EU-C2000 and EU-C2000 EUS EXERA and EndoEcho COMPACT ENDOSCOPIC ULTRASOUND CENTER Instructions Nov 2007

Contents

4.6

Connection to the video system center ...

4.7

Connection to the video system center and the ultrasound center EU-M system... 55

4.8

Connection to the digital file equipment ...

62

4.9

Connection to an AC mains power supply ...

64

4.10 Connection of ultrasonic connector...

66

Chapter 5

Preparation and Inspection ...

71

5.1

Turning the ultrasound center ON and OFF...

72

5.2

Note when turning the ultrasound center ON or OFF ...

74

5.3

Inspection if the power fails to come on ...

75

5.4

Inspection of the ultrasonic image...

75

5.5

Adjusting the monitor ...

76

5.6

Inspection of the video system center...

76

Operation...

77

6.1

Monitor display ...

78

6.2

The on-screen menus ...

80

(1) exam/patient information (main menu #1) ... (2) stored images (main menu #2) ... (3) patient report (main menu #3)... (4) system setup (main menu #4)...

81 84 85 86

Set up...

94

Setting the date and time ... Setting up a video printer ... Setting up function key assignments... Entering/editing patient information...

94 95 96 97

Adjusting the ultrasonic image ...

99

2D image ... Power Doppler image...

99 101

Display functions ...

104

Freeze ... Cine review... Zoom ... Image direction... Labeling images ...

104 104 105 107 108

Saving and reviewing images ...

110

Save ... Review... Delete individual saved images... Delete all saved images ...

110 110 111 113

Measurement functions...

114

Chapter 6

6.3

6.4

6.5

6.6

6.7

ii

45

COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

Contents

6.8

Chapter 7

Distance measurement... Area/circumference measurement by approximating an ellipse ... Volume calculation...

114 115 116

Recording...

120

Image recording using the video printer ... Image recording using a video tape recorder (VTR)... Image recording using a digital file equipment ...

120 120 121

Care, Storage and Disposal... 122

7.1

Care ...

122

7.2

Storage ...

123

7.3

Disposal ...

124

Chapter 8

Troubleshooting ... 125

8.1

Troubleshooting guide ...

125

8.2

Returning the ultrasound center for repair ...

127

Appendix ... 128 Measurements ...

128

System chart ...

133

Operating and storage environments...

136

Specifications ...

136

Terms ...

139

Acoustic output tables ...

141

EMC information ...

144

COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

iii

Contents

iv

COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

Labels and Symbols

Labels and Symbols Safety-related labels and symbols are attached to the ultrasound center at the locations shown below. If labels or symbols are missing or illegible, contact Olympus.

Caution label

Refer to instructions. Crossed-out wheeled bin’ symbol

Refer to instructions.

CE marking

Model information plate Potential equalization terminal

The product name, compatible power supply name and serial number are shown. EU-C60

EU-C2000

Direct current

Direct current

COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

1

Labels and Symbols

Electrical rating plate The product name and rated voltage are shown.

CE marking

LOT The lot number is shown.

AC power adapter (MAJ-1039)

CE marking

IPX1 The label indicates that the foot switch is protected from dripped water.

Foot switch (MAJ-679)

2

COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

Important Information - Please Read Before Use

Important Information - Please Read Before Use Intended use This ultrasound center has been designed to be used with Olympus ultrasonic endoscopes or ultrasonic transducers manufactured by SonoSite, Inc. to observe real-time ultrasonic images. Do not use this instrument for any purpose other than its intended use.

Instruction manual Two instruction manuals, “MANUAL FOR USE WITH ULTRASONIC ENDOSCOPE” and “MANUAL FOR USE WITH EXTRACORPOREAL TRANSDUCER”, are contained in the package of this ultrasound center. Refer to this instruction manual when the ultrasound center is used in conjunction with an ultrasonic endoscope. Refer to the “MANUAL FOR USE WITH EXTRACORPOREAL TRANSDUCER” for additional information on using the ultrasound center in conjunction with an extracorporeal transducer. This instruction manual contains essential information on using this ultrasound center safely and effectively. Before use, thoroughly review this manual and the manuals of all equipment which will be used during the procedure and use the equipment as instructed. Keep this and all related instruction manuals in a safe, accessible location. If you have any questions or comments about any information in this manual, please contact Olympus.

 Terms used in this manual See “Terms” in the Appendix.

User qualifications The operator of this ultrasound center must be a physician or medical personnel under the supervision of a physician and must have received sufficient training in clinical endoscopic technique. This manual, therefore, does not explain or discuss clinical endoscopic procedures.

COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

3

Important Information - Please Read Before Use

Instrument compatibility Refer to the “System chart” in the Appendix to confirm that this ultrasound center is compatible with the ancillary equipment being used. Using incompatible equipment can result in patient injury and/or equipment damage. This instrument complies with EMC standard for medical electrical equipment; edition 2 (IEC 60601-1-2: 2001). However, when connected with an instrument that complies with EMC standard for medical electrical equipment; edition 1 (IEC 60601-1-2: 1993), the whole system complies with edition 1.

Repair and modification This ultrasound center, AC power adapter (MAJ-1039) and ancillary cables do not contain any user-serviceable parts. Do not disassemble, modify or attempt to repair them; patient or user injury and/or equipment damage can result. Some problems that appear to be malfunctions may be correctable by referring to Chapter 8, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 8, contact Olympus.

Signal words The following signal words are used throughout this manual.

Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage.

Indicates additional helpful information.

4

COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

Important Information - Please Read Before Use

Dangers, warnings and cautions Follow the dangers, warnings and cautions given below when handling this ultrasound center. This information is to be supplemented by the dangers, warnings and cautions given in each chapter.

•

Never install and operate the ultrasound center in locations where: − The concentration of oxygen is high. − Oxidizing agents (such as nitrous oxide (N2O)) are present in the atmosphere. − Flammable anesthetics are present in the atmosphere. Otherwise, explosion or fire may result because this ultrasound center is not explosion-proof.

•

The ultrasound center is a TYPE BF applied part. Leakage current from a TYPE BF applied part may be dangerous and cause ventricular fibrillation or otherwise seriously affect the cardiac function of the patient. Accordingly, always adhere to the following points: − Never apply a connected ultrasonic endoscope directly to the heart or any area near the heart. − Never allow an endo-therapy accessory, another endoscope, etc. applied to or near the heart to come into contact with an ultrasonic endoscope connected to the ultrasound center.

•

Observe the following precautions carefully. Failure to do so may place the patient and/or medical personnel at the risk of electric shock. − Keep liquids away from the ultrasound center. If spilled liquid has entered the ultrasound center, stop the operation immediately and contact Olympus. − Do not prepare, inspect or use the ultrasound center with wet hands. − Always connect all ancillary equipment to an AC mains outlet via an isolation transformer. − Never allow metal parts of an ancillary equipment to come into contact with the ultrasonic endoscope.

•

To prevent electric shock hazards, the main frame of the ultrasound center must be grounded securely and effectively.

COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

5

Important Information - Please Read Before Use

6

•

Use only a grounded wall mains outlet when connecting the ultrasound center. Failure to do so may cause electric shock or fire.

•

To avoid the risk of electric shock, before using the ultrasonic endoscope, inspect the face and cable. Do not use the ultrasonic endoscope if it is damaged.

•

To avoid the risk of electric shock, always disconnect the power cord from the wall mains outlet and disconnect the AC power adapter from the ultrasound center before cleaning the ultrasound center.

•

To avoid the risk of electric shock and/or fire, inspect the AC power adapter (MAJ-1039) and its cord, the power cord and the plug on a regular basis. Do not use them if they are damaged.

•

Do not connect any cable except the DC cable of the AC power adapter (MAJ-1039) to the DC power inlet of the ultrasound center.

•

To avoid the risk of electric shock, do not touch the socket of the ultrasound center.

•

Do not use the ultrasound center in an environment where electric noise is generated by electrosurgical equipment, etc. In such environment, the electric noise may appear in the ultrasonic image.

•

When using the ultrasonic endoscope in conjunction with an X-ray device, electric noise may appear in the ultrasonic image.

•

To prevent damage to the ultrasound center, never touch the electrical contacts of the socket.

•

Do not place objects on or near the ventilation grill of the ultrasound center while it is in use.

•

When the ultrasound center is used in conjunction with any other electrical device, always ensure that the device has undergone a full safety check.

•

Only equipment which compiles with standard IEC 60601-1, or equipment which has been verified as compliant with an equivalent safety standard should be connected with this ultrasound center.

COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

Important Information - Please Read Before Use

•

Under certain circumstances, the ultrasonic connector can reach temperatures that exceed IEC 60601-1 limits for patient contact (this does not include the face of the ultrasonic endoscope). Therefore, only the operator should handle the ultrasound center. Patient contact with hot surfaces may result in discomfort or minor patient injuries.

