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TJF-Q180V Cleaning and Disinfection Checklist
TJF-Q180V Cleaning and Disinfection Checklist This checklist is used to evaluate and confirm if cleaning and disinfection of the TJF-Q180V has been performed as instructed in the Olympus reprocessing manual. The reprocessing technician should perform cleaning and disinfection of the endoscope in the same way as routine reprocessing without referring to this checklist. The evaluator stands next to the reprocessing technician and checks the reprocessing work using this checklist. After that, the evaluator determines whether or not there was any deviation in the reprocessing process. WARNING: The reprocessing technician must not use this checklist while performing reprocessing as it may pose an infection control risk.
Facility name S/N of TJF-Q180V Procedure No. or Patient ID No. Procedure date
Reprocessing WARNING: The reprocessing technician must not sign this checklist while performing reprocessing as it may pose an infection control risk.
Technician: Print name Signature Date
Technician: Print name Signature Date
Evaluator: Print name Signature Date Ver.1.2 (March 2015) Olympus Medical Systems Corp.
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Contents General Policy... 3 Automated Endoscope Reprocessor... 4 Precleaning (at the patient bed side)... 5 Leakage Testing of the Endoscope... 9 Manually Cleaning the Endoscope and Accessories... 11 Manual High-Level Disinfection... 29 Rinsing... 36 Alcohol Flush... 42 Cleaning and Disinfection using an Automated Endoscope Reprocessor... 46
Ver.1.2 (March 2015) Olympus Medical Systems Corp.
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General Policy
1
Reprocessing technician should receive sufficient education on the following items: ・ • Professional health and safety policies of the facility ・ • Structure and handling of endoscope and accessories ・ • Handling of pertinent chemicals ・ • Cleaning and Disinfection procedure of TJF-Q180V
Received
Not received
Received
Not received
Established
Not established
Not repaired
Repaired
Documented
Not documented
Complete
Not complete
Established
Not established
No deviation
Deviation
Reprocessing Technician name:
Reprocessing Technician name:
2
Maintain an internal system of identifying contaminated versus reprocessed endoscopes and accessories to prevent both mix-ups and cross-contamination.
3
In the event that the TJF-Q180V has been repaired by a non-Olympus facility, contact that repair facility for instructions regarding reprocessing. Instructions provided in the TJF-Q180V REPROCESSING MANUAL are not valid for Olympus devices repaired by a non-Olympus facility. The Olympus recommended reprocessing procedures have not been validated for reprocessing devices repaired by a non-Olympus facility.
4
Document as performed items such as: local SOPs (standard operating procedures), confirmation of technician training, routine testing of the disinfectant’s MEC (minimal effective concentration), confirmation of the disinfectant’s use-life, etc.
5
For leakage testing and manual cleaning of the endoscope and accessories, use either fresh, potable tap water or water that has been processed (e.g., filtered, deionized or purified) to improve its chemical and/or microbiological quality. Consult with your hospital’s infection control committee.
6
Establish a local policy regarding the method and frequency of cleaning and disinfecting the endoscope storage cabinet, which staff members can access the cabinet, which items can be stored in the cabinet, etc.
Evaluation of the “General Policy” Deviation Comments:
Ver.1.2 (March 2015) Olympus Medical Systems Corp.
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Automated Endoscope Reprocessor (AER) Policy
1
Confirm that the manufacturer of the AER has validated compatibility of the AER with the TJF-Q180V. Only Olympus-recommended or Olympus-endorsed AERs have been validated by Olympus.
Confirmed
2
Before using an AER, confirm that it is capable of reprocessing the TJF-Q180V including all channels, the forceps elevator recess, and accessories.
Not confirmed
N/A
Capable
Not capable
Confirmed
Not confirmed
No deviation
Deviation
If you are uncertain as to the ability of your AER to reprocess the TJF-Q180V including all channels, the forceps elevator recess, and accessories, contact the manufacturer of the AER for specific instructions and information on compatibility and required connectors.
3
Confirm availability of all required connectors. For details concerning appropriate connectors, refer to the instructions of the AER manufacturer.
Evaluation of the “Automated Endoscope Reprocessor” Policy Deviation Comments:
Ver.1.2 (March 2015) Olympus Medical Systems Corp.
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Date
Procedure finish time
Precleaning start time
Precleaning technician
Precleaning (at the patient bed side) Preparation
1
Complete
Not complete
Complete
Not complete
Complete
Not complete
4
Turn the suction pump ON.
