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OLYMPUS

OLYMPUS Uretero-Reno Videoscope URF-V2x Reprocessing Manual

Revision Ver RC1223 03

OLYMPUS Videoscope Systems

89 Pages

REPROCESSING MANUAL  INSTRUCTIONS  Chapter 1  General Policy  1  Chapter 2  Function and Inspection of the Accessories for Reprocessing  9  Compatible Reprocessing Methods and Chemical Agents  17  Reprocessing Workflow for Endoscopes and Accessories  29  Chapter 5  Reprocessing the Endoscope  35  Chapter 6  Reprocessing the Accessories  67  Chapter 7  Reprocessing Endoscopes and Accessories Using an Automated Endoscope Reprocessor/Washer-Disinfector  79  Storage and Disposal  81  Chapter 3  URETERO-RENO VIDEOSCOPE  OLYMPUS URF-V2 OLYMPUS URF-V2R  Chapter 4  Chapter 8  Accessories: • Sterilization tray (WA05991A*1, sold separately)  • Sterilization cap (MAJ-1538) • Single use single-ended cleaning brush (BW-400B)  • Channel-opening cleaning brush (MH-507)  • Single use channel-opening cleaning brush (MAJ-1339, sold separately)  • Suction connector cleaning brush (BW-15SH)  • Forceps/irrigation plug (isolated type) (MAJ-891)  • Luer-split (MAJ-2092, sold separately)  *1 These products may not be available in some areas... MAJ-1538  WA05991A  BW-400B  MH-507 MAJ-1339  BW-15SH  MAJ-891  MAJ-2092  Refer to the endoscope’s companion manual, the “OPERATION MANUAL” with your endoscope model listed on the cover, for operation information... SA: CAUTION: Federal law restricts this device to sale by or on the order of a physician...  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 ... 7  1...  Reprocessing and storage after use ...   1...  Reprocessing before patient procedure ...   Chapter 2 Function and Inspection of the Accessories for Reprocessing 9 2...  Sterilization cap (MAJ-1538) ...  9  2...  Sterilization tray (WA05991A, sold separately) ... 0  2...  Single use single-ended cleaning brush (BW-400B) ... 1  2...  Suction connector cleaning brush (BW-15SH) ... 2  2...  Channel-opening cleaning brush (MH-507) ...  14  2...  Single use channel-opening cleaning brush (MAJ-1339) ... 15  Chapter 3 Compatible Reprocessing Methods and Chemical Agents17 3...  Compatibility summary ...  17 Microbiological efficacy ... 18 Material durability ... 8 List of compatible methods validated in terms of microbiological efficacy and material durability 19 List of compatible methods validated in terms of material durability ...  21  3...  Water (for reprocessing) ... 3  3...  Detergent solution ... 23  3...  Disinfectant solution ... 4  3...  Rinse water ... 5  3...  Alcohol ... 25  3...  Ethylene oxide gas sterilization ... 6  3...  Steam sterilization (autoclaving) ... 28  Chapter 4 Reprocessing Workflow for Endoscopes and Accessories 29 URF-V2/V2R REPROCESSING MANUAL  i
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Page 1

REPROCESSING MANUAL

INSTRUCTIONS

Chapter 1

General Policy

1

Chapter 2

Function and Inspection of the

Accessories for Reprocessing

9

Compatible Reprocessing

Methods and Chemical Agents

17

Reprocessing Workflow for

Endoscopes and Accessories

29

Chapter 5

Reprocessing the Endoscope

35

Chapter 6

Reprocessing the Accessories

67

Chapter 7

Reprocessing Endoscopes and

Accessories Using an

Automated Endoscope

Reprocessor/Washer-Disinfector

79

Storage and Disposal

81

Chapter 3

URETERO-RENO VIDEOSCOPE

OLYMPUS URF-V2

OLYMPUS URF-V2R

Chapter 4

Chapter 8

Accessories:

• Sterilization tray (WA05991A*1, sold separately)

• Sterilization cap (MAJ-1538)

• Single use single-ended cleaning brush (BW-400B)

• Channel-opening cleaning brush (MH-507)

• Single use channel-opening cleaning brush

(MAJ-1339, sold separately)

• Suction connector cleaning brush (BW-15SH)

• Forceps/irrigation plug (isolated type) (MAJ-891)

• Luer-split (MAJ-2092, sold separately)

*1 These products may not be available in some areas.

