FLEXIBLE CYSTOSCOPE Instruction Manual

Important Information For Users of KARL STORZ Instruments Thank you for placing confidence in the name of KARL STORZ. As with all our other products, we have invested years of experience and much care in production of this flexible fiberscope. You, and your company, have chosen a modern high-quality KARL STORZ instrument. These instructions are designed to assist you in cleaning, caring for and storing your KARL STORZ flexible fiberscopes. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

General Warning The user of KARL STORZ flexible fiberscopes should be thoroughly trained in their use and the applicable medical procedures. Use of these instruments should not be undertaken until the user has fully familiarized himself/herself with the instructions for use, assembly and care. Instruction manuals should be carefully studied and available to the endoscopy team during the procedure. It is essential to follow the instructions contained in the instruction manual, with particular attention to the cautions and warnings. Care must be exercised during endoscopic procedures. These instruments may be broken and the surrounding tissue may be damaged. Possible injuries may include perforation, infection and electrical or thermal burns. Non-Sterile: Must be sterilized before use. CAUTION: Do not mix sterilization methods as it will accelerate product deterioration.

2

Illustrated Description

⑥

⑤

①

②

⑩

⑦ ⑪

④

⑭

⑨

⑫ ⑭

⑬

DISTAL TIP

Parts of the flexible fiberscope

Specifications:

① Light cable adapter

11272 CU1/C2 (11272 C1)

11274 BCU1*

Direction of view:

0˚

0˚

Field of view:

116˚

88.5˚

Depth of field:

5-50 mm

1-50 mm

Tip deflection:

210˚ up

170˚ up

140˚ down

120˚ down

② Vent port

③ Deflection lever ④ Working shaft

⑤ T-Luer connector for irrigation ⑥ Working channel inlet ⑦ Eyepiece

⑧ Diopter adjusting focus ring ⑨ Handle

Tip diameter:

5.2 mm

2.5 mm

⑩ Distal tip

Working shaft diameter:

5.25 mm

2.8 mm

⑪ Active deflection segment

Working channel diameter

2.33 mm

1.2 mm

⑫ Objective lens

Working shaft length:

370 mm

250 mm

⑬ Working/Irrigation channel

Total length:

670 mm

575 mm

⑭ Fiber-optic illumination

*Black shaft without rings 3

③

⑧

Contents

Important information for users of KARL STORZ instruments____________________________________________________ 2 Illustrated description______________________________________________________________________________________ 3 General information for the safe use of the Flexible Fiberscope___________________________________________________ 6 Handling instructions_____________________________________________________________________________________ 11 Inspection before use_____________________________________________________________________________________ 12 Operating instructions_____________________________________________________________________________________ 13 Use of lasers and electrosurgical instruments with flexible cystoscopes_________________________________________ 15 Cleaning and sterilization instructions________________________________________________________________________ 16 General information for the 11272 CU1/C2 (11272 C1)______________________________________________________ 16 Water quality requirements for the 11272 CU1/C2 (11272 C1)________________________________________________ 17 Cleaning equipment and accessories for the 11272 CU1/C2 (11272 C1)_______________________________________ 18 Bedside pre-cleaning (at point of use) for the 11272 CU1/C2 (11272 C1)_______________________________________ 19 Leakage test for the 11272 CU1/C2 (11272 C1)____________________________________________________________ 20 Manual cleaning for the 11272 CU1/C2 (11272 C1)_________________________________________________________ 22 Detergent cleaning_____________________________________________________________________________________ 22 Water rinsing__________________________________________________________________________________________ 24 Drying________________________________________________________________________________________________ 25 Inspection_____________________________________________________________________________________________ 25 General information for the 11274 BCU1__________________________________________________________________ 26 Water quality requirements for the 11274 BCU1____________________________________________________________ 27 Cleaning Equipment and Accessories for the 11274 BCU1___________________________________________________ 28 Bedside pre-cleaning (at point of use) for the 11274 BCU1___________________________________________________ 29 Leakage test for the 11274 BCU1________________________________________________________________________ 30 Manual cleaning for the 11274 BCU1_____________________________________________________________________ 32 Detergent cleaning_____________________________________________________________________________________ 32 Water rinsing__________________________________________________________________________________________ 34 Drying________________________________________________________________________________________________ 35 Inspection_____________________________________________________________________________________________ 35 Sterilization instructions for Flexible Cystoscopes____________________________________________________________ 36 Sterilization methods____________________________________________________________________________________ 37 STERRAD® 100S sterilization system______________________________________________________________________ 37 4