Complete
Not complete
5
Close the cap on the biopsy valve.
Complete
Not complete
6
Lower the forceps elevator by turning the elevator control lever.
Complete
Not complete
7
Immerse the distal end of the insertion section in the clean water.
Complete
Not complete
Immediately following the patient procedure, with the endoscope still connected to the equipment used in the patient procedure (i.e., the light source, video system center, suction pump), turn the video system center and light source OFF.
2
Prepare a clean 500 ml container of water.
Wipe the insertion section
3
Dip a clean, lint-free cloth or sponge in the clean water and wipe the entire insertion section of the endoscope. Wipe from the boot at the control section toward the distal end.
Aspirate water
Suction valve (MH-443)
Cap
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8
30 seconds complete
Not complete
Raise/Lower 3 times complete
Not complete
10
Complete
Not complete
11
10 seconds complete
Not complete
12
Complete
Not complete
13
Complete
Not complete
14
Complete
Not complete
15
Complete
Not complete
16
Complete
Not complete
Depress the suction valve (MH-443) on the endoscope and aspirate the water through the endoscope for 30 seconds.
9
While continuing the immersion and the aspiration, raise and lower the forceps elevator three times, by turning the elevator control lever.
Remove the distal end from the water.
Depress the suction valve and aspirate air for 10 seconds.
Turn the suction pump OFF.
Flush the air/water channel with water and air Turn the light source ON.
Switch OFF the airflow regulator on the light source.
Detach the air/water valve (MH-438) from the endoscope and place it in the detergent solution.
Attach the AW channel cleaning adapter (MH-948) to the air/water cylinder of the endoscope. Air/water valve AW channel cleaning adapter
(continued on next page)
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17
Complete
Not complete
18
Complete
Not complete
19
30 seconds complete
Not complete
20
10 seconds complete
Not complete
21
Complete
Not complete
22
Complete
Not complete
23
Complete
Not complete
24
Complete
Not complete
25
Complete
Not complete
Complete
Not complete
Immerse the distal end of the insertion section in the clean water.
Switch the airflow regulator on the light source to maximum output (“HIGH”or “3”).
Depress the button of the AW channel cleaning adapter to flush the air/water channel with water from the water container for 30 seconds.
Release the button to flush air for 10 seconds.
Turn the light source OFF.
Detach accessories from the endoscope Detach the videoscope cable (MAJ-1430, MAJ-843, or MH-976) from the electrical connector of the endoscope.
Detach the suction tube from the suction connector on the endoscope connector.
Detach the metal tip of the water container (MAJ-901 or MH-884) from the air/water supply connector on the endoscope connector.
Put the metal tip of the water container tube into the receptacle on the lid of the water container.
Attach the water resistant cap (MH-553)
26
Confirm that the exterior surface of the electrical connector is free from scratches.
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Attach the cap to the electrical connector.
Complete
Not complete
No deviation
Deviation
Evaluation of the “Precleaning” Deviation Comments:
Ver.1.2 (March 2015) Olympus Medical Systems Corp.
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Start time
Reprocessing technician name
Leakage Testing of the Endoscope
1
Detach the endoscope from the light source.
Complete
Not complete
2
Transport the endoscope to the reprocessing area. Use a covered container if required by local policy.
Complete
Not complete
3
Detach the AW channel cleaning adapter (MH-948), the suction valve (MH-443), and the biopsy valve (MB-358) from the endoscope and place them in the detergent solution.
Complete
Not complete
4
Fill a clean, large basin with water.
Complete
Not complete
Attach the leakage tester connector of the leakage tester (MB-155) to the output socket of the maintenance unit (MU-1) or the light source. Turn the maintenance unit or the light source ON. Set the light source’s airflow regulator switch to its maximum level.
Complete
Not complete
Depress the pin located inside the connector cap of the leakage tester and listen to confirm that air is emitted from the connector cap.
6
Complete
Not complete
Confirm that both the connector cap of the leakage tester and the venting connector of the water resistant cap are dry. If not, dry with a clean, lint free cloth. Attach the connector cap to the venting connector by pushing on and rotating clockwise until it stops.
7
Complete
Not complete
5
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8
With the leakage tester attached, immerse the endoscope in the water and observe for approximately 30 seconds while deflecting the bending section of the endoscope by turning the endoscope’s UP/DOWN and RIGHT/LEFT angulation control knobs, and while raising and lowering the forceps elevator by moving the endoscope’s elevator control lever. Confirm that there is no location on the endoscope from which a continuous series of air bubbles emerge.
