CH-S700-XZ-EA Operation Manual July 2022

Contents

Contents Please Read Before Use... 3 Labels and Symbols ... 3 Labels on the body of the product ... 3 Symbols ... 5

To use this product safely ... 6 Intended purpose... 6 Contraindications ... 6 Clinical benefits... 6 Applicability of endoscopy and endoscopic treatment ... 6 Instruction manual ... 7 User qualifications ... 7 Instrument compatibility ... 8 Reprocessing before the first use/reprocessing and storage after use ... 8 Spare equipment ... 8 Maintenance management ... 8 Prohibition of improper repair and modification ... 8 Classification of safety of optical radiation... 9 Classification of laser product... 9 Signal words ... 10 Precautions... 11

Chapter 1 Checking the Package Contents ... 17 1.1

Checking the package contents... 17

Chapter 2 Instrument Nomenclature and Functions ... 19 2.1

Nomenclature and functions ... 20

Chapter 3 Preparation and Inspection... 23 3.1

The workflow of preparation and inspection ... 23

3.2

Preparation of the equipment... 24

3.3

Inspection of the camera head... 25

3.4

Inspection of ancillary equipment ... 26

3.5

Connection of the camera head and ancillary equipment... 27 3.5.1 3.5.2

3.6

Connection to the video system center ... 27 Connection to the endoscope... 28

Functionality inspection of ancillary equipment connected to the camera head ... 30 3.6.1 3.6.2 3.6.3 3.6.4 3.6.5

Inspection of the ancillary equipment ... 30 Inspection of the endoscopic image ... 30 Inspection of the remote switches ... 31 Inspection of the one touch/continuous auto focus ... 31 Inspection of the manual focus... 34

Chapter 4 Operation ... 37 4.1

Precautions ... 37 CH-S700-XZ-EA OPERATION MANUAL

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Contents

4.2

Focus adjustment ...39 4.2.1 4.2.2

One touch/continuous auto focus adjustment ... 39 Manual focus adjustment ... 40

4.3

Positioning the endoscopic image ...41

4.4

Color adjustment ...42

4.5

Optical-digital observation ...43

4.6

Disconnection from the endoscope...44

4.7

Transportation and reprocessing of the camera head...45

Chapter 5 Troubleshooting...47 5.1

Troubleshooting ...47

5.2

Troubleshooting guide...48

5.3

Withdrawal of the endoscope with an irregularity...49

5.4

Returning the camera head for repair...50

Appendix ...51 Combination equipment ...51 System chart... 51

Specifications...54 Environment ... 54 Specifications ... 54

EMC information ...57 Guidance and manufacturer’s declaration - Electromagnetic emissions... 57 Guidance and manufacturer’s declaration - Electromagnetic immunity ... 57

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CH-S700-XZ-EA OPERATION MANUAL

This chapter provides a summary of this instruction manual and important information to use this product safely. The instructions for this product are described in the following two instruction manuals. Instruction manual

Description

Operation manual (this manual)

The operation manual explains the structure of this product, the basic way to operate this product, troubleshooting, and so on. Please read this manual first.

Reprocessing manual

The reprocessing manual explains how to reprocess, store, and transport this product.

Labels and Symbols Safety-related labels and symbols are attached to the body of the product and the package, and indicated in the instruction manuals. This section describes what those labels and symbols signify.

Labels on the body of the product The labels are attached to the following locations. If the labels are missing or illegible, please contact Olympus.

 Camera Head part

Corporate name

CH-S700-XZ-EA OPERATION MANUAL

Autoclavable device

3

Please Read Before Use

Please Read Before Use

Labels and Symbols

 Video Connector

Please Read Before Use

EO sterilization forbidden TYPE CF applied part UP mark

UDI

Model name

Caution Serial number

CE Mark

Medical device

Ingress protection rating

Refer to the instruction manual A country of manufacture

Product name

4

CH-S700-XZ-EA OPERATION MANUAL

Labels and Symbols

Symbols The followings are symbols used for this product.

70 °C

Description

Symbol

Description

Consult instructions for use or consult electronic instructions for use

Caution

TYPE CF applied part

EO sterilization forbidden

Serial number

Manufacturer

Date of Manufacture

Medical device

Ingress protection rating is 7.

Authorized representative in the European Community/European Union

Importer (into European Union)

Fragile, handle with care

Keep away from sunlight

Keep dry

Temperature limitation

–47 °C

95%

Please Read Before Use

Symbol

Humidity limitation

10% 1060 hPa

Atmospheric pressure limitation

Translation

700 hPa

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To use this product safely

To use this product safely

Please Read Before Use

Intended purpose The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

Contraindications Do not perform observation or treatment of the heart or its vicinity in combination with devices classified as TYPE BF applied part. 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.

Clinical benefits Supports to achieve the clinical benefit of connected endoscopes, video system centers, light sources, and other ancillary equipment by providing endoscopic diagnosis, treatment, and observation.

