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OLYMPUS

OLYMPUS ENF and LF Reprocessing Manual

Revision Ver GR4877 20

OLYMPUS Videoscope Systems

46 Pages

INSTRUCTIONS OLYMPUS ENF/LF (Endoscope With Channel)  This instruction manual is for the Rhino-laryngo and Tracheal Intubation fiberscopes models with a suction or instrument channel... efer to the endoscope’s companion manual, the ENF or LF OPERATION MANUAL for inspection and operation information... SA: CAUTION: Federal law restricts this device to sale by or on the order of a physician...  Contents  Contents Symbols...  1  Chapter 1  General Policy ...   2  1...  Instructions...  2  1...  Signal Words...  3  1...  Precautions ... 3  Chapter 2  Compatible Reprocessing Methods and Chemical Agents ... 7  2...  Compatibility Summary ... 7  2...  Detergent Solution ...  9  2...  Disinfectant Solution ...  9  2...  Rinsing Water ...   10  2...  ETO Gas Sterilization ...   10  2...  Steam Sterilization (Autoclaving) of Accessories... 12  Chapter 3  Cleaning, Disinfection and Sterilization Procedures ... 4  3...  Required Reprocessing Equipment ...   14  3...  Cleaning, Disinfection and Sterilization Procedures ...  19  3...  Precleaning ... 20  3...  Leakage Testing ...  22  3...  Manual Cleaning ...  25  3...  High Level Disinfection ... 30  3...  Rinsing After High Level Disinfection... 32  3...  Sterilization ... 33  3...  Cleaning, Disinfection and Sterilization Procedures for Reusable Parts and Cleaning Equipment... 33  Chapter 4  Cleaning and Disinfection Equipment... 39  Chapter 5  Storage ...   41  Storage ... 41  5...  ENF/LF ENDOSCOPE REPROCESSING MANUAL  i
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Page 1

INSTRUCTIONS

OLYMPUS ENF/LF

(Endoscope With Channel)

This instruction manual is for the Rhino-laryngo and Tracheal Intubation fiberscopes models with a suction or

instrument channel.

Refer to the endoscope’s companion manual, the ENF or LF OPERATION MANUAL for inspection and

operation information.

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

Page 3

Contents

Contents

Symbols.........................................................................................

1

Chapter 1

General Policy .........................................................

2

1.1

Instructions......................................................................................

2

1.2

Signal Words...................................................................................

3

1.3

Precautions .....................................................................................

3

Chapter 2

Compatible Reprocessing Methods and Chemical

Agents ......................................................................

7

2.1

Compatibility Summary ...................................................................

7

2.2

Detergent Solution ..........................................................................

9

2.3

Disinfectant Solution .......................................................................

9

2.4

Rinsing Water .................................................................................

10

2.5

ETO Gas Sterilization .....................................................................

10

2.6

Steam Sterilization (Autoclaving) of Accessories............................

12

Chapter 3

Cleaning, Disinfection and Sterilization Procedures

.................................................................................. 14

3.1

Required Reprocessing Equipment ................................................

14

3.2

Cleaning, Disinfection and Sterilization Procedures .......................

19

3.3

Precleaning .....................................................................................

20

3.4

Leakage Testing .............................................................................

22

3.5

Manual Cleaning .............................................................................

25

3.6

High Level Disinfection ...................................................................

30

3.7

Rinsing After High Level Disinfection..............................................

32

3.8

Sterilization .....................................................................................

33

3.9

Cleaning, Disinfection and Sterilization Procedures

for Reusable Parts and Cleaning Equipment..................................

33

Chapter 4

Cleaning and Disinfection Equipment...................

39

Chapter 5

Storage .....................................................................

41

Storage ...........................................................................................

41

5.1

ENF/LF ENDOSCOPE REPROCESSING MANUAL

i

Page 4

Contents

ii

ENF/LF ENDOSCOPE REPROCESSING MANUAL

Page 5

Symbols

Symbols

The meaning(s) of the symbol(s) shown on the back cover of this instruction

manual are as follows:

Manufacturer

Authorized representative in the European Community

ENF/LF ENDOSCOPE REPROCESSING MANUAL

1

Page 6

Chapter 1 General Policy

Chapter 1 General Policy

1.1

2

Instructions

•

This instruction manual covers the reprocessing of Rhino-laryngo and

Tracheal Intubation fiberscope models with a suction or instrument

channel.