Performed
Not performed
Deflected
Not deflected
Raised and lowered
Not raised and lowered
No leakage
Leakage
Complete
Not complete
10
Complete
Not complete
11
Complete
Not complete
12
Complete
Not complete
13
Complete
Not complete
Evaluation of the “Leakage Testing”
No deviation
Deviation
Air bubbles
Channel opening
9
Bending section
Remove the endoscope from the water with the leakage tester still attached.
Turn the maintenance unit or the light source OFF.
Detach the leakage tester from the maintenance unit or the light source.
Wait 30 seconds, or until the covering of the bending section contracts to its pre-expansion size. Detach the leakage tester from the water resistant cap.
Thoroughly dry the leakage tester using a clean, lint-free cloth.
Deviation Comments:
Ver.1.2 (March 2015) Olympus Medical Systems Corp.
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Start time
Reprocessing technician name
Manually Cleaning the Endoscope and Accessories Clean the external surface
1
Fill a clean, large basin with the detergent solution at the concentration recommended by the detergent manufacturer.
Complete
Use a medical-grade, low-foaming, neutral pH detergent. Follow the instructions provided by the detergent manufacturer regarding concentration, temperature, contact time, and expiration date.
Not complete
Actual Condition Detergent Name:
Concentration: Temperature: Contact time: Expiration date:
2
Immerse the endoscope in the detergent solution.
3
Thoroughly brush or wipe all external surfaces of the endoscope, using a clean, lint-free cloth, brush or sponge. Pay particular attention to the air/water nozzle opening and the objective lens on the distal end of the insertion section, and ensure that all surfaces of the distal end are thoroughly cleaned.
Complete
Not complete
All external surfaces complete
Not complete
Distal end complete
Not complete
Air/water nozzle opening
Objective lens
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Brush the forceps elevator and elevator recess
4
Lower the forceps elevator by turning the elevator control lever in the opposite direction of the “tU” direction until it stops. Perform the following brushing in the detergent solution.
Complete
Not complete
Complete
Not complete
Brush handle touched
Not complete
Complete
Not complete
Elevator control lever
5
Straighten the bending section of the endoscope.
6
Brush the forceps elevator including the guidewire-locking groove and the forceps elevator recess with the single use channel-opening cleaning brush (MAJ-1339) or the single use combination cleaning brush (BW-412T) as follows:
a) Insert the brush into the forceps elevator recess along the forceps elevator until the brush handle touches the distal end of the endoscope and pull the brush out of the forceps elevator recess in the detergent solution.
b) B rush the guidewire-locking groove in the detergent solution.
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c) B rush both grooves in the detergent solution.
First groove complete Not complete Second groove complete
7
Raise the forceps elevator by turning the elevator control lever in the “tU” direction until resistance is felt.
Complete
Not complete
Complete
Not complete
Insertion complete
Not complete
Rotation complete
Not complete
Elevator control lever
8
While holding the distal end, brush the forceps elevator and the forceps elevator recess with the single-use channel-opening cleaning brush as follows: a) Insert the brush into the forceps elevator recess along the back of the forceps elevator until the distal end of the brush touches the bottom of the forceps elevator recess in the detergent solution.
a
Forceps elevator
Forceps elevator recess
b) Insert the brush into the forceps elevator recess and rotate the brush one full revolution in the detergent solution. Forceps elevator
Forceps elevator recess b
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c) Brush both sides of the forceps elevator in the detergent solution.
First side complete Not complete Second side complete
9
Operate the elevator control lever to raise and lower the forceps elevator in the detergent solution at least three times.
10
Inspect whether there is debris on the forceps elevator and in the forceps elevator recess (Inspection by the reprocessing technician).
3 times complete
Not complete
No debris confirmed on the elevator
Debris confirmed on the elevator
No debris confirmed in the recess
Debris confirmed in the recess Go to 12
11
Inspect whether there is debris on the forceps elevator and in the forceps elevator recess (Inspection by the evaluator).
No debris confirmed on the elevator
Debris confirmed on the elevator
No debris confirmed in the recess
Debris confirmed in the recess
WARNING - The evaluator must not touch the endoscope. That may pose an infection control risk. (continued on next page)
Ver.1.2 (March 2015) Olympus Medical Systems Corp.
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12
Repeat Steps 4 through 11 until no debris is observed upon inspection of the forceps elevator and the forceps elevator recess.
