CH-S700-XZ-EA 4K Camera Head Reprocessing Instructions

Contents

Contents Please Read Before Use... 3 To use this product safely ... 3 About this instruction manual... 3 Important information regarding reprocessing ... 5 Precautions... 7

Chapter 1 Nomenclature and Functions... 9 1.1

Nomenclature and functions of the camera head device ... 10

Chapter 2 Compatible Reprocessing Methods ... 13 2.1

List of compatible reprocessing methods ... 13

2.2

Conditions of fluids for reprocessing and reprocessing devices ... 14 2.2.1 2.2.2 2.2.3 2.2.4 2.2.5 2.2.6 2.2.7

2.3

Water for reprocessing ... 14 Detergent solution for manual cleaning ... 15 Disinfectant solution for manual disinfection ... 16 WD (Washer disinfector) ... 17 STERRAD® sterilization ... 20 V-PRO® sterilization ... 20 Steam sterilization (autoclaving) ... 21

Signs of degradation from reprocessing ... 22

Chapter 3 Reprocessing Workflow ... 23 3.1

Reprocessing workflow in which an automated reprocessor is used ... 24

3.2

Reprocessing workflow in which an automated reprocessor is not used... 25

Chapter 4 Preparing and Inspecting the Equipment for Reprocessing ... 27 4.1

Preparing the equipment for reprocessing... 27

4.2

Inspecting the equipment for reprocessing... 28

Chapter 5 Reprocessing the Camera Head Device ... 29 5.1

Precleaning the camera head device... 29 5.1.1 5.1.2 5.1.3 5.1.4

5.2

Manually cleaning the camera head device ... 35 5.2.1 5.2.2 5.2.3 5.2.4 5.2.5 5.2.6

5.3

Equipment needed ... 30 Preparing for precleaning ... 31 Precleaning the external surfaces ... 33 Transporting the camera head device to the reprocessing location ... 34 What to do if cleaning is delayed... 36 Equipment needed ... 37 Preparing for manual cleaning ... 38 Soaking in the detergent solution ... 39 Cleaning the external surfaces ... 41 Rinsing the detergent solution off ... 43

Manually disinfecting the camera head device ... 47 CH-S700-XZ-EA REPROCESSING MANUAL

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Contents

5.3.1 5.3.2 5.3.3 5.3.4

5.4

Automatically cleaning and disinfecting the camera head device ...56 5.4.1

5.5

Equipment needed ... 48 Preparing for manual disinfection ... 49 Soaking in the disinfectant solution ... 50 Rinsing the disinfectant solution off ... 53 Automatically cleaning and disinfecting using Washer disinfector ... 56

Drying the camera head device...57 5.5.1 5.5.2

Equipment needed ... 58 Drying the camera head device... 58

5.6

Inspecting the camera head device ...59

5.7

Sterilizing the camera head device ...61 5.7.1 5.7.2 5.7.3 5.7.4

Equipment needed ... 61 STERRAD® sterilization ... 62 V-PRO® sterilization ... 63 Steam sterilization (autoclaving) ... 64

Chapter 6 Storing the Camera Head Device ...65 6.1

Storing the disinfected camera head device...65

6.2

Storing the sterilized camera head device ...66

Chapter 7 Transporting the Camera Head Device...67 7.1

Transporting the camera head device inside the facility...67 7.1.1 7.1.2 7.1.3

7.2

2

Transporting the contaminated camera head device ... 67 Transporting the disinfected camera head device... 67 Transporting the sterilized camera head device... 68

Transporting the camera head device outside the facility ...69

CH-S700-XZ-EA REPROCESSING MANUAL

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

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

To use this product safely

About this instruction manual • This instruction manual provides the reprocessing and storage procedures, which have been validated by Olympus for the camera head device listed below. − Camera head (CH-S700-XZ-EA) • This instruction manual is based on the requirements of ISO 17664: 2021. • Refer to the following for the meaning of the terms, symbols, and signal words used in this instruction manual.

