Flexible Bronchoscope 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: The device is supplied as a non-sterile item. It must be thoroughly cleaned followed by sterilization before use.

2

Illustrated Description

⑭ ⑫

⑬

⑮

④

⑪

⑨

Specifications: 11005 BC1

Light cable adapter Vent port

Direction of view:

0°

Deflection lever

Field of view:

88.5°

Working shaft

Depth of field:

1-50 mm

T-Luer connection for irrigation

Tip deflection:

170° up

Working channel inlet

120° down

Eyepiece

Tip diameter:

2.5 mm

Diopter adjusting focus ring

Working shaft diameter:

2.8 mm

Handle

Working channel diameter:

1.2 mm

Distal tip

Working shaft length:

700 mm

Active deflection segment

Total length:

1000 mm

Objective lens Working channel Fiber-optic illumination Strain relief

①

②

DISTAL TIP

Parts of the Flexible Bronchoscope

3

⑥

⑦ ⑩

① ② ③ ④ ⑤ ⑥ ⑦ ⑧ ⑨ ⑩ ⑪ ⑫ ⑬ ⑭ ⑮

⑤

③

⑧

Contents

Important information for users of KARL STORZ instruments____________________________________________________ 2 Illustrated description______________________________________________________________________________________ 3 General information for the safe use of the Flexible Bronchoscope________________________________________________ 5 Handling instructions______________________________________________________________________________________ 8 Inspection before use_____________________________________________________________________________________ 12 Operating instructions_____________________________________________________________________________________ 13 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 Bronchoscopes_________________________________________________________ 26 Sterilization methods____________________________________________________________________________________ 27 STERRAD® Systems sterilization _________________________________________________________________________ 27 V-PRO Systems sterilization______________________________________________________________________________ 28 References for cleaning and sterilization___________________________________________________________________ 30 Storage_________________________________________________________________________________________________ 31 Endoscope return instructions______________________________________________________________________________ 32 Accessories_____________________________________________________________________________________________ 33 Shipping________________________________________________________________________________________________ 34 Return policy____________________________________________________________________________________________ 34 Repair program__________________________________________________________________________________________ 35 Warranty policy__________________________________________________________________________________________ 35 Limitation of liability_______________________________________________________________________________________ 36

4

General Information for the Safe Use of the Flexible Bronchoscope

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.

5

General Information for the Safe Use of the Flexible Bronchoscope

Description of Device The KARL STORZ Flexible Bronchoscope is a flexible fiber optic fiberscope with a magnifying eyepiece. The optical component of the KARL STORZ Flexible Bronchoscope consists of: • a flexible shaft housing an optical image bundle, an objective lens and fiber optic light carriers • 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 fiber optic cables The insertable portion of the instrument is divided into a working shaft section and a deflection section. The features of the shaft include: • a working channel that features a Luer fitting located on the proximal handle to accept a Luer lock adapter • distal tip deflection up and down • a proximal strain relief that connects the working shaft to the handle

6

General Information for the Safe Use of the Flexible Bronchoscope

Indications for Use The KARL STORZ Flexible Bronchoscopes are to be used to view the nasal sinuses, larynx and bronchi during ENT endoscopic surgical procedures.

Contraindications The KARL STORZ Flexible Bronchoscopes are contraindicated for use when, in the opinion of a qualified physician, such use would be dangerous for the patient.

7

Handling Instructions

Warning: For use only by clinicians trained in flexible bronchoscopy. Warning: Remove the pressure compensation cap (P/N 11025E) from the vent port for use during fiberscopic procedures. Warning: The flexible bronchoscope 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 bronchoscope. Warning: Do not use the flexible bronchoscope, 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 bronchoscope. Warning: If the flexible bronchoscope functions abnormally during a procedure, stop immediately and withdraw it slowly and carefully. Warning: The flexible bronchoscope 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 bronchoscopes 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. 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 bronchoscope. Warning: Never leave an illuminated light cable with, or without, a flexible bronchoscope 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 bronchoscope is not in use. Warning: Do not look directly into an illuminated light cable or flexible bronchoscope. Damage to the eyes may result.

8

Handling Instructions

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, 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 bronchoscope 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. Warning: Do not use the flexible bronchoscope with high frequency or laser accessories in the presence of flammable anesthetics. There is a risk of explosion. CAUTION: DO NOT steam autoclave the flexible bronchoscope. 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 plasma (hydrogen peroxide, etc.) 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 bronchoscope 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. 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.

Figure 2

CAUTION: The presence of acute pulmonary infection, including bronchitis and pneumonia, may increase the risks associated with bronchoscopy. CAUTION: The maximum temperature for decontamination and sterilization is 65° C (149° F). CAUTION: Never immerse the flexible bronchoscope in saline solution, as brief contact leads to corrosion and pitting.

9

Handling Instructions

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

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

2.

To prevent inadvertent damage to the flexible bronchoscope, KARL STORZ recommends placing the flexible bronchoscope 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, non-deflected 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 bronchoscope 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 bronchoscope 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.

8.

Prior to each use, inspect any insulated ancillary devices to ensure there are no 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 bronchoscope. 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 bronchoscope 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. 10. Handle the flexible bronchoscope with care. Mishandling of the flexible bronchoscope, particularly at the distal end, may result in damage. Damage to the flexible bronchoscope may allow liquid and other materials to penetrate causing unclear images. 10

Handling Instructions

11. When cleaning and sterilizing the flexible bronchoscope and accessories, KARL STORZ recommends that the flexible bronchoscope be handled separately from other instruments. CAUTION: Do not autoclave the flexible bronchoscope. 12. Store the flexible bronchoscope either in the sterilization tray specific to the flexible endoscope, or suspended in the appropriate wall rack. 13. Do not store the flexible endoscope in the foam padded case. CAUTION: Do not store the flexible bronchoscope at temperatures greater than 50° C (122° F).

