CH-S400-XZ-EA 4K Autoclavable Camera Head Reprocessing Manual

Contents

Contents Chapter 1 General Policy ... 1 1.1

Instructions ... 1

1.2

Importance of reprocessing ... 2

1.3

Signal words ... 2

1.4

Precautions ... 3

1.5

Reprocessing before the first use ... 5

1.6

Reprocessing and storage after use ... 6

1.7

Reprocessing before patient procedure ... 7

Chapter 2 Function and Inspection of the Accessory for Reprocessing ... 9 2.1

Cleaning brush (MAJ-1534, sold separately) ... 9

Chapter 3 Compatible Reprocessing Methods ... 11 3.1

Compatibility summary ... 11

3.2

List of compatible methods ... 12

3.3

Detergent solution for manual cleaning ... 13

3.4

Disinfectant solution for manual disinfection ... 14

3.5

Water ... 15

3.6

Rinse water ... 15

3.7

Washer-Disinfector ... 15

3.8

Hydrogen peroxide sterilization ... 18

3.9

Steam sterilization (autoclaving) ... 20

3.10 Signs of degradation from reprocessing and maximum number of reprocessing ... 21

Chapter 4 Reprocessing Workflow for Camera head and Accessories ... 23 4.1

Summary of reprocessing workflow ... 23

4.2

Workflow for reprocessing camera head and accessory ... 24

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Contents

Chapter 5 Reprocessing the Camera Head ... 25 5.1

Summary of reprocessing the camera head ... 25

5.2

Preparing the equipment for reprocessing ... 27 Equipment needed ... 27

5.3

Precleaning the camera head ... 28 Equipment needed ... 28 Precleaning ... 28

5.4

Manually cleaning the camera head ... 29 Equipment needed ... 29 Disconnect the camera head from the camera control unit ... 29 Immerse the camera head in detergent solution ... 30 Clean the external surface ... 33 Remove detergent solution from the camera head ... 34 Dry the camera head ... 34

5.5

Manually disinfecting the camera head ... 35 Equipment needed ... 35 Preparation ... 35 Immerse the camera head in disinfectant solution ... 35 Remove the camera head from disinfectant solution ... 36

5.6

Rinsing the camera head following disinfection ... 37 Equipment needed ... 37 Rinse the camera head ... 38 Dry the camera head ... 38

5.7

Sterilizing the camera head ... 39 Steam sterilization (autoclaving) of the camera head ... 39 STERRAD® 100S/100NX®/NX® sterilization of the camera head ... 40 V-PRO® maX sterilization of the camera head ... 41

Chapter 6 Reprocessing the Accessory ... 43 6.1

Summary of reprocessing the accessory ... 43 Equipment needed ... 44

6.2

Manually cleaning the accessory ... 45 Manually cleaning the accessory ... 45 Dry the accessory ... 45

6.3

Manually disinfecting the accessory ... 46

6.4

Rinsing the accessory following disinfection ... 47 Rinse the accessory ... 47 Dry the accessory ... 47

6.5

Sterilizing the accessory ... 48 Steam sterilization (autoclaving) ... 48

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Contents

Chapter 7 Reprocessing the Camera Head and accessory Using an Washer-Disinfector ... 49 7.1

Reprocessing the camera head and accessory using an Washer-Disinfector ... 49 Reprocessing the camera head and accessory ... 49 Dry the camera head and accessory ... 50

Chapter 8 Storage and Disposal ... 51 8.1

Precaution of storage and disposal ... 51

8.2

Storing the disinfected camera head and accessory ... 53

8.3

Storing the sterilized camera head and accessory ... 53

8.4

Disposal ... 53

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Contents

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CH-S400-XZ-EA REPROCESSING MANUAL

1.1 Instructions

Chapter 1 1.1

General Policy

Ch.1

Instructions • This manual contains the reprocessing methods recommended by Olympus for the camera heads and accessories listed on the front cover. • This instruction manual contains essential information on reprocessing camera heads and accessories safely and effectively. • Before reprocessing, thoroughly review this manual and the manuals for the reprocessing equipment and chemicals that will be used for reprocessing. Reprocess all the devices as instructed. • Note that the complete instruction manual set for the camera head consists of this manual and the “OPERATION MANUAL” with your camera head model listed on the cover. Both manuals accompanied the camera head at shipment. • Keep this manual and all related manuals in a safe and accessible location (e.g., in the reprocessing area). • If you have any questions or comments about any information in this manual, or if a problem that cannot be solved occurs while reprocessing, contact Olympus. • This manual is based on the requirement of ISO 17664: 2017.