 Terms Terms

Description

Reprocessing

The cleaning, disinfection, and sterilization processes that ensure safe use of the camera head device.

Precleaning

The cleaning performed immediately after using a camera head device at the site of use.

Manual cleaning and manual disinfection

The cleaning and disinfection performed manually, without using an automated reprocessor.

Automated cleaning and automated disinfection

The cleaning and disinfection performed by an automated reprocessor.

WD

An abbreviation for washer disinfector, which can perform a series of processes, cleaning and thermal disinfection automatically.

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Please Read Before Use

Please Read Before Use

To use this product safely

 Symbols Symbol

Description

What the symbol indicates

Please Read Before Use

No debris

Indicates that there should be no debris.

No water or fluid

Indicates that there should be no water (or fluid).

Keep camera head device immersed

Indicates that the entire camera head device (including the video connector and camera cable) should be kept immersed completely.

Specific timer

Indicates that a condition or action should last a specified time. “--” indicates specific time, for example 10 seconds or 15 minutes.

Specific timer

Indicates that a condition or action should last a specified time. For the specified time, refer to manual instructions of related devices or chemicals.

--

 Signal words Signal word

What the signal word indicates 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 REPROCESSING MANUAL

To use this product safely

Important information regarding reprocessing  Basic requirements to use this product

• The effectiveness of reprocessing is affected by various factors such as equipment, chemicals, devices to be used for reprocessing, the person in charge of reprocessing, and the procedures for reprocessing. The effectiveness of sterilization in particular is affected by various factors such as how the item to be sterilized is wrapped, the position of the item to be sterilized in the sterilizer, and how the sterilizer is loaded. • Each healthcare facility is required to establish the most appropriate system to prevent infection and prevent contaminated devices and reprocessed devices from being mixed up. For example, partition contaminated areas, clean areas, and storage areas from one another. • A person in charge of reprocessing must understand the contents of all the instruction manuals of this product and the equipment and chemicals used for reprocessing. • Keep this instruction manual and all the relevant instruction manuals in a safe and accessible place, such as the place where reprocessing is performed.

 Reprocessing after receiving this product This product was not reprocessed when it was shipped from Olympus. Be sure to reprocess this product before use or storage.

 Confirmation before use Confirm the following before use. If you suspect that the device is contaminated, reprocess the device again. − Confirm that the device has been properly reprocessed and stored according to this instruction manual. − Confirm that the expiration date of the sterilized device has not passed, and that there is nothing wrong with the sterilization wrapping materials, such as a tear or beads of moisture on or inside the materials.

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Please Read Before Use

• Each healthcare facility that uses this product is required to establish the most appropriate procedures for reprocessing and storage with consideration for criteria such as the relevant national laws and standards and the guidelines issued by professional organizations. Also the facility needs to validate the safety and effectiveness of the procedures for reprocessing and storage applied in the facility, and to regularly monitor the implementation of the procedures.

To use this product safely

 Reprocessing and storage after use • To reduce the risk of infection, perform precleaning immediately after each use, followed by manual cleaning. This product must be manually cleaned within 1 hour after each use. After performing reprocessing, store this product properly. Please Read Before Use

• If you cannot perform manual cleaning within 1 hour after use, follow the instructions in the following section. − Section 5.2.1, “What to do if cleaning is delayed”.

 Disposal When disposing of this product, as well as the equipment, chemicals, and other items used for reprocessing, comply with the relevant national laws and standards and the guidelines issued by professional organizations.

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CH-S700-XZ-EA REPROCESSING MANUAL

To use this product safely

Precautions

Please Read Before Use

Observe the warnings and cautions described below when reprocessing and storing this product. Also observe the warnings and cautions described in each chapter.

