EU-C60 and EU-C2000 EUS EXERA and EndoEcho COMPACT ENDOSCOPIC ULTRASOUND CENTER Instructions May 2009

Contents

Chapter 6

Operation...

29

6.1

Monitor display ...

30

6.2

The on-screen menus ...

32

(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)...

33 36 37 38

6.3

Set up...

46

6.4

Applying acoustic coupling gel ...

46

6.5

Installing a transducer cover ...

46

6.6

Adjusting the ultrasonic image ...

47

Transducers, exam types, and imaging modes... Change of the exam type ... 2D image ... Color Power Doppler image ... PowerMap DCPD image ...

47 48 48 50 51

6.7

Display functions ...

53

6.8

Display a pictograph and a scan plane marker ...

54

6.9

Displaying biopsy guide lines ...

56

6.10 Saving and reviewing images ...

59

6.11 Measurement functions...

59

6.12 OB measurements ...

59

Selection of the calculations (calcs) author ... Estimation of the fetal age... Calculation of the estimated delivery date (EDD)... Calculation of the estimated fetal weight (EFW) ... Calculation of the AFI ...

59 60 64 68 70

6.13 Cardiac measurements and calculations ...

74

6.14 Recording...

79

Chapter 7

Care, Storage and Disposal ...

80

7.1

Care ...

80

7.2

Storage ...

87

7.3

Disposal ...

87

Troubleshooting ...

88

Chapter 8

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COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

Contents

Appendix ...

89

Measurements ...

89

System chart ...

89

Operating and storage environments ...

89

Specifications ...

89

Terms ...

90

Acoustic output tables ...

94

Cardiac references ...

94

Obstetrical references ...

96

Pictographs ...

100

EMC information ...

103

COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

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Contents

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COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

Labels and Symbols

Labels and Symbols Refer to “Labels and Symbols” in the instruction manual, “MANUAL FOR USE WITH ULTRASONIC ENDOSCOPE” of the EU-C60/EU-C2000.

COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

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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. The specific intended uses for the ultrasound center in conjunction with SonoSite transducers for each examination type (exam type) and imaging mode are listed below: Abdomen: This system transmits ultrasonic energy into the upper and lower quadrants of the abdomen of an adult or pediatric patient to obtain 2D, CPD, or PowerMap DCPD images, which can be used to assess the presence and the extent of disease and/or injury. Study of small parts and superficial structures including breasts, shoulders, thyroid, and the abdominal wall: This system transmits ultrasonic energy into superficial soft tissue structures in the body to obtain 2D, CPD, or PowerMap DCPD images of the structure and pathology of the breast, thyroid, abdominal wall, shoulders, wrist, ankle, and knee. Pediatric scans of organs, superficial structures, and bony structures: This system transmits ultrasonic energy into the abdomen, pelvis and superficial structures of pediatric patients to obtain 2D, CPD, or PowerMap DCPD images of the abdominal organs, great vessels, pelvic structures and pediatric hips. General cardiac studies in adults and pediatric patients: This system allows the clinician to perform focused cardiac studies. This system transmits ultrasonic energy into the thorax of adults and pediatric patients to obtain 2D, CPD, or PowerMap DCPD images of the heart, great vessels, and anatomic or pathologic structures. This system can be used to assess overall cardiac performance and size, determine the presence and location of fluid around the heart and lungs, aid in pericardiocentesis and pleuralcentesis procedures, and visualize blood flow through cardiac valves.

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COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

Important Information - Please Read Before Use

GYN/Infertility: This system transmits ultrasonic energy into the lower abdomen or vagina of a female patient to obtain 2D or CPD images of the reproductive system, which can be used to assess the presence and extent of diseases in the female pelvic organs, monitor ovarian follicle size, and aid in chorionic villi sampling (CVS) procedures. Obstetrics: This system transmits ultrasonic energy into the abdomen or vagina of a pregnant woman to obtain 2D images of a fetus, which can be used to estimate gestational age, number and weight, assess the presence and extent of diseases and confirm viability. CPD or PowerMap DCPD imaging is intended for high-risk pregnant women. High risk pregnancy indications include, but are not limited to, multiple pregnancy, fetal hydrops, placental abnormalities, maternal hypertension, diabetes, and lupus.

CPD or PowerMap DCPD images can be used as an adjunctive method, not as a screening tool, for the detection of structural anomalies of the fetal heart, and as an adjunctive method, not as a screening tool, for the diagnosis of intrauterine growth retardation (IUGR). Prostate: This system transmits ultrasonic energy through the prostate of an adult patient to obtain 2D or CPD images of structures, which can be used to assess the presence and extent of diseases or injuries.

COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

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Important Information - Please Read Before 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 extracorporeal transducer.This manual contains additional information only. It does not replace the “MANUAL FOR USE WITH ULTRASONIC ENDOSCOPE” completely. Therefore, cross-reference are given where necessary. Refer to the “MANUAL FOR USE WITH ULTRASONIC ENDOSCOPE” when the ultrasound center is used in conjunction with an ultrasonic endoscope. 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 technique. This manual, therefore, does not explain or discuss clinical procedures.

