CH-S400-XZ-EA 4K AUTOCLAVABLE CAMERA HEAD Operation Manual Feb 2020

Contents

Contents Labels and Symbols ... 1 Important Information - Please Read Before Use ... 3 Intended use ... 3 Contraindications ... 3 Applicability of endoscopy and endoscopic treatment ... 3 Instruction manual ... 4 User qualifications ... 4 Instrument compatibility ... 5 Reprocessing before the first use/reprocessing and storage after use ... 5 Spare equipment ... 5 Maintenance management ... 5 Prohibition of improper repair and modification ... 6 Classification of laser product ... 6 Signal words ... 6 Precautions ... 7 Precautions for disappeared or frozen endoscopic image ... 10

Chapter 1 Checking the Package Contents ... 13 1.1

Checking the package contents ... 13

Chapter 2 Instrument Nomenclature and Functions ... 15 2.1

Nomenclature and functions ... 15

Chapter 3 Preparation and Inspection ... 17 3.1

The workflow of preparation and inspection ... 17

3.2

Preparation of the equipment ... 19

3.3

Inspection of the camera head ... 20

3.4

Inspection of ancillary equipment ... 21

3.5

Connection of the camera head and ancillary equipment ... 22 Connection to the camera control unit ... 22 Connection to the endoscope ... 24

3.6

Functionality inspection of ancillary equipment connected to the camera head ... 25 Inspection of the ancillary equipment ... 25 Inspection of the endoscopic image ... 25 Inspection of the remote switches ... 26 Inspection of the one touch auto focus ... 26 Inspection of the manual focus ... 28

CH-S400-XZ-EA OPERATION MANUAL

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Contents

Chapter 4 Operation ... 29 4.1

Precautions ... 29

4.2

Focus adjustment ... 31 One touch auto focus adjustment ... 32 Manual focus adjustment ... 32

4.3

Positioning the endoscopic image ... 33

4.4

Color adjustment ... 33

4.5

Observation of the NBI image ... 34

4.6

Disconnection from the endoscope ... 35

4.7

Transporting outside the hospital ... 36

Chapter 5 Troubleshooting ... 37 5.1

Troubleshooting ... 37

5.2

Troubleshooting guide ... 38

5.3

Withdrawal when any irregularity is observed ... 39

5.4

Returning the camera head for repair ... 40

Appendix ... 41 Combination equipment ... 41 System chart ... 41

Specifications ... 44 Environment ... 44 Specifications ... 44

EMC information ... 46

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CH-S400-XZ-EA OPERATION MANUAL

Labels and Symbols

Labels and Symbols Safety-related labels and symbols are attached to the camera head at the locations shown below. If labels or symbols are missing or illegible, contact Olympus. Symbol

Description Refer to instructions.

Caution

Manufacturer

Authorized representative in the European Community

Serial number

Ingress protection rating is 7.

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Labels and Symbols

AUTOCLAVABLE It is displayed that the product is compatible with steam sterilization (autoclaving).

Model name plate

Caution Caution related to drying the video connector is displayed.

Model name plate

Caution

7512345

Rear side

Refer to instructions.

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CH-S400-XZ-EA OPERATION MANUAL

Important Information - Please Read Before Use

Important Information - Please Read Before Use

 Intended use The camera head has been designed to be used with Olympus endoscopes, camera control unit, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

 Contraindications As a TYPE BF piece of electro-medical equipment, the endoscope attached to this camera head must never be applied directly to the heart. Leakage current from TYPE BF equipment may be dangerous and cause ventricular fibrillation or seriously affect the cardiac function of the patient. Accordingly, always adhere to the following points:  Never apply the connected endoscope to the heart or an area near the heart.  Never allow an accessory or another endoscope, which is in contact with the heart (or an area near the heart), to contact an endoscope connected to the camera head.

 Applicability of endoscopy and endoscopic treatment If there are official standards on the applicability of endoscopy and endoscopic treatment that are defined by the hospital’s administrations or other official institutions, such as academic societies on endoscopy, follow those standards. Before starting endoscopy and endoscopic treatment, thoroughly evaluate its properties, purposes, effects, and possible risks (their nature, 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.

