Z.one pro Service Manual Ver 6.0 April 2020

©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 z.onepro Ultrasound System 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. April 2020

For information and pricing on ZONARE system upgrades, transducers, accessories, and new features, please call 1-877-966-2731, ext. 3.

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TABLE OF CONTENTS 1

INTRODUCTION ... 8

TECHNICAL SUPPORT ... 8 EMAIL: [email protected]... 8 SALES SUPPORT: 1-877-966-2731, [email protected]... 8 2

PURPOSE ... 9 Product Overview ... 9 Definitions/Acronyms... 9 Documentation Conventions... 11

3

SAFETY ... 13 WARNINGS & Cautions... 13

4

SYSTEM SPECIFICATIONS ... 22 General system specifications ... 22 Display ... 24 Battery Pack Specifications ... 24 Standards and Compliance ... 27

5

SYSTEM OVERVIEW ... 29 Major System Assemblies... 29 User Interface Overview... 30 Keyboard Functions... 34

KEY ... 34 SYSTEM CONTROL ... 34 DESCRIPTION ... 34 On-Screen “Dashboard” System Status ICONs... 36 Accessory Components ... 39 Rear I/O Panel ... 40 6

SYSTEM UNCRATING & INSTALLATION PROCEDURES – UPDATE ENTIRE SECTION ... 41 Product Shipment ... 41 Electrical Requirements ... 41 Environmental and Space Requirements ... 41 Uncrating ... 41 Mechanical Inspection ... 44 System Installation ... 45 z.onepro Service Manual

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ZONARE MODULE COVER INSTRUCTIONS ... 45 z.onepro System Verification ... 46 7

BASIC SYSTEM CONFIGURATION ... 49 Entering “Institution” Name ... 49 Configuring “Barcode” Scanner ... 50 Configuring “Audio/Video” ... 51 Entering “Time/Region” Information ... 52 Entering “Trackball” Configuration ... 53 Configuring “Imaging” Parameters ... 54

8

ARCHIVE MENU FUNCTIONS ... 56 “Media” & “Store/Print” Setup ... 56 “Exam Export” Options ... 59 “Exam Management” Setup ... 60 Archive “Export” Options ... 65 “Serial Port” Setup - (Export Calc Report Data) ... 66

9

DICOM CONFIGURATION ... 69 Overview... 69 Parameter Definitions ... 70 Pre-Install Survey Form ... 73 “DICOM” Configuration Procedure - Menus ... 77 “Network” Setup ... 85 “FTP” Setup ... 86

10 ADVANCED SYSTEM SETUP CONFIGURATION... 89 “Security” Setup Menus... 89 “Power Save” Setup Menu ... 90 11 FUNCTIONAL DESCRIPTIONS... 92 System Capabilities ... 92 Major FRUs ... 92 12 SYSTEM DIAGRAMS... 95 Power Block Diagram ... 96 Cabling Diagram ... 97 System Block Diagram ... 98 13 PERIPHERALS & ACCESSORIES ... 99 CD/DVD Drive ... 99 Black & White Printer ... 101 z.onepro Service Manual

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Color Printer ... 110 Network Report Printer... 111 Pedal Footswitch ... 116 14 SOFTWARE PROCEDURES ... 117 Backup Operations ... 117 RESTORE Operations: ... 118 Standard Software Installation Procedure ... 120 “Clean” Software Install Procedure ... 122 ZONARE FTP Site... 123 “DIAGNOSTIC” Panel Operations... 123 15 SYSTEM MAINTENANCE ... 132 User Diagnostics Panel ... 133 (Exam) Preset Mgmt/System Setup... 136 Software Upgrade/Installation ... 138 Installing System Software... 139 Basic System Care ... 139 Transducer Maintenance ... 142 16 SYSTEM TROUBLESHOOTING... 146 Technical Support Contact Information ... 146 TECHNICAL SUPPORT ... 146 EMAIL: [email protected]... 146 SALES SUPPORT: 1-877-966-2731, [email protected]... 146 Troubleshooting ... 147 System Status LED & Error Code Definitions ... 152 Battery Performance – Charge Times - Reconditioning... 161 17 REPLACEMENT PROCEDURES ... 163 Recommended Tools ... 163 z.onepro Module – Removal/Replacement ... 164 17” Display – Removal/Replacement... 168 Power Module – Removal/Replacement ... 176 User Interface – Removal/Replacement... 180 OLED Assembly (UI Assy) – Removal/Replacement ... 186 Dock Module - Removal/Replacement ... 190 Gas Spring – Removal/Replacement... 194

