CH-S200-XZ-EA HD 3CMOS Camera Head Reprocessing Manual Dec 2021

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 ... 5

1.7

Reprocessing before patient procedure ... 6

Chapter 2 Function and Inspection of the Accessory for Reprocessing ... 7 2.1

Cleaning brush (MAJ-1534, sold separately) ... 7

Chapter 3 Compatible Reprocessing Methods and Chemical Agents ... 9 3.1

Compatibility summary ... 9 Microbiological efficacy ... 10 Material durability ... 10 List of compatible methods validated in terms of microbiological efficacy and material durability ... 11

3.2

Water (for reprocessing) ... 12

3.3

Detergent solution ... 12

3.4

Disinfectant solution ... 12

3.5

Rinse water ... 13

3.6

Steam sterilization (autoclaving) ... 13

Chapter 4 Reprocessing Workflow for the Camera Head and Accessory ... 15 4.1

Summary of reprocessing workflow ... 15

4.2

Workflow for manually cleaning and disinfecting the camera head and accessory ... 16

4.3

Workflow for manually cleaning and sterilizing the camera head and accessory ... 17

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Contents

Chapter 5 Reprocessing the Camera Head ... 19 5.1

Summary of reprocessing the camera head ... 19

5.2

Preparing the equipment for reprocessing ... 21 Equipment needed ... 21

5.3

Precleaning the camera head ... 22 Equipment needed ... 22 Precleaning ... 22

5.4

Manually cleaning the camera head ... 23 Equipment needed ... 23 Disconnect the camera head from the video system center ... 23 Immerse the camera head in detergent solution ... 24 Clean the external surface ... 27 Remove detergent solution from the camera head ... 29 Dry external surfaces ... 29

5.5

Manually disinfecting the camera head ... 29 Equipment needed ... 29 Preparation ... 30 Immerse the camera head in disinfectant solution ... 30 Remove the camera head from disinfectant solution ... 31

5.6

Rinsing the camera head following disinfection ... 32 Equipment needed ... 32 Rinse the camera head ... 33

5.7

Sterilizing the camera head ... 34 Steam sterilization (autoclaving) of the camera head ... 34 STERRAD® 100S/100NX® /NX® sterilization of the camera head ... 35 V-PRO® maX sterilization of the camera head ... 36

Chapter 6 Reprocessing the Accessory ... 37 6.1

Summary of reprocessing the accessory ... 37 Equipment needed ... 38

6.2

Manually cleaning the accessory ... 39

6.3

Manually disinfecting the accessory ... 40

6.4

Rinsing the accessory following disinfection ... 41 Rinse the accessory ... 41

6.5

Sterilizing the accessory ... 42 Steam sterilization (autoclaving) ... 42

Chapter 7 Storage and Disposal ... 43

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7.1

Precaution of storage and disposal ... 43

7.2

Storing the disinfected camera head and accessory ... 45

7.3

Storing the sterilized camera head and accessory ... 45

7.4

Disposal ... 45 CH-S200-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 listed on the front cover. • This instruction manual contains essential information on reprocessing camera heads 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.

 Terms used in this manual Disinfection: Some countries classify the disinfection level and define “high-level disinfection”, and other countries do not. The term “disinfection” is used, including meaning “high-level disinfection” in this manual. For disinfectant solution, follow the instructions as described in Section 3.4, “Disinfectant solution”.

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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 hospital • 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.

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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 it. • All disinfection methods and all sterilization methods 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 may cause adverse reactions in patients. Therefore, rinse all external surfaces of the camera head thoroughly with water to remove residual disinfectant 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. • 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.

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1.4 Precautions

Ch.1

WARNING • 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. • 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, follow the respective guidelines in your country. • 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. • Do not sterilize the camera head with ethylene oxide gas. It may pose an infection control risk to the patients and/or operators who get in contact with the camera head.

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1.5 Reprocessing before the first use

Ch.1

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.

1.6

Reprocessing and storage after use WARNING • Do not reuse rinse water. • 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.

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1.7 Reprocessing before patient procedure

Ch.1

1.7

Reprocessing before patient procedure WARNING • Improper storage practices, such as not thoroughly drying external surfaces prior to storage, will lead to an infection control risk. • 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 heads prior to their first use of the day. 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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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.

 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 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 3.2, “Water (for reprocessing)” and clean the brush until no debris is observed on the brush.

4 Check the grip section for scratches and other damage.

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2.1 Cleaning brush (MAJ-1534, sold separately)

CAUTION If the ancillary equipment malfunctions, do not use it.

Ch.2 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

Compatible Reprocessing Methods and Chemical Agents Ch.3

3.1

Compatibility summary

The camera head is compatible with several methods of reprocessing. However, not all reprocessing methods are compatible with all camera heads. Reprocessing with incompatible methods can cause equipment damage even if the number of reprocessing cycles is small. For appropriate reprocessing methods, see Table 3.1. Follow the policies at your local institution when choosing which methods listed in Table 3.1 to employ.

CAUTION • The 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 material compatibility. Olympus provides information regarding validated methods in terms of the following two criteria.  Microbiological efficacy  Material durability

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3.1 Compatibility summary

 Microbiological efficacy If it is stated that a method is “validated” in terms of microbiological efficacy, it means that instruments have been reprocessed successfully using the standardized method described in this manual.

Ch.3

 Material durability If it is stated that a method is “validated” in terms of material durability, it means that the method can be adopted as a repetitive reprocessing procedure.

