gif-fq260z_gastrointestinal_videoscope_and_cf-fh260.pdf
Page 1
INSTRUCTIONS
EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE
OLYMPUS GIF-FQ260Z
EVIS LUCERA COLONOVIDEOSCOPE
OLYMPUS CF-FH260AZL/I
Refer to the endoscope’s companion manual, the “OPERATION MANUAL” whose cover lists the model of
your endoscope, for inspection and operation information.
Page 3
Contents
Contents
Symbols.........................................................................................
1
Chapter 1
General Policy .........................................................
2
1.1
Instructions......................................................................................
2
1.2
Importance of cleaning, disinfection and sterilization......................
2
1.3
Signal words ...................................................................................
3
1.4
Precautions .....................................................................................
3
1.5
Reprocessing before the first use/reprocessing and storage after use
6
Chapter 2
Compatible Reprocessing Methods and Chemical
Agents ......................................................................
7
2.1
Compatibility summary....................................................................
7
2.2
Detergent solution...........................................................................
9
2.3
Disinfectant solution........................................................................
10
2.4
Rinsing water ..................................................................................
10
2.5
Ethylene oxide gas sterilization.......................................................
10
2.6
Steam sterilization (autoclaving) of accessories .............................
12
Chapter 3
Cleaning, Disinfection and Sterilization Procedures
.................................................................................. 13
3.1
Required reprocessing equipment ..................................................
13
3.2
Cleaning, disinfection and sterilization procedures for the endoscope
........................................................................................................
22
3.3
Precleaning .....................................................................................
23
3.4
Leakage testing...............................................................................
29
3.5
Manual cleaning..............................................................................
35
3.6
High-level disinfection .....................................................................
49
3.7
Rinsing after high-level disinfection ................................................
51
3.8
Sterilization .....................................................................................
55
3.9
Cleaning, disinfection and sterilization procedures for reusable parts
and reprocessing equipment...........................................................
57
Chapter 4
Cleaning and Disinfection Equipment...................
65
Chapter 5
Storage and Disposal..............................................
68
5.1
Storage of the endoscope...............................................................
69
5.2
Storage of reusable parts and reprocessing equipment .................
70
5.3
Disposal ..........................................................................................
70
EVIS LUCERA GIF-FQ260Z, CF-FH260AZL/I REPROCESSING MANUAL
i
Page 4
Contents
ii
EVIS LUCERA GIF-FQ260Z, CF-FH260AZL/I 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
EVIS LUCERA GIF-FQ260Z, CF-FH260AZL/I REPROCESSING MANUAL
1
Page 6
Chapter 1 General Policy
Chapter 1 General Policy
1.1
1.2
Instructions
•
This manual contains the cleaning, disinfection and sterilization
methods recommended by Olympus for the endoscopes listed on the
front cover.
•
This instruction manual contains essential information on reprocessing
these instruments safely and effectively.
•
Before reprocessing, thoroughly review the manuals of the reprocessing
chemicals and all equipment which will be used and reprocess the
equipment as instructed.
•
Note that the complete instruction manual set for this endoscope
consists of this manual and the “OPERATION MANUAL” whose cover
lists the model of your endoscope, both of which accompanied the
endoscope at shipment.
•
Keep this manual and all related manuals in a safe and accessible
location.
•
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.
Importance of cleaning, disinfection and
sterilization
The medical literature reports incidents of cross contamination resulting from
improper cleaning, disinfection or sterilization. It is strongly recommended that
all individuals engaged in reprocessing closely observe all instructions given in
this manual and the manuals of all ancillary equipment, and have a thorough
understanding of the following items:
2
•
Professional health and safety criteria of your hospital
•
Individual cleaning, disinfection and sterilization protocols
•
Structure and handling of endoscopic equipment
•
Handling of pertinent chemicals
EVIS LUCERA GIF-FQ260Z, CF-FH260AZL/I REPROCESSING MANUAL
Page 7
Chapter 1 General Policy
For the types and conditions of the means of cleaning, disinfection and
sterilization to be adopted, please make judgments from your professional
viewpoints.
1.3
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.
1.4
Precautions
•
Failure to properly clean and high-level disinfect or sterilize
endoscopic equipment after each procedure may
compromise patient safety. To minimize the risk of
transmitting diseases from one patient to another, after each
procedure the endoscope and its ancillary equipment must
undergo thorough manual cleaning followed by high-level
disinfection or sterilization as described in Chapter 3,
“Cleaning, Disinfection and Sterilization Procedures”.
Reprocess not only the external surface of the endoscope
but also all channels.
