ZS3 Service Manual Ver 9.x

©2020 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. 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 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 1

Introduction ... 7 Purpose ... 8 Definitions/Acronyms ... 8 Documentation Conventions ... 10 Symbols ... 10

2

Safety ... 12 Facility Needs ... 12 Notes When Returning or Transporting the System, Probes, and Repair Parts ... 13 Warning & Cautions ... 13

3

System Specifications ... 25 General System Specifications ... 25 Display... 27 Battery Pack Specifications ... 28 Standards and Compliance ... 33

4

System Overview... 35 Major System Assemblies ... 35 User Interface Overview ... 36 Keyboard Functions ... 39 On-Screen “Dashboard” System Status ICONs ... 42 Accessory Components... 44 Rear I/O Panel ... 45

5

System Uncrating & Installation Procedures... 46 Product Shipment... 46 Electrical Requirements... 46 Environmental and Space Requirements ... 46 Uncrating ... 46 Mechanical Inspection ... 50 System Installation ... 50 ZS3 System Verification ... 52

6

Setup... 55 System ... 55 Preset Mgmt ... 56 Calc ... 57 Annotation ... 57

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Body Pattern ... 57 Protocols ... 58 Stress Echo ... 58 DICOM ... 58 Network ... 59 Keys... 59 Peripherals... 59 Backup/Restore ... 60 7

Security ... 61 Access Control ... 61 Enabling Location Access Control ... 62 Enabling Account Access Control... 63 System Login ... 63 Local Privilege Management ... 64 LDAP Privilege Management ... 70 User Field Name ... 72 Enable Barcode Login ... 72 Enable Encryption ... 73

8

Patient Information Management ... 74 Patient Information ... 74 New Patient Information ... 75 Retrieve Patient Information ... 80

9

DICOM/HL7 ... 86 DICOM Preset ... 87 Service Preset ... 89 DICOM Verifying ... 103 DICOM Services... 104 DICOM Media Storage ... 110

10 Peripheral... 112 Print Service ... 112 Barcode Reader Configuration ... 113 Power Save ... 115 11 Network ... 117 Network Setup ... 117 FTP Setup ... 122

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QPath/QView ... 123 VPN ... 125 12 Functional Descriptions ... 128 System Capabilities... 128 Major FRUs ... 128 13 System Diagrams ... 133 Power Block Diagram ... 134 Cabling Diagram... 135 System Block Diagram ... 136 14 Peripherals & Accessories ... 137 Black & White Printer ... 137 Color Printer... 144 Pedal Footswitch ... 146 Ultrasound Gel Warmer ... 146 ZS3 Intracavity probe holder ... 153 15 Software Procedures ... 158 Backup Operations... 158 Restore Operations ... 159 Software Upgrade & Installation ... 162 Diagnostic Panel Operations... 168 16 Care and Maintenance ... 177 Overview ... 177 Basic System Care... 178 Transducer Maintenance ... 181 System Check ... 181 17 Preventative Maintenance Forms ... 189 18 System Troubleshooting... 193 Diagnostics ... 194 Troubleshooting... 197 System Status LED & Error Code Definitions... 207 Battery Performance – Charge Times - Reconditioning ... 217 How to Obtain MAC Address ... 218 19 Replacement Procedures ... 222 Recommended Tools ... 222 ZS3 Module – Removal/Replacement... 223

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Casters – Removal/Replacement ... 227 19” Display – Removal/Replacement ... 228 Display Arm – Removal/Replacement... 233 Cart Battery – Removal/Replacement ... 239 Power Module – Removal/Replacement ... 243 User Interface – Removal/Replacement ... 248 Dock Board/SSD - Removal/Replacement ... 254 Gas Spring – Removal/Replacement ... 259 20 Parts Catalog... 263 System ... 264 Display... 264 Accessories ... 266 User Interface ... 270 Module & Cart Electronics ... 271 Internal Cabling ... 272 Power Module... 273 Miscellaneous Cart Items ... 274 Peripherals... 274 Options and Upgrading Package ... 275 Revision History ... 295

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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

[email protected]

Website

www.mindray.com

Telephone

+86 755 81888998

Fax

+86 755 26582680

United States and Canada Address

800 MacArthur Boulevard, Mahwah, NJ 07430

Telephone

1-800-288-2121, 1-201-995-8000

Technical Support

1-877-913-9663, 1-650-316-3199

Technical Support Email

[email protected]

