SIUI CTS-7700 Bedienungsanleitung

DCY2.782.7700SS/V5.0/B-E

Digital Ultrasound Imaging System

OPERATION MANUAL

Contents

Preface………………………………………………………………………………………….Ⅲ

1 Application Scope, Operation Condition, Safety and Caution.........................1-1

1.1 Application Scope.................................................................................................1-1

1.2 Operation Condition..............................................................................................1-1

1.3 Power Requirement..............................................................................................1-2

1.4 Safety....................................................................................................................1-3

1.5 Caution..................................................................................................................1-4

1.6 Classification…………………………………………………………………………….1-6

2 Composition, Principle and Specifications.......................................................2-1

2.1 Composition and Operation Principle...................................................................2-1

2.2 Technical Specifications .......................................................................................2-2

3 Introduction to Components Parts.....................................................................3-1

3.1 System Configuration............................................................................................3-1

3.2 Introduction to Component Parts..........................................................................3-4

4 Installation, Maintenance and Inspection..........................................................4-1

4.1 System Installation................................................................................................4-1

4.2 Maintenance and Inspection.................................................................................4-1

4.3 Relocation of System…………………………… …………………………………… 4-4

5 System Setup.......................................................................................................5-1

5.1 Operation Method for System Setup Menu..........................................................5-1

5.2 Setup Menu and Methods.....................................................................................5-1

6 Imaging.................................................................................................................6-1

6.1 Preparation ...........................................................................................................6-1

6.2 Selecting Probe and Exam Type..........................................................................6-1

6.3 Preliminary Imaging..............................................................................................6-6

6.4 Adjusting Image....................................................................................................6-9

6.5 Changing Image Display Range.........................................................................6-12

6.6 Image processing................................................................................................6-13

7 Annotation of Image Information .......................................................................7-1

7.1 Inputting Patient Information.................................................................................7-1

7.2 Adding Annotation on Image ................................................................................7-2

7.3 Body Mark.............................................................................................................7-8

7.4 Adding Arrow ......................................................................................................7-11

8 Measurement and Calculation............................................................................8-1

8.1 Key and Menu for Measurement & Calculation....................................................8-1

8.2 Display and Clear of Meas/Calc Result...............................................................8-16

8.3 Operation of Meas/Calc......................................................................................8-17

9 Cineloop, Image Storage and Print ....................................................................9-1

9.1 Cineloop................................................................................................................9-1

9.2 File Storage...........................................................................................................9-2

9.3 Temporary Image Store and Recall......................................................................9-3

9.4 Image Print............................................................................................................9-4

10 Maintenance, Troubleshooting, Transport and Storage ................................10-1

10.1 System Maintenance ........................................................................................10-1

10.2 Troubleshooting................................................................................................10-1

10.3 Contact Information...........................................................................................10-3

10.4 Transport and Storage Condition......................................................................10-3

10.5 Disposal............................................................................................................10-3

Appendix A Abbreviation............................................................................................... A-1

Appendix B Trackball Function Indication………………..…… ……….…….……... B-1

Appendix C Discription of Symbol.......................................................................... C-1

Appendix D Acoustic Output Parameter...………………..…………….…….…….... D-1

Appendix E Range,Precision and Accuracy of Ajustment/Display Parameter.…E-1

DCY2.782.7700SS/V5.0/B-E

Preface

III

Preface

To use this system correctly and safely and to ensure a long life, the user should

thoroughly understand the functions, operations, instructions as well as its maintenance.

Please read the information in this manual carefully before using the system.

This system has been designed and manufactured safely for the operators and patients.

However, for ensuring safety and reliability, please pay attention to the following

instructions:

a) This system should be operated only by or under the guidance of a qualified

person.

b) This system,belongs to Type BF Class I according to IEC 60601-1:2005. Please

operate this system by following the safety requirements described in Chapter 1.

c) Do not try to remodel the system. If necessary, contact our agent or us for help.

d) The system has been completely adjusted and fixed before delivery. Do not try to

readjust any adjustable parts that have been well fixed.

e) If any abnormality occurs during operation, turn off the power supply immediately

and contact our agent or us for help.

f) Connect the power cable of the unit to a grounded power socket at ground

impedance of 0.1Ωor less.

g) Accessory equipment connected to the analog and digital interfaces must be

certified according to the respective IEC standards (e.g. IEC 60950 for data

processing equipment and IEC 60601-1 for medical equipment). Furthermore all

configurations shall comply with the valid version of the system standard IEC

60601-1-1. Everybody who connects additional equipment to the signal input part

or signal output part configures a medical system, and is therefore responsible that

the system complies with the requirements of the valid version of the system

standard IEC 60601-1-1. If in doubt, consult the technical service department or

your local representative.

h) The system does not provide special protection functions or measures for use with

high frequency operation equipment. The users should be cautious for such

application.

i) This Operation Manual may be slightly different from that of your equipment due to

system software version, as well as configuration of options and accessories. The

Preface

actual system that you purchase shall prevail.

j) The company shall be responsible for accuracy and integrity of this Operation

Manual.

k) The company reserves the final right to interpret this Operation Manual.

Application Scope, Operation Conditions, Safety and Cautions

1-1

Chapter 1

Application Scope, Operation Conditions,

Safety and Cautions

1.1Application Scope

The system is a general-purpose diagnostic ultrasound imaging system designed

exclusively for use in a wide variety of extracorporeal body imaging procedures. A

general-purpose system supports various transducers and related application software

packages allowing for the collection, display and analysis of ultrasound information.

