GIF XP160
Olympus GIF XP160, GIF XTQ160, GIF 160, CF Q160L/I, GIF Q160Z Instructions 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
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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
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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.
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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/cm
2
,
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
Chapter 2 Compatible Reprocessing Methods and Chemical Agents
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EVIS EXERA GIF/CF/PCF TYPE 160 Series 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 equipment damage. For
appropriate reprocessing methods, refer to Table 2.1 below, the
recommendations of your infection control committee and all national and local
hospital guidelines and policies.
8
Chapter 2 Compatible Reprocessing Methods and Chemical Agents
EVIS EXERA GIF/CF/PCF TYPE 160 Series REPROCESSING MANUAL
Steam sterilization (autoclaving)
ETO gas sterilization
2 – 3.5% glutaraldehyde
70% ethyl or isopropyl alcohol
Detergent solution
Ultrasonic
cleaning
Endoscope
Water-resistant cap
(MH-553)
Water-resistant cap
(MAJ-583)
Water-resistant cap
(MAJ-942)
Forceps suction plug
(T-plug) (MH-405)
Channel cleaning brush
(BW-17K, BW-20T)
Channel-opening
cleaning brush (MH-507)
Air/water valve (MH-438)
Suction valve (MH-443)
Channel plug (MH-944)
Injection tube (MH-946)
Suction cleaning
adapter (MH-856)
AW channel cleaning
adapter (MH-948)
Mouthpiece (MB-142,
MA-474)
Biopsy valve (MB-358)
Auxiliary water tube
(MAJ-855)
applicable not applicable
Table 2.1
Chapter 2 Compatible Reprocessing Methods and Chemical Agents
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EVIS EXERA GIF/CF/PCF TYPE 160 Series REPROCESSING MANUAL
Endo-therapy accessories which are marked by the words
“AUTOCLAVE” or “AUTOCLAVABLE”, or accessories with a
green model reference label, are compatible with
autoclaving.
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 – 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 the 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.
10
Chapter 2 Compatible Reprocessing Methods and Chemical Agents
EVIS EXERA GIF/CF/PCF TYPE 160 Series REPROCESSING MANUAL
2.4 Rinsing water
Once removed from 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 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 and other accessories listed as compatible with ethylene oxide
(ETO) gas sterilization in Table 2.1 can be sterilized by ETO gas and aerated
within the parameters given in Table 2.2. When performing sterilization, follow
the hospital’s protocol and the sterilization equipment manufacturer’s
instructions.
Figure 2.1
Figure 2.2
EVIS videoscope models
(except CF-Q160ZL/I and CF-Q160DL/I)
CF-Q160ZL/I and CF-Q160DL/I
Chapter 2 Compatible Reprocessing Methods and Chemical Agents
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EVIS EXERA GIF/CF/PCF TYPE 160 Series REPROCESSING MANUAL
• Before sterilization, the instrument must be thoroughly
cleaned and dried. Residual moisture inhibits sterilization.
• 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.
• Exceeding the recommended parameters may cause
equipment damage.
• When reprocessing EVIS videoscope models, remove the
water-resistant cap before ETO gas sterilization (see Figures
2.1 and 2.2).
• Repeated ETO gas sterilization procedures will gradually
deteriorate the instrument. Do not perform ETO gas
sterilization to the instrument unnecessarily.
ETO gas exposure parameters
Process Parameters
ETO gas sterilization Temperature 57C (135F)
Pressure 0.1 – 0.17 MPa
(1 – 1.7 kgf/cm
2
)
(16 – 24 psig)
Humidity 55%
Exposure time 1.75 hours
ETO gas
concentration
0.6 – 0.7 mg/cm
3
(600 – 700 mg/l)
Aeration Minimum aeration
parameters
12 hours in an aeration chamber
at 50 – 57C (122 – 135F) or
7 days at room temperature
Table 2.2
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Chapter 2 Compatible Reprocessing Methods and Chemical Agents
EVIS EXERA GIF/CF/PCF TYPE 160 Series REPROCESSING MANUAL
Gas mixture
For the USA
12% ETO/88% CFC
For countries other than the USA
20% ETO/80% CO
2
2.6 Steam sterilization (autoclaving) of accessories
The accessories listed as compatible with steam sterilization (autoclaving) in
Table 2.1 can be sterilized by steam within the parameters given in Table 2.3.
When steam sterilizing, follow the hospital’s protocol and the sterilization
equipment manufacturer’s instructions.
• 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.
• Exceeding the recommended parameters may cause
equipment damage.
• 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.
• Inspect each instrument package for openings, tears or other
damage. If an instrument package is opened or damaged,
seal the components in a new package and sterilize again.
Chapter 2 Compatible Reprocessing Methods and Chemical Agents
13
EVIS EXERA GIF/CF/PCF TYPE 160 Series REPROCESSING MANUAL
• 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.
