Gima CHISON ECO 1 VET ULTRASOUND User guide

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Ultrasound Diagnostic System
Model
ECO1 VET ECO3 VET
V1.8
OPERATION MANUAL
Direction: CHUM ECO-001
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ECO 1/3 VET Ultrasound Diagnostic System
Regulatory Requirement
This product conforms to the essential requirements of the Medical Device Directive 93/42/EEC. Accessories without the CE mark are not guaranteed to meet the Essential Requirements of the Medical Device Directive.
This manual is a reference for the ECO 1 VET/ECO 3 VET. Please verify that you are using the latest revision of this document. If you need the latest revision, contact your distributor.
NOTE:
Important
1.No part of this manual may be reduced, modified, copied or reprinted, in whole or
in part, without written permission from CHISON.
2.The contents of this manual are subject to change without prior notice and without
our legal obligation.
3.Before operating the system, please read and understand this manual. After reading,
keep this manual in an easily accessible place. If you have any question or doubt, please contact CHISON's authorized service engineer.
4.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
1.It is the customer’s responsibility to maintain and manage the system after delivery.
2.The warranty does not cover the following items, even during the warranty period:
a)Damage or loss due to misuse or abuse with system and probes, for example, drop the probe, the liquid or the metal part fall into the system. b)Damage or loss caused by Acts of God such as fires, earthquakes, floods, lightning, etc. c)Damage or loss caused by failure to meet the specified conditions for this system, such as inadequate power supply, improper installation or environmental conditions. d)Damage or loss caused by non approved transportation by CHISON. e)Damage or loss due to use 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 its authorized agents.
3.Do not make changes or modifications to the software or hardware of this system
and probes.
4.During operate the system, if user has any doubt, difficulty or any unclear, please
contact CHISON's authorized service engineer immediately. Please describe the situation clearly to solve the question in time. Before solve the question, please don’t operate the system.
5.This system shall not be used by persons other than fully qualified and certified
medical personnel.
6.The System modified or repaired by people other than CHISON’s qualified service
engineers, CHISON shall not be liable for the system.
7.The purpose of this system is to provide physicians with data for clinical diagnosis.
It is the physician’s responsibility for diagnostic procedures. CHISON shall not be liable for the results of diagnostic procedures
8.This manual contains warnings regarding foreseeable potential dangers, but user
shall always be alert to dangers other than those indicated as well. CHISON shall not be liable for damage or loss that results from negligence or from ignoring the precautions and operating instructions described in this operation manual.
9.Due to negligence not following operation manual, CHISON shall not be liable for
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Caution The users should read the operation manual carefully before operating the
devices. Turning on the device means the users have read the operation manual and accept the listed cautions, warnings, and notes in the manuals. If the users disagree and cannot accept the cautions, the users can ask for returning the device.
the results.
10.Each time before and after ultrasound examination, please check the probe surface,
probe cable and sheath whether they are abnormal, such as cracking, peeling and deformation. Also check whether the lens is strongly fixed. Abnormal probes may cause electric shock and injure the patient. Once any abnormal, user must stop using and contact CHISON's authorized service engineer.
11.If the probe is dropped or scratched by hard part, please stop using the probe
immediately. And contact CHISON's authorized service engineer to make sure the safety and effectiveness is in good condition before use.
12.If there is any liquid or metal to enter to the system, please power off the system
and stop using it immediately. Please first contact CHISON’s authorized service
engineer to make sure it’s safe before restart using it.
13.Please don't use solvents (such as paint thinner, benzine, or alcohol) or abrasive
cleansers for cleaning the system (including monitor and probes, etc). It may corrode the system and probes.
14.While the system or probe is over life time, please refer to operation manual
section 9.4
15.Important data must be backed up on external memory media. CHISON shall not
be liable for loss of data stored in the memory of this system caused by operator error or accidents.
16.Please put this operation manual with the system to ensure operator and manager
can reach it at any time.
17.LCD display screen may have some dark or light dots, it is normal for the LCD. It
does not mean that LCD screen is defective.
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Content
Chapter 1 Introduction .............................................................................................................................. 1
1.1 System Overview ...................................................................................................................... 1
1.2 Contact Information ................................................................................................................ 1
Chapter 2 System Safety .......................................................................................................................... 2
2.1 Safety Overview ........................................................................................................................ 2
2.2 Electrical Safety ........................................................................................................................ 3
2.3 Labels ........................................................................................................................................ 5
2.4 Patient Environmental Devices ............................................................................................... 6
2.5 Biological Safety ....................................................................................................................... 8
2.6 Scanning Patients and Education ........................................................................................... 9
Chapter 3 System Introduction ............................................................................................................... 11
3.1 Console Overview ................................................................................................................... 11
3.2 Physical Specification ............................................................................................................. 11
3.3 System View in Different Views ............................................................................................ 12
3.4 Function Introduction ............................................................................................................ 13
3.5 Installation Procedures .......................................................................................................... 15
Chapter 4 Control Panel ......................................................................................................................... 21
4.1 Alphanumeric Keyboard ....................................................................................................... 21
4.2 Function Keys/Knob .............................................................................................................. 21
4.3 Central Control ...................................................................................................................... 24
4.4 The key of Image Mode ......................................................................................................... 25
4.5 Control of Image .................................................................................................................... 26
Chapter 5 Operation and Exam Mode .................................................................................................... 29
5.1 Preparing the System for Use ................................................................................................ 29
5.2 Choose Exam Mode ................................................................................................................ 29
5.3 Patient Data Entry ................................................................................................................. 30
5.4 Image Interface Display ......................................................................................................... 31
5.5 Display Mode .......................................................................................................................... 31
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5.6 Image Adjustment ................................................................................................ .................. 32
5.7 B Image Menu Adjustment ................................................................................................... 34
5.8 Full Screen Show (need to activate this function in setup) ................................................. 36
5.9 Edit Comment......................................................................................................................... 36
5.10 Set Body Mark ...................................................................................................................... 38
5.11 Set the Direction of Arrow ................................................................................................... 39
5.12 Image and Cine Disposition ................................................................................................. 40
5.13 Image Browse ....................................................................................................................... 41
5.14 Archive Management ........................................................................................................... 42
5.15 Report .................................................................................................................................... 44
5.16 DICOM ................................................................................................................................. 45
Chapter 6 Measurement and Calculation ................................................................................................ 47
6.1 Keyboard for Measurement .................................................................................................. 47
6.2 B Mode general Measurement methods ............................................................................... 48
6.3 Normal measurement and calculation in B mode................................................................ 50
6.4 Canine measurement and calculation ................................................................................... 51
6.5 Feline measurement and calculation .................................................................................... 52
6.6 Equine measurement ............................................................................................................. 53
6.7 Bovine Measurement and Caculation ................................................................................... 53
6.8 Ovine Measurement and Calculation ................................................................................... 54
6.9 Normal Measurement and Calculation in M, B/M mode ................................................... 54
6.10 General Measurement in M mode ...................................................................................... 56
6.11 Canine Measurement in M Mode ....................................................................................... 56
6.12 Feline Measurement in M Mode ......................................................................................... 56
6.13 Equine Measurement in M Mode ....................................................................................... 56
6.14 Bovine Measurement in M Mode ........................................................................................ 56
6.15 Ovine Measurement in M Mode ......................................................................................... 56
Chapter 7 Preset ...................................................................................................................................... 57
7.1 General setting ........................................................................................................................ 57
7.2 Measurement .......................................................................................................................... 58
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7.3 Annotation .............................................................................................................................. 67
7.4 Body marks ............................................................................................................................. 69
7.5 Exam Mode ............................................................................................................................. 70
7.6 Keyboard................................................................................................................................. 72
7.7 DICOM ................................................................................................................................... 73
7.8 NET Work .............................................................................................................................. 75
7.9 System ..................................................................................................................................... 75
Chapter 8 System Maintenance .............................................................................................................. 77
8.1 Machine Clean ........................................................................................................................ 77
8.2 Probe Maintenance ................................................................................................................ 77
8.3 Safety Check ........................................................................................................................... 79
8.4 Malfunction Check ................................................................................................................. 79
Chapter 9 Probes .................................................................................................................................... 80
9.1 General Description ............................................................................................................... 80
9.2 Care and Maintenance ........................................................................................................... 80
9.3 Probe Operation Instructions ............................................................................................... 90
9.4 Service Responsibility ............................................................................................................ 90
Appendix A: Acoustic Output Report Table ........................................................................................... 92
Appendix B: Guidance and Manufacturer’s Declaration ...................................................................... 110
Appendix C: Measurement Results Summary ...................................................................................... 114
Appendix D: Display Accuracy and Acoustic Measurement Uncertainties.......................................... 116
Appendix E: Transducer Maximum Surface Temperature ................................................................... 117
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ECO 1/3 VET Ultrasound Diagnostic System
Chapter 1 Introduction
This manual contains necessary information for safe system operation. Read and understand all instructions in this manual before operating the system. Always keep this manual with the equipment, and periodically review the procedures for operation 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 physician for evaluation of ABD, OB, GYN, Vessel, Small Parts, MSK/PT, Nerve, Big animal, Reproduction, Small animal cardiac.
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 your local distributor or the appropriate support resource shown below:
CHISON website www.chison.com Service Support CHISON Medical Imaging Co., Ltd.
Tel:0086-0510-85311707 Fax: 0086-0510-85310726 E-mail: service@chison.com.cn
Placing an Order CHISON Medical Imaging Co., Ltd.
Tel: 0086-0510-8531-0593/0937 Fax: 0086-0510-85310726 Email: export@chison.com.cn
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
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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 animal. 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. Do not modify this system in any way. Necessary modifications must be made only by
the manufacturer or its designated agents.
This system has been fully adjusted at the factory. Do not adjust any fixed adjustable
parts.
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. Recheck the leakage current and other safety performance
indices of the entire system to avoid potential system damage caused by leakage from a
current superposition.
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.
The system should be installed only by personnel authorized by the manufacturer. Do not
attempt to install the system by yourself.
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, otherwise an explosion
may occur.
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
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when need to remove the probe.
To prevent from arm or neck injury, the operator should not stay at the same position for
too long during patient scanning without taking break.
Do not put liquid on top of the main unit.
NOTE
*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
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
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
Parts of probe likely to come into contact with operator or patient meet the requirements
of drip-proof equipment (IPX1) Parts of probe intended to be immersed in normal use meet the requirements of watertight equipment (IPX7)
The IP Classification of System is Ordinary Equipment (IPX0)
Safety level when used in the presence of FLAMMABLE ANAESTHETIC MIXED WITH
(for Probes marked with BF symbol)
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:
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Proper grounding of the system is critical to avoid electrical shock. For protection, ground
the chassis with a three-wire 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 verify 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 may be necessary.
Use either power supply cords provided by or designated by CHISON. Products equipped
with a power source 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.)
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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.
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 Labels
2.3.1 Warning Symbols
Real panel label
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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
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 user manual
must be read.
The “Alternating current” symbol indicates
that the equipment is suitable for alternating current only.
The CE mark of Conformity indicates this
equipment conforms with the Council Directive 93/42/EEC
CORRECT: The correct connection of the battery connector WRONG: The wrong connection of the battery connector
This symbol is followed by the manufacturing date of the device in the form YYYY-MM.
2.4 Patient Environmental Devices
Left side:
1 LAN port 1 VGA port: External monitor 2 USB ports 1 Footswitch port 1 Power in port
Rear panel:
2 Probe ports 1 USB port
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1 Video out port 1 Remote port
Acceptable Devices
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.
If devices are connected without the approval of CHISON, the warranty will be INVALID.
The system can’t be used with HF surgical equipment, otherwise the burns to patient may
occur.
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-D711MD 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/EN60601-1-1.
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Adapter is considered as a part of ME equipment 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 60601-1-1 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 and CE Marking.
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.
Peripheral 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 and CE Marking. 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
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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.
2.6 Scanning Patients and Education
The Track-1 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. 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).
In any case, maxmimum MI and TI are less than 1.0.
2.6.1 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. B-mode) 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. The frozen
frame and Cine loop capabilities allow images to be reviewed and discussed without
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exposing the patient to continuous scanning.
Do not use endo-cavitary probes if there is noticeable self heating of the probe when
operating in the air. Although applicable to any probe, take particular care during trans­vaginal exams during the first eight weeks of gestation.
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 during diagnostic ultrasound
when exposing: an embryo less than eight weeks after gestation; or the head, brain or spine of any fetus or neonate.