•
ALL channels of the endoscope, including the auxiliary water
channel where existing, 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.
EVIS LUCERA GIF-FQ260Z, CF-FH260AZL/I REPROCESSING MANUAL
3
Page 8
Chapter 1 General Policy
4
•
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.
•
Olympus only confirms validation of endoscope reprocessors
it recommends. When using an endoscope reprocessor that
is not recommended by Olympus, the manufacturer of the
endoscope reprocessor is responsible for validation of the
reprocessor with the endoscope models listed in its
instruction manual.
•
Before using an endoscope reprocessor, confirm that it is
capable of reprocessing the endoscope including all
channels. If there are channels and/or other parts of the
endoscope that cannot be cleaned and/or high-level
disinfected by the endoscope reprocessor, manual cleaning
and high-level disinfection or sterilization must be performed
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 the endoscope including all
channels, contact the endoscope reprocessor’s manufacturer
for specific instructions and/or information on 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 surface of the endoscope, all channels and the
cleaning equipment thoroughly with 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.
EVIS LUCERA GIF-FQ260Z, CF-FH260AZL/I REPROCESSING MANUAL
Page 9
Chapter 1 General Policy
•
Store alcohol in an air-tight container. Alcohol stored in an
open container is a fire hazard and will result in a loss of
efficacy due to evaporation.
•
Be sure to perform a leakage test on the endoscope prior to
manual cleaning, and do not use the endoscope if a leak is
detected. Use of an endoscope with a leak may cause a
sudden loss of the endoscopic image, damage to the
bending mechanism or other malfunctions.
•
Prior to each procedure, confirm that the endoscope has
undergone proper cleaning, disinfection and sterilization. If it
is determined that the endoscope has not been properly
reprocessed, reprocess it again following the instructions
given in this 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 bar). Higher
pressures may cause damage to the endoscope.
EVIS LUCERA GIF-FQ260Z, CF-FH260AZL/I REPROCESSING MANUAL
5
Page 10
Chapter 1 General Policy
Model
•
When reprocessing an endoscope that has the flexibility
adjustment mechanism, make sure that the insertion tube is
set to its most-flexible condition (indicated by the “z” mark on
the flexibility adjustment ring). If the endoscope is cleaned
and disinfected or sterilized while the insertion tube is too
rigid, the endoscope may be damaged (for CF-FH260AZL/I
only).
•
When reprocessing an endoscope, confirm that the
water-resistant cap is securely attached to the endoscope
connector and the zoom connector (for CF-FH260AZL/I only)
before immersion in reprocessing fluids. If the water-resistant
cap is not securely attached, water, detergent solution and/or
disinfectant solution could enter the endoscope and damage
the equipment. The compatible water-resistant caps are
shown in Table 1.1.
Water-resistant cap
GIF-FQ260Z
MH-553
CF-FH260AZL/I
MH-553 and MAJ-583
Table 1.1
1.5
Reprocessing before the first use/reprocessing
and storage after use
This instrument was not cleaned, disinfected or sterilized before shipment.
Before using this instrument for the first time, reprocess it according to the
instructions given in this manual.
After using this instrument, reprocess and store it according to the instructions
given in this manual. Improper and/or incomplete reprocessing or storage can
present an infection control risk, cause equipment damage or reduce
performance.
6
EVIS LUCERA GIF-FQ260Z, CF-FH260AZL/I 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 below, the
recommendations of your infection control committee and all national and local
hospital guidelines and policies.
EVIS LUCERA GIF-FQ260Z, CF-FH260AZL/I REPROCESSING MANUAL
7
Page 12
Chapter 2 Compatible Reprocessing Methods and Chemical Agents
Steam sterilization (autoclaving)
Ethylene oxide gas sterilization
ACECIDE disinfectant solution ∗3
(use OER-A)
2 – 3.5% glutaraldehyde
70% ethyl or isopropyl
alcohol
Detergent solution
Ultrasonic
cleaning
Endoscope
∗1
Water-resistant cap
(MH-553)
Chain for
Water-resistant cap
(MAJ-1119)
Water-resistant cap
(MAJ-583)
∗2
∗2
Channel cleaning brush
(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)
AW channel cleaning
adapter (MH-948)
Suction cleaning
adapter (MH-856)
Mouthpiece
(MB-142)
Auxiliary water tube
(MAJ-855)
Biopsy valve (MB-358)
applicable
not applicable
Table 2.1
8
EVIS LUCERA GIF-FQ260Z, CF-FH260AZL/I REPROCESSING MANUAL
Page 13
Chapter 2 Compatible Reprocessing Methods and Chemical Agents
∗1 The endoscope is only compatible with ultrasonic cleaning as performed in
an endoscope reprocessor such as OER and OER-A (OER and OER-A
are not available in some areas).