MAJ-1538

WA05991A

BW-400B

MH-507

MAJ-1339

BW-15SH

MAJ-891

MAJ-2092

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

cover, for operation information.

USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician.

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 .......................................................................... 7

1.6

Reprocessing and storage after use ...................................................................... 7

1.7

Reprocessing before patient procedure ................................................................ 8

Chapter 2 Function and Inspection of the Accessories for

Reprocessing 9

2.1

Sterilization cap (MAJ-1538) .................................................................................... 9

2.2

Sterilization tray (WA05991A, sold separately) .................................................... 10

2.3

Single use single-ended cleaning brush (BW-400B) ........................................... 11

2.4

Suction connector cleaning brush (BW-15SH) .................................................... 12

2.5

Channel-opening cleaning brush (MH-507) ......................................................... 14

2.6

Single use channel-opening cleaning brush (MAJ-1339) ................................... 15

Chapter 3 Compatible Reprocessing Methods and Chemical Agents .

17

3.1

Compatibility summary .......................................................................................... 17

Microbiological efficacy ........................................................................................................ 18

Material durability ................................................................................................................ 18

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

19

List of compatible methods validated in terms of material durability .................................... 21

3.2

Water (for reprocessing) ........................................................................................ 23

3.3

Detergent solution .................................................................................................. 23

3.4

Disinfectant solution .............................................................................................. 24

3.5

Rinse water ............................................................................................................. 25

3.6

Alcohol .................................................................................................................... 25

3.7

Ethylene oxide gas sterilization ............................................................................ 26

3.8

Steam sterilization (autoclaving) .......................................................................... 28

Chapter 4 Reprocessing Workflow for Endoscopes and Accessories

29

URF-V2/V2R REPROCESSING MANUAL

i

Page 4

Contents

4.1

Summary of reprocessing workflow ..................................................................... 29

4.2

Workflow for cleaning and sterilizing endoscopes and accessories using an

AER/WD 30

4.3

Workflow for manually cleaning and sterilizing endoscopes and accessories 32

Chapter 5 Reprocessing the Endoscope ........................................... 35

5.1

Summary of reprocessing the endoscope ........................................................... 35

5.2

Preparing the equipment for reprocessing .......................................................... 36

Equipment needed .............................................................................................................. 36

5.3

Precleaning the endoscope ................................................................................... 38

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

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

Wipe the insertion section ...................................................................................................

Flush the instrument channel with water .............................................................................

Detach the endoscope from the video system center .........................................................

Detach the endoscope from the light source .......................................................................

5.4

38

39

39

40

41

41

Leakage testing of the endoscope ........................................................................ 42

Equipment needed .............................................................................................................. 42

Perform the leakage test ..................................................................................................... 43

5.5

Manually cleaning the endoscope ........................................................................ 49

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

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

Brush the channel ................................................................................................................

Flush the instrument channel with detergent solution .........................................................

Immerse the endoscope in detergent solution .....................................................................

Remove detergent solution from the channel ......................................................................

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

5.6

Manually disinfecting the endoscope and accessories ...................................... 57

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

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

Immerse the endoscope in disinfectant solution ..................................................................

Remove the endoscope from disinfectant solution ..............................................................