Contents

STERRAD® NX sterilization system________________________________________________________________________ 37 STERRAD® 100NX sterilization system____________________________________________________________________ 37 References for cleaning and sterilization___________________________________________________________________ 38 Storage_______________________________________________________________________________________________ 39 Endoscope return instructions______________________________________________________________________________ 40 Accessories_____________________________________________________________________________________________ 41 Shipping________________________________________________________________________________________________ 42 Return policy____________________________________________________________________________________________ 42 Repair program__________________________________________________________________________________________ 43 Warranty policy__________________________________________________________________________________________ 43 Limitation of liability_______________________________________________________________________________________ 44

5

General Information for the Safe Use of the Flexible Fiberscope

User Qualifications These instruments may only be used by licensed physicians and qualified medical personnel who have been trained in their use.

Warnings and Cautions Please read this manual carefully. It is very important that the user be thoroughly familiar with the operation of the instrument prior to use on a patient. The terms “Warning”, “Caution” and “Note” are intended to draw your attention to important parts of the instruction manual. All warnings, precautions and notes should be thoroughly reviewed prior to use of the instrument. Close attention to all warnings, precautions and notes is necessary for safe and effective operation of the flexible fiberscope.

Definitions Warning: A warning indicates that the personal safety of the patient or physician may be compromised. Disregarding the warning may result in serious injury to the patient or the physician. CAUTION: A caution indicates that the device may be damaged if the caution is disregarded. Note: A note provides additional information regarding the safe operation of the instrument.

6

General Information for the Safe Use of the Flexible Fiberscope

Description of Device The optical portion of the KARL STORZ flexible cystoscope consists of an optical image bundle, two light fiber bundles, objective lenses and an eyepiece. The flexible cystoscope also features a working channel with a T-Luer fitting, to accommodate the use of small diameter flexible instruments, electrodes and/or laser fibers. The distal tip of the flexible cystoscope can be deflected up or down. The optical system of the flexible cystoscope is very delicate. Consequently it is essential that the flexible cystoscope be handled carefully if it is to have a long service life with consistent quality. Models 11272 CU1 and 11272 C2 (11272 C1) are identical except that model 11272 C2 (11272 C1) features reverse deflection.

Indications for Use (for 11272 CU1/C2 (11272 C1)) The KARL STORZ flexible cystoscope is indicated for examination of conditions of the lower urinary tract in adult patients. At the discretion of the urologist, the flexible cystoscope may be used to deliver therapeutic devices within the limits of the product’s capabilities.

Contraindications (for 11272 CU1/C2 (11272 C1)) The KARL STORZ flexible cystoscope is contraindicated for use when, in the opinion of a qualified physician, such use would create a condition that would be dangerous for the patient.

7

General Information for the Safe Use of the Flexible Fiberscope

Indications for Use (for 11274 BCU1) The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and accessories are intended for use by a physician in the visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.

Contraindications (for 11274 BCU1) • Presence of bladder tumor • Presence of supravesical urothelial tumor KARL STORZ flexible ureteroscopes are contraindicated for use whenever ureteroscopy is contraindicated. Adverse Events: The following complications have been reported or can potentially occur with the use of the flexible ureteroscope: • Difficult ureteroscopic insertion may cause ureteral trauma. • Mucosal edema may cause difficulty with ureteroscopic insertion. • Stenosis or stricture • Ureteral perforation and creation of a false passage and pyelonephritis. • Obstruction due to clots • Pyelonephritis

