Storz 11272 VH-TL User manual

Flexible HD Cysto-Urethroscope 11272 VH-TL/VHU-TL
Instruction Manual

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Important Information for Users of KARLSTORZ Instruments
Thank you for your expression of confidence in the KARL STORZ brand name. Like all of our other products, this
product is the result of years of experience and great care in manufacture. You and your organization have decided in
favor of a modern, high-quality item of equipment from KARL STORZ.
This instruction manual is intended to serve as an aid in the proper handling, cleaning and sterilization of the Flexible
HD Cysto-Urethroscope. All essential details of the equipment and all actions required on your part are clearly pre-
sented and explained. We thus ask that you read this manual carefully before proceeding to work with the instrument.
Keep this manual available for ready reference.
Federal (USA) law restricts this device to sale by or on the order of a physician.
KARL STORZ is constantly working on the further development of all products. Please appreciate that changes to the
scope of supply in form, equipment, and technology are possible for this reason. Therefore, no claims may be derived
from the information, figures, and descriptions in this manual.
RxOnly

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Important information for users of KARL STORZ instruments________________________________________________ 2
Illustrated description__________________________________________________________________________________ 5
General information for the safe use of the Flexible HD Cysto-Urethroscope___________________________________ 6
Specifications ________________________________________________________________________________________ 6
Operating conditions __________________________________________________________________________________ 7
Equipment classification _______________________________________________________________________________ 7
User qualification _____________________________________________________________________________________ 8
Warnings and cautions ________________________________________________________________________________ 8
Definitions ___________________________________________________________________________________________ 8
Device description ____________________________________________________________________________________ 9
Indications for use ____________________________________________________________________________________ 9
Contraindications _____________________________________________________________________________________ 9
Safety precautions when using the Flexible HD Cysto-Urethroscope ________________________________________ 10
Warnings and cautions _______________________________________________________________________________ 10
Unpacking the device ________________________________________________________________________________ 12
Basic equipment _____________________________________________________________________________________ 12
Handling instructions _________________________________________________________________________________ 13
Handling ____________________________________________________________________________________________ 13
Operating ___________________________________________________________________________________________ 13
Holding the Flexible HD Cysto-Urethroscope correctly ____________________________________________________ 13
Handling the shaft ___________________________________________________________________________________ 13
Directions for use ____________________________________________________________________________________ 14
Handling the deflection mechanism_____________________________________________________________________ 14
Handling the accessories _____________________________________________________________________________ 15
Compatible camera control units _______________________________________________________________________ 16
Connection to the camera control unit __________________________________________________________________ 16
Control buttons ______________________________________________________________________________________ 17
Default button settings________________________________________________________________________________ 17
Program head buttons________________________________________________________________________________ 17
Focus ______________________________________________________________________________________________ 17
Inspection prior to use ________________________________________________________________________________ 18
Inspecting the surfaces _______________________________________________________________________________ 18
Checking the deflection_______________________________________________________________________________ 18
Inspecting the LED function ___________________________________________________________________________ 19
Contents

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Inspecting the instruments and the working channel ______________________________________________________ 19
Cleaning and sterilization instructions ___________________________________________________________________ 20
General information __________________________________________________________________________________ 20
Water quality requirements ____________________________________________________________________________ 21
Cleaning equipment and accessories ___________________________________________________________________ 22
Bedside pre-cleaning (at point of use)___________________________________________________________________ 22
Leakage testing______________________________________________________________________________________ 23
Manual cleaning _____________________________________________________________________________________ 25
Detergent cleaning ___________________________________________________________________________________ 25
Water rinsing ________________________________________________________________________________________ 27
Drying ______________________________________________________________________________________________ 27
Inspection __________________________________________________________________________________________ 28
Sterilization _________________________________________________________________________________________ 28
STERRAD®sterilization _______________________________________________________________________________ 29
V-PRO®maX/60 sterilization___________________________________________________________________________ 30
Reference for cleaning and sterilization _________________________________________________________________ 30
Storage_____________________________________________________________________________________________ 31
Endoscope return instructions _________________________________________________________________________ 32
Troubleshooting______________________________________________________________________________________ 33
Shipping ____________________________________________________________________________________________ 34
Return policy ________________________________________________________________________________________ 34
Repair program ______________________________________________________________________________________ 35
Warranty policy ______________________________________________________________________________________ 35
Limitation of liability __________________________________________________________________________________ 36
Software ownership and licensing ______________________________________________________________________ 37
Electromagnetic compatibility__________________________________________________________________________ 38
Contents