5.7

49

50

50

55

55

56

56

57

57

58

59

Rinsing the endoscope following disinfection .................................................... 60

Equipment needed .............................................................................................................. 61

Rinse the endoscope and accessories ................................................................................ 62

Alcohol flush ........................................................................................................................ 63

5.8

Sterilizing the endoscope and accessories ......................................................... 64

Ethylene oxide gas sterilization of the endoscope and accessories .................................... 64

5.9

Presoaking the endoscope .................................................................................... 66

Equipment needed .............................................................................................................. 66

Chapter 6 Reprocessing the Accessories ......................................... 67

6.1

Summary of reprocessing the accessories ......................................................... 67

Equipment needed .............................................................................................................. 68

ii

URF-V2/V2R REPROCESSING MANUAL

Page 5

Contents

6.2

Manually cleaning the accessories ...................................................................... 69

Disassembling the forceps/irrigation plug (isolated type) (MAJ-891) ................................... 69

Manually cleaning the accessories ...................................................................................... 70

6.3

Manually disinfecting the accessories ................................................................. 72

6.4

Rinsing the accessories following disinfection .................................................. 74

Rinse the accessories ......................................................................................................... 74

Alcohol flush ........................................................................................................................ 75

6.5

Sterilizing the accessories .................................................................................... 76

Ethylene oxide gas sterilization ........................................................................................... 76

Steam sterilization (autoclaving) .......................................................................................... 77

Chapter 7 Reprocessing Endoscopes and Accessories Using an

Automated Endoscope Reprocessor/Washer-Disinfector

79

7.1

Reprocessing endoscopes and accessories using an automated endoscope

reprocessor/washer-disinfector 79

Chapter 8 Storage and Disposal ......................................................... 81

8.1

Precautions for storage and disposal .................................................................. 81

8.2

Storing the sterilized endoscope and accessories ............................................. 82

8.3

Disposal .................................................................................................................. 82

URF-V2/V2R REPROCESSING MANUAL

iii

Page 6

Contents

iv

URF-V2/V2R 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

endoscopes and accessories listed on the front cover.

• This instruction manual contains essential information on reprocessing endoscopes and

accessories safely and effectively.

• Before reprocessing, thoroughly review this manual and the manuals for the reprocessing

equipment and chemicals that will be used for reprocessing. Reprocess all the devices as

instructed.

• Note that the complete instruction manual set for the endoscope and accessories consists of

this manual and the “OPERATION MANUAL” with your endoscope model listed on the cover.

Both manuals accompanied the endoscope 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

AER/WD:

AER and WD are abbreviations for Automated Endoscope Reprocessor and

Washer-Disinfector, which are used for reprocessing the endoscopes and accessories.

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”.

URF-V2/V2R REPROCESSING MANUAL

1

Page 8

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 endoscope, accessories, and all the other reprocessing

equipment

• Structure and handling of the endoscope 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.

URF-V2/V2R REPROCESSING MANUAL

Page 9

1.4 Precautions

1.4

Ch.1

Precautions

WARNING

• An insufficiently reprocessed endoscope and/or accessory may pose an infection

control risk to the patients and/or operators who contact them.

• The endoscope reprocessor, 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 an AER/WD) and all

sterilization methods (whether performed by ethylene oxide gas or steam) require

thorough prior cleaning of the instruments being reprocessed. 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 endoscope and the accessories used

with the endoscope.

• The channel of the endoscope and all accessories used with the endoscope during

the patient procedure must be reprocessed after each patient procedure, even if

the channel or accessories were not used during the patient procedure. Insufficient

reprocessing of these components may pose an infection control risk to patients

and/or operators.

• Residual disinfectant solution may cause adverse reactions in patients. Therefore,

rinse all external surfaces and the channel of the endoscope and accessories

thoroughly with water to remove residual disinfectant 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.

URF-V2/V2R REPROCESSING MANUAL

3

Page 10

1.4 Precautions

Ch.1

WARNING

• Establish an internal system of identifying contaminated versus reprocessed

endoscopes and accessories 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

endoscope and/or accessories with contaminated gloves or placing them on a

contaminated hanger or surface, including letting them touch the floor, will

recontaminate them.