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DVD Drive – Removal/Replacement... 198 Transducer TCON Board – Removal/Replacement ... 200 18 PARTS CATALOG ... 202 System ... 202 Display ... 203 Accessories ... 204 Transducers ... 205 User Interface... 207 Module & Cart Electronics ... 208 Internal Cabling ... 210 Power Module ... 211 Miscellaneous Cart Items... 212 Peripherals ... 212 Options and Upgrading Package ... 213 19 INDEX ... 214 DOCUMENT TITLE: Z.ONEPRO SERVICE MANUAL... 216

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TABLE OF FIGURES FIGURE 1: MAIN SHIPPING CONTAINER REMOVAL ... 42 FIGURE 2: LOADING RAMP LOWERING ... 42 FIGURE 3: REMOVABLE SECTION OF SHIPPING BASE ... 42 FIGURE 4: REMOVING PROTECTIVE STORAGE BAG ... 43 FIGURE 5.1 & 8.2 : DIRECTIONAL AND BRAKE RELEASE ... 43 FIGURE 6.1: DIRECTIONAL/SWIVEL CASTER FIGURE 7.2: (X3) BREAKING CASTER... 94 FIGURE 8: HEIGHT ADJUSTMENT MECHANISM ... 94 FIGURE 9: CD/DVD PART NUMBERS ... 99 FIGURE 10: PRINTER BRACKET MOUNTING TO Z.ONEPRO CART ... 102 FIGURE 11: CABLE CONNECTIONS (UP-D711)... 102 FIGURE 12: OPERATOR CONTROLS (UP-D711) ... 105 FIGURE 13: TRANSDUCER IMMERSION LIMITS ... 145 FIGURE 14: TRANSDUCER CONNECTOR PIN DAMAGE – (EXAMPLE) ... 147 FIGURE 15: SYSTEM CIRCUIT BREAKER ... 168 FIGURE 16: DISPLAY COVER FIGURE 21: DISPLAY COVER REMOVED ... 169

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1

INTRODUCTION ...

ZONARE Contact Information

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Mindray Building, Keji 12th Road South, High-Tech Industrial Park, Nanshan, Shenzhen, 518057,P.R.China

Technical Support North America: Phone support: 877-913-9663 or 650-316-3199 Email: [email protected] Sales support: 1-877-966-2731, [email protected] www.zonare.com

Europe and Asia: Address:

Mindray Building, Keji 12th Road South, High-tech industrial park, Nanshan, Shenzhen 518057,P.R.China

Website:

www.mindray.com

E-mail Address:

[email protected]

Tel:

+86 755 81888998

Fax:

+86 755 26582680

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2

PURPOSE

This manual provides information to assist service personnel in performing maintenance, and repair procedures that may be required to support z.onepro Ultrasound System. The ZONARE z.onepro is used for ultrasound evaluation of the following applications: 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. ZONARE Ultrasound Imaging Systems may be used in a hospital (e.g. imaging laboratory, emergency room, patient bedside, operating room), medical clinic, physician’s office or a mobile imaging center. Please refer to the z.onepro Ultrasound Platform Instructions For Use for more information. The z.onepro 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 ZONARE transducers. The Cart performs the calculations involved in processing the data to produce the displayed ultrasound images. Cart options include, but are not limited to, echocardiography (which includes continuous wave (CW), physiologic signals (ECG and respiration) and the cardiac calculation package), advanced vascular (which includes CW) and the streamlined Special Procedures user interface. Available with the system are one or more ZONARE Curvilinear, Endocavity, Linear, or Phased array transducers allowing for many clinical applications. Accessories include, but are not limited to the 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, DVD, and other industry standard archiving devices. Note: The availability of options may be limited based on country or region of use. Product Overview The system consists of a limited number of Field Replaceable Units (FRU’s). The FRU’s for this unit are: •

17” Display

•

User Interface Assembly

•

System Module

•

Power Module

•

Z-PAK Battery Pack

•

Misc cables and mechanical assemblies

Definitions/Acronyms 2D: ... Two dimensional (B-Mode, Color mode) z.onepro Service Manual

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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: 2.1.1 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. ZONARE meets the WEEE Standard. For more information on returning or recycling this system, please contact Mindray or the distributor from whom you purchased the system.