Applicability of endoscopy and endoscopic treatment • If there are official standards on the applicability of endoscopy and endoscopic treatment that are defined by the healthcare facility’s administrators 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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CH-S700-XZ-EA OPERATION MANUAL

To use this product safely

Instruction manual

Please Read Before Use

• The instruction manuals for this product contains essential information on using this product safely and effectively. Before use, thoroughly review the instruction manuals for this product and for all equipment that will be used during the procedure and use this product as instructed. • Keep the instruction manuals for this product and all the relevant equipment where it is safe and accessible. • If you have any questions or comments about any information in the instruction manuals for this product, contact Olympus.

 Terms Terms

Description

WLI (White Light Imaging) observation

This is observation using white light.

Optical-digital observation

This is observation using specific filtered light.

NBI (Narrow Band Imaging) observation

This is optical-digital observation using blue and green narrow band light.

IR (Infrared) observation

This is optical-digital observation using infrared light to excite fluorescence dye.

Image sensor

The image sensor is a device that converts light into electrical signals.

Reprocessing

Reprocessing means a series of processes: cleaning, disinfection, sterilization. It enables camera heads to be used safely.

User qualifications • Endoscopy and endoscopic treatment should be performed by a physician who meets the following requirements. 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 society on endoscopy, the physician follow that standard. If there is no official qualification standard, the physician must be approved by the medical safety manager of the healthcare facility or person in charge of the department. • The physician should be qualified to operate and perform safely 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 instrument should be used by persons trained in how to use it in the cases other than endoscopy and endoscopic treatment.

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To use this product safely

Instrument compatibility

Please Read Before Use

Refer to “Combination equipment” on page 51 to confirm that this instrument is compatible with the ancillary equipment being used.

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”.

Spare equipment Be sure to prepare spare equipment 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 healthcare facility should inspect the items specified in this manual periodically following regulations, guidelines, etc. required of you.

Prohibition of improper repair and modification Repairing or modifying the device should be done by persons only Olympus has approved. The device that has been improperly repaired or modified is not to be repaired without charge even though it is within the warranty period.

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CH-S700-XZ-EA OPERATION MANUAL

To use this product safely

Classification of safety of optical radiation

Risk Group 2 • UV emitted from this device. Skin irritation may result. Do not keep the distal end of the endoscope in contact with skin for a long time. • The light emitted may be harmful to the eyes. Do not stare directly into the distal end of the endoscope while the examination light is ON.

Classification of laser product This camera head is CLASS 1 LASER PRODUCT in combination use with the video system center (OTV-S700).

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Please Read Before Use

This camera head is Risk Group 2 product in combination use with the video system center (OTV-S700).

To use this product safely

Signal words The following signal words are used throughout this manual. Please Read Before Use

Signal word

What the signal word indicates 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, could 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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CH-S700-XZ-EA OPERATION MANUAL

To use this product safely

Precautions

Please Read Before Use

Observe the danger, warning and cautions given below when using this product. Also observe each warning and caution given in each chapter.

 Regarding handling of the device

If strong impact was inflicted on the camera head, do not use the camera head anymore and contact Olympus. Serious damage that would result in irregularity in image, heat radiation, or malfunctioning could have been done to the device.

• Each part of the camera head must not be subjected to strong force or impact. Inflicting strong force or impact on each part of the camera head may result in a breakdown of the device. − Do not squeeze, pull, twist, rub the camera cable hard. Also do not bend the camera cable into a small arc whose diameter is 20 cm or smaller. − Do not inflict strong impact on the camera head part and the video connector with the electrical contacts. • When you bundle the camera cable, coil up without twisting it. The cable can be coiled without twists by piling loops that are made by crossing the cable in front and back alternately. When you straighten the cable, do not pull at it but slowly uncoil the loops. Pulling at the cable may break the device.

A

B

Repeat Step A and B alternately.

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To use this product safely

 Regarding preparation and inspection of the device

Please Read Before Use

• Only use combinations of devices recommended by Olympus. Use of unrecommended combinations may result in not only a breakdown of the devices but also serious harm. • Confirm the following before using the device. If you are suspicious about contamination of the device, reprocess it again and then use it. − The state of being disinfected or sterilized has been properly maintained and managed. − It is before expiration date of the sterilized device. − There is no irregularity in the wrapping material for sterilization, a tear, moisture beads on its surface and such. • Prepare a backup device in case of a breakdown of the device during use. Also when performing an endoscopic surgery, make preparations to move into a laparotomy. • Observe the following when connecting the device to an electrical power source. If not, it may result in a fire or electrical shock. − Connect the plug with an earth terminal directly to a medical electrical outlet of the medical facility. Do not use an extension cord. − When using related devices other than medical electrical equipment, be sure to connect to an electrical power source through an isolation transformer Olympus recommends. • Observe the following when connecting the camera head to the video system center. If not, it may lead to irregularity in image, heat radiation, or malfunctioning. − If the electrical contacts of the video connector or optical connecting part is dirty or wet, wipe them clean and dry them fully, and then connect. − Confirm that the video connector is locked after it is connected. − Turn off the video system center before you connect or disconnect the video connector. − When disconnecting the video connector, do not pull at the camera cable. • When attaching the camera head to the endoscope, observe the following. If not, not only it may lead to irregularity in image, but also the endoscope may fall off during use. − Before attaching, confirm that the eyepiece of the endoscope is tightly in place. − After attaching, confirm that the endoscope and the camera head are firmly attached without rattling.