5
Illustrated Description
⑪⑫
③
13242 XL leakage tester 11025 E pressure compensation cap
③
②
②④
⑤
⑥
⑧
⑨
⑩
⑦
①

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① Connecting cord Connects to IMAGE1 S CCU.
② Housing plug Permanently plugs suction valve hole.
NOTE: This plug is not removable.
③ Handle Houses the deection lever, the buttons, and the LED light
source.
④ Working channel port
⑤ Deflection lever
⑥ Distal tip
⑦ Connection for leakage tester or Connects to the leakage tester (Part Number: 13242XL) and
pressure compensation cap the pressure compensation cap (Part Number: 11025E).
⑧ Left button Default setting = Standby
⑨ Right button Default setting = Zoom
⑩ Select button Default setting = Menu
⑪ Leakage tester
⑫ Pressure compensation cap
Specifications: 11272 VH-T L / VHU -TL
Direction of view: 0°
Field of view: 100°
Depth of field: 3–50 mm
Tip deflection: 210° up
140° down
Working shaft diameter: 5.5 mm
Working channel diameter: 2.33 mm
Working shaft length: 37 cm
Illumination: Integrated LED Light Source
Sensor: CMOS Technology
Weight: 1.26 lbs
General Information for the Safe Use of the Flexible HD Cysto-Urethroscope

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Operating Conditions
Ambient temperature: 15° — 30° C (59° — 86° F)
Humidity: 15% — 80%
Equipment Classification
Type of protection against moisture: Ordinary
Degree of protection against electric shocks: CF-type
Mode of operation: Continuous
Equipment test certificates:
Equipment is certified and manufactured in accordance with IEC 60601-1 (3rd Edition), IEC 60601-2-18 (2nd Edition),
CSA 22.2 No. 601 (3rd Edition).
Electromagnetic compatibility:
This instrument has been tested and complies with the EMC limits as per EN/IEC 60601-1-2:
2007 CISPR 11 Class A
General Information for the Safe Use of the Flexible HD Cysto-Urethroscope

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User Qualification
The KARL STORZ Flexible HD Cysto-Urethroscope may only be used by persons with an appropriate medical quali-
fication and who are acquainted with the technique of flexible cystoscopy. The information given in these instructions
only serves to instruct in the correct handling and preparation of the Flexible HD Cysto-Urethroscope.
It is not intended as an introduction to the technique of flexible cystoscopy.
Please read these safety instructions carefully before using this instrument and ensure that you are very familiar with
its operation and control.
Warning and Cautions
Please read this manual carefully and follow the instructions exactly. The words Warning, Caution, and Note convey
special meanings. Wherever they are used in this manual, they should be carefully reviewed to ensure the safe and
effective operation of this product.
Definitions
Warning: A Warning indicates that the personal safety of the patient or physician may be involved. Disregarding a
Warning could result in injury to the patient or physician.
CAUTION: A Caution indicates that particular service procedures or safety precautions must be followed to avoid
any damage to the product.
Note: A Note indicates special information about operating the product or clarifies important information.

General Information for the Safe Use of the Flexible HD Cysto-Urethroscope

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Device Description
The KARL STORZ Flexible HD Cysto-Urethroscope has a working length of 37 cm with an outer diameter of 5.5 mm.
The shaft consists of a working channel 2.33 mm in diameter that can be used for insertion of various flexible instru-
ments. The distal tip houses a CMOS imaging sensor for capturing images and videos. The handle encloses a LED
light source, deflection lever and control buttons.
The LED light source provides the illumination for visualization of the anatomy under examination. The deflection
lever deflects the distal tip 210° in an up direction, and 140° in a down direction. The control buttons can be pro-
grammed to perform functions such as white balance, image capture, and zoom. The control buttons can also be
programmed to provide access to the setup menu. The KARL STORZ Flexible HD Cysto-Urethroscope, when used
with the compatible IMAGE1 S Camera Control Units (CCU), forms the KARL STORZ Flexible HD Cysto-Urethroscope
System. Please refer to the IMAGE1 S CCU manual for instructions on how to use the CCU. The Flexible HD Cysto-
Urethroscope is an applied part that should only be used with supply units (CCUs) specified for this purpose by
KARLSTORZ.
Indications for Use
The Flexible HD Cysto-Urethroscope system is used to provide visualization and operative access during diagnostic
and therapeutic endoscopic procedures of urinary tract, including the urethra, bladder, ureters, and kidneys.
Contraindications
The Flexible HD Cysto-Urethroscope system is contraindicated whenever urological endoscopic procedures are
contraindicated.
General Information for the Safe Use of the Flexible HD Cysto-Urethroscope

