Mindray Zonare ZS3 User manual

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ZS3 Ultrasound System
Instructions for Use

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©2019 Shenzhen Mindray Bio-Medical Electronics Co., Ltd.All rights reserved.
For this Instructions for usemanual, the issue date is 2018-12.
ZONARE, the ZONARE logo, 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 ZS3 and the
z.onepro with and without the SP UI option) is covered by one or more of thefollowing 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
Technical Support
North America and Asia:
Phone support: 1-877-913-9663 or 1-650-316-3199 option 7 (ultrasound)
Email: [e-mail]
Sales support: 1-877-966-2731,
Email: [e-mail]
www.mindraynorthamerica.com
Europe: Phone support: [phone]
Email: [e-mail]
www.mindray.de
Europe and Asia:
Address: Mindray Building, Keji 12th Road South, High-tech industrial park,
Nanshan, Shenzhen 518057, P.R.China
E-mail Address: [e-mail]
www.mindray.com
Tel: [phone]
Fax: [phone]
CAUTION
United States Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner (USA).

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Contents
Contents.......................................................................................................................................III
Intellectual PropertyStatement ........................................................................................................IV
Responsibility on the Manufacturer Party .......................................................................................IV
Warranty.............................................................................................................................................V
Exemptions......................................................................................................................................V
1. Introduction.........................................................................................................................1
2. GettingStarted ....................................................................................................................6
3. Imaging.............................................................................................................................18
4. Transducers and Needle-Guided Brackets...........................................................................31
Transducers .......................................................................................................................................31
Needle-guided Bracket .....................................................................................................................42
TEE/Laparoscopic Transducers.......................................................................................................45
Wearing the Probe Sheath ................................................................................................................52
Transducer Tracking .........................................................................................................................55
5. Measurements and Calculations..........................................................................................57
6. Annotations, Arrows, and Body Markers...............................................................................66
7. Archiving,Review and Management....................................................................................69
8. AdvancedFeatures and Options........................................................................................76
Contrast Enhanced Ultrasound (CEUS).........................................................................................76
Contrast Enhanced Ultrasound Quantification Imaging (CEUS-QI)..........................................80
Elastography...................................................................................................................................83
Tissue Tracking Quantitative Analysis (TTQA)..........................................................................89
9. 3D & 4D Imaging with Advanced Lighting...........................................................................92
10. Needle Optimization Mode (For Improved Needle Visualization) .......................................99
11. Protocols.........................................................................................................................101
12. Stress Echo.....................................................................................................................103
13. Setup..............................................................................................................................107
14. System Security..............................................................................................................111
15. Maintenance ...................................................................................................................116
16. Safety.............................................................................................................................118
17. AcousticOutput...............................................................................................................128
18. DisplayAccuracyandPrecision........................................................................................133
19. GuidanceDocuments.......................................................................................................135
20. StandardsandCompliance..............................................................................................136
21. ProductLabeling..............................................................................................................143
22. Specifications..................................................................................................................144

IV
Intellectual PropertyStatement
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray)
owns the intellectual property rights to this Mindray product and this manual. This manual may
refer to information protected by copyright or patents and does not convey any license under the
patent rights or copyright of Mindray, or of others.
Mindray intends to maintain the contents of this manual as confidential information. Disclosure of
the information in this manual in any manner whatsoever without the written permission of
Mindray is strictly forbidden.
Release, amendment, reproduction, distribution, rental, adaptation, translation or any other
derivative work of this manual in any manner whatsoever without the written permission of
Mindray is strictly forbidden.
, and are the trademarks, registered or otherwise, of Mindray in China and
other countries. All other trademarks that appear in this manual are used only for informational or editorial
purposes. They are the property of their respective owners.
This posting serves as notice under 35 U.S.C. §287(a) for Mindray patents:
http://www.mindrayna.com/patents.
Responsibility on the Manufacturer Party
Contents of this manual are subject to change without prior notice.
All information contained in this manual is believed to be correct. Mindray shall not be liable for
errors contained herein or for incidental or consequential damages in connection with the
furnishing, performance, or use of this manual.
Mindray is responsible for the effects on safety, reliability and performance of this product, only if:
all installation operations, expansions, changes, modifications and repairs of this product are
conducted by Mindray authorized personnel;
the electrical installation of the relevant room complies with the applicable national and local
requirements; and
the product is used in accordance with the instructions for use.
Note
This equipment must be operated by skilled/trained clinical professionals.
Warning
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.