•

This manual describes the recommended procedures for cleaning and

disinfecting or sterilizing this instrument.

•

Thoroughly review the manuals of all equipment which will be used with

this instrument and use the equipment as instructed.

•

If you have any questions or comments about any information in this

manual, or if a problem that cannot be solved occurs while you are using

the instrument, contact Olympus.

•

The medical literature reports incidents of patient cross contamination

resulting from improper cleaning, disinfection or sterilization. It is

strongly recommended that reprocessing personnel have a thorough

understanding of and follow all national and local hospital guidelines and

policies.

A specific individual or individuals in the endoscopy unit should be

responsible for reprocessing endoscopic equipment. It is highly

desirable that a trained backup be available should the primary

reprocessing individual(s) be absent.

•

All individuals responsible for reprocessing should thoroughly

understand:

•

your institution’s reprocessing procedures

•

occupational health and safety regulations

•

national and local hospital guidelines and policies

•

the instructions in this manual

•

the mechanical aspects of endoscopic equipment

•

pertinent germicide labeling

ENF/LF ENDOSCOPE REPROCESSING MANUAL

Page 7

Chapter 1 General Policy

1.2

Signal Words

The following signal words are used throughout this manual:

Indicates a potentially hazardous situation which, if not

avoided, could result in death or serious injury.

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.

Indicates additional helpful information.

1.3

Precautions

•

Failure to properly clean and high-level disinfect or sterilize

endoscopic equipment after each examination can

compromise patient safety. To minimize the risk of

transmitting diseases from one patient to another, after each

examination the endoscope must undergo thorough the

manual cleaning followed by high-level disinfection or

sterilization.

•

ALL channels of the endoscope MUST be cleaned and

high-level disinfected or sterilized during EVERY

reprocessing cycle, even if the channels were not used

during the previous patient procedure. Otherwise, insufficient

cleaning and disinfection or sterilization of the endoscope

may pose an infection control risk to the patient and/or

operators performing the next procedure with the endoscope.

•

If the endoscope is not cleaned meticulously, effective

disinfection or sterilization may not be possible. Clean the

endoscope and accessories thoroughly before disinfection or

sterilization to remove microorganisms or organic material

that could reduce the efficacy of disinfection or sterilization.

ENF/LF ENDOSCOPE REPROCESSING MANUAL

3

Page 8

Chapter 1 General Policy

4

•

This instruction manual specifies medicines and endoscope

reprocessor for cleaning, high-level disinfection and

sterilization which can be used in combination with

endoscope, and those medicines and endoscope

reprocessors which cannot be used with endoscope. For

those which do not appear in this manual, contact

Olympus-designated service centers, Olympus branches or

sales representatives. In case that inappropriate medicines

or endoscope reprocessor are used, it may accelerate the

deterioration of the endoscope and may cause come-off of

parts and adverse event on patients’ health. For the usage of

these medicines and endoscope reprocessor, follow the

instruction manuals of those. Olympus does not assure the

effect of cleaning, disinfection and sterilization. Contact the

manufacturers of those medicines and endoscope

reprocessor.

•

Olympus confirms validation of the endoscope reprocessors

recommended by Olympus only. If using endoscope

reprocessor that are not recommended by Olympus, the

endoscope reprocessor manufacturers are responsible for

validation of the endoscope reprocessor with the endoscope

models listed in its intended use statement. If using an

endoscope reprocessor, confirm that it is capable of

reprocessing endoscope including all channels. If there are

channels and/or other parts which cannot be cleaned and

high-level disinfected by the endoscope reprocessor, have to

undergo manual cleaning and high-level disinfection or

sterilization as described in Chapter 3, “Cleaning,

Disinfection and Sterilization Procedures” after using the

endoscope reprocessor. Otherwise, insufficient cleaning and

disinfection or sterilization of the endoscope may pose an

infection control risk to the patient and/or operators

performing the next procedure with the endoscope. If you are

uncertain as to the ability of your endoscope reprocessor to

clean and high-level disinfect endoscope including all

channels, contact the endoscope reprocessor supplier for

specific instructions and/or connectors.