Website

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 ZS3 Ultrasound System (9.x). The Mindray/Zonare ZS3 Ultrasound System is used for ultrasound evaluation of the following applications: Opthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal, thoracic(cardiac), and vascular); Intraoperative (Neuro); 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. Users include ultrasound imaging technicians (sonographers) and physicians. Mindray/Zonare Ultrasound Imaging Systems 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. Please refer to the ZS3 Instructions For Use for more information. The ZS3 Ultrasound System 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. The ZS3 Cart is available in two options: with or without Echocardiography. The Echocardiography option allows users to perform advanced cardiac and intracardiac imaging and related functions beyond what is available without the echocardiography option. Included with the system are one or more Mindray/Zonare Curvilinear, Endocavity, Linear, or Phased array transducers allowing for many clinical applications. Accessories include, but are not limited to the Mindray/Zonare ZPAK Battery and off-the-shelf components: bar code reader, foot pedal, printers, biopsy guides, ECG cables and a wireless Ethernet interface. Case studies can be stored to USB memory stick, and other industry standard archiving devices. Note: The availability of options may be limited based on country or region of use.

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

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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

V

Voltage

Hz

Cycles per second 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

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Symbol

Description 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

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 Council Directive 93 / 42 / EEC concerning Medical Devices. The number adjacent to the CE marking (0123) is the number of the EU-notified body certified for meeting the requirements of the Directive. MR Unsafe – the system is not intended to be used within magnetic resonance (MR) environment.

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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 extremely important to read the following definitions of WARNING information, prior to beginning any service on any sub-system within the system. As you see applicability of each of these noted WARNINGs, during the course of the servicing process, be prepared to avoid harm to persons and equipment by proper adherence. It is not possible to anticipate every condition and situation in which ultrasound system will be used. The following warnings and cautions represent typical situations that require special attention. User knowledge and experience with a specific application and environment must also be taken into consideration in order to help ensure the safety of personnel and equipment. Safety Standards All Mindray 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 60601-237 (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), including limits for

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current leakage and isolation from a primary power line. Testing for compliance with the essential requirements of the Medical Device Directive has been performed.

Warnings • •

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Do not use an aftermarket probe other than those specified by Mindray. The probes may damage the system causing a profound failure, e.g. a fire in the worst case. 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 person, who 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 you have any questions regarding these requirements, please consult your sales representative. When the wireless LAN function is turned on, the ultrasound system may suffer interference from other equipment, even if that other equipment complies with CISPR EMISSION requirements. Keep at least 20 cm away from the ultrasound system when the wireless LAN function is in use. Do not connect or disconnect the system’s power cord or its accessories (e.g., a printer or a recorder) without turning OFF the system power first. This may damage the system and its accessories or cause electric shock. If the system is powered off improperly during operation, it may result in data damage of the system hard disk or system failure. Please use the ultrasound gel compliant with the relevant local regulations. The cover contains natural rubber that can cause allergic reactions in some individuals. In normal diagnostic ultrasound mode, there is no danger of a normaltemperature burn; however, keeping the probe on the same region of the patient for a long time may cause such a burn. Do not use the system to examine a fetus for a long period of time. When using intra-cavity probes, do not activate the probe outside the patient’s body. Power off the system if you will not use the system for a long period of time (including storage/ transportation condition), and you should not allow the system in standby status, otherwise the batteries will be out of power and permanently damaged. If you will not use the system for a long period of time, please periodically check the battery and ensure that the battery power is sufficient. Otherwise, the battery may permanently be damaged. If any fault is find during checking, please contact Mindray Customer Service Department or sales representative.

