CH-S200-08-LB HD 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 ... 6

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 ... 14

3.4

Disinfectant solution for manual disinfection ... 14

3.5

Water ... 15

3.6

Rinse water ... 16

3.7

Washer-Disinfector ... 16

3.8

Ethylene oxide gas sterilization ... 19

3.9

Hydrogen peroxide sterilization ... 20

3.10 Steam sterilization (autoclaving) (Cleaning brush (MAJ-1534) only) ... 22 3.11 Signs of degradation from reprocessing and its number of times ... 24

Chapter 4 Reprocessing Workflow for the Camera Head and Accessory ... 27 4.1

Workflow for manually cleaning and disinfecting the camera head and accessory ... 27

4.2

Workflow for manually cleaning and sterilizing the camera head device and accessory ... 28

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Contents

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

Summary of reprocessing the camera head device ... 29

5.2

Nomenclature of the camera head device ... 31

5.3

Preparing the equipment for reprocessing ... 32 Equipment needed ... 32

5.4

Precleaning the camera head device ... 33 Equipment needed ... 33 Precleaning ... 34

5.5

Manually cleaning the camera head device ... 35 Equipment needed ... 35 Immersing the camera head device in detergent solution ... 36 Clean the external surface ... 46 Rinse off the detergent solution ... 59 Dry the external surface ... 66 Inspect the external surface after it has been dried ... 67

5.6

Manually disinfecting the camera head device ... 68 Equipment needed ... 68 Immerse the camera head device in the disinfectant solution ... 68 Remove camera head device from disinfectant solution ... 75

5.7

Rinsing the disinfectant solution and drying the camera head device ... 75 Equipment needed ... 75 Rinsing off the disinfectant solution ... 76 Dry the external surface ... 83 Inspect the external surface after it has been dried ... 84

5.8

Sterilization ... 85 Inspect the external surface for debris ... 85 Equipment needed ... 86 Ethylene oxide gas sterilization ... 86 STERRAD® 100S/100NX®/NX® sterilization ... 88 V-PRO® maX sterilization ... 90

5.9

Presoaking the camera head device ... 91 Equipment needed ... 92 Presoaking the camera head device ... 92

Chapter 6 Reprocessing the Accessory ... 93 6.1

Summary of reprocessing the accessory ... 93 Equipment needed ... 94

6.2

Manually cleaning the accessory ... 95

6.3

Manually disinfecting the accessory ... 96

6.4

Rinsing the accessory following disinfection ... 98 Rinse the accessory ... 98

6.5

Sterilizing the accessory ... 99 Steam sterilization (autoclaving) ... 99

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Contents

Chapter 7 Reprocessing the Camera Head and Accessory Using a Washer-Disinfector ... 101 7.1

Reprocessing the camera head and accessory using a Washer-Disinfector ... 101

Chapter 8 Storage and Disposal ... 103 8.1

Precautions of storage and disposal ... 103

8.2

Storing the disinfected camera head and accessory ... 105

8.3

Storing the sterilized camera head and accessory ... 106

8.4

Disposal ... 106

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Contents

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1.1 Instructions

Chapter 1 1.1

General Policy

Ch.1

Instructions • This manual contains the reprocessing methods recommended by Olympus for the camera head devices listed on the front cover. • This instruction manual contains essential information on reprocessing camera heads device safely and effectively. • Before reprocessing, thoroughly review this manual and the manuals of 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 device consists of this manual and the “OPERATION MANUAL” with your camera head device model listed on the cover. Both manuals accompanied the camera head device 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 requirements of ISO 17664: 2017.

 Terms used in this manual WD: WD is the abbreviation for Washer-Disinfector, which is used for reprocessing heat-stable endoscopes, accessories and medical instruments employing pH-alkaline or neutral cleaning and thermal disinfection. 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 for manual 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 of 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 device, accessories, and all the other reprocessing equipment • Structure and handling of camera head device 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. There are no manual:

signs in this

DANGER

Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.

WARNING

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

CAUTION

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage.

NOTE

2

DANGER

Indicates additional helpful information.

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1.4 Precautions

1.4

Ch.1

Precautions WARNING • An insufficiently reprocessed camera head device and accessory may pose an infection control risk to the patients and/or operators who contact them. • Video system center, 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 a WD), and all sterilization methods (whether performed by ethylene oxide gas, low temperature gas, steam, STERRAD® or V-PRO®) require thorough cleaning of the instruments before. If the instruments are 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 and its accessories. • Residual disinfectant solution and detergent solution may cause adverse reactions in patients. Therefore, rinse all external surfaces of the camera head device thoroughly with water to remove residual disinfectant solution and detergent solution following 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 head devices 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 device 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 device 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 device 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 device and accessory. • Only use a WD that meets the requirements of the relevant parts of ISO 15883 series. • Before using a WD, confirm that it is capable of reprocessing the camera head device. • 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 device 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, please follow the respective guidelines in your country.

