Z.one pro Instructions for Use Rev 5.0

©2023 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. For this Instructions for use manual, the issue date is 2023-04.

ZONARE, the ZONARE logo, ZS3 and z.one pro are all trademarks of Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All other trademarks are the property of their respective holders. The z.one pro Ultrasound Platform and products derived there from (for example, but not limited to, the z.one pro and the z.one pro 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

Technical Support North America and Asia: Phone support: 1-877-913-9663 or 1-650-316-3199 option 7 (ultrasound) Email: [email protected] Sales support: 1-877-966-2731, Email: [email protected] www.mindraynorthamerica.com Europe: Phone support: +49 (913) 1974-9412 Email: [email protected] 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: [email protected] www.mindray.com Tel: +86 755 81888998 Fax: +86 755 26582680 CAUTION United States Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner (USA).

II

Contents Contents ... III Intellectual Property Statement ... IV Responsibility on the Manufacturer Party ... IV Warranty ... V Exemptions ... V Notification of Adverse Events ... V Important Information... V 1.

Introduction ... 1

2. 3. 4.

Getting Started ... 7 Imaging ... 20 Transducers and Needle-Guided Brackets ... 31 Transducers ... 31 Needle-guided Bracket ... 42 TEE Transducers/Laparoscopic Transducers... 44 Wearing the Probe Sheath ... 50 Transducer Tracking ... 53

5.

Measurements and Calculations ... 55

6.

Annotations, Arrows, and Body Markers ... 63

7.

Archiving, Review and Management ... 66

8.

Advanced Features and Options ... 73 Contrast Enhanced Ultrasound (CEUS) ... 73 Elastography ... 76

9.

3D & 4D Imaging with Advanced Lighting (Option) ... 81

10.

Needle Optimization Mode (For Improved Needle Visualization) ... 87

11.

Protocols ... 89

12.

Stress Echo... 91

13.

Setup ... 95

14.

System Security ... 99

15.

Maintenance ... 104

16.

Safety ... 106

17.

Acoustic Output ... 117

18.

Display Accuracy and Precision ... 122

19.

Guidance Documents ... 124

20.

Standards and Compliance ... 125

21.

Product Labeling... 131

22.

Specifications ... 132

III

Intellectual Property Statement 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.

IV

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.

Notification of Adverse Events As a health care provider, you may report the occurrence of certain events to SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD., and possibly to the competent authority of the Member state in which the user and / or patient is established. These events, include device-related death and serious injury or illness. In addition, as part of our Quality Assurance Program, SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. requests to be notified of device failures or malfunctions. This information is required to ensure that SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. provides only the highest quality products.

Important Information According to the conclusion of clinical evaluation and residual risk evaluation, for the intended patients, there is no known side effects that can occur during or after the use of the medical device. And there is no need for the operator to make extra preparations. Besides, the residual risks are disclosed in the corresponding chapter of this manual as precautions or warnings.

V

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 For FDA regions 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; Transrectal; Trans-vaginal; Trans-esoph.(non-Card); Musculoskeletal (Conventional); Musculoskeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Trans-esoph. (Cardiac); Intra-cardiac; Peripheral vessel. For CE regions It is intended for use in Ophthalmic, Abdominal (includes renal, GYN/Pelvic), Adult Cardiac, Fetal, Musculo-skel (conventional), Pediatric, Peripheral Vascular, Musculo-skel (Superficial), Adult Cephalic/ trans-cranial, Adult Cardiac, Pediatric Cardiac, Intra-operative (Neuro, abdominal, thoracic (cardiac) and vascular (PV)), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Small Organ (Thyroid, Breast, Testes, etc), Transesophageal Echocardiography (non-cardiac and cardiac), Urology, Laparoscopic, Contrast, 3D/4D exam. It is intended for clinical ultrasound diagnosis and examination Intended users include doctor, nurse, clinical technologist, radio technologist and ultrasonographer proficient in medicine knowledge. The diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. Intended medical conditions are hospital (e.g., imaging laboratory, emergency room, patient bedside, and operating room), medical clinic, physician’s office or an imaging center Note: The availability of application may be limited based on country or region of use.

Contraindication None.

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Device Description The z.one pro Ultrasound Platform and products derived there from (for example, but not limited to, the ZS3 and the z.one pro with and without the SP UI option) is used for ultrasound evaluation of the following applications: Laparoscopic, Fetal, Abdominal, Intraoperative, 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 z.one pro 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. Standard Configuration 

Main unit



Storage bins



System software



Accessories: 

Power cables



Operator's manual



Operator’s manual in multi-language (disk)

Options No.