Warning against activation of transducer assembly intended for intra-corporeal use
outside patient’s body if transducer assembly does not comply with emc requirements (may cause harmful interference with other equipment)
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Chapter 3 System Introduction
3.1 Console Overview
ECO 1/3 VET Ultrasound Diagnostic System
Console Overview
3.2 Physical Specification
335mmLength×155mm(Width)×350mmHeight
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3.3 System View in Different Views
System Front View
System Side View
1.Ethernet 2.VGA 3.USB 4.Footswicth 5.Power in
Console Overview
1.Probe Holder 2.Probe 3.Keyboard
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System Rear View
1. Probe 2. USB 3. Remote 4. Video Out 5. Battery Holder 6. Probe Holder
3.4 Function Introduction
1.Possess B, B/B, 4B, B/M, M display mode M, B/M mode possess 4 kinds of scan velocity;
2.Possess many combination of focus, total gain control 8 segments STC;
3.Possess depth scan and image left-right up-down rolling-over function;
4.Possess a lot of imaging technology for example multiple compound imaging (space frequency
compound), multiple frequency, multiple zoom ratio, pan zoom, screen scroll, chroma, harmonic imaging etc;
5.Possess image processing, total gain, dynamic range, frequency, focus number, focus position, zoom, compound, scan width, line density, smooth, edge enhancement, frame, persistence, gray scale, restrain boost multi-beam, acoustic power, M velocity;
6.Possess distance proportion circumference volume rate angle histogram in B mode distance time velocity heart rate measurement function in M mode ;GYN measurement software package, small parts measurement software package, ventricle function measurement software package and user defined formula;
7.Possess body mark arrow case number display, real time clock display annotation in image user-defined annotation;
8.Possess multi-language interface display User interface change, shear plate, printing ,DICOM3.0 biopsy guided functions;
9.It has permanent storage for image and cine and optional 320GB HDD. It can also be connected to removable storage via USB port. To realize mass storage ,can recall saved image for analysis;
10.Cine loop storage 256frames real time image;
11.Screen rotation function make you adjust screen angle according to users' requirement 0~30°;
12.Output standard PAL or NTSC video signal and VGA signal;
13.Print or export graphic report.
3.4.1 Image Modes
B mode B/M mode M mode
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2B mode
C3-A, 2.5-5.0MHz Convex Array Indications for Use: ABD, OB, GYN,URO
L7M-A, 5.3-10.0MHz Linear Array Indications for Use: Vessel, Small Parts, Equine Tendon
L7S-A, 5.3-11.0MHz Linear Array Indications for Use: Vessel, Small Parts, Equine Tendon
MC6-A, 4.5-8.0MHz Micro-convex Array Indications for Use: Canine Abdomen, Feline Abdomen, Small Animal Cardiac
L7V-A Linear Array, 5.3-10.0MHz Linear Array Indications for Use: Big Animal, Reproduction
MC5V-A, 4.0-7.0MHz Micro-convex Array Indications for Use: Canine Abdomen, Feline Abdomen,
Configuration
ECO1 VET
ECO3 VET
Color
Grey/White
Black/White
Probe
1(standard), 2(option)
2(standard)
Maximum memory
8GB
8GB
4B mode
3.4.2 Accessories
ECO 1/3 VET Ultrasound Diagnostic System
Transducers
:
Peripherals
VGA output for external monitor VIDEO output for B&W video printer LAN port output LAN for DICOM and image review station USB 2.0 for flash drive Foot switch AC/DC adapter: MDS-060AAS19 B
Input: 100-250V~1.5-0.75A, 50-60Hz Output: 19V 3.15A DELTA ELECTRONICS, INC.
Battery Pack: BT-2500, 4400mAh, DONGGUAN POWER INC
3.4.3 Configuration of the System
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320G HDD
No
Option
Built in battery
Option
Standard
Compound, i-Image, SRA,THI
Standard
Standard
Trapezoidal
No
Standard
Chroma
Standard
Standard
DICOM 3.0
Option
Option
Graphic Printer
Option
Option: HP LaserJet P2055d, HP LaserJet P1102, HP LaserJet Pro 200 color M251n
Probe configuration
Six: C3-A, L7M-A, L7S-A, MC6-A, MC5V-A, L7V-A
Six: C3-A, L7M-A, L7S-A, MC6-A, MC5V-A, L7V-A
3.5 Installation Procedures
Note: Please do not turn on the power switch until finishing all the installation and necessary
preparation.
3.5.1 Environment Condition
The system should be operated under the following environment.
3.5.1.1 Operation Environment Requirement
Ambient Temperature: 10 ℃~40 Relative Humidity: 30%75%RH Atmospheric Pressure: 700hPa1060hPa
3.5.1.2 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
3.5.1.3 Electrical Requirements
Power Consumption: less than 60 VA Voltage Fluctuation
WARNING
Grounding
Maintain a fluctuation range of less than ±10% of voltage labeling on rear panel of the system, otherwise the system may be damaged.
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Before connecting the power cable, connect the attached ground protection cable from Equipotentiality terminal on system rear panel to a specialized grounding device.
NOTE
Please follow the outlined power requirements. Only use power cables that
meet the system guidelinesfailure to follow these procedures may produce 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,recharging or storage, immediately remove it and stop
using it. If you have any questions about the battery,Short term (less than one month) storage of battery pack: Store the battery in a 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 ECO VET 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 ECO VET automatically shut down.2. Charge the ECO VET to 100% FCC (full current capacity).3. Discharge of Venue 40
for complete shut down(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.
3.5.1.4 Operation Space
Please leave enough free space from the back of the system to ensure well ventilation.
Caution: Leave enough free space from the back of the system, Otherwise, with the increasing
of the temperature inside the unit, malfunction may occur.
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3.5.1.5 System Positioning & Transporting
Moving the System
When moving or transporting the system, take the precautions described below to ensure maximum safety for personnel, the system and other equipments.
Before Moving the System
Press 3 s, system will forced shut down and completely switch off the system.
Disconnect all cables from off-board peripheral devices (external printer, etc.) from the
console.
NOTE
To prevent damage to the power cord, DO NOT pull excessively on the cord or sharply bend the cord while wrapping it.
Store all probes in their original cases or wrap them in soft cloth or foam to prevent
damage.
Replace gel and other essential accessories in the appropriate storage case. Ensure that no loose items are left on the console.
When Moving the System
Carry the system with handle, or put the system on the cart to move it.
NOTE
Walk slowly and carefully when moving the system. Do not let the system strike walls or doorframe.
Transporting the System
Use extra care when transporting the system in a vehicle. After preparing the system as described above, take the following additional precautions:
Only use vehicles that are suitable for transport of the system. Before transporting, place the system in its original storage carton. Load and unload the system to a vehicle parked on a level surface. Load the unit abroad the vehicle carefully and over its center of gravity. Keep the unit
still and upright.
Ensure that the transporting vehicle can bear the weight of system plus the passengers. Secure the system firmly with straps or as directed within the vehicle to prevent
movement during transport. Any movement, coupled with the weight of the system, could cause it to break loose.
Drive carefully to prevent damage from vibration. Avoid unpaved roads, excessive
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speeds, and erratic stops or starts.
3.5.2 Powering the System
3.5.2.1 Acclimation Time
After being transported, the unit requires one hour for each 2.5 º increment if its
temperature is below 10 ºC or above 40 ºC.
NOTE
Please keep at least 20 to 30 cm spare space away from the back of the system to ensure well ventilation. Otherwise, with the increasing of the temperature inside the unit, malfunction may occur.
3.5.2.2 Connecting the electric power
ECO 1/3 VET Ultrasound Diagnostic System
After making sure that the AC power supply in hospital is in normal status, and this AC voltage type matches to the power requirements indicated on the label of system, then please connect the plug of power cord to the POWER IN socket at the rear panel of the systemand connect the other end of power cord to the AC power supply socket in hospital. Please use the power cable provided by the manufacturer, other type of power cable is not allowed.
Press 1 s, system boot,
press and pop up dialog for shut down. Click the enter key then power off.
or press 3 s, system will forced shut down
CAUTION
Connecting the system to the wrong AC power supply may cause damage to the system and danger to the operators and animals.
3.5.3 Probe Installment
CautionPlease only use the probes provided by manufacturer for this model, other types of
probes are not allowed to use with this system! Otherwise it may cause the damage to the system and the probe.
CAUTION
Before connecting the probe, please carefully check the probe lens, probe cable and probe
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connector to see whether there is anything abnormal, such as cracks, falls off. Abnormal probe is not allowed to connect to the system; otherwise there is possibility of electricity shock.
Hold the probe connector lock switch, and insert the connector socket vertically. Release the probe lock switch. Check the locked probe with one hand to make sure that it’s not loose, and it’s
securely connected
CAUTION
Only power supply at “turn off” state, can install / take-down the probe, otherwise it will
damage the machine or the probe.
When installing and disassembling probe, please put the probe head inside the probe holder,
it can prevent the probe falling down to the ground.
3.5.3.1 Probe Disassembly
Turn the dead lock switch 90degree in counterclockwise direction, extract probe connector plug vertically.
3.5.4 Accessories Installment
Caution:Please only use the optional parts provided or suggested by manufacturer! Using other types of optional devices may cause the damage to the system and the connected optional devices.
3.5.4.1 Video printer installment
1.Put video printer stably.
2.Connect cable of video printer to video port in the back of the device. And connect the other side
to video signal output port in the rear side.
3.Connect the printer line to print control port in the printer rear side, And connect the other side to the print control port in the unit rear side.
4.Connect power cable of video printer to power system..
5.Adjust printer parameter preset according to the type of printing paper
Caution: Do not use any other power cable to replace 3-wire power cable
manufacturer provides, otherwise there is danger of electric shock. Video printer sign introduction
: Video signal input port
Video signal output port
Print control port
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Video printer switch
3.5.4.2 Graphic printer installment
Put graphic printer stably, connect printer cable to USB port in the left side of the unit. Connect the power cable of graphic printer to power system.
Caution Please see packing list for fundamental configuration!
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Chapter 4 Control Panel
4.1 Alphanumeric Keyboard
Alphanumeric Keyboard
ECO 1/3 VET Ultrasound Diagnostic System
The alphanumeric keys are used for inputting patient number, name, character and figure etc.
4.2 Function Keys/Knob
4.2.1 SWITCH
Turn on or off the device
4.2.2 PATIENT
Set up a new patient data, input name and other information.
4.2.3 PROBE
Press this button for selecting probe. It can only select the connected probe.
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4.2.4 SETUP
Press this button to get in or out the system setting page.
4.2.5 END
Press END key to finish the exam.
4.2.6 BODYMARK
Press this key to enter into body mark working status, select the body mark and confirm the probe scanning position on the screen. It is only available in frozen status.
4.2.7 COMMENT
Press this key to enter into comment status, and add comments in the image area on the screen.
4.2.8 ARROWS
Add arrows key to the image area.
4.2.9 DEL
Press this key to clear the measurement lines, body mark, and comments.
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4.2.10 Print
PRINT1: Print the screen image by video printer connected to the system. PRINT2: Print the report by printer connected to the system (Only report page works). Or print the image in the scanning page; Or print the image in the review page.
4.2.11 Archive
File management of system, you can view and edit the patient data.
4.2.12 Report
Produce/ Save/ Recall an examination report.
4.2.13 Parameter Control Button
Increase/decrease the corresponding parameters of the screen, Or open/close the function.
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4.3 Central Control
1
2
3
4
5
6 7 8
9
10
1. UPDATE 2.EXIT 3.Cursor 4.Change 5.MENU
6. Dist 7.Trace 8.Calc 9.ENTER 10.Trackball
ECO 1/3 VET Ultrasound Diagnostic System
4.3.1 ENTER
This multifunction key is work with trackball. The function switches with the unit status. Such as, set the cursor position, body mark position, comment position, toggle trackball function, selected the menu, and confirm the input.
4.3.2 UPDATE
This multifunction key is work with trackball. The function switches with the unit status. Such as, call the annotation and back in measuring.
4.3.3 Exit
Press this key can exit measurement, dialog, and menu.
4.3.4 Cursor
Press this key to show or hide the cursor.
4.3.5 Change
Press this key to change the menu.
4.3.6 Dist
Press this key to enter into distance measurement.
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4.3.7 Trace
Press this key to enter into trace or ellipse measurement, and press UPDATE to change between trace and ellipse.
4.3.8 Calc
Press this key to enter into measurement software package.
4.3.9 MENU
Press MENU-knob for second time to select the item and adjust the parameters. Press MENU-knob for third time to exit from current item. Rotate the MENU- knob to select the item
4.3.10 Trackball
Trackball is the main operation tool on screen. Position calipers in measurement, the function of the trackball is different under diverse working status.
4.4 The key of Image Mode
4.4.1 B
Display B mode
4.4.2 B/B
Press this key to enter into 2B mode.
4.4.3 4B
Press this key to enter into 4B mode.
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4.4.4 M
Press this key to change the mode between B/M and M.
4.5 Control of Image
4.5.1 THI
Press this key to open or close the THI function.
4.5.2 AIO
Only press this key for automatic optimization image.
4.5.3 CINE
Only press this key to save the current cine loop.
4.5.4 SAVE
Only press this key to save the current image.
4.5.5 Left and Right Invert
Press this key to invert the image from left and right.
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4.5.6 Up and Down Invert
Press this key to invert the image from up and down.
4.5.7 STC
ECO 1/3 VET Ultrasound Diagnostic System
STC can be used for adjusting gain compensation in different image depth.
4.5.8 GAIN
Rotate the knob to adjust the gain of B mode and M mode.
