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
3
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.

4
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
5
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.

6
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.