UCES-4 Systems Integration ENDOALPHA Instructions Sw ver 1.5

Contents

Contents Labels and Symbols ... 1 MEDICAL CONTROL UNIT FOR ENDOSURGERY (UCES-4) ... 1 EXTENSION UNIT FOR UCES-4 (MAJ-2191) ... 4 Back cover of this instruction manual ... 5

Important Information - Please Read Before Use ... 6 Intended use / Intended purpose ... 6 Patient target groups ... 6 Contraindications ... 6 Clinical benefit ... 6 Applicability for endoscopy and endoscopic surgery ... 6 Instruction manual ... 7 User qualifications ... 8 Instrument compatibility ... 8 Repair and modification ... 8 Signal words ... 9 Dangers, warnings, and cautions ... 9 Caution on interference with other devices ... 11 About Security ... 13

Functions of the System ... 14

Chapter 1 Checking the Package Contents ... 17 1.1

Checking the package contents list ... 17 MEDICAL CONTROL UNIT FOR ENDOSURGERY (UCES-4) ... 17 EXTENSION UNIT FOR UCES-4 (MAJ-2191) ... 18 INTERFACE FOR ESU (VIO SERIES) (MAJ-2249) ... 19 INTERFACE FOR ESU (FORCE SERIES) (MAJ-2250) ... 19 UNIVERSAL INTERFACE (MAJ-2251) ... 20 INTERFACE FOR OLYMPUS LINK DEVICE (MAJ-2268) ... 20 IR INTERFACE FOR UCES-4 (MAJ-2252) ... 21 ENDOALPHA STOP SWITCH FOR OR TABLE (MAJ-1882) ... 21 OLYMPUS optional equipment ... 22

Chapter 2 Nomenclature and Functions ... 23 2.1

Symbols and descriptions ... 23

2.2

MEDICAL CONTROL UNIT FOR ENDOSURGERY (UCES-4) ... 34

2.3

Optional components ... 38 EXTENSION UNIT FOR UCES-4 (MAJ-2191) ... 38 INTERFACE FOR ESU (VIO SERIES) (MAJ-2249) ... 40 INTERFACE FOR ESU (FORCE SERIES) (MAJ-2250) ... 41 UNIVERSAL INTERFACE (MAJ-2251) ... 42 INTERFACE FOR OLYMPUS LINK DEVICE (MAJ-2268) ... 43 IR INTERFACE FOR UCES-4 (MAJ-2252) ... 44 ENDOALPHA STOP SWITCH FOR OR TABLE (MAJ-1882) ... 45

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Contents

Chapter 3 Installation and Connection ... 47 3.1

Installation and connection ... 47

3.2

Installation of the MEDICAL CONTROL UNIT FOR ENDOSURGERY (UCES-4) and EXTENSION UNIT FOR UCES-4 (MAJ-2191) and connection to ancillary equipment ... 48

3.3

Connection of ancillary equipment ... 49 Connection configuration including CV-190 ... 58 Connection configuration including OTV-S190 ... 60 Connection configuration including CV-1500 ... 62 Connection configuration including OTV-S200 or OTV-S300 ... 64 Connection configuration including OTV-S200 or OTV-S300 and CLV-S200-IR ... 66 Connection configuration including OTV-S400 ... 68 Connection configuration including OTV-S700 ... 70 Connection configuration including 3DV-190 ... 72 Connection of OLYMPUS LINK DEVICE using INTERFACE FOR OLYMPUS LINK DEVICE (MAJ-2268) ... 74

3.4

Connection of touch panel ... 81

3.5

Connection of the EXTENSION UNIT FOR UCES-4 (MAJ-2191) ... 82

3.6

Connection of a wireless microphone unit ... 84

3.7

Connection of the ENDOALPHA STOP SWITCH FOR OR TABLE (MAJ-1882) .. 85

3.8

Connection of a USB flash drive ... 86

3.9

Connection to a wall mains outlet ... 88

Chapter 4 Inspection ... 89 4.1

Inspection ... 89

4.2

Inspection workflow ... 90

4.3

Inspection of power ON ... 91

4.4

Inspection of touch panel ... 92 Example of inspection when the Video System Center (CV-190) is connected ... 92

4.5

Inspection of the connections of ancillary equipment ... 93

4.6

Inspection of the microphone ... 94

4.7

Inspection of voice reply ... 95 Example of inspection when the Video System Center (CV-190) is connected ... 95

4.8

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Inspection of the ENDOALPHA STOP SWITCH FOR OR TABLE (MAJ-1882) ... 97