 Terms used in this manual WD: WD is the abbreviation for Washer-Disinfector, which is used for reprocessing the heat-stable endoscopes, accessories and medical instruments employing alkaline cleaning and thermal disinfection.

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1.2 Importance of reprocessing

Ch.1

1.2

Importance of reprocessing

The medical literature reports incidents of cross-contamination resulting from improper reprocessing. It is strongly recommended that all individuals engaged in reprocessing closely observe all instructions given in this manual and the manuals for all ancillary equipment, and have a thorough understanding of the following items: • Professional health and safety policies of your healthcare facility • Instruction manuals for the camera head, accessories, and all the other reprocessing equipment • Structure and handling of camera head and accessories • Handling of pertinent chemicals When selecting appropriate methods and conditions for cleaning and disinfection and sterilization, follow the policies at your institution, applicable national laws and standards, and professional society guidelines and recommended practices, in addition to the instructions given in this manual.

1.3

Signal words

The following signal words are used throughout this manual:

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

2

Indicates additional helpful information.

CH-S400-XZ-EA REPROCESSING MANUAL

1.4 Precautions

1.4

Ch.1

Precautions WARNING • An insufficiently reprocessed camera head may pose an infection control risk to the patients and/or operators who contact them. • The camera head reprocessor, light source, and/or front panels of equipment may cause an infection control risk. Perform proper cleaning and disinfection as described in their respective instruction manuals. A tap or basin that medical personnel come in contact with may cause an infection control risk as well. Perform proper replacement, cleaning, and disinfection. • All disinfection methods (whether performed manually or by an WD) and all sterilization methods (whether performed by low temperature or steam) require thorough prior cleaning of the instrument being reprocessed. If the equipment is not adequately cleaned prior to disinfection/sterilization, these processes will be ineffective. Immediately after each patient procedure and before disinfection/sterilization, thoroughly clean the camera head. • Residual disinfectant solution and detergent solution may cause adverse reactions in patients. Therefore, rinse all external surfaces of the camera head thoroughly with water to remove residual disinfectant solution and detergent solution after disinfection. • The results of sterilization depend on various factors. These factors include how the equipment was packaged, and the placing and loading of the package in the sterilization device. Verify the sterilization process using biological and/or chemical indicators. Follow the guidelines for sterilization issued by national authorities, professional organizations, and infection control professionals, including the frequency of the above verification, as well as the instruction manual for the sterilization device. • Establish an internal system of identifying contaminated versus reprocessed camera heads to prevent both mix-ups and cross-contamination. Some national or professional guidelines recommend separating dirty (contaminated) area, clean area, and storage area. Touching a reprocessed camera head with contaminated gloves or placing it on a contaminated hanger or surface, including letting it touch the floor, will recontaminate it. • Prior to each patient procedure, confirm that the camera head has been properly reprocessed and stored. If there are any doubts or questions, reprocess it again before the patient procedure, following the instructions given in this manual.

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1.4 Precautions

Ch.1

WARNING • The accessory listed on the front cover of this manual is consumable, meaning that this accessory cannot be refurbished or repaired and is intended to be replaced once it shows any signs of wear and tear. Should any irregularity be observed, use a replacement accessory instead. Using a defective accessory may cause equipment malfunction, reduce the efficacy of reprocessing, present a risk to patients and/or operators, or damage the camera head and/or accessories. • Patient debris and used reprocessing chemicals pose infection control risks. To guard against contact with dangerous chemicals and potentially infectious material, wear appropriate personal protective equipment during reprocessing. Such protective equipment should include appropriate eyewear, face mask, cap, moisture-resistant clothing, shoe covers, and chemical-resistant gloves that fit properly and are long enough to prevent skin exposure. • The reprocessing room must be adequately ventilated to minimize the risks from chemical vapors. • Always remove contaminated personal protective equipment before leaving the reprocessing area to prevent contamination from spreading. • Only Olympus-recommended or Olympus-endorsed WDs have been validated by Olympus. When using a WD that is not recommended by Olympus, the manufacturer of the WD is responsible for validating compatibility of the WD with each Olympus camera head and accessory. • Only use the WD that meets the requirements of the relevant parts of ISO 15883 series. • Instructions provided in this manual are not valid for Olympus devices repaired by a non-Olympus facility. The Olympus recommended reprocessing procedures have not been validated for reprocessing devices repaired by a non-Olympus facility. In the event that your device has been repaired by a non-Olympus facility, it may pose an infection control risk to the patients and/or operators who contact them. • Prions, which are the pathogenic agents of the Creutzfeldt-Jakob disease (CJD), cannot be destroyed or inactivated by the reprocessing methods stated in this instruction manual. When using the camera head on patients with CJD or variant Creutzfeldt-Jakob disease (vCJD), be sure to use it for such patients only, or immediately dispose of it after use in an appropriate manner to prevent the usage of exposed devices on other patients. For methods to handle CJD/vCJD, follow the respective guidelines in your country.