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• • • • •

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To dispose of the system or any part, contact Mindray Customer Service Department or sales representative. Mindray is not responsible for any system content or accessories that have been discarded improperly. DO NOT touch the Signal I/O ports if in contact with the patient; otherwise patient injury may result. Do not allow the patient to contact the live parts of the ultrasound system or other devices, e.g. signal I / O ports. Electric shock may occur. When faults occur during installing or leading the outside protective wire, the ultrasound system should be powered by the internal power supply. Do not remove any of the System covers other than the module cover. Other than the scan module there are no user-serviceable parts internal to the system. Only trained Mindray/Zonare service personnel should access the system’s internal electronics. The ultrasound systems contain no operator-serviceable components within the enclosures. To avoid electrical shock, do not remove covers. As with any other electrical equipment, always observe care when operating this instrument. For service issues, contact Mindray/Zonare Technical Support. Failure to follow these restrictions may void your warranty or service contract coverage. To reduce the risk of electric shock, DO NOT connect the ZS3 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 plug 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/Zonarerecommended peripherals and accessories. Use of non-specified peripherals and accessories could result in risk of electrical shock or injury. The ultrasound systems represent a potential explosion hazard if used in the presence of flammable anesthetics. The system does not contain a user-serviceable lithium ion battery. The optional ZPAK cart battery is not a user serviceable item. Contact Mindray/Zonare’s Technical Support group for assistance with the ZPAK battery. Follow guidelines provided by relevant IEC standards) when connecting peripherals. The USB Memory Sticks supplied by Mindray/Zonare are the recommended brand, type, and sizes for use in ZS3 Systems. They have been verified for optimum reliability and performance. No modification of the system is permitted. Modifying the system may subject the operator or patient to hazardous conditions. The ZS3 ultrasound system represents a potential explosion hazard if used in the presence of flammable gases or oxygen rich environment. Use only transducers that are specifically approved for the ultrasound system. If the proper identification of a connected transducer is not displayed on screen, do not proceed with its use.

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Transducers covers may be contaminated and must be handled accordingly. Inspect the transducer and ZS3 System before each use. Inspect the transducer face, housing, cable, connectors, and cases. Do not use the unit if damage is detected. 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 Mindray/Zonare ultrasound system. If pins are bent, broken, or missing, do not use the transducer and call Mindray/Zonare Technical Support. To avoid electrical shock, always unplug the ultrasound system AC power cord from wall outlet before cleaning any part. 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 or has been soaked longer than the maximum specified time. 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. The transducer must be removed from patient contact before application of a high-voltage defibrillation. 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. If using relevant 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 chapter 16 limits. This equipment must only be connected to a supply main with protective earth. Validate that measured and calculated results shown in Calc Package reports reflect the clinical observations. Auto-Dop Trace is intended to serve as an adjunct to the diagnostic process in evaluating blood flow during PW Doppler examinations. When using the Auto-Dop Trace feature, please evaluate the results to verify that you are in agreement before committing the values to the Calc Report Package. 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/Zonare. Prior to initiating any disinfection process, disconnect the transducer from the ultrasound system. Ensure that any connected external equipment, such as external monitors, printers and peripherals, comply with relevant standards such as IEC60601-1 and IEC60601-1-2.

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If an external video monitor is connected to the ZS3 system, it is necessary to ensure that an RF ferrite is clamped to the cable as close to the ZS3 system as possible. Use a ferrite such as Fair-Rite Products Corp. 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. 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. There are many types of system use and system error messages that might be displayed during the use of the ZS3 Ultrasound System. If a message is encountered that is not self-explanatory, contact Mindray/Zonare service for assistance. Do not touch any of the connector contacts while performing a patient examination to prevent the possibility of a hazardous current path. Do not expose the device to a magnetic resonance (MR) environment.

Warnings - Ocular 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

Warnings – 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 60° 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. − Inspect the battery for damage before charging or placing the battery in the ZS3 System. − Do not connect battery to an electrical power outlet.

Warnings – ECG •

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/Zonare. Make sure

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that bare parts of the electrodes and the patient do not come in contact with conductive parts, 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.

Warnings – TEE Transducer • • •

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The multiplane TEE transducer should be used only by a qualified physician who has received appropriate training in proper operation of the probe and in endoscopic techniques as dictated by current relevant medical practices. Electrical Hazard: Any evidence of damage indicates the probe cannot be used and should be returned to Mindray/Zonare for evaluation and repair. Biological Hazard: Adequate cleaning and, if necessary, disinfection are carried out to prevent disease transmission. It is the responsibility of the user to verify and maintain the effectiveness of the procedure used. A single-use, sterile disposable sheath for TEE purposes can be used. 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 Mindray/Zonare ultrasound system. If pins are bent, broken, or missing, do not use the transducer and call Mindray/Zonare Technical Support. Immediately replace a transducer that exhibits any damage symptoms. Before introducing the probe, do not rub or spray the tip of the probe with an anesthetic agent. Avoid forceful manipulations and excessive force in using the probe that could result in patient injury. Withdraw the probe only with the deflection control in the unlock mode and with the distal end of the probe straight. The use of a bite guard is mandatory. Failure to use the bite guard may result in damage to the probe, which could result in a safety hazard. Damage to the probe due to biting is not covered by the probe's warranty. 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 probe. Contact the service organization to re-adjust the steering of the probe. In this way, the risk of "buckling" or "U-turning" of the probe in the esophagus is minimized. Avoid damage to the probe by allowing nothing to protrude beyond the case when closing the lid. Prior to cleaning any device, turn off the system and disconnect power cord from AC power source to avoid electrical shock. Always use protective eyewear and clothing when cleaning or disinfecting the transducers.

