CV-180 EVIS EXERA II VIDEO SYSTEM CENTER Instructions Sept 2010

Contents

Contents Labels and Symbols ...

1

Important Information - Please Read Before Use...

3

Intended use ...

3

Instruction manual ...

3

User qualifications ...

5

Instrument compatibility ...

5

Repair and modification ...

6

Signal words ...

6

Dangers, warnings and cautions...

7

Cardiac applications...

11

Summary of Equipment Functions ...

12

Chapter 1

Checking the Package Contents...

14

Chapter 2

Nomenclature and Functions ...

15

2.1

Front panel...

15

2.2

Rear panel ...

19

2.3

Keyboard...

22

2.4

Side panels ...

27

2.5

Videoscope cable EXERA II (MAJ-1430)...

27

2.6

Set-up of screen options ...

28

2.7

Monitor ...

29

2.8

Pointer...

33

Inspection ...

34

3.1

Inspection of the power supply ...

35

3.2

Inspection of the examination light...

36

3.3

Inspection of the automatic brightness control function ...

37

3.4

Inspection of the monitor display ...

38

3.5

Inspection of the freeze function ...

39

3.6

Inspection of the release function ...

39

3.7

Inspection of the PinP (picture in picture) function...

39

3.8

Inspection of the orientation function ...

39

3.9

Inspection of the special light observation function...

40

3.10 Inspection of the scope switches and foot switches ...

40

Chapter 3

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Contents

3.11 Power OFF...

Chapter 4

Operation...

41

4.1

Operation flow ...

44

4.2

Connection of an endoscope ...

46

4.3

Turning the video system center ON...

50

4.4

Recall of user preset data ...

51

4.5

White balance adjustment...

52

4.6

Patient data ...

57

4.7

Observation of the endoscopic image...

59

4.8

Recording of the observation image ...

59

4.9

Termination of the operation ...

60

Functions...

62

Front panel ...

62

Image source buttons... PinP (picture in picture) display... Image enhancement mode (ENH.)... Iris mode... White balance... Brightness adjustment (Exposure) ... STOP button and PC card indicator ... PC card slot and eject button ... RESET button ...

62 64 67 69 70 71 75 76 80

Keyboard...

81

Domepoint ... Clearing characters from the screen (“F1”) ... System setup (“Shift” + “F1”) ... Scope information (“F2”) ... User preset (“Shift” + “F2”) ... Cursor (“F3”)... Patient data (“Shift” + F3) ... Freeze mode (“F4”) ... Browse (“Shift” + “F4”)... Stopwatch (“F5”)... Automatic gain control (AGC) (“F6”)... Contrast mode (“Shift” + “F6”) ... Image zooming (“F7”)... Color bar (“Shift” + “F7”) ... Image size (“F8”) ... Printer lock (“Shift” + “F8”)... Image enhancement (“F9”)... White balance adjustment (“Shift” + “F9”) ... Color tone adjustment (“COLOR”)... Freeze (“FREEZE”) ... Release (“RELEASE”)... Arrow pointer (“Shift” + arrow keys and domepoint)...

81 82 84 84 85 85 86 86 87 88 89 90 91 93 94 95 96 97 98 99 101 102

Chapter 5 5.1

5.2

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EVIS EXERA II VIDEO SYSTEM CENTER CV-180

Contents

5.3

5.4

5.5 5.6

5.7 5.8

Color mode (“Shift” + “Alt” + “1”, “2”, “3”, “4”)... Ending examination (“EXAM END”)...

104 105

Image recording and playback (PC card) ...

106

Storage level of the PC card... Recording the frozen image on a PC card... PC card menu... Basic operation of the PC card menu ... Formatting of the PC card... Playback images from the PC card ... Deleting images from a PC card... Deleting folder from PC card ... Annotation of images ... Playback image annotation... Playback the images using the personal computer ... Image files and folders...

106 108 110 111 114 115 117 118 119 122 124 125

Image recording and playback (other than PC card) ...

127

Image filing system ... Videocassette recorder (VCR)...