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1.5 Reprocessing before the first use

Ch.1

WARNING • The camera head may be damaged by published methods for destroying or inactivating prions. For information on the durability of Olympus equipment against a particular reprocessing method, contact Olympus. In general, Olympus cannot guarantee the effectiveness, safety, and durability of reprocessing methods not described in this reprocessing manual. If you chose to use a reprocessing method not recommended in this manual, the local institution and/or physicians must assume responsibility for its safety and efficacy. Make sure to carefully inspect each piece of camera head’s equipment for irregularities (damage) prior to each patient procedure. Do not use the equipment if any irregularity is found. • Good quality control practices typically require appropriate documentation. Items such as local SOPs (Standard Operating Procedures), confirmation of operator training, routine testing of the disinfectant’s MEC (Minimal Effective Concentration), confirmation of the disinfectant’s use-life, etc. should be documented as performed. • In case of performing any microbial test or other test using extraction fluid on the reprocessed camera head, the reprocessing process has to be performed again according to this “REPROCESSING MANUAL” before patient procedure.

CAUTION • To prevent damage, do not apply excessive force to the camera head during reprocessing. • Vapors from disinfectant solution and alcohol may damage electronic devices such as computers. Properly manage the quality and durability of the devices used in reprocessing rooms and the ventilation performance of the rooms.

1.5

Reprocessing before the first use

New camera heads and repaired camera heads are not reprocessed prior to shipping from Olympus, regardless of whether those camera heads are for new purchase, demo, or loaner purposes. Reprocess all such camera heads received from Olympus according to the instructions given in this manual before storage and before using them in a patient procedure.

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1.6 Reprocessing and storage after use

Ch.1

1.6

Reprocessing and storage after use WARNING • Do not reuse detergent solution. • Do not reuse rinse water. • Detergent and disinfectant solutions are only effective when used according to the detergent and disinfectant manufacturer’s instructions. Follow the manufacturer’s instructions regarding activation (if required), concentration, temperature, contact time and use life required to achieve successful cleaning and disinfection. • Disinfectant solution is only effective when used according to the disinfectant manufacturer’s instructions. Follow the manufacturer’s instructions regarding activation (if required), concentration, temperature, contact time and use life required to achieve disinfection. • If the disinfectant solution is reused, check its efficacy by proper methods, such as using a test strip, according to the disinfectant manufacturer’s recommendations prior to use. • To maintain sterility of equipment following sterilization, use sterile packaging according to national guidelines. • Store the camera head and accessory in a proper storage cabinet, following the policies at your institution, applicable national laws and standards, and professional society guidelines and recommended practices. • Improper storage practices, such as not thoroughly drying external surfaces prior to storage, will lead to an infection control risk.

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1.7 Reprocessing before patient procedure

1.7

Ch.1

Reprocessing before patient procedure WARNING Improper handling, such as touching a reprocessed camera head with contaminated gloves, placing a reprocessed device on a contaminated hanger or surface, allowing devices to touch the floor, etc. will recontaminate the device.

NOTE Some national or professional guidelines recommend reprocessing camera head prior to their first use of the day, when the certain time passes after disinfecting/sterilizing, or in case the storage time recommended by the national authorities is exceeded. Confirm that the camera head has undergone proper reprocessing following its last use and that it has been stored properly. Check the storage period of reprocessed camera heads, and check for surface contamination (e.g., dust). Check the expiration date marked on all items and check for tears or breaches in the sterile packaging. If there are any doubts or questions concerning whether a device is contaminated, reprocess it again following the instructions given in this manual.

