Flexible Fiberscope with Lumen and Stopcocks Competency Checklist April 2016

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KARL STORZ-ENDOSKOPE

KARL STORZ Flexible Fiberscopes with Lumen and Stopcocks Competency Checklist

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Bedside Pre-cleaning (at point of use)

Initials/Date

Water Quality Recommendation: Utility Water 1.

Prior to pre-cleaning, turn off the Light Source and detach the Flexible Endoscope from the Fiber Optic Light cable. Detach the Fiber Optic Light Cable from the Light Source. Wipe the entire exterior of the Flexible Endoscope with a soft, lint-free, cloth, mOistened with water, or a diluted mild/neutral pH enzymatic cleaning solution (e.g. Enzol). This step is to remove gross debriS from the exterior of the Flexible Endoscope. Note: Refer to Fiber Optic Light cable instruction manual for reprocessing instructions for the Fiber OptiC Light cable.

2. Ensure that one of the stopcocks of the instrument port is closed during this process. Immerse the distal tip of the Flexible Endoscope in a basin of water. Suction (using a syringe) the channel with a minimum of 50 mL (1.7 oz) of water, or a diluted mild/neutral pH enzymatic cleaning solution (e.g. Enzol) through the open stopcock.

3. Repeat this step with the OPPOSite stopcock closed.

4. Inspect the vent port and the area removing any visible debris on the external surface with a 70% isopropyl alcohol wipe.

5. carefully place the Flexible Endoscope into a covered tray or container and transport the scope to the decontamination area. Ensure the Flexible Endoscope is kept protected during transport. Note: Complete cleaning of the patient-used Flexible Endoscope should be started within two hours of the bedside pre-cleaning. If transit time is greater than 2 hours, ensure that additional manual cleaning (see Manual Cleaning Section) is performed if visible reSidual debriS is still present.

2 KARL STORZ Endoscopy-America, Inc.

2151 E. Grand Avenue EI Segundo, CA 90245-5071

Phone 310 338 8100 Toll Free 800 421 0837 ZI7770US-A·04120 16

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KARL STORZ--- ENDOSKOPE

KARL STORZ Flexible Fiberscopes with Lumen and Stopcocks Competency Checklist

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leakage Test

Initials/Date

Water Recommendation: Utility Water

1. If present, remove the Pressure Compensation Cap (PIN: Z10455) from the Flexible Endoscope.

2. Inspect the vent port. Confirm that the area is clean. If debris is present carefully remove the debris with a 70% isopropyl alcohol wipe.

3. Ensure that both the FleXible Endoscope vent port and KARL STORZ leakage Tester (PIN: 13242Xl) are completely dry before conducting the leak test. 4.

Attach the KARl STORZ leakage Tester (PIN: 13242Xl) or automated leak tester using the adaptor at the end of the tubing to the Flexible Endoscope's vent port using a clockwise push and turn motion until it stops.

5.

Pump up the KARL STORZ leakage Tester (PIN: 13242XL) until a pressure of 200 mmHg is reached. Fully articulate the distal tip 5 times in each direction using the control lever, then reduce the pressure by pressing the pressure release button until the pressure reaches 160 mmHg.

Note: If using an automated leak tester, set the leak tester pressure to 160 mmHg and turn it on.

WARNING: If 160 mmHg pressure decreases on the KARL STORZ leakage Tester (PIN: 13242Xl), do not continue with reprocessing. Refer to Endoscope Return Instructions for return instructions.

WARNING: Do not perform a wet leak test in water containing detergent as bubble observation is difficult to perform with detergent present. 6.

While pressurized, submerge the entire Flexible Endoscope into a basin or sink containing a minimum of 2.6 gallons (10 l) of room temperature water (no detergent). The leak tester should be outside the basin or sink and should not be immersed. Ensure the Flexible Endoscope is COMPlETELY submerged.

If surface bubbles are visible on the Flexible Endoscope after submerging, use a syringe filled with water to remove them. 7.

Ensure that one stopcock is closed. While submerged, draw at least lOmL of water using a syringe. Attach the filled syringe to the other stopcock and flush the water. Open both stopcocks.

3 KARL STORZ Endoscopy-America, Inc.

2151 E. Grand Avenue EI Segundo, CA 90245-5071

Phone 310 338 8100 Toll Free 800 421 0837 ZI7770US-A-0412016

ST0~1

KARL STORZ ·····ENDOSKOPE

KARL STORZ Flexible Fiberscopes with Lumen and Stopcocks Competency Checklist

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Leakage Test cont'd

Initials/Date

8. Keep the Flexible Endoscope submerged for 1 minute, while fully deflecting the distal tip as follows:

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Place the distal tip in the neutral (straight) position and hold for 15 seconds.

