Olympus OLYMPUS OSF-3 User manual

Refer to the endoscope’s companion manual, the “OLYMPUS OSF-3 OPERATION MANUAL” for inspection
and operation information.
USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician.
INSTRUCTIONS
SIGMOIDOFIBERSCOPE
OLYMPUS OSF-3

Contents
i
OSF-3 ENDOSCOPE REPROCESSING MANUAL
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 ..................................................... 6
2.1 Compatibility Summary ................................................................... 6
2.2 Detergent Solution .......................................................................... 8
2.3 Disinfectant Solution ....................................................................... 8
2.4 Rinsing Water ................................................................................. 9
2.5 ETO Gas Sterilization ..................................................................... 9
2.6 Steam Sterilization (Autoclaving) of Accessories............................ 11
Chapter 3 Cleaning, Disinfection and Sterilization Procedures
.................................................................................. 13
3.1 Required Reprocessing Equipment ................................................ 13
3.2 Cleaning, Disinfection and Sterilization Procedures ....................... 19
3.3 Precleaning ..................................................................................... 20
3.4 Leakage Testing ............................................................................. 23
3.5 Manual Cleaning ............................................................................. 26
3.6 High Level Disinfection ................................................................... 35
3.7 Rinsing After High Level Disinfection.............................................. 37
3.8 Sterilization ..................................................................................... 39
3.9 Cleaning, Disinfection and Sterilization Procedures for
Removable Parts and Cleaning Equipment .................................... 40
Chapter 4 Washing and Disinfection Equipment................... 45
4.1 Washing and Disinfection Equipment ............................................. 45
Chapter 5 Storage and Disposal.............................................. 47
5.1 Storage ........................................................................................... 47
5.2 Disposal .......................................................................................... 47

Contents
ii OSF-3 ENDOSCOPE REPROCESSING MANUAL

Symbols
1
OSF-3 ENDOSCOPE REPROCESSING MANUAL
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

2
Chapter 1 General Policy
OSF-3 ENDOSCOPE REPROCESSING MANUAL
Chapter 1 General Policy
1.1 Instructions
• Chapters 1 through 4 describe recommended procedures and
equipment for cleaning and disinfection or sterilization of 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 reprocessing,
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

Chapter 1 General Policy
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OSF-3 ENDOSCOPE REPROCESSING MANUAL
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. During use, the instrument
normally comes in contact with intact mucous membranes.
To minimize the risk of transmitting diseases from one patient
to another, after each examination the endoscope must
undergo thorough manual cleaning followed by high-level
disinfection or sterilization after each examination.
• 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 hamper disinfection or sterilization efficiency.

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Chapter 1 General Policy
OSF-3 ENDOSCOPE REPROCESSING MANUAL
• 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.
• 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, 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 clothing 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 the buildup
of 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.

Chapter 1 General Policy
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OSF-3 ENDOSCOPE REPROCESSING MANUAL
• 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.
• When aerating or irrigating the endoscope channels, the air
or water pressure must not exceed 0.2 MPa (2 kgf/cm2,
29 psig).
• Make sure that the ETO Cap is not installed on the Venting
Connector before immersion in reprocessing fluids.

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Chapter 2 Compatible Reprocessing Methods and Chemical Agents
OSF-3 ENDOSCOPE REPROCESSING MANUAL
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 damage. For appropriate
reprocessing methods, refer to Table 2.1 below, the recommendations of your
infection control committee and national and local hospital guidelines and
policies.

Chapter 2 Compatible Reprocessing Methods and Chemical Agents
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OSF-3 ENDOSCOPE REPROCESSING MANUAL
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.
Steam Sterilization (Autoclave)
ETO Gas Sterilization
2 to 3.2% Glutaraldehyde
70% Ethyl or Isopropyl
Alcohol
Detergent Solution
Ultrasonic
Cleaning
Endoscope
Channel Cleaning Brush
(BW-20T)
Channel-opening
Cleaning Brush
(MH-507)
Air/Water Valve
(MB-196)
Suction Valve
(MB-197)
All-Channel Irrigator
(CW-3)
Channel Cleaning
Adapter (MB-19)
AW Channel Cleaning
Adapter (MB-107)
Biopsy Valve (MB-358)
ETO Cap (MB-156)
applicable not applicable
Table 2.1

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Chapter 2 Compatible Reprocessing Methods and Chemical Agents
OSF-3 ENDOSCOPE REPROCESSING MANUAL
2.2 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 U.S. Food and Drug Administration 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 3.2% 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.
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.

Chapter 2 Compatible Reprocessing Methods and Chemical Agents
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OSF-3 ENDOSCOPE REPROCESSING MANUAL
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 use
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.
Figure 2.1
• Before sterilization, the instrument must be thoroughly
cleaned and dried. Residual moisture inhibits sterilization.
The ETO Cap must be attached to the Venting
Connector on the Scope Connector prior to ETO
gas sterilization.

