FLEXIBLE URETEROSCOPE Instruction Manual

Important Information For Users of KARL STORZ Instruments Thank you for placing confidence in the name of KARL STORZ. As with all of our other products, we have invested years of experience and much care in production of this flexible fiberscope. You and your organization 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 fiberscope. 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. The instruments may be broken and the surrounding tissue may be damaged. Possible injuries may include perforation, infection and electrical or thermal burns. Non-Sterile: KARL STORZ instruments are provided NON-STERILE, and must be thoroughly cleaned followed by sterilization, prior to the initial use and before each subsequent use. CAUTION: Do not mix sterilization methods as it will accelerate product deterioration.

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Illustrated Description

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⑬ ⑩ ⑮

DISTAL TIP

Parts of the flexible fiberscope ① Light cable adapter ② Vent port ③ Deflection lever ④ Working shaft ⑤ T-Luer connection for irrigation ⑥ Working channel inlet ⑦ Eyepiece ⑧ Diopter adjusting focus ring ⑨ Handle ⑩ Distal tip ⑪ Active deflection segment ⑫ Objective lens ⑬ Working/irrigation channel ⑭ Laserite laser resistant material ⑮ Fiber-optic illumination 3

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Specifications: Direction of view: Field of view: Depth of field: Tip deflection: Tip diameter: Working shaft diameter: Working channel diameter: Working shaft length: Total length:

11278 AC1 0˚ 90˚ 2-50 mm 285˚ up 285˚ down 2.5 mm 2.85 mm 1.2 mm 450 mm 775 mm

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Contents

Important information for users of KARL STORZ instruments____________________________________________________ 2 Illustrated description______________________________________________________________________________________ 3 General information for the safe use of the Flexible Ureteroscope_________________________________________________ 5 Handling instructions______________________________________________________________________________________ 9 Inspection before use_____________________________________________________________________________________ 11 Operating instructions_____________________________________________________________________________________ 12 Cleaning and sterilization instructions________________________________________________________________________ 16 General information ____________________________________________________________________________________ 16 Water quality requirements_______________________________________________________________________________ 17 Cleaning equipment and accessories______________________________________________________________________ 18 Bedside pre-cleaning (at point of use)_____________________________________________________________________ 19 Leakage test__________________________________________________________________________________________ 20 Manual cleaning________________________________________________________________________________________ 22 Detergent cleaning_____________________________________________________________________________________ 22 Water rinsing__________________________________________________________________________________________ 24 Drying________________________________________________________________________________________________ 25 Inspection_____________________________________________________________________________________________ 25 Sterilization instructions for Flexible Ureteroscopes__________________________________________________________ 26 Sterilization methods____________________________________________________________________________________ 27 STERRAD® 100S sterilization system______________________________________________________________________ 27 STERRAD® NX sterilization system________________________________________________________________________ 27 STERRAD® 100NX sterilization system____________________________________________________________________ 27 References for cleaning and sterilization___________________________________________________________________ 28 Storage_________________________________________________________________________________________________ 29 Endoscope return instructions______________________________________________________________________________ 30 Accessories_____________________________________________________________________________________________ 31 Shipping________________________________________________________________________________________________ 32 Return policy____________________________________________________________________________________________ 32 Repair program__________________________________________________________________________________________ 33 Warranty policy__________________________________________________________________________________________ 33 Limitation of liability_______________________________________________________________________________________ 34 4

General Information for the Safe Use of the Flexible Ureteroscope

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.

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General Information for the Safe Use of the Flexible Ureteroscope

Description of Device The KARL STORZ flexible ureteroscopes are indicated for use during diagnostic and therapeutic fiberscopic procedures of the ureter and kidney. The optical component of the KARL STORZ flexible ureteroscope consists of: • a flexible shaft housing, an optical image bundle, an objective lens, a fiber optic light carrier • a magnifying eyepiece with a focusing ring that rotates to adjust to the appropriate diopter correction for the user • a reticle, or marker in the field of view, that indicates the 12 o’clock position as a point of reference • a light post connection with screw-on adapters for fiberoptic light cables The insertable portion of the instrument is divided into a flexible shaft section and a deflection section. The features of the shaft include: • a working channel that accepts flexible accessories • a working channel that features a T-Luer fitting located on the proximal housing to accept two Luer lock adapters simultaneously • active distal tip deflection • a proximal strain relief that connects the flexible shaft to the handpiece

Indications for Use The KARL STORZ Flexible Ureteroscope is indicated for examination of the upper urinary tract including the ureter and kidneys and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Contraindications The KARL STORZ Flexible Ureteroscope is contraindicated whenever endourologic procedures are contraindicated.