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Contents

Chapter 5 Operation ... 99 5.1

Precautions ... 99

5.2

Power supply ... 101

5.3

Operation of the touch panel ... 102

5.4

Hierarchy of control windows ... 103 Logon type 1 ... 104 Logon type 2 ... 106 Automatic logon ... 108

5.5

Operations of the logon flow ... 109 Logon ID selection window ... 109 Procedure selection window ... 111

5.6

Operating in the operation mode ... 112 Home window ... 114 Main Screen Panel ... 116 Operating the ancillary equipment ... 117 OR table control ... 120 Operating of 3D Visualization unit (3DV-190)/3D monitor (LMD-2451MT/LMD-3251MT/LMD-3251ST/LMD-X310ST/LMD-X550ST/LMD-XH320ST /LMD-XH550ST) ... 123 USB flash drive image view window ... 126 Patient Information Input window ... 130 History record window ... 132 SceneSelection List window ... 134 SceneSelection Setting window ... 135 Information Mode window ... 137

5.7

Operations with voice control ... 138

5.8

Operations using the endoscope remote switches ... 141

5.9

Settings in the administrator mode ... 142 Registration of SceneSelection Settings ... 144 Registration of Logon ID ... 145 Registration of procedure ... 147 Registration flow of SceneSelection Settings ... 149 Clock Adjustment ... 160 System Settings ... 161

5.10 Touch panel calibration settings ... 202 5.11 Recommended operating of 3D visualization unit and 3D monitor ... 204 Example of connection of 3D visualization unit and 3D monitor ... 204 Settings at the time of installation ... 207 Operating procedure of the 2D/3D switch ... 207

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Contents

Chapter 6 Reprocessing, Storage, and Disposal ... 209 6.1

Reprocessing ... 209

6.2

Surface disinfectant cleaner ... 212

6.3

Signs of degradation from reprocessing ... 213

6.4

Preparing equipment for reprocessing ... 214

6.5

Reprocessing the MEDICAL CONTROL UNIT FOR ENDOSURGERY (UCES-4) ... 215

6.6

Storage ... 218

6.7

Disposal ... 218

Chapter 7 Troubleshooting ... 219 7.1

Troubleshooting ... 219

7.2

Troubleshooting guide ... 219

7.3

Error messages ... 223

7.4

Returning UCES-4 products for repair ... 235

Appendix ... 237 System chart ... 237 Specifications ... 242 Environment ... 242 Specifications ... 243

EMC information ... 251

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UCES-4 Ver.1.5 INSTRUCTION MANUAL

Labels and Symbols

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

 MEDICAL CONTROL UNIT FOR ENDOSURGERY (UCES-4)  Rear panel Manufacturer name Blue

Refer to instruction about connection cables. CE marking

MEDICAL DEVICE

Symbol mark (

Medical Device

Equipotential terminal

)

Electrical rating indication label

Date of Manufacture

MEDICAL CONTROL UNIT FOR ENDOSURGERY MODEL: UCES-4 POWER INPUT: 100 – 240 V 50/60 Hz 100 VA

Serial number Crossed-out wheeled bin’ symbol

Authorized representative in the European Community

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Labels and Symbols

 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).

 OLYMPUS logo screen

MEDICAL DEVICE Medical Device

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Labels and Symbols

 Version information

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

 EXTENSION UNIT FOR UCES-4 (MAJ-2191)  Rear panel Electrical rating indication label Blue

EXTENSION UNIT FOR UCES-4 MODEL: MAJ-2191 POWER INPUT: 100 – 240 V 50/60 Hz 60 VA

Manufacturer name

Refer to instruction about connection cables.

Symbol mark (

)

Equipotential terminal

Crossed-out wheeled bin’ symbol CE marking

Date of Manufacture

Serial number

Authorized representative in the European Community

NOTE The EXTENSION UNIT FOR UCES-4 (MAJ-2191) is used when connecting equipment placed farther away from the MEDICAL CONTROL UNIT FOR ENDOSURGERY (UCES-4). For details, refer to Section 3.5, “Connection of the EXTENSION UNIT FOR UCES-4 (MAJ-2191)”.

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UCES-4 Ver.1.5 INSTRUCTION MANUAL

Labels and Symbols

 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).

 Back cover of this instruction manual Symbol

Description Manufacturer

Authorized representative in the European Community

Translation

Importer (into European Union)

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Important Information - Please Read Before Use

Important Information - Please Read Before Use

 Intended use / Intended purpose This medical control unit for endosurgery has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment.

 Patient target groups Not dedicated to a specific patient population. Patient target groups are defined by Olympus endoscopes and ancillary equipment used with the MEDICAL CONTROL UNIT FOR ENDOSURGERY (UCES-4).

