CV-260SL EVIS LUCERA VIDEO SYSTEM Instructions April 2014

Contents

Contents Labels and Symbols ...

1

Important Information - Please Read Before Use...

2

Intended use ...

2

Applicability of endoscopy and endoscopic treatment ...

2

Instruction manual ...

2

User qualifications ...

5

Instrument compatibility ...

5

Repair and modification ...

5

Signal words ...

6

Dangers, warnings and cautions ...

6

Summary of Equipment Functions ...

10

Displaying the endoscopic images on the monitor ...

10

Special light observations ... Adjusting the endoscopic images ... Entering patient data... Customizing the operations ... Recording images... Operation of ancillary equipment ...

10 10 11 11 11 11

Chapter 1

Checking the Package Contents...

12

Chapter 2

Nomenclature and Functions ...

13

2.1

Symbols and descriptions ...

13

2.2

Front panel...

14

2.3

Rear panel ...

18

2.4

Keyboard...

21

2.5

Side panels ...

28

2.6

Videoscope cable LUCERA ...

29

2.7

Set-up of screen options ...

30

2.8

Monitor ...

31

SDTV monitor display (e.g.)... HDTV monitor display (e.g.) ... Setting display (e.g.) ...

31 36 38

EVIS LUCERA VIDEO SYSTEM CENTER CV-260SL

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Contents

Chapter 3

Inspection...

39

3.1

Inspection work flow...

40

3.2

Inspection of the power supply ...

41

3.3

Inspection of the examination light...

42

3.4

Inspection of the automatic brightness adjustment function ...

43

3.5

Inspection of the monitor display...

44

3.6

Inspection of the freeze function ...

45

3.7

Inspection of the release function ...

46

3.8

Inspection of the video printer remote function ...

46

3.9

Inspection of the endoscope’s remote switches and foot switches...

46

3.10 Inspection of the special light observation function...

46

3.11 Power OFF...

50

Chapter 4

Operation...

51

4.1

Operation flow ...

54

4.2

Connection of an endoscope ...

56

EVIS series videoscope and ultrasonic videoscope... OES series fiberscope... Summary of connection...

57 58 60

4.3

Turning the video system center ON...

61

4.4

White balance adjustment...

62

4.5

AFI color balance adjustment...

67

4.6

Recall of user preset data ...

73

4.7

Patient data ...

76

4.8

Observation of the endoscopic image...

79

4.9

Recording of the observation image ...

79

4.10 Termination of the operation ...

80

Chapter 5 5.1

ii

Function...

82

Front panel ...

82

Image source buttons... Zoom mode button ... Printer button... Color tone selector button and color tone level adjustment button ... MCA area button and MCA button ... White balance button... Iris mode button... Color enhancement mode button ... Normal light observation... NBI observation... IRI observation ... Image enhancement button... Reset button ...

82 83 84 85 86 88 88 89 90 94 95 96 100

EVIS LUCERA VIDEO SYSTEM CENTER CV-260SL

Contents

5.2

5.3

Keyboard...

102

Ending examination (“EXAM END”)... Displaying the “User Preset/Select Name” menu (“USER PRESET”)... Displaying the “System Setup” menu (“SYSTEM SETUP”)... Displaying the “Scope Information” menu (“SCOPE INFO”)... Displaying the “Patient Data/Select Name” menu (“PATIENT DATA”) ... Displaying the title screens (“TITLE SCREEN”) ... Displaying the color bar and the 50% white screen (“SHIFT” + “TITLE SCREEN”) ... Searching image file (“SEARCH”) ... Displaying index images (“SHIFT” + “SEARCH”) ... Resetting the SCV counter (“COUNTER RESET”)... Setting the number of images on the print sheet (“#PER PAGE”)... Setting the number of sheets to be printed (“PRINT QTY”)... Locking the keyboard (“KEY LOCK”)... Keyboard option function 1 (“OPTION 1”) ... Monochrome display (“B/W”) ... Contrast mode (“CONTRAST”)... Automatic gain control (AGC) (“SHIFT” + “CONTRAST”) ... Remote control of the ancillary equipment (“VTR”, “PRINTER” and “REMOTE”)... Keyboard option function 2 (“OPTION 2”) ... Selecting the method of letter input from the keyboard (“CAPS LOCK”, “INS”) ... Release (“RELEASE”) ... Freeze (“FREEZE”)... Displaying the IHb chart screen (“IHb CHART”) ... Displaying the zoom scale (“SCALE”) ... Displaying the endoscope’s instrument channel information (“SHIFT” + “SCALE”) ... Stop watch (“STOP WATCH”, “SHIFT” + “STOP WATCH”) ... Clearing characters from the screen (“REMOVE DATA”)... Clearing the image information from the screen (“SHIFT” + “REMOVE DATA”) ... Image size (“IMAGE SIZE”) ... Changing the observation mode (“WLI”, “AFI”, “NBI”, “IRI”) ... Cursor (“CURSOR”)... Arrow pointer (“SHIFT” + arrow keys)...