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Articulate the distal tip to the full up position and hold for 15 seconds.

• •

Articulate the distal tip to the full down position and hold for 15 seconds. Place the distal tip in the neutral (straight) position again and hold for 15 seconds.

9. Observe for a formation of bubbles on the exterior of the Flexible Endoscope or a stream of air bubbles.

10. If the Flexible Endoscope has a leak as determined by a fall in pressure as seen on the KARL STORZ Leakage Tester (PIN: 13242XL) or if bubbles are discovered per the steps above, immediately remove the Flexible Endoscope from the water. Press the pressure release button on the KARL STORZ Leakage Tester (PIN: 13242XL) or turn off the automated leak tester to reduce the pressure to O. Detach the Leakage Tester (PIN: 13242XL) from the Flexible Endoscope and refer to the "Endoscope Return Instructions" for further instructions. 11. If the Flexible Endoscope does not leak, remove it from the water bath and press the pressure release button on the KARL STORZ Leakage Tester (PIN: 13242XL) to release pressure to "0" or follow the air pump's manufacturer instructions for releasing pressure from the Flexible Endoscope. 12. After the pressure drops to "0", detach the KARL STORZ Leakage Tester (PIN: 13242XL) or automated leak tester from the Flexible Endoscope and proceed to manual cleaning.

4 KARL STORZ Endoscopy-America, Inc.

2151 E. Grand Avenue EI Segundo, CA 90245-5071

Phone 310 338 8100 Toll Free 800 421 0837 Z17770US-A-04/2016

STe~l

KARL STORZ--ENDOSKOPE

KARL STORZ Flexible Fiberscopes with Lumen and Stopcocks Competency Checklist

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Manual Cleaning

Initials/Date

Detergent Cleaning Water Quality Recommendation: Utility or Critical Water 1. Disinfect the sink or basin to be used for cleaning following your healthcare

facility's recommended method. After disinfecting, be sure to thoroughly rinse the sink or basin with water to remove all of the disinfectant chemicals. 2. Prepare the enzymatic cleaning solution in the sink or basin.

3. Completely immerse the Flexible Fiberscope in the enzymatic cleaning solution.

4. While immersed, ensure one stopcock is closed and use a 30cc syringe attached to other stopcock to suction up a minimum of 20mL of cleaning solution through the instrument channel. 5. Discard the solution drawn through the channel in a separate container. Caution: Do not discard in the basin the Flexible Fiberscope is being cleaned in.

6. Repeat steps 4 & 5 using the opposite stopcock.

7. While immersed, use a soft, lint-free cloth to clean the exterior of the entire Flexible Fiberscope. A minimum of one complete wipe of the entire exterior of the Flexible Fiberscope should be performed. If visible debris remains, continue wiping until no debris is visible.

8. Use the soft, Flat Cleaning Brush (P/N: 27652/3) to brush the exterior surfaces of the scope handle, including the interface areas between the deflection lever and handle and suction and instrument port. Brush the entire handle surface a minimum of 3 times. If visible debriS remains, continue brushing until no debris is visible. 9.

Open both stopcocks and brush both ports with Short Cleaning Brush (P/N: 9990/50). Insert the brush into the port and rotate 360 0 three times.

5 KARL STORZ

Endoscopy-America, Inc.

2151 E. Grand Avenue EI Segundo, CA 90245-5071

Phone 310 338 8100 Toll Free 800 421 0837 Z17770US-A-0412016

STe~l

KARL STORZ-ENDOSKOPE

KARL STORZ Flexible Fiberscopes with Lumen and Stopcocks Competency Checklist

V

Manual Cleaning, cont'd.

Initials/Date

10. Insert the Long Cleaning Brush (P/N: 11276CL2/10) into the luer port and push through the channel until the brush exits the distal end. Rub the bristles to remove any debris and pull the brush back through the channel. Rub the bristles to remove any debris and repeat two (2) more times (for a minimum of 3 brush passes). If visible debris remains, repeat until no visible debris is observed on the brush bristles. 11. Close the instrument luer stopcock and attach a 30 cc syringe to the irrigation luer stopcock. Draw a minimum of 20 mL of cleaning solution into the syringe and flush back through the instrument channel. 12. Repeat step 11 with the opposite stopcock. Remove syringe from stopcock.

13. Remove the locking nut from the stopcocks and dismantle the stopcock pieces. Immerse in the cleaning solution. Clean the openings and short channel of each stopcock and locking nut using the soft, Flat Cleaning Brush (P/N: 27652/3) and Short cleaning Brush (P/N: 11275CS/10). 14. Keep the Flexible Fiberscope immersed for the manufacturer recommended contact time (e.g. Enzol immersion of a minimum of 1 minute). 15. Re-assemble stopcocks.