 Contraindications None known.

 Clinical benefit Supports to achieve the clinical benefit of compatible devices by providing functions of central control unit.

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

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UCES-4 Ver.1.5 INSTRUCTION MANUAL

Important Information - Please Read Before Use

 Instruction manual This instruction manual contains essential information on using this equipment safely and effectively. Before use, thoroughly review this manual and the manuals for all equipment that 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, contact Olympus.

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Important Information - Please Read Before Use

 User qualifications If there is an official standard on the qualification for endoscopy and endoscopic surgery that is defined by the medical administration or other official institutions such as the academic society for endoscopic surgery, follow that standard. If there is no official qualification standard, the operator of this equipment must be a physician approved by the medical safety manager of the healthcare facility or person in charge of the department (department of surgery, etc.). The medical safety manager of the healthcare facility or person in charge of the department should select a physician who is capable of safely performing the planned endoscopy and endoscopic surgery by following the official guidelines set by the academic society on endoscopic surgery, etc., and considering the difficulty of endoscopy and endoscopic surgery.

 Instrument compatibility Refer to “System chart” on page 237 to confirm that this system is compatible with the ancillary equipment being used. Using incompatible equipment can result in patient injury and/or equipment damage. This instrument complies with the EMC standard for medical electrical equipment, edition 4 (IEC 60601-1-2: 2014). When connecting to an instrument that complies with a previous edition of the EMC standard for medical electrical equipment edition, the EMC characteristics could be vulnerable. Some ancillary equipment may not be available in some areas. Contact Olympus for specific information.

 Repair and modification This system does not contain any user-serviceable parts. Do not disassemble, modify, or attempt to repair it; patient or user injury and/or equipment damage can result. Some problems that appear to be malfunctions may be correctable by referring to Chapter 7, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 7, contact Olympus.

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UCES-4 Ver.1.5 INSTRUCTION MANUAL

Important Information - Please Read Before Use

 Signal words The following signal words are used throughout this manual:

DANGER

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

WARNING

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

CAUTION

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.

NOTE

Indicates additional helpful information.

 Dangers, warnings, and cautions Observe the dangers, warnings, and cautions given below when handling these instruments. This information is to be supplemented by the dangers, warnings, and cautions given in each chapter.

DANGER • Strictly observe the following precautions. Failure to do so may place the patient and medical personnel in danger of an electric shock:  When using this equipment to examine a patient, make sure that metal parts of the endoscope, accessories, or camera do not come in contact with metal in the facility or in other system components. Metal-to-metal contact can create an electrical connection and cause unintentional current flow to the patient (e.g., leakage current).  Do not prepare, inspect, or use these instruments with wet hands.

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Important Information - Please Read Before Use

DANGER • This equipment is not explosion-proof. Never use it in an environment containing flammable gases or high concentrations of oxygen, and keep all flammable gases and liquid away from this equipment while it is being used. Otherwise, an explosion or a fire may result.

WARNING • Do not use this equipment for any purpose other than its intended use. • Strictly observe the following precautions. Failure to do so may place the patient and medical personnel in danger of an electric shock:  This equipment should be grounded to ensure safety. To prevent risk of an electric shock, be sure to plug the supplied power cords into a hospital-grade power outlet.  Keep liquid away from all electrical equipment. If spilled liquid enters the equipment, stop the procedure immediately and contact Olympus.  Supply power to all ancillary equipment through a wall mains outlet or isolation transformer outlet to prevent an electric shock. Never use equipment if its safety has not been confirmed. • Use only the power cord specified by Olympus. Otherwise, equipment malfunction and/or power cord burns may result. Also, never use it for other equipment. • Do not use this product in any place where it may be subject to strong electromagnetic radiation (i.e., in the vicinity of a microwave therapeutic device, MRI, wireless set, shortwave therapeutic device, cellular/portable phone, etc.). This may impair the performance of the product.

NOTE • When the power supply of this product and the peripheral devices are ON, do not connect or disconnect the attached I/F cables, INTERFACE FOR ESU (VIO SERIES) (MAJ-2249), INTERFACE FOR ESU (FORCE SERIES) (MAJ-2250), UNIVERSAL INTERFACE (MAJ-2251), INTERFACE FOR OLYMPUS LINK DEVICE (MAJ-2268), IR INTERFACE FOR UCES-4 (MAJ-2252), UCR CABLE FOR UCES-3 (MAJ-1877), ENDOALPHA STOP SWITCH FOR OR TABLE (MAJ-1882), a USB mouse, a keyboard, or video capture device. In case you want to connect or disconnect cables or the USB mouse, turn OFF the power supply of the equipment. • Do not apply excessive force to the connectors of the interface exchanger and peripheral devices. • Avoid the use in a dusty environment. Otherwise, equipment may be damaged.