ENF/LF ENDOSCOPE REPROCESSING MANUAL

Page 9

Chapter 1 General Policy

•

Patient debris and reprocessing chemicals are hazardous.

Wear personal protective equipment to guard against

dangerous chemicals and potentially infectious material.

During cleaning and disinfection or sterilization, wear

appropriate personal protective equipment, such as eye

wear, a face mask, moisture-resistant clothing and

chemical-resistant gloves that fit properly and are long

enough so that your skin is not exposed. Always remove

contaminated protective equipment before leaving the

cleaning area.

•

Thoroughly rinse off the disinfectant solution. Rinse the outer

surface of the endoscope, channels and cleaning equipment

thoroughly with water to remove the disinfectant solution

residue.

•

The disinfection/sterilization room must be adequately

ventilated. Adequate ventilation protects against toxic

chemical fumes.

•

Store alcohol in an air-tight container. Alcohol stored in an

open container may cause fires and will lose its efficacy due

to evaporation.

•

With the cleaning, disinfection and sterilization methods

stated in this instruction manual, prions, which are

considered to be the pathogenic substance of the

Creutzfeldt-Jakob disease (CJD) cannot be destroyed or

inactivated. When using this instrument on a patient with CJD

or variant Creutzfeldt-Jakob disease (vCJD), be sure to use

this product for such patient only and/or immediately dispose

of this product after use in an appropriate manner. For

methods to handle CJD, please follow the respective

guidelines in your country.

•

This instrument is not durable, or does not have sufficient

durability against the respective methods stated in the

guidelines of each country for destroying or inactivating

prions. For information on the durability against each

method, please contact Olympus. If cleaning, disinfection

and sterilization methods not stated in this instruction manual

are performed, Olympus cannot guarantee the effectiveness,

safety and durability of this instrument. Make sure to confirm

that there is no abnormality before use, and use under

responsibility of a physician. Do not use if any abnormality is

found.

ENF/LF ENDOSCOPE REPROCESSING MANUAL

5

Page 10

Chapter 1 General Policy

6

•

When aerating or irrigating the endoscope channels, the air

or water pressure must not exceed 0.2 MPa (2 kgf/cm2,

29 psia).

•

Before immersing the endoscope in detergent or disinfectant

solution, confirm that the ETO Cap is not attached to the

Endoscope Connector.

ENF/LF ENDOSCOPE REPROCESSING MANUAL

Page 11

Chapter 2 Compatible Reprocessing Methods and Chemical Agents

Chapter 2 Compatible Reprocessing

Methods and Chemical

Agents

2.1

Compatibility Summary

Olympus endoscopic equipment is compatible with several methods of

reprocessing. Certain components and accessories, however, are not

compatible with some methods, which can cause equipment damage. For

appropriate reprocessing methods, refer to Table 2.1, the recommendations of

your infection control committee and national and local hospital guidelines and

policies.

ENF/LF ENDOSCOPE REPROCESSING MANUAL

7

Page 12

Chapter 2 Compatible Reprocessing Methods and Chemical Agents

Steam Sterilization (Autoclaving)

ETO Gas Sterilization

2 to 3.5% Glutaraldehyde

70% Ethyl or Isopropyl Alcohol

Detergent Solution

Ultrasonic

Cleaning

Endoscope

Miniature Light Source

(MAJ-524)

Halogen Lamp

(MAJ-525, option)

ETO Cap

(MB-156)

Channel Cleaning Brush

(BW-15B or BW-7B)

Suction Connector

Cleaning Brush

(BW-15SH)

Channel-opening

Cleaning Brush

(MH-507)

Suction Valve

(MD-493)

Syringe Valve

(MB-884)

Biopsy Valve

(MD-495)

Light Guide Adapter

(MAJ-1413)

applicable

not applicable

Table 2.1

•

8

Endo-Therapy Accessories and other items which are

marked by the words “AUTOCLAVE” or “AUTOCLAVABLE”,

a green band or yellow-green marking are compatible with

autoclaving.

