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INSTRUCTIONS OES COLONOFIBERSCOPE OLYMPUS
CF TYPE 40 L/I OES GASTROINTESTINAL FIBERSCOPE
OLYMPUS
GIF TYPE Q40
OLYMPUS
GIF TYPE XQ40
EVIS COLONOVIDEOSCOPE
CF TYPE 140 L/I OLYMPUS CF TYPE 1T140L/I OLYMPUS CF TYPE Q140 L/I OLYMPUS
OLYMPUS
PCF TYPE 140 L/I
CF TYPE 240 L/I OLYMPUS CF TYPE 240A L/I OLYMPUS CF TYPE 240D L/I OLYMPUS CF TYPE Q240 L/I OLYMPUS CF TYPE Q240A L/I OLYMPUS CF TYPE Q240Z L/I OLYMPUS PCF TYPE 240 L/I OLYMPUS PCF TYPE P240A L/I OLYMPUS
EVIS SIGMOIDOVIDEOSCOPE OLYMPUS
CF TYPE 140S
OLYMPUS
PCF TYPE 240S
EVIS GASTROINTESTINAL VIDEOSCOPE
GIF TYPE 140 OLYMPUS GIF TYPE 1T140 OLYMPUS GIF TYPE P140 OLYMPUS GIF TYPE Q140 OLYMPUS GIF TYPE XQ140 OLYMPUS
GIF TYPE 1T240 OLYMPUS GIF TYPE Q240 OLYMPUS GIF TYPE Q240X OLYMPUS GIF TYPE Q240Z OLYMPUS GIF TYPE SP240 OLYMPUS GIF TYPE XP240 OLYMPUS GIF TYPE XQ240 OLYMPUS
EVIS SMALL INTESTINAL VIDEOSCOPE OLYMPUS
SIF TYPE Q140
OLYMPUS
SIF TYPE Q240
Refer to the endoscope’s companion manual, the “OPERATION MANUAL” whose cover lists the model of your endoscope, for inspection and operation information. USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician.
Contents
Contents Symbols...
1
Chapter 1
General Policy ...
2
1.1
Instructions...
2
1.2
Signal words ...
3
1.3
Precautions ...
3
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 ...
13
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...
38
3.6
High-level disinfection ...
50
3.7
Rinsing after high-level disinfection ...
52
3.8
Sterilization ...
55
3.9
Cleaning, disinfection and sterilization procedures for reusable parts and reprocessing equipment...
57
Chapter 4
Cleaning and Disinfection Equipment...
63
Chapter 5
Storage and Disposal...
65
5.1
Storage ...
65
5.2
Disposal ...
66
Chapter 2
Chapter 3
GIF/CF/PCF/SIF TYPE 40/140/240 Series ENDOSCOPE REPROCESSING MANUAL
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Contents
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GIF/CF/PCF/SIF TYPE 40/140/240 Series ENDOSCOPE REPROCESSING MANUAL
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
GIF/CF/PCF/SIF TYPE 40/140/240 Series ENDOSCOPE REPROCESSING MANUAL
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Chapter 1 General Policy
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
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GIF/CF/PCF/SIF TYPE 40/140/240 Series ENDOSCOPE REPROCESSING MANUAL
Chapter 1 General Policy
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.
GIF/CF/PCF/SIF TYPE 40/140/240 Series ENDOSCOPE REPROCESSING MANUAL
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Chapter 1 General Policy
4
•
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, 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.
GIF/CF/PCF/SIF TYPE 40/140/240 Series ENDOSCOPE REPROCESSING MANUAL
Chapter 1 General Policy
•
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.
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When reprocessing OES fiberscope models, confirm that the ETO cap is not attached to the venting connector before immersing the endoscope in reprocessing fluids.
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When reprocessing the CF-Q240ZL/I, confirm that the water-resistant cap (MAJ-583) is securely attached to the zoom connector before immersion in reprocessing fluids.
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When reprocessing the CF-240DL/I, confirm that the water-resistant cap (MAJ-942) is securely attached to the UPD scope connector before immersion in reprocessing fluids.
GIF/CF/PCF/SIF TYPE 40/140/240 Series ENDOSCOPE REPROCESSING MANUAL
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Chapter 1 General Policy
•
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 hard, the endoscope may be damaged.
Endoscope models
Water-resistant cap
CF-Q240ZL/I
MH-553, MAJ-583
CF-240DL/I
MH-553, MAJ-942
Other
MH-553
Table 1.1
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GIF/CF/PCF/SIF TYPE 40/140/240 Series ENDOSCOPE REPROCESSING MANUAL
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.
GIF/CF/PCF/SIF TYPE 40/140/240 Series ENDOSCOPE REPROCESSING MANUAL
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Chapter 2 Compatible Reprocessing Methods and Chemical Agents
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) Channel cleaning brush (BW-9Y) 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) Suction cleaning adapter (MH-856) AW channel cleaning adapter (MH-948) Mouthpiece (MB-142, MA-474) Biopsy valve (MB-358) Washing tube (MH-974) ETO cap (MB-156) applicable
Table 2.1
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GIF/CF/PCF/SIF TYPE 40/140/240 Series ENDOSCOPE REPROCESSING MANUAL
not applicable
Chapter 2 Compatible Reprocessing Methods and Chemical Agents
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.
