SIUI CTS-900 Manuale utente

DCY2.782.900SS/V6.0/A-E

CTS-900

Digital Ultrasound Imaging System

OPERATION MANUAL

CONTENTS

Preface …………………………………………………………………………………… III

1. Application Scope, Operation Conditions, Safety and Cautions…………. 1-1

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

1.2 Operation Conditions…………………………………………………………….... 1-1

1.3 Power Requirements……………………………………………………………..... 1-2

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

1.5 Cautions……………………………………………………………........................ 1-4

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

2. System Composition, Principle and Specification…………………………… 2-1

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

2.2 Specification….…………………………………………………………………… 2-2

3. Introduction to Components………………………………………………..... 3-1

3.1 System Configuration……………………………………………………………… 3-1

3.2 Introduction to Component Parts…………………………………………………. 3-2

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

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

4.2 Inspection and Maintenance……………………………………………………… 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 Frequency and Exam Type…………………………………… 6-1

6.3 Preliminary Imaging………………………………………………………………... 6-5

6.4 Adjusting Image……………………………………………………………………. 6-8

6.5 Changing Image Display Range…………………………………………………. 6-11

6.6 Image Processing………………………………………………………………….. 6-11

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

7.1 Inputting Patient Information……………………………………………………… 7-1

7.2 Adding Annotation on Image……………………………………………………… 7-3

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

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………………………………………….. 8-15

8.3 Operation of Meas/Calc…………………………………………………………… 8-16

9. CineLoop, Image Storage and Print……………………………………………..... 9-1

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

9.2 Quickly Store and Recall of Image………………………..……………………… 9-1

9.3 File Storage…………………………………………………………………………. 9-2

9.4 Search Disk Directory……………………………………………………………... 9-6

9.5 Print Image………………………………………………………………………….. 9-6

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

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

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

10.3 Contact Information of SIUI Service Department……………………………... 10-3

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

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

Appendix A: Abbreviation……………………………………………………………… A-1

Appendix B: Touchpad Function Indication………………………………………. B-1

Appendix C: Description of Symbol…………………………………………………. C-1

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

Appendix E: Range, Precision and Accuracy of Adjustment/Display

Parameters…………………………………………………………… E-1

DCY2.782.900SS/V6.0/A-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 internally powered equipment, Type BF 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) Any peripheral devices connected to the analog or digital interfaces must be in

compliance with relevant IEC standards (e.g. IEC 60950 for data processing

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

connections shall comply with the valid version of IEC 60601-1-1 on system

standard. Anyone who connects peripheral devices to the system IN/OUT ports

shall ensure that the whole system complies with requirements of the valid version

of IEC 60601-1-1. If in doubt, consult the technical service department or your local

representative.

g) 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.

h) 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

actual system that you purchase shall prevail.

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

Preface

Manual.

j) 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

1.1 Application 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).

1.2 Operation Conditions

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

correct operation:

zAmbient Temperature: 0℃to 40℃

zRelative Humidity: 30% to 85%

zAtmospheric Pressure: 700hPa to 1060hPa.

【Note 1】: If the operation condition is beyond the ranges above, no correct ultrasonic

images are ensured.

【Note 2】: If the system is stored for a long time, the ventilation of the stored place shall be

considered.

【Note 3】:The system is air cooled with a fan.

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

station for instance, may cause the system to operate incorrectly or to display with noise.

Application Scope, Operation Conditions, Safety and Cautions

1-2

The system must be separated from such emission sources or electromagnetic waves.

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

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

through power cable.

1.3 Power Requirements

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

below, otherwise, the system may be damaged.

a) Main Unit Power Voltage:

Battery: DC12V-16.8V, or

External Power Adapter: DC12V±1.2V

b) Accessories Power Voltage:

Adapter External Power Supply: 100V-240V~;

Battery Charger External Power Supply: DC12V±1.2V.

c) Power Frequency: 50Hz±1Hz or 60Hz±1Hz for power adapter.

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 connect any additional removable multiple socket or cables to the removable

multiple socket used by the system devices or to the system devices;

f) Do not connect any accessories or devices that are not described in this manual to the

unit or the system built up as per this manual. Otherwise it would lead to unexpected

danger;

g) When the system built up as per this manual is in use, all the device power plugs shall

be connected to the same special removable multiple socket. If the removable multiple

socket is supplied by a special power device, the power device shall comply with

IEC60601-1 and IEC60601-1-1 requirements. The removable multiple socket used for

the system shall comply with requirements in Annex EEE of IEC60601-1-1.

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

danger;

i) The maximum load capacity of the removable multiple socket shall not be less than the

Application Scope, Operation Conditions, Safety and Cautions

1-3

total load of all 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 120VA, so as to avoid damage to

the system due to mains fluctuation.

1.4 Safety

This system has been designed and manufactured in compliance with international standard

IEC 60601-1:2005. To operate it correctly and safely, 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 gas, oxygen or hydrogen);

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

c) This unit needs a protective grounding device. Its power cable must 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 no

ground terminal is available;

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

for this product is proved to be innocuous through a long-period trial. It will not result in

allergy and stimulation to human body and skin;

e) Ultrasound safety: ALARA (As Low As Reasonably Achievable) principle should be

observed. Patients should always be exposed to the lowest practical transmit power

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

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

position of the body for a long time; please check the display of acoustic output and MI,

when powering on the system, inputting new patient ID or shifting from non-fetal to fetal

application.

WARNING: To avoid the risk of electric shock, this equipment must only be

Application Scope, Operation Conditions, Safety and Cautions

1-4

connected to a supply mains with protective earth.

1.5 Cautions

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. DO NOT have any chemical substance (e.g. lubricant)

contact the silica keypad of the operation panel, so as to prevent the silica keypad

from swelling;

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 EMC

requirements, which might result in harmful interference to other device(s) in the

environment;

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