127 129

Printing images ...

131

Video printer ...

131

Pre-entry of patient data ...

136

Basic operation in the patient menu ... Entering new patient data ... Displaying patient data ... Editing previously entered patient data... Deleting previously entered patient data ... Clearing all patient data previously entered... Recording patient data into PC card... Loading patient data from PC card ...

136 137 140 141 142 143 144 146

Scope information ...

148

Displaying and entering scope information...

149

Special light observation ...

151

NBI (narrow band imaging)...

151

Chapter 6

Fuse replacement ... 153

Chapter 7

Care, Storage and Disposal... 155

7.1

Care ...

155

7.2

Storage ...

156

7.3

Disposal ...

156

EVIS EXERA II VIDEO SYSTEM CENTER CV-180

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Contents

Chapter 8 8.1

Installation work flow ...

158

8.2

Installation of the equipment ...

159

8.3

Fitting of accessories ...

162

8.4

Light source ...

164

8.5

Monitor ...

170

8.6

Keyboard...

178

8.7

Videocassette recorder (VCR) ...

179

8.8

Video printer...

181

8.9

OLYMPUS flushing pump (OFP) ...

183

8.10 Foot switch ...

184

8.11 Ultrasound center...

185

8.12 Connection to the AC mains power supply ...

189

Chapter 9

Function setup ... 193

9.1

Turning power ON...

193

9.2

System setup ...

194

Basic operation of the system setup ... System ... Printer... Image filing system... Monitor ... Videocassette recorder ... Saving the system setup ... Summary of settings...

194 197 201 206 208 211 213 214

User preset ...

216

Basic operation of the user preset... Remote switch and foot switch (EXERA and VISERA) ... Release function... Recording format for PC card... Freeze function... Image enhancement (normal observation)... Color mode... Image size ... Iris... Iris speed... Auto gain control (AGC) ... Contrast... Exposure area ... Electronic shutter... Patient data display ... Scope nickname... Release index time... Indication of the special light observation... Monitor orientation function ...

216 219 223 224 225 226 228 229 232 235 237 238 239 240 241 242 243 244 245

9.3

iv

Installation and Connection... 157

EVIS EXERA II VIDEO SYSTEM CENTER CV-180

Contents

PinP (picture in picture) function... Special light observation... Image enhancement (NBI observation) ... Saving the user preset... Resetting the user preset data to the factory defaults ... Deleting user preset data... Summary of settings ...

246 250 250 251 252 253 255

Chapter 10 Troubleshooting ... 259 10.1 Troubleshooting guide ...

259

10.2 Returning the video system center for repair ...

268

Appendix ... 269 System chart ...

269

Transportation, storage, and operation environment ...

276

Specifications ...

276

EMC information ...

282

EVIS EXERA II VIDEO SYSTEM CENTER CV-180

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EVIS EXERA II VIDEO SYSTEM CENTER CV-180

Labels and Symbols

Labels and Symbols Safety-related labels and symbols are attached on the locations shown below. If labels or symbols are missing or illegible, contact OLYMPUS.

 Rear panel CSA/UL marking

Fuse rating Caution that only the exclusive cable can be connected.

FUSES T5AL250V

Potential equalization terminal Manufacturer name Electric rating The product name, rated voltage and frequency are shown. EVIS EXERA II VIDEO SYSTEM CENTER MODEL OLYMPUS CV-180 INPUT 100-240V 50/60Hz 150VA

Serial number plate

EVIS EXERA II VIDEO SYSTEM CENTER CV-180

1

Labels and Symbols

 Back cover of this instruction manual Manufacturer

Authorized representative in the European Community

2

EVIS EXERA II VIDEO SYSTEM CENTER CV-180

Important Information - Please Read Before Use

Important Information - Please Read Before Use Intended use This video system center has been designed to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation. Do not use this video system center for any purpose other than its intended use.