ENF/LF ENDOSCOPE REPROCESSING MANUAL

Page 13

Chapter 2 Compatible Reprocessing Methods and Chemical Agents

2.2

•

Some items with no markings are compatible with

autoclaving. To determine the compatibility of such

equipment with steam sterilization, refer to the item’s

instruction manual.

•

Do not subject the endoscope or the Miniature Light Source

to a general-purpose ultrasonic cleaner or an ultrasonic

cleaner intended for accessories, as the high frequencies

generated by these devices can cause equipment damage.

•

Do not steam sterilize the Light Guide Adapter (MAJ-1413).

Equipment damage may result.

•

The endoscope is not compatible with STERRAD® NX.

Instrument damage and patient injury may result. Regarding

the compatibility of other plasma sterilization processes,

please contact Olympus.

Detergent Solution

Use a medical-grade, low-foaming, neutral pH detergent or enzymatic detergent

and follow the manufacturer’s dilution and temperature recommendations.

Contact Olympus for the names of specific brands that have been tested for

compatibility with the endoscope. Do not reuse detergent solutions.

Excessive detergent foaming can prevent fluid from

adequately contacting internal lumens (e.g. channels).

2.3

Disinfectant Solution

In the U.S., agents used to achieve high-level disinfection are defined as liquid

chemical germicides registered with the Environmental Protection Agency as

“sterilant/disinfectants” which are used according to the time, temperature and

dilution recommended by the disinfectant manufacturer for achieving high-level

disinfection. These conditions usually coincide with those recommended by the

disinfectant manufacturer for 100% kill of Mycobacterium tuberculosis.

In general, 2.0% to 3.5% glutaraldehyde solutions, when used according to the

manufacturer’s instructions for achieving high-level disinfection, are compatible

with Olympus endoscopes. Contact Olympus for the names of specific brands

that have been tested for compatibility with this endoscope.

ENF/LF ENDOSCOPE REPROCESSING MANUAL

9

Page 14

Chapter 2 Compatible Reprocessing Methods and Chemical Agents

If the disinfectant solution is reused, routinely check its efficacy with a test strip

recommended by the manufacturer. Do not use solutions beyond their expiration

date.

Alcohol is not a sterilant or high-level disinfectant.

2.4

Rinsing Water

Once removed from the disinfectant solution, the instrument must be thoroughly

rinsed with sterile water to remove any disinfectant residue. If sterile water is not

available, clean potable tap water or water which has been processed (e.g.

filtered) to improve its microbiological quality may be used.

When non-sterile water is used after manual or automated disinfection, wipe the

endoscope and flush the channels with 70% ethyl or isopropyl alcohol, then

air-dry all internal channels to inhibit the growth of residual bacteria. Do not

reuse rinsing water.

2.5

ETO Gas Sterilization

This instrument or other accessories compatible with ETO gas sterilization as

shown in Table 2.1 can be sterilized by ethylene oxide gas and aerated within

the parameters given in Tables 2.2 and 2.3. When performing sterilization, follow

the hospital’s protocol and the sterilization equipment manufacturer’s

instructions.

10

•

Before sterilization, the instrument must be thoroughly

cleaned and dried. Residual moisture inhibits sterilization.

•

Exceeding the recommended parameters may cause

equipment damage.

•

The results of sterilization depend on various factors such as

how the sterilized instrument was packed or the positioning,

method of placing and loading of the instrument in the

sterilization device. Please verify the sterilization effects by

using biological or chemical indicators. Also follow the

guidelines for sterilization issued by medical administrative

authorities, public organizations or the infection management

sections at each medical facility, as well as the instruction

manual of the sterilization device.

ENF/LF ENDOSCOPE REPROCESSING MANUAL

Page 15

Chapter 2 Compatible Reprocessing Methods and Chemical Agents

•

All instruments must be properly aerated following ETO gas

sterilization to remove toxic ethylene oxide residuals.

•

Attach the ETO Cap to the Endoscope Connector before

ETO gas sterilization. If the ETO Cap is not attached on the

endoscope during sterilization, the vacuum created within the

sterilization chamber can rupture the covering of the Bending

Section.