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Safety Precautions When Using the Flexible HD Cysto-Urethroscope
The Flexible HD Cysto-Urethroscope must be used according to the recognized medical rules and procedures of
endoscopy.
Note: The patient leakage current limit of the CF-applied parts may be exceeded if CF-applied parts (application on
heart) are used in combination with other BF-applied parts.
In this case, the patient leakage current can be reduced by using only CF-applied parts.
Note: The video endoscope does not offer any electric insulation against high frequency (HF) currents. Protection
against high frequency currents should be ensured through the use of correct HF instruments. Please read the
instructions for use in the instruction leaflet supplied with the HF-applied part for more information.
Note: The Flexible HD Cysto-Urethroscope is not intended to be inserted into the ureters. The Flexible HD Cysto-
Urethroscope is intended to be used for visualization of the ureteral orifice to aid in the placement and removal of
devices within the ureters.
Warnings and Cautions
Warning: Every time the Flexible HD Cysto-Urethroscope is used, you must first check that it, and any accessories
used in combination with it, is in perfect condition. A damaged Flexible HD Cysto-Urethroscope or damaged acces-
sories must not be used.
Warning: Combinations of medical devices can only be considered safe if:
• They are identified as such in the respective instruction manual.
• The intended purpose and the interface specifications of the devices used in combination permit this.
Pay careful attention to the instructions and interface specifications of medical devices used in combination.
Warning: The Flexible HD Cysto-Urethroscope is delivered non-sterile and must be cleaned and sterilized according
to validated reprocessing instructions before the initial use as well as before any further application.
Warning: Do not point the light beam of the Flexible HD Cysto-Urethroscope into the eyes. Looking into the light
beam may cause eye damage.
Warning: Only use accessories (guide probes, cleaning brushes, etc.) that are specifically intended for use with the
Flexible HD Cysto-Urethroscope and can be operated in line with generally-accepted technical standards and occu-
pational safety guidelines.

General Information for the Safe Use of the Flexible HD Cysto-Urethroscope

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Warning: Danger of explosion if flammable gases are used in the immediate proximity of the Flexible HD Cysto-
Urethroscope. The Flexible HD Cysto-Urethroscope must not be used in the presence of flammable or combustible
media.
Warning: As a result of the light emitted by the Flexible HD Cysto-Urethroscope, the tip of the latter may heat up.
Prolonged direct contact of the light-emitting surfaces on tissue can lead to burns, and must therefore be avoided at
all cost.
Warning: Always unplug the Flexible HD Cysto-Urethroscope before carrying out any maintenance and cleaning
work on it.
Warning: If a malfunction should occur during application on a patient, stop the application immediately. Place the
distal tip of the Flexible HD Cysto-Urethroscope in the neutral, non-deflected position, and remove the Flexible HD
Cysto-Urethroscope slowly and carefully from the patient.
Warning: The Flexible HD Cysto-Urethroscope 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 HD Cysto-Urethroscope that are repaired by unauthorized personnel.
Warning: The pressure compensation cap must be in place on the vent port for:
• Hydrogen peroxide gas sterilization.
• Shipping.
Warning: Thermal hazards may exist from high temperatures radiated by the Flexible HD Cysto-Urethroscope’s illu-
mination system. Do not use this product at maximum light intensity from the light source. When this product oper-
ates at maximum light intensity for longer than 30 minutes, temperature at the distal end may exceed 41° C (105.8° F).
Prolonged use of the product can cause burns to the patient, user, and operating accessories.
CAUTION: The pressure compensation cap must be removed from the vent port for:
• Endoscopic interventions.
• Immersion in liquids.
CAUTION: Do not expose the Flexible HD Cysto-Urethroscope to direct sunlight or excessive heat, to avoid damage
to the device.
CAUTION: Flexible HD Cysto-Urethroscope must never be exposed to X-rays to avoid damage.
CAUTION: Do not steam sterilize (autoclave) the Flexible HD Cysto-Urethroscope.
CAUTION: The maximum permissible temperature for decontamination, sterilization, transport, and storage is 65° C
(149˚ F).
General Information for the Safe Use of the Flexible HD Cysto-Urethroscope