Instruction manual This instruction manual contains essential information on using this video system 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 Light source: The light source provides light and electrical signals to the endoscope. It also provides electrical signals to the video system center. Video printer: The video printer is a device that prints the frozen video image. Wall mains outlet: The wall mains outlet is a wall AC mains power outlet socket having the exclusive terminal for grounding. Isolation transformer: The isolation transformer is a safety device that is used to isolate noninsulated equipment with potentially high leakage currents to decrease the possibility of electric shock. Image sensor (CCD): Image sensor (CCD) is a device that converts light into electrical signals. EVIS EXERA II VIDEO SYSTEM CENTER CV-180

3

Important Information - Please Read Before Use

Automatic brightness control: The automatic brightness control automatically adjusts the intensity of the light emitted from the light source so that the endoscopic image will be maintained at constant brightness even if the distance between the distal end of the endoscope's insertion tube and the subject changes. Color adjustment: Color adjustment adjusts the color balance on the video monitor. Iris: The iris function is used to electrically measure the brightness of an endoscopic image to obtain a control signal for the purpose of automatic light adjustment. Freeze: The freeze function creates a stationary view of the moving image. Release: The release function is used to capture and record an endoscopic image. Edge enhancement: Edge enhancement is an image processing technique that electronically sharpens the edges of an image. Structure enhancement: Structure enhancement is an image processing technique that electronically emphasizes the detailed patterns and edges of an image to increase sharpness. PinP (Picture in picture): PinP function displays both the image of the endoscopic live image and the image of an external device on the monitor simultaneously. PC card: A digital medium for storage of images, etc. Wash out: Wash out is the inability to see details in the endoscopic image due to excessive brightness. HDTV: High Definition Television. This is a format for high resolution video transmission featuring higher definition than the standard SDTV format.

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EVIS EXERA II VIDEO SYSTEM CENTER CV-180

Important Information - Please Read Before Use

SDTV: Standard Definition Television. It is the format used in standard video systems. Special light observation: This is a observation using filtered light. NBI (narrow band imaging): This is one of the special light observations using the narrow band observation light.

User qualifications If there is an official standard on user qualifications to perform endoscopy and endoscopic treatment that is defined by the medical administration or other official institutions, such as academic societies on endoscopy, follow that standard. If there is no official qualification standard, the operator of this instrument must be a physician approved by the medical safety manager of the hospital or person in charge of the department (department of internal medicine, etc.). The physician should be capable of safely performing the planned endoscopy and endoscopic treatment following guidelines set by the academic societies on endoscopy, etc., and considering the difficulty of endoscopy and endoscopic treatment. This manual does not explain or discuss endoscopic procedures.

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

EVIS EXERA II VIDEO SYSTEM CENTER CV-180

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Important Information - Please Read Before Use

Repair and modification This video system center does not contain any user-serviceable parts. Do not disassemble, modify or attempt to repair it; patient or operator injury, equipment damage and/or the impossibility to obtain the expected functionality can result. Some problems that appear to be malfunctions may be correctable by referring to Chapter 10, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 10, contact Olympus. This instrument is to be repaired by Olympus technicians only.

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.

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EVIS EXERA II VIDEO SYSTEM CENTER CV-180

Important Information - Please Read Before Use

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

•

Strictly observe the following precautions. Failure to do so may place the patient and medical personnel in danger of electric shock.  When this video system center is used to examine a patient, do not allow metal parts of the endoscope or its accessories to touch metal parts of other system components. Such contact may cause unintended current flow to the patient.  Keep fluids away from all electrical equipment. If fluids are spilled on or into the unit, stop operation of the video system center immediately and contact Olympus.  Do not prepare, inspect or use this video system center with wet hands.

•

Never install and operate the video system center in locations where:  the concentration of oxygen is high;  oxidizing agents (such as nitrous oxide (N2O)) are present in the atmosphere;  flammable gases are present in the atmosphere;  flammable liquids are near. Otherwise, explosion or fire may result because this video system center is not explosion-proof.

EVIS EXERA II VIDEO SYSTEM CENTER CV-180

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Important Information - Please Read Before Use

•

In case of instrument failure or malfunction, always keep another video system center in the room ready for use.