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1.7 Reprocessing before patient procedure

Ch.1

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2.1 Cleaning brush (MAJ-1534, sold separately)

Chapter 2

Function and Inspection of the Accessory for Reprocessing

Ch.2

A certain accessory is required for reprocessing the camera head. This chapter describes the function of the accessory. It also describes how to inspect the accessory before using it to reprocess the camera head.

2.1

Cleaning brush (MAJ-1534, sold separately)

Grip section

Figure 2.1

 Function The cleaning brush is used to brush the external surfaces and openings of the camera head.

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2.1 Cleaning brush (MAJ-1534, sold separately)

 Inspection 1 Check the brush head for loose or missing bristles. 2 Check the bristles for any damage. If the bristles are crushed, gently straighten them

Ch.2

with your gloved fingertips.

3 Visually check for debris on the bristles of the brush head. If there is debris on the brush, immerse the brush in the water as described in Section 3.5, “Water” and clean the brush until no debris is observed on the brush.

4 Check the grip section for scratches and other damage. CAUTION If the ancillary equipment malfunctions, do not use it.

NOTE The cleaning brush does not need to be reprocessed prior to its first use.

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3.1 Compatibility summary

Chapter 3 3.1

Compatible Reprocessing Methods

Compatibility summary

Ch.3

The camera headend and accessory are compatible with several methods of reprocessing. For information concerning the applicable reprocessing methods and parameters, refer to Section 3.2, “List of compatible methods”. Additionally, some reprocessing methods may cause degradation of medical devices that shortens product life. For information concerning degradation of medical devices from reprocessing and maximum number of reprocessing, refer to Section 3.10, “Signs of degradation from reprocessing and maximum number of reprocessing”, “Signs of degradation from reprocessing and maximum number of reprocessing”. Follow the policies at your local institution when choosing which methods to employ.

CAUTION • Methods listed as “compatible” in Table 3.1 are compatible for routine use only when used according to manufacturer’s instructions. Repeated use and reprocessing of camera heads leads to gradual wear and tear. Furthermore, reprocessing methods that employ higher temperatures and more caustic/corrosive materials may lead to faster deterioration. In general, sterilization processes are harsher on equipment than disinfection processes. Before each patient procedure, inspect the camera head for damage, according to the instructions described in this manual and its companion “OPERATION MANUAL”. • The instructions provided in this manual regarding material compatibility are not valid for Olympus devices repaired by a non-Olympus facility. Olympus repairs devices to manufacturer’s specifications using original equipment manufacturer’s (OEM) materials. The use of non-OEM materials to repair an Olympus device may affect the material compatibility of the device with certain reprocessing chemicals or methods. In the event that your device has been repaired by a non-Olympus facility, contact the repair facility for instructions regarding compatible reprocessing methods.

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3.2 List of compatible methods

3.2

List of compatible methods

Reprocessing methods listed in Table 3.1 have been validated with this camera head and accessory. For details on the chemicals and devices that can be used, refer to Section 3.3 and subsequent sections.

Ch.3

Camera head (CH-S400-XZ-EA)

Cleaning brush (MAJ-1534)

Ultrasonic cleaning Manual Alkaline enzymatic detergent cleaning Neutral enzymatic detergent Manual disinfection Drying Automatic cleaning and disinfection Sterilization

Peracetic acid Glutaraldehyde Alcohol AER

ETD Double (Peracetic acid) ETD 4 (Peracetic acid) ETD 4 (Glutardehyde) WD (Alkaline detergent, thermal disinfection) Hydrogen V-PRO® maX (Non lumen cycle) peroxide STERRAD® NX® with ALLClear™ Technology (Standard cycle) STERRAD® NX® (Standard cycle) STERRAD® 100NX® with ALLClear™ Technology (Duo cycle) STERRAD® 100NX® (Duo cycle) STERRAD® 100S (Short cycle) Steam (autoclaving) Ethylen oxide gas Low Temperature steam and formaldehyde (LTSF) compatible

Table 3.1

12

List of compatible methods

CH-S400-XZ-EA REPROCESSING MANUAL

not compatible

3.3 Detergent solution for manual cleaning

3.3

Detergent solution for manual cleaning WARNING • Excessive foaming prevents detergent solution from properly contacting the surfaces and channel walls of the endoscope and accessories, and may impair effective cleaning.