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Symbol

Description Consult the Instructions for Use

ZONARE 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

Shipping & Storage: Pressure limits

Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner (USA).

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3

SAFETY

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. WARNINGS & Cautions It is not possible for ZONARE to anticipate every condition and situation in which ZONARE 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 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 UL 60601 (Standard Medical Electrical Equipment, Part 1: General Requirements for Safety), IEC 60601 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance), IEC 60601-2-37 (Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment) 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 Warnings & Precautions associated with the use of ZONARE’s z.onepro Ultrasound System and compatible transducers.

Warnings • •

• •

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 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 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 z.onepro 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

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• • • • • • • • • • • • •

•

• • • • • •

To maintain proper grounding reliability, use only ZONARE-recommended 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’s Technical Support group for assistance with the ZPAK battery. Follow guidelines provided by IEC 60601 when connecting peripherals. The USB Memory Sticks supplied by ZONARE are the recommended brand, type, and sizes for use in the z.onepro 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. To reduce the risk of electric shock, do not connect the z.onepro input or output connections to equipment that is not properly connected to an Earth ground. The z.onepro 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 and licensed for the ultrasound system. If the proper identification of a connected transducer is not displayed on screen, do not proceed with its use. Transducers covers may be contaminated and must be handled accordingly. Inspect the transducer and Ultrasound 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 ZONARE ultrasound system. If pins are bent, broken, or missing, do not use the transducer and call 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 IEC 60601 compliant equipment that was not provided by ZONARE, it is required that total leakage currents be tested and validated to be below the IEC 60601 limits. This equipment must only be connected to a supply main with protective earth.

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• • • • • • • • • •

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. 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. If an external video monitor is connected to the z.onepro system, it is necessary to ensure that an RF ferrite is clamped to the cable as close to the z.onepro system as possible. Use a ferrite such as FairRite Products Corp. 0431167281 (or an equivalent). 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 z.onepro Ultrasound System. If a message is encountered that is not self explanatory, contact Mindray 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.

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 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 z.onepro System or a ZONARE provided battery charger.

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− Inspect the battery for damage before charging or placing the battery in the z.onepro 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. • To avoid electrical shock, do not touch the battery contact. 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 ZONARE. Make sure 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 • • • •

• • • • • •

•

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 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 ZONARE ultrasound system. If pins are bent, broken, or missing, do not use the transducer and call 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 biteguard is mandatory. Failure to use the biteguard 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.

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• • • • • •

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. 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 shaft may be placed into a disinfection solution. Do not use other disinfection methods like Iodine, Steam, Heat or Ethylene Oxide. When servicing the z.onepro 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: C4-1, C6-2, C9-3, C9-3sp, E9-4, L8-3, L10-5, L14-5w, P4-1c and P8-3TEE. The A2CW and A5CW transducers are enabled if the system is configured with either the Echocardiography or the Advanced Vascular Imaging Feature Sets. 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 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 ZONARE’s safety integrity. Any equipment not supplied by ZONARE must be approved by ZONARE. 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. 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. 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 ZONARE ultrasound systems. zonare 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.

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• • • •

• • • • • • •

• •

• • • • • •

Use of peripherals or other equipment not provided by ZONARE may result in system damage or degraded performance. Carefully review the labeling of any such equipment before connecting to the 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. 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 antistaticmats. To minimize potential ESD damage and electrical contact contamination, avoid touching the metal contacts for the transducer connections, at both the z.onepro port and the transducer connector. If the z.onepro System has been moved between environments with extremes of temperature and/or humidity, allow the z.onepro 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 ‘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 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. The use of non- Mindray approved cables and accessories may result in increased radiated emissions as well as decreased immunity to external signal fields. Before beginning to image a new patient, be sure to conclude any in-progress patient exam by pressing the New Patient key. Failure to do so will result in any subsequent storing of images being mistakenly written to the previous patient exam directory. Some components or devices such as transducer covers used with ZONARE systems are for singlepatient use only. Reuse, reprocessing, or re-sterilization of these devices may compromise their structural integrity. Any image sets stored on the system, that are not identified by patient name and number, will be stored with a unique number based off of the system ID. Exercise care in adjusting all settings to avoid obscuring low-level signals that may have diagnostic value. Improper settings can seriously degrade image quality. Do not touch exposed metal of transducer connector.