• Prior to each patient procedure, confirm that the endoscope and accessories have

been properly reprocessed and stored. If there are any doubts or questions,

reprocess them again before the patient procedure, following the instructions given

in this manual.

• Perform a leakage test on the endoscope after each precleaning procedure. Do not

use the endoscope if a leak is detected. Use of an endoscope with a leak may

cause a sudden loss of the endoscopic image, damage to the bending mechanism,

or other malfunctions. Use of a leaking endoscope may also pose an infection

control risk.

Leakage tester

Figure 1.1

• 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 accessories listed on the front cover of this manual cannot be refurbished or

repaired and are intended to be replaced once they show any signs of wear and

tear. Should any irregularity be observed, use a replacement accessory instead.

Using defective accessories may cause equipment malfunction, reduce the efficacy

of reprocessing, present a risk to patients and/or operators, or damage the

endoscope and/or accessories.

4

URF-V2/V2R REPROCESSING MANUAL

Page 11

1.4 Precautions

Ch.1

WARNING

• Single-use brushes, such as the single use single-ended cleaning brush

(BW-400B) and the single use channel-opening cleaning brush (MAJ-1339), are

designed for cleaning only one endoscope and its related accessories. Dispose of

the single-use brush immediately after use. Using a single-use brush to clean

multiple endoscopes and/or accessories may reduce its cleaning efficacy and may

damage the brush leading to brush breakage or the endoscope and/or accessory

damage.

• 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 AERs/WDs have been

validated by Olympus. When using an AER/WD that is not recommended by

Olympus, the manufacturer of the AER/WD is responsible for validating

compatibility of the AER/WD with each Olympus endoscope and accessory.

• Before using an AER/WD, confirm that it is capable of reprocessing the endoscope

including the channel and accessories. Be sure to attach all required

connectors/adaptors. Otherwise, insufficient reprocessing may pose an infection

control risk. If you are uncertain as to the ability of your AER/WD to reprocess the

endoscope including the channel and accessories, contact the manufacturer of the

AER/WD for specific instructions and information on compatibility and required

connectors/adaptors.

• 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, contact the

repair facility for instructions regarding reprocessing.

URF-V2/V2R REPROCESSING MANUAL

5

Page 12

1.4 Precautions

Ch.1

WARNING

• 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 endoscope and accessories on patients with

CJD or variant Creutzfeldt-Jakob disease (vCJD), be sure to use them for such

patients only, or immediately dispose of them 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 endoscope and accessories 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 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 endoscopic 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.

CAUTION

• Before immersing the endoscope in reprocessing fluids, confirm that the

sterilization cap (MAJ-1538) is not attached to the endoscope. If the sterilization

cap is attached, the reprocessing fluids will be able to penetrate the inside of the

endoscope, and it can be damaged.

• Do not turn the insertion tube rotation ring in reprocessing fluids. The reprocessing

fluids will be able to penetrate the inside of the endoscope, and it can be damaged.

• When aerating or irrigating the endoscope channels, the air or water pressure must

not exceed 0.2 MPa (2 kgf/cm2, 28 psig). Higher pressures may cause damage to

the endoscope.

• Store spare accessories in their original packaging to prevent damage.

• To prevent damage, do not apply excessive force to the endoscope and

accessories 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.

6

URF-V2/V2R REPROCESSING MANUAL

Page 13

1.5 Reprocessing before the first use

1.5

Ch.1

Reprocessing before the first use

New endoscopes, repaired endoscopes, accessories, and the carrying case for endoscopes are not

reprocessed prior to shipping from Olympus, regardless of whether those instruments are for new

purchase, demo, or loaner purposes. Reprocess all such endoscopes and accessories 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.

• Do not reuse alcohol.

• Alcohol is not a sterilant or high-level disinfectant.

• To maintain sterility of equipment following sterilization, use sterile packaging and

wraps according to national guidelines.

