfection. Do
not immerse the transducer for longer than the specified cleaning/disinfecting time.
Do not use any transducer that has been immersed beyond the maximum limit.
Do not allow disinfectant to contact metal surfaces. Always use protective eyewear
and clothing when cleaning or disinfecting device.
Disinfectant wipes and topical spray products are not FDA cleared high-level
disinfectants and do not provide adequate protection should the transducer become
cross- contaminated.
Precautions – Ocular (Ophthalmic) Imaging
To avoid injury to the patient, use only the Ocular Preset when imaging through the
eye. The FDA has established lower acoustic energy limits for ophthalmic use. The
system will not exceed these limits only if the Ocular Preset is selected.
Precautions - Battery
To avoid electrical shock, do not touch the battery contact.
To avoid risk of fire, explosion, or burns:
Do not disassemble or alter the battery.
Do not short-circuit the battery by directly connecting the positive and negative
terminals with metal objects.
Do not heat or discard the battery in a fire.
Do not expose the battery to temperatures above 65° C (150° F).
Do not expose the battery to temperatures above 65° C (150° F). Do not charge the
battery near a heat source.
Do not leave the battery in direct sunlight.
Do not use a damaged battery.
Charge the battery at room temperature.
The battery should only be charged within the ZS3 Elite System.
Inspect the battery for damage before charging or placing the battery in the System.
Do not connect battery to an electrical power outlet.
Do not continue to recharge the battery if it does not recharge fully after 4 hours.
Avoid a battery ‘over-discharge’ condition which could damage the battery:
-If the battery has been discharged fully, and the power (On/Off) button is
pressed, the system will not power on.
-The power button will flash an amber/green pattern to alert user that the battery
has been fully discharged and the system cannot run on battery; however, if
plugged in, the system will function normally until battery is charged.
Precautions - ECG

ZS4 Service Manual Page 19 of 279
The ECG and the Respirometer functionality are not intended for ECG diagnosis. It
must not be used for intraoperative applications of the heart. Use only the
recommended patient cable supplied by Mindray. Make sure that bare parts of the
electrodes and the patient do not come in contact with conductive surfaces, such as
metal examination beds, trolleys, and similar items.
Before defibrillation, always disconnect the ECG cable connector from the system
and make sure the connector does not come in contact with other persons or
conductive surfaces, such as metal examination beds, trolleys, and similar items.
Operating your system with ECG signals below 0.25 mV may cause inaccurate
results.
Precautions – TEE Transducer
The multiplane TEE transducer should only be used by a qualified physician who
has received appropriate training in proper operation of the transducer and in
endoscopic techniques as dictated by current relevant medical practices.
The multiplane TEE transducer is a precision instrument, which must be handled
with care. It may be damaged when dropped or abused. Do not allow the ultrasonic
window in the tip to come into contact with a sharp object. Do not touch this window
unnecessarily. Never exert force onto the acoustic window.
This equipment contains no operator serviceable components. To prevent electric
shock, do not remove any covers or panels.
Prior to Exam
Examine the transducer prior to each use. See the TEE Maintenance Guide or the
TEE Quick Reference Guide for details.
Inspect the transducer connector pins for contamination or damaged pins that might
interrupt signal flow through the connection. Be sure to check pins before
connecting transducer to the ultrasound system. If pins are bent, broken, or missing,
do not use the transducer and call Mindray Technical Support.
Check if the maximum deflection of the tip is 90° to 120° upward, 60° to 90°
downwards and 30° to 45° left/right. If the deflection shows an unwanted amount of
free play or exceeds the maximal deflection angles given above, do not use the
transducer. Contact Mindray Technical Support for readjustment of the transducer
steering to minimize the risk of the transducer "buckling" or "U- turning" in the
esophagus.
Perform an electrical leakage test prior to each use of the transducer. See the TEE
Maintenance Guide or the TEE Leakage Test Quick Reference Guide for details.
Connect the transducer to the Ultrasound system. Adjust the acoustic power to the
highest value possible. Select Color Doppler mode. Wait for 2 minutes. Feel at the
distal end of the transducer if there is a temperature increase that could be harmful
for the patient.
Immediately replace a transducer that exhibits any damage symptoms.
During the Exam
The use of a bite guard is mandatory. Failure to use the bite guard may result in
damage to the transducer, which could result in a safety hazard. Damage to the
transducer due to biting is not covered by the transducer warranty.
Always use single-use transducer sheath.