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3.1 Compatibility summary

 List of compatible methods validated in terms of microbiological efficacy and material durability For sterilization

Ethylene oxide gas sterilization Steam sterilization (autoclaving)

Ch.3

STERRAD® 100S (Short cycle)*1 /100NX® (Duo cycle)*1 /NX®(Standard cycle)*1 V-PRO®maX (Non Lumen cycle)*2 For disinfection

2 – 3.5% glutaraldehyde

For cleaning

Detergent solution Ultrasonic cleaning

Camera head (CH-S200-XZ-EA)

Cleaning brush (MAJ-1534) compatible

not compatible

Table 3.1 *1 Olympus products have been validated by ASP (Advanced Sterilization Products) for the microbiological efficacy. As for the sterilizer, contact ASP. Also, refer to the “STERRAD® 100S/100NX®/NX®” instruction manual. *2 Olympus products have been validated by STERIS Corporation for the microbiological efficacy. As for the sterilizer, contact STERIS Corporation. Also, refer to the “V-PRO® maX” instruction manual.

WARNING U.S. FDA recommends cleaning and sterilization, and not high-level disinfection, of the camera head (CH-S200-XZ-EA).

NOTE • Camera heads that are marked by the words “AUTOCLAVE” or “AUTOCLAVABLE” are compatible with steam sterilization (autoclaving).

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3.2 Water (for reprocessing)

3.2

Water (for reprocessing)

Water is used for manual cleaning of the camera head. For this purpose, 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 hospital’s infection control committee.

Ch.3

When rinsing the camera head following disinfection, use the water as described in Section 3.5, “Rinse water”.

3.3

Detergent solution WARNING • Excessive foaming prevents detergent solution from properly contacting the surfaces of the camera head, and may impair effective cleaning. • Do not reuse detergent solution.

Use a medical-grade, low-foaming, neutral pH detergent. Follow the instructions provided by the detergent manufacturer regarding concentration, temperature, contact time, and expiration date. Contact Olympus for the names of specific brands of detergent solution that have been tested for compatibility with camera heads.

3.4

Disinfectant solution

Use a disinfectant cleared/approved by your national regulatory agency for use in reprocessing flexible endoscopes. In case national or professional guidelines applicable for your institution define “high-level disinfection” and require using a high-level disinfectant for the camera heads, follow the requirement. Follow the disinfectant manufacturer’s instructions regarding activation (if required), concentration, temperature, contact time, and expiration date. For further information regarding the compatibility of glutaraldehyde-based or non glutaraldehyde-based disinfectant solution, contact Olympus.

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3.5 Rinse water

3.5

Rinse water

Use sterile water for rinsing the camera head following disinfection. If sterile water is not available, 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 hospital’s infection control committee regarding local policies on water quality.

3.6

Steam sterilization (autoclaving)

The camera head and accessory listed as compatible with steam sterilization in Table 3.1 can be sterilized by steam within the parameters given in Table 3.2. When steam sterilizing, follow all national, professional, and institutional reprocessing protocols as well as the instructions provided by the manufacturer of your sterilization equipment.

WARNING Steam sterilization of the camera head and accessory must be performed according to the conditions specified in this section. Autoclaving the camera head and accessory using a sterilization cycle that does not meet the specified conditions may result in a failure to achieve sterilization of the camera head and accessory.

CAUTION • If the condition of the steam sterilization exceed the parameters (i.e. 134C (274F), 18 minutes) given in Table 3.2, the camera head and accessory may be damaged. • Employ the full autoclaving cycle indicated in Table 3.2, including the vacuum-drying cycle after autoclaving. Without the vacuum-drying cycle, the camera head and accessory may malfunction or become damaged.

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Ch.3

3.6 Steam sterilization (autoclaving)

 Parameters for prevacuum steam sterilization cycles

Ch.3

Value

Process phase

Parameter

Prevacuum steam sterilization cycle

Set temperature

132C (270F)

134C (274F)

134C (274F)

Set exposure time

4 minutes

3 minutes

18 minutes

Drying

Set drying time

For countries other than the USA

a minimum of 30 minutes

For the camera head • If the sterile packaging of camera head or accessory taken out of the sterilizer is wet, sterilization effect may not be maintained. Reconsider conditions such as drying time and sterilize again. • Drying time depends on kinds of sterilizer, type of sterile packaging and volume of loading. Confirm the appropriate drying time beforehand.

Table 3.2

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4.1 Summary of reprocessing workflow

Chapter 4

4.1

Reprocessing Workflow for the Camera Head and Accessory

Summary of reprocessing workflow

Ch.4

This chapter describes the workflow for reprocessing the camera head.

WARNING Deviation from the recommended workflow may pose an infection control risk.

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4.2 Workflow for manually cleaning and disinfecting the camera head and accessory

4.2

Workflow for manually cleaning and disinfecting the camera head and accessory

Camera head

Ch.4

Cleaning brush (MAJ-1534)

Patient procedure Section 5.3, “Precleaning the camera head” Section 5.4, “Manually cleaning the camera head” Section 5.5, “Manually disinfecting the camera head” Section 5.6, “Rinsing the camera head following disinfection” Section 6.2, “Manually cleaning the accessory” Section 6.3, “Manually disinfecting the accessory” Section 6.4, “Rinsing the accessory following disinfection” Section 7.2, “Storing the disinfected camera head and accessory”

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4.3 Workflow for manually cleaning and sterilizing the camera head and accessory

4.3

Workflow for manually cleaning and sterilizing the camera head and accessory NOTE *1 If required by the local policy of your institution, disinfect and rinse the camera head manually between manual cleaning and sterilization.

Ch.4

Cleaning brush (MAJ-1534)

Camera head

Patient procedure Section 5.3, “Precleaning the camera head” Section 5.4, “Manually cleaning the camera head” *1 Section 5.7, “Sterilizing the camera head”

Section 6.2, “Manually cleaning the accessory” *1 Section 6.5, “Sterilizing the accessory” Section 7.3, “Storing the sterilized camera head and accessory”

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