4K 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 ... 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 ... 10 List of compatible methods validated in terms of material durability ... 11

3.2

Water (for reprocessing) ... 11

3.3

Detergent solution ... 12

3.4

Disinfectant solution ... 12

3.5

Rinse water ... 12

3.6

Automatic thermal cleaning/disinfection ... 13

3.7

Ethylene oxide gas sterilization ... 15

3.8

Steam sterilization (autoclaving) ... 16

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Chapter 4 Reprocessing Workflow for the Camera Head and Accessory ... 17 4.1

Summary of reprocessing workflow ... 17

4.2

Workflow for manually cleaning and disinfecting the camera head and accessory ... 18

4.3

Workflow for manually cleaning and sterilizing the camera head and accessory ... 19

4.4

Workflow for manually cleaning and sterilizing the camera head and accessory ... 20

Chapter 5 Reprocessing the Camera Head ... 21 5.1

Summary of reprocessing the camera head ... 21

5.2

Preparing the equipment for reprocessing ... 23 Equipment needed ... 23

5.3

Precleaning the camera head ... 24 Equipment needed ... 24 Precleaning ... 24

5.4

Manually cleaning the camera head ... 25 Equipment needed ... 25 Disconnect the camera head from the camera control unit ... 25 Immerse the camera head in detergent solution ... 26 Clean the external surface ... 27 Remove detergent solution from the camera head ... 27 Dry external surfaces ... 28

5.5

Manually disinfecting the camera head ... 28 Equipment needed ... 28 Preparation ... 28 Immerse the camera head in disinfectant solution ... 29 Remove the camera head from disinfectant solution ... 29

5.6

Rinsing the camera head following disinfection ... 30 Equipment needed ... 30 Rinse the camera head ... 31

5.7

Sterilizing the camera head ... 32 Ethylene oxide gas sterilization of the camera head ... 32

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Contents

Chapter 6 Reprocessing the Accessory ... 33 6.1

Summary of reprocessing the accessory ... 33 Equipment needed ... 34

6.2

Manually cleaning the accessory ... 35

6.3

Manually disinfecting the accessory ... 36

6.4

Rinsing the accessory following disinfection ... 37 Rinse the accessory ... 37

6.5

Sterilizing the accessory ... 38 Steam sterilization (autoclaving) ... 38

Chapter 7 Reprocessing the Camera Head Using an Automatic Thermal Cleaning/Disinfector ... 39 7.1

Reprocessing the camera head using an automatic thermal cleaning/disinfector ... 39

Chapter 8 Storage and Disposal ... 41 8.1

Precaution of storage and disposal ... 41

8.2

Storing the disinfected camera head and accessory ... 43

8.3

Storing the sterilized camera head and accessory ... 43

8.4

Disposal ... 43

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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 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 them. • All disinfection methods (whether performed manually or by an automatic thermal cleaning/disinfector), and all sterilization methods (whether performed by ethylene oxide gas 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 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. • Store alcohol in an airtight container. Alcohol stored in an open container may cause a fire hazard and may result in a loss of efficacy due to evaporation. • 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.

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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. • Do not steam sterilize the camera head. The camera head will be damaged.

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 and wraps 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 and 3.2. Follow the policies at your local institution when choosing which methods listed in Table 3.1 and 3.2 to employ.

CAUTION • Methods listed as “compatible” in Table 3.1 and 3.2 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”. • 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. Just because the material durability is confirmed, it does not mean a certain degree of microbiological effectiveness is guaranteed.

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

Steam sterilization (autoclaving) Ethylene oxide gas sterilization (gas mixture 20% ethylene oxide gas/80% CO2, for countries other than the USA) Ethylene oxide gas sterilization (100% ethylene oxide gas)

For disinfection

2 – 3.5% glutaraldehyde

For cleaning

Detergent solution Ultrasonic cleaning ‣

Camera head (CH-S400-XZ-EB)

‥

‸ ․

Cleaning brush (MAJ-1534)

compatible

Table 3.1

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not compatible

3.2 Water (for reprocessing)

 List of compatible methods validated in terms of material durability STERRAD® 100S/100NX(Duo cycle)/NX (Standard cycle)*1

Ch.3

Automatic thermal cleaning/disinfector*2 ‣

‥

‸ ․

Camera head (CH-S400-XZ-EB)

Cleaning brush (MAJ-1534)

compatible

not compatible

Table 3.2 *1 ASP (Advanced Sterilization Products) tests the microbiological efficacy of Olympus products in sterility. As for the microbiological efficacy, contact ASP. Also, refer to the “STERRAD® 100S/100NX(Duo cycle)/NX (Standard cycle)” instruction manual. *2 This method may not be available in some areas.

