SiteRite Halcyon Instructions for Use Ver 1.0

Regulatory Requirement This manual is a reference for the Site~Rite® Halcyon™ Ultrasound System. Please verify that you are using the latest revision of this document. If you need the latest revision, contact Bard Access Systems. Bard and Site~Rite Halcyon are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owner(s).

NOTE: Important 1. 2. 3.

4.

No part of this manual may be reduced, modified, copied or reprinted, in whole or in part, without written permission from CHISON. The contents of this manual are subject to change without prior notice and without our legal obligation. Before operating the system, please read and understand this manual. After reading, keep this manual in an easily accessible place. If you have any questions, please contact Bard Access Systems or a CHISON authorized service engineer. CHISON's Warranty only cover material and parts costs for repair, but do not cover any labor cost or onsite service cost at end user's side.

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NOTE: Important information It is the customer’s responsibility to maintain and manage the system after delivery. The warranty does not cover the following items, even during the warranty period: a) Damage or loss due to customer misuse or abuse with system and probes. b) Damage or loss caused by Environment Damage such as fires, earthquakes, floods, lightning, etc. c) Damage or loss caused by failure to meet the specified environmental conditions for this system. d) Damage or loss caused by shipping in non-approved CHISON packaging. e) Damage or loss due to the system outside the region where the system was originally sold. f) Damage or loss involving the system purchased from a source other than CHISON or Bard Access Systems. 3. Do not make changes or modifications to the software or hardware of this system and probes. 4. During operate, if the user has any problems with the system; please contact Bard Access Systems or a CHISON's authorized service engineer immediately. Please describe the situation in a clear and concise manner in order to solve the problem in a timely manner. Please resolve the issue before operating the system. 5. This system shall used only by fully qualified and certified medical personnel. 6. Having the system modified or repaired by people other than Bard Access Systems or CHISON’s qualified service engineers, voids the warrantee. 7. The purpose of this system is to provide physicians with data for clinical diagnosis. It is the clinician’s responsibility for any type of diagnostic conclusion. CHISON shall not be liable for the results or conclusions based on a clinical diagnosis. 8. This manual contains warnings regarding potential hazards associated with the use of the product. However the user should always be alert to hazards other than those indicated in this manual. CHISON shall not be liable for damage or loss that results from negligence or from ignoring the precautions and operating instructions described in these instructions for use. 9. Before and after each ultrasound examination, please inspect the probe surface, probe cable and sheath for any damage, such as cracking, peeling or deformation. Assure also that the lens is attached securely to the probe face. Damaged probes may cause electric shock and injury to the patient. If the probe is damaged, please stop using the machine and contact Bard Access Systems or a CHISON authorized service engineer. 10. If there is any liquid or metal ingress, please power off the system and stop using it immediately. Please contact Bard Access Systems or a CHISON authorized service engineer before using the system again. 11. Please don't use solvents (such as paint thinner, or benzine) or abrasive cleansers to clean the system (including monitor and probes, etc). It may corrode the system and probes. 12. While the system or probe is over life time, please refer to instructions for use section 15.3 13. CHISON shall not be liable for loss of data stored in this system caused by operator error or accidents. 14. Please store the instructions for use with the system to ensure the operator can reach it at any time. 15. It is normal for an LCD display screen to have some dark or light dots. 1. 2.

Caution： Users should read the instructions for use carefully before operating the system. Turning the system on implies that the user has read the instructions for use and accepts the listed cautions, warnings, and notes in the manuals.

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TABLE OF CONTENTS Chapter 1 Introduction ... 6 1.1 System Overview ... 6 1.2 Contact Information ... 6 Chapter 2 System Safety ... 7 2.1 Safety Overview ... 7 2.2 Electrical Safety ... 7 2.3 Warning Symbols ... 9 2.4 Patient Environmental Devices ... 10 2.5 Biological Safety ... 12 2.6 Scanning Patients and Education ... 13 Chapter 3 Preparing the System for Use ... 19 3.1 Site Requirement... 19 3.2 System Specifications ... 20 3.3 System Positioning & Transporting ... 23 3.4 Powering the System ... 24 3.5 Probes... 24 Chapter 4 Control panel ... 26 4.1 Overview of display area ... 26 4.2 Operating area of active state ... 27 4.3 Operation area of color mode ... 30 4.4 Operation area of PW mode ... 31 4.5 Operation area of freeze mode... 32 4.6 Machine Information Area ... 33 4.7 The thumbnail area of saving images... 33 4.8 Cine memory bar ... 33 4.9 On Screen Keyboard ... 33 4.10 PICC Interface ... 33 Chapter 5 Imaging ... 35 5.1 Select display mode ... 35 5.2 Select Examination mode ... 35 5.3 Image control and adjustment ... 36 5.4 Adjustment in color flow mode ... 38 5.5 Adjustment in PW mode ... 40 5.6 Image Settings ... 41 Chapter 6 Measurement and Calculation ... 42 6.1 Measurement methods: ... 42 6.2 Other measurements and calculations in B, B/B and 4B mode ... 43 6.3 OB measurement and calculation... 45 6.4 GYN Measurement ... 48 6.5 Small parts measurement and calculation ... 49 6.6 Urology measurement and calculation... 50 6.7 Normal measurement and calculation in M, B/M mode ... 51 6.8 Measurement in M mode... 52 6.9 Measurement in B mode... 54 6.10 measurement in PW mode ... 55 Chapter 7 Cine-Memory ... 57 7.1 Store the real-time image ... 57 4