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General Information for the Safe Use of the Flexible Ureteroscope Warning: For use only by clinicians trained in ureteroscopy. Warning: Remove the pressure compensation cap (P/N Z10455) from the vent port for use during endoscopic procedures. Warning: KARL STORZ instruments are provided non-sterile and must be thoroughly cleaned followed by sterilization, prior to the initial use and before each subsequent use. Warning: Use only accessories that conform to nationally accepted electrical standards (IEC, UL, or CSA) with the flexible ureteroscope. Warning: Do not use the flexible ureteroscope, 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 ureteroscope. Warning: If the flexible ureteroscope functions abnormally during a procedure, stop immediately and withdraw the scope slowly and carefully. 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 ureteroscope. Warning: Never leave an illuminated light cable with, or without, a flexible ureteroscope 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 flexible ureteroscope is not in use. Warning: Do not look directly into an illuminated light cable or the flexible ureteroscope. Damage to the eyes may result. CAUTION: Never pass the flexible ureteroscope through a deflecting cystoscopic bridge to introduce into the ureteral orifice. Warning: When using electrodes or laser fibers, it is recommended that the operator use protective filtering eye-wear to prevent possible eye damage. 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 at all times. Otherwise, damage to the working channel, the objective lens and/or the patient may occur. Warning: Before removal from the patient, the distal tip of the flexible ureteroscope must be returned to the neutral (non-deflected) position to prevent damage to the instrument and/or injury to the patient. To return to the neutral position, return the control lever to the middle position.

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General Information for the Safe Use of the Flexible Ureteroscope CAUTION: DO NOT steam autoclave the flexible ureteroscope. CAUTION: Remove the pressure compensation cap (P/N Z10455)) from the vent port before immersion in liquid. (See Figure 1) CAUTION: Place the pressure compensation cap (P/N Z10455)) on the vent port before STERRAD® sterilization. (See Figure 2) CAUTION: Place the pressure compensation cap (P/N Z10455) on the vent port before shipping. (See Figure 2) 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 ureteroscope is deflected at an extreme angle. Such actions may damage the instrument channel or accessory and may lead to complications such as the inability to manipulate the accessory. Figure 1

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. CAUTION: The maximum temperature for decontamination and sterilization is 65° C (149° F). CAUTION: Never immerse the flexible ureteroscope in physiological saline, as brief contact leads to corrosion and pitting. CAUTION: When using a stone basket, DO NOT withdraw the stone through the working channel. After the stone has been secured within the basket, withdraw the entire scope and the basket from the patient. After the stone has been removed from the basket, retract the basket completely through the working channel. Warning: Do not use the flexible ureteroscope with high frequency or laser accessories in the presence of flammable anesthetics. There is a risk of explosion.

Figure 2

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Warning: Gas emboli, the entrapment of air in the systemic circulation, may occur when using liquid media. Prime all media inflow lines and minimize the exchange of instruments to reduce the incidence of gas emboli.

Handling Instructions

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

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

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To prevent inadvertent damage to the flexible ureteroscope, KARL STORZ recommends placing the flexible ureteroscope 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 ureteroscope 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 ureteroscope is deflected at an extreme angle. Such actions may damage the instrument channel or accessory and may lead to complications such as the inability to manipulate the accessory. 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.

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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.

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Never kink or severely bend the shaft of the flexible ureteroscope. 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 ureteroscope must be returned to the neutral (non-deflected) 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.

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Handling Instructions

10. Handle the flexible ureteroscope with care. Mishandling of the flexible ureteroscope, particularly at the distal end, may result in damage. Damage to the flexible ureteroscope may allow liquid and other materials to penetrate causing unclear images. 11. When cleaning and sterilizing the flexible ureteroscope and accessories, KARL STORZ recommends that the flexible ureteroscope be handled separately from other instruments. CAUTION: Do not autoclave the flexible ureteroscope. 12. Store the flexible ureteroscope either in the sterilization tray specific to the flexible ureteroscope or hanging suspended in the appropriate KARL STORZ wall rack specific to the flexible ureteroscope. Warning: Do not store endoscope in its shipping case. Since the packing case does not allow adequate ventilation and will retain moisture when closed, it may support microbial growth, adding to the possibility of contamination. Use the packing case only to ship the endoscope back to KARL STORZ. CAUTION: Do not store the flexible ureteroscope at temperatures greater than 50° C (122° F).