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Do not allow the disinfectant to come in contact with metal surfaces (transducer connector). Use a soft cloth and warm soapy water to remove any disinfectant that remains on metal surfaces. Keep the control handle and transducer connector out of any cleaning or disinfection solutions. The control handle and cable may be cleaned with a damp cloth, but only the distal end of the probe up to the 100cm marker on the P8-3 TEE and 70cm marker on the P8-3m TEE shaft may be placed into a disinfection solution. Do not use other disinfection methods like Iodine, Steam, Heat or Ethylene Oxide. When servicing the ZS3 System, always be sure to turn the circuit breaker to the OFF position.

Precautions Transducers are individually licensed according to system configuration. Only the following transducers are available without an advanced feature configuration: L30-8, P7-3c, C12-4lp, C4-1, C6-2, C6-1, C9-3, C9-3sp, C8-3 3D, C10-3, C18-85, E9-3 3D, E9-3, E9-4, L8-3, L10-5, L14-5w, L14-5sp, L205, P4-1c, P8-3TEE and P8-3mTEE. The A2CW and A5CW transducers are enabled if the system is configured with "CW Enabled", and can be used under either the Echocardiology (optional) or the Advanced Vascular Imaging (mandate) mode. Attempting to use any other transducers will result in an error message. 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/Zonare is to be connected to the system, it must meet all applicable electrical safety standards that apply to the system in order to maintain Mindray/Zonare’s safety integrity. Any equipment not supplied by Mindray/Zonare must be approved by Mindray/Zonare. Use of non-Mindray/Zonare-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. Mindray/Zonare 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. Avoid rolling the cart wheels over cables. Use of cable hooks is recommended to minimize chance of damage to cables. If a transducer that has not been approved and licensed for use with the ultrasound system to which it is connected, or if a licensed transducer is not properly connected, the corresponding transducer identification data will not display on the LCD Display. Imaging will be disabled. Resolve this issue before continuing use.

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The ultrasound system and/or the transducer could be damaged if a nonapproved transducer is connected. Improper cleaning or disinfection of patient applied parts may cause permanent damage. Carefully review the manufacturer’s directions for any component used with Mindray/Zonare ultrasound systems. MINDRAY assumes no liability with respect to single-use devices that are reused, reprocessed, or resterilized and makes no warranties, expressed or implied (including the warranties of merchantability or fitness for a particular use), with respect to such devices. Use of peripherals or other equipment not provided by Mindray/Zonare may result in system damage or degraded performance. Carefully review the labeling of any such equipment before connecting to the Mindray/Zonare system. Improper setting of imaging controls may obscure diagnostically valuable information in the display. The factory default preset maps were preselected as appropriate for most imaging circumstances. Improper user configuration of custom presets may obscure diagnostically valuable information. Mindray/Zonare ultrasound systems are manufactured in compliance with existing electromagnetic immunity (EMI) and electromagnetic compatibility (EMC) requirements. Use of the systems in the presence of an electromagnetic field can cause degradation of the ultrasound image. 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 port and the transducer connector. If the ZS3 System has been moved between environments with extremes of temperature and/or humidity, allow the ZS3 System to rest for at least 30 minutes in a controlled environment before using. Do not use the ultrasound system if any error message displays on the screen. Do not block airflow to any ventilation holes on the system. Do not submerge the transducer past the points indicated in ‘Mindray/Zonare Transducers Cleaning and Disinfection’. Do not spill liquid on the systems or transducers. 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. The use of non-shielded cables may result in increased emissions and decreased immunity to external signals Operating the systems in the presence of external electromagnetic fields can degrade the quality of the ultrasound image. High-frequency devices, such as

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