Ch.3

• Do not reuse detergent solution. Use a neutral (20 – 45°C) or alkaline (20 – 40°C, <pH 10.8) low-foaming enzymatic detergent with no abrasion labeled for use with endoscopes, accessories and medical instruments that has been approved by your national regulatory for use in reprocessing endoscopes, accessories and medical instruments. Follow the instructions provided by the detergent manufacturer regarding concentration, temperature, contact time, use life, expiration date and rinsing unless otherwise specified by Olympus. The detergents shown in Table 3.2 were used for validation. Trade name

Type

Manufacturer

neodisher® Mediclean forte

Alkaline enzymatic

Dr. Weigert

Endozime® AW

Neutral enzymatic

Ruhof

Table 3.2

Detergents used for validation

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3.4 Disinfectant solution for manual disinfection

3.4

Disinfectant solution for manual disinfection WARNING • As per Advanced Sterilization Products® Safety Alert, dated January 3, 2005, entitled “Labeling Change to Cidex® OPA Solution Instructions for Use” - “In rare instances Cidex® OPA Solution has been associated with anaphylaxis-like reactions in bladder cancer patients undergoing repeated cystoscopies. Therefore, ASP is contraindicating the use of Cidex® OPA Solution for the reprocessing of any urological instruments to be used on patients with a history of bladder cancer.”

Ch.3

• If the disinfectant solution is reused, check its efficacy by proper methods, such as using a test strip, according to the disinfectant manufacturer’s recommendations prior to use. Use a peracetic acid or glutaraldehyde disinfectant with the properties shown in Table 3.3 that has been approved by your national regulatory agency for use in reprocessing flexible endoscopes and accessories. If national or professional guidelines applicable to your institution define “high-level disinfection” and require using a high-level disinfectant for endoscopes, accessories and medical instruments, follow the requirement. Disinfectant

Peracetic acid

Glutaraldehyde

Percentage solution

2 W/V% solution (dissolving the powdery agent with water)

Undiluted solution (mixing undiluted solution with activator)

Disinfectant concentration

Peracetic acid approximately 1000 ppm

Glutaraldehyde approximately 2.4%

Operating temperature

Approximately 25°C

Approximately 25°C

Solution shelf life

Within 24 hours

Within 14 days

Table 3.3

Peracetic acid and Glutaraldehyde disinfectant with properties

Unless otherwise specified by Olympus, follow the disinfectant manufacturer’s instructions regarding activation (if required), concentration, temperature, contact time, use life, expiration date and rinsing. If the disinfectant manufacturer does not specify how many times the disinfectant should be rinsed, perform rinsing at least two times. The disinfectants shown in Table 3.4 were used for validation. Trade name

Type

Manufacturer

Sekusept™ Aktiv

Peracetic acid

ECOLAB

Cidex®

Glutaraldehyde

Advanced Sterilization Products

Activated Dialdehyde Solution

Table 3.4

14

Disinfectants used for validation

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3.5 Water

3.5

Water

 General using for the reprocessing Use either fresh, potable water or water that has been processed (e.g., filtered, deionized, or purified) to improve its chemical and/or microbiological quality. Consult with your institution’s infection control committee.

3.6

Ch.3

Rinse water CAUTION Do not reuse rinse water.

 Rinsing after disinfection Olympus recommends using sterile water, fresh potable water or water that has been processed (e.g., filtered, deionized, or purified) to improve its chemical and/or microbiological quality. Some national or professional guideline recommend using sterile water for rinsing endoscopes, accessories and medical instruments. Consult with your institution’s infection control committee regarding local policies on water quality.

3.7

Washer-Disinfector WARNING • Use only a WD whose compatibility for cleaning accessories has been certified by the WD’s manufacturers, and which meets ISO 15883-1: 2006+A1, ISO 15883-2: 2006 requirement. Using an incompatible WD may pose an infection control risk and may considerably damage the accessories. • Perform manual cleaning of the accessories as described in the instruction manual before loading them into a WD. If the accessories are not properly cleaned, subsequent reprocessing will be ineffective.

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