OES BRONCHOFIBERSCOPE Instructions Addendum

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INSTRUCTIONS USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician. Addendum OES BRONCHOFIBERSCOPE BF-MP60 1 Instructions The sections below provide updated information or instructions on the chemicals to be used for reprocessing, the sterilization conditions, rinsing after high-level disinfection, and recommendation on using sterilization. Changes are summarized below and are denoted by underlined text in the subsequent sections of this Addendum. #1 Clarification of regulatory jurisdiction of the chemicals (for all the listed models) described in Chapter 2, “2.3 Disinfectant solution” in the reprocessing manual is updated to be more accurate description. #2 Conditions for ETO gas sterilization described in Chapter 2, “2.5 ETO gas sterilization” in the reprocessing manual is updated to align with the newly validated conditions. #3 Recommendation on using sterilization instead of disinfection (for all the listed models) is added to Chapter 3, “3.2 Cleaning, disinfection and sterilization procedures” in the reprocessing manuals from an infection control perspective. #4 Rinsing steps after high-level disinfection (for all the listed models) described in Chapter 3, “3.7 Rinsing after high-level disinfection” in the reprocessing manual is updated to align with the disinfectant manufacture’s instruction. Other parts of the instruction manual are not changed. 2 “2.3 Disinfectant solution” in Chapter 2 In the U.S., agents used to achieve high-level disinfection are defined as liquid chemical germicides regulated by 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. WARNING Alcohol is not a sterilant or high-level disinfectant. 3 “2.5 ETO gas sterilization” in Chapter 2 WARNING • 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. CAUTION • Exceeding the recommended parameters may cause equipment damage (see Table 2.2). 4411_03_03AD_v1.1 –1–

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INSTRUCTIONS

USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician.

Addendum OES BRONCHOFIBERSCOPE

BF-MP60 1 Instructions The sections below provide updated information or instructions on the chemicals to be used for reprocessing, the sterilization conditions, rinsing after high-level disinfection, and recommendation on using sterilization. Changes are summarized below and are denoted by underlined text in the subsequent sections of this Addendum. #1 Clarification of regulatory jurisdiction of the chemicals (for all the listed models) described in Chapter 2, “2.3 Disinfectant solution” in the reprocessing manual is updated to be more accurate description. #2 Conditions for ETO gas sterilization described in Chapter 2, “2.5 ETO gas sterilization” in the reprocessing manual is updated to align with the newly validated conditions. #3 Recommendation on using sterilization instead of disinfection (for all the listed models) is added to Chapter 3, “3.2 Cleaning, disinfection and sterilization procedures” in the reprocessing manuals from an infection control perspective. #4 Rinsing steps after high-level disinfection (for all the listed models) described in Chapter 3, “3.7 Rinsing after high-level disinfection” in the reprocessing manual is updated to align with the disinfectant manufacture’s instruction. Other parts of the instruction manual are not changed.

2 “2.3 Disinfectant solution” in Chapter 2 In the U.S., agents used to achieve high-level disinfection are defined as liquid chemical germicides regulated by 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.

WARNING Alcohol is not a sterilant or high-level disinfectant.

3 “2.5 ETO gas sterilization” in Chapter 2 WARNING • 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.

CAUTION • Exceeding the recommended parameters may cause equipment damage (see Table 2.2).

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CAUTION • Attach the ETO cap to the endoscope connector before sterilizing. If the ETO cap is not attached to the endoscope during ETO gas sterilization, the air inside the endoscope will expand and could rupture the covering of the bending section and/or damage the angulation mechanism (see Figure 2.1).

ETO cap (MB-156) Venting connector

Connecting the ETO cap

Figure 2.1

 Parameters for 100% ethylene oxide gas sterilization cycles The endoscope and accessories listed as compatible with ethylene oxide gas sterilization in Table 2.1 can be sterilized by 3M Steri-Vac 5XL or STERIS Amsco® Eagle® 3017 ethylene oxide gas sterilizers with the “55C cycle” given in Table 2.2, and aerated with 12 hours or more at 55C (130F). When performing ethylene oxide gas sterilization, follow all national, professional, and institutional reprocessing protocols as well as the instructions provided by the manufacturer of your sterilization equipment. Process phase Sterilization

Aeration

Parameter

Value

Temperature

55C (130F)

Relative humidity

50 – 80%

Ethylene oxide gas concentration

0.735 – 0.740 mg/cm3 (735 – 740 mg/L)

Exposure time

60 minutes

Minimum aeration parameters

12 hours in an aeration chamber at 55C (130F)

Table 2.2

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4 “3.2 Cleaning, disinfection and sterilization procedures” in Chapter 3 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)

Leakage testing (Section 3.4)

Manual cleaning (Section 3.5)

High Level Disinfection*1 (Section 3.6)

Sterilization (Section 3.8)

Rinsing after high-level disinfection (Section 3.7)

Storage (Chapter 5)

*1 Sterilization can be selected for the scope as a preferable reprocessing method instead of high level disinfection if sterilization is recommended based on decision by medical professionals.