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Chapter 2 Compatible Reprocessing Methods and Chemical Agents
OSF-3 ENDOSCOPE REPROCESSING MANUAL
• 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.
• All instruments must be properly aerated following ETO gas
sterilization to remove toxic ethylene oxide residuals.
• Install the ETO Cap on the Venting Connector of the
Endoscope Connector before ETO gas sterilization as shown
in Figure 2.1. If ETO gas sterilization is performed while the
ETO Cap is removed, air inside the Endoscope will expand
and could rupture the covering of the Bending Section.
• Repeated ETO gas sterilization procedures will gradually
deteriorate the instrument. Do not ETO gas sterilize the
instrument unnecessarily.
ETO gas sterillization is not permitted in some European
countries.
For USA
ETO Gas Exposure Parameters (Gas mixture 12% ETO/88% CFC)
Process Parameters
ETO Gas Sterilization Temperature 57°C (135°F)
Pressure 0.1 to 0.17 MPa
(1 to 1.7 kgf/cm2)
(16 to 24 psig)
Humidity 55%
Exposure Time 1.75 hours
ETO Gas Concentration 600 to 700 mg/l
Aeration (Minimum) 12 hours in an aeration chamber at 50 to 57°C (122 to
135°F) or 7 days at room temperature
Table 2.2

Chapter 2 Compatible Reprocessing Methods and Chemical Agents
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OSF-3 ENDOSCOPE REPROCESSING MANUAL
For Countries Other Than the United States
ETO Gas Exposure Parameters (Gas mixture 20% ETO/80% CO2)
2.6 Steam Sterilization (Autoclaving) of Accessories
These accessories listed as compatible with steam sterilization (autoclaving) in
Table 2.1 can be sterilized by steam within the parameters given in Table 2.4.
When steam sterilizing, follow the hospital’s protocol and the sterilization
equipment manufacture’s instructions.
• 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.
• Effective sterilization will not be possible if items are packed
tightly together in the autoclave; always pack items loosely.
Process Parameters
ETO Gas Sterilization Temperature 57°C (135°F)
Pressure 0.1 to 0.17 MPa
(1 to 1.7 kgf/cm2)
(16 to 24 psig)
Humidity 55%
Exposure Time 1.75 hours
ETO Gas Concentration 600 to 700 mg/l
Aeration (Minimum) 12 hours in an aeration chamber at 50 to 57°C (122 to
135°F) or 7 days at room temperature
Table 2.3

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Chapter 2 Compatible Reprocessing Methods and Chemical Agents
OSF-3 ENDOSCOPE REPROCESSING MANUAL
• Inspect the instrument package for openings, tears and other
damage. If the instrument package is open or damaged, seal
the components in new packaging and re-sterilize as
described below.
• 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.
Temperature Exposure Time
Prevacuum 132 to 134°C
(270 to 274°F) 5minutes
Table 2.4

Chapter 3 Cleaning, Disinfection and Sterilization Procedures
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OSF-3 ENDOSCOPE REPROCESSING MANUAL
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 wrap the endoscope’s Insertion
Tube and Universal Cord into a coil with a diameter smaller
than 40 cm. The endoscope can be damaged if coiled too
tightly.

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures
OSF-3 ENDOSCOPE REPROCESSING MANUAL
Figure 3.1
• Detergent Solution • Large non-metallic Basin with a Tight
Fitting Lid for Detergent and Disinfectant
solution
• Personal Protective
Equipment
• Rinsing Water • Large Basin for Rinsing • Soft brush
• 70% ethyl or isopropyl Alcohol • Large Basin for Leakage Testing • Lint-free Cloth
• Disinfectant Solution •30cm
3(30 ml) Syringe
Channel Cleaning Brush
(BW-20T)
AW Channel Cleaning
Adapter (MB-107)
Maintenance Unit
(MU-1, sold separately)
Channel-opening
Cleaning Brush (MH-507)
All-channel Irrigator
(CW-3)
ETO Cap (MB-156) Channel Cleaning
Adapter (MB-19)
Biopsy Valve
(MB-358)
Leakage Tester
(MB-155, sold
separately)
Suction Pump (KV-4)

Chapter 3 Cleaning, Disinfection and Sterilization Procedures
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OSF-3 ENDOSCOPE REPROCESSING MANUAL
Reprocessing Equipment Parts and Functions
For inspection of other equipment than that mentioned below, refer to the
instruction manual for the equipment being used.
All-channel Irrigator (CW-3)
Used to plug the openings of the Instrument Channel Port, Air/Water Cylinder,
and Suction Cylinder during cleaning. Used to inject detergent solution,
disinfectant solution and sterile water into the Air/Water and Suction Channels
and to flush air through channels to expel fluids (see Figure 3.2).
Figure 3.2
Channel Cleaning Brush (BW-20T)
The Channel Cleaning Brush is used to brush the inside of the suction channel
and the holes in the Air/Water and Suction Valves (see Figure 3.3).
Figure 3.3
Flange
Lock Cover
CO2Cap Channel Cap
Main Body
Suction
Port
Air/water
Port
Intake Tube
(with Filter)
Non-slip
Finger Rest
Metal Tip

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures
OSF-3 ENDOSCOPE REPROCESSING MANUAL
ETO Cap (MB-156)
Installed on the Venting Connector of the Endoscope Connector to allow ETO
gas sterilization (see Figure 3.4).
Figure 3.4
Channel-opening Cleaning Brush (MH-507)
The Channel-opening Cleaning Brush is used to brush the outer surface of the
Distal End of the endoscope, the Suction Cylinder and the Instrument Channel
Opening (see Figure 3.5).
Figure 3.5
Notice Card