4.5.9 ANGLE/ZOOM Knob
Rotate the knob to adjust the angle or zoom. Press this knob to change the function between angle and zoom.
4.5.10 DEPTH/FOCUS Knob
Press the knob to adjust the depth and function position. Press the knob to change the function between depth and focus position.
4.5.11 Information Area Indicating Machine Status
Left-to-Right of the up row: hard disk, cable network, USB Hard disk: press this icon to show the capacity of disc to used save data or USB flash disk in
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current system Cable network: show the present situation of cable network; press this icon to show the IP address of current system. USB: show whether this system connects USB flash disk or not, press this icon to show USB safely remove interface.
Left-to-Right of the down row: input method, DICOM Task Sequence, battery gauge
Input method: press this icon to switch Chinese and English input method. Task manager: press this icon to show DICOM Task Sequence and its situation ,To terminate the
DICOM task, delete, and so onNeed to activate DICOM Battery gauge: show the connecting situation of the battery, just press this icon to show the present State of charge and discharge, remaining electric quantity and available time.
4.5.12 Indicator Light
From left to right: Adapter Indicator, Charge Indicator, Sleep Indicator. Adapter Indicator: when the main unit connects to the adapter with power supply, the indicator
lights, otherwise extinguishes. Charge Indicator: When the battery is charging, the indicator lights, Once the battery is charged,
the indicator goes out. Sleep Indicator: When the main unit is in sleep mode, the indicator lights, otherwise
extinguished.
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Chapter 5 Operation and Exam Mode
This chapter mainly describes the process of the normal operation of the device, including the preparation before examination, how to get the image, optimize the image, add comments, body mark and so on.
5.1 Preparing the System for Use
5.1.1 The Device Inspection
(1)The device is placed stability; (2) The grid voltage AC 100-240V, 50Hz-60Hz; (3)Cable is properly connected, firm and ground, the adapter is properly connected to the device; (4)Probe is connected and fixed.
5.1.2 Power On
Long press 1 second to start the machine, wait for the system to enter the user interface, activate the probe slot into the B-mode.
5.2 Choose Exam Mode
5.2.1 The Probe Identification
The system default automatically identify the current probe type, When the probe is inserted, Press
to switch the probe.
CAUTION: Please connect or disconnect the probe only after the system is freezing, in
order to ensure stability and extend the service life of the probe.
5.2.2 Mode Selection
In probe selection interface, probe and clinical application selection page is displayed, you can choose needed probe and inspection part, and press the default into the B-mode, start scan detection. NOTE: The system has been set clinical application pre-set before leaving factory, each probe has its own pre-set. The detailed operation steps of the clinical application pre-set of the probe, please refer to the pre-set section.
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5.3 Patient Data Entry
Press the to display the Patient screen
Patient’s Information Screen
Function Buttons on Patient screen: [Archive]: Operation on the patient information which has already existed; [Wordlist]Recall patient information in worklist. And need to open the DICOM function; [New Patient]Create a new patient information identity; [New Study]Choose exam applications for the new patient; [End Study]Edit patient’s exam item; [OK]Save patient information; [Cancel]Cancel the operation of new patient information; Operation Methods:
(1) Move the Trackball to the position of inputting character, then input patient information by character keyboard. (2)Use the Trackball and the [ENTER] key to switch between different input options: ID, patient name, doctor's name, birthday (It can be automatically calculated when input age), age (It can be automatically calculated when input birthday), gender. (3)Select the exam items, and input the regular inspection information. (4)After inputting the required information, click on the OK button to save the patient information, the system will return to the B-mode. (5)Recall information of the previous patient, you can use the Archive or Worklist to recall patient information to exam.
CAUTION: Creating a diagnostic record, you should check the accuracy of the patient
information before saving measurement or image; otherwise, it will be stored in the wrong patient records. After checking the patient, press the [END] key to save the patient information in the system.
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4
2
3 5 6 10 9 7
8
1
5.4 Image Interface Display
1, Logo 2, Control menu 3, Image status prompt 4, Image parameter area 5, System state prompt 6, Image parameter area 7, Gray-scale strip 8, Start point of scanning 9, Image Region 10, Cine loop
5.5 Display Mode
Display Mode: B,2B,4B,M,B/M, they can be shifted by the mode key.
5.5.1 B Mode
Press [B] Mode key, and display the single B Mode image, B Mode is the basic mode for two-dimensional scanning and diagnosis.
5.5.2 B/B Mode
Press [2B] to display double B mode images side by side. One image is in real-time status; the other is in frozen status. The real-time image has start scan marker and ruler marker .Press 2B button in [B/B] mode, the original active image is frozen while the original frozen image is activated.
5.5.3 4B Mode
Press [4B] button to enter into 4B mode, the screen will display four B mode images side by side, but only one image is in real-time status. Pressing it again can switch the real-time status among four images.
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5.5.4 B/M Mode
Press [B/M] button, a real time B-mode image and a real-time M-mode image will be displayed at the same time. And a sample line will appear in the B-mode image area, which indicates the active sample position for M image on the B image area. Click the position on the B image area to fix the position of sampling line.
5.5.5 M Mode
Press [M] button again, B mode image will disappear; M mode image is still active on the whole screen. M mode image stands for the tissue movement status at the sampling line. The M mode image varies with time, so it is mainly used for cardiac applications.
5.6 Image Adjustment
5.6.1 Frequency
In real status, press the first line button of [frequency] to increase the frequency, and press the second line button of [frequency] to decrease the frequency.
5.6.2 Dynamic
Dynamic range is used for adjusting the contrast resolution of B mode image and mode image, compressing or enlarging the display range of gray scale. At the real-time status, press the first line button of [Dynamic] to increase the Dynamic, and press the second line button of [Dynamic] to decrease the Dynamic. The range is 30 to 90.
5.6.3 i-Image
In real status, press the corresponding button of [i-Image] to adjust, the range is 0~3.
5.6.4 Compound
In real status, press the corresponding button of [compound] to adjust, and the range is 0~3.
The SRA can’t be edited after opening the compound.
5.6.5 SRA
In real status, press the corresponding button of [SRA] to turn on or off.
5.6.6 M Speed Adjustment
In real M status, press the corresponding button of [Speed] to adjust M speed, and the range is 1~4.
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5.6.7 Gain
In real status, rotate [Gain] button to adjust the Gain, and the range is 0~255, the step is 5.
5.6.8 STC
STC curves can be used for adjusting gain compensation in different image depth. Drag the slide of STC to adjust the value. STC curve will disappear automatically 1 second later after stopping adjustment.
5.6.9 Depth
Press [DEPTH/FOCUS] selection knob until the indicator of [DEPTH] is lit, then rotate the knob to change the depth of image.
5.6.10 Focus Pos
Press the [DEPTH/FOCUS] selection knob until the indicator of [FOCUS POS] is lit. Then turn the knob to change Focus Position.
5.6.11 ANGLE/ZOOM
Press [ANGLE/ZOOM]button until the indicator of [ANGLE] is lit, and the angle of sample gate will rotate with the rotation direction. Press [ANGLE/ZOOM]button to confirm the ZOOM button is lit, and it will appear the zoom box, rotate the button to select the zoom steps.
5.6.12 INVERT
B mode image and B/M mode image can be reversed horizontally and vertically.
Press the key, the displayed image is reversed in the right-left horizontal direction.
Press the key, the displayed image is reversed in the up-down direction. The horizontal flip status indicators of the upper-left corner of the image window have the
following meanings:
The meaning of the symbol “ ” indicating the probe initiative scanning position “ ” situated in
the left indicates that the first scanning line in the left of the screen is corresponding to the initiative scanning position of the probe,
” situated in the right indicates that the first scanning line in the right of the screen is corresponding to the initiative scanning position of the probe.
5.6.13 THI(ECO1 VET Without THI)
Turn ON/OFF THI
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5.6.14 AIO
Only press this key to optimize image.
5.7 B Image Menu Adjustment
Click [Change] button or [MENU] button to display the menu. Rotate[MENU]button or press[Cursor]button to display the cursor ,and move the sample box to the corresponding function, press [MENU]button to update the function, then rotate[MENU]button to adjust the function, press [MENU]again to exit the function.
5.7.1 Scan Width
Select [Scan Width], and adjust the scan width to the corresponding size.
5.7.2 Focus Num
In B mode, 4 focus points can be selected simultaneously, and the number controlled by the depth, SRA and Compond. Move the cursor to [Focus Num] selection to adjust, and the range is 1~4.
5.7.3 Persistence
In real status, adjust the contrast and resolution. In real status, press the first line button of [Persistence] to adjust. The range is 0~7.
5.7.4 Line Density
Scan Line Density function is only valid for the image in B mode, B/B mode, B/M mode or 4B mode image. The line density has two types: high density and low density. High density means better image quality while low density image has higher frame rate. To do the adjustment, please select the submenu item [LINE DENSITY] and press [MENU] to adjust the line density.
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5.7.5 Smooth
Smoothness function is used for restraining the image noise and performing axial smooth processing to make the image smoother.
Move the cursor to [Smoothness] selection to adjust, and the range is 0~7.
5.7.6 Edge Enhance
Edge enhancement is used for enhancing the image outline. In this way the user can view the tissue structure more clearly.
Move the cursor to [Edge] selection to adjust, and the range is 0~7.
5.7.7 Acoustic Power
Acoustic power means the acoustic power transmitting from the probe. At the real-time status, Move the cursor to [Acoustic power] selection to adjust, and the range is 0~15,and the least adjustable level is 1 dB/level.
5.7.8 Utility
This function includes post processing, slide show and other items. Press [MENU] button, then choose Utility selection, it will appear Utility options.
5.7.8.1 Post Processing
5.7.8.1.1 Chroma
Adjust the type of the chroma. Update [Chroma], and rotate [MENU] button to select the Chroma type, the range is 0~31.
5.7.8.1.2 2D Map
Select the type of the scale curve. Update [2D Map], and rotate [MENU] button to select the scale curve type, the range is 0~4.
5.7.8.1.3 B Gamma
Adjust image gray value parameters. Update [B Gamma], and rotate [MENU] button to select the B Gamma parameters, the range is 0~8.
5.7.8.1.4 B Rejection
Adjust image gray scale inhibition parameters Update [B Rejection], and rotate [MENU] button to adjust B Rejection parameters, the range is 0~256.
5.7.9 Advance
In B Mode, select Advance, after pressing [MENU] button, it will appear Advance options.
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Classification
Function Description
Abdomen
Abdomen, general anatomy term
5.7.9.1 Zoom Coef
Adjust the size of the ruler. Update [Zoom Coef], and rotate [MENU] button to adjust, the range is 60%~100%.
5.7.9.2 MB
Through opening MB to improve image quality Press [MENU] to turn on or turn off the MB function.
5.7.9.3 Trapezoidal Mode
Press [MENU]to turn on or turn off the trapezoidal function.
5.7.9.4 Biopsy
Show or hide biopsy. Press the [MENU] to show or hide biopsy line.
5.8 Full Screen Show (need to activate this function in setup)
Full screen the image area. Press [Gain] knob to activate the function; Press [EXIT] button to exit full screen show. When full screen shows, press [MENU] knob to show the menu of current mode (except body mark, annotation, measurement).
5.9 Edit Comment
5.9.1 Overview
The comment is to enter text or symbols on the image, the device is Chinese and English annotation system.
ENTER COMMENT: Press enter into comments status;
Exit COMMENT: Press again or[FREEZE]key to exit;
Comment means input the words or symbols on images for making explanation. Add comments can through keyboard input directly or using the default comments.
The default comments are classified by examination mode as follows:
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Obstetrics
Anatomy term of Obstetrics
Gynecology
Anatomy term of Gynecology
Heart
Anatomy term of Heart
Small Parts
Anatomy term of Small Parts
Lesion
Lesion term:Abdomen、Obstetrics、Gynecology、Heart、Small Parts
NOTE: If you need to custom the default comments, refer to the pre-set section.
5.9.2 Input Characters
Operation
1. Press button, then system will go into the comment process.
2. Move the cursor to the position where need to comments.
3. Input characters at cursor position by keyboard then press [ENTER] key to confirm.
4. Press COMMENT-key again to exit. The COMMENT-key will light off and the
comments process is finished.
5.9.3 Input Comment Library Characters
1In comment status, move trackball to image area to edit; 2Press[Font size]to adjust front size of comments, the range is 10~20; 3Rotate[MENU]to select needed comments, then press[MENU] to exit ;
5.9.4 Edit Quick Comments
1Press[Edit]to pop quick comment edit box; 2Input customized comments; 3Press[Done]to finish edit, press[X]to cancel edit;
5.9.5 Input Quick Comments
1Press[Text]to select needed quick comments; 2Adjust front size of comments; 3Press[Input]to place comments in the image area;
5.9.6 Move Comments
1In comment status, move trackball to the comment, press ENTER key to activate it; 2Move trackball to place the comment to target area; 3Press ENTER again to confirm the comment;
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5.9.7 Edit Comments
1In comment status, move trackball to the comment, press ENTER key to activate it 2Press[BACKSPACE]to delete unnecessary characters; 3Press[ENTER]to confirm;
5.9.8 Delete Comments
5.9.8.1 Delete Characters
In comment status, activate the comment that need to be deleted, then press the ENTER key, it will display "|" on the screen, press[BACKSPACE]key to delete the character.