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CAUTION: Do not hit the distal tip of the Flexible HD Cysto-Urethroscope against hard objects, and never use a
sharp object to remove dirt.
CAUTION: Never lay heavy objects on the Flexible HD Cysto-Urethroscope.
Unpacking the Device
Check for missing items and evidence of shipping damage.
File any complaints immediately with KARL STORZ or the supplier.
Basic Equipment
Flexible HD Cysto-Urethroscope 11272 VH-TL/VHU-TL with the following accessories:
1 Instruction manual Z23875US
1 Leakage tester 13242 XL
1 Pressure compensation cap 11025 E
1 Channel brush 110910
1 Flat cleaning brush 27652
1 Luer plug 29100
1 Short cleaning brush 9990
Optional Accessories
1 Grasping forceps 5 Fr. 27023FE
1 Biopsy forceps 5 Fr. 27023ZE
1 Self-sealing cap 27550ZAG
General Information for the Safe Use of the Flexible HD Cysto-Urethroscope

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Handling
Note: Damage to the Flexible HD Cysto-Urethroscope resulting from incorrect operation is not covered by the manu-
facturer’s warranty.
Operating
The following instructions outline the correct operation of the Flexible HD Cysto-Urethroscope and the corresponding
accessories. Suitable accessories for your Flexible HD Cysto-Urethroscope, such as biopsy forceps, can be found in
the general surgery catalog or extracts from this catalog.
Holding the Flexible HD Cysto-Urethroscope Correctly
Grip the handle of the Flexible HD Cysto-Urethroscope in your left or right hand, as shown in the picture. With this
kind of control grip, the Flexible HD Cysto-Urethroscope can be operated with one hand.
Handling the Shaft
Warning: Applying lubricant to the lens may cloud the image and interfere with normal scope operation.
Use a suitable water-soluble lubricant (e.g. Surgilube) for the distal section of the insertion shaft. Observe the lumen
the whole time during use. If you lose your orientation, pull the shaft back slightly in the neutral position until vision is
restored.
If, during use, the image fails, is disturbed, or becomes blurred, or if vision in general is impeded, put the deflec-
tion mechanism into the neutral position and slowly pull the shaft of the Flexible HD Cysto-Urethroscope out of the
patient’s body. If the Flexible HD Cysto-Urethroscope is used in the patient after the image has failed or when there is
interference, this may result in a serious injury to the patient.
CAUTION: Do not carry the Flexible HD Cysto-Urethroscope by the shaft. Do not pull, clamp or twist the shaft of the
Flexible HD Cysto-Urethroscope.
CAUTION: The shafts of the Flexible HD Cysto-Urethroscope must never be kinked or coiled up too tightly. It is best
to suspend the shaft of the Flexible HD Cysto-Urethroscope by securely holding the handle in a vertical position.