Remarks

Item

1.

CW Enable

2.

ECG Enable

3.

Strain Elastography

4.

ARFI

5.

Small Parts CEUS

6.

GYN CEUS

7.

Abdominal CEUS

8.

Cardiac CEUS

9.

CEUS Sequence

10.

HD Scope

11.

Advanced Cardiac

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Not applicable for the FDA region. Only applicable for liver in the FDA region Only applicable for LVO in the FDA region Only applicable for liver and LVO in the FDA region / Including AutoEF and Expanded Echo Calcs. 2|Page

No.

Remarks

Item

12.

Smart OB/NT

13.

AutoIMT

14.

Stress Echo

15.

Total Recall

16.

Protocol

17.

Needle OPT

18.

Anat Mmode

19.

Battery Pack

20.

ECG cable

21.

Barcode Reader

22.

USB Foot Pedal

23.

Ultrasound gel warmer assembly

24.

Intra-cavitary probe holder pack

25.

Printer bracket

26.

28.

SONY UP-D711MD black/white printer pack SONY UP-D711MD printer bracket pack Hook

29.

Keyboard protective cover

30.

Wireless Ethernet Routers and Bridges

27.

/

Including ultrasound gel warmer and bracket. Installed in the right side. Including intra-cavitary probe holder and bracket. Not applicable for the FDA region.

/

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.

Key to Symbols The following symbols may be used in this document or elsewhere in product labeling.

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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

Catalog number

Shipping & Storage: Fragile

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Symbol

Description

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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The general meaning assigned to geometric shapes, safety colors and contrast colors for safety signs are as follows: Geometric shape

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Meaning

Safety color

Contrast color

Graphical symbol color

Prohibition

Red

White

Black

Mandatory action

Blue

White

White

Warning

Yellow

Black

Black

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2. Getting Started Please read this document carefully before using the ultrasound system.

Overview of Console, System and Features

17 inch display Speakers

User Interface Storage Bins Gel Bottle Holder

Control Panel height adjust

Cable management hooks

Power button

2 USB Ports Bins

Multi-Transducer Port (MTP)

Note: Only the right front caster is for directional locking (green tab). The other three casters (black tab) are for brake locking.

Figure 2.1: z.one pro System Components LCD Display The z.one pro full-sized 17-inch LCD Display shows the ultrasound image, plus patient and imaging information in designated areas of the screen. • Overall screen display = 1280 x 1024 pixels Full Screen Image Display (Figure 2.7) The z.one pro allows you to enlarge the imaging portion of the monitor to (1152 X 864). You can easily go from the imaging portion display of (960 x 720) to (1152 X 864) with the push of a z.one pro Instructions

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Function Key which can be configured in Setup/Keys or alternately by using the Pointer to click on the Full Image Display ICON located in the lower left corner of the imaging screen.

Once in Full Image Display, the screen will display Thumbnails or F Keys/OLEDs and Small Thumbnails. Use the Pointer to click on the Switch Button ICON on the far right hand side of the screen to toggle between F Keys and OLEDs. Click on Thumbnail ICON to toggle between large and small thumbnails.

While Full Image Display is active, any Menus such as Calculations or Annotations will ‘time out’ and disappear from the screen after a short time to prevent image overlap. Pointing to the black margin to the left of the Menu area (yellow oval below) of the screen will bring the menu back.

Control Panel The z.one pro has a full –featured control panel/ user interface (see Quick Start Guide below). Multi-Transducer Port The multi-transducer port (MTP) allows up to three imaging transducers simultaneously z.one pro Instructions