11

Inspection Before Use

The flexible bronchoscope 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 shaft of the flexible bronchoscope can cause damage to its internal mechanisms. DO NOT USE ANY FLEXIBLE BRONCHOSCOPE WITH OUTWARD SIGNS OF DAMAGE. CAUTION: The distal tip of the flexible bronchoscope must be protected against damage from impact. Never apply excessive force such as twisting or severely bending the shaft of the flexible bronchoscope. 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 Channel Inlet: Check that the working channel inlet is clean. With the flexible bronchoscope 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 encountered, DO NOT ATTEMPT TO INTRODUCE THE WIRE FURTHER. The channel may be damaged, and the flexible bronchoscope should not be used. Warning: Do not use the flexible bronchoscope, its accessories, or ancillary instruments that show visible signs of damage or that are difficult to use. Any malfunction of an accessory during a procedure could result in injury to the patient and damage to the flexible bronchoscope.

12

Operating Instructions

The following instructions are recommended for the proper operation of the flexible bronchoscope and accessories. This is not a reference for endoscopic techniques. Consult medical literature for endoscopic techniques. Accessories for the flexible bronchoscope may include rubber inlet seals and self-sealing port seals as well as flexible forceps and brushes. Warning: REMOVE THE PRESSURE COMPENSATION CAP (P/N 11025E) PRIOR TO USE IN ENDOSCOPIC PROCEDURES. Warning: The flexible bronchoscope 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 bronchoscope. 1.

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

2.

Attach the light cable to the light post. KARL STORZ recommends the use of 3.5 mm fiber optic light cables (P/N 495 NA) with the flexible bronchoscope.

3.

Attach oxygen supply tubing to the working channel inlet.

4.

Attach the sterile, single-use suction valve (P/N 11301 CE/20) to the endoscope. Gently press both knobs on the sides of the suction valve (P/N 11301 CE) while guiding them into the slots on the valve seat, until the suction valve (P/N 11301 CE) is firmly in place. Release the knobs.

5.

Attach suction tubing to the suction outlet port.

6.

Prepare the flexible bronchoscope entry site according to proper endoscopic techniques.

7.

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

8.

Insert the flexible bronchoscope according to proper endoscopic techniques.

9.

Turn on oxygen supply (under anesthesia) and suction.

10. Press suction button to activate suction. Warning: Always adjust the light source to the minimum illumination intensity necessary to achieve optimum visualization of the fiberoptic 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 bronchoscope. 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. 13

Operating Instructions

11. The distal portion of the flexible bronchoscope may be articulated via the deflection lever. Deflection must be done slowly and evenly. 12. Prior to the removal of the flexible bronchoscope, the active deflection segment should be in the straight (non-deflected) position. Warning: If the flexible bronchoscope functions abnormally during the procedure, STOP, release deflection 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 bronchoscope. 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 bronchoscope. 14. When inserting an instrument into the working/instrument channel, the flexible bronchoscope must be in the straight (non-deflected) position. 15. When using forceps or other accessories that can be opened or closed, ensure that the instrument is completely closed prior to insertion into the instrument channel. Opening the accessory in the working channel could cause damage, resulting in flooding of the interior of the flexible bronchoscope. CAUTION: If undue resistance is encountered in advancing the accessory through the working channel of the flexible bronchoscope, DO NOT attempt to force the accessory. Withdraw the accessory, apply a water soluble lubricant (e.g., Codman Preserve or the equivalent per manufacturer’s instructions) 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. When the tip of the flexible bronchoscope 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. 16. KARL STORZ recommends rinsing and soaking the flexible bronchoscope and accessories immediately after use to prevent blood from drying onto the instrument. 17. KARL STORZ recommends leakage testing of the flexible bronchoscope 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 Bronchoscopes Implementing the following handling recommendations when using lasers or electrosurgical instruments may prolong the effective life of the flexible bronchoscope. 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 bronchoscope during electrosurgical procedures, ensure that the electrode tip extends beyond the flexible bronchoscope 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 bronchoscope. 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.

15

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. The soft, lint-free cloths should be disposed of after a single use (i.e. use separate cloths for the detergent  Note: 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 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 TIR34:2014/(R)2017 Water for the Reprocessing of Medical Devices

17

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 11276 CL2/10) 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 11025E) Leakage tester (P/N 13242 XL)

18

Cleaning and Sterilization Instructions

Bedside Pre-cleaning (at point of use) Water Quality Recommendation: Utility water 18. 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. 19. 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. 20. Repeat step 2 with the opposite Luer. 21. Inspect the vent port area removing any visible debris on the external surface with a 70% isopropyl alcohol wipe. 22. 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. 23. Dispose of all plugs. Note: Complete cleaning of the patient-used flexible endoscope should be started within two hours of the bedside pre-cleaning.

19

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 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 13242 XL) to prevent possible damage to the flexible endoscope. CAUTION: Check the KARL STORZ Leakage Tester (P/N 13242 XL) for any damage prior to use. Damaged KARL STORZ Leakage Testers (P/N 13242 XL) should not be used and should be returned to KARL STORZ for repair or replacement. CAUTION: The KARL STORZ Leakage Tester (P/N 13242 XL) 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. In lieu of the KARL STORZ Leakage Tester (P/N 13242 XL), an automated air pump, Zutron Medical Automated  Note: 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 13242 XL) are completely dry before conducting the leak test.

4.

Attach the KARL STORZ Leakage Tester (P/N 13242 XL) 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 13242 XL) 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.