7.2 Manual playback... 57 7.3 Automatic playback ... 57 7.4 Cine Save/Recall ... 57 Chapter 8 Annotation ... 58 8.1 Introduction... 58 8.2 Input characters through the on-screen keyboard: ... 58 8.3 Move the annotation ... 58 8.4 Edit the annotation ... 58 8.5 Clear the annotation ... 58 Chapter 9 Body Marks ... 59 9.1 Introduction... 59 9.2 Operation of body marks ... 60 Chapter 10 Archive Management... 61 10.1 Path selecting ... 61 10.2 Information viewing ... 61 10.3 Documentation ... 61 Chapter 11 Needle Guide/Probe Cover Procedure ... 63 11.1 Basic Steps for Needle Guide/Probe Cover Procedures ... 63 Chapter 12 Reports ... 64 12.1 Introduction... 64 12.2 Content... 64 12.3 Import image ... 64 12.4 Print ... 64 12.5 Save ... 64 12.6 Export ... 64 Chapter 13 Preset ... 65 13.1 General setting ... 65 13.2 Measure ... 65 13.3 Annotation ... 66 13.4 DICOM ... 66 13.5 UI (User Interface) ... 67 13.6 Touch Screen ... 67 13.7 Network ... 67 13.8 System ... 67 13.9 Probe Button Configuration Settings ... 68 Chapter 14 System Maintenance ... 70 14.1 Cleaning ... 70 14.2 Probe maintenance ... 70 14.3 Safety check ... 71 14.4 Troubleshooting ... 71 Chapter 15 Probes ... 73 15.1 General Description ... 73 15.2 Care and Maintenance ... 73 15.3 Service Responsibility ... 78 Appendix A: Maximum Acoustic Output Report ... 80 Appendix B: Measurement Results Summary ... 81 Appendix C: Pulsed Wave Doppler Velocity Measurement Results Summary... 82 Appendix D: Guidance and Manufacturer’s Declaration ... 83 Appendix E: Display Accuracy and Acoustic Measurement Uncertainties ... 87 Appendix F: Transducer Maximum Surface Temperature... 88 5

Chapter 1 Introduction This manual contains the necessary information for safe system operation. Read and understand all of the instructions in this manual before operating the system. Keep this manual with the equipment, and periodically review it to ensure compliance to all operational and safety precautions.

1.1 System Overview Indications for Use The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified clinician for evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Cardiac (adult & pediatric); Peripheral Vascular, Vascular Access, Musculoskeletal Conventional & Superficial.

Contraindication The system is NOT intended for Ophthalmic use or any use that causes the acoustic beam to pass through the eye.

1.2 Contact Information For additional information or assistance, please contact us at the numbers shown below:

Service Support

Bard Access Systems Tel: 1-800-296-4146 Opt. 1 E-mail: [email protected]

Placing an Order

Contact your local sales representative or contact Bard Access Systems Tel: 1-800-443-3385 Email: [email protected]

Manufacturer

CHISON Medical Imaging Co., Ltd. No.228, ChangJiang East Road, Block 51 and 53 Phase 5 Industrial Park, ShuoFang, New District, Wuxi, Jiangsu, China, 214142

Distributor

Bard Access Systems, Inc. 605 North 5600 West Salt Lake City, UT 84116 USA www.BardAccess.com

Caution: Federal law restricts the device to sale by or on the order of a licensed Clinician.

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Chapter 2 System Safety 2.1 Safety Overview This section discusses measures to ensure the safety of both the operator and patient. To ensure the safety of both operator and patient, please read the relevant details in this chapter carefully before operating this system. Disregarding the warnings or violation of relevant rules may result in personal injury or even loss of life for operator or patient.