8

General Information for the Safe Use of the Flexible Fiberscope Warning: For use only by clinicians trained in cystoscopy. Warning: Remove the pressure compensation cap (P/N 11025E) from the vent port for use during fiberscopic procedures. Warning: The flexible cystoscope is supplied NON-STERILE and must be cleaned and sterilized prior to use and reuse. Warning: Use only accessories that conform to nationally accepted electrical standards (IEC, UL, or CSA) with the flexible cystoscope. Warning: Do not use the flexible cystoscope, if its accessories or ancillary instruments show visible signs of damage or that are difficult to use. Warning: The Flexible Cystoscope may only be repaired by personnel authorized by KARL STORZ. Unauthorized repairs may impair functioning and safety, and are therefore strictly forbidden. KARL STORZ gives no warranty for Flexible Cystoscopes that are repaired by unauthorized personnel. Warning: Always adjust the light source to the minimum illumination intensity necessary to achieve optimum visualization of the endoscopic image. Warning: Never leave an illuminated light cable with, or without, a flexible cystoscope on or near a patient or surgical drape. Turn the light source to Standby or Initial Mode when the flexible cystoscope is not in use. Warning: Do not look directly into an illuminated light cable or the flexible cystoscope. Damage to the eyes may result. Warning: When using electrodes or laser fibers, it is recommended that the operator use protective filtering eyewear to prevent possible eye damage. Warning: When using electrodes or laser fibers, ensure that the active portion of the electrode or laser fiber is clear of the working channel and in full view before activating. Warning: Before removal from the patient, the distal tip of the flexible cystoscope must be returned to the neutral (nondeflected) position to prevent damage to the instrument and/or injury to the patient. To return to the neutral position, turn the control lever to the middle position. Warning: If the flexible cystoscope functions abnormally during a procedure, stop immediately and withdraw the scope slowly and carefully.

9

General Information for the Safe Use of the Flexible Fiberscope CAUTION: DO NOT steam autoclave the flexible cystoscope. CAUTION: Remove the pressure compensation cap (P/N 11025E) from the vent port before immersion in liquid. (See Figure 1) CAUTION: Place the pressure compensation cap (P/N 11025E) on the vent port before STERRAD® sterilization. (See Figure 2). CAUTION: Place the pressure compensation cap (P/N 11025E) on the vent port before shipping. (See Figure 2) Figure 1

CAUTION: Care should be taken during the passage of ancillary instruments through the working channel. Do not attempt to pass accessories when the distal tip of the flexible cystoscope is deflected at an extreme angle. CAUTION: Avoid bending the strain relief at any sharp angle. CAUTION: The maximum temperature for decontamination, sterilization, or transport is 65° C (149° F). CAUTION: Never immerse the Flexible cystoscope in physiological saline, as brief contact leads to corrosion and pitting.

Figure 2

10

Handling Instructions

To ensure the long lasting quality of the flexible cystoscope, please follow the handling instructions described below. 1.

To prevent breakage, the flexible cystoscope should be supported by firmly grasping the handle. Never handle the flexible cystoscope by the flexible shaft or the distal end alone. Always pick up the flexible cystoscope by the handle first, then provide secondary support for the flexible shaft.

2.

To prevent inadvertent damage to the flexible cystoscope, KARL STORZ recommends placing the flexible cystoscope and accessories on a separate sterile Mayo stand or table away from the other endoscopic and standard surgical instruments being used during a procedure.

3.

When not in use, the flexible shaft of the instrument should be in a neutral, nondeflected position.

4.

Do not operate the deflection control lever with excessive force.

5.

Carefully protect the distal objective lens from damage: Never use the tip of the flexible cystoscope to dislodge or move objects.

CAUTION: Care should be taken during the passage of ancillary instruments through the working channel. Do not attempt to pass accessories when the distal tip of the flexible cystoscope is deflected at an extreme angle. 6.

Keep the distal tip of any electrode, laser fiber, probe or other ancillary device in the field of view at all times.

7.

Irrigation flow diminishes with accessory insertion and forced irrigation with a syringe may be necessary. Avoid excessive irrigation pressure.

8.

Prior to each use, inspect any insulated ancillary devices to ensure there are not splits, cracks, holes, burn marks, or other imperfections to the insulation. Do not use ancillary devices with visible signs of damage.

9.

Never kink or severely bend the shaft of the flexible cystoscope. The shaft and light carrier bundles may be damaged.

CAUTION: Avoid bending the strain relief at any sharp angle, as undue stress may be placed on the shaft and damage to the instrument may result. Warning: Before removal from the patient, the distal tip of the flexible cystoscope must be returned to the neutral (nondeflected) position to prevent damage to the instrument and/or injury to the patient. To return to the neutral position, turn the control lever to the middle position. 10. Handle the flexible cystoscope with care. Mishandling of the flexible cystoscope, particularly at the distal end, may result in damage. 11. When cleaning and sterilizing the flexible cystoscope and accessories, KARL STORZ recommends that the flexible cystoscope be handled separately from other instruments. 11

Inspection Before Use

CAUTION: Do not autoclave the flexible cystoscope. 12. Store the flexible cystoscope either in the sterilization tray specific to the flexible cystoscope or hanging suspended in the appropriate KARL STORZ wall rack specific to the flexible cystoscope. Warning: Do not store endoscope in its shipping case. Since the packing case does not allow adequate ventilation and will retain moisture when closed. Use the packing case only to ship the endoscope back to KARL STORZ. CAUTION: Do not store the flexible cystoscope at temperatures greater than 50° C (122° F).

