Olympus GIF XP160 User manual

Refer to the endoscope’s companion manual, the “OPERATION MANUAL” whose cover lists the model of
your endoscope, for operation information.
USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician.
INSTRUCTIONS
EVIS EXERA GASTROINTESTINAL VIDEOSCOPE
OLYMPUS GIF TYPE XP160
OLYMPUS GIF TYPE 160
OLYMPUS GIF TYPE Q160
OLYMPUS GIF TYPE Q160Z
OLYMPUS GIF TYPE 1TQ160
OLYMPUS GIF TYPE XTQ160
EVIS EXERA COLONOVIDEOSCOPE
OLYMPUS CF TYPE Q160L/I
OLYMPUS CF TYPE Q160AL/I
OLYMPUS CF TYPE Q160ZL/I
OLYMPUS CF TYPE Q160DL/I
OLYMPUS PCF TYPE 160AL/I
EVIS EXERA SIGMOIDOVIDEOSCOPE
OLYMPUS CF TYPE Q160S

Contents
i
EVIS EXERA GIF/CF/PCF TYPE 160 Series 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 ...................................................................... 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......................... 24
3.3 Precleaning ..................................................................................... 25
3.4 Leakage testing............................................................................... 31
3.5 Manual cleaning.............................................................................. 37
3.6 High-level disinfection ..................................................................... 50
3.7 Rinsing after high-level disinfection ................................................ 52
3.8 Sterilization ..................................................................................... 56
3.9 Cleaning, disinfection and sterilization procedures for reusable parts
and reprocessing equipment........................................................... 58
Chapter 4 Cleaning and Disinfection Equipment................... 65
Chapter 5 Storage and Disposal.............................................. 67
5.1 Storage ........................................................................................... 67
5.2 Disposal .......................................................................................... 68

Contents
ii EVIS EXERA GIF/CF/PCF TYPE 160 Series REPROCESSING MANUAL

Symbols
1
EVIS EXERA GIF/CF/PCF TYPE 160 Series 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
EVIS EXERA GIF/CF/PCF TYPE 160 Series REPROCESSING MANUAL
Chapter 1 General Policy
1.1 Instructions
• Chapters 1, “General Policy” through 4, “Cleaning and Disinfection
Equipment” describe recommended procedures and equipment 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 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:
occupational health and safety regulations
all 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
EVIS EXERA GIF/CF/PCF TYPE 160 Series 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. 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.
• ALL channels of the endoscope, including auxiliary water
channel where fitted, 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.

4
Chapter 1 General Policy
EVIS EXERA GIF/CF/PCF TYPE 160 Series 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 personal protective equipment before leaving
the reprocessing area.
• Thoroughly rinse off the disinfectant solution. Rinse the
external surfaces of the endoscope, all channels and
cleaning equipment thoroughly with clean water to remove
any 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 is a fire hazard and will lose its efficacy due to
evaporation.

Chapter 1 General Policy
5
EVIS EXERA GIF/CF/PCF TYPE 160 Series 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 0.5 MPa (5 kgf/cm2,
71 psig).
• When reprocessing EVIS videoscope models, confirm that
the water-resistant cap (MH-553) is securely attached to the
endoscope connector before immersion in reprocessing
fluids.
• When reprocessing the CF-Q160ZL/I, confirm that the
water-resistant cap (MAJ-583) is securely attached to the
zoom connector before immersion in reprocessing fluids.
• When reprocessing the CF-Q160DL/I, confirm that the
water-resistant cap (MAJ-942) is securely attached to the
UPD scope connector before immersion in reprocessing
fluids.

6
Chapter 1 General Policy
EVIS EXERA GIF/CF/PCF TYPE 160 Series REPROCESSING MANUAL
• When reprocessing an endoscope that has the flexibility
adjustment mechanism, make sure that the insertion tube is
set to the softest condition (indicated by the “” mark on the
flexibility adjustment ring) before immersing the endoscope in
cleaning/disinfectant solution.
If the endoscope is cleaned and disinfected or sterilized while
the insertion tube is stiff, the endoscope may be damaged.
Endoscope models Water-resistant cap
CF-Q160ZL/I MH-553, MAJ-583
CF-Q160DL/I MH-553, MAJ-942
Other MH-553
Table 1.1