Users should observe the following precautions:  This system complies with Type BF general equipment, and the IEC standard. Please refer to Chapter 2 “System Safety” to use this system properly.  Do not modify this system in any way. Modifications must be made only by the manufacturer or its designated agents.  In the event of a malfunction, turn off the system immediately and inform the manufacturer or its designated agents.  The power cable of the system should only be connected to a grounded power socket. Do not remove the ground cable for any reason.  Only connect this system, either electronically or mechanically, with devices that comply with the EN60601-1 standard.  The system does not incorporate any specialized protective measures in the event it is configured with high-frequency operation devices. The operator should use caution in these types of applications.  Only an authorized service engineer may perform maintenance.  Only a qualified operator, or someone under qualified supervision, should use the system.  Do not use this system in the presence of flammable substances.  Do not continuously scan the same part of a patient or expose the patient to prolonged scanning, otherwise it may harm the patient.  When using the system for ultrasound testing, use only qualified ultrasound gel that complies with system standards.  Do not unplug probe when the system is in active operation. Always go to EXAM screen to remove the probe.  To prevent injury, the operator should not stay in the same position for too long during patient scanning.  Do not put liquid on top of the main unit.

NOTE *The system has built-in screen saver to avoid display wear. It is not recommended to constantly turn on and off the unit. *To dispose of this product properly, please call your local service department.

2.2 Electrical Safety Type of protection against electric shock 

Class I Equipment 7

CLASS I EQUIPMENT in which protection against electric shock does not rely on BASIC INSULATION only, but includes a protective earth ground. This additional safety precaution prevents exposed metal parts from becoming LIVE in the event of an insulation failure.

NOTE: The mains supply shall be cut off after disconnecting the power line and the net power. Degree of protection against electric shock 

Type BF Applied part (for Probes marked with BF symbol)

TYPE BF APPLIED PART providing a specified degree of protection against electric shock, with particular regard to allowable LEAKAGE CURRENT.

Level of protection against harmful ingress of water 

The IP Classification of the System is Ordinary Equipment (IPX0)

Safety level when used in the presence of FLAMMABLE ANAESTHETIC MIXED WITH AIR (or WITH OXYGEN or WITH NITROUS OXIDE): 

The Equipment is not suitable for use in the environment with FLAMMABLE ANAESTHETIC MIXED WITH AIR (or WITH OXYGEN or WITH NITROUS OXIDE)

Mode of operation 

Continuous Operation For maximum safety, always follow these guidelines:  Proper grounding of the system is critical to avoid electrical shock. Always ground the chassis with a threewire cable and plug, and plug the system into a hospital-grade, three-hole outlet.  Do not remove or circumvent the grounding wire.  Do not remove the protective covers on the system. These covers protect users from hazardous voltages. Cabinet panels must remain in place while the system is in use. A qualified electronic technician must make all internal replacements.  Do not operate this system in the presence of flammable gases or anesthetics.  All peripheral devices (unless certified as medical grade) that are connected to the system must be powered through the electrical outlet through an optional isolation transformer.

Notice upon Installation of Product Separation distance and effect from fixed radio communications equipment: field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast transmitter cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ultrasound system is used exceeds the applicable RF compliance level as stated in the immunity declaration, the ultrasound system should be observed to ensure normal operation. If abnormal operation is observed, additional measures may be necessary, such as re-orienting or relocating the ultrasound system or using an RF shielded examination room as necessary. 

Use either power supply cords provided by or designated by CHISON. Products equipped with a power source 8

plug should be plugged into the fixed power socket which has the protective grounding conductor. Never use any adaptor or converter to connect with a power source plug (e.g. three-prong-to-two-prong converter). 

Locate the equipment as far away as possible from other electronic equipment.



Be sure to use only the cables provided by or designated by CHISON. Connect these cables following the installation procedures (e.g. wire power cables separately from signal cables).



Lay out the main equipment and other peripherals following the installation procedures described in this manual.

Notice against User Modification The user should never modify this product. User modifications may cause degradation in Electrical Safety. Modification of the product includes changes in: 

Cables (length, material, wiring, etc.)



System configuration/components

User modifications may cause degradation in EMC performance. Modification of the product includes changes in: 

Cables (length, material, wiring, etc.)



System installation/layout



System configuration/components



Securing system parts (cover open/close, cover screwing)

2.3 Warning Symbols

Caution, consult accompanying documents. This symbol advises the reader to consult the accompanying documents for important safety related information such as warnings and pre-cautions that can not be presented on the device itself.