Handling Instructions

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Handling the Deflection Mechanism
Warning: Before each use, the functionality of the deflection lever and the connected distal tip must be checked. A
defective Flexible HD Cysto-Urethroscope must not be used.
Warning: When inserting the Flexible HD Cysto-Urethroscope into the patient, the distal tip of the Flexible HD Cysto-
Urethroscope must be in the straight, non-deflected position.
Warning: Accessories must only be inserted into the working channel of the Flexible HD Cysto-Urethroscope with
the distal tip in the neutral, non-deflected position. The deflection lever must never be operated with force or abruptly
to avoid injuring the patient or damaging the device.
Warning: Before removing the Flexible HD Cysto-Urethroscope from the patient, the distal tip must be put into the
neutral position, as otherwise injuries to the patient or damage to the instrument may occur.
Warning: If the distal tip can no longer be properly controlled via the deflection lever, or if the deflection mechanism
develops any other fault, the Flexible HD Cysto-Urethroscope must not be used.
Warning: If a functional defect occurs during use on the patient, discontinue use immediately. Put the distal tip
of the Flexible HD Cysto-Urethroscope into the neutral, non-deflected position and remove the Flexible HD Cysto-
Urethroscope slowly and carefully from the patient.
Warning: Do not use force to turn the deflection lever to avoid either injuring the patient or damaging the instrument.
CAUTION: The resistance that can be felt when deflecting the tip using the deflection lever increases as the angle of
deflection increases. Actuate the deflection gently and carefully, without any sudden or jerky movements, only as far
as the limit stop.
Note: The neutral position of the distal tip is straight, without any deflection whatsoever.
The distal tip can be deflected 210° upward or 140° downward by continuously actuating the deflection lever slowly
and carefully. The distal end will deflect in accordance with the direction of actuation.
Before use, the user must always have full control over the deflection and must develop a sure feel for the deflection
mechanism and in particular for the neutral position.
Deflection functions as follows with the type 11272 VH-TL endoscope:
• If the lever is pushed upwards, the tip is lowered.
• If the lever is pushed downwards, the tip is deflected upwards.
This mechanism is inverted with model 11272 VHU-TL.

Directions for Use

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Handling the Accessories
Warning: When HF electrodes or laser probes are used, it must be ensured that power is not applied until the active
parts have emerged from the working channel and are in the user’s field of view, and the site of the operation is clear-
ly recognizable. Activation in the working channel may lead to serious injury to the patient and damage to the Flexible
HD Cysto-Urethroscope.
Warning: When HF electrodes or laser probes are used, it must be ensured that power is only applied when there
are no flammable gases in the operating field or in the proximity of the Flexible HD Cysto-Urethroscope.
CAUTION: Only use flexible accessories (forceps, cleaning brushes, etc.) from KARL STORZ. Accessories from other
manufacturers may damage the Flexible HD Cysto-Urethroscope.
CAUTION: Only introduce the instruments into the proximal port of the Flexible HD Cysto-Urethroscope.
CAUTION: Do not force accessories through the working channel, to avoid damaging the device. It should be pos-
sible to move the accessory easily, without any hindrance, and with closed jaws through the entire channel.
CAUTION: Do not introduce any accessory into the Flexible HD Cysto-Urethroscope when the distal tip is deflected.
CAUTION: Inserting sharp-tipped accessories into the working channel may damage the Flexible HD
Cysto-Urethroscope.
CAUTION: The working channel is not designed for removal of tissue and/or foreign bodies. Remove the tissue or
foreign bodies from the patient by removing the entire Flexible HD Cysto-Urethroscope.
Directions for Use

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Compatible Camera Control Units
Camera Control Unit IMAGE1 S CCU
Light Source Integrated LED in the Flexible HD Cysto-Urethroscope
Warning: The KARL STORZ Flexible HD Cysto-Urethroscope should not be used in combination with CCUs from
other manufacturers. The use of non-compatible units may cause injury to the patient or damage to the instrument.
It must be ensured that parts of the endoscope that are not electrically insulated do not come into contact with con-
ductive surfaces or live parts of other units, at any time.
Please refer to the IMAGE1 S CCU instruction manual for complete instruction on how to use the CCUs.
Connection to the Camera Control Unit
Warning: The keyboard of the IMAGE1 S must not come into contact with patients or be placed in the vicinity of
patients.
CAUTION: Ensure proper connector alignment before connection to avoid damage.
The Flexible HD Cysto-Urethroscope is connected to the CCU for operation.
For operation, an IMAGE1 S system with an IMAGE1 S Connect and an IMAGE1 X-Link are required. Both camera
modules must be connected to each other.
The Flexible HD Cysto-Urethroscope is then connected to the IMAGE1 X-Link.
Directions for Use