∗2 The water-resistant cap and the chain for water-resistant cap can only be
ultrasonically cleaned if connected to the endoscope that is being cleaned
in an endoscope reprocessor with an ultrasonic cleaning phase.
∗3 ACECIDE disinfectant solution is exclusively for OER-A.
Alcohol is not a sterilant or high-level disinfectant.
2.2
•
Endo-therapy accessories which are marked by the words
“AUTOCLAVE” or “AUTOCLAVABLE”, or accessories with a
green model reference label are compatible with autoclaving.
•
The endoscope is compatible with some endoscope
reprocessors distributed by Olympus. Refer to the respective
instruction manual for details on operation. For any other
details, please contact your local Olympus organization.
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 the interior of the channels.
EVIS LUCERA GIF-FQ260Z, CF-FH260AZL/I REPROCESSING MANUAL
9
Page 14
Chapter 2 Compatible Reprocessing Methods and Chemical Agents
2.3
Disinfectant solution
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
according to the manufacturer’s recommendations. Do not use solutions beyond
their expiration date.
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
Ethylene oxide gas sterilization
The instruments and other accessories listed as compatible with ethylene oxide
gas sterilization in Table 2.1 on page 8 can be sterilized by ethylene oxide gas
and aerated within the parameters given in Table 2.2. When performing ethylene
oxide gas sterilization, follow the cleaning, disinfection and sterilization protocols
of your hospital and the instruction manuals of the sterilization equipment.
10
•
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.
EVIS LUCERA GIF-FQ260Z, CF-FH260AZL/I REPROCESSING MANUAL
Page 15
Chapter 2 Compatible Reprocessing Methods and Chemical Agents
•
All instruments must be properly aerated following ethylene
oxide gas sterilization to remove toxic ethylene oxide
residuals.
•
Disconnect the water-resistant caps from the endoscope
connector and the zoom connector (for CF-FH260AZL/I only)
before ethylene oxide gas sterilization. If the water-resistant
caps are attached during ethylene oxide gas sterilization, the
air inside the endoscope will expand and rupture the covering
of the bending section and/or damage the angulation
mechanism.
•
Exceeding the recommended parameters may cause
equipment damage (see Table 2.2).
Ethylene oxide gas exposure parameters
Process
Ethylene oxide gas
sterilization
Aeration
Parameters
Temperature
57°C
Pressure
0.1 – 0.17 MPa
Humidity
55%
Exposure time
1.75 hours
Ethylene oxide
gas concentration
0.6 – 0.7 mg/cm3
(600 – 700 mg/l)
Minimum aeration
parameters
12 hours in an aeration chamber
at 50 – 57°C or 7 days at room
temperature
Table 2.2
Gas mixture
20% Ethylene oxide gas/80% CO2
EVIS LUCERA GIF-FQ260Z, CF-FH260AZL/I REPROCESSING MANUAL
11
Page 16
Chapter 2 Compatible Reprocessing Methods and Chemical Agents
2.6
Steam sterilization (autoclaving) of accessories
The accessories listed as compatible with steam sterilization (autoclaving) in
Table 2.1 on page 8 can be sterilized by steam within the parameters given in
Table 2.3. When steam sterilizing, follow the cleaning, disinfection and
sterilization protocols of your hospital 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.
•
Do not steam sterilize the endoscope. Steam sterilization
(autoclaving) will severely damage the endoscope.
•
Exceeding the recommended parameters may cause
equipment damage (see Table 2.3).
Process
Prevacuum
Table 2.3
12
Parameters
Temperature
132 – 134°C
Exposure time
5 minutes
Steam sterilization (autoclaving) exposure parameters
EVIS LUCERA GIF-FQ260Z, CF-FH260AZL/I REPROCESSING MANUAL
Page 17
Chapter 3 Cleaning, Disinfection and Sterilization Procedures
Chapter 3 Cleaning, Disinfection and
Sterilization Procedures
ALL channels of the endoscope, including the auxiliary water
channel where existing, 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
•
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.
•
For proper reprocessing results, do not coil the insertion tube
or the universal cord with a diameter of less than 40 cm. If
the diameter is less than 40 cm, it will be difficult to insert the
channel cleaning brush (BW-20T).
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 in size and
deep enough to allow the endoscope to be completely
immersed.