Usages include, e.g. general-purpose imaging, cardiac, OB/GYN, breast, prostate,

vascular, intra-surgical, depending on the operating system specific software packages

and compatible ultrasound transducers (this product does not support intra-surgical and

endocavity transducers).

1.2Operation Conditions

a) The system should be operated under the following ambient conditions for the safe

and correct operation :

zAmbient Temperature: 0℃～40℃；

zRelative Humidity: 30% To 85%;

zAtmospheric Pressure: 700hpa To 1060hpa.

【Note】:If the operation is beyond the ranges above, no normal ultrasound images

are ensured. If the system is stored for a long time, the ventilation of the stored

place shall be considered.

b) Strong sources of radiated emissions or electromagnetic waves, from broadcast &TV

station for instance, may cause the system to display with noise. Keep this system

Application Scope, Operation Conditions, Safety and Cautions

1-2

away from these kind of radiated emissions or electromagnetic waves.

c) Do not operate this system while other devices are operating with motor or silex

switch in the same power phase; otherwise, noise will disturb your system through

the power cable.

1.3 Power Requirements

Never use this system when the power supply does not meet the following requirements,

otherwise, the system may possibly be damaged.

a) Power Voltage: Single phase, 100-240V~, tolerance±10%; 50Hz/60Hz±1Hz, (230V ±

23V~ for EU countries), 50Hz±1Hz;

b) Connection of grounded device: use a grounded socket. Before connecting to the

power supply, connect the additional potential equalization conductor to the

equipotential terminal on another grounded system or an external grounded device;

c) The removable multi-jack socket provided together with the system can only be used

to supply power for the system equipment. The connection of electric devices that are

not part of the system and the removable multi-jack socket may result in danger.

d) If the non-medical electrical equipment, supplied as a part of the system, is intended to

be supplied via a multiple portable socket-outlet with a separating transformer, the

direct connection of the non-medical electrical equipment to the wall outlet may result

in risks；

e) Do not try to deviate any additional multi-jack socket or wire from the removable

multi-jack socket of system devices or from the system devices;

f) Any accessories or equipment which are not listed in this manual should not be

connected to this system, otherwise, it may result in danger；

g) When the system configured as per this manual is in use, all power supply plugs of the

devices shall be connected to the same special removable multi-jack socket if the

removable multi-jack socket is powered by a special power supply device, this power

supply device shall be in compliance with requirements of EC60601-1 and

Application Scope, Operation Conditions, Safety and Cautions

1-3

IEC60601-1-1; the removable multi-jack socket for the system shall comply with

requirements of IEC60601-1-1 Appendix EEE;

h) Do not place the removable multi-jack socket on the ground, otherwise, it may result in

danger.

i) The maximum load capacity of the removable multi-jack socket shall not be less than

the total load of all the devices consisting of the system, or it may result in danger.

【Tip】: In regions where mains supply is not stable, it is recommended to use

power supply from a stabilizer with output power of 250VA, so as to avoid

damage to the system due to mains fluctuation.

1.4 Safety

The system is designed and manufactured in compliance with the international standard

IEC 60601-1:2005 To operate it safely and correctly, please follow the instructions below:

a) This system is not explosion-proof. Do not operate it in a flammable or easy

explosive environment(e.g. in the presence of anesthetics, oxygen or hydrogen);

b) The system is not waterproof. Never allow water or other liquid to drip on to the

system;

c) The system needs a protective grounding device. Its power cable should be

connected to a grounding socket. If the system is powered by a power supply

without grounding, its equipotential terminal must be connected to the

equipotential terminal on another grounded system or an additional grounded

device. Do not use the system where there is no ground terminal is available;

d) Biological safety: the same as other diagnostic ultrasound products, the material

used for this products is proved to be innocuous through a long-period trial. It will

not result in allergy or stimulation to human body and skin;

e) Ultrasound safety: ALARA（As low as reasonably achievable）should be observed.

Patients should always be exposed to the lowest practical transmit power levels

for the shortest possible time. Freeze the system and keep the probe away from

the patient if no scanning is done. Do not examine the patient with the probe on a

Application Scope, Operation Conditions, Safety and Cautions

1-4

fixed position of the body for a long time; please check the display of acoustic

output and MI, when powering on the system, input new patient ID or shift from

non-fetal to fetal application.

1.5Cautions

a) While operating the system, please follow the methods and procedures

described in this manual.

b) Always turn off the system and protect it with a dust-proof cover whenever the

system is not in use.

c) The system should be operated in a clean environment. Avoid operating it in a

place with direct sunshine, impetuous temperature change, full of dust, close to

heat source or high humidity; do not put anything on top of the main unit.

d) Avoid severe vibration; otherwise the components in the system might be

damaged.

e) Before connecting or disconnecting probe(s), firstly ensure that the main unit is

set in frozen state. It would be better to turn off the main unit power supply.

f) Freeze the image whenever no exam is performed.

g) All endocavity probes, when in use, should be covered with probe cover

compliant to ISO4074:2002. Biological warning for probe cover: If the covers

used for endocavity probes are condoms, they should be nonlubricant and

nonmedicated. Practitioners should be aware that condoms have been shown to

be less prone to leakage than commercial probe covers, have a six-fold

enhanced AQL (acceptable quality level) when compared with standard

examination gloves. Their AQL equals to that of surgical gloves. Users should be

aware of latex-sensitivity issues and have available nonlatex-containing covers.

h) The transducer assembly specific to endo-cavity use shall be not excited when it

is out of the patient’s body. Otherwise, such excitation does not comply with

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