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1.5 Reprocessing before the first use

Ch.1

WARNING • The camera head device may be damaged by published methods for destroying or inactivating prions. For information on the durability of Olympus equipment against a particular reprocessing method, please contact Olympus. In general, Olympus cannot guarantee the effectiveness, safety, and durability of reprocessing methods not described in this reprocessing manual. If you choose 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 device’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 device 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. • Do not steam sterilize this camera head device. This camera head device will be damaged.

1.5

Reprocessing before the first use

New camera head devices and repaired camera head devices are not reprocessed prior to shipping from Olympus, regardless of whether those camera head devices are for new purchase, demo, or loaner purposes. Reprocess all such camera head devices 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. • Disinfectant solutions are 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 successful disinfection. • If the disinfectant solution is reused, check its efficacy by proper methods, such as using test strip, according to the disinfectant manufacturer’s recommendations prior to use. • To maintain sterility of equipment following sterilization, use sterile packaging and wraps according to national guidelines. • Store the camera head device and accessories 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.

1.7

Reprocessing before patient procedure WARNING Improper handling, such as touching a reprocessed camera head device 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 devices 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.

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1.7 Reprocessing before patient procedure

Confirm that the camera head device has undergone proper reprocessing following its last use and that it has been stored properly. Check the storage period of reprocessed camera head devices, 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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Ch.1

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) Brush head

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

 Inspection Inspect the cleaning brush by checking the following points. Check both visually and by touch.

1.

Check the brush head for loose or missing bristles.

2.

Visually check for debris on the bristles of the brush head. If there is debris on the brush, reprocess it as described in Chapter 6. NOTE The cleaning brush does not need to be reprocessed prior to its first use.

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2.1 Cleaning brush (MAJ-1534, sold separately)

Ch.2

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3.1 Compatibility summary

Chapter 3

3.1

Compatible Reprocessing Methods Ch.3

Compatibility summary

The camera head 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 3.11, “Signs of degradation from reprocessing and its number of times”. 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 the manufacturer’s instructions. Repeated use and reprocessing of camera head and accessory lead 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 and accessory for damage, according to the instructions described in this manual and its companion “OPERATION MANUAL”. • The Instructions provided in this manual regarding compatible reprocessing methods 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 and reprocessing efficacy 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

Cleaning blush (MAJ-1534)

Ultrasonic cleaning Manual cleaning

Alkaline enzymatic detergent

Manual disinfection

Peracetic acid

Drying

Alcohol

Automatic cleaning and disinfection

AER

Neutral enzymatic detergent Glutaraldehyde ETD Double (Peracetic acid) ETD 4 (Peracetic acid) ETD 4 (Glutaraldehyde) WD (Alkaline detergent, thermal disinfection) compatible

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not compatible

3.2 List of compatible methods

Camera head

Sterilization

Hydrogen perioxide

Cleaning blush (MAJ-1534)

V-PRO® maX (Non Lumen cycle)*1

Ch.3

STERRAD® NX® with ALL Clear Technology (Standard cycle)*2, *3 STERRAD® NX® (Standard cycle)*2 STERRAD® 100NX® with ALL Clear Technology (Duo cycle)*2, *3 STERRAD®100NX® (Duo cycle)*2 STERRAD® 100S (Short cycle )*2 Steam sterilization (autoclaving) Ethylene oxide gas sterilization compatible

Table 3.1

not compatible

List of compatible methods

*1 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. *2 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. *3 Olympus products can be processed with or without ALLClear™ Technology. For further details, contact ASP.

CAUTION Do not sterilize the camera head with steam. Do not reprocess the camera head in an AER. Otherwise, the camera head will be damaged.

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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 of the camera head and accessory, 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 camera head and accessory that has been approved by your national regulatory for use in reprocessing flexible scopes and accessories. 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

Manufacturer

Alkaline enzymatic

Dr. Weigert

Endozime® AW

Neutral enzymatic

Ruhof

Table 3.2

3.4

Type

neodisher® Mediclean forte

Detergents used for validation

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.” • 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.

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3.5 Water

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. 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

Ch.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’s 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® Activated Dialdehyde Solution

Glutaraldehyde

Advanced Sterilization Products

Table 3.4

3.5

Disinfectants used for validation

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.

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