102 103 103 104 104 105 108 110 110 112 112 113 113 114 114 115 117 118 119 119 120 121 122 124 125 126 127 131 132 135 135 136

Image recording and playback...

138

Photography unit... Videocassette recorder (VCR)... Video printer ... Image filing system ...

138 139 142 149

EVIS LUCERA VIDEO SYSTEM CENTER CV-260SL

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Contents

5.4

5.5

5.6

150

Basic operation in the patient menu ... Entering new patient data... Editing previously entered patient data ... Deleting previously entered patient data ... Clearing all patient data previously entered ... Displaying patient data ...

150 152 153 154 156 156

Endoscope information ...

158

Endoscope’s memory chip ... Displaying endoscope information ... Displaying and entering endoscope information ...

158 158 163

Special light observation ...

165

Chapter 6

Fuse Replacement ... 170

Chapter 7

Care, Storage and Disposal ... 172

7.1

Care ...

172

7.2

Storage ...

173

7.3

Disposal ...

173

Chapter 8

Installation and Connection... 174

8.1

Installation work flow ...

175

8.2

Installation of the equipment ...

176

Installation on the mobile workstation (WM-NP1, WM-WP1, WM-260, WM-W260) ... Installation in another location...

177 178

Fitting of accessories ...

179

Videoscope cable holder (MAJ-879) ... White cap set (MAJ-941)...

179 180

8.4

Light source ...

181

Compatible light sources ...

181

8.5

Monitor ...

183

Compatible monitors ... OEV143 or OEV203 ... OEV191... OEV181H ... OEV191H ...

183 183 185 187 189

8.6

Keyboard...

191

8.7

Videocassette recorder (VCR) ...

192

8.8

Video printer...

193

8.9

Photography unit ...

195

8.10 Endoscope position detecting unit (UPD) ...

197

8.3

iv

Pre-entry of patient data ...

EVIS LUCERA VIDEO SYSTEM CENTER CV-260SL

Contents

8.11 Ultrasound center...

199

EU-M2000... EU-C2000 ... EU-M30...

199 201 203

8.12 Foot switch...

204

8.13 OLYMPUS flushing pump (OFP) ...

205

8.14 Connection to the AC mains power supply ...

207

Chapter 9

Function Setup ... 212

9.1

Turning power ON...

212

9.2

System setup ...

213

Basic operation of the system setup... Date and time ... Display of patient data ... Video printer ... Freeze mode... Rainbow color correction ... Release time... SDTV monitor ... HDTV monitor ... Foot switch function ... Monitor... Remote control ... Front panel LED... Bleep... Keyboard option... Switching time of AFI observation ... Scope nickname ... Summary of settings ...

213 216 218 219 222 223 224 226 227 230 233 234 238 239 239 241 242 243

User preset ...

246

Basic operation of the user preset ... Default data ... Entering new user preset data... Editing previously entered user preset data ... Deleting previously entered user preset data ... Loading the user preset data ... User name ... Endoscope’s remote switch function ... Enhancement type (normal light observation) ... Operation method of enhancement (normal light observation)... Structure enhancement (normal light observation)... Edge enhancement (normal light observation) ... Color enhancement (normal light observation)... Iris ... Setup for the IHb chart screen... Zoom mode... Image size ... Enhancement type (AFI observation) ... Structure enhancement (AFI observation)...