Inspection Before Use The flexible cystoscope should be thoroughly inspected immediately upon arrival and prior to each surgical procedure. The following parts require inspection: Working Shaft: Check the entire surface of the working shaft for any abnormal conditions or damage, such as dents, cuts, wrinkles, or tears. Any indentation in the flexible shaft of the flexible cystoscope can cause damage to its internal mechanisms. DO NOT USE ANY FLEXIBLE CYSTOSCOPE WITH OUTWARD SIGNS OF DAMAGE. CAUTION: The distal tip of the flexible cystoscope must be protected against damage from impact. Never apply excessive force such as twisting or severely bending the shaft of the flexible cystoscope. Objective Lens and Eyepiece: Check the objective lens (distal tip) and eyepiece to assure that they are free of fingerprints, smudges or dust. If necessary, gently clean with a cotton tip applicator and 70% isopropyl alcohol. Deflection Lever: Slowly manipulate the deflection lever to see that it functions smoothly. Rapid manipulation of the deflection lever will shorten the life of the deflection cables. Working/Irrigation Channel Inlet: Check that the working channel/irrigation channel inlet is clean. With the flexible cystoscope in a straight, nondeflected position, check the working channel by slowly inserting an appropriate size guide wire through the working channel inlet. There should be minimal resistance. If significant resistance is encountered, DO NOT ATTEMPT TO INTRODUCE THE WIRE FURTHER. The channel may be damaged, and the flexible cystoscope should not be used. Warning: Do not use the flexible cystoscope, its accessories, or ancillary instruments that show visible signs of damage or that are difficult to use. Any malfunction of an accessory or instrument during a procedure could result in injury to the patient and damage to the flexible cystoscope.

12

Operating Instructions

The following instructions are recommended for the proper operation of the flexible cystoscope and accessories. This is not a reference for endoscopic techniques. Consult medical literature for endoscopic techniques. Accessories for the flexible cystoscope may include rubber inlet seals, self sealing port seals, guide wires, laser fibers, flexible scissors and forceps, electrodes, catheters, etc. Warning: REMOVE THE PRESSURE COMPENSATION CAP (P/N 11025E) PRIOR TO USE IN ENDOSCOPIC PROCEDURES. Warning: The flexible cystoscope is provided NON-STERILE and must be cleaned and sterilized prior to initial use and before each subsequent reuse. CAUTION: Read this instruction manual thoroughly and be familiar with its contents prior to using the flexible cystoscope. 1.

Operate all light source equipment according to manufacturer’s instructions.

2.

Prepare the cystoscope entry site according to proper endoscopic techniques.

3.

Attach the light cable to the light post. KARL STORZ recommends the use of 3.5 mm fiber optic light cables (KARL STORZ part no. 495 NA) with the flexible cystoscope.

4.

The distal portion of the working shaft should be straight (nondeflected) when inserting into the patient.

5.

Insert the flexible cystoscope according to proper endoscopic techniques.

Warning: Always adjust the light source to the minimum illumination intensity necessary to achieve optimum visualization of the endoscopic image. The higher the light intensity setting of the light source, the greater the heat energy that will be generated at the distal end of the flexible cystoscope. Warning: Never leave an illuminated light cable, with or without, an endoscope on or near a patient or surgical drape. The risk of patient burns increases as well as the possibility of ignition of any flammable material. Turn the light source to standby or initial mode when the scope is not in use. 6.

The distal portion of the flexible cystoscope can be adjusted via the deflection lever. Deflection should be done slowly and evenly.

7.

Prior to the removal of the flexible cystoscope, the active deflection segment should be in the straight position (nondeflected).

Warning: If the flexible cystoscope functions abnormally during the procedure, stop immediately and withdraw it from the patient slowly and carefully.

13

Operating Instructions

8.

Care must be taken to ensure that any accessories to be used are of an appropriate diameter and length. Improper selection and use of accessories can damage the flexible cystoscope. Contact KARL STORZ Customer Service or your sales representative at (800) 421-0837 should you have questions regarding the suitability of an accessory for use with the flexible cystoscope.

9.

When inserting an instrument into the working channel, the flexible cystoscope must be in the straight (nondeflected) position.