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Important Information - Please Read Before Use

 Instruction manual This instruction manual contains essential information on using this instrument 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. Note that the complete instruction manual set for this camera head consists of this manual and the “REPROCESSING MANUAL” with your camera head model listed on the cover. It also accompanied the camera head at shipment. 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.

 Terms used in this manual NBI (Narrow Band Imaging) observation: This is observation using narrowband light.

WLI (White Light Imaging) observation: This is observation using white light.

Image sensor: Image sensor is a device that converts light into electrical signals.

 User qualifications If there are official standards for user qualifications to perform endoscopy and endoscopic treatment that are defined by the hospital’s medical administrators or other official institutions, such as academic societies on endoscopy, follow those standards. If there are no official qualification standards, 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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CH-S400-XZ-EA OPERATION MANUAL

Important Information - Please Read Before Use

 Instrument compatibility Refer to the “Combination equipment” on page 41 to confirm that this instrument is compatible with the ancillary equipment being used. Using incompatible equipment can result in patient or operator 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.

 Reprocessing before the first use/reprocessing and storage after use This instrument was not reprocessed before shipment. Before using this instrument for the first time, reprocess it according to the instructions given in the camera head’s companion “REPROCESSING MANUAL” with your camera head model listed on the cover. After using this instrument, reprocess and store it according to the instructions given in the camera head’s companion “REPROCESSING MANUAL”. Improper and/or incomplete reprocessing or storage can pose an infection control risk, cause equipment damage, or reduce performance.

 Spare equipment Be sure to prepare another camera head to avoid interruption of the examination due to equipment failure or malfunction.

 Maintenance management The probability of failure of the camera head and ancillary equipment increases as the number of procedures performed and/or the total operating hours increase. In addition to the inspection before each procedure, the person in charge of medical equipment maintenance in each hospital should inspect the items specified in this manual periodically following regulations, guidelines, etc. required of you. A camera head with an observed irregularity should not be used, but should be inspected by following Section 5.2, “Troubleshooting guide”. If the irregularity is still observed after inspection, contact Olympus.

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Important Information - Please Read Before Use

 Prohibition of improper repair and modification This camera head does not contain any user-serviceable parts. Do not disassemble, modify, or attempt to repair it; patient or operator injury and/or equipment damage may result. Equipment that has been disassembled, repaired, altered, changed, or modified by persons other than Olympus’ own authorized service personnel is excluded from Olympus’ limited warranty and is not warranted by Olympus in any manner.

 Classification of laser product This camera head is CLASS 1 LASER PRODUCT in combination use with the camera control unit OTV-S400.

 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

6

Indicates additional helpful information.

CH-S400-XZ-EA OPERATION MANUAL

Important Information - Please Read Before Use

 Precautions Follow the dangers, warnings, and cautions given below when handling this camera head. This information is to be supplemented by the dangers, warnings, and cautions given in each chapter.

DANGER • Failure to adhere to the following precautions may place the patient and medical personnel in danger of an electric shock.  When this camera head is used to examine a patient, do not allow the metal parts of the endoscope or its accessories to touch metal parts of other system components. This camera head is electrically connected to metal parts of other system components, and contact may cause unintended current flow to the patient.  Do not prepare, inspect, or use this camera head with wet hands. • Never install and/or operate the camera head under the following conditions. An explosion or a fire could occur.  The concentration of oxygen is high.  Oxidizing agents (such as nitrous oxide (N2O)) are present in the atmosphere.  Flammable anesthetics are present in the atmosphere.  Flammable liquids are near.