246 250 251 252 253 254 255 255 260 261 262 263 264 265 266 268 270 272 273

9.3

EVIS LUCERA VIDEO SYSTEM CENTER CV-260SL

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Contents

Edge enhancement (AFI observation)... Enhancement type (NBI observation) ... Structure enhancement (NBI observation) ... Edge enhancement (NBI observation) ... Enhancement type (IRI observation)... Structure enhancement (IRI observation) ... Edge enhancement (IRI observation)... Color enhancement (IRI observation) ... Resetting the user preset data to the factory defaults... Summary of settings...

274 275 276 277 278 279 280 281 282 283

Chapter 10 Troubleshooting ... 286 10.1 Troubleshooting guide ...

286

10.2 Returning the video system center for repair ...

296

Appendix... 297

vi

System chart ...

297

Transportation, storage, and operation environment ...

300

Specifications ...

301

EMC information...

306

EVIS LUCERA VIDEO SYSTEM CENTER CV-260SL

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

Serial number plate Caution that only the exclusive cable can be connected.

Crossed-out wheeled bin’ symbol

Fuse rating

㩷 㩷  㩷 㩷

Manufacturer name Electric rating The product name, rated voltage and frequency are shown.

㩷

㩷

Potential equalization terminal CE marking

EVIS LUCERA VIDEO SYSTEM CENTER MODEL OLYMPUS CV-260SL INPUT 220-240V 50/60Hz 150VA

 Back cover of this instruction manual Manufacturer

Authorized representative in the European Community

EVIS LUCERA VIDEO SYSTEM CENTER CV-260SL

1

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 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.

Applicability of endoscopy and endoscopic treatment If there is an official standard on the applicability of endoscopy and endoscopic treatment that is defined by the hospital’s administration or other official institutions such as academic societies on endoscopy, follow that standard. Before starting endoscopy and endoscopic treatment, thoroughly evaluate its properties, purposes, effects, and possible risk (their natures, extent and probability). Perform endoscopy and endoscopic treatment only when its potential benefits are greater than its risks. Fully explain to the patient the potential benefits and risks of the endoscopy and endoscopic treatment as well as any examination/treatment methods that can be performed in its place, and perform the endoscopy and endoscopic treatment only after obtaining the consent of the patient. Even after starting the endoscopy and endoscopic treatment, continue to evaluate the potential benefits and risks, and immediately stop the endoscopy/treatment and take proper measures if the risks to the patient become greater than the potential benefits.

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.

2

EVIS LUCERA VIDEO SYSTEM CENTER CV-260SL

Important Information - Please Read Before Use

 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. OES video converter: The OES video converter and OES video system convert a fiberscope image to a video signal which can be viewed on the monitor. 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 non-insulated 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. Automatic brightness adjustment: The automatic brightness adjustment 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 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.

EVIS LUCERA VIDEO SYSTEM CENTER CV-260SL

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Important Information - Please Read Before Use

Structure enhancement: Structure enhancement is an image processing technique that electronically emphasizes the detailed patterns and edges of an image to increase sharpness. IHb (index of hemoglobin): IHb is the value calculated with the formula IHb = 32 × log2(R/G) (where R is the brightness of Red in an image and G is the brightness of Green in an image). The IHb value increases as the image becomes reddish. Adaptive IHb color enhancement: Adaptive IHb color enhancement is an image processing technique that emphasizes the differences of colors in images to clarify the color tones. IHb distribution: IHb distribution represents the average IHb value of an image by displaying the IHb values of image pixels using simulated colors. Wash out: Wash out is the inability to see details in the endoscopic image due to excessive brightness. Correction: Correction is an image processing technique that corrects deviation of color positions in an image by estimating the original colors in those positions. HDTV: High Definition Television. This is a format for high resolution video transmission featuring higher definition than the standard SDTV format. SDTV: Standard Definition Television. It is the format used in standard video systems. Special light observation: This is an observation using filtered light. AFI (Auto-Fluorescence Imaging) observation: This is a special light observations using the blue light. NBI (Narrow Band Imaging) observation: This is a special light observations using the narrow band observation light. IRI (Infra-Red Imaging) observation: This is a special light observations using the infra-red light.