5.9.8.2 Delete Single Comment
Activate the comment that need to be deleted, press[DEL]to delete comment;
5.9.8.3 Delete All Contents of the Comment
Don’t activate the single comment, press[DEL]to delete all characters that has input;
Caution: Press[DEL]key, but it will delete the measurement and body mark at the same time;
5.9.9 Set the Position of Default Comment
Operation: 1Press[Save Home Pos.]to move cursor to the initial position; 2Press[Load Home Pos.]to set the initial position;
5.10 Set Body Mark
5.10.1 General Description
The body mark indicates Animal’s examination position and the direction of probe scan on the
image. Body marks are divided into: Bovine, Canine, Equine, Feline and Ovine, each has different body mark. Each type of body mark automatically is corresponding to current examination mode.
Icon:
Bovine Mark
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Canine Mark
Equine Mark
Feline Mark
Ovine Mark
5.10.2 Body Mark Operation
Operation
1 Press to enter into the body status. 2 Select the body mark that you need.
3 Move trackball after adding the body mark image and then adjust the position of probe.
Rotate [MENU] or [ANGLE] knob can adjust the probe direction. Press Enter- key to confirm when adjustment was finished.
4 Move the Trackball to change the position of the body mark;
5 If you want to exit from the body mark function, press again; 6 Press [EXIT]to exit body status and the body mark is fastened to the screen.
7 Press [DEL] to delete body marks.
5.11 Set the Direction of Arrow
Operation
1Press to display arrow;
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2Press [Change] button to select cursor type: arrow or cross. And change the size of the
cursor.
3Adjust the position of probe. Rotate [MENU] or [ANGLE] knob can adjust the probe
direction.
4Press [ENTER] to confirm when adjustment was finished. 5Press[EXIT]to exit the arrow settings. 6Press[DEL]to clear the arrows has inputed,
5.12 Image and Cine Disposition
5.12.1 The Principle of Cine Storage
In real image status, the image can be stored in the movie memory in chronological order, maximum frames can be set. The maximum number of frames of the film storage can be set, please refer to pre-set chapter. If the movie memory is full, the recent frame saved into memory, the previous frame removed from memory.
Cine loop indicate diagram
5.12.2 Manual Loop
Press[FREEZE]to freeze image, pop cine playback bar, at this time, move cursor to play by hand; Track ball rolling to the right, the loop play with ascending order side by side. Or press[Next/Pre]to play.
5.12.3 Automatic Loop
After freezing image, press[Play/Pause]to play, press it again to stop. Press [ENTER]to choose the are of automatic playback area needed.
5.12.4 Save and Recall Image
1.Press to save current image, the image will be displayed below the screen;
2.If you need to recall images that has been stored, move cursor to needed image, press
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[ENTER]to recall it; Or you can recall archived patient’s information to recall image, please refer
to archive chapter.
5.12.5 Save and Recall Cine
In freeze status, press to save cine, then it will be displayed below the screen, move cursor to needed cine, press [ENTER]to recall cine.
5.12.6 Delete images
After recalling the images , press the [Delete images] to delete the files.
5.12.7 Send images
After recalling the images , press the [Send images] to send images to USB flash disk , DICOM storage and print. Hint: Activate the DICOM before DICOM storage and print.
5.13 Image Browse
Press to enter image information browsing interface. Press [ENTER]to any function in the image.
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Review interface
ID: ID of Current patient. Name: Current patient’s name. Information: Enter into current patient’s information interface. Report: Enter into current patient’s report interface; Send images: Send image to USB flash disk , DICOM storage and print; Print the imageprint the image which be chosen, it will be printed as the arrangement set; Delete images: Delete selected image; Row*Column: Select image’s format; Pre page: Page up; Next page: Page back; New Exam: Exit current examination and open a new dialog box. Continue Exam: Exit image browsing interface and go on checking current patient; Archive: Open up archive management interface; Cancel: Turn off image browsing interface;
5.14 Archive Management
Archive management can search for patient’s information which has been stored in system. Press [Archive]to archive management interface, all process can be opened up by moving cursor.
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Archive interface
Item: Type selection, select Patient’s ID or Name; Keyword: Search for key words; Period: Time filter, select todayone weekone month three monthssix months, recent one
year and all
Multiple Choice: Multiple choice; Dada Source: Path choice, select hard disk or U disk; Patient info: Enter into patient’s information interface; Review Report: Enter into report interface; Backup Exam: Select examination information to USB flash disk; Restore Exam: Recover examination information from USB flash disk; Send Exam: Send selected examination information to USB flash disk or DICOM Storage/Print
(Need to activate the DICOM);
Delete Exam: Delete selected examination information; Patient View: Change display mode of information; Expand All: Select Patient View, it will display sub-directory; Collapse All: Exit sub-directory; Select All: Select all examination information; New Exam: Exit current patient’s examination; Continue Exam: Exit archive management interface and go on checking current patient; Easy View: Exit archive management interface and open up image browsing interface; Cancel: Exit archive management interface and go on checking current patient;
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5.15 Report
Press[ENTER]on the image to add the image into the report page. The report can be saved and
printed. It is convenient for the doctor to view and edit the patients’ information. Reports contain normal report, abdominal report, cardiac report, small part report etc. Move the cursor to the required report page and press[ENTER] to choose.
Click the “Report” button and the page pop up the report page of the current exam mode. Change
the other exam mode report by the drop-down box.
Report Interface
ReportTitle: Report options, different kinds of report can choose, such as Normal, OB/GYN etc. Hosp: Display the hospital name. Abdomen Report: Display the kind of report. Patient Name: Display the patient name. Age: Display the patient age. Gender: Display the patient sex. Patient ID: Display the patient ID. Diagnostic: Input the diagnostic instructions. Description: Input the description of symptom. Tips: Input note information. Send DICOM SR: After activating DICOM , send DICOM structural report to server. Print: Print the report with image.
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Export: Export the PDF report to the U disk. Save: Save the report in system. The image on the right side: Press [ENTER]on the image to add the image into the report.
5.16 DICOM
5.16.1 DICOM Worklist
Press [Worklist] in Patient Interface , pop up the following dialog box
ID:input ID or some characters , fuzzy query needs server Search By:select term , ID or name; ID:display the ID of patients Name:display the names of pstients BirthDate:display the birthdate of patients Sex:display sex of patients Doctor:display names of doctors Acc#:dispaly the NO. of patients Search:press this button to do search operation Apply:selete the searched patient and press this button , input all patient information into the
new patient interface Clear:clear all searched content.
5.16.2 DICOM Storage
Check the “save and send” in setting , then DICOM stroage when saving cine and images . Press
send button in archive or freeze interface. DICOM Send interface as follows:
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DICOM Send Interface Select DICOMStroage in left , choose DICOM server and press Export button to DICOM storage. Enter DIOCM Task Sequece and watch or edit DICOM process.
5.16.3 DICOM Print
DICOM Print operation is the same as DICOM storage
5.16.4 DICOM SR
Press Send DICOM SR button in report interface , this task is added into DICOM Tash Sequence.
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Chapter 6 Measurement and Calculation
Main content of this chapter: Normal calculation and measurement on B mode image and M mode image, OB calculation measurement etc, system can enter into corresponding measurement mode depend on current exam mode, and enter into the corresponding report depend on the measurement mode.
System has built-in the default measurement according to the exam mode, the change of measurement please refer to the chapter of preset settings.
6.1 Keyboard for Measurement
6.1.1 Trackball
Trackball is used to move the cursor, main functions are as follows:
1Before starting a measurement, use the trackball to choose the menu options; 2After starting a measurement, move the trackball to move the cursor, during the measurement, the cursor should not be moved out image area;
3During the Ellipse method measurement, use trackball to change the length of short axis. 4Update the moving of the measurement result, move the traceball to change the position of the measurement result.
6.1.2 [ENTER]
During the measurement, the functions of [ENTER]key are as follows: 1When cursor is on the menu, press the key to choose the options and start the measurement. 2During the measurement, press the key to anchor the start point and end point.
6.1.3 [UPDATE]
1Before the measurement, press[UPDATE]to change the measurement method, such as ellipse,
trace. The changeable measurement item has “< >”.
2During the measurement, UPDATE-KEY is used to switch the start point and end point, long axis and short axis when the measurement is not finished. 3、During the distance measurement, press the[ENTER]to fix the start point, when the end point is not fixed, press the UPDATE-KEY to switch the start point and end point.
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4、During the Ellipse measurement, when fix the long axis, but the short axis is not fixed, press the UPDATE-KEY to switch the long axis and short one.
6.1.4 [DEL]
Main functions are as follows: In frozen status, press the[DEL], delete all the measurement results, comments and traces.
6.1.5 [Change]
Press[Change]to switch other menu; Press[Exit]to exit;
6.1.6 [Exit]
Press[Exit]to exit the measurement menu.
6.1.7 Parameters control button
Press the corresponding button to update the function and use the function.
6.2 B Mode general Measurement methods
The system B mode contains Distance, Ellipse, and Trace.
6.2.1 Distance
Measurement steps: 1: Press the [Calc] button to enter into measurement. Update the [distance] item in the menu or press the quick measure button [Dist], it will display a segment “+”icon. 2: Move the “+”icon by cursor to fit the one point of the line. Press [ENTER] key to fix the start point and the cursor can be moved to the next position. 3: Press [UPDATE] key can change the activated point, and fit the other point of the line. 4: Move the cursor to the end-point, press [ENTER] again to complete the measurement. 5: After the measurement, the result will display in the measurement results area. 6: Repeat the steps from 1 to 4 to start next “distance” measurement. Press [DEL] key to delete all the measurements.
Note:
Each group of measurement is limited, if the measurement results beyond, it will begin a new group of measurement automatically.
6.2.2 Ellipse
Measurement steps:
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1: Press the [Calc] button to enter into measurement. Update the [Ellipse] item in the menu or press the quick measure button [Ellipse], it will display a segment “+”icon. 2: Move the “+”icon by cursor, Press [ENTER] key to fix the point and the cursor can be moved to form a round. 3: Press [UPDATE] key can exchange the activated point and the fixed point. 4: Move the cursor to the end-point of the ellipse, press [ENTER] to fix the axis, at the same time, the next axis be updated, and can change the size of the axis by the cursor. 5: Now press [UPDATE] key can exit to the step 4. 6: After fixing the next axis, can press [ENTER] key to complete the measurement. 7: After the measurement, the result will display in the measurement results area. 8: Repeat the steps from 1 to 6 to start next “ellipse” measurement. Press [DEL] key to delete all the measurements.
Note:
Each group of measurement is limited, if the measurement results beyond, it will begin a new group of measurement automatically.
6.2.3 Trace
Measurement steps: 1: Press the [Calc] button to enter into measurement. Update the [Trace] item in the menu or press the quick measure button [Trace], it will display a segment “+”icon. 2: Move the “+”icon by cursor, Press [ENTER] key to fix the point and the cursor can be moved to the next position. 3: Make the cursor tracing along the edge of required area, the traced line can be not closed.. 4: Now press [UPDATE] key to cancel the tracing. 5: Press [ENTER] key again in the endpoint, the start point and end point of trace line will be closed by a straight line. 6: After the measurement, the result will display in the measurement results area. 7: Repeat the steps from 1 to 5 to start next “trace” measurement. Press [DEL] key to delete all the measurements.
Note:
Each group of measurement is limited, if the measurement results beyond, it will begin a new group of measurement automatically.
6.2.4 Histogram
Histogram is used to calculate the gray distribution of the ultrasound echo signals within a specified area. Use the rectangle, ellipse or trace method to draw along the desired measurement area. The result is shown in the form of histogram. Histogram can be measured only on the frozen image.
Measurement steps by rectangular method: Click [FREEZE]key to freeze the image.
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Meas. Menu
Submenu
Unit
Meas. Method/ Meas. Formula
Comment
Distance
cm
Refer to distance Meas.
area/circle
Area cm2 Circle cm
Refer to Ellipse
and trace meas.
Ellipse and trace. Press[UPDATE]to change.
Press [ENTER] in [Histogram] menu to enter into measurement status. Click [ENTER] to fix one apex of the rectangle. Move the trace ball to change the cursor position and fix the diagonal point of the rectangle Move the trace ball to change the cursor position, fix the diagonal point of the rectangle, and
press [ENTER]again to confirm the measurement area. The result will display on the measurement result area..
Measure the histogram by ellipse or trace method: The method is the same as that to measure y ellipse or trace method, press [UPDATE] to change the measurement between ellipse and trace. The horizontal axis represents the gray scale of the image ranging from 0 to 255. The vertical axis represents the distribution ratio of each gray scale. The value shown on the top of vertical axis represents the percentage of the maximally distributed gray in the whole gray distribution.