•

Inspect the instrument packages for openings, tears and

other damage. If the packages are open or damaged, seal

the components in new packaging and sterilize again.

 For USA

ETO Gas Exposure Parameters (Gas mixture 12% ETO/88% CFC)

Process

ETO Gas Sterilization

Parameters

Temperature

57°C (135°F)

Pressure

0.1 to 0.17 MPa

(1.0 to 1.7 kgf/cm2, 16 to 24 psig)

Aeration (Minimum)

Humidity

55%

Exposure Time

1.75 hours

ETO Gas

Concentration

600 to 700 mg/l

12 hours in an aeration chamber at 50 to 57°C (122 to

135°F) or 7 days at room temperature

Table 2.2

ENF/LF ENDOSCOPE REPROCESSING MANUAL

11

Page 16

Chapter 2 Compatible Reprocessing Methods and Chemical Agents

 For Countries Other Than the United States

ETO Gas Exposure Parameters (Gas mixture 20% ETO/80% CO2)

Process

Parameters

ETO Gas Sterilization

Temperature

57°C (135°F)

Pressure

0.10 to 0.17 MPa

(1.0 to 1.7 kgf/cm2, 16 to 24 psig)

Aeration (Minimum)

Humidity

55%

Exposure Time

1.75 hours

ETO Gas

Concentration

600 to 700 mg/l

12 hours in an aeration chamber at 50 to 57°C (122 to

135°F) or 7 days at room temperature

Table 2.3

2.6

Steam Sterilization (Autoclaving) of Accessories

Steam sterilize (autoclave) within the parameters given in Table 2.4 below.

When steam sterilizing, follow the hospital’s protocol and the sterilization

equipment manufacturer’s instructions. Prior to steam sterilization (autoclaving)

of accessories, meticulous manual cleaning followed by at least 5 minutes of

ultrasonic cleaning at 38 to 47 kHz is required.

12

•

Before sterilization, the instrument must be thoroughly

cleaned and dried. Residual moisture inhibits sterilization.

•

Exceeding the recommended parameters may cause

equipment damage.

•

The results of sterilization depend on various factors such as

how the sterilized instrument was packed or the positioning,

method of placing and loading of the instrument in the

sterilization device. Please verify the sterilization effects by

using biological or chemical indicators. Also follow the

guidelines for sterilization issued by medical administrative

authorities, public organizations or the infection management

sections at each medical facility, as well as the instruction

manual of the sterilization device.

•

Do not steam sterilize the endoscope. Steam sterilization

(autoclaving) will severely damage the endoscope.

ENF/LF ENDOSCOPE REPROCESSING MANUAL

Page 17

Chapter 2 Compatible Reprocessing Methods and Chemical Agents

•

Effective sterilization will not be possible if items are packed

tightly together in the autoclave; always pack items loosely.

•

Inspect the instrument packages for openings, tears and

other damage. If the package is open or damaged, seal the

components in new packaging and sterilize again.

•

Allow the packages to dry within the autoclave, using the

autoclave’s drying cycle (if available) or by opening the door

of the autoclave and allowing the packages to air dry.

Handling a wet package can compromise its sterility.

•

Endo-Therapy Accessories and other items which are

marked by the words “AUTOCLAVE” or “AUTOCLAVABLE”,

a green band or yellow-green marking are compatible with

autoclaving.

•

Some items with no markings are compatible with

autoclaving. To determine the compatibility of such

equipment with steam sterilization, refer to the item’s

instruction manual.

Prevacuum

Temperature

Exposure Time

132 to 134°C

(270 to 274°F)

5 minutes

Table 2.4

ENF/LF ENDOSCOPE REPROCESSING MANUAL

13

Page 18

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Chapter 3 Cleaning, Disinfection and

Sterilization Procedures

ALL channels of the endoscope MUST be cleaned and

high-level disinfected or sterilized during EVERY

reprocessing cycle, even if the channels were not used

during the previous patient procedure. Otherwise, insufficient

cleaning and disinfection or sterilization of the endoscope

may pose an infection control risk to the patient and/or

operators performing the next procedure with the endoscope.

3.1

Required Reprocessing Equipment

Preparation of the Equipment

Prior to cleaning, disinfection or sterilization, prepare the equipment shown in

Figure 3.1.