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UCES-4 Ver.1.5 INSTRUCTION MANUAL

Important Information - Please Read Before Use

 Caution on interference with other devices Be careful not to place the RF (radio frequency) wireless microphone unit extremely close to or on top of medical and other radio frequency devices. Such positioning may cause malfunctioning of the microphone unit.

WARNING • Do not use RF wireless microphone units near patients who use electrical medical devices (e.g., pacemakers). Placing the RF wireless microphone unit close to such a medical device may result in device malfunction. • Be sure that this instrument is not used closer than 30 cm to or stacked with other equipment (other than the components of this instrument or system) to avoid electromagnetic interference. Electromagnetic interference may occur on this instrument near equipment marked with the following symbol or other portable and mobile RF communications equipment, such as cellular phones. If electromagnetic interference occurs, corrective measures may be necessary, such as reorienting or relocating this instrument, or shielding the location.

• If the RF wireless microphone unit is used, carefully follow the cautions below:  By using the RF wireless microphone unit, voice control is enabled. Electromagnetic interference may occur on this microphone near equipment marked with the following symbol or other portable and mobile RF communications equipment, such as cellular phones. If electromagnetic interference occurs, corrective measures may be necessary, such as moving the RF communications equipment away, reorienting or relocating the microphone unit, or shielding the location.

 Refer to the instruction manual for the RF wireless microphone unit for information on the specification of the RF wireless microphone unit’s radio transmitter. • Use the wireless microphone unit only in areas where its safety has been initially confirmed.

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Important Information - Please Read Before Use

WARNING • When using this equipment in domestic environments and connected to the public mains network, electromagnetic interference with other devices may occur. If electromagnetic interference occurs, mitigation measures may be necessary, such as reorienting or relocating this equipment, or shielding the location.

CAUTION • The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required), this equipment might not offer adequate protection to radio- frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

NOTE • If the RF wireless microphone unit is used, carefully follow the cautions below:  Set the same radio frequency for the receiver and the transmitter.  If several RF wireless microphone units are used within the coverage of wireless transmission, provide each unit with a different wireless frequency. Otherwise, lines are crossed and the voice control display may appear in part of the touch panel screen.  If the RF wireless microphone unit is used, voice control may not work due to the influence of the electrosurgical unit’s output.

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UCES-4 Ver.1.5 INSTRUCTION MANUAL

Important Information - Please Read Before Use

 About Security Considering possibility of risk of leakage in personal information and tampering with data by a third party, manage and protect your account information by making a unique password. Considering possibility that data may be stolen, destroyed, and/or falsified, ensure that the USB flash drive is not infected with a computer virus. Follow the facility security policy (ies) for storage and management of this product.

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Functions of the System

Functions of the System The ENDOALPHA integrated endosurgery system has the following system functions.

 Centralized control • The ancillary equipment connected to the MEDICAL CONTROL UNIT FOR ENDOSURGERY (UCES-4) and EXTENSION UNIT FOR UCES-4 (MAJ-2191) can be controlled in a centralized way using the touch panel. • Ancillary equipment can be controlled by means of voice. • Ancillary equipment can be controlled using remote switches of the endoscope in a sterile field.

 Centralized display The settings of the functions of connected ancillary equipment can be displayed on the screen of the touch panel.

 Message display Various warning and error messages can be displayed on the screen of the touch panel.

 Voice reply The ancillary equipment settings, warning messages, and error messages can be fed back in voice.

 SceneSelection settings The operations of the ancillary equipment, performed at the beginning of each scene in the procedure, can be registered and recalled with a one-touch operation for performing them at once.

 Display customization The contents of the display of the touch panel can be customized.

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UCES-4 Ver.1.5 INSTRUCTION MANUAL

Functions of the System

 Still image and video viewing Still images and videos recorded on a USB flash drive can be viewed on the centralized display screen.

 Automatic smoke evacuation When an electrosurgical unit/ultrasonic generator and an insufflator are connected to the MEDICAL CONTROL UNIT FOR ENDOSURGERY (UCES-4)/EXTENSION UNIT FOR UCES-4 (MAJ-2191) and output, the generated smoke or vapor can be evacuated automatically.

 Preview The control target image can be previewed on the control window of the digital recorder, room camera, surgical camera, or video switcher and the Information Mode panel. This function makes it possible to modify the ancillary equipment settings while observing the image.

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