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CH-S700-XZ-EA OPERATION MANUAL

To use this product safely

• Check all the following switches, even though you are not going to use all of them. If not, malfunctioning during use may occur, and it may result in serious harm. − Manual focus switch − One touch/continuous auto focus switch • When using this product with a high-frequency surgical instrument, be sure to use an endoscope with an insulated eyepiece made of plastic. If not, it may result in not only a breakdown of the device but also a burn.

 Regarding use of the device

• Do not perform observation or treatment of the heart or its vicinity in combination with devices classified as TYPE BF applied part. 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. − The Medical Electrical Equipment Safety Standard (IEC 60601-1) states that all devices used for procedures aimed at observing or treating the heart must have a TYPE CF applied part with a low level of leakage current. Be sure to check the classification of the combination device before use. • Do not use the device in the following locations. It may lead to an explosion or a fire. − Where oxygen density is high. − In the atmosphere of oxides such as laughing gas (N2O). − Where flammable anesthetic gas is used. − In the vicinity of flammable liquid.

• Use the endoscope only for the purposes described in intended use of this product. Using the endoscope for other than its intended purpose may result in not only a breakdown of the device but also serious harm. • Do not use the device under condition and in an environment other than those described in “Environment” on page 54. Using the device in the other environment may cause the device to heat excessively or irregularity in image.

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Please Read Before Use

− Remote switches

To use this product safely

• Observe the following in order to avoid electromagnetic interference. If not, it may lead to irregularity in image or malfunctioning. Please Read Before Use

− This endoscopic system should neither be situated near other medical devices nor piled up with them. − If interference with nearby other medical devices occurs, take measures to reduce the effect such as changing the location or direction of this endoscopic system. − Do not use this endoscopic system in vicinity to a microwave therapeutic device, a shortwave therapeutic device, an MRI device, an RF (radio-frequency) communication device such as a mobile phone, or a device with the following mark.

• Do not touch peripheral devices with the metal part of the endoscope during use. This product and the ground may be connected electrically, and therefore it may result in electrical shock. • Do not hold or fix the camera cable with forceps and such. It may lead not only to breaking of the camera cable but also to irregularity in image. • Hold the camera head, not the camera cable, and operate the endoscope during use. If not, it may lead to not only breaking of the camera cable but also to irregularity in image. • Information acquired from optical-digital observation is for reference and not to guarantee the validation for diagnosis. Observe and diagnose comprehensively all the subject regions for observation including WLI (White Light Imaging) observation. If not, correct observation or diagnosis may be impossible.

Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.

In case any serious incident happens to User or Patient while operating the device, the incident should be reported to Olympus and the competent authority of the respective member state or country.

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CH-S700-XZ-EA OPERATION MANUAL

To use this product safely

 Regarding irregularity of the device

• Stop using the devices immediately and observe the following when irregularity such as an endoscopic image disappears or focus adjustment becomes impossible occurred. If not, it may result in serious harm. − Turn OFF the video system center and turn it ON again immediately, then find out whether an endoscopic image recovers or not. − If an endoscopic image recovers, while observing the endoscopic image, withdraw the endoscope from the patient and stop using the devices. − If an endoscopic image does not recover, detach the camera head from the endoscope and look into the eyepiece of the endoscope directly and withdraw the endoscope. − If using various kinds of EndoTherapy accessories, before withdrawing the endoscope, withdraw the EndoTherapy accessory first in a way considered to be the safest.

 Regarding repair of the device

Repairing or modifying the device should be done by persons only Olympus has approved. Repairing or modifying by the unapproved may result in serious harm.

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Please Read Before Use

• Do not use the device if you are doubtful of its normality. Also stop using the device if you detect any irregularity while using the device. Continuing to use the device may result in serious harm.

To use this product safely

Please Read Before Use

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CH-S700-XZ-EA OPERATION MANUAL

Chapter

1

Ch. 1

Checking the package contents

Checking the Package Contents

1.1

Checking the Package Contents

Match all items in the package with the components shown below. Inspect each item for damage. If the camera head is damaged, a component is missing, or you have any questions, do not use the items; immediately contact Olympus.

 Camera head

CH-S700-XZ-EA

 Accessories

Operation manual

CH-S700-XZ-EA OPERATION MANUAL

Reprocessing manual

4K Camera head: Cautions and usage tips

17

1.1 Checking the package contents

Ch. 1 Checking the Package Contents

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CH-S700-XZ-EA OPERATION MANUAL

Chapter

2

Instrument Nomenclature and Functions

The instrument nomenclature and functions are described in this chapter. Ch. 2 Instrument Nomenclature and Functions

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