Use basins which are at least 40 cm by 40 cm (16” by 16”) in

size and deep enough to allow the endoscope to be

completely immersed. Do not coil the endoscope’s Insertion

Tube and Universal Cord with a diameter smaller than 40 cm.

The endoscope can be damaged if coiled too tightly.

14

ENF/LF ENDOSCOPE REPROCESSING MANUAL

Page 19

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Channel

Cleaning Brush

(BW-15B)

Channel Cleaning Brush

(BW-7B for LF-2/DP/GP)

Channel-opening

Cleaning Brush

(MH-507)

Leakage Tester

(MB-155)

ETO Cap

(MB-156)

Suction Connector

Cleaning Brush

(BW-15SH for LF-2/DP/GP)

Maintenance Unit

(MU-1)

Suction Pump

(KV-4)

• Detergent Solution

• Large Basin for Rinsing

• Personal Protective

Equipment

• Disinfectant Solution

• Large Basin for Leakage Testing

• Soft-Bristled Toothbrush

• Rinsing Water

• 30 cm3 (30 ml) Syringe

• Lint-free Cloths

• 70% Ethyl or Isopropyl Alcohol

• Cotton Swab

• Large Non-metallic Basin with a Tight

• Soft Sponge

Fitting Lid for Detergent and

Disinfectant Solution

Figure 3.1

ENF/LF ENDOSCOPE REPROCESSING MANUAL

15

Page 20

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Reprocessing Equipment Parts and Functions

For inspection of other equipment than that mentioned below, refer to the

instruction manual for the equipment being used.

Do not use the Channel Cleaning Brush for cytologic tissue

sampling or other diagnostic or therapeutic purposes. Patient

injury, cross-contamination or equipment damage may occur.

 ETO Cap (MB-156)

When performing ETO gas sterilization, the ETO Cap must be attached to the

Venting Connector on the Endoscope Connector (see Figure 3.2).

Connector

Figure 3.2

 Channel Cleaning Brush (BW-15B or BW-7B)

The Channel Cleaning Brush is used to brush the inside of the channel (see

Figure 3.3).

Metal Tip

Figure 3.3

16

ENF/LF ENDOSCOPE REPROCESSING MANUAL

Page 21

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

 Channel-opening Cleaning Brush (MH-507)

The Channel-opening Cleaning Brush is used to brush the Suction Valve

Housing (see Figure 3.4).

Figure 3.4

 Suction Connector Cleaning Brush (BW-15SH)

The Suction Connector Cleaning Brush is used to brush the inside of the Suction

Connector (see Figure 3.5).

Metal Tip

Figure 3.5

ENF/LF ENDOSCOPE REPROCESSING MANUAL

17

Page 22

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Inspection of the Equipment

For inspection of other equipment than that mentioned below, refer to the

instruction manual for the equipment being used.

The cleaning brushes are consumable items. Should the

slightest irregularity be suspected, use a spare instead.

Using a defective brush may cause equipment damage.

 Inspection of the ETO Cap

Check that the ETO Cap is free from scratches, flaws and debris (see Figure

3.2).

 Inspection of the Channel Cleaning and Suction Connector

Cleaning Brushes

1.

Confirm that the brush section and the Metal Tip of the distal end are

securely in place. Check for loose or missing bristles (see Figures 3.3 and

3.5).

2.

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

3.

Check for debris on the shaft and/or in the bristles of the brush.

 Inspection of the Channel-opening Cleaning Brush

18

1.

Check for loose or missing bristles (see Figure 3.4).

2.

Check for debris on the shaft and/or in the bristles of the brush.

ENF/LF ENDOSCOPE REPROCESSING MANUAL

Page 23

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

3.2

Cleaning, Disinfection and Sterilization

Procedures

Endoscope Reprocessing Summary Chart

Withdrawal of the Endoscope

Precleaning (Section 3.3)

Leakage Testing (Section 3.4)

Manual Cleaning

(Section 3.5)

High Level Disinfection

(Section 3.6)

Sterilization

(ETO Gas)

(Section 3.8)

Rinsing After High Level

Disinfection (Section 3.7)

Storage (Chapter 5)

ENF/LF ENDOSCOPE REPROCESSING MANUAL

19

Page 24

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

ALL channels of the endoscope MUST be cleaned and

high-level disinfected or sterilized during EVERY

reprocessing cycle, even if the channels were not used

during the previous patient procedure. Otherwise, insufficient

cleaning and disinfection or sterilization of the endoscope

may pose an infection control risk to the patient and/or

operators performing the next procedure with the endoscope.