4

EVIS LUCERA VIDEO SYSTEM CENTER CV-260SL

Important Information - Please Read Before Use

Normal light observation (WLI = White Light Imaging): This is the ordinary observation using the RGB light. MCA (Mucosal Color Adjustment): The mucosal color adjustment adjusts the difference in color tone between living mucosa of various patients in the AFI observation.

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 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 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. EVIS LUCERA VIDEO SYSTEM CENTER CV-260SL

5

Important Information - Please Read Before Use

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.

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

•

As a TYPE BF applied part, the endoscope connected to this video system center must never be applied directly to the heart. Leakage current from the 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 the endoscope connected to this video system center to the heart or any area near the heart.  Never allow an endo-therapy accessory or another endoscope applied to or near the heart to come in contact with the endoscope connected to this video system center.

•

6

Strictly observe the following precautions. Failure to do so may place the patient and medical personnel in danger of electric shock.

EVIS LUCERA VIDEO SYSTEM CENTER CV-260SL

Important Information - Please Read Before Use

 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.

•

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.

•

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.

•

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.

EVIS LUCERA VIDEO SYSTEM CENTER CV-260SL

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Important Information - Please Read Before Use

•

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.  It has not been demonstrated to aid in differentiating establishing the presence or absence of dysplasia or neoplastic changes within mucosa or mucosal lesions.

8

•

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.

•

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.

EVIS LUCERA VIDEO SYSTEM CENTER CV-260SL

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 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

EVIS LUCERA VIDEO SYSTEM CENTER CV-260SL

9

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.

•

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

Special light observations AFI observation, NBI observation or IRI observation is available. 

Section 5.6, “Special light observation” on page 165

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

Adjustment of the image color 

•

Changing the iris mode 

•

“Image enhancement button” on page 96

Changing the image size 

10

“Contrast mode (“CONTRAST”)” on page 115

Enhancement of edge lines and patterns of the images 

•

“Iris mode button” on page 88

Changing the contrast mode 

•

“Color tone selector button and color tone level adjustment button” on page 85

“Image size (“IMAGE SIZE”)” on page 132

EVIS LUCERA VIDEO SYSTEM CENTER CV-260SL

Summary of Equipment Functions

•

Enlargement of the images 

“Zoom mode button” on page 83

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 4.7, “Patient data” on page 76

Up to 40 sets of patients data can be stored. 

Section 5.4, “Pre-entry of patient data” on page 150

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 246

Recording images •

The endoscopic image can be recorded on the image-recording device connected to this instrument, and the recorded images can be played back. 

•

Section 5.3, “Image recording and playback” on page 138

The endoscopic image can be printed from the printer connected to this instrument. 

“Video printer” on page 142

Operation of ancillary equipment •

Photography unit 

•

Videocassette recorder 

•

“Photography unit” on page 138

“Videocassette recorder (VCR)” on page 139

Video printer 

“Video printer” on page 142

EVIS LUCERA VIDEO SYSTEM CENTER CV-260SL

11

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 instrument is damaged, a component is missing or you have any questions, do not use the instrument; immediately contact Olympus.

EVIS LUCERA video system center (CV-260SL)

Keyboard (MAJ-1536)

Videoscope cable LUCERA (MAJ-1154)

HDTV/SDTV monitor cable (MAJ-1586)

Spare fuse (MAJ-1432, 2 pcs.)

12

Power cord

White cap (MH-155)

Foot holder (MAJ-1159, 4 pcs.)

Water container (MAJ-901)

White cap holder (MAJ-960)

HDTV monitor cable (MAJ-1587)

Videoscope cable holder (MAJ-879)

Instruction manual

EVIS LUCERA VIDEO SYSTEM CENTER CV-260SL

Chapter 2 Nomenclature and Functions

Chapter 2 Nomenclature and Functions 2.1

Symbols and descriptions  Front panel Power ON/OFF

 Rear panel Serial number

Potential equalization terminal

Fuse

Alternating current

Caution, refer to instructions.

EVIS LUCERA VIDEO SYSTEM CENTER CV-260SL

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