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• • • • • • • •

•

• • • • • • •

Validate all entries in the Measurement Summary. Ultrasound imaging capabilities can vary from patient to patient. Ultrasound should be used as one component in a comprehensive diagnostic plan. Never leave a probe in the disinfection solution for more than 45 minutes. Please refer to the instructions for use that came with the disinfectant for minimal required exposure times. Do not forget to rinse the probe directly after disinfection. Only use water-soluble acoustic coupling gel. Other coupling gels can cause probe damage. 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. Use of a non-compatible USB Memory Stick may result in file corruption or long file transfer times. Please confirm proper operation of any memory stick prior to attempting to use for clinical data. Make sure the z.onepro System has fully completed downloading upgrades, importing/exporting, or collecting log data to the USB Memory Stick before removing it from the z.onepro System. Failure to do so will result in loss of data. Wide variability in CD and DVD quality may prevent the system from reliably writing to and reading from some commercially available discs. ZONARE has tested the CD and DVD in the table below and currently recommends their use. For up-to-date CD/DVD recommendations, go to: http://www.zonare.com/support/accessories/media. Before deleting any Exam data from the z.onepro System, always verify that data was successfully transferred to the CD/DVD by viewing it on an external reader/player..Review the user maintenance section of the instructions for use for proper technique and approved agents for cleaning the external surfaces of the system. Review the z.onepro DICOM conformance statement before integrating with any PACS system. Validate Structured Report export prior to clinical use. Use-time from the optional z.onepro 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. Export patient studies in a timely manner. Do not use the system storage as the sole location of patient studies for an extended period of time. IQ scan data should not be relied on for primary storage of diagnostic data. Use of IQ scan data across software versions is not guaranteed. Diagnostic data exported to CD/DVD should be verified on an external system before deleting that data from the z.onepro system. The system is not indicated for differentiation between malignant and benign breast lesions.

USB Memory Stick CAUTIONs USB Memory Sticks that are purchased from outside sources (besides ZONARE) may not be compatible for use with a system. USB Memory Sticks which are labeled as “U3 Smart Technology” on their label or packaging will NOT be recognized (or function) by a system. In the case of having one of these incompatible format USB Memory Sticks. There are freeware U3 Smart Technology “Removal” programs available on the internet, that can be downloaded and run to make the USB Memory Sticks useable in the system.

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Precautions – TEE Transducer •

TEE: 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. • TEE: Examine the transducer prior to each use. See the TEE Maintenance Guide or the TEE Quick Reference Guide (K90056) for details. • TEE: Clean and disinfect after each use. • TEE: Always use a bite guard. • TEE: Always use single-use probe sheath. • TEE: Ensure articulation locks are disengaged and straighten mechanism during device insertion or extraction from patient. • TEE: Remove the transducer from the patient prior to defibrillation. • TEE: Handle with care, very delicate instrument. • TEE: Do not store the disinfected transducer in the carrying case. Only use the case for transportation. • TEE transducer is a delicate medical instrument, handle with care. • The multiplane TEE probe is a precision instrument, which must be handled with care. It may be damaged when dropped or abused. In particular, 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. • The transducer connector is not watertight, and should always be kept dry. The control handle, although spray-watertight, should not be immersed. • This equipment contains no operator serviceable components. To prevent electric shock, do not remove any covers or panels. • Never manually deflect the distal tip of the probe; use only the deflection control wheels. • Do not kink, tightly coil, or apply excessive force on the probe cable or shaft. Insulation failure may result. • Under normal conditions at full acoustic power the temperature of the tip does not exceed 43°C. Be sure to check at least monthly that the temperature increase of the tip is within limits: • Connect the probe 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 probe if there is a temperature increase that could be harmful for the patient. • When a brush is used for cleaning the transducer, use only a soft brush; coarse/stiff-bristle brushes may cause transducer damage • 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 shaft may be placed into a disinfection solution. • During immersion disinfection, never immerse the transducers longer than 45 minutes. Damage may occur to the transducer housing and/or components if disinfection times exceed these recommended limits. Precautions – Panoramic Imaging

z.onepro Service Manual

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