 Reprocessing in general

• Be sure to follow the reprocessing procedures and their detailed conditions in this instruction manual when reprocessing the camera head device. Failure to do so may result in not only a breakdown of the device but also inadequate reprocessing, possibly leading to infection. • Be sure to check the device before storage or sterilization. If the device has deteriorated, it may be impossible to reprocess the device properly or maintain the effectiveness of reprocessing. • Please note that the reprocessing methods described in this instruction manual cannot destroy or inactivate prions, the pathogenic agents of Creutzfeldt-Jakob disease (CJD). When using the camera head device on patients with CJD or variant Creutzfeldt-Jakob disease (vCJD), be sure to dedicate its use for only such patients, or immediately dispose of it after use in an appropriate manner, to prevent potentially contaminated devices from being used on other patients. For methods on how to handle CJD, follow the respective guidelines in your country.

Do not immerse equipment not used for reprocessing into water or chemicals together with the camera head device. Otherwise, they may hit each other, possibly damaging the camera head device.

 Handling the device

If the camera head device is subjected to strong impact, stop its use and contact Olympus. The equipment may be seriously damaged, possibly leading to image abnormalities, malfunctions, or parts falling off.

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To use this product safely

Be sure not to apply strong force or impact to any part of the camera head device. Otherwise, the equipment may malfunction. Please Read Before Use

− Do not squeeze, pull, twist, or rub the camera cable. Also do not bend the camera cable into a small arc whose diameter is 20 cm or smaller. − Do not apply strong impact on camera head part and the video connector with the electrical contacts.

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CH-S700-XZ-EA REPROCESSING MANUAL

Chapter

1

Nomenclature and Functions

This chapter describes the nomenclature and functions of each part of the following device.

CH-S700-XZ-EA REPROCESSING MANUAL

Nomenclature and Functions

− Camera head device

Ch. 1

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1.1 Nomenclature and functions of the camera head device

1.1

Nomenclature and functions of the camera head device

A

Ch. 1 Nomenclature and Functions

B

C3 C1 C2

A1

A3

A4

A5 C

A2

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CH-S700-XZ-EA REPROCESSING MANUAL

1.1 Nomenclature and functions of the camera head device

No.

Nomenclature

Description

A

Camera head part

The connection portion where an endoscope is connected. Use the switches to perform various functions.

A1

Endoscope lock ring

The mechanism for fixing an endoscope to the endoscope mount. To release the endoscope, turn this ring in the direction of the arrow head.

A2

Endoscope mount

The component where an endoscope is connected

A3

Manual focus switch

The switch for manually adjusting the focus position

A4

One touch/Continuous auto focus switch

The switch for automatically adjusting the focus position

A5

Remote switches

Switches (three in total) for performing various functions of the video system center.

B

Camera cable

The cable that connects the camera head device part and the video connector.

C

Video connector

The connector where the video system center is connected

C1

Electrical contacts

Contacts where the camera head device and the video system center are electrically connected

C2

Optical connecting part

Part where the camera head device and the video system center are optically connected

C3

UP mark

A symbol that indicates which side of the video connector should face upward

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Nomenclature and Functions

CH-S700-XZ-EA REPROCESSING MANUAL

Ch. 1

1.1 Nomenclature and functions of the camera head device

Ch. 1 Nomenclature and Functions

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CH-S700-XZ-EA REPROCESSING MANUAL

Chapter

2

Compatible Reprocessing Methods

This chapter describes compatible reprocessing methods, their detailed requirements, and limits on the number of reprocessing cycles. Ch. 2

List of compatible reprocessing methods

The following table indicates the compatible reprocessing methods of this product. There are some detailed requirements when applying these reprocessing methods. For the detailed requirements, refer to Section 2.2, “Conditions of fluids for reprocessing and reprocessing devices”.

Camera head (CH-S700-XZ-EA) Manual cleaning

Neutral or alkaline, enzymatic detergent



Manual disinfection

Peracetic acid



Glutaraldehyde



Automatic cleaning and disinfection

Washer-disinfector (Alkaline detergent)



Sterilization

STERRAD® NX® (STANDARD Cycle)*1



STERRAD® 100NX® (DUO Cycle)*1



STERRAD® 100S (Short cycle)



V-PRO® maX (Non Lumen Cycle)



Steam (autoclaving)



Ethylene oxide gas



Low Temperature steam and formaldehyde (LTSF)

  Compatible  Not compatible

*1 It can be applied to both with/without ALLClear™ technology.