URF-V2/V2R REPROCESSING MANUAL

7

Page 14

1.7 Reprocessing before patient procedure

Ch.1

1.7

Reprocessing before patient procedure

WARNING

• Improper storage practices, such as not thoroughly drying external and internal

surfaces (lumens) prior to storage, will lead to an infection control risk.

• Improper handling, such as touching a reprocessed endoscope and/or accessories

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 endoscopes

prior to their first use of the day.

Confirm that the endoscope and accessories have undergone proper reprocessing following their last

use and that they have been stored properly. Check the storage period of reprocessed endoscopes,

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.

8

URF-V2/V2R REPROCESSING MANUAL

Page 15

2.1 Sterilization cap (MAJ-1538)

Chapter 2

Function and Inspection of

the Accessories for

Reprocessing

Ch.2

Certain accessories are required for reprocessing the endoscope. This chapter describes the function

of these accessories. It also describes how to inspect these accessories before using them to

reprocess the endoscope.

2.1

Sterilization cap (MAJ-1538)

Connector

Figure 2.1

 Function

When performing gas sterilization (e.g., ethylene

oxide gas sterilization, hydrogen peroxide low

temperature plasma), the sterilization cap must be

attached to the venting connector on the light guide

connector.

Venting connector

Sterilization cap

Figure 2.2

 Inspection

Confirm that the sterilization cap is free from scratches, flaws, and debris.

URF-V2/V2R REPROCESSING MANUAL

9

Page 16

2.2 Sterilization tray (WA05991A, sold separately)

2.2

Sterilization tray (WA05991A, sold separately)

Ch.2

Figure 2.3

 Function

This sterilization tray is used to transport and sterilize the endoscope and accessories.

 Inspection

Check every part of the sterilization tray for damage.

10

URF-V2/V2R REPROCESSING MANUAL

Page 17

2.3 Single use single-ended cleaning brush (BW-400B)

2.3

Single use single-ended cleaning brush

(BW-400B)

Tip

Ch.2

Handle

Bristles

Brush head

Shaft

Figure 2.4

 Function

The single use single-ended cleaning brush is used to brush the inside of the instrument

channel of the endoscope.

Instrument channel port

Instrument channel

Figure 2.5

 Inspection

1

2

Remove the brush from its packaging just prior to use.

3

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

your gloved fingertips.

4

Check for bends, scratches, and other damage to the shaft.

Confirm that the tip and brush head at the distal end are securely attached. Check the

brush head for loose or missing bristles.

CAUTION

Do not reprocess the single use single-ended cleaning brush prior to use. The

brush may be damaged.

URF-V2/V2R REPROCESSING MANUAL

11

Page 18

2.4 Suction connector cleaning brush (BW-15SH)

2.4

Suction connector cleaning brush (BW-15SH)

Ch.2

Bristles

Metal chip

Shaft

Brush head

Figure 2.6

 Function

The suction connector cleaning brush is used to brush the instrument channel junction of the

endoscope, the forceps/irrigation plug (isolated type) (MAJ-891), and the luer-split (MAJ-2092).

Instrument channel junction

Figure 2.7

Forceps/irrigation plug (isolated type) (MAJ-891)

Figure 2.8

12

URF-V2/V2R REPROCESSING MANUAL

Page 19

2.4 Suction connector cleaning brush (BW-15SH)

Ch.2

Luer-split (MAJ-2092)

Figure 2.9

 Inspection

1

Confirm that the brush head and the metal tip of the distal end are securely attached.

Check the brush head for loose or missing bristles.

2

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

your gloved fingertips.

3

4

Check for bends, scratches, and other damage to the shaft.

Visually check for debris on the shaft and/or 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.

NOTE

The suction connector cleaning brush does not need to be reprocessed prior to its

first use.

URF-V2/V2R REPROCESSING MANUAL

13

Page 20

2.5 Channel-opening cleaning brush (MH-507)

2.5

Channel-opening cleaning brush (MH-507)

Ch.2

Shaft

Bristles

Brush handle

Brush head

Figure 2.10

 Function

The channel-opening cleaning brush is used to brush the instrument channel port of the

endoscope.