10. When using forceps, scissors or other accessories that can be opened or closed, ensure that the instrument is completely closed prior to insertion into the instrument channel. Do not attempt to open or operate the accessory until the distal end is completely free of the working channel. 11. A rubber inlet seal or self-sealing biopsy port seal should be placed on the accessory inlet prior to introduction of the instrument. Note: When the working end of an accessory is passed through a seal for the first time, a temporary resistance will be encountered. Hold the accessory shaft tightly near the distal end and push through gently. CAUTION: If undue resistance is encountered in advancing the accessory through the working channel of the flexible cystoscope, do not attempt to force the accessory. Withdraw the accessory, apply a sterile water soluble lubricant to the tip, and attempt to insert the instrument again. CAUTION: Sharp accessories such as laser fibers may cause damage to the working channel if passed when the distal tip is deflected. Attempts to force entry or withdrawal of accessory devices may contribute to damage to the instrument channel or accessory. 12. KARL STORZ recommends rinsing and soaking the flexible cystoscope and accessories immediately after use to prevent bodily fluids from drying onto the instrument. 13. KARL STORZ recommends leak testing of the flexible cystoscope after each procedure to prevent damage to the scope during cleaning and sterilization. If it fails the leakage test, return it to KARL STORZ for repair.

14

Operating Instructions

Use of Lasers and Electrosurgical Instruments with Flexible Cystoscopes Implementing the following handling recommendations when using lasers or electrosurgical instruments may prolong the effective life of the flexible cystoscope. CAUTION: Pass the laser fiber into the endoscope channel only when the distal tip of the working shaft is in the straight (nondeflected, neutral) position. Warning: When using electrodes or laser fibers, make sure that the active portion of the electrode or laser fiber is clear of the working channel and in full view before activating. Warning: To prevent damage to the flexible cystoscope during electrosurgical procedures, ensure that the electrode tip extends beyond the cystoscope endtip. CAUTION: When using laser fibers, please refer to the instruction manual included with your laser fiber delivery system for complete instructions for use. CAUTION: When using electrosurgical equipment, refer to the instruction manual included with the equipment for complete instructions for use. CAUTION: Carefully examine the laser fiber prior to re-use. CAUTION: Hold the laser shaft close to the working channel inlet and advance it gently using repeated short strokes. The tip of the laser fiber is sharp and may cut into the working channel. CAUTION: When using electrosurgical instruments be sure that the insulation is not chipped or cracked. Use only insulated instruments that are in compliance with IEC standards when using an electrosurgical unit.

15

Cleaning and Sterilization Instructions

General Information for the 11272 CU1/C2 (11272 C1) Warning: The flexible endoscope is delivered non-sterile and must be thoroughly cleaned and sterilized before initial and subsequent uses. Warning: Occupational safety guidelines must be observed and applied when cleaning contaminated flexible endoscopes and instruments. Ensure appropriate Personal Protective Equipment (PPE) is used by all staff during reprocessing. Warning: Sterilization can only be performed successfully if: • The instruments are freed of organic materials and residues of pharmaceutical products and cleaning products (i.e. thoroughly cleaned). • The recommended sterilization parameters are maintained. • Sterilization equipment is properly maintained and calibrated. CAUTION: The maximum permitted temperature is 65° C (149° F) for decontamination and sterilization. CAUTION: Personal Protective Equipment (PPE) is required to ensure safety of the operator when cleaning any contaminated medical device. Follow occupational safety guidelines and your institution’s policies for PPE requirements. CAUTION: The flexible endoscope must be protected from objects that could cause damage to the device such as wire bristle brushes, sharp objects etc. Soft, lint-free cloths and/or sponges along with ONLY the correct KARL STORZ cleaning brush(es) should be used to clean the flexible endoscope. CAUTION: To prevent biofilm formation it is critical that flexible endoscopes be thoroughly dried prior to storage. Biofilm formation will interfere with sterilization of the flexible endoscopes and could lead to infection transmission. Note: The soft, lint-free cloths should be disposed of after a single use (i.e. use separate cloths for the detergent cleaning, water rinsing and drying phases). Note: When preparing cleaning solutions, follow the manufacturer’s instructions for proper exposure time, dilution and temperatures.