•

Never insert anything into the ventilation grills of the video system center. It can cause an electric shock and/or fire.

•

Although the illumination light emitted from the endoscope's distal end is required for endoscopic observation and treatment, it may also cause alteration of living tissues such as protein denaturation of liver tissue and perforation of the intestines by inappropriate use. Observe the following warnings on the illumination.  Always set the minimum required brightness. The brightness of the image on a video monitor may differ from the actual brightness at the distal end of an endoscope. Especially in combination with endoscopes using an electrical shutter function, pay attention to the brightness level setting of the light source. When this instrument is used with a light source compatible with automatic brightness control function, be sure to use this function. The automatic brightness control function can keep the illumination light properly. Refer to the instruction manual of the light source for details.  Do not continue observation in the proximity to tissue or keep the distal end of the endoscope in contact with living tissue for a long time. It may cause patient burns.  When discontinuing the use of the endoscope, be sure to turn the light source OFF so that the endoscope does not irradiate unnecessary light.

8

•

This product may interfere with other medical electronic equipment used in combination with it. Before use, refer to the Appendix to confirm the compatibility of this instrument with all equipment to be used.

•

Do not use this product in any place where it may be subject to strong electromagnetic radiation (for example, in the vicinity of a microwave therapeutic device, MRI, wireless set, short-wave therapeutic device, cellular/portable phone, etc.). This may impair the performance of the product.

EVIS EXERA II VIDEO SYSTEM CENTER CV-180

Important Information - Please Read Before Use

•

If the endoscopic image dims during use, blood, mucus or debris may adhere to the light guide on the distal end of the endoscope. Carefully withdraw the endoscope from the patient and remove the blood or mucus in order to obtain optimum illumination and to ensure the safety of the examination. If you continue to use the endoscope in such a condition, the distal end temperature may rise and cause mucosal burns. It may also cause patient and/or operator injury.

•

Do not rely on the special light observation method alone for primary detection of lesions or for a decision regarding any potential diagnostic or therapeutic intervention.

•

For reasons described below, do not rely on the NBI imaging modality alone for primary detection of lesions or to make a decision regarding any potential diagnostic or therapeutic intervention.  It has not been demonstrated to increase the yield or sensitivity of finding any specific mucosal lesion including colonic polyps or Barrett’s esophagus.

•

To display observation images, connect the output terminal of the video system center directly to the monitor. Do not make the connection via any ancillary equipment. Images may disappear during observation depending on the condition of ancillary equipment.

•

Do not use a pointed or hard object to press the buttons on the front panel and/or keyboard. This may damage the buttons.

•

Do not touch the electrical contacts inside the video system center's connectors.

•

Do not apply excessive force to this video system center and/or other instruments connected. Otherwise, damage and/or malfunction can occur.

•

Do not connect or disconnect the endoscope connector while this video system center is turned ON. Connecting or disconnecting the endoscope while this video system center is ON may destroy the CCD. Turn the video system center OFF before connecting or disconnecting the endoscope.

•

Clean and vacuum dust the ventilation grills using a vacuum cleaner, when necessary. Otherwise, the video system center may break down and gets damaged from overheating.

EVIS EXERA II VIDEO SYSTEM CENTER CV-180

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Important Information - Please Read Before Use

•

Be sure that this instrument is not used adjacent to or stacked with other equipment (other than the components of this instrument or system) to avoid electromagnetic interference.

•

Electromagnetic interference may occur to this instrument when it is placed near equipment marked with the following symbol or other portable and mobile RF communications equipment such as cellular phones. If radio interference occurs, mitigation measures may be necessary, such as reorienting or relocating this instrument or shielding the location.

As defined by the international safety standard (IEC 606011), 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 B/BF applied part (the instrument can safely be applied to any organ except the heart). The part of the body that 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

TYPE B applied part

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EVIS EXERA II VIDEO SYSTEM CENTER CV-180

Important Information - Please Read Before Use

Cardiac applications •

Use only the devices listed in the “System chart” in the Appendix for endoscopic observation or treatment of the heart or areas near the heart. Other combinations of equipment may cause ventricular fibrillation or seriously affect the cardiac function of the patient.