Process Parameters
Prevacuum Temperature 132 – 134C
(270 – 274F)
Exposure time 5minutes
Table 2.3 Steam sterilization (autoclaving) exposure parameters
14
Chapter 3 Cleaning, Disinfection and Sterilization Procedures
EVIS EXERA GIF/CF/PCF TYPE 160 Series REPROCESSING MANUAL
Chapter 3 Cleaning, Disinfection and
Sterilization Procedures
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.
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.
• For proper reprocessing results, do not coil the insertion tube
or the universal cord with a diameter of less than 40 cm.
• Do not coil the endoscope’s insertion tube or universal cord
with a diameter of less than 12 cm. The endoscope can be
damaged if coiled too tightly.
Chapter 3 Cleaning, Disinfection and Sterilization Procedures
15
EVIS EXERA GIF/CF/PCF TYPE 160 Series REPROCESSING MANUAL
Figure 3.1
• Detergent solution • Large basins for rinsing and
leakage testing
• Sterile, lint-free cloths
• Clean water
•30cm
3
(30 ml) syringe
• Sterile cotton swabs
• Sterile water • Soft brush • Small containers
• 70% ethyl or isopropyl alcohol • Personal protective equipment • Small basin
• Disinfectant solution
• Large basins with tight fitting
lids for detergent and
disinfectant solution
• Clean, lint-free cloths
• 500 cm
3
(500 ml) container
Water-resistant cap
(MH-553)
Water-resistant cap
(MAJ-583
for CF-Q160ZL/I only)
Water-resistant cap
(MAJ-942
for CF-Q160DL/I only)
Channel-opening
cleaning brush
(MH-507)
Channel cleaning brush
(BW-20T)
(BW-17K
for GIF-XTQ160 only)
Biopsy valve
(MB-358)
Channel plug
(MH-944)
Suction cleaning adapter
(MH-856)
AW channel cleaning
adapter (MH-948)
Auxiliary water tube
(MAJ-855
for endoscopes with
auxiliary water
feeding only)
Maintenance unit
(MU-1)
Leakage tester
(MB-155)
Suction pump
(KV-5, KV-4, SSU-2)
Injection tube
(MH-946)
16
Chapter 3 Cleaning, Disinfection and Sterilization Procedures
EVIS EXERA GIF/CF/PCF TYPE 160 Series 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.
Water-resistant cap (MH-553)
The water-resistant cap is attached to the electrical connector on the endoscope
to protect the connector from water penetration during reprocessing. For leakage
testing, the venting connector on the water-resistant cap must be connected to
the leakage tester (see Figure 3.2).
Figure 3.2
Water-resistant cap (MAJ-583 for CF-Q160ZL/I only)
The water-resistant cap (MAJ-583) is attached to the zoom connector on the
endoscope to protect the connector from water penetration during reprocessing.
The water-resistant cap is connected to the endoscope by a chain (see Figure
3.3).
Figure 3.3
Venting connector
Chain
Seal
Thread
Chain
Chapter 3 Cleaning, Disinfection and Sterilization Procedures
17
EVIS EXERA GIF/CF/PCF TYPE 160 Series REPROCESSING MANUAL
Water-resistant cap (MAJ-942 for CF-Q160DL/I only)
The water-resistant cap (MAJ-942) is attached to the UPD scope connector on
the endoscope to protect the connector from water penetration during
reprocessing. The water-resistant cap is connected to the endoscope by a chain
(see Figure 3.4).
Figure 3.4
Channel plug (MH-944)
The channel plug is used to plug the openings of the instrument channel port,
air/water and suction cylinders during cleaning (see Figure 3.5).
Figure 3.5
Seal
Thread
Chain
Biopsy valve cap
Cylinder plug
18
Chapter 3 Cleaning, Disinfection and Sterilization Procedures
EVIS EXERA GIF/CF/PCF TYPE 160 Series REPROCESSING MANUAL
Injection tube (MH-946)
The injection tube is used to inject detergent solution, disinfectant solution, water
and alcohol into the air/water and suction channels and to flush air through the
channels to expel fluids (see Figure 3.6).
Figure 3.6
Auxiliary water tube (MAJ-855 for endoscopes with
auxiliary water feeding only)
The auxiliary water tube is used to inject detergent solution, disinfectant solution,
water and alcohol into the auxiliary water channel and to flush air through the
channel to expel fluids (see Figure 3.7).
Figure 3.7
Suction
channel tube
Notice card
Connector plug
Air pipe port
Air/water
channel port
(including the filter mesh)
Air/water
channel tube
Suction port
Suction
channel port
Clip
Luer port
Chapter 3 Cleaning, Disinfection and Sterilization Procedures
19
EVIS EXERA GIF/CF/PCF TYPE 160 Series REPROCESSING MANUAL
Channel cleaning brush (BW-17K, BW-20T)
The channel cleaning brush is used to brush the inside of the instrument/suction
channels and the holes in the air/water and suction valves (see Figure 3.8).
Figure 3.8
Channel-opening cleaning brush (MH-507)
The channel-opening cleaning brush is used to brush the external surface of the
distal end of the endoscope, the suction cylinder and the instrument channel port
(see Figure 3.9).
Figure 3.9
Metal tip
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