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OLYMPUS

OLYMPUS HD Autoclavable Camera CH-S190-XZ-x Reprocessing Instructions

Revision Ver GT9027 01

OLYMPUS Camera System

51 Pages

REPROCESSING MANUAL  INSTRUCTIONS  HD AUTOCLAVABLE CAMERA HEAD  OLYMPUS CH-S190-XZ-E OLYMPUS CH-S190-XZ-Q  Chapter 1  General Policy  1  Chapter 2  Function and Inspection of the Accessory for Reprocessing  7  Compatible Reprocessing Methods and Chemical Agents  9  Reprocessing Workflow for the Camera Head and Accessory  17  Chapter 5  Reprocessing the Camera Head  21  Chapter 6  Reprocessing the Accessory  33  Chapter 7  Reprocessing the Camera Head Using an Automatic Thermal Cleaning/ Disinfector  39  Storage and Disposal  41  Chapter 3  Chapter 4  Chapter 8  Accessories: • Cleaning brush (MAJ-1534, sold separately)  Refer to the camera head’s companion manual, the “OPERATION MANUAL” with your camera head model listed on the cover, for operation information...  Contents  Contents Chapter 1 General Policy ... 1 1...  Instructions ...  1  1...  Importance of reprocessing ...  2  1...  Signal words ...   1...  Precautions ...  3  1...  Reprocessing before the first use ... 5  1...  Reprocessing and storage after use ...   1...  Reprocessing before patient procedure ...   Chapter 2 Function and Inspection of the Accessory for Reprocessing ... 7 2...  Cleaning brush (MAJ-1534, sold separately) ...  7  Chapter 3 Compatible Reprocessing Methods and Chemical Agents ... 3...  Compatibility summary ... 9 Microbiological efficacy ... 10 Material durability ... 0  3...  Water (for reprocessing) ... 2  3...  Detergent solution ... 12  3...  Disinfectant solution ... 2  3...  Rinse water ... 3  3...  Automatic thermal cleaning/disinfection ... 3  3...  Ethylene oxide gas sterilization ... 5  3...  Steam sterilization (autoclaving) ... 16  Chapter 4 Reprocessing Workflow for the Camera Head and Accessory ...  4...  Summary of reprocessing workflow ... 17  4...  Workflow for manually cleaning and disinfecting the camera head and accessory ... 8  4...  Workflow for manually cleaning and sterilizing the camera head and accessory ... 9  4...  Workflow for reprocessing the camera head and accessory using an automatic thermal cleaning/disinfector ...  20  CH-S190-XZ-E/Q REPROCESSING MANUAL  i
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Page 1

REPROCESSING MANUAL

INSTRUCTIONS

HD AUTOCLAVABLE CAMERA HEAD

OLYMPUS CH-S190-XZ-E

OLYMPUS CH-S190-XZ-Q

Chapter 1

General Policy

1

Chapter 2

Function and Inspection of the

Accessory for Reprocessing

7

Compatible Reprocessing

Methods and Chemical Agents

9

Reprocessing Workflow for the

Camera Head and Accessory

17

Chapter 5

Reprocessing the Camera Head

21

Chapter 6

Reprocessing the Accessory

33

Chapter 7

Reprocessing the Camera Head

Using an Automatic Thermal

Cleaning/ Disinfector

39

Storage and Disposal

41

Chapter 3

Chapter 4

Chapter 8

Accessories:

• Cleaning brush (MAJ-1534, sold separately)

Refer to the camera head’s companion manual, the “OPERATION MANUAL” with your camera head model listed on

the cover, for operation information.

Page 3

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

3.2

Water (for reprocessing) ........................................................................................ 12

3.3

Detergent solution .................................................................................................. 12

3.4

Disinfectant solution .............................................................................................. 12

3.5

Rinse water ............................................................................................................. 13

3.6

Automatic thermal cleaning/disinfection ............................................................. 13

3.7

Ethylene oxide gas sterilization ............................................................................ 15

3.8

Steam sterilization (autoclaving) .......................................................................... 16

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 reprocessing the camera head and accessory using an

automatic thermal cleaning/disinfector ............................................................... 20

CH-S190-XZ-E/Q REPROCESSING MANUAL

i

Page 4

Contents

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

Manually cleaning the camera head ..................................................................... 24

Equipment needed ..............................................................................................................

Disconnect the camera head from the video system center ................................................

Clean the external surface ...................................................................................................

Immerse the camera head in detergent solution .................................................................

Remove detergent solution from the camera head .............................................................

Dry external surfaces ...........................................................................................................

5.4

Manually disinfecting the camera head ................................................................ 27

Equipment needed ..............................................................................................................

Preparation ..........................................................................................................................

Immerse the camera head in disinfectant solution ..............................................................

Remove the camera head from disinfectant solution ..........................................................

5.5

24

24

25

26

26

26

27

27

28

28

Rinsing the camera head following disinfection ................................................. 29

Equipment needed .............................................................................................................. 29

Rinse the camera head ....................................................................................................... 30

5.6

Sterilizing the camera head ................................................................................... 31

Ethylene oxide gas sterilization of the camera head ........................................................... 31

Steam sterilization (autoclaving) of the camera head .......................................................... 32

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

ii

Reprocessing the camera head using an automatic thermal cleaning/

disinfector ...............................................................................................................39

CH-S190-XZ-E/Q REPROCESSING MANUAL

Page 5

Contents

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

CH-S190-XZ-E/Q REPROCESSING MANUAL

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Page 6

Contents

iv

CH-S190-XZ-E/Q REPROCESSING MANUAL

Page 7

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 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 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 of 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.