Dangerous electric voltage. Unplug the main plug before opening the system!

Do not use the following devices near this equipment: cellular phone, radio receiver, mobile radio transmitter, radio controlled toy, etc. Use of these devices near this equipment could cause this equipment to perform outside the published specifications. Keep power to these devices turned off when near this equipment.

Be careful of static.

WASTE OF ELECTRICAL AND ELECTRONIC EQUIPMENT (WEEE): This symbol is used for Environment Protection, it indicates that the waste of electrical and electronic equipment must not be disposed as unsorted waste and must be collected separately. Please contact your local Authority or distributor of the manufacturer for information concerning the decommissioning of your equipment.

Type-BF applied part

9

This symbol is followed by the serial number of the device.

MANUFACTURER: This symbol is accompanied by the name and the address of the manufacturer.

Power On/off. CAUTION: This Power Switch cannot isolate Mains Supply completely.

This symbol signifies that the instructions for use must be read. Rx only

The “Alternating current” symbol indicates that the equipment is suitable for alternating current only. Direct current To indicate on the rating plate that the equipment is suitable for direct current only; to identify relevant terminals.

This symbol indicates that in the united states of America, Federal law restricts the device to sale by or on the order of a licensed practitioner or therapist.

This symbol is followed by the manufacturing date of the device in the form YYYY-MM-DD.

This symbol is probe locked button

This symbol refers to the limit range of operating temperature.

CORRECT: The correct connection of the battery connector WRONG: The wrong connection of the battery connector

2.4 Patient Environmental Devices Profile side (refer to Fig. 3-1 b in Chapter 3): 

Ethernet port



USB port



VGA port



Video port



Power port



Probe



Probe socket lock switch

Rear panel (refer to Fig.3-1 d in Chapter 3) 

Touch pen



Probe socket lock switch



Probe Anti-theft lock interface



Bracket



Battery box



Power switch

Acceptable Devices 10

The Patient Environmental devices shown above are specified to be suitable for use within the PATIENT ENVIRONMENT.

CAUTION: 

DO NOT connect any probes or accessories without approval by CHISON within the PATIENT ENVIRONMENT.



DO NOT touch patient and devices without IEC/EN 60601-1 approval to avoid the leakage current risk within the PATIENT ENVIRONMENT.

Unapproved Devices CAUTION: 

DO NOT use unapproved devices.



Connecting unapproved devices to the system will void the warranty.



The system cannot be used with HF surgical equipment.

Any device connected to this system must conform to one or more of the requirements listed below: 

IEC standard or equivalent standards appropriate to devices.



The devices shall be connected to PROTECTIVE EARTH (GROUND).

CAUTION: Unsafe operation or malfunction may result. Use only the accessories, options and supplies approved or recommended in these instructions for use. Peripheral used in the patient environment The system has been verified for overall safety, compatibility and compliance with the following on-board image recording devices: B/W video printer: Sony UP-X898MD The system may also be used safely while connected to devices other than those recommended above if the devices and their specifications, installation, and interconnection with the system conform to the requirements of IEC/EN 60601-1. The connection of equipment or transmission networks other than as specified in the user instructions can result in an electric shock hazard or equipment malfunction. Substitute or alternate equipment and connections require verification of compatibility and conformity to IEC/EN 60601-1 by the installer. Equipment modifications and possible resulting malfunctions and electromagnetic interference are the responsibility of the owner.

General precautions for installing an alternate off-board, remote device or a network would include: 

The added device(s) must have appropriate safety standard conformance.



There must be adequate mechanical mounting of the device and stability of the combination.



Risk and leakage current of the combination must comply with IEC/EN 60601-1.



Electromagnetic emissions and immunity of the combination must conform to IEC/EN 60601-1-2. 11

Peripherals used in the non-patient environment The system has been verified for compatibility, and compliance for connection to a local area network (LAN) via a wire LAN, provided the LAN components are IEC/EN 60950 compliant.

General precautions for installing an alternate off-board, remote device or a network would include: 

The added device(s) must have appropriate safety standard conformance.



The added device(s) must be used for their intended purpose having a compatible interface.