EVIS LUCERA GIF-FQ260Z, CF-FH260AZL/I REPROCESSING MANUAL
13
Page 18
Chapter 3 Cleaning, Disinfection and Sterilization Procedures
Water-resistant cap
(MH-553)
Channel cleaning brush
(BW-20T)
Injection tube
(MH-946)
Channel-opening
cleaning brush
(MH-507)
Suction pump
(KV-4/5, SSU-2)
(sold separately)
AW channel cleaning
adapter (MH-948)
Channel plug
(MH-944)
Leakage tester
(MB-155)
(sold separately)
Light source
(CLV-260SL/260NBI/260)
(sold separately)
Suction cleaning adapter
(MH-856)
Auxiliary water tube (MAJ-855)
(for CF-FH260AZL/I only)
Maintenance unit
(MU-1)
(sold separately)
Water-resistant cap (MAJ-583)
(for CF-FH260AZL/I only)
• Personal protective equipment
• Soft brush
• 500 cm3 (500 ml) containers
• Clean lint-free cloths
• Large basins with tight fitting lids∗1
• Sterile lint-free cloths
• Small basins with tight fitting lids
(size: 25 (W) × 10 (H) × 25 (D) cm or more)
• Sterile cotton swabs
• Clean water
• 30 cm3 (30 ml) syringe
• Detergent solution
• Disinfectant solution
• Sterile water
• 70% ethyl or isopropyl alcohol
∗1 Use basins which are at least 40 cm by 40 cm in size and deep enough to allow the endoscope
to be completely immersed.
Figure 3.1
14
EVIS LUCERA GIF-FQ260Z, CF-FH260AZL/I REPROCESSING MANUAL
Page 19
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.
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).
Groove
Venting connector
Seal
Figure 3.2
Water-resistant cap (MAJ-583, for CF-FH260AZL/I only)
The water-resistant cap (MAJ-583) is attached to the zoom connector of 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).
Chain
Seal
Screw
Figure 3.3
EVIS LUCERA GIF-FQ260Z, CF-FH260AZL/I REPROCESSING MANUAL
15
Page 20
Chapter 3 Cleaning, Disinfection and Sterilization Procedures
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 3.4).
Biopsy valve cap
Cylinder plug
Figure 3.4
Injection tube (MH-946)
The injection tube is used to inject detergent solution, disinfectant solution, water
and alcohol into the air/water channel, instrument channel and suction channel
and to flush air through the channels to expel fluids (see Figure 3.5).
Suction channel tube
Notice card
Suction
channel port
Connector plug
Air pipe port
Air/water
channel port
Filter tube
Air/water
channel tube
Suction port
(including the filter mesh)
Figure 3.5
16
EVIS LUCERA GIF-FQ260Z, CF-FH260AZL/I REPROCESSING MANUAL
Page 21
Chapter 3 Cleaning, Disinfection and Sterilization Procedures
Channel cleaning brush (BW-20T)
The channel cleaning brush is used to brush the inside of the instrument and
suction channels and the interior and/or openings of the suction valve, air/water
valve, AW channel cleaning adapter and biopsy valve (see Figure 3.6).
Metal tip
Shaft
Brush head
Figure 3.6
Channel-opening cleaning brush (MH-507)
The channel-opening cleaning brush is used to brush the suction cylinder and
the instrument channel port (see Figure 3.7).
Brush head
Brush handle
Shaft
Figure 3.7
EVIS LUCERA GIF-FQ260Z, CF-FH260AZL/I REPROCESSING MANUAL
17
Page 22
Chapter 3 Cleaning, Disinfection and Sterilization Procedures
Auxiliary water tube (MAJ-855, for CF-FH260AZL/I 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 3.8).
Clip
Luer port
Figure 3.8
Suction cleaning adapter (MH-856)
The suction cleaning adapter is used to aspirate reprocessing fluids from the
distal end of the endoscope through the instrument channel (see Figure 3.9).
Connecting end
Weighted end
Figure 3.9
18
EVIS LUCERA GIF-FQ260Z, CF-FH260AZL/I REPROCESSING MANUAL
Page 23
Chapter 3 Cleaning, Disinfection and Sterilization Procedures
AW channel cleaning adapter (MH-948)
During precleaning, the AW channel cleaning adapter is connected to the
air/water cylinder. When the adapter is depressed, water is fed through the
air/water nozzle. Air is continuously fed when the adapter is not depressed (see
Figure 3.10).
Notice card
Slider
Non-return valve
Piston
Packing
Figure 3.10
Inspection of equipment
For inspection of other equipment than that mentioned below, refer to the
instruction manual for the equipment being used.