Instrument channel port

Figure 2.11

 Inspection

1

2

Check the brush head for loose or missing bristles.

3

4

Check for bends, scratches, and other damage to the shaft.

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

with your gloved fingertips.

Visually check for debris on the shaft and/or 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.

NOTE

The channel-opening cleaning brush does not need to be reprocessed prior to its

first use.

14

URF-V2/V2R REPROCESSING MANUAL

Page 21

2.6 Single use channel-opening cleaning brush (MAJ-1339)

2.6

Single use channel-opening cleaning brush

(MAJ-1339)

Ch.2

Brush head

Handle

Figure 2.12

 Function

The single use channel-opening cleaning brush is used to brush the instrument channel port of

the endoscope.

Instrument channel port

Figure 2.13

 Inspection

1

2

3

Remove the brush from its packaging just prior to use.

4

Check for bends, scratches, and other damage to the shaft.

Check the brush head for loose or missing bristles.

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

with your gloved fingertips.

CAUTION

Do not reprocess the single use channel-opening cleaning brush prior to use. The

brush may be damaged.

URF-V2/V2R REPROCESSING MANUAL

15

Page 22

2.6 Single use channel-opening cleaning brush (MAJ-1339)

Ch.2

16

URF-V2/V2R REPROCESSING MANUAL

Page 23

3.1 Compatibility summary

Chapter 3

Compatible Reprocessing

Methods and Chemical

Agents

Ch.3

3.1

Compatibility summary

The endoscope and accessories are compatible with several methods of reprocessing. However, not

all reprocessing methods are compatible with all endoscopes and all accessories. 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 endoscopes and accessories 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 endoscope and accessories 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.

URF-V2/V2R REPROCESSING MANUAL

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3.1 Compatibility summary

Olympus provides information regarding validated methods in terms of the following two criteria.

 Microbiological efficacy

 Material durability

Ch.3



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.



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 that a certain degree of

microbiological effectiveness is guaranteed.

18

URF-V2/V2R REPROCESSING MANUAL

Page 25

3.1 Compatibility summary



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)

Ch.3

Ethylene oxide gas sterilization

(100% ethylene oxide gas)

For disinfection

ACECIDE disinfectant solution*1

2 – 3.5% glutaraldehyde

For alcohol flush

70% ethyl or

70% isopropyl alcohol

For cleaning

Detergent solution

Ultrasonic

cleaning

Endoscope

*2

Sterilization cap (MAJ-1538)

Sterilization tray (WA05991A)

Forceps/irrigation plug

(Isolated type) (MAJ-891)

Luer-split (MAJ-2092)

Suction connector cleaning

brush (BW-15SH)

Channel-opening cleaning

brush (MH-507)

compatible

not compatible

Table 3.1

*1 ACECIDE disinfectant solution is exclusively for an Olympus-recommended endoscope reprocessor, such as

OER-A, OER-AW, and OER-Pro (ACECIDE may not be available in some areas).

*2 The endoscope is only compatible with ultrasonic cleaning as performed in an Olympus-recommended

endoscope reprocessor, such as OER-A, OER-AW, and OER-Pro (OER-A, OER-AW, and OER-Pro may not

be available in some areas). When using an AER/WD that is recommended by Olympus other than listed

above, contact Olympus.

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3.1 Compatibility summary

NOTE

• Accessories that are marked by the words “AUTOCLAVE” or “AUTOCLAVABLE”, or

with green markings (such as a green component or label) are compatible with

steam sterilization (autoclaving).

• The endoscope is compatible with some endoscope reprocessors such as the

ETD*1 system distributed by Olympus. Refer to the instruction manual for details on

operation. For any other details, contact Olympus.

Ch.3

*1

20

This product may not be available in some areas.

URF-V2/V2R REPROCESSING MANUAL

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