WARNING ALL channels of the endoscope MUST be cleaned and high-level disinfected or sterilized during EVERY reprocessing cycle, even if the channels were not used during the previous patient procedure. Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope.

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5 “3.7 Rinsing after high-level disinfection” in Chapter 3 WARNING After reprocessing, purge the channels of the endoscope to thoroughly dry them. Otherwise, bacteria may proliferate in the channels and pose an infection-control risk to the patient and/or operators performing the next procedure with the endoscope. After high-level disinfection, rinse the endoscope and all equipment according to the procedures described below. Use water of appropriate microbiological quality. 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, fresh potable tap water or water which has been processed (e.g. filtered) to improve its microbiological quality may be used with 70% ethyl or isopropyl alcohol rinse (see “Non-sterile water rinse and alcohol flush” on page 39). Also consult with your hospital’s infection control committee.

 Equipment needed Prepare the following equipment and wear appropriate personal protective equipment. • Personal protective equipment • Sterile, lint-free cloths • Large basin • Sterile water (for sterile water rinse) • 70% ethyl or isopropyl alcohol • Suction cleaning adapter •

(MAJ-222)

30 cm3 (30 ml) syringe

• Suction pump (with sterile suction tube) • Clean water (non-sterile water) • Small basin • Sterile cotton swabs

CAUTION Alcohol is flammable. Handle with care.

 Sterile water rinse 1 Fill a basin with sterile water. Use a basin which is at least 40 cm by 40 cm (16” by 16”) in size and deep enough to allow the endoscope to be completely immersed.

2 Immerse the endoscope and suction cleaning adapter in the sterile water. Using a sterile, lint-free cloth, thoroughly rinse and wipe all external surfaces.

3 4 5 6 7 8

Connect the suction cleaning adapter to the endoscope and connect the suction pump’s tube to the adapter. Turn ON the suction pump. Aspirate sterile water for 30 seconds. Remove the endoscope from the sterile water and aspirate air for 60 seconds. Turn OFF the suction pump. Hold the control section with the instrument channel port pointing down and disconnect the suction cleaning adapter from the endoscope (see Figure 3.14).

9 Repeat Step 1 through 8 above for the necessary number of times described in the disinfectant manufacturer’s instructions with new rinsing water.

Suction cylinder cap

10 Using a sterile, lint-free cloth, thoroughly wipe and dry the external

Port cap

surfaces of the endoscope and suction cleaning adapter.

11 Dry the endoscope and suction cleaning adapter. 12 Store the components following the instructions given in Chapter 5, “Storage”.

Suction opening

Figure 3.14

NOTE Flushing the channels with 70% ethyl or isopropyl alcohol after rinsing them with sterile water facilitates drying the inside of the channels.

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 Non-sterile water rinse and alcohol flush CAUTION Alcohol is flammable. Handle with care.

1 Fill a basin with non-sterile water. Use a basin which is at least 40 cm by 40 cm (16” by 16”) in size and deep enough to allow the endoscope to be completely immersed.

2 Immerse the endoscope and suction cleaning adapter in the non-sterile water. Using a sterile, lint-free cloth, thoroughly rinse and wipe all external surfaces.

3 4 5 6 7 8 9 10

Connect the suction cleaning adapter to the endoscope and connect the suction pump’s tube to the adapter. Turn ON the suction pump. Aspirate non-sterile water for 30 seconds. Remove the endoscope from the non-sterile water and aspirate air for 60 seconds. Immerse the distal end of the endoscope in 70% ethyl or isopropyl alcohol. Aspirate alcohol for 5 seconds. Remove the distal end of the endoscope from the alcohol and aspirate air for 20 seconds. Turn OFF the suction pump. Hold the control section with the instrument channel port pointing down and disconnect the suction cleaning adapter from the endoscope (see Figure 3.14).

11 Repeat Step 1 through 10 above for the necessary number of times described in the disinfectant manufacturer’s instructions with new rinsing water.

12 Using a sterile, lint-free cloth, thoroughly wipe and dry the external surfaces of the endoscope and suction cleaning adapter.

13 Using a sterile, lint-free cloth moistened with alcohol, thoroughly wipe the external surfaces of the endoscope and suction cleaning adapter.

14 Using sterile cotton swabs, dry the inside of the suction cylinder and instrument channel port. 15 Dry the endoscope and all equipment. 16 Store the components following the instructions given in Chapter 5, “Storage”.

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