2.5 Biological Safety This product, as with all diagnostic ultrasound equipment, should be used only for valid reasons and should be used both for the shortest period of time and at the lowest power settings necessary (ALARA - As Low As Reasonably Achievable) to produce diagnostically acceptable images. The AIUM offers the following guidelines: Clinical Safety Quoted from AIUM Approved March 26, 1997 Diagnostic ultrasound has been in use since the late 1950s. Given its known benefits and recognized efficacy for medical diagnosis, including use during human pregnancy, the American Institute of Ultrasound in Medicine herein addresses the clinical safety of such use: There are no confirmed biological effects on patients or instrument operators caused by exposures from present diagnostic ultrasound instruments. Although the possibility

exists that such

biological effects may be identified in the future, current data indicate that the benefits to patients of the prudent use of diagnostic ultrasound outweigh the risks, if any that may be present.

Heating: Elevating tissue temperature during obstetrical examinations creates medical concerns. At the embryo development stage, the rise in temperature and the length of time exposed to heat combine to determine potential detrimental effects. Exercise caution particularly during Doppler/Color exams. The Thermal Index (TI) provides a statistical estimate of the potential temperature elevation (in centigrade) of tissue temperature. Three forms of TI are available: Soft Tissue Thermal Index (TIS), Bone Thermal Index (TIB) and Cranial Bone Thermal Index (TIC). Soft Tissue Thermal Index (TIS): Used when imaging soft tissue only, it provides an estimate of potential temperature increase in soft tissue. Bone Thermal Index (TIB): Used when bone is near the focus of the image as in the third trimester OB examination, it provides an estimate of potential temperature increase in the bone or adjacent soft tissue. Cranial Bone Thermal Index (TIC): Used when bone is near the skin surface as in transcranial examination, it provides an estimate of potential temperature increase in the bone or adjacent soft tissue.

Cavitation: Cavitation may occur when sound passes through an area that contains a cavity, such as a gas bubble or air pocket (in the lung or intestine, for example). During the process of cavitation, the sound wave may cause the bubble to contract or resonate. This oscillation may cause the bubbles to explode and damage the tissue. The Mechanical Index (MI) has been created to help users accurately evaluate the likelihood of cavitation and the related adverse effects. MI recognizes the importance of non-thermal processes, cavitation in particular, and the Index is an attempt to indicate the probability that they might occur within the tissue. 12

2.6 Scanning Patients and Education The Track-3 or IEC60601-2-37 output display standard allows users to share the responsibility for the safe use of this ultrasound system. Follow these usage guidelines for safe operation:  In order to maintain proper cleanliness of the probes, always clean them between patients.  Always use a disinfected sheath on all EV/ER probes during every exam.  Continuously move the probe, rather than staying in a single spot, to avoid elevated temperatures in one part of the patient’s body.  Move probe away from the patient when not actively scanning.  Understand the meaning of the TI, TIS, TIB, TIC and MI output display, as well as the relationship between these parameters and the thermal/cavitation bio-effect to the tissue.  Expose the patient to only the very lowest practical transmit power levels for the shortest possible time to achieve a satisfactory diagnosis (ALARA - As Low As Reasonably Achievable).

Safe Scanning Guidelines 

Ultrasound should only be used for medical diagnosis and only by trained medical personnel.



Diagnostic ultrasound procedures should be done only by personnel fully trained in the use of the equipment, in the interpretation of the results and images, and in the safe use of ultrasound (including education as to potential hazards).



Operators should understand the likely influence of the machine controls, the operating mode (e.g. Bmode, color Doppler imaging or spectral Doppler) and probe frequency on thermal and cavitation hazards.



Select a low setting for each new patient. Output should only be increased during the examination if penetration is still required to achieve a satisfactory result, and after the Gain control has been moved to its maximum value.



Maintain the shortest examination time necessary to produce a useful diagnostic result.

Do not hold the probe in a fixed position for any longer than is necessary. It should be removed from the patient whenever there is no need for real-time imaging or spectral Doppler acquisition. The frozen frame and Cine loop capabilities allow images to be reviewed and discussed without exposing the patient to continuous scanning. 

Take particular care to reduce output and minimize exposure time of an embryo or fetus when the temperature of the mother is already elevated.



Take particular care to reduce the risk of thermal hazard durin g diagnostic ultrasound when exposing: an embryo less than eight weeks after gestation; or the head, brain or spine of any fetus or neonate.



Operators should continually monitor the on-screen thermal ind ex (TI) and mechanical index (MI) values and use control settings that keep these settin gs as low as possible while still achieving diagnostically useful results. In obstetric examinations, TIS (soft tissue thermal index) should be monitored during scans carried out in the first eight weeks after gestation, and TIB (bone thermal index) thereafter. In applications where the probe is very close to bone (e.g. trans-cranial applications), TIC (cranial bone thermal index) should be monitored.