All equipment mentioned below are consumables. Should the
slightest irregularity be suspected, use a spare instead.
Using defective equipment may make it difficult to effectively
reprocess the endoscope, and could cause endoscope
and/or equipment damage.
Do not immerse the water-resistant cap alone into water.
Moisture remaining inside the cap may penetrate the
electrical connector and cause equipment damage.
Inspection of the water-resistant cap (MH-553)
1.
Confirm that the inside of the water-resistant cap is dry and free from debris
(see Figure 3.2 on page 15). Wipe with a dry lint-free cloth if the inside of the
water-resistant cap is wet or if debris is detected.
2.
Confirm that the seal inside the water-resistant cap is free from scratches,
flaws and debris.
3.
Check to ensure that the venting connector is not loose.
EVIS LUCERA GIF-FQ260Z, CF-FH260AZL/I REPROCESSING MANUAL
19
Page 24
Chapter 3 Cleaning, Disinfection and Sterilization Procedures
Inspection of the water-resistant cap (MAJ-583, for
CF-FH260AZL/I only)
1.
Confirm that the inside of the water-resistant cap is dry and free from debris
(see Figure 3.3 on page 15). Wipe with a dry lint-free cloth when the inside
of the water-resistant cap is wet or if debris is detected.
2.
Confirm that the seal of the water-resistant cap is free from scratches, flaws
and debris.
3.
Confirm that the thread of the water-resistant cap is free from deformation
and other flaws.
Inspection of the channel plug (MH-944)
Confirm that the cylinder plug and biopsy valve cap are free from cracks,
scratches, flaws and debris (see Figure 3.4 on page 16).
Inspection of the injection tube (MH-946)
1.
Confirm that all components of the injection tube are free from cracks,
scratches, flaws and debris (see Figure 3.5 on page 16).
2.
Confirm that the filter mesh is in the suction port.
3.
Attach the 30 cm3 (30 ml) syringe to the air/water channel port. With the
filter mesh immersed in rinsing water, withdraw the syringe’s plunger and
confirm that rinsing water is drawn into the syringe. Depress the plunger and
confirm that rinsing water is emitted from the air pipe port. Confirm that
water is not emitted from the suction port.
4.
Attach the 30 cm3 (30 ml) syringe to the suction channel port. With the filter
mesh immersed in rinsing water, withdraw the syringe plunger and confirm
that rinsing water is drawn into the syringe. Depress the plunger and confirm
that rinsing water is emitted from the distal end of the suction channel tube.
Confirm that water is not emitted from the suction port.
Inspection of the channel cleaning brush (BW-20T)
20
1.
Confirm that the brush head and the metal tip of the distal end are securely
in place. Check for loose or missing bristles of the brush (see Figure 3.6 on
page 17).
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 head.
EVIS LUCERA GIF-FQ260Z, CF-FH260AZL/I REPROCESSING MANUAL
Page 25
Chapter 3 Cleaning, Disinfection and Sterilization Procedures
Inspection of the channel-opening cleaning brush
(MH-507)
1.
Check for loose or missing bristles of the brush (see Figure 3.7 on page 17).
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 head.
Inspection of the auxiliary water tube (MAJ-855, for
CF-FH260AZL/I only)
Check for cracks, scratches, flaws, debris and other damage (see Figure 3.8 on
page 18).
Inspection of the suction cleaning adapter (MH-856)
Check for cracks, scratches, flaws, debris and other damage (see Figure 3.9 on
page 18).
Inspection of the AW channel cleaning adapter (MH-948)
Check for cracks, scratches, flaws, debris and other damage (see Figure 3.10 on
page 19).
EVIS LUCERA GIF-FQ260Z, CF-FH260AZL/I REPROCESSING MANUAL
21
Page 26
Chapter 3 Cleaning, Disinfection and Sterilization Procedures
3.2
Cleaning, disinfection and sterilization
procedures for the endoscope
After the procedure, clean, disinfect and sterilize the endoscope according to the
procedure described below.
Endoscope reprocessing summary chart
Withdrawal of the endoscope
Precleaning
(Section 3.3 on page 23)
Leakage testing
(Section 3.4 on page 29)
Manual cleaning
(Section 3.5 on page 35)
High-level disinfection
(Section 3.6 on page 49)
Sterilization
(Section 3.8 on page 55)
Rinsing after high-level
disinfection
(Section 3.7 on page 51)
Storage and Disposal
(Chapter 5)
ALL channels of the endoscope, including the auxiliary water
channel where existing, 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.
22
EVIS LUCERA GIF-FQ260Z, CF-FH260AZL/I REPROCESSING MANUAL