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Compatible Reprocessing Methods

2.1

2.2 Conditions of fluids for reprocessing and reprocessing devices 2.2.1 Water for reprocessing

2.2

Conditions of fluids for reprocessing and reprocessing devices

2.2.1

Water for reprocessing

Water for reprocessing is divided into the following two types in this instruction manual.

Ch. 2 Compatible Reprocessing Methods

 Water • Water is used for precleaning, diluting detergents, and rinsing in the cleaning process. • Use fresh, drinkable tap water or water from which chemicals and microorganisms have been removed by filtration, deionization*1, or distillation. *1 Deionization means to remove ionized salts from the water by using a specially manufactured ion-exchange resin.

 Rinse water

Do not reuse rinse water. • Rinse water is used for final rinsing after disinfection. • Use sterile water, clean potable water, or water from which chemicals and microorganisms have been removed by filtration, deionization*1, or distillation. *1 Deionization means to remove ionized salts from the water by using a specially manufactured ion-exchange resin.

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CH-S700-XZ-EA REPROCESSING MANUAL

2.2 Conditions of fluids for reprocessing and reprocessing devices 2.2.2 Detergent solution for manual cleaning

2.2.2

Detergent solution for manual cleaning

• Do not reuse the detergent solution. • Do not foam the detergent solution excessively. Air bubbles in the foam can prevent the detergent solution from sufficiently touching the surfaces of the camera head device, resulting in the camera head device inadequately cleaned.

• Use a neutral or an alkaline ( pH10.8), enzymatic detergent that is approved for use with endoscopes or medical devices by your national regulatory agency. Also use a detergent solution that is low-foaming and does not contain any abrasive substances. • Follow the instructions given by each detergent manufacturer on concentration, temperature, soaking time, expiration date, number of rinses, and so on, unless otherwise instructed by Olympus. • The following table indicates the detergents used for the validation. Trade name

Type

Manufacturer

neodisher® Mediclean forte

Alkaline enzymatic

Dr. Weigert

® AW

Neutral enzymatic

Ruhof

Endozime

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Compatible Reprocessing Methods

Do not use strong alkaline detergent or strong acidic detergent. Using either of these detergents may severely deteriorate the camera head device.

Ch. 2

2.2 Conditions of fluids for reprocessing and reprocessing devices 2.2.3 Disinfectant solution for manual disinfection

2.2.3

Disinfectant solution for manual disinfection

When reusing a disinfectant solution, check its effectiveness with a test strip recommended by the disinfectant manufacturer or by another method before use. Ch. 2 Compatible Reprocessing Methods

Do not use a disinfectant solution that contains benzalkonium chloride. Doing so may severely deteriorate the camera head device. • Use a peracetic acid or a glutaraldehyde disinfectant solution that is approved for use with endoscopes or medical devices by your national regulatory agency. Refer to the following table for details on the applicable conditions. • In case national or professional guidelines applicable for your institution define “high-level disinfection” and require using a high-level disinfectant for the camera head device, follow the requirement. • Follow the instructions given by each disinfectant manufacturer on a concentration, temperature, soaking time, expiration date, number of rinses, and so on, unless otherwise instructed by Olympus. If the disinfectant manufacturer does not specify the number of rinses, rinse at least twice. Disinfectant

Peracetic acid

Glutaraldehyde

Percentage solution

2 W/V% solution Undiluted solution (dissolving the powdery agent with water) (mixing undiluted solution with activator)

Disinfectant concentration

Peracetic acid approximately 1000 ppm

Glutaraldehyde approximately 3.4%

Operating temperature

Approximately 25°C

Approximately 25°C

Solution shelf life

Within 24 hours

Within 28 days

• The following table indicates the disinfectants used for the validation. Trade name