6.2.5 Cross-section Diagram
Cross-section Diagram is used to measure the gray distribution of the ultrasound signals in the vertical or horizontal direction on a certain profile (section). This measurement is only available in the frozen mode. Measurement steps:
Click [FREEZE] key to freeze the image. Click[Meas.]key , and choose [B NORMAL MEAS]. Draw a straight line at the measuring position. The method is the same as that to measure
distance. The calculated result of the profile will be displayed at the centre of the screen. 1-The horizontal (or vertical) axis represents the projection of the profile line on the horizontal direction. 2-The vertical (or horizontal) axis represents the gray distribution of the corresponding points on the profile line. The range is 0 to 255.
6.3 Normal measurement and calculation in B mode
Click display [B], [B/B] or 4B to enter into B, B/B or 4B mode, then click [Calc] key to enter into measurement status. Or press [Change] to choose the normal measurement.
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Meas. Menu
Submenu
Unit
Meas. Method/ Meas. Formula
Comment
Volume 1straight line
ml
Refer to distance Meas. Formula: V π/6×D3
D means: Depth
Volume 1ellipse
ml
Refer to ellipse meas. Formula: V π/6×A×B2
A: Long Axis B: Short Axis
Volume 2 straight line
ml
Refer to distance Meas. Formula: V π/6×D1×D22
D1: the longer distance D2: the shorter distance
Volume 3 straight line
ml
Refer to distance Meas. Formula: V
π/6
×D1×D2×D3
D1, D2, D3: Distance
Volume 1 straight line 1 ellipse
ml
Refer to distance and ellipse Meas. Formula: V π/6×A×B×M
A: Long Axis B: Short Axis M: Distance
Ratio
Ratiodistance
Refer to distance Meas. Formula: R=D1/D2
D1: First Distance D2: Second Distance
Ratioarea
Refer to ellipse Meas. Formula: R=A1/A2
A1: First Area A2: Second Area
Angle
deg
Refer to distance Meas.
Angle Range: 0°~ 180°
Histogram
Refer to histogram
Cross-section diagram
Refer to Cross-section
6.4 Canine measurement and calculation
Choose canine exam mode. Press [Calc] to enter into canine measurement status in B, B/B, 4B mode. Or press [Change] to choose the canine measurement.
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Meas. Menu
Submenu
Unit
Meas. Method/ Meas. Formula
Comment
GS cm
Refer to distance Meas.
CRL
cm
Refer to distance Meas.
HC Diameter
cm
Refer to distance Meas.
Body Length
cm
Refer to distance Meas.
Volume
ml
Refer to distance Meas. Formula: V π/6×L×W×H
L: Length W: Width H: Height
Thyroid
Length Width Height
cm
Refer to distance Meas.
L: Thyroid Length W: Thyroid Width H: Thyroid Height
Bladder Volume
ml
Refer to distance Meas. Formula: V π/6×L×H×W
L: Bladder Length W: Bladder Width H: Bladder Height
Meas. Menu
Submenu
Unit
Meas. Method/ Meas. Formula
Comment
GS cm
Refer to distance Meas.
CRL
cm
Refer to distance Meas.
HC Diameter
cm
Refer to distance Meas.
Body Length
cm
Refer to distance Meas.
Volume
ml
Refer to distance Meas. Formula: V π/6×L×W×H
L: Length W: Width H: Height
Thyroid
Length Width Height
cm
Refer to distance Meas.
L: Thyroid Length W: Thyroid Width H: Thyroid Height
Bladder
ml
Refer to distance
L: Bladder Length
6.5 Feline measurement and calculation
Choose feline exam mode. Press [Calc] to enter into feline measurement status in B, B/B, 4B mode. Or press [Change] to choose the feline measurement.
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Meas. Menu
Submenu
Unit
Meas. Method/ Meas. Formula
Comment
Volume
Meas. Formula: V π/6×L×H×W
W: Bladder Width H: Bladder Height
Meas. Menu
Submenu
Unit
Meas. Method/ Meas. Formula
Comment
GS cm
Refer to distance Meas.
Volume
ml
Refer to distance Meas. Formula: V π/6×L×W×H
L: Length W: Width H: Height
Thyroid
Length Width Height
cm
Refer to distance Meas.
L: Thyroid Length W: Thyroid Width H: Thyroid Height
Bladder Volume
ml
Refer to distance Meas. Formula: V π/6×L×H×W
L: Bladder Length W: Bladder Width H: Bladder Height
Meas. Menu
Submenu
Unit
Meas. Method/ Meas. Formula
Comment
BPD
cm
Refer to distance Meas.
CRL
cm
Refer to distance Meas.
Body Length
cm
Refer to distance Meas.
Volume
ml
Refer to distance Meas. Formula: V π/6×L×W×H
L: Length W: Width H: Height
Thyroid
Length Width
cm
Refer to distance Meas.
L: Thyroid Length W: Thyroid Width
6.6 Equine measurement
Choose equine exam mode. Press [Calc] to enter into equine measurement status in B, B/B, 4B mode. Or press [Change] to choose the equine measurement.
6.7 Bovine Measurement and Caculation
Choose Bovine exam mode. Press [Calc] to enter into bovine measurement status in B, B/B, 4B mode. Or press [Change] to choose the bovine measurement.
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Meas. Menu
Submenu
Unit
Meas. Method/ Meas. Formula
Comment
Height
H: Thyroid Height
Bladder Volume
ml
Refer to distance Meas. Formula: V π/6×L×H×W
L: Bladder Length W: Bladder Width H: Bladder Height
Meas. Menu
Submenu
Unit
Meas. Method/ Meas. Formula
Comment
BPD
cm
Refer to distance Meas.
CRL
cm
Refer to distance Meas.
Body Length
cm
Refer to distance Meas.
GS cm
Refer to distance Meas.
Volume
ml
Refer to distance Meas. Formula: V π/6×L×W×H
L: Length W: Width H: Height
Thyroid
Length Width Height
cm
Refer to distance Meas.
L: Thyroid Length W: Thyroid Width H: Thyroid Height
Bladder Volume
ml
Refer to distance Meas. Formula: V π/6×L×H×W
L: Bladder Length W: Bladder Width H: Bladder Height
6.8 Ovine Measurement and Calculation
Choose ovine exam mode. Press [Calc] to enter into ovine measurement status in B, B/B, 4B mode. Or press [Change] to choose the ovine measurement.
6.9 Normal Measurement and Calculation in M, B/M mode
click [M] key to enter M or B/M mode, press [Calc] key to enter into M mode measurement status. Or press [M Measurement] on the menu to enter into M mode measurement status.
6.9.1 Distance
Measurement steps:
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Select menu item-“Distance” to enter into measurement. Click on the M image area, it will display a blue dotted line with two horizontal short line. The
blue dotted line represents the position need to be measured. The distance between the two short
lines is the distance you want to measure. The yellow short line represents it’s in active status.
Click it and drag the short line to anywhere you want to put. . Click [UPDATE] button to active the two short lines in turns and dragon them to change the distance between them. The measurement result will be displayed on the result area.
6.9.2 Time
Measurement steps:
Select menu item[Time] to enter into measurement. Click on the M image area, it will display two blue straight dotted line. The blue dotted line
with one yellow short line on it represents it is in active status. The distance between the two straight lines stands for time you want to measure. You can drag the active straight line to anywhere you want to change the measured time. Click [UPDATE] button to active the two straight lines in turns and dragon them to change the distance between them. The measurement result will be displayed on the result area .
6.9.3 Heart rate
Heart rate is used to calculate the number of heart beats per minute from cardiac image. Measurement steps:
Choose[Heart rate]menu item to enter into measurement. The method is same as M Time measurement. After the above measurement, the calculated heart rate result is displayed in the measurement
result area. Repeat the steps form1 to 3 to start next measurement.
6.9.4 Velocity
Measurement step:
Choose[Velocity]menu item to enter into measurement.
Select the start point of the measurement and click on the screen. The yellow “+” cursor is
active. Drag the cursor to the peak systolic wave.
Click on the Switch key to active another point. Drag the active point to the end diastolic wave. Repeat 1-3 to do another measurement.
Note: The maximum number of the measurement result on the image area is one. The second measurement result will cover the first one. The measurement result area will list all the measurement values.
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Meas. Menu
Submenu
Unit
Meas. Method/ Meas. Formula
Comment
Distance
cm
Refer to M distance Meas.
Time
s
Refer to M time Meas.
Velocity
cm/s
Refer to M velocity Meas.
HR One Cycle
bpm
Refer to M time Meas.
Double Cycles
bpm
Refer to M time Meas.
6.10 General Measurement in M mode
At real-time status, click [B/M] key twice to enter M mode, click [Calc]key to enter into M mode cardiology measurement status.
6.11 Canine Measurement in M Mode
The same with M mode general measurement.
6.12 Feline Measurement in M Mode
The same with M mode general measurement.
6.13 Equine Measurement in M Mode
The same with M mode general measurement.
6.14 Bovine Measurement in M Mode
The same with M mode general measurement.
6.15 Ovine Measurement in M Mode
The same with M mode general measurement.
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Function name
Setting method
Function description
Hospital Department
Input freely
Set up the hospital name which is shown at top left
corner of “General Setting” dialog box, 20 characters
Max. can be input
Date and Time
Input freely
Set up the system date (calendar format), select current date directly. Date format can be changed by format
Chapter 7 Preset
This chapter introduces the operation to make settings of the system through preset menu at preset mode. Preset function is used to set up working environment and status, parameters of each examination mode. The setting will be stored in the memory of system and not be lost even after the system is switched off. When the system is switched on, it will work automatically with the status which is required by the operator. In preset interface, all operation relies on moving trackball to required Function button position. Press [ENTER] button to start operation.
7.1 General setting
Press the [SETUP] key to enter system setting interface. User can do user-defined setting. Click [X] in the title bar or the exit key on the button can exit the system setting interface.
Form 1 General setting
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setting.
Date Format
Set up freely
Set up date format: Year/Month/Date, Month/Date/Year, Date/Month/Year
Time zone
Set up freely
Set up the working clock of the system.
Language
Select language
Select the language of operation interface(Simplified Chinese English and so on)
Screen shot Type
Select the need type
Set the content which screen picture contain: only picture, image area and patient information, full screen
Frame number choice
Set up freely
Set the default frame when save the film
Options for image area
Click the button to open the setting box
Set the TGC curve, including always show, always hide and hide for 1 to 8 seconds.
Options for Transmitted Images
Click the button to open the setting box
Adjust the parameters of transmitted images: brightness, contrast, gamma.
Options for PC print image
Click the mode you need and open the setting box to choose the different parameter
Including print area and arrangement condition in the image foresee interface
default
Press button
Recover all preset to factory setting
7.2 Measurement
Measurement includes general measurement setting and measurement formula setting
7.2.1 General measurement setting
General settings can only change the display of measurement unit.
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General Measurement settings interface
Distance: cm, mm Area: cm2, mm2 Volume: ml, l Time: s, ms Speed: cm/s, mm/s Acceleration: cm/s2, mm/s2 Angle: deg, rad Weight: g, kg Measure Result Optional: whether clear results upon unfreeze, and the automatic froze image Measure Resultthe color of the result font is alternative, including yellow/white/orange/green Follicle Method: ways to measure follicle, you can choose two distances and three distances.
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Caption
Display names of all items that is displayed name in measurement menu
7.2.2 Measurement formula setting
7.2.2.1 Interface Description-Measurement Menu
Interface for Edition of measurement Formula
Region: pull down and select needed measurement menu Manage: pop up measurement software edition interface ,add modify delete change marshalling
sequence in measurement menu.
BM: display measurement of each Exam mode Up: press this button to move selected measurement term up Down: press this button to move selected measurement term down Add Folder: add a measurement item. In the left column when the term is fold there is “+”
otherwise “-”
Add Measurement: add a measurement item for a term in the right column there is selected item and detailed parameter.
Add Calc Measurementadd a cal item for a measurement term Remove: remove selected measurement term or item. Default: restore all measurement term as factory setting. Save: save measurement item modification users did Check : display needed items on measurement menu, otherwise not displayed
Sheet 2 Folder Edit content description
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Var Name
The name of built-in selected measurement menu, user don’t need modify while display order according to the names
Unique Name
Built-in code, user don’t need modify
Measurement rule
None: Disable rule , Repeat: Repeat this item , Sequential: measure by sequence
Default item
After choosing the Repeat and Sequential , choose one measurement or calculation to activate the measurement rule
Caption
Display the name of selected term that is display names in the measurement menu
Var Name
The name of built-in selected measurement menu, user don’t need modify while display order according to the names
Unique Name
Built-in code, user don’t need modify
Display In Menu
Check the required item and it will display on the measurement menu. The item without checking will not display on the measurement menu.
