OTV-S7Pro VISERA Pro VIDEO SYSTEM CENTER Instructions March 2020

Contents

Contents Labels and Symbols ...

1

Important Information - Please Read Before Use...

3

Intended use ...

3

Applicability of endoscopy and endoscopic treatment ...

3

Instruction manual ...

3

User qualifications ...

5

Instrument compatibility ...

6

Repair and modification ...

6

Signal words ...

6

Dangers, warnings and cautions...

7

Security ...

11

Cardiac applications...

12

Summary of Equipment Functions ...

14

Chapter 1

Checking the Package Contents...

16

Chapter 2

Nomenclature and Functions ...

17

2.1

Symbols and descriptions ...

17

2.2

Front panel...

18

2.3

Rear panel ...

22

2.4

Keyboard...

25

2.5

Side panels ...

29

2.6

Setup of screen options ...

30

2.7

Monitor ...

31

2.8

Pointer...

34

Inspection ...

35

3.1

Inspection of the power supply ...

36

3.2

Inspection of the examination light...

37

3.3

Video monitor display inspection ...

37

3.4

Inspection of the automatic brightness control function ...

38

3.5

Inspection of the monitor display ...

39

3.6

Inspection of the freeze function ...

40

3.7

Inspection of the release function ...

40

3.8

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

40

3.9

Inspection of the orientation function ...

40

3.10 Inspection of the special light observation function...

41

Chapter 3

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

41

3.12 Power OFF...

41

Chapter 4

Operation...

42

4.1

Operation flow ...

45

4.2

Connection of an endoscope ...

47

4.3

Turning the video system center ON...

51

4.4

Recall of user preset data ...

52

4.5

White balance adjustment...

53

4.6

Patient data ...

58

4.7

Observation of the endoscopic image...

60

4.8

Recording of the endoscopic image...

60

4.9

Termination of the operation ...

61

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 77 78 82

Keyboard...

83

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”)... Auto 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”)...

83 84 86 86 87 87 88 88 89 90 91 92 93 95 96 97 98 99 100 101 103

Chapter 5 5.1

5.2

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Contents

Arrow pointer (“Shift” + arrow keys and domepoint) ... Color mode (“Shift” + “Alt” + “1”, “2”, “3”, “4”, “5”) ... Ending examination (“EXAM END”)...

104 106 107

Image recording and playback (PC card) ...

108

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...

108 110 112 113 116 117 119 120 121 124 126 127

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

129

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

129 131

Printing images ...

133

Video printer ...

133

Pre-entry of patient data ...

138

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 ...

138 139 142 143 144 145 146 148

5.7

Scope information ...

150

Displaying and entering scope information...

151

5.8

Special light observation ...

153

NBI (Narrow Band Imaging)... PDD (Photo Dynamic Diagnosis)...

153 155

5.3

5.4

5.5 5.6

Chapter 6

Fuse Replacement... 157

Chapter 7

Care, Storage and Disposal... 159

7.1

Care ...

159

7.2

Storage ...

160

7.3

Disposal ...

160

Chapter 8

Installation and Connection ... 161

8.1

Installation work flow...

162

8.2

Installation of the equipment ...

163

8.3

Light source ...

166

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Contents

8.4

Monitor ...

171

8.5

Keyboard...

179

8.6

Videocassette recorder (VCR) ...

180

8.7

Video printer...

182

8.8

Foot switch ...

184

8.9

S6 camera head connecting unit for S7V...

185

8.10 Connection to the AC mains power supply ...

187

Chapter 9

Function Setup... 191

9.1

Turning power ON...

191

9.2

System setup ...

192

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

192 195 200 204 206 209 211 212

User preset ...

214

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

214 217 221 222 223 224 226 227 230 232 233 234 235 236 237 239 240 242 245 247 248 249 250 252

9.3

Chapter 10 Troubleshooting ... 254

iv

10.1 Troubleshooting guide ...

254

10.2 Returning the video system center for repair ...

264

VISERA Pro VIDEO SYSTEM CENTER OTV-S7Pro

Contents

Appendix ... 265 System chart ...

265

Transportation, storage, and operation environment ...

269

Specifications ...

269

EMC information ...

275

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VISERA Pro VIDEO SYSTEM CENTER OTV-S7Pro

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.

 Front panel

UDI label The UDI label is required by some countries’ regulations regarding the identification of a medical device also known as Unique Device Identification (UDI).

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Labels and Symbols

 Rear panel Crossed-out wheeled bin’ symbol CE marking

Fuse rating Caution, refer to instructions.

FUSES T5AL250V

Potential equalization terminal Manufacturer name Electric rating The product name, rated voltage and frequency are shown. VISERA Pro VIDEO SYSTEM CENTER MODEL OLYMPUS OTV-S7Pro INPUT 220-240V 50/60Hz 150VA

Serial number plate

 Back cover of this instruction manual

Manufacturer

Authorized representative in the European Community

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VISERA Pro VIDEO SYSTEM CENTER OTV-S7Pro

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.

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. VISERA Pro VIDEO SYSTEM CENTER OTV-S7Pro

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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. 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 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. Electronic shutter: Electronic shutter is the device that changes the exposure time of the image sensor so that the brightness of an image is maintained on the video monitor. 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.

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VISERA Pro VIDEO SYSTEM CENTER OTV-S7Pro

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. 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. SDTV: Standard Definition Television. It is the format used in standard video systems. HDTV: High Definition Television. This is a format for high resolution video transmission featuring higher definition than the standard SDTV format. Special light observation: This is an observation using filtered light. NBI (Narrow Band Imaging): This is one of the special light observations using the narrow band observation light. PDD (Photo Dynamic Diagnoses) observation This is one of the special light observations using the exciting 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. 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.

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Important Information - Please Read Before Use

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.

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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VISERA Pro VIDEO SYSTEM CENTER OTV-S7Pro

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.

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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 electronic 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.

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.

VISERA Pro VIDEO SYSTEM CENTER OTV-S7Pro

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 aid in differentiating establishing the presence or absence of dysplasia or neoplastic changes within mucosa or mucosal lesions.

•

To display endoscopic 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 the 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.

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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 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

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VISERA Pro VIDEO SYSTEM CENTER OTV-S7Pro

Important Information - Please Read Before Use

Security Considering the possibility of data theft, corruption, and falsification, check that the xD picture card is not infected with a computer virus and then make connections. Use the device constituting “OTV-S7Pro” in an appropriate connection configuration as well as an operating environment. Use of “OTV-S7Pro” in an inappropriate connection configuration as well as in an inappropriate use environment may lead to malfunction and/or data loss. Install the device following the installation instruction and installation environment recommended by the manufacturer of the device. Otherwise, it may cause damage or malfunction of the device. As for the storage management for the product, follow the facility’s security policy, considering the possibility of leakage of personal information by unauthorized access and data falsification by third parties.

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Important Information - Please Read Before Use

Cardiac applications

12

•

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 mark.

•

The Olympus surgical holder for telescope (SH-1) has an electrically isolated arm structure which isolates the endoscope from the ground. This design makes the SH-1 suitable for cardiac applications.

VISERA Pro VIDEO SYSTEM CENTER OTV-S7Pro

Important Information - Please Read Before Use

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