MI> 0.3

There is a possibility of minor damage to neonatal lung or intestine. If such exposure is necessary, reduce the exposure time as much as possible. 13

MI> 0.7

There is a risk of cavitation if an ultrasound contrast agent containing gas microspheres is being used. There is a theoretical risk of cavitation without the presence of ultrasound contrast agents.

The risk increases with MI values above this

threshold.

TI> 0.7

The overall exposure time of an embryo or fetus should be restricted in accordance with Table 2-2 below as a reference: Maximum exposure time (minutes) 60 30 15 4 1

TI 0.7 1.0 1.5 2.0 2.5

Table 2-2 Maximum recommended exposure times for an embryo or fetus 

Non-diagnostic use of ultrasound equipment is not generally recommended. Examples of non-diagnostic uses of ultrasound equipment include repeated scans for operator training, equipment demonstration using normal subjects, and the production of souvenir pictures or videos of a fetus. For equipment of which the safety indices are displayed over their full range of values, the TI should always be less than 0.5 and the MI should always be less than 0.3. Avoid frequent repeated exposure of any subject. Scans in the first trimester of pregnancy should not be carried out for the sole purpose of producing souvenir videos or photographs, nor should their production involve increasing the exposure levels or extending the scan times beyond those needed for clinical purposes.



Diagnostic ultrasound has the potential for both false positive and false negative results. Misdiagnosis is far more dangerous than any effect that might result from the ultrasound exposure. Therefore, diagnostic ultrasound system should be performed only by those with sufficient training and education.

Understanding the MI/TI Display Track-3 follows the Output Display Standard for systems that include fetal Doppler applications. The acoustic output will not be evaluated on an application-specific basis, but the global maximum de-rated Ispta must be ≤ 720 mW/cm2 and either the global maximum MI must be ≤ 1.9 or the global maximum de-rated Isppa must be ≤ 190 W/cm2. An exception is for ophthalmic use, in which case the TI = max (TIS_as, TIC) is not to exceed 1.0; Ispta.3 ≤50mW/cm2, and MI ≤ 0.23. Track-3 gives the user the freedom to increase the output acoustic power for a specific exam, and still limit output acoustic power within the global maximum de-rated Ispta ≤ 720 mW/cm2 under an Output Display Standard.

For any diagnostic ultrasonic systems, Track-3 provides an Output Indices Display Standard. The diagnostic ultrasound systems and its operator’s manual contain the information regarding an ALARA (As Low As Reasonably Achievable) education program for the clinical end-user and the acoustic output indices, MI and TI. The MI describes the likelihood of cavitation, and the TI offers the predicted maximum temperature rise in tissue as a result of the diagnostic examination. In general, a temperature increase of 2.5°C must be present consistently at one spot for 2 hours to cause fetal abnormalities. Avoiding a local temperature rise above 1°C 14

should ensure that no thermally induced biologic effect occurs. When referring to the TI for potential thermal effect, a TI equal to 1 does not mean the temperature will rise 1 degree C. It only means an increased potential for thermal effects can be expected as the TI increases. A high index does not mean that bio-effects are occurring, but only that the potential exists and there is no consideration in the TI for the scan duration, so minimizing the overall scan time will reduce the potential for effects. These operator control and display features shift the safety responsibility from the manufacturer to the user. So it is very important to have the Ultrasound systems display the acoustic output indices correctly and the education of the user to interpret the value appropriately.

RF: (De-rating factor) In Situ intensity and pressure cannot currently be measured. Therefore, the acoustic power measurement is normally done in the water tank, and when soft tissue replaces water along the ultrasound path, a decrease in intensity is expected. The fractional reduction in intensity caused by attenuation is denoted by the de-rating factor (RF),

RF = 10 (-0.1 a f z) Where ‘a’ is the attenuation coefficient in dB cm-1 MHz-1, f is the transducer center frequency, and z is the distance along the beam axis between the source and the point of interest.

De-rating factor RF for the various distances and frequencies with attenuation coefficient 0.3dB cm-1 MHz-1 in homogeneous soft tissue is listed in the following table. An example is if the user uses 7.5MHz frequency, the power will be attenuated by .0750 at 5cm, or 0.3x7.5x5=-11.25dB. The De- rated Intensity is also referred to as ‘.3’ at the end (e.g. Ispta.3). Distance (cm) 1 2 3 4 5 6 7 8

Frequency (MHz) 1 0.9332 0.8710 0.8128 0.7586 0.7080 0.6607 0.6166 0.5754

3

5

7.5

0.8128 0.6607 0.5370 0.4365 0.3548 0.2884 0.2344 0.1903

0.7080 0.5012 0.3548 0.2512 0.1778 0.1259 0.0891 0.0631

0.5957 0.3548 0.2113 0.1259 0.0750 0.0447 0.0266 0.0158

I’=I*RF Where I’ is the intensity in soft tissue, I is the time-averaged intensity measured in water.