Type

Manufacturer

Sekusept™ Aktiv

Peracetic acid

ECOLAB

METRICIDE PLUS 30®

Glutaraldehyde

METRIX® RESEARCH

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CH-S700-XZ-EA REPROCESSING MANUAL

2.2 Conditions of fluids for reprocessing and reprocessing devices 2.2.4 WD (Washer disinfector)

2.2.4

WD (Washer disinfector)

• Use only a WD that is whose compatibility for cleaning medical device has been certified by the WD’s manufacturers, and which meets ISO 15883-1, ISO 15883-2 requirement. Using an incompatible WD may pose an infection control risk and may considerably damage the medical device.

• Do not use an undesignated detergent, neutralizer, or WD program. Do not use strong alkaline detergent, strong acidic detergent and lubricant. Using these may lead to severe degradation of the medical device. • Arrange the device properly and fix them using accessories of the WD, e.g., a rack, basket, tray, holder and such, so that parts of the device will not touch each other. • Remove the device from the WD immediately after automated cleaning and disinfection is finished. If not, the device may become corroded. • For details on the operation of the WD, refer to the instruction manual of the WD. • Use compatible accessories (a rack, basket, tray or holder) with the WD.

 Program

Make sure that the temperature of the water inflow into the cleaning units is sufficiently cold (e.g., ≤25°C) to avoid thermal coagulation of protein. Do not use programs starting with high temperatures. The WD program should consist of the following stages:

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Compatible Reprocessing Methods

• Perform manual cleaning of the medical device according to this instruction manual before loading them into a WD. If the medical device are not properly cleaned, subsequent reprocessing will be ineffective.

Ch. 2

2.2 Conditions of fluids for reprocessing and reprocessing devices 2.2.4 WD (Washer disinfector)

(1)

(2)

(3)

(4)

(5)

(6)

Ch. 2 Compatible Reprocessing Methods

Step

Description

1

Precleaning (≤25°C)

2

Cleaning (with detergent, 55°C, 10 minutes)

3

Rinsing (with or without neutralizer)

4

Heating (hot water)

5

Thermal disinfection which serves as the final rinsing (without detergent and neutralizer, 93°C, 5 minutes)

6

Drying (95°C, 10 minutes) (Setting values*1) *1 Olympus tested the compatibility of medical device with the WD compatible with ISO 15883-1, 2. The drying temperature and the drying duration were 110°C and 20 minutes, respectively*2. *2 This value may not be the actual temperature of the medical device being processed in the chamber, but it is a setting value for the WD. The drying temperature for which Olympus confirmed compatibility is 110°C as the WD setting value. In the drying process, the temperature around the product can be affected by various factors (e.g., chamber size, loading amount, layout of devices in the chamber).

• ISO 15883-2 regulate that disinfection temperature give an A0 of at least 600. Olympus recommends that WD provide an A0 value of 3,000. • Do not use a program that exceeds 55°C in the cleaning process and 93°C in the disinfection process. • Do not use a program that exceeds 10 minutes in the disinfection process. • Confirm that there are no sudden temperature fluctuations in the program you have selected. • Olympus performed validation using a WD compliant with ISO 15883-1, 2 requirements.

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CH-S700-XZ-EA REPROCESSING MANUAL

2.2 Conditions of fluids for reprocessing and reprocessing devices 2.2.4 WD (Washer disinfector)

 Detergent solution for WD • Use a low-foaming, medical-grade, alkaline enzymatic detergent (20 – 55°C, ≤pH 10.8). • Use a detergent that is compatible with WD and is approved for use by your national regulatory agency. • The following table indicates the detergent used for the validation. Trade name ®

neodisher Mediclean forte

Type Alkaline enzymatic

Manufacturer Dr. Weigert

Ch. 2 Compatible Reprocessing Methods

 Neutralizer

If rinsing with neutralizers after cleaning/disinfection is necessary, make sure to remove all traces of neutralizers by using the water as described in the instruction manuals for WD. Use neutralizers recommended in the instruction manuals for the WD and detergent.

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