•

To avoid discomfort or minor risk of operator injury when handling the ultrasonic connector, the ultrasound center should not be operated for more than 60 minutes continuously in REAL-TIME mode (as opposed to FREEZE mode).

•

Do not use the ultrasound center if it exhibits erratic or inconsistent behavior. Discontinuities in the scanning sequence indicate a hardware failure that must be corrected before use.

•

Perform ultrasonic procedures prudently. Use the ALARA (as low as reasonably achievable) principle.

•

When using the ultrasound center, always wear appropriate personal protection equipment. Blood, mucus and other potentially infectious material adhering to the ultrasonic endoscope could pose an infection control risk.

•

When using the video monitor or recording devices such as the video printer or VTR, some parts of an image could be cut off unless it is resized so that it fits completely on the monitor. If there is such a “cut off”, be careful not to read the wrong patient information or read the image incorrectly.

•

Before using a high frequency endo-therapy accessory, refer to Section 4.3 “Using endo-therapy accessories” in the instruction manual of the endoscope.

•

Do not install this ultrasound center on its side. Otherwise, the ultrasound center may fall and become damaged and/or cause injury.

•

Do not use the ultrasound center under conditions other than those specified in “Operating and storage environments” in the Appendix.

•

Do not use a pointed or hard object to press the switches on the top panel. This may break the switches.

COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

7

Important Information - Please Read Before Use

8

•

Electrostatic discharge (ESD), or static shock, is a naturally occurring phenomenon. ESD is common in conditions of low humidity, which can be caused by heating or air conditioning. Static shock is a discharge of the electrical energy from a charged body to a lesser or non-charged body. The degree of discharge can be significant enough to cause damage to a transducer or the ultrasound center. The following precautions can help reduce ESD: apply anti-static spray to carpets or linoleum, and anti-static mats.

•

Do not use the ultrasound center if an error message appears on the image display: note the error code, turn off the ultrasound center and contact Olympus.

•

Excessive bending or twisting of cables can cause equipment damage and/or intermittent operation.

•

Do not open the flip cover except to connect or remove an ultrasonic connector. Otherwise, spilled liquid may enter the ultrasound center and cause damage.

•

Improper cleaning or disinfection of any part of the ultrasound center can cause permanent damage. For cleaning and disinfection instructions, see Chapter 7, “Care, Storage and Disposal”.

•

Do not use solvents such as thinner or benzene, or abrasive cleaners on any part of the ultrasound center. Doing so could cause equipment damage.

•

Be careful not to connect an incorrect cable or reverse the signal input terminal and output terminal when connecting cables.

•

Electromagnetic interference may occur on this instrument near equipment marked with the following symbol or other portable and mobile RF (Radio Frequency) communications equipment such as cellular phones. If electromagnetic interference occurs, mitigation measures may be necessary, such as reorienting or relocating this instrument, or shielding the location.

COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

Important Information - Please Read Before Use

As defined by the international safety standard (IEC 60601-1), medical electrical equipment is classified into the following types: TYPE CF applied part (the instrument can safely be applied to any part of the body, including the heart), and TYPE BF applied part (the instrument can safely be applied to any organ except the heart). The part of the body an endoscope or electrosurgical accessory can safely be applied to depends on the classification of the equipment to which the instruments are connected. Before beginning the procedure, check the current leakage classification type of each instrument to be used for the procedure. Classification types are clearly specified in the instruments’ instruction manuals. Symbol

Classification TYPE CF applied part

TYPE BF applied part

COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

9

Important Information - Please Read Before Use

The ALARA principle ALARA (as low as reasonably achievable) is the guiding principle for the use of diagnostic ultrasound. Qualified medical professionals, using good judgement and insight, determine the exposure that is as low as reasonably achievable. There are no rules sufficient to determine the correct response to every situation. Therefore, the physician keeps exposure low, bioeffects minimal, and images diagnostic. A thorough knowledge of the imaging modes, transducer capability, system setup, and scanning technique is necessary. The imaging mode determines the nature of the ultrasonic beam. A stationary beam results in greater exposure than a scanned beam, which moves over an area, spreading exposure over that area. Transducer capability depends upon transducer frequency, penetration, resolution, and field of view. System setup establishes the starting point and determines control adjustments from that point. Scanning technique depends upon physician knowledge and experience. Anatomy, physiology, pathology, physics, and system operation are also factors to consider in applying the ALARA principle. There are variables which affect the way the physician implements the ALARA principle. These variables include body size, location of the bone relative to the focal point, attenuation in the body, and ultrasonic exposure time. Exposure time is an especially useful variable, because it can be controlled by the physician. The ability to limit the exposure over time supports the ALARA principle.