Choose measurement methods
Check the methods in measurement menu , press [update] to switch the method, Otherwise , the measurement is not available
Display in
Check and display the item in measurement menu ,
7.2.2.2 Interface Description-Measurement Manipulation
Interface for Edition of Measurement Formula Sheet 3 Measurement Edit content description
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Report
otherwise ,the item is not displayed
Name
Measurement operation of specific measurement display in results
Unit
Data unit which measurement operation produces
Display In Report
Whether display in the report or not.
Average Method
The average rule of data
Modify
Press this button to pop up interface to modify measurement operation
Remove
Press this button to delete selected measurement operation
Caption
Display the name of selected term that is display names in the measurement menu
Var Name
The name of built-in selected measurement menu, user don’t need modify while display order according to the names
Unique Name
Built-in code, user don’t need modify
Tool Type/Tool
Select available measurement tool type B distance (B line),area/circumference(ellipse, trace),M distance(M vertical line),time(M horizontal line),M slope(M
7.2.2.3 Interface Description-Measurement Calculation
Interface for Edition of Measurement Formal
Sheet 4 Calc Measurement Edit content description
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slant)
Display In Menu
Check the required item and it will display on the measurement menu. The item without checking will not display on the measurement menu.
On Line Select
Press[UPDATE]to change the measurement method by checking it.
Name
Needed measurement operation of specific measurement and calculation
Unit
Data unit which measurement operation produces
Display In Report
Whether display in the report or not. Up
Press this button to move measurement operation up
Down
Press this button to move measurement operation down
Average Method
The average rule of data
Add
Press this button to pop up interface to add add measurement operation
Modify
Press this button to pop up interface to modify measurement operation
Remove
Press this button to delete selected measurement operation
7.2.2.4 Create Measurement Operation
Press [Add] in measurement operation interface, pop up the following dialog box
Interface for Edition of Measurement Formula
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Caption
Display the name of selected term that is display names in the measurement menu
Var Name
The name of built-in selected measurement menu, user don’t need modify while display order according to the names
Unique Name
Built-in code, user don’t need modify
Ruler Result
Needed measurement operation of specific measurement and calculation
Edit
Enter into interface to edit formula when selecting calculation
item
Maximum
The maximum value displays in result zone and report
Minimun
The minimum value displays in result zone and report
Unit
Data unit which measurement operation produces
Display In Report
Whether display in the report or not. Method
The average rule of data
Sheet 5 Operation content description of creating new measurement
7.2.2.5 Formula Edit-Normal
It is necessary to enter into the following interface when creating measurement operation except OB
Interface for Edition of Measurement Formula
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Formula: edit formula in input box via keyboard and built-in formula. Validate: press this button to check whether the formula is right or not after editing formula. Clear: clear the content in the input box Unit: select the unit of calculation consequence Measurement Items: display all available measurement operation in the measurement menu. Function: built-in formula, number input and some parameters that system needs such as BSA,
SPSA.etc
Cancel: cancel editing formula and close the interface OK: save edited operation and close the interface
7.2.2.6 Formula Edit-OB
It is necessary to call built-in OB formula sheet when creating OB measurement operation the following function interface is required.
Caution: the results of GA and EDD don’t require unit, the unit of this class has been built-in.
Measurement Items: display created measurement term by now OB Tables: built-in OB formula table OB List
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Measure Item: OB Measurement Item GA Tables: Gestational list for the current measuring project. Growth Table: Growth table for the current measuring. Info: Display the gestational age and fetal weight for the current measuring. Cancel:Cancel the operation of choosing the formula Save:Save the users’ choice of formulas
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7.3 Annotation
ECO 1/3 VET Ultrasound Diagnostic System
Annotation Setting Interface
7.3.1 Annotation Library
The annotation database of the system is classified as : abdomen、OB、GYN、Cardiac、small part Pathological change Annotation can be made by inputting characters from the soft keyboard or recalling the terms saved in annotation database. Press [Comment Lib] pull down button, pop up annotation name within system , through trackball and [ENTER] to show required annotation status.
7.3.1.1 Edit Annotation Library
Operation:
1.At the annotation status, Move the cursor to the [Edit Comment Type]button then press [ENTER] key, the annotation will be updated, and can be edited.
2.Input name into the new created annotation status box, Move the cursor to the [Create]button then press [ENTER] key, then create new annotation status and appear in selected annotation status list
3.Move the cursor to the [Delete] button, press [ENTER] key, then delete current annotation status in the selected annotation list.
4.Alter name of current annotation status list in [Current Type Name]input box, press[ENTER] on the[Rename]button, then rename the selected annotation status name.
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7.3.2 Edit Annotation
Operator uses only current annotation instead of all content annotation status provides, inlay common annotation If necessary, user can import annotation or self-compiled annotation into common annotation.
7.3.2.1 Add annotation from annotation library
Operation:
1.Select needed source annotation status via Trackball and [ENTER]
2.Select needed annotation at [CommentLib]column then press the[ENTER]button to activate
this annotation.
3.press[ENTER] on[>]button to import selected annotation into user-selected annotation status; press[ENTER] on[>]button to move selected annotation in[Comment Selected]column into source annotation.
4.press[ENTER]on[>>]button to import all annotation in source into user-selected annotation status; press[ENTER]on[>>] button to move all annotation in[Comment Selected]column into source annotation.
7.3.2.2 Add annotation manually
Operation:
1.Activate [Edit Comment]input box via Trackball and [ENTER] button, then input needed abbreviation and full name of annotation.
2.press[ENTER]on[Add]button, meanwhile this handout will be added into source and user-selected annotation status.
7.3.2.3 Alter annotation
Operation:
1.Alter annotation in user-selected status, the abbreviation and full name of annotation will be displayed in [Edit Comment] box.
2.Activate needed abbreviation and full name via [ENTER] and alter via keyboard.
3.Press [ENTER]on[Modify]button, modify the annotation in both source and user-selected
status.
7.3.2.4 Delete annotation in library
Operation: Select needed annotation in source status, press [ENTER] on [Delete From Lib] button then the annotation deleted.
7.3.3 Comment and Arrow Option
Optional: whether clear comments and arrows upon unfreeze.
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Optional: whether freeze upon comments and arrows.
7.4 Body marks
ECO 1/3 VET Ultrasound Diagnostic System
Interface for Body Mark Setting
7.4.1 Body Marks Library
Built-in body marks: Bovine, Canine, Equine, Feline and Ovine. Press [BodyMarkLib] pull down button, pop up name of built-in body marks, show needed body marks via Trackball and [ENTER] button.
7.4.1.1 Edit body marks library
Operation:
1.Press [ENTER]on [Edit BodyMark Type], pop edit box.
2.Input name into the new created body marks box, Move the cursor to the [Create]button then
press [ENTER] key, then the new body marks will be created and appear in selected body marks list
3.Move the cursor to the [Delete] button then press [ENTER] key, then delete current body marks in the selected list.
4.alter current annotation status list name in [Current Type Name]input box, press [ENTER] on the [Rename] button, then rename the selected body marks.
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7.4.2 Body mark edition
Operation:
1.Select needed source body marks via Trackball and [ENTER]
2.Select needed body marks at [BodyMarkLib] column then press the [ENTER] button to
activate it.
3.press[ENTER] on[>]button to import selected body marks into user-selected status; press [ENTER] on[>]button to move selected body marks in[BodyMark Selected] column into source body marks.
4.press[ENTER]on[>>]button to import all body marks in source into user-selected status; press[ENTER]on[>>] button to move all body marks in[BodyMarks Selected] column into source .
7.4.3 Body mark Option
Optional: whether clear bodymark upon unfreeze. Optional: whether freeze upon bodymark.
7.5 Exam Mode
7.5.1 Exam Mode Edit
Press Utility in the submenu of [MENU], the parameters control area shows as following. According to the corresponding control button to turn on or off the function.
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Preset: Display the current preset. Rename: Rename the current preset. Load Preset: Load the preset displayed. Save: Save the current preset. Save As: Save the current preset as others.
7.5.2 Exam Mode Selection
Choose Utility and press [MENU],the following interface pop up. Open the relate function by
corresponding control area.
Interface for ExamMode Setting
Probe: select needed probe and ExamMode fit for it. ExamModeLib: show all existed Exam modes. ExamMode Selected: show Exam modes in probe column. >: import selected Exam modes from ExamModeLib column to ExamMode Selected column. >>: import all Exam modes from ExamModeLib column into ExamMode Selected column. <: delete selected Exam modes in ExamMode Selected column. <<: delete all Exam modes in ExamMode Selected column. Set as default: set selected Exam modes in ExamMode Selected column as default Move up: move selected Exam modes in ExamMode Selected column up. Move down: move selected Exam modes ExamMode Selected column down. Copy to: copy the exam mode selected in ExamMode to a specified preset.
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7.5.3 Exam mode selection
Operator can define needed Exam mode in detail including annotation, body marks, measurement menu import and export etc.
Interface for Exam Mode Setting
ExamMode: show all existed Exam modes in system Comment: double click[ENTER]to activate widget box, can choose existed annotation status
name. After setting, the default of the Exam mode is user-selected.
BodyMark: same as Comment, select user-needed default body marks. Measurement: same as Comment, select user-needed default measurement menu. Rename: rename selected Exam mode Delete: delete selected Exam mode Export: export all built-in Exam modes into USB flash disk. Import: import all built-in Exam modes into USB flash disk. Restore: restore all Exam mode as factory setting.
7.6 Keyboard
Users can set the number buttons and the store button on the keyboard, easy to use.
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Interface for Keyboard Setting
Output: including store images, store films, store images to U disk, store film to U disk, etc.
function options.
Image mode: including image full screen, biopsy, chroma, etc. Print: including video print, pc print etc. Others: including arrow, archive.
7.7 DICOM
DICOM includes DICOM Storage , DICOM Worklist , DICOM Print and DICOM SR . If DICOM is to be applied , please make sure DICOM has been activated . In the system page of setting interface , you can check whether DICOM is open or not . If you want to activate DICOM , please contact with Chison. There must be DICOM SCP server which has been installed with PACS or other relative DICOM server software
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Local AE Title:input local DICOM Title to sepearte the DICOM equippments in local network. Service:display the local DICOM function worklist , AE Title: display the name of local DICOM AE title , IP: display the IP of DICOM server, Port: display the port of DICOM server Timeout(s): display the delay tim Available: display whether DICOM is default or not , Verify: Press verify button and display whether DICOM setting is correct or not Add: add DICOM function and pop up setting dialog, Delete: delete the existed DICOM function Set as default: set one DICOM service as default , Send while saving: check this item and enable DICOM storage while saving image or cine , send
clip or image according to activated function. Send in archive: send DICOM storage in archive or review , send clip or image according to activated function.
7.6.1 Add/Edit DICOM Function
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Default: check this option , set DICOM function as default; Service: choose DICOM Storage , DICOM Worklist , DICOM Print or DICOM SR; Server AE Title: input DICOM server AE name; Server IP address: input DICOM IP address; SCP port: input DICOM server SCP port; Timeout: set the delay time of DICOM; Tip: choosing the DICOM Print type must be before relative print setting.
7.8 NET Work
Set the unit’s and target unit’s IP and do the connection testing.
7.9 System
7.9.1 System information
Display the software version, Hardware version, System version
7.9.2 Upgrade
Software and Hardware can be updated by USB flash drives. Software upgrade File Path: X:\update\XXX or X:\update_SN\XXX.
Hardware update File Path: “X:\fpga_update\XXX”, Keyboard upgrade File Parth: “X:\ keyboard_update \XXX”.
X means USB flash drives.XXX means upgrade content .It should restart manually after hardware update, and after software update, machine can be restarted automatically.
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7.9.3 Function Setting
DICOM: Click [Open] key, it will bring up the DICOM Key Input dialog box. Input the DICOM SN, and click [OK]key to save and exit. Full screen show: refer to DICOM.
7.9.4 Installment setting
Input relevant key to open trial function and the detail please contact CHISON Company.
7.9.5 Video VGA
Choose the video data: NTSC , PAL-M, PAL-D. Video opened: Choose the item to open this function.
VGA opened: Choose the item to open this function.
7.9.6 Image function
Export hardware SN and import hardware secret key, it only for engineer use.
7.9.7 System Maintenance
Only an authorized service engineer may perform maintenance.
7.9.8 Digital Graphic Printer Option
Adjust the parameters of Video Printer OptionDark, Light, Sharpness, Gamma. Select the parameters needed to adjust, press [Confirm] button on the slider of the parameter, and move the trackball to change the parameter.
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Chapter 8 System Maintenance
8.1 Machine Clean
Caution: do turn off the power before cleaning and pull out the cable from socket. There is
possibility of electric shock if the device is on
Clean methods: Use the soft dry cloth to wrap the machine. If the device is quite dirty, use wet soft cloth. After wiping the blot, use soft dry cloth to wipe dry
Caution:
1. Don’t use organic solvent such s alcohol ,otherwise surface may be ruined
2. When cleaning the machine, don’t let the liquid inflow the machine, otherwise it may malfunction and there is danger of electric shock.
3. When it is necessary to clean the probe connector and peripheral instrument, please contact
Sales office contact customer service or agent of Chison. Any self-cleaning may result in malfunction or degrading the function of device.