•

For cardiac applications, never support the endoscope with a metal surgical arm which is not electrically isolated from the ground. If not isolated, the endoscope will be connected to the ground through the surgical arm and bed, and will conduct unexpected leakage current which may seriously affect the cardiac function of the patient.

•

The use of medical devices not specifically designed for cardiac applications may cause ventricular fibrillation or seriously affect the cardiac function of the patient. As specified by the international standard IEC 60601-1, any applied part used for observation or treatment of the heart or areas near the heart must meet “TYPE CF applied part” requirements for low electrical leakage current. When using endoscopes for endoscopic cardiac applications, the applied part requirements include all devices directly connected to the endoscope, such as the light guide cable, camera head and telescope holder. Each of these devices must individually meet the “TYPE CF applied part” requirements for leakage current limits if they are to be used for cardiac applications.

The OLYMPUS light guide cables and camera heads listed in the “System chart” in the Appendix (TYPE CF applied part) which are suitable for cardiac applications bear a

EVIS EXERA II VIDEO SYSTEM CENTER CV-180

mark.

11

Summary of Equipment Functions

Summary of Equipment Functions This instrument is a system controller of the endoscopic image observation system that displays, records and prints the endoscopic images. Some of the functions of this instrument described below are enabled only when the required equipment are connected to this instrument. For more details, refer to the instruction manuals for this instrument and the other instruments connected.

Displaying the endoscopic images on the monitor •

The endoscopic live image and the other images of, for example, the ultrasonic endoscope connected to this instrument can be displayed on the monitor.

•

The endoscopic image and other external images can be displayed on the same monitor at the same time (PinP function).  “PinP (picture in picture) display” on page 64

•

Either a standard-definition (SDTV) monitor or high-definition (HDTV) monitor can be used.

Special light observation Endoscopic observation using filtered light is available.  Section 5.8, “Special light observation” on page 151

Adjusting the endoscopic images Images can be adjusted to enable clear and convenient observation.

12

•

Adjustment of the image color “Color tone adjustment (“COLOR”)” on page 98

•

Adjustment of the image brightness  “Brightness adjustment (Exposure)” on page 71

•

Changing the iris mode  “Iris mode” on page 69

•

Changing the contrast mode  “Contrast mode (“Shift” + “F6”)” on page 90

•

Enhancement of edge lines and patterns of the images “Image enhancement mode (ENH.)” on page 67

•

Changing the image size  “Image size (“F8”)” on page 94

EVIS EXERA II VIDEO SYSTEM CENTER CV-180

Summary of Equipment Functions

•

Enlargement of the images  “Image zooming (“F7”)” on page 91

Entering patient data •

The patient data such as name, sex, etc. can be entered and displayed on the monitor with the endoscopic live image.  Section 4.6, “Patient data” on page 57 and Section 5.6, “Pre-entry of patient data” on page 136.)

•

Up to 40 sets of patients data can be stored on the PC card. These patient data can be copied to the other CV-180.  “Recording patient data into PC card” on page 144

Customizing the operations Up to 20 remote switch settings and other functions such as iris mode, image enhancement, etc., can be stored.  Section 9.3, “User preset” on page 216

Recording images •

The endoscopic image can be recorded on the PC card.  Section 5.3, “Image recording and playback (PC card)” on page 106

•

The endoscopic image can be recorded on the image-recording device connected to this instrument, and the recorded images can be played back.  Section 5.4, “Image recording and playback (other than PC card)” on page 127

•

The endoscopic image can be printed from the printer connected to this instrument.  Section 5.5, “Printing images” on page 131

Operation of ancillary equipment •

Video casette recorder  “Videocassette recorder (VCR)” on page 129

•

Video printer Section 5.5, “Printing images” on page 131

•

Image filing system “Image filing system” on page 127

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