Tissue Model: Tissue temperature elevation depends on power, tissue type, beam width, and scanning mode. Six models are developed to mimic possible clinical situations.

15

Thermal Models

Composition

Mode

Specification

Application

1

TIS

Soft tissue

Unscanned

Large aperture (>1cm2)

Liver PW

2

TIS

Soft tissue

Unscanned

Small aperture (<1cm2)

Pencil Probe

3

TIS

Soft tissue

Scanned

Evaluated at surface

Breast color

4

TIB

Soft tissue and bone

Scanned

Soft tissue at surface

Muscle color

5

TIB

Soft tissue and bone

Unscanned

Bone at focus

Fetus head PW

6

TIC

Soft tissue and bone

Unscanned/scanned

Bone at surface

Transcranial

Soft tissue: Soft tissue describes low fat content tissue that does not contain calcifications or large gas-filled spaces. Scanned: (auto-scan) Refers to the steering of successive burst through the field of view, e.g. B and color mode. Unscanned: Emission of ultrasonic pulses occurs along a single line of sight and is unchanged until the transducer is moved to a new position. For instance, the PW, CW and M mode.

TI: TI is defined as the ratio of the In Situ acoustic power (W.3) to the acoustic power required to raise tissue temperature by 1°C (Wdeg), TI = W.3/Wdeg. Three TIs corresponding to soft tissue (TIS) for abdominal; bone (TIB) for fetal and neonatal cephalic; and cranial bone (TIC) for pediatric and adult cephalic, have been developed for applications in different exams. An estimate of the acoustic power in milliwatts necessary to produce a 1°C temperature elevation in soft tissue is: Wdeg = 210/fc,

for model 1 to 4, where fc is the center frequency in MHz.

Wdeg = 40 K D

for model 5 and 6, where K (beam shape factor) is 1.0, D is the aperture diameter in cm at the depth of interest.

MI: Cavitation is more likely to occur at high pressures and low frequencies in pulse ultrasound wave in the tissue, which contains the bubble or air pocket (for instance, the lung, intestine, or scan with gas contrast agents). The threshold under optimum conditions of pulsed ultrasound is predicted by the ration of the peak pressure to the square root of the frequency. MI = Pr’ / sqrt(fc) Pr’ is

the

de-rated

(0.3)

peak

rare-fractional

pressure

in Mpa at the point where PII is the

maximum, and fc is the center frequency in MHz. PII is the Pulse Intensity Integral that the total energy per

unit

area

carried by the

wave during

the

time

duration

of

the

pulse. The peak rare-

fractional pressure is measured in hydrophone maximum negative voltage normalized by the hydrophone calibration parameter.

Display Guideline: For different operation modes, different indices must be displayed. However, only one index needs to be shown at 16

a time.

Display is not required if maximum MI is less than 1.0 for any setting of the operating mode, or if

maximum TI is less than 1.0 for any setting of the operating mode. For TI, if the TIS and TIB are both greater than 1.0, the scanners need not be capable of displaying both indices simultaneously. If the index falls below 0.4, no display is needed.

Display and Report in Different Mode Located on the upper middle section of the system display monitor, the acoustic output display provides the operator with real-time indication of acoustic levels being generated by the system. For B-Scan Mode Only display and report MI, and start from 0.4 if maximum MI > 1.0, display in increments of 0.2. For Color Mode Only display and report TIS or TIB and start from 0.4 if maximum TI > 1.0, display in increments of 0.2 for values of indices of 2.0 or less, and 0.5 for values of indices greater than 2.0. Below is a simple guideline for the user when TI exceeds one limit exposure time to 4(6-TI) minutes based on the ‘National Council on Radiation Protection. Exposure Criteria for Medical Diagnostic Ultrasound: I. Criteria Based on Thermal Mechanisms. Report No.113 1992’.

Operator Control Features: The user should be aware that certain operator controls may affect the acoustic output. It is recommended to use the default (or lowest) output power setting and compensate using Gain control to acquire an image. Other than the output power setting in the soft-menu, which has the most direct impact on the power; the PRF, image sector size, frame rate, depth, and focal position also slightly affect the output power. The default setting is normally around 70% of the allowable power depending on the exam application mode.