WARNING • Do not use this instrument for any purpose other than its indications for use. Patient or operator injury and/or equipment damage may result. • After using this camera head, reprocess and store it according to the instructions given in the camera head’s companion “REPROCESSING MANUAL” with your camera head model listed on the cover. Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and/or infection. • This camera head may interfere with other medical electronic equipment used in combination with it. Before use, fully confirm the compatibility of this camera head to all equipment with which it will be used. • Do not insert the video connector while the electrical contacts or optical connecting part are wet and/or dirty. This may result in an electric shock, causing severe damage to the camera head and compromising patient and/or operator safety. • Do not use this camera head 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.

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Important Information - Please Read Before Use

WARNING • Electromagnetic interference may occur on this camera head near equipment marked with the following symbol or other portable and mobile RF (Radio Frequency) communications equipment, such as cellular phones. If electromagnetic interference occurs, mitigation measures may be necessary, such as reorienting or relocating this camera head, or shielding the location.

• Be sure that this camera head is not used adjacent to or stacked with other equipment (other than the components of this camera head or system) to avoid electromagnetic interference. • For reasons described below, do not rely on the NBI*1 observation mode alone for primary detection of lesions to make a decision regarding any potential diagnostic or therapeutic intervention.  NBI has not been demonstrated to increase the yield or sensitivity of finding any specific mucosal lesion.  NBI has not been demonstrated to aid in differentiating and establishing the presence or absence of dysplasia or neoplastic changes within mucosa or mucosal lesions. *1

Narrow Band Imaging. For more details, refer to the instruction manual for the camera control unit OTV-S400.

CAUTION • Use the camera head within a range of ambient temperatures shown in “Specifications” on page 44. When using the camera head at a higher than ambient temperature in the operating environment, the external surface temperature of the camera head may rise excessively. • Do not strike the camera head. The camera head may be damaged. • Do not hit or bend the electrical contacts and optical connecting part on the video connector. The connection to the camera control unit may be impaired and faulty contact can result. • Do not coil the camera cable with a diameter of less than 20 cm. The camera cable may be damaged.

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CH-S400-XZ-EA OPERATION MANUAL

Important Information - Please Read Before Use

CAUTION • Be careful not to twist the camera cable when it is coiled. The camera cable may be damaged. The cable can be coiled without twists by piling loops that are made by crossing the cable in front and back alternately.

A

‥ ‣

․

‸

B

‥ ‣

․

‸

Repeat Step A and B alternately.

• Never excessively bend, pull, twist, coil, squeeze, or crush the camera cable, which could damage the camera cable. • Turn the camera control unit ON only when the video connector is connected to the camera control unit. In particular, confirm that the camera control unit is OFF before connecting or disconnecting the video connector. Failure to do so can result in equipment damage, including destruction of the electrical circuits inside the camera head. • Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure. CH-S400-XZ-EA OPERATION MANUAL

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Important Information - Please Read Before Use

 Precautions for disappeared or frozen endoscopic image WARNING • If the endoscopic image disappears unexpectedly or frozen image cannot be restored during an examination, immediately stop using the camera head and withdraw the endoscope from the patient according to Section 5.3, “Withdrawal when any irregularity is observed”. Continued use of the endoscope under this condition could result in patient injury, bleeding, and/or perforation. • Follow the precautions given below. Otherwise, the endoscopic image may disappear unexpectedly or the frozen image may not be restored during the examination.  Never reprocess, or store this camera head with sharp-tipped instruments (tweezers, forceps, knives, etc.). This could scratch or tear holes in the camera cable, which could allow water to penetrate and damage electrical circuits inside the camera head.  Do not drop the camera head or allow it to strike other objects. Strong impacts could damage the electrical circuits inside the camera head.  Before connecting the video connector to the camera control unit, confirm that the video connector, including the electrical contacts and optical connecting part, is completely dry and clean. If the camera head is used with the electrical contacts or optical connecting part wet and/or dirty, the camera head and camera control unit may malfunction.  Never excessively pull the camera cable, but straighten it gradually when it is coiled. The camera cable could be damaged.  Never excessively bend, pull, twist, coil, squeeze, or crush the camera cable. The camera cable could be damaged.  Do not use excessive force when wiping the external surfaces of the camera cable. The camera cable could be damaged.  Never attempt to lift the entire assembly by the camera cable while the camera head is attached to the endoscope. The camera cable could be damaged.  Never use a clamp or forceps to attach the camera cable to another object. The camera cable could be damaged.