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.

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COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

Important Information - Please Read Before Use

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.

COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

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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 extracorporeal transducer 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 extracorporeal transducer 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 extracorporeal transducer.

•

6

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

Important Information - Please Read Before Use

•

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 extracorporeal transducer, inspect the face, housing and cable. Do not use the extracorporeal transducer 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, do not use any extracorporeal transducers that has been immersed for longer than the specified cleaning or disinfection time.

•

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.

•

The transducer must be removed from the patient before the application of a high-voltage defibrillation pulse.

•

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 extracorporeal transducer 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.

COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

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Important Information - Please Read Before Use

8

•

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.

•

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 extracorporeal transducer). 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.

•

Olympus does not currently recommend a specific brand of acoustic standoff.

•

Do not use an extracorporeal transducer that is not listed in this manual as compatible with the ultrasound center (see the “System chart” in the Appendix). Otherwise, the system software may be damaged and/or not work properly.

•

When using the ultrasound center, always wear appropriate personal protection equipment. Blood, mucus and other potentially infectious material adhering to the extracorporeal transducer 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.

•

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

COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

Important Information - Please Read Before Use

•

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.

•

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.

•

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 submerge the ultrasonic connector in liquid. The cable is not waterproof beyond the ultrasonic connector/cable interface.

•

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

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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

Natural rubber latex medical alert Some covers for extracorporeal transducers contain natural rubber latex and talc, which can cause allergic reactions in some individuals.

The ALARA principle Refer to “The ALARA principle” in the instruction manual, “MANUAL FOR USE WITH ULTRASONIC ENDOSCOPE” of the EU-C60/EU-C2000.

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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.

1.1

Compact endoscopic ultrasound center (EU-C60/EU-C2000) Refer to Section 1.1, “Compact endoscopic ultrasound center (EU-C60/EU-C2000)” in the instruction manual, “MANUAL FOR USE WITH ULTRASONIC ENDOSCOPE” of the EU-C60/EU-C2000.

COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

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Chapter 1 Checking the Package Contents

1.2

Optional components The items listed below are optional, and may be purchased from Olympus, SonoSite, Inc. or your local SonoSite representative.

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 1.1

Extracorporeal transducers  SonoSite C60/5-2 MHz 60 – mm curved array

Figure 1.2

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COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

Chapter 1 Checking the Package Contents

 SonoSite ICT/7-4 MHz 11 – mm intracavitary

Figure 1.3

 SonoSite C15/4-2 MHz 15 – mm micro-curved array

Figure 1.4

 SonoSite L38/10-5 MHz 38 – mm linear array

Figure 1.5

COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

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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

14

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

Chapter 2 Nomenclature and Functions

 Displayed image This icon returns to the previous display. This icon displays the measurement types and calculations available in the selected exam type. This icon appears on the image and as a menu item.

This icon appears on the image and as a menu item. This icon appears as a menu item that starts an ellipse measurement. It also toggles between distance and ellipse measurements. This icon deletes a measurement and removes the measurement traces from the display, or all text added to an image. This icon represents the 2D mode of the curved array transducer (C60/5-2). This icon represents the CPD mode of the curved array transducer (C60/5-2). This icon represents the PowerMap DCPD mode of the curved array transducer (C60/5-2). This icon represents the 2D mode of the intracavitary transducer (ICT/7-4). This icon represents the CPD mode of the intracavitary transducer (ICT/7-4). This icon represents the 2D mode of the micro-curved array transducer (C15/4-2). This icon represents the CPD mode of the micro-curved array transducer (C15/4-2). This icon represents the PowerMap DCPD mode of the micro-curved array transducer (C15/4-2). This icon represents the 2D mode of the linear array transducer (L38/10-5).

COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000

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Chapter 2 Nomenclature and Functions

This icon represents the CPD mode of the linear array transducer (L38/10-5). This icon appears in menus to indicate a list of selections. This icon appears in menus to indicate that selecting the menu item displays another menu. This icon represents the resolution optimization setting in the 2D mode and the low optimization setting in the CPD or PowerMap DCPD mode. This icon represents the general optimization setting in the 2D mode and the medium optimization setting in the CPD or PowerMap DCPD mode. This icon represents the penetration optimization setting in the 2D mode and the high optimization setting in the CPD or PowerMap DCPD mode. This icon represents the narrow 2D mode optimization setting in the PowerMap DCPD mode. This icon indicates the selection of a setting.

This icon indicates that system maintenance is required.

This icon indicates that a field accepts text entry. This icon indicates that the system is performing a background task. This icon indicates that the ultrasonic image is magnified. This icon appears as a menu item. It is used to select a pictograph. This icon appears on the pictograph and it can be moved with the trackball. This icon appears on the ultrasonic image and it can be moved with the trackball. This icon indicates that the 1st page of the patient report is being displayed. This icon indicates that the 2nd page of the patient report is being displayed.

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COMPACT ENDOSCOPIC ULTRASOUND CENTER EU-C60, EU-C2000