3.3

Precleaning

Preclean the endoscope at the bedside in the procedure room immediately

following the procedure. These steps are to be performed when the Light Source

and Suction Pump are turned ON and still connected to the endoscope.

Equipment Needed

Prepare the following equipment:

• Personal Protective Equipment

• Clean, Lint-free Cloths

• Detergent Solution in a 500 cm3 (500 ml) Container

Wipe Down the Insertion Tube

Handle the Insertion Tube carefully. Tightly gripping or

sharply bending the Insertion Tube or Bending Section can

stretch or severely damage the Insertion Tube and the

Bending Section’s covering.

20

1.

Prepare detergent solution in a 500 cm3 (500 ml) container.

2.

Wipe the entire Insertion Tube with a clean, lint-free cloth soaked in

detergent solution. Wipe from the Boot toward the Distal End.

ENF/LF ENDOSCOPE REPROCESSING MANUAL

Page 25

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Aspirate Detergent Solution

Monitor the bottle on the Suction Pump carefully to ensure

that it does not overflow, as this could result in damage to the

Suction Pump.

1.

Turn the Suction Pump ON.

2.

Immerse the Distal End of the Insertion Tube in detergent solution. Depress

the Suction Valve Lever and aspirate detergent solution into the channel for

30 seconds.

3.

Remove the Distal End of the Insertion Tube from detergent solution.

Depress the Suction Valve Lever and aspirate air for 10 seconds.

4.

Turn the Suction Pump OFF.

5.

Turn the Light Source OFF.

Disconnect the Endoscope and, Reusable Parts

1.

Disconnect the suction tube from the Suction Connector.

2.

Remove the Biopsy Valve from the Suction Valve. If it is Single-use Biopsy

Valve, discard it after removal (see Figure 3.6).

Figure 3.6

3.

Rotate the Suction Valve until the White Line on the Suction Valve Holder is

aligned with the white dot on the Suction Valve Housing, and pull it upward

to remove the valve.

4.

Disconnect the Endoscope Connector from the Light Source.

The Endoscope Connector is very hot immediately after it is

disconnected. Avoid touching it.

ENF/LF ENDOSCOPE REPROCESSING MANUAL

21

Page 26

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

5.

When using the LF-TP/DP/GP, rotate the Attachment Ring and remove the

Miniature Light Source from the endoscope.

6.

Confirm that the lamp of the Miniature Light Source is turned off.

7.

When using the Light Guide Cable

(WA03200A/A3090/A3091/A3093/A3920/A3921/A3923) with the

LF-TP/DP/GP, remove the Light Guide Cable and Light Guide Adapter from

the endoscope.

When using the LF-TP/DP/GP, the Socket of the Miniature

Light Source, the endoscope’s Light Guide and the connector

of the Light Guide Cable will be very hot immediately after the

Miniature Light Source and Light Guide Cable are removed.

Avoid touching them.

Make sure that the illumination is off when disconnecting the

Miniature Light Source from the endoscope. If the Miniature

Light Source has been removed with the illumination on,

reconnect it to the endoscope and turn the illumination off.

The illumination cannot be turned on and off while the

Miniature Light Source is disconnected from the endoscope.

3.4

Leakage Testing

After precleaning, perform leakage testing the endoscope to ensure that it is

waterproof.

Equipment Needed

Prepare the following equipment:

• Personal Protective Equipment

• Large Basin

• Maintenance Unit or Light Source

(MU-1, CLK-4 or CLV-U40)

• Leakage Tester

(MB-155)

•

22

Never connect or disconnect the Leakage Tester connector

cap while immersed. Doing so could allow water to enter the

endoscope and may damage the endoscope.

ENF/LF ENDOSCOPE REPROCESSING MANUAL

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