10

COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

Important Information - Please Read Before Use

Applying ALARA The system imaging mode selected by the physician is determined by the information required. 2D imaging provides anatomical information; CPD imaging provides information about the energy or amplitude strength of the Doppler signal over time at a given anatomical location; PowerMap DCPD imaging provides information about the presence and direction of detectable blood flow using the energy or amplitude strength of the Doppler signal over time at a given anatomical location. Understanding the nature of the imaging mode being used allows the trained physician to apply the ALARA principle. Prudent use of ultrasound occurs when patient exposure to ultrasound is limited to the lowest output for the shortest time necessary to achieve acceptable diagnostic results. Decisions that support prudent use are based on the type of patient, exam type, patient history, ease or difficulty of obtaining diagnostically useful information, and potential localized heating of the patient due to transducer surface temperature. The ultrasound center limits transducer surface temperature to 41°C (106°F). A power monitor protection circuit protects against over-current conditions. If the power monitor protection circuit senses an over-current condition, the drive current to the transducer is shut off immediately, preventing over-heating of the transducer surface. Validation of the power monitor protection circuit is performed during normal system operation. The physician uses the system controls to adjust image quality and ultrasonic output. The system controls are divided into three categories relative to output: controls that directly affect output, controls that indirectly affect output, and receiver controls.

Direct controls The selection of the exam type limits acoustic output through their default settings. The acoustic output parameters that are set at default levels based on the exam type are the mechanical index (MI) and the spatial peak temporal average intensity (I SPTA). The ultrasound center will not exceed an MI of 1.0, or an I SPTA of 720 mW/cm2 in any exam type. In addition, the ultrasound center will not exceed a thermal index (TI) of 1.0 in any exam type.

Indirect controls The controls that indirectly affect output are those affecting imaging mode, optimization, transducer selection, and depth. The imaging mode determines the nature of the ultrasonic beam. Tissue attenuation is directly related to transducer frequency. The higher the PRF (pulse repetition frequency), the more output pulses occur over a given period of time.

COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

11

Important Information - Please Read Before Use

Receiver controls The receiver controls are the gain controls. Receiver controls do not affect output. They should be used, if possible, to improve image quality before using controls that directly or indirectly affect output.

Output display The ultrasound center and transducer combinations do not exceed either a TI of 1.0 or an MI of 1.0 in any operating mode. Therefore, the output display, which includes TI and MI, is not required and is not displayed.

Related guidance documents

12

•

Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, 1997.

•

Medical Ultrasound Safety, American Institute of Ultrasound in Medicine (AIUM), 1994.

•

Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, NEMA UD2-1998.

•

Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine, 1993.

•

Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine, 1998.

COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

Chapter 1 Checking the Package Contents

Chapter 1 Checking the Package Contents Match all items in the package with the components shown below. Inspect each item for damage. If the ultrasound center is damaged, a component is missing or you have any questions, do not use the ultrasound center; immediately contact Olympus.

COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

13

Chapter 1 Checking the Package Contents

1.1

Compact endoscopic ultrasound center (EU-C60/EU-C2000)

BNC cable (MB-677)

Compact endoscopic ultrasound center (EU-C60/EU-C2000) Remote cable (MH-907)

Foot switch cable (MAJ-1040)

Foot switch (MAJ-679)

Monitor remote cable (MAJ-1042) AC power adapter (MAJ-1039)

Power cord

Notice sheet

Instruction manual (Manual for use with ultrasonic endoscope)

Instruction manual (Manual for use with extracorporeal transducer)

Notice label

Figure 1.1

14

COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

Chapter 1 Checking the Package Contents

1.2

Optional components The items listed below are optional. If necessary, contact Olympus.

Tray unit  Olympus MAJ-1073 The tray unit (MAJ-1073) is used to install the ultrasound center to the trolley (WM-30, WM-60, WM-N60, WM-D60, TC-P2, TC-EU).

Figure 1.2

Ultrasonic endoscope  Olympus GF-UC160P-OL5, GF-UCT160-OL5, GF-UC2000P-OL5, GF-UCT2000-OL5

Figure 1.3

COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

15

Chapter 2 Nomenclature and Functions

Chapter 2 Nomenclature and Functions 2.1

Symbols and descriptions  Left side panel Power ON

Power OFF

 Foot switch Freeze

Release

 Control panel

16

Menu (ID)

B/CPD

Optimize

Save

Contrast

US/EXT

Zoom

Cine review

Gain

Measure

Near

Select

Far

Depth

COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000