8.2 Probe Maintenance
The probes used by this machine can be divided into two series: body surface and intracavity During all ultrasound scan , ultrasonic radiation on the human body should be as less as possible.
Caution:
Only person Received professional training can use the probes. Probes can’t receive pressure sterilizer, when operation in sterile area, disposable sterile probe
hood should be applied.
Make sure not to drop the transducer on hard surface. This can damage the transducer elements
and compromise the electrical safety of the transducer.
Be careful when operation, make sure not to scratch the probe surface. Avoid kinking or pinching the transducer cable. Make sure not to connect the probe to plug or put adjacent cable into any kind of liquid. Keep the probe clean and dry. Power off or freeze when fixing or dismantling the probe. Make sure not to use or deposit the probe in the environment above 50 degree.
If any abnormal phenomena of probe is found, immediately stop operation and contact with Sale
Office, Customer Service department or Agents of manufacturer.
Cleaning
The cleaning procedure is fit for all probes. After operation every probe should do cleaning according to stated procedure of this passage. Inspection should be done for intracavity probe depends on condition of use
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Cleaning procedure:
1. Wipe the remaining coupling gel and blot with flowing clear water. Avoid the joint part between cable and probe touching the water or others
2. Use wet gauze or other soft cloth with a little liquid soap to clean the probe totally. Don’t use cleaning agent and cleaner with abrasiveness
3. Use flowing water to rinse fully. Use soft cloth which has been soaked by the concentration of
70% isopropyl alcohol to scrub. Then check the probe to make sure there is no blot.
4. Use clean cloth to dry the probe
caution: Don’t put the body surface probe into liquid below acoustical lens. Intracavity probe can’t exceed insertion region. Prohibit putting connector of probe into any liquid.
Infection
Infection procedure id fit for intracavity probe If it is necessary to use in surgery, please abide with instruction of professional infection person infection procedure:
1. Obey the cleaning procedure to clean the probe totally
2. Prepare and retreat The concentration of 2% glutaraldehyde solution as the infection
solution according to the instruction of manufacturer
3. Put the insertion region of probe into infection solution, the inserting depth can’t exceed insertion region. Don’t let the probe connector touch any liquid.
4. Soak the probe for 3 h
5. Pull out the probe, immediately rinse totally with sterile water and saline. To make sure of no any solution remaining. Please obey the rule to do right rinsing procedure including enough rinsing water and times
6. When probe is used in sterile area ,make sure to use disposable sterile probe hood
caution:
Don’t soak probe connector into any liquid Don’t let the soaking depth of intracavity probe exceed insertion region Prohibit soaking the probe in the liquid for more than 12 h Only use qualified inspection resolution
Deposit:
Please replace the probe in clean and dry environment, avoid direct sunshine Keep the environment to deposit the probe during -1050, Do not put it in high pressure and vacuum environment. When accessing probe be careful and avoid ruin. During transportation or leisure, the probe should be deposited in probe box.
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serial number
malfunction
reason
Measures
1
Switch button lights
but power LED not
Battery lose efficacy, Adapter works irregular
Check the connector between cable and power
2
Power Led lights but
LED no image
The interval time is too short to restart
Restart after 1 minute
3
LED display character menu but no scan image
1. Launch power, gain or
STC control errors
2. Not connect to probe or
the probe connection is not correct
3. Device is in freezing
condition
1.Control launch power , gain or STC control
2.Make sure of right connection
3.Exit from freezing condition
4
Abnormal image
1. Exam mode errors
2. Image processing setting
errors
1. Whether Exam mode is proper or not
2. Adjust image processing setting or set it as default
5
Probe works improperly
1.The plug plugs loosely
2.Internal circuit protects
1.Extract the probe and reinsert
2.Restart
6
No OB calculation package menu
Do not select the OB application before scanning.
Select the OB application
7
PRINT-key doesn’t work
1.The connected printer is approved
2.Printer power is not on
3.Printer is not connect well
1.Change the approved printer
2.Turn on the printer
3.Connect the printer again
8.3 Safety Check
To make sure this device works normally, a piece of maintenance plan is suggested to make to check the device regularly If any abnormal phenomena, immediately stop operation and contact with Sale Office, Customer Service department or Agents of manufacturer.
If no image or menu but image, please check following malfunction table. If the malfunction can’t
be solved, please contact with Sale Office, Customer Service department or Agents of manufacturer.
8.4 Malfunction Check
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Chapter 9 Probes
Scanhead (Lens)
Binding line
9.1 General Description
ECO 1/3 VET Ultrasound Diagnostic System
Convex Probe Overview
The probes provide high spatial and contrast ultrasound imaging of frequencies from 2.0MHz to
11.0MHz. These probes operate by pulsing sound waves into the body and listening to the returning echoes to produce high-resolution brightness mode, and a real time display.
9.2 Care and Maintenance
The probes that come with the system are designed to be durable and dependable. These precision instruments should be inspected daily and handled with care. Please observe the following precautions:
Do not drop the transducer on hard surface. This can damage the transducer elements and
compromise the electrical safety of the transducer.
Avoid kinking or pinching the transducer cable. Use only approved ultrasonic coupling gels. Follow the instructions for cleaning and disinfecting that come with each probe.
9.2.1 Inspecting Probes
Before and after each use, inspect carefully the probe’s lens, cable, casing, and connector.
Look for any damage that would allow liquid to enter the probe. If any damage is suspected, do
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not use the probe until it has been inspected and repaired/replaced by an authorized Service Representative.
NOTE
Keep a log of all probe maintenance, along with a picture of any probe malfunction.
WARNING
The probes are designed to be used only with this ultrasound system. Use of these probes on any other system or a non-qualified probe may cause electrical shock or damage on the system/transducer.
9.2.2 Cleaning and Disinfecting
Place the probe into the solution of cleaning-disinfectant. Make sure not to immerse the probe
into the liquid beyond the immersion level given in the pictures below. Make sure that the probe is covered with the cleaning-disinfectant up to the immersion level during the complete disinfection time.
For the recommended cleaning and disinfection time, please see your Operating Manual . Scrub the probe as needed using a soft sponge, gauze, or cloth to remove all visible residue from
the probe surface.
Rinse the probe with enough clean, potable water to remove all disinfectant residues. Use a soft cloth to clean the cable and the user section of the probe with the cleaning disinfectant
liquid. Make sure that the surface of the probe and cable is wetted thoroughly with the cleaning-disinfectant.
Allow probe to air dry completely. Reconnect the probe to the ultrasound console and place the probe into it’s holder.
Probe Immersion Levels
CAUTION
These transducers are not designed to withstand heat sterilization methods. Exposure to temperatures in excess of 60 º C will cause permanent damage. The transducers are not designed to be totally submerged in fluid, as permanent damage will result if the
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entire transducer is submerged.
Probe Safety
Handling precautions
Ultrasound probes are highly sensitive medical instruments that can easily be damaged by improper handling. Use care when handling and protect from damage when not in use. DO NOT use a damaged or defective probe. Failure to follow these precautions can result in serious injury and equipment damage.
Electrical shock hazard:
The probe is driven with electrical energy that can injure the patient or user if live internal parts are contacted by conductive solution:
DO NOT immerse the probe into any liquid beyond the level indicated by the immersion level diagram. Never immerse the probe connector into any liquid. Prior to each use, visually inspect the probe lens and case area for cracks, cuts, tears, and other signs of physical damage. DO NOT use a probe that appears to be damaged until you verify functional and safe performance. You need to perform a more thorough inspection, including the cable, strain relief, and connector, each time you clean the probe. Before inserting the connector into the probe port, inspect the probe connector pins. If a pin is bent, DO NOT use the probe until it has been inspected and repaired/replaced by a CHISON Service Representative. Electrical leakage checks should be performed on a routine basis by CHISON Service or qualified hospital personnel.
Mechanical hazard:
A defective probe or excess force can cause patient injury or probe damage: Observe depth markings and do not apply excessive force when inserting or manipulating endocavitary probe.
Inspect probes for sharp edges or rough surfaces that may injure sensitive tissue. DO NOT apply excessive force to the probe connector when inserting into the probe port. The
pin of a probe connector may bend.
Special handling instructions
Using protective sheaths
The use of market cleared probe sheaths is recommended for clinical applications. Reference FDA March 29, 1991 "Medical Alert on Latex Products".
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Protective sheaths may be required to minimize disease transmission. Probe sheaths are available for use with all clinical situations where infection is a concern. Use of legally marketed, sterile probe sheaths is strongly recommended for endo-cavitary procedures. DO NOT use pre-lubricated condoms as a sheath. In some cases, they can damage the probe. Lubricants in these condoms may not be compatible with probe construction. Devices containing latex may cause severe allergic reaction in latex sensitive individuals. Refer to FDA’s March 29, 1991 Medical Alert on latex products. DO NOT use an expired probe sheath. Before using a sheath, verify if it has expired.
Endocavitary Probe Handling Precautions
If the sterilization solution comes out of the endocavitary probe, please follow the cautions below:
Sterilant Exposure to Patient (e.g., Cidex): Contact with a sterilant to the patient’s skin for
mucous membrane may cause an inflammation. If this happens, refer to instruction manual of the sterilant. Sterilant Exposure from Probe handle to Patient (e.g. Cidex): DO NOT allow the sterilant to contact the patient. Only immerse the probe to its specified level. Ensure that no solution has
entered the probe’s handle before scanning the patient. If sterilant comes into contact with the patient, refer to the sterilant’s instruction manual.
Sterilant Exposure from Probe connector to Patient (e.g. Cidex): DO NOT allow the sterilant to contact the patient. Only immerse the probe to its specified level. Ensure that no solution has entered the probe’s connector before scanning the patient. If sterilant comes into contact with the patient, refer to the sterilant’s instruction manual.
Endocavitary Probe Point of Contact: Refer to the sterilant’s instruction manual.
Probe handling and infection control:
This information is intended to increase user awareness of the risks of disease transmission associated with using this equipment and provide guidance in making decisions directly affecting the safety of the patient as well as the equipment user.
Diagnostic ultrasound systems utilize ultrasound energy that must be coupled to the patient by direct physical contact. Depending on the type of examination, this contact occurs with a variety of tissues ranging from intact skin in a routine exam to recirculating blood in a surgical procedure. The level of risk of infection varies greatly with the type of contact.
One of the most effective ways to prevent transmission between patients is with single use or disposable devices. However, ultrasound transducers are complex and expensive devices that must be reused between patients. It is very important, therefore, to minimize the risk of disease
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transmission by using barriers and through proper processing between patients.
Risk of Infection
ALWAYS clean and disinfect the probe between patients to the level appropriate for the type of examination and use FDA-cleared probe sheaths where appropriate.
Adequate cleaning and disinfection are necessary to prevent disease transmission. It is the responsibility of the equipment user to verify and maintain the effectiveness of the infection control procedures in use. Always use sterile, legally marketed probe sheaths for intra-cavitary procedures.
Probe Cleaning process:
DO disconnect the probe from the system prior to cleaning/disinfecting the probe. Failure to do so could damage the system.
Perform Cleaning probe after each use
Disconnect the probe from the ultrasound console and remove all coupling gel from the probe by wiping with a soft cloth and rinsing with flowing water. Wash the probe with mild soap in lukewarm water. Scrub the probe as needed using a soft sponge, gauze, or cloth to remove all visible residue from the probe surface. Prolonged soaking or scrubbing with a soft bristle brush (such as a toothbrush) may be necessary if material has dried onto the probe surface.
WARNING
To avoid electrical shock, always turn off the system and disconnect the probe before cleaning the probe.
CAUTION
Take extra care when handling the lens face of the Ultrasound transducer. The lens face is especially sensitive and can easily be damaged by rough handling. NEVER use excessive force when cleaning the lens face.
Rinse the probe with enough clean potable water to remove all visible soap residue. Air dry or dry with a soft cloth.
CAUTION
To minimize the risk of infection from blood-borne pathogens, you must handle the probe and all disposables that have contacted blood, other potentially infectious materials, mucous membranes, and non-intact skin in accordance with infection control procedures. You must wear protective gloves when handling potentially
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infectious material. Use a face shield and gown if there is a risk of splashing or splatter.
Disinfecting the probes:
After each use, please disinfect the probes. Ultrasound probes can be disinfected using liquid chemical germicides. The level of disinfection is directly related to the duration of contact with the germicide. Increased contact time produces a higher level of disinfection.
In order for liquid chemical germicides to be effective, all visible residue must be removed during the cleaning process. Thoroughly clean the probe, as described earlier before attempting disinfection.
You MUST disconnect the probe from the system prior to cleaning/disinfecting the probe. Failure to do so could damage the system.