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

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3.3 Detergent solution

3.3

Detergent solution WARNING • Excessive foaming prevents detergent solution from properly contacting the surfaces of the camera head, and may impair effective cleaning.

Ch.3

• 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.

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.

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3.6 Automatic thermal cleaning/disinfection

3.6

Automatic thermal cleaning/disinfection

This method may not be available in some areas.

WARNING

Ch.3

Use only detergents whose feature validated processes in accordance with national and local laws and/or guidelines. There is an infection risk when using insufficient detergents.

CAUTION • Use only washer/disinfector which are intended specifically for cleaning and disinfection of camera heads by the washer/disinfector’s manufacturer. Use only washer/disinfector according to ISO 15883-1, 2. • For details on the operation of the automatic thermal cleaning/disinfector, refer to its instruction manual. • Select a program optimized for cleaning camera heads. • Use only detergents whose compatibility for cleaning camera heads is certified by the automatic thermal cleaning/disinfector’s manufacturers and which are approved by a competent authority. Incompatible detergents may considerably damage Olympus camera heads. Preferably, use enzyme-based agents. Avoid agents containing highly alkaline or acidic compounds, such as citric or phosphoric acid. Corrosion of the instrument’s material may occur. • However, if rinsing with neutralizers after cleaning/disinfection is necessary, make sure to remove all traces of neutralizers by using the water as described in Section 3.5, “Rinse water”. Make sure that the water inflow into the cleaning units starts with sufficient cold temperatures (e.g., 20C) to avoid thermal coagulation of protein. Do not use programs starting with high temperatures (e.g., 93C). • Do not use a lubricant in automatic cleaning/disinfection procedures. Malfunction of camera head may occur. • Regularly maintain the automatic thermal cleaning/disinfector as recommended by its manufacturer.

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3.6 Automatic thermal cleaning/disinfection

 Automatic cleaning/disinfection program

Ch.3

(1)

(2) (3)

(4)

(5)

(6)

Figure 3.1 The washer/disinfector’s program should include at least the following stages: (1) Pre-cleaning (without detergent, 20C) (2) Cleaning (with detergent, 40 – 45C, 5 min) (3) Rinsing (4) Heating (5) Thermal disinfection which serves as the final rinsing (e.g., 93C, 10 min) (6) Drying

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3.7 Ethylene oxide gas sterilization

3.7

Ethylene oxide gas sterilization

The camera head listed as compatible with ethylene oxide gas sterilization in Table 3.1 can be sterilized by ethylene oxide gas and aerated within the parameters given in Table 3.3 and 3.4. When performing ethylene oxide gas sterilization, follow all national, professional, and institutional reprocessing protocols as well as the instructions provided by the manufacturer of your sterilization equipment.

CAUTION Exceeding the recommended parameters may cause equipment damage.

 Parameters for 100% ethylene oxide gas sterilization cycles Process phase Sterilization

Aeration

Parameter

Value

Temperature

55C (130F)

Vacuum (Absolute pressure)

0.05 – 0.07 MPa (7.25 – 10.15 psia)

Relative humidity

50 – 80%

Ethylene oxide gas concentration

0.735 – 0.740 mg/cm3 (735 – 740 mg/L)

Exposure time

60 minutes

Minimum aeration parameters

12 hours in an aeration chamber at 50 – 57C(122 – 135F) or 7 days at room temperature

Table 3.3

 Parameters for 20% ethylene oxide gas/80% CO2 gas sterilization cycles, for countries other than the USA

Process phase Sterilization

Aeration

Parameter

Value

Temperature

55C (130F)

Relative pressure

0.1 – 0.17 MPa

Relative humidity

35 – 85%

Ethylene oxide gas concentration

0.6 – 0.7 mg/cm3 (600 – 700 mg/L)

Exposure time

2 – 4 hours

Minimum aeration parameters

12 hours in an aeration chamber at 50 – 57C (122 – 135F) or 7 days at room temperature

Table 3.4

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Ch.3