V
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS
FOR ANY PARTICULAR PURPOSE.
Exemptions
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.
This warranty shall not extend to:
Malfunction or damage caused by improper use or man-made failure.
Malfunction or damage caused by unstable or out-of-range power input.
Malfunction or damage caused by force majeure such as fire and earthquake.
Malfunction or damage caused by improper operation or repair by unqualified or
unauthorized service people.
Malfunction of the instrument or part whose serial number is not legible enough.
Others not caused by instrument or part itself.

ZS3 Instructions for Use
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1. Introduction
United States Federal Law restricts this device to sale by or on the order of a
licensed healthcare practitioner, licensed by the law of the jurisdiction in which
they practice, to use or order the use of this device.
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.
Indications for Use
The ultrasound system is 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.
Device Description
The ZS3 Ultrasound Platform and products derived there from (for example, but not limited
to, the ZS3 and the z.onepro with and without the SP UI option) is used for ultrasound
evaluation of the following applications: Laparoscopic, Fetal, Abdominal, Intra-operative,
Pediatric, Ophthalmic, Small Organ/Parts (breast/testes, thyroid, etc.), Transvaginal,
Transrectal, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular,
Tissue Elasticity, Contrast Imaging, Musculoskeletal, Superficial Musculoskeletal and
Peripheral Vascular applications. Users include ultrasound imaging technicians
(sonographers) and physicians. This ultrasound system may be used in a hospital (e.g.
imaging laboratory, emergency room, patient bedside, and operating room), medical clinic,
physician’s office or a mobile imaging center.
The ZS3 Ultrasound Platform consists of two major components: 1) Cart; and, 2)
Transducer(s). The Cart contains the software driven imaging electronics and user
interfaces (keyboard, 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.

ZS3 Instructions for Use
2 | P a g e
Standard Configuration
Main unit
Storage bins
System software
Accessories:
Power cables
Operator's manual
Operator’s manual in multi-language (disk)
Options
No.
Item
Remarks
1.
CW Enable
/
2.
ECG Enable
3.
Strain Elastography
4.
ARFI
5.
2D SWI
6.
Small Parts CEUS
Not
applicable for the FDA
region.
7.
GYN CEUS
8.
Abdominal CEUS
Only applicable for liver in the
FDA region
9.
Cardiac CEUS
Only applicable for LVO in
the FDA region
10.
CEUS QI
Only applicable for liver and
LVO in the FDA region
11.
CEUS Sequence
Only applicable for liver and
LVO in the FDA region
12.
HD Scope
/
13.
Advanced Cardiac
Including AutoEF and
Expanded Echo Calcs.
14.
Smart OB/NT
/
15.
AutoIMT
16.
Stress Echo
17.
Total Recall
18.
Protocol
19.
Needle OPT
20.
Anat Mmode
21.
TTQA
22.
Battery Pack
23.
ECG cable
24.
Barcode Reader
25.
USB Foot Pedal
26.
Ultrasound gel warmer assembly
Including ultrasound gel
warmer and bracket.

ZS3 Instructions for Use
3 | P a g e
No.
Item
Remarks
27.
Intra-cavitary probe holder pack
Installed in the right side.
Including intra-cavitary probe
holder and bracket.
Not applicable for the FDA
region.
28.
Printer bracket
/
29.
SONY UP-D711MD black/white
printer pack
30.
SONY UP-D711MD printer bracket
pack
31.
Hook
32.
Keyboard protective cover
33.
Wireless Ethernet Routers and
Bridges
Peripherals Supported
Item Model
Digital black/white video printer SONY UP-D711MD
Digital color video printer SONY UP-D25MD
Note: The availability of options may be limited based on country or region of use.
The following symbols may be used in this document or elsewhere in product labeling.
Symbol
Description
Informationthat may relate to safety of the patient, theoperator, or theequipment
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
Key to Symbols

ZS3 Instructions for Use
4 | P a g e
Caution: ESD sensitive
Recyclable material
VVoltage
Hz Cycles per second
Waste Electrical & Electronic Equipment Standard
Applies to EU Member States only: this system should not betreated 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
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