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Inspection Before Use

The flexible ureteroscope must 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 shaft of the flexible ureteroscope can cause damage to its internal mechanisms. DO NOT USE ANY FLEXIBLE URETEROSCOPE WITH OUTWARD SIGNS OF DAMAGE. CAUTION: The distal tip of the flexible ureteroscope must be protected against damage from impact. Never apply excessive force such as twisting, or severely bending the shaft of the flexible ureteroscope. 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/irrigation channel inlet is clean. With the flexible ureteroscope in a straight (non-deflected) 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 encoun-tered, DO NOT ATTEMPT TO INTRODUCE THE WIRE FURTHER. The channel may be damaged, and the flexible ureteroscope should not be used. Warning: Do not use the flexible ureteroscope, 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 ureteroscope.

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Operating Instructions

The following instructions are recommended for the proper operation of the flexible ureteroscope and accessories. This is not a reference for endoscopic techniques. Consult medical literature for endoscopic techniques. Accessories for the flexible ureteroscope may include rubber inlet seals, self sealing port seals, guide wires, stone baskets, electrohydraulic lithotriptor probes, laser fibers, flexible scissors and forceps, electrodes, catheters, etc. Warning: REMOVE THE PRESSURE COMPENSATION CAP (P/N Z10455) PRIOR TO USE IN ENDOSCOPIC PROCEDURES. Warning: The flexible ureteroscope is provided NON-STERILE and must be cleaned and sterilized prior to initial use and each subsequent reuse. CAUTION: Read this instruction manual thoroughly and be familiar with its contents prior to using the flexible ureteroscope. 1.

Operate all irrigation and light source equipment according to the manufacturer’s instructions. Pressurized irrigation systems must not exceed 300 mmHg.

2.

Prepare the flexible ureteroscope 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. 495NA) with the flexible ureteroscope.

4.

Attach the irrigation tubing to the side irrigation port Luer on the working channel. Pressurized irrigation systems must not exceed 300 mmHg.

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Rotate the ocular focus control to adjust to the user’s diopter correction. Note: The diopter control must be turned to the “0” position when using video or photographic equipment.

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The distal portion of the working shaft must be straight (non-deflected) when inserting into the patient.

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Insert the flexible ureteroscope according to proper endoscopic techniques.

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Use of the flexible ureteroscopes requires an understanding of the advanced ureteroscope design and the unique handling features of the scope. The following instructions are provided to efficiently use the advanced characteristics of the ureteroscope without causing damage to the ureteroscope.

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Accessing the lower pole of the kidney Access the lower pole of the kidney by entering the lower collecting system or the uretero-pelvic junction.

CAUTION: Do not attempt to force a passive or ‘secondary’ deflection by pushing the flexible ureteroscope against the wall of the kidney, as this may damage both the optical fibers and the deflecting mechanism of the scope.

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Operating Instructions

10. Positioning the flexible ureteroscopes The normal deflection for the flexible ureteroscopes is 285° in two directions. The flexible ureteroscopes can also achieve an “S” curve to conform to the contour of the kidney. The S-curve allows the flexible ureteroscopes to enter the otherwise difficult to reach anterior lateral and posterior lateral infundibulum of the kidney. Do not attempt to turn the distal tip by manually twisting the distal shaft of the ureteroscope. Twisting the distal shaft, independent of the hand piece may cause damage to the ureteroscope. The flexible ureteroscopes shaft will follow the deflecting tip when gently advancing the ureteroscope while maintaining visualization in the direction intended. Gradual turning of the shaft using the hand piece will position the flexible ureteroscopes precisely where it is intended it to go. 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 ureteroscope. 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. 11. The distal portion of the flexible ureteroscope may be articulated via the deflection lever. Deflection must be done slowly and evenly. 12. Prior to the removal of the flexible ureteroscope, the active deflection segment should be in the straight position (non-deflected). Warning: If the flexible ureteroscope functions abnormally during the procedure, STOP immediately and withdraw it from the patient slowly and carefully. 13. 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 ureteroscope. 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 ureteroscope. 14. When inserting an instrument into the working/instrument channel, the flexible ureteroscope must be in the straight (non-deflected) position. 15. 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. Opening the accessory in the working channel could cause damage, resulting in flooding of the interior of the flexible ureteroscope.