Controls Affecting Acoustic Output The potential for producing mechanical bioeffects (MI) or thermal bioeffects (TI) can be influenced by certain controls. Direct: The Acoustic Output control has the most significant effect on Acoustic Output. Indirect: Indirect effects may occur when adjusting controls. Controls that can influence MI and TI are detailed under the Bioeffects portion of each control in the Optimizing the Image chapter. Always observe the Acoustic Output display for possible effects.

Best practices while scanning

HINTS: Raise the Acoustic Output only after attempting image optimization with controls that have no effect on Acoustic Output, such as Gain and TGC.

WARNING: Be sure to have read and understood control explanations for each mode used before attempting to adjust the Acoustic Output control or any control that can affect Acoustic Output. Use the minimum necessary acoustic output to get the best diagnostic image or measurement during an examination. Begin the exam with the probe that provides an optimum focal depth and penetration.

Acoustic Output Default Levels 17

In order to assure that an exam does not start at a high output level, the system initiates scanning at a reduced default output level. This reduced level is preset programmable and depends upon the exam icon and probe selected. It takes effect when the system is powered on or New Patient is selected. To modify acoustic output, adjust the Power Output level on the Soft Menu.

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Chapter 3 Preparing the System for Use 3.1 Site Requirement 3.1.1 Operation Environmental Requirement The following environmental conditions are within system tolerances for operation: Temperature:

10º C ~ 40º C

Relative Humidity:

30%~75%, non-condensing

Atmosphere Pressure:

700hPa ~ 1060hPa

Strong radiation sources or powerful electromagnetic waves (e.g. electro-magnetic waves from radio broadcasting) may result in image ghosting or noise. The system should be isolated from such radiation sources or electromagnetic waves.

3.1.2 Transport and Storage Environmental Requirement The following environmental transport and storage conditions are within system tolerances:

Temperature:

-5º C ~ 40º C

Relative Humidity:

≤ 80% non-condensing

Atmosphere Pressure:

700hPa ~ 1060hPa

3.1.3 Electrical Requirements Power Requirements Input: 100-250V~1.5-0.75A, 50-60Hz Battery Pack: BT-2500, 4400mAh, DONGGUAN POWER INC

Power Consumption: less than 60 watts Voltage Fluctuation WARNING To avoid system damage, maintain a fluctuation of less than ±10% of the voltage displayed on rear panel of the system.

NOTE 



Please follow the outlined power requirements. Only use power cables that meet the system guidelines-failure to follow these procedures may cause system damage. Line power may vary in different geographic locations. Refer to the detailed ratings on the rear panel of the system for detailed information.



Battery

To avoid the battery bursting, igniting, or fumes from the battery; causing equipment damage, observe the following precautions: Do not immerse the battery in water or allow it to get wet. Do not put the battery into a microwave oven or pressurized container. If the battery leaks or emits an odor, remove it from all possible flammable sources. If the battery emits an odor or heat, is deformed or discolored, or in a way appears abnormal during use, during recharging, or during storage, immediately remove it and stop using it. Short term (less than one month) storage of battery pack: Store the battery in a 19

temperature range between 0 degrees C (32 degrees F) and 50 degrees C(122 degrees F). Long term (3 months or more) storage of battery pack: Store the battery in a temperature range between-20 degrees C (-4 degrees F) and 45 degrees C(113 degrees F); Upon receipt of the Site~Rite® Halcyon™ Ultrasound System and before first time usage, it is highly recommended that the customer performs one full discharge/charge cycle. If the battery has not been used for >2 months, the customer is recommended to perform one full discharge/charge cycle. It is also recommended to store the battery in a shady and cool area with FCC (full current capacity).• One Full Discharge/Charge Cycle Process:1. Full discharge of battery to let the Site~Rite® Halcyon™ Ultrasound System automatically shut down.2. Charge the Site~Rite® Halcyon™ Ultrasound System to 100% FCC (full current capacity).3. Discharge of Site~Rite® Halcyon™ Ultrasound System for complete shutdown (takes one hour for discharge).• When storing packs for more than 6 months, charge the pack at least once during the 6 month timeframe to prevent leakage and deterioration in performance

3.2 System Specifications 3.2.1 Console Overview

Fig. 3-1 a: Console Overview The following pictures show the system in different views.

Fig. 3-1 b: System Side View 1: LAN port 2: USB port 4: Handle 5: S-Video port 7: Probe port 8: Electronic pen 9: Probe connector lock switch

Fig. 3-1 c: System Front View 1: Screen bezel 2: Screen area

3: VGA port 6: Power port

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