16

Cleaning and Sterilization Instructions

Water Quality Requirements for the 11272 CU1/C2 (11272 C1) CAUTION: Flexible endoscopes must never be immersed in normal saline solution, as even brief contact can result in pitting and corrosion. Definitions Utility Water: Water as it comes from the tap that meets the specifications as defined per the table below. This water is mainly used for flushing, washing, and rinsing. Critical Water: Water that is extensively treated (usually by a multistep treatment process that could include a carbon bed, softening, DI and RO, or distillation) to ensure that the microorganisms and the inorganic and organic material are removed from the water; a final submicron filtration could also be part of the treatment process. This water is mainly used for the final rinse. Type of Water

Utility Water

Critical Water

Water Use Specifications

Units

Flushing/Washing/ Rinsing

Final Rinse

Hardness

mg/L

< 150*

<1

Conductivity (mg/L = ppm)

µS/cm

< 500

< 10

6–9

5–7

< 250

<1

pH Chlorides

mg/L

Bacteria

cfu/mL

n/a

< 10**

< 10

Endotoxin

EU/mL

n/a

< 20**

< 10

* If hardness is greater than 150 mg/L, a water softener is recommended unless used for washing and the cleaning chemistry is capable of handling higher levels of hardness. ** After high-level disinfection. Source: AAMI TIR 34:2014 Water for the Reprocessing of Medical Devices

17

Cleaning and Sterilization Instructions

Cleaning Equipment and Accessories for the 11272 CU1/C2 (11272 C1) Mild/neutral pH enzymatic cleaning solution (e.g. Enzol) Cleaning basin or sink Flat cleaning brush (P/N 27652/3) Short cleaning brush (P/N 9990/50) Long cleaning brush (P/N 110910-50) 60 cc Syringe Soft, lint-free cloth Lens cleaner or cotton tip applicator 70% Isopropyl alcohol Luer plug (P/N 29100-BK) Pressure compensation cap (P/N 11025E) Leakage Tester (P/N 13242XL)

18

Cleaning and Sterilization Instructions

Bedside Pre-cleaning (at point of use) for the 11272 CU1/C2 (11272 C1) 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 Luers of the instrument port is plugged during this process (e.g. use the Luer plug (P/N 29100-BK) or a gloved finger to cover the port). Immerse the distal tip of the flexible endoscope in a basin of water. Suction (using a syringe) the channel with a minimum of 100 mL (3.4 oz.) of water, or a diluted mild/neutral pH enzymatic cleaning solution (e.g. Enzol) through the non-plugged port.

3.

Repeat step 2 with the opposite Luer.

4.

Inspect the vent port 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.

6.

Dispose of all plugs.

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.

19

Cleaning and Sterilization Instructions

Leakage Test for the 11272 CU1/C2 (11272 C1) Water Quality Recommendation: Utility water CAUTION: Before proceeding to manual cleaning, always perform a leak test on the flexible endoscope. Leaking flexible endoscopes must not be used in medical procedures as they pose a patient safety risk. If a flexible endoscope is leaking, it should be sent to KARL STORZ for repair or replacement (see flexible endoscope Return Instructions). The use of unauthorized repair facilities voids the product warranty and recommended reprocessing methods from KARL STORZ. CAUTION: KARL STORZ requires the use of the KARL STORZ Leakage Tester (P/N 13242XL) to prevent possible damage to the flexible endoscope. CAUTION: Check the KARL STORZ Leakage Tester (P/N 13242XL) for any damage prior to use. Damaged KARL STORZ Leakage Testers (P/N 13242XL) should not be used and should be returned to KARL STORZ for repair or replacement. CAUTION: The KARL STORZ Leakage Tester (P/N 13242XL) should be disinfected prior to use by wiping it down with a 70% isopropyl alcohol wipe. CAUTION: The pressure compensation cap (P/N 11025E) must be removed from the vent port (if present) before immersion in any liquids. Note: In lieu of the KARL STORZ Leakage Tester (P/N 13242XL), an automated air pump, Zutron Medical Automated Leak Tester (P/N ZUTR30005) may be used to pressurize the flexible endoscope during the wet leak test. Refer to the pump manufacturer’s instructions for operating procedures. Note: Disinfect the sink or basin to be used for leak testing using a healthcare approved surface disinfectant. After disinfecting, be sure to thoroughly rinse the sink or basin with water to remove all of the disinfectant chemicals.

20

1.

If present, remove the pressure compensation cap (P/N 11025E) 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 (P/N 13242XL) are completely dry before conducting the leak test.

4.

Attach the KARL STORZ Leakage Tester (P/N 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 (P/N 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.