GIF/CF/PCF/SIF TYPE 40/140/240 Series ENDOSCOPE REPROCESSING MANUAL
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Chapter 2 Compatible Reprocessing Methods and Chemical Agents
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.
EVIS videoscope models (except CF-Q240ZL/I and CF-240DL/I)
Figure 2.1
CF-Q240ZL/I and CF-240DL/I
Figure 2.2
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GIF/CF/PCF/SIF TYPE 40/140/240 Series ENDOSCOPE REPROCESSING MANUAL
Chapter 2 Compatible Reprocessing Methods and Chemical Agents
OES fiberscope models
Figure 2.3
•
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). When reprocessing OES fiberscope models, install the ETO cap on the venting connector of the endoscope’s light guide connector section before ETO gas sterilization (see Figure 2.3). If ETO gas sterilization is performed while the water-resistant cap is installed or the ETO cap is not attached, 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 perform ETO gas sterilization to the instrument unnecessarily.
GIF/CF/PCF/SIF TYPE 40/140/240 Series ENDOSCOPE REPROCESSING MANUAL
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Chapter 2 Compatible Reprocessing Methods and Chemical Agents
ETO gas exposure parameters Process ETO gas sterilization
Parameters Temperature
57C (135F)
Pressure
0.1 – 0.17 MPa (1 – 1.7 kgf/cm2) (16 – 24 psig)
Aeration
Humidity
55%
Exposure time
1.75 hours
ETO gas concentration
0.6 – 0.7 mg/cm3 (600 – 700 mg/l)
Minimum aeration
12 hours in an aeration chamber at 50 – 57C (122 – 135F) or 7 days at room temperature
parameters
Table 2.2
Gas mixture For the USA 12% ETO/88% CFC For countries other than the USA 20% ETO/80% CO2
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GIF/CF/PCF/SIF TYPE 40/140/240 Series ENDOSCOPE REPROCESSING MANUAL
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 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.
•
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.
Process Prevacuum
Table 2.3
Parameters Temperature
132 – 134C (270 – 274F)
Exposure time
5 minutes
Steam sterilization (autoclaving) exposure parameters
GIF/CF/PCF/SIF TYPE 40/140/240 Series ENDOSCOPE REPROCESSING MANUAL
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Chapter 3 Cleaning, Disinfection and Sterilization Procedures
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.
14
•
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.
GIF/CF/PCF/SIF TYPE 40/140/240 Series ENDOSCOPE REPROCESSING MANUAL
Chapter 3 Cleaning, Disinfection and Sterilization Procedures
Water-resistant cap (MH-553)
Channel cleaning brush (BW-20T for GIF/CF/PCF models only)
Water-resistant cap (MAJ-583 for CF-Q240ZL/I only)
Channel cleaning brush (BW-9Y for SIF models only)
Biopsy valve (MB-358)
Leakage tester (MB-155, sold separately)
Water-resistant cap (MAJ-942 for CF-240DL/I only)
Injection tube (MH-946)
Maintenance unit (MU-1, sold separately)
Channel-opening cleaning brush (MH-507)
Washing tube (MH-974 for endoscopes with auxiliary water feeding only)
AW channel cleaning adapter (MH-948)
Channel plug (MH-944)
Suction cleaning adapter (MH-856)
Suction pump (KV-4, SSU-2, sold separately)
ETO cap (MB-156 for OES fiberscope models only)
• Detergent solution
• Large basins for rinsing and leakage testing
• Sterile, lint-free cloths
• Clean water
• 30 cm3 (30 ml) syringe
• Sterile cotton swabs
• Sterile water
• 5 cm3 (5 ml) syringe
• Small containers
• 70% ethyl or isopropyl alcohol
• Personal protective equipment
• Small basin
• Disinfectant solution
• Soft brush
• Large basins with tight fitting lids for detergent and disinfectant solution
• Clean, lint-free cloths
• 500 cm3 (500 ml) container
Figure 3.1 GIF/CF/PCF/SIF TYPE 40/140/240 Series ENDOSCOPE REPROCESSING MANUAL
15
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 for EVIS videoscope models only) 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).
Venting connector
Figure 3.2
Water-resistant cap (MAJ-583 for CF-Q240ZL/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).
Chain
Seal
Thread
Figure 3.3
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GIF/CF/PCF/SIF TYPE 40/140/240 Series ENDOSCOPE REPROCESSING MANUAL
Chapter 3 Cleaning, Disinfection and Sterilization Procedures
Water-resistant cap (MAJ-942 for CF-240DL/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).
Chain
Seal
Thread
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).
Biopsy valve cap
Cylinder plug
Figure 3.5
GIF/CF/PCF/SIF TYPE 40/140/240 Series ENDOSCOPE REPROCESSING MANUAL
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