DO NOT soak probes in liquid chemical germicide for longer than is stated by the germicide instructions for use. Extended soaking may cause probe damage and early failure of the enclosure, resulting in possible electric shock hazard. Prepare the germicide solution according to the manufacturer's instructions. Be sure to follow all precautions for storage, use and disposal. The transducer is not designed to be totally submerged in fluid. Permanent damage will result if the entire transducer is submerged. The immersed part shall not exceed the transducer binding line. Place the cleaned and dried probe in contact with the germicide for the time specified by the germicide manufacturer. High-level disinfection is recommended for surface probes and is required for endocavitary probes (follow the germicide manufacturer's recommended time). After removing from the germicide, rinse the probe following the germicide manufacturer's rinsing instructions. Flush all visible germicide residue from the probe and allow to air dry. Ultrasound transducers can easily be damaged by improper handling and by contact with certain chemicals. Failure to follow these precautions can result in serious injury and equipment damage Do not immerse the probe into any liquid beyond the level specified for that probe. Never immerse the transducer connector or probe adapters into any liquid. Avoid mechanical shock or impact to the transducer and do not apply excessive bending or pulling force to the cable.
Transducer damage can result from contact with inappropriate coupling or cleaning agents: Do not soak or saturate transducers with solutions containing alcohol, bleach, ammonium
chloride compounds or hydrogen peroxide
Avoid contact with solutions or coupling gels containing mineral oil or lanolin Avoid temperatures above 60°C. Under no circumstances should the transducer be subjected to
heat sterilization method. Exposure to temperatures above 60º C will cause permanent damage to the transducer. Inspect the probe prior to use for damage or degeneration to the housing, strain relief, lens and seal. Do not use a damaged or defective probe.
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Coupling gels
DO NOT use unrecommended gels (lubricants). They may damage the probe and void the warranty. AQUASONIC Gel made by R. P. Kincheloe Company in USA is recommended.
In order to assure optimal transmission of energy between the patient and probe, a conductive gel must be applied liberally to the patient where scanning will be performed.
DO NOT apply gel to the eyes. If there is gel contact to the eye, flush eye thoroughly with water.
Coupling gels should not contain the following ingredients as they are known to cause probe damage:
Methanol, ethanol, isopropanol, or any other alcohol-based product. Mineral oil Iodine Lotions Lanolin Aloe Vera Olive Oil Methyl or Ethyl Parabens (para hydroxybenzoic acid) Dimethylsilicone
Planned maintenance
The following maintenance plan is suggested for the system and probes to ensure optimum operation and safety.
Daily: inspect the probes After each use: clean the probes, disinfect the probes. As necessary: inspect the probes, clean the probes, disinfect the probes.
Returning/Shipping Probes and Repair Parts
Transportation dept. and our policy require that equipment returned for service MUST be clean and free of blood and other infectious substances. When you return a probe or part for service, you need to clean and disinfect the probe or part prior to packing and shipping the equipment. Ensure that you follow probe cleaning and disinfection instructions provided in this Manual.
This ensures that employees in the transportation industry as well as the people who receive the package are protected from any risk.
AIUM outlines cleaning the endocavitary transducer:
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Guidelines for Cleaning and Preparing Endocavitary Ultrasound Transducers Between Patients From AIUM
Approved June 4, 2003
The purpose of this document is to provide guidance regarding the cleaning and disinfection of transvaginal and transrectal ultrasound probes.
All sterilization/disinfection represents a statistical reduction in the number of microbes present on a surface. Meticulous cleaning of the instrument is the essential icon to an initial reduction of the microbial/organic load by at least 99%. This cleaning is followed by a disinfecting procedure to ensure a high degree of protection from infectious disease transmission, even if a disposable barrier covers the instrument during use.
Medical instruments fall into different categories with respect to potential for infection transmission. The most critical level of instruments are those that are intended to penetrate skin or mucous membranes. These require sterilization. Less critical instruments (often called "semi-critical" instruments) that simply come into contact with mucous membranes such as fiber optic endoscopes require high-level disinfection rather than sterilization.
Although endocavitary ultrasound probes might be considered even less critical instruments because they are routinely protected by single use disposable probe covers, leakage rates of 0.9% ­2% for condoms and 8%-81% for commercial probe covers have been observed in recent studies. For maximum safety, one should therefore perform high-level disinfection of the probe between each use and use a probe cover or condom as an aid in keeping the probe clean.
There are four generally recognized categories of disinfection and sterilization. Sterilization is the complete elimination of all forms or microbial life including spores and viruses.
Disinfection, the selective removal of microbial life, is divided into three classes: High-Level Disinfection - Destruction/removal of all microorganisms except bacterial spores. Mid-Level Disinfection - Inactivation of Mycobacterium Tuberculosis, bacteria, most viruses,
fungi, and some bacterial spores. Low-Level Disinfection - Destruction of most bacteria, some viruses and some fungi. Low-level disinfection will not necessarily inactivate Mycobacterium Tuberculosis or bacterial spores.
The following specific recommendations are made for the use of Endocavitary ultrasound transducers. Users should also review the Centers for Disease Control and Prevention document on sterilization and disinfection of medical devices to be certain that their procedures conform to the
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CDC principles for disinfection of patient care equipment.
1. CLEANING After removal of the probe cover, use running water to remove any residual gel or debris from the probe. Use a damp gauze pad or other soft cloth and a small amount of mild non-abrasive liquid soap (household dishwashing liquid is ideal) to thoroughly cleanse the transducer. Consider the use of a small brush especially for crevices and areas of angulation depending on the design of your particular transducer. Rinse the transducer thoroughly with running water, and then dry the transducer with a soft cloth or paper towel.
2. DISINFECTION
Cleaning with a detergent/water solution as described above is important as the first step in proper disinfection since chemical disinfectants act more rapidly on clean surfaces. However, the additional use of a high level liquid disinfectant will ensure further statistical reduction in microbial load. Because of the potential disruption of the barrier sheath, additional high level disinfection with chemical agents is necessary. Examples of such high level disinfectants include but are not limited to: 2.4-3.2% glutaraldehyde products (a variety of available proprietary products including "Cidex," "Metricide," or "Procide"). Non-glutaraldehyde agents including Cidex OPA (o-phthalaldehyde), Cidex PA (hydrogen peroxide & peroxyacetic acid).
7.5% Hydrogen Peroxide solution. Common household bleach (5.25% sodium hypochlorite) diluted to yield 500 parts per million
chlorine (10 cc in one liter of tap water). This agent is effective, but generally not recommended by probe manufacturers because it can damage metal and plastic parts.
Other agents such as quaternary ammonium compounds are not considered high level disinfectants and should not be used. Isopropanol is not a high level disinfectant when used as a wipe and probe manufacturers generally do not recommend soaking probes in the liquid.
The FDA has published a list of approved sterilants and high level disinfectants for use in processing reusable medical and dental devices. That list can be consulted to find agents that may be useful for probe disinfection.
Practitioners should consult the labels of proprietary products for specific instructions. They should also consult instrument manufacturers regarding compatibility of these agents with probes. Many of the chemical disinfectants are potentially toxic and many require adequate precautions such as proper ventilation, personal protective devices (gloves, face/eye protection, etc.) and thorough rinsing before reuse of the probe.
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3. PROBE COVERS The transducer should be covered with a barrier. If the barriers used are condoms, these should be nonlubricated and nonmedicated. Practitioners should be aware that condoms have been shown to be less prone to leakage than commercial probe covers, and have a six-fold enhanced AQL (acceptable quality level) when compared to standard examination gloves. They have an AQL equal to that of surgical gloves. Users should be aware of latex-sensitivity issues and have available nonlatex-containing barriers.
4. ASEPTIC TECHNIQUE
For the protection of the patient and the health care worker, all endocavitary examinations should be performed with the operator properly gloved throughout the procedure. Gloves should be used to remove the condom or other barrier from the transducer and to wash the transducer as outlined above. As the barrier (condom) is removed, care should be taken not to contaminate the probe with secretions from the patient. At the completion of the procedure, hands should be thoroughly washed with soap and water.
Note: Obvious disruption in condom integrity does NOT require modification of this protocol. These guidelines take into account possible probe contamination due to a disruption in the barrier sheath.
In summary, routine high-level disinfection of the endocavitary probe between patients, plus the use of a probe cover or condom during each examination is required to properly protect patients from infection during endocavitary examinations. For all chemical disinfectants, precautions must be taken to protect workers and patients from the toxicity of the disinfectant.
Amis S, Ruddy M, Kibbler CC, Economides DL, MacLean AB. Assessment of condoms as probe covers for transvaginal sonography. J Clin Ultrasound 2000;28:295-8.
Rooks VJ, Yancey MK, Elg SA, Brueske L. Comparison of probe sheaths for endovaginal sonography. Obstet. Gynecol 1996;87:27-9.
Milki AA, Fisch JD. Vaginal ultrasound probe cover leakage: implications for patient care. Fertil Steril 1998;69:409-11.
Hignett M, Claman P. High rates of perforation are found in endovaginal ultrasound probe covers before and after oocyte retrieval for in vitro fertilization-embryo transfer. J Assist Reprod Genet 1995;12:606-9.
Sterilization and Disinfection of Medical Devices: General Principles. Centers for Disease Control, Division of Healthcare Quality Promotion. http://www.cdc.gov/ncidod/hip/sterile/sterilgp.htm
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(5-2003).
ODE Device Evaluation Information--FDA Cleared Sterilants and High Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices, March 2003. http://www.fda.gov/cdrh/ode/germlab.html (5-2003).
9.3 Probe Operation Instructions
For details on connecting, activating, deactivating, disconnecting, transporting and storing the probes.
9.3.1 Scanning the Patient
In order to assure optimal transmission of energy between the patient and probe, a conductive gel must be applied liberally to the patient where scanning will be performed.
After the examination is complete, follow the cleaning and disinfecting, or sterilizing procedures as appropriate.
9.4 Service Responsibility
If users install, use and maintain the system fully according to CHISON’s installation manual,
operation manual and service manual, then CHISON ECO main unit has a life time of 5 years and CHISON ECO probes have life time of 5 years after ex-work. The warranty of the system and probes after ex-work is as the time in the warranty card.
The system is a precise electronic system. Only the CHISON’s authorized service engineer could replace the defective parts. Any assembly, disassembly, handling, repair, or replacement by any other people may have adverse impact on the safety and effectiveness of the systems and probes, and thus will reduce the life time of the system and probes, and such systems and probes will not be covered by CHISON warranty after the above improper handling. Standard maintenance must be performed by CHISON’s authorized service engineer during the life time of the product.
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CAUTION: When the above life time is expired, the effectiveness
and safety of system and probes maybe greatly affected, so it’s NOT
suggested to continue using the system and probes even the system and probes seem work properly. But if user still wants to continue using the system and probes, user should first contact CHISON service center at CHISON headquarter to arrange the necessary safety check and calibration by CHISON’s authorized service engineer. If CHISON headquarter service center provides the calibration certificate for the related system or probe, then user could continue use the system or probes according to the calibration certificate. However, if CHISON headquarter service center concludes that the system or probe is no longer complied to the safety and effectiveness standard, then user should immediately stop using the system or probe. User understands that such check and calibration cost will be born by the user. Systems and probes keep on using after the life time may also be difficult to repair and maintain, so it’s suggested to renew the product after the life time.
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Acoustic Output Table
Transducer Model: C3-A Operating Mode: B
Index Label
MI
TIS
TIB
TIC
Scan
Non-scan
Non-scan
Aaprt≤1cm
2
Aaprt 1cm2
Global Maximum Index Value
0.459
0.09
#
Associated
Pra
Mpa
0.889
Acoustic
P
mW
2
#
Parameter
Min of [Pa(Zs), Ita.a(Zs) ]
mW
Zs
cm
Zbp
cm
Zb
cm
Z at max.Ipi.a
cm
3.05
deq(Zb)
cm
fawf
MHz
3.76
3.848
#
Dim of Aaprt
X
cm
2.088
#
Y cm
1.1
#
Other
td
μs
0.546
Information
prr
Hz
2293.6
pr at max.Ipi
MPa
1.31
deq at max.Ipi
cm
Ipa.a at max.MI
W/cm2
32.433
Operating
Mode
B B
#
Control
Focus
cm
4 2
#
Conditions
A Power
%
100
100
#
Appendix A: Acoustic Output Report Table
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Acoustic Output Table
Transducer Model: C3-A Operating Mode: THI-B
Index Label
MI
TIS
TIB
TIC
Scan
Non-scan
Non-scan
Aaprt≤1cm
2
Aaprt 1cm2
Global Maximum Index Value
0.317
0.094
#
Associated
Pra
Mpa
0.626
Acoustic
P
mW
20
#
Parameter
Min of [Pa(Zs), Ita.a(Zs) ]
mW
Zs
cm
Zbp
cm
Zb
cm
Z at max.Ipi.a
cm
3.5
deq(Zb)
cm
fawf
MHz
3.894
4.031
#
Dim of Aaprt
X
cm
2.088
#
Y cm
1.1
#
Other
td
μs
1.227
Information
prr
Hz
1938.
pr at max.Ipi
MPa
0.996
deq at max.Ipi
cm
Ipa.a at max.MI
W/cm2
39.47
Operating
Mode
THI-B
THI-B
#
Control
Focus
cm
4 2
#
Conditions
A Power
%
100
100
#
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