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1. Install the CCU on a firm, level surface.
2. Plug the power cord into the specified power socket.
3. Plug the Flexible HD Cysto-Urethroscope supply cable into the HD socket of the CCU.
4. Turn on the CCU to power up the endoscope imager and the integrated light source.
Control Buttons
The Flexible HD Cysto-Urethroscope has three control buttons which can be assigned specific functions in the CCU’s
device menu. The assignment is retained after switching off and on again.
• Left (Up) ⑧
• Right (Down) ⑨
• Select ⑩
Default Button Settings
The factory default button settings are:
• Select = Menu
• Left = Standby
• Right = Zoom
Program Head Buttons
Refer to the CCU Instruction Manual for instructions on programming the head buttons.
Focus
The image focus is adjusted automatically via CMOS technology. Manual focusing is not possible/necessary.
⑧⑨ ⑩
Directions for Use

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Inspection Prior to Use
Warning: Every time the Flexible HD Cysto-Urethroscope is used, it, and any accessories used in combination, must
be inspected to ensure that they are in perfect condition. A damaged Flexible HD Cysto-Urethroscope or damaged
accessories must not be used.
Inspecting the Surfaces
Warning: The surface of the flexible shaft must be inspected visually and by carefully feeling it, to detect any cracks,
cuts, dents, foreign bodies or other forms of damage.
CAUTION: Do not squeeze the distal tip of the Flexible HD Cysto-Urethroscope too tightly.
Every time the Flexible HD Cysto-Urethroscope is used, you must check all surfaces to confirm that they are in per-
fect condition i.e. no sharp edges, dents, protrusion, holes, or other irregularities that may trap debris.
Inspect the supply cable for damage (cut, dents, scratches, etc.) and the supply connector for loose connections.
Checking the Deflection
Warning: Actuate the deflection lever gently and carefully as far as the limit stop. The deflection lever must never
be operated with force or abruptly, to avoid injuring the patient or damaging the device. Move the deflection lever
smoothly and slowly.
Warning: Before use, always check that the deflection lever and the distal tip connected to it function correctly. A
defective Flexible HD Cysto-Urethroscope must not be used.
The distal tip is deflected by means of the deflection lever. Turn the deflection lever slowly; the end piece should move
downward. Turn the deflection lever in the opposite direction to produce an upward movement.
Directions for Use

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Directions for Use
Inspecting the LED Function
CAUTION: The CCU must be switched off before connecting the Flexible HD Cysto-Urethroscope.
Prepare the IMAGE1 S CCU as described above and connect to the Flexible HD Cysto-Urethroscope. Emission of
light at the distal end should be recognizable. Light intensity is automatically regulated by the CCU.
Verify that the scope will focus on objects at 3 mm and 50 mm away by pointing the Flexible HD Cysto-Urethroscope
at a nearby object (3 mm from the distal tip) and verify that the image on the monitor is a clear, high-quality image.
Move the distal tip to a distance of approximately 50 mm and verify that the image clarity and brightness on the moni-
tor remains constant.
Warning: If the image fails or there is interference during use in the patient, put the distal tip into the neutral position
and remove the Flexible HD Cysto-Urethroscope from the patient’s body gently and carefully. If the Flexible HD Cysto-
Urethroscope is used in the patient after the image has failed or when there is interference, this may result in serious
injury to the patient.
Inspecting the Instruments and the Working Channel
CAUTION: Accessories—such as biopsy forceps that are bent or twisted—may no longer function properly, are dif-
ficult to pass through the channel, and may cause serious damage to the channel. They must therefore be replaced.
Check the working channel by introducing the appropriate instrument.
Visual may not be an exact
representation of the endoscope

20
General Information
Warning: A flexible endoscope intended for percutaneous use must be sterilized. Do not high-level
disinfect.
Warning: HLD is only intended for flexible endoscopes that are used/indicated for use in the urethra and
bladder.
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 a contaminated flexible
endoscope 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.
• When preparing cleaning solutions, the manufacturer’s instructions for proper exposure time, dilution, and tem-
peratures are followed.
Warning: The flexible endoscope must not be used during the discharge of a cardiac defibrillator. Remove the flex-
ible endoscope from the operation area before discharge takes place.
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 con-
taminated 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 brushes should be used to clean the flexible endoscope.
CAUTION: To prevent biofilm formation, it is critical that the flexible endoscope be thoroughly dried prior to storage.
Biofilm formation will interfere with sterilization of the flexible endoscope and could lead to infection transmission.
Note: The 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).
Cleaning and Sterilization Instructions