CH-S190-XZ-E/Q REPROCESSING MANUAL

Page 9

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 air tight 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.

CH-S190-XZ-E/Q REPROCESSING MANUAL

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1.4 Precautions

Ch.1

WARNING

• Patient debris and 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, please 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, please 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.

4

CH-S190-XZ-E/Q REPROCESSING MANUAL

Page 11

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 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.

CH-S190-XZ-E/Q REPROCESSING MANUAL

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Page 12

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.

6

CH-S190-XZ-E/Q REPROCESSING MANUAL

Page 13

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)

Figure 2.1

 Function

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

 Inspection

1

2

Check the brush head for loose or missing bristles.

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.

Check the bristles for any damage. If the bristles are crushed, gently straighten them

with your gloved fingertips.

NOTE

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

CH-S190-XZ-E/Q REPROCESSING MANUAL

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Page 14

2.1 Cleaning brush (MAJ-1534, sold separately)

Ch.2

8

CH-S190-XZ-E/Q REPROCESSING MANUAL

Page 15

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, refer to 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 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,

please contact the repair facility for instructions regarding material compatibility.

Olympus distinguishes validated methods in terms of the following two points.

 Microbiological efficacy

 Material durability

CH-S190-XZ-E/Q REPROCESSING MANUAL

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Page 16

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 biological

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-S190-XZ-E)

(CH-S190-XZ-Q)

Cleaning brush (MAJ-1534)

compatible

Table 3.1

10

CH-S190-XZ-E/Q REPROCESSING MANUAL

not compatible

Page 17

3.1 Compatibility summary

 List of compatible methods validated in terms of material

durability

Low temperature steam and formaldehyde

sterilization*1

STERRAD®NX

Ch.3

STERRAD®200

STERRAD®50/100S*2

Automatic thermal

cleaning/disinfector*1

Camera head

(CH-S190-XZ-E)

*3

(CH-S190-XZ-Q)

Cleaning brush (MAJ-1534)

*3

compatible

not compatible

Table 3.2

*1 This method may not be available in some areas.

*2 ASP tests the microbiological efficacy of Olympus products in sterility. As for the microbiological efficacy,

contact ASP. Also see the “STERRAD® 50/100S/200/NX” instruction manual.

*3 For further details, please contact Olympus.

NOTE

Camera heads that are marked by the words “AUTOCLAVE” or “AUTOCLAVABLE”,

are compatible with steam sterilization (autoclaving).

CH-S190-XZ-E/Q REPROCESSING MANUAL

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Page 18

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.

12

CH-S190-XZ-E/Q REPROCESSING MANUAL

Page 19

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

Automatic thermal cleaning/disinfection

This method may not be available in some areas.

WARNING

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).

CH-S190-XZ-E/Q REPROCESSING MANUAL

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Ch.3

Page 20

3.6 Automatic thermal cleaning/disinfection

CAUTION

• 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.

Ch.3

 Automatic cleaning/disinfection program

(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

14

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Page 21

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

57C (135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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15

Ch.3

Page 22

3.8 Steam sterilization (autoclaving)

3.8

Steam sterilization (autoclaving)

The camera head listed as compatible with steam sterilization in Table 3.1 can be sterilized by steam

within the parameters given in Table 3.5. When steam sterilizing, follow all national, professional, and

institutional reprocessing protocols as well as the instructions provided by the manufacturer of your

sterilization equipment.

Ch.3

WARNING

Steam sterilization of the camera head must be performed according to the

conditions specified in this section. Autoclaving the camera head using a

sterilization cycle that does not meet the specified conditions may result in a failure

to achieve sterilization of the camera head.

CAUTION

• Exceeding the recommended parameters may damage the camera heads.

• Employ the full autoclaving cycle indicated in Table 3.5, including the

vacuum-drying cycle after autoclaving. Without the vacuum-drying cycle, the

camera head may malfunction or become damaged.

Prevacuum steam sterilization cycle

1 Evacuation

2 Steaming and evacuation

3 Heating

4 Sterilization (132 – 134C, 5 min.)

5 Evacuation

6 Drying

Table 3.5

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Page 23

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.

CH-S190-XZ-E/Q REPROCESSING MANUAL

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Page 24

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, “Manually cleaning the camera head”

Section 5.4, “Manually

disinfecting the camera head”

Section 5.5, “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 8.2, “Storing the disinfected camera head and accessory”

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Page 25

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, “Manually cleaning the camera head”

*1

Section 5.6, “Sterilizing the

camera head”

Section 6.2, “Manually cleaning

the accessory”

*1

Section 6.5, “Sterilizing the

accessory”

Section 8.3, “Storing the sterilized camera head and accessory”

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4.4 Workflow for reprocessing the camera head and accessory using an automatic thermal

cleaning/disinfector

4.4

Workflow for reprocessing the camera head and

accessory using an automatic thermal

cleaning/disinfector

Ch.4

Camera head

Cleaning brush

(MAJ-1534)

Patient procedure

Section 5.3, “Manually cleaning the camera head”

Section 7.1, “Reprocessing

the camera head using an

automatic thermal

cleaning/disinfector”

Section 5.6, “Sterilizing the

camera head”

Section 6.2, “Manually cleaning

the accessory”

Section 6.5, “Sterilizing the

accessory”

Section 8.3, “Storing the sterilized camera head and accessory”

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CH-S190-XZ-E/Q REPROCESSING MANUAL

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