6-a) Complete
6-b) Complete
6-c) Complete
8-a) Complete
Not done
8-b) Complete
8-c) Complete
9 (3 times) Complete
No debris confirmed on the elevator
Debris confirmed on the elevator
No debris confirmed in the recess
Debris confirmed in the recess
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13
Inspect whether there is debris on the forceps elevator and in the forceps elevator recess (Inspection by the evaluator).
No debris confirmed on the elevator
Debris confirmed on the elevator
No debris confirmed in the recess
Debris confirmed in the recess
14
Complete
Not complete
15
Brushing complete
Not complete
No debris confirmed
Debris confirmed
No debris confirmed
Debris confirmed
Instrument channel complete
Instrument channel not complete
Suction channel complete
Suction channel not complete
No parts
Parts
WARNING - The evaluator must not touch the endoscope. That may pose an infection control risk.
Lower the forceps elevator by turning the elevator control lever in the opposite direction of the “tU” direction until it stops.
Brush the distal end of the endoscope except the forceps elevator and the forceps elevator recess, using the single use channel-opening cleaning brush, until no debris is observed upon inspection of the brush.
16
Inspect whether no debris is observed on the brush (Inspection by the evaluator). WARNING - The evaluator must not touch the endoscope. That may pose an infection control risk.
Brush the channels
17
Confirm that no parts remain inside either the instrument channel or the suction channel of the endoscope by carefully passing a new brush through both channels.
Ver.1.2 (March 2015) Olympus Medical Systems Corp.
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Brush from the suction cylinder to the distal end of the insertion section
18
Complete
Not complete
19
Short strokes
Long strokes
Emerged
Not emerged
Straighten the bending section of the endoscope.
Insert the brush at a 45° angle into the opening located in the side wall of the suction cylinder. Using short strokes, feed the brush through the instrument channel until it emerges from the distal end of the endoscope’s insertion section. Opening Suction cylinder
45°
Instrument channel
Distal end
Not brushed Suction channel
Suction cylinder
20
Inspect whether there is debris on the bristles when the brush emerges from the distal end. Clean the bristles in the detergent solution using your gloved fingertips to remove any debris.
Inspection complete
Inspection not complete
Cleaning complete
Cleaning not complete
21
Complete
Not complete
22
Inspection complete
Inspection not complete
(continued on next page)
Cleaning complete
Cleaning not complete
Carefully pull the brush back through the channel and out of the suction cylinder.
Inspect whether there is debris on the bristles when the brush emerges from the suction cylinder. Clean the bristles in the detergent solution using your gloved fingertips to remove any debris.
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23
Repeat steps 19 through 22 until no debris is observed upon inspection of the brush.
No debris observed
Debris observed
19 Complete
20 Complete
Not complete
21 Complete
24
Inspect whether no debris is observed on the brush (Inspection by the evaluator).
No debris observed
Debris observed
No debris observed
Debris observed
WARNING - The evaluator must not touch the endoscope. That may pose an infection control risk.
Brush from the suction cylinder to the endoscope connector
25
Insert the brush straight into the suction cylinder. Using short strokes, feed the brush through the suction channel until it emerges from the suction connector on the endoscope connector. Suction cylinder
Short strokes
Long strokes
Emerged
Not emerged
Opening
Not brushed
Suction channel
Suction cylinder
26
Inspect whether there is debris on the bristles when the brush emerges from the suction connector. Clean the bristles in the detergent solution using your gloved fingertips to remove any debris.
Inspection complete
Inspection not complete
Cleaning complete
Cleaning not complete
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27
Complete
Not complete
28
Inspection complete
Inspection not complete
Cleaning complete
Cleaning not complete
No debris observed
Debris observed
Carefully pull the brush back through the channel and out of the suction cylinder.
Inspect whether there is debris on the bristles when the brush emerges from the suction cylinder. Clean the bristles in the detergent solution using your gloved fingertips to remove any debris.
29
Repeat steps 25 through 28 until no debris is observed upon inspection of the brush.
25 Complete
26 Complete
Not complete
27 Complete
30
Inspect whether no debris is observed on the brush (Inspection by the evaluator).
No debris observed
Debris observed
No debris observed
Debris observed
Complete
Not complete
WARNING - The evaluator must not touch the endoscope. That may pose an infection control risk.
Brush the suction cylinder
31
Insert the single use channel-opening cleaning brush into the suction cylinder, until half of the brush section is inserted. Suction cylinder
(continued on next page)
Ver.1.2 (March 2015) Olympus Medical Systems Corp.
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