16. Draw a minimum of 20 mL air into the 30 cc syringe. Re-attach the syringe to the instrument luer stopcock and close the irrigation luer stopcock. Holding the distal end of the Flexible Fiberscope out of the cleaning solution, flush the air to expel all the cleaning solution from the channel. 17. Remove the Flexible Fiberscope from the cleaning solution.

18. Discard all the cleaning accessories and use new accessories for water rinsing.

6 KARL STORZ Endoscopy-America, Inc.

2151 E. Grand Avenue EI Segundo, CA 90245-5071

Phone 310 338 8100 Toll Free 800421 0837 ZI7770US-A-0412016

KARL STORZ Flexible Fiberscopes with Lumen and Stopcocks

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KARL STORZ~ENDOSKOPE

Competency Checklist

1. Disinfect a new sink or basin to be used for rinsing following your healthcare facility's recommended method. After disinfecting, be sure to thoroughly rinse the sink or basin with water to remove all of the disinfectant chemicals. 2.

with a minimum room temperature water. Ensure there is sufficient volume of rinse water to COMPLETELY immerse the Flexible Fiberscope.

3. Completely immerse the Flexible Fiberscope in the water.

4.

5.

Close one stopcock and attach a 30 cc syringe to the other stopcock. Draw a minimum of 20 mL into the syringe and flush back out the channel.

6.

Repeat step 5

opposite

7. Remove the locking nut from the stopcock and dismantle the stopcock pieces. Immerse in rinse water. Wipe the stopcock pieces, while immersed, with a soft, lint-free cloth.

S. Re-assemble the stopcocks.

9.

Discard the water and repeat with fresh water for a total of two (2) immersion/flush/rinses.

10. Continue to the critical water rinse once two (2) immersion/flush/rinses have been completed.

7 KARL STORZ Endoscopy-America, Inc.

2151 E. Grand Avenue EI Segundo, CA 90245-5071

Phone 310 338 8100 Toll Free 800 421 0837 Z17770US-A-0412016

STelll

KARL STORZ-- ENDOSKOPE

KARL STORZ Flexible Fiberscopes with Lumen and Stopcocks Competency Checklist

V

Critical Water Rinsing

Initials/ Date

Water Quality Recommendation: Critical Water 1. Transfer the Flexible Fiberscope to a fresh basin of critical rinse water. Ensure there is sufficient volume of rinse water to completely immerse the endoscope. 2.

Thoroughly wipe the exterior of the entire Flexible Fiberscope with a fresh, soft, lint-free cloth. A minimum of one complete wipe should be done.

3.

Close one stopcock and attach a 30 cc syringe to the other stopcock. Draw a minimum of 20 mL into the syringe and flush back out the channel.

4. Repeat step 3 with opposite stopcock.

5. Remove the locking nut from the stopcock and dismantle the stopcock pieces. Immerse in rinse water. Wipe the stopcock pieces, while immersed, with a soft, lint-free cloth.

6. Re-assemble the stopcocks.

7.

Close one stopcock and fill syringe with a minimum of 20 mL of air. Hold the distal end of the Flexible Fiberscope out the cleaning solution and flush air through the channel to expel water from the channel.

8. Repeat step 7 with the opposite stopcock.

9. Discard the water and all cleaning accessories.

8 KARL STORZ Endoscopy-America, Inc.

2151 E. Grand Avenue EI Segundo, CA 90245-5071

Phone 310 338 8100 Toll Free 800 421 0837 Zl7770US-A·0412016

STelll

KARL STORZ~ ENDOSKOPE

KARL STORZ Flexible Fiberscopes with Lumen and Stopcocks

Competency Checklist

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Initials/Date

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Drying 1. Remove the Flexible Fiberscope from the water and dry the exterior with a fresh soft, lint-free cloth.

Inspection 1. Visually inspect the Flexible Fiberscope for cleanliness. Do not proceed with

sterilization if residual soil is visible. Repeat all steps of the manual cleaning if residual soil is observed.

2. Prior to sterilization, inspect the Flexible Fiberscope for signs of damage (cuts, dents, or scratches) that may trap residual debris. If damage is found, the Flexible Fiberscope should be immediately tagged and labeled as damaged to prevent any further patient use. Refer to the "Flexible Fiberscope Return Instructions" for further instructions.

3. If no damage is found on visual inspection, clean the distal lens using a 70% isopropyl alcohol wipe. Wipe in a circular movement.

4. If no damage is found on visual inspection, proceed to sterilization.

9 KARL STORZ Endoscopy-America, Inc.

2151 E. Grand Avenue EI Segundo, CA 90245-5071

Phone 310 338 8100 Toll Free 800 421 0837 ZI7770US~A~04/2016