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connect to the system. You can easily activate any of the transducers connected to the cart. Transducer Holders The Safe storage for transducers is provided on both sides of the z.one pro System (Figure 2.1). Internal Cart Solid State Drive (SSD) All exam images are initially archived to the Cart SSD. This data can be then be transferred to PACS, USB drives, networked or thermal printers, and FTP destinations. It can also be backed up and restored on other z.one pro systems. See Chapter 7. Archiving, Review and Management for more details. The standard size of the SSD is 128 GB. NOTE: The internal hard drive is not intended for use as a long-term archive. Back up of exam data is recommended regularly. USB Ports Four USB ports (two in the front and two in the back) allow importing/ exporting of exams to/from the system as well as to install software and to backup/restore system and preset preferences. Note: Before deleting any exam data from the cart hard drive, always verify that data was successfully transferred to the USB device by viewing it on an external computer. When exams are exported onto the USB device, a DICOM viewer program (Showcase®) and its user’s manual are simultaneously exported onto the USB, allowing the exams to be opened, annotated, and saved in several formats on any commercial PC. Barcode Reader (Option) Patient accession numbers, ID, name, age, DOB, gender, Operator ID etc. can be entered via a selection of Mindray-approved barcode readers that can connect to a system USB port (note: capability and content is dependent on type of scanner used). Foot Pedal (Option) A remote 2-pedal footswitch is optionally available for connection to the system via any available USB port. The left and right pedals may be individually configured to one of over forty possibilities including Freeze and Store using Setup/Keys. Backup ZPak Battery (Option) A backup battery may be ordered that can power the system for up to 1 ½ hours of normal use in the absence of a connection to an active AC power outlet, depending on usage. The battery allows the system to be operated in normal use without connection to an active AC Power outlet. The backup is mounted at the base of the system and is automatically kept charged (as needed) whenever the z.one pro system is connected to active AC power . Printers and Other Peripherals Mindray offers a number of optional medical-grade (IEC 60601 compliant) peripherals. Detailed instructions, for proper peripheral use, are covered in the manufacturer’s instructions provided at the time of shipment. Front I/O Panel z.one pro Instructions

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1

2 3 4

No.

Function

1.

Name Network port.

2.

Serial Port - eSATAp

Used for connecting router, ultrasound workstation, server, etc. Used for connecting storage device.

3.

USB Port

Used for connecting storage device.

4.

High definition multimedia interface.

Used for connecting TV, projector, ultrasound workstation video capture card, etc.

Front I/O Panel 1

2 3

No.

Function

1.

Name USB Port

Used for connecting storage device.

2.

CW Port

Used for connecting a pencil probe.

3.

ECG Port

Connects to ECG leads, to directly obtain the ECG signals of the patient. Connects the signal output port of ECG monitoring device.

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Moving the z.one pro system Moving the System 1. 2.

3. 4. 5. 6.

Lower the adjustable height to MINIMUM using the height adjustment release lever. Fold the monitor display down to a horizontal position and lock in place. The monitor arm will lock into a non-rotating position when the two parts of the articulating arm are in-line with each other AND centered with the system. Ensure that the transducer cables are wrapped over the cable hooks. Place wheel(s) in the non-swivel position. Ensure that all wheels do not have the brakes set ON and push the cart from the front when transferring from location to location. When moving the cart over obstacles, always pull from the front.

Before Scanning 1. 2.

Before scanning a patient, apply the brake by fully depressing any of the three brake pedals. To disengage brakes, flip up the pedals.

Height Adjustment The height of the user interface console can be adjusted by squeezing the release lever located inside the right-front handle. Refer to Figure 2.3: Height Adjustment.

Figure 2.3: Height Adjustment

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User Interface and Onscreen Display

Figure 2.4: Keyboard

Figure 2.5: User Interface (See Section 3 Imaging for more details)

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User Interface (Special Procedures interface)

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Patient and Institution Information

Menu s

Trackball – Priority ICON

Image Area

Image Parameter s

OLEDs Programmable Keys

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Figure 2.7: Full Image Onscreen Display Patient and Institution Information Includes Manufacturer Logo and Institution Name: Configured in Setup/System/General. Includes Patient Name, ID, Gender, and Age: Information entered on the Patient ID page. Also displays: Probe/Preset as selected with transducer, exam type, exam date/time, and Operator Menus Includes annotation lists, measurement options, calculations menus, stress echo navigation, and protocol information. Trackball and set keys are used to navigate this area. Image Area Displays the ultrasound images, Doppler spectral strip, M Mode strip, image depth markers, ECG and respirometer waveforms, probe indicator, and calculations/measurement results window. Image Parameters Displays the image parameter for the active window. If there is more than one imaging mode active, the parameters are displayed for each mode. Trackball-Priority ICON Displays: • 2 Set Keys with labels indicating active state of keys • 1 Select Key with labeling indicating active state of key • 1 Pointer Key labeled • Trackball with center graphic indicating active state of trackball z.one pro Instructions

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