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CH-S400-XZ-EA OPERATION MANUAL

Important Information - Please Read Before Use

CAUTION • Turn the camera control unit ON only when the video connector is connected to the camera control unit. In particular, confirm that the camera control unit is OFF before connecting or disconnecting the video connector. Failure to do so can result in equipment damage, including destruction of the electrical circuits inside the camera head. • Do not hit or bend the electrical contacts on the video connector. The connection to the camera control unit may be impaired and faulty contact can result.

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Important Information - Please Read Before Use

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CH-S400-XZ-EA OPERATION MANUAL

1.1 Checking the package contents

Chapter 1

1.1

Checking the Package Contents Ch.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.

 Camera head

CH-S400-XZ-EA

 Accessories

Operation manual

Reprocessing manual

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4K Camerahead: Cautions and usage tips

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1.1 Checking the package contents

Ch.1

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CH-S400-XZ-EA OPERATION MANUAL

2.1 Nomenclature and functions

Chapter 2

Instrument Nomenclature and Functions

The instrument nomenclature and functions are described in this chapter.

2.1

Nomenclature and functions

Ch.2

1

3

2

4 7

‸

․

‣ ‥

5

12

8 9 11

6

10

No.

Nomenclature

Function

1

Endoscope lock ring

This ring is moved to attach or detach the endoscope mount to the endoscope.

2

Endoscope mount

The endoscope is connected to this mount.

3

One touch auto focus switch

The focus is automatically adjusted by pressing the switch.

4

Remote switch 1

The function of the switch is selected on the camera control unit. For more information on selecting the functions, refer to the instruction manual for the camera control unit.

5

Remote switch 2

The function of the switch is selected on the camera control unit. For more information on selecting the functions, refer to the instruction manual for the camera control unit.

6

Remote switch 3

The function of the switch is selected on the camera control unit. For more information on selecting the functions, refer to the instruction manual for the camera control unit.

7

Focus ring

The focus is adjusted by turning the ring.

8

Camera cable

This cable connects the camera head to the camera control unit.

9

Video connector

This connector is connected to the video connector socket on the front panel of the camera control unit.

10

UP mark

When the video connector is connected to the camera control unit, this mark should be facing upward.

11

Electrical contacts

Connect the camera head and the camera control unit electrically.

12

Optical connecting part

Connect the camera head and the camera control unit optically.

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2.1 Nomenclature and functions

Ch.2

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CH-S400-XZ-EA OPERATION MANUAL

3.1 The workflow of preparation and inspection

Chapter 3

Preparation and Inspection

The equipment prepared before using this camera head and procedures for the inspection of the camera head and equipment are described in this chapter. The following inspection judges whether the device has exceeded its use life.

3.1

The workflow of preparation and inspection

The workflow of preparation and inspection is shown below. Before each case, prepare and inspect this camera head as instructed below. Inspect other equipment to be used with this camera head as instructed in their respective instruction manuals. Should any irregularity be observed after inspection, follow the instructions as described in Chapter 5, “Troubleshooting”. If this camera head malfunctions, do not use it. Return it to Olympus for repair as described in Section 5.4, “Returning the camera head for repair”.

WARNING • Never use the camera head on a patient if any irregularity is observed. The irregular camera head may compromise patient or user safety and may result in more severe equipment damage. In addition, it may pose an infection control risk. • This camera head was not reprocessed before shipment. Before using this camera head for the first time, reprocess it according to the instructions as described in the camera head’s companion “REPROCESSING MANUAL” with your camera head model listed on the cover.

CAUTION Refer to “ Connection to the endoscope” on page 24 to check that the endoscope is firmly fixed to the camera head, and refer to Section 4.2, “Focus adjustment” to check that the endoscopic image is properly displayed on the monitor. Using the camera head in combination with an incompatible endoscope may impair the observation.

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Ch.3