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Operating Instructions

16. A rubber inlet seal or self sealing biopsy port (P/N 11274BC/3–disposable or P/N 27022Y–reusable) should be placed on the accessory inlet prior to introduction of an 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 an accessory through the working channel of the flexible ureteroscope, DO NOT attempt to force the accessory. Withdraw the accessory, apply a water soluble lubricant (e.g., Codman Preserve or the equivalent per the manufacturer’s instructions) to the tip and attempt to insert the instrument again. Prior to removal of the flexible ureteroscope from the patient, the working shaft must be in the straight (non-deflected) 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. Otherwise, damage to the working channel, the objective lens and/or the patient may occur. CAUTION: When using laser fibers, please refer to the instruction manual included with your laser delivery system for complete instructions for use, including initial inspection of the laser fiber, proper technique for stripping/cleaving laser fibers, as well as recommended cleaning and sterilization instructions. Defective or improperly cleaved laser fibers may cause inadvertent damage to the flexible ureteroscope. Only laser fibers with diameters less than 400 microns are compatible with the flexible ureteroscope. CAUTION: Sharp accessories such as laser fibers or EHL probes may cause damage to the working channel if passed when the distal tip is deflected. When the tip of the ureteroscope is not deflected, less resistance is noted. When the tip is deflected, resistance increases as the angle of deflection increases. Attempts to force entry or withdrawal of accessory devices may contribute to damage to the instrument channel or accessory. CAUTION: When using a stone basket, DO NOT withdraw the stone through the working channel. After the stone has been secured within the basket, withdraw the entire scope and the basket from the patient. After the stone has been removed from the basket, retract the closed basket completely through the working channel. 17. KARL STORZ recommends rinsing and soaking the flexible ureteroscope and accessories immediately after use to prevent blood from drying onto the instrument. 18. KARL STORZ recommends leak testing of the flexible ureteroscope 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.

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Operating Instructions

Use of Lasers and Electrosurgical Instruments with Flexible Ureteroscopes Implementing the following handling recommendations when using lasers or electrosurgical instruments may prolong the effective life of the flexible ureteroscope. CAUTION: Pass the laser fiber into the endoscope channel only when the distal tip of the working shaft is in the straight (non-deflected, neutral) position. Laser energy travels over quartz fibers; the fiber is sharp and will perforate the endoscope working channel if the scope tip is deflected during laser insertion. 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. Otherwise, damage to the working channel, the objective lens and/or the patient may occur. If the tip of the laser fiber is not clearly visible during use, stop firing until the laser fiber tip is again visible. Warning: To prevent damage to the flexible ureteroscope during electrosurgical procedures, ensure that the electrode tip extends beyond the ureteroscope endtip. CAUTION: When using laser fibers, please refer to the instruction manual included with your laser delivery system for complete instructions for use, including initial inspection of the laser fiber, proper technique for stripping/cleaving laser fibers, as well as recommended cleaning and sterilization instructions. Defective or improperly cleaved laser fibers may cause inadvertent damage to the flexible ureteroscope. CAUTION: When using electrosurgical equipment, please refer to the instruction manual included with your equipment for complete instructions for use. CAUTION: Carefully examine the laser fiber prior to re-use. Minute cracks or microfissures develop along the laser fiber shaft with use. When the fiber is bent as the endoscope tip is deflected, these microfissures may “leak” laser energy and burn the working channel. 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.

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Cleaning and Sterilization Instructions

General Information 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.

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Cleaning and Sterilization Instructions

Water Quality Requirements 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

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Cleaning and Sterilization Instructions

Cleaning Equipment and Accessories 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 11276CL2/10) 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 Z10455) Leakage Tester (P/N 13242XL)

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Cleaning and Sterilization Instructions

Bedside Pre-cleaning (at point of use) 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) 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.

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Cleaning and Sterilization Instructions

Leakage Test 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 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 Z10455) 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.

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1.

If present, remove the pressure compensation cap (P/N 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 (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.