Storz FLEX-XC Series User manual

Flexible Video-Uretero-Renoscope
FLEX-XC series 11278 VU/VSU
Instruction
Manual

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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 mod-
ern, high-quality piece 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 Video-
Uretero-Renoscope. All essential details of the equipment and all actions required on your part are clearly presented and
explained. We thus ask that you read this manual carefully before proceeding to work with the instrument. Keep this manual
readily available for reference.
CAUTION: 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.
Important Information
for Users of KARLSTORZ
Instruments

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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 Video-Uretero-Renoscope ________________________________________________ 6
Specifications _________________________________________________________________________________________________________________ 6
Operating conditions _________________________________________________________________________________________________________ 6
Equipment classification______________________________________________________________________________________________________ 6
User qualification _____________________________________________________________________________________________________________ 7
Warnings and cautions _______________________________________________________________________________________________________ 7
Definitions _____________________________________________________________________________________________________________________ 7
Device description ____________________________________________________________________________________________________________ 8
Indications for use ____________________________________________________________________________________________________________ 8
Contraindications_____________________________________________________________________________________ 8
Safety precautions when using the Flexible Video-Uretero-Renoscope ___________________________________________________ 8
Warnings and cautions _______________________________________________________________________________________________________ 9
Unpacking the device ______________________________________________________________________________________________________ 10
Basic equipment and accessories ________________________________________________________________________________________ 10
Handling instructions ____________________________________________________________________________________________________________ 11
Handling_____________________________________________________________________________________________________________________ 11
Operating ___________________________________________________________________________________________________________________ 11
Holding the Flexible Video-Uretero-Renoscope correctly_________________________________________________________________ 11
Handling the shaft __________________________________________________________________________________________________________ 11
Handling the deflection mechanism _______________________________________________________________________________________ 12
Handling the accessories __________________________________________________________________________________________________ 13
Directions for use ________________________________________________________________________________________________________________ 14
Compatible camera control units __________________________________________________________________________________________ 14
Connection to the camera control unit ____________________________________________________________________________________ 14
Control buttons _____________________________________________________________________________________________________________ 15
Default button settings _____________________________________________________________________________________________________ 15
Program head buttons _____________________________________________________________________________________________________ 15
Inspection prior to use______________________________________________________________________________________________________ 16
Inspecting the surfaces_____________________________________________________________________________________________________ 16
Checking the deflection ____________________________________________________________________________________________________ 17
Inspecting the LED function________________________________________________________________________________________________ 18
Inspecting the instruments and the instrument channel __________________________________________________________________ 18
Contents

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Cleaning and sterilization instructions___________________________________________________________________________________________ 19
General information__________________________________________________________________________________ 19
Water quality requirements _________________________________________________________________________________________________ 20
Cleaning equipment and accessories _____________________________________________________________________________________ 21
Bedside pre-cleaning (at point of use) _____________________________________________________________________________________ 21
Leakage test ________________________________________________________________________________________________________________ 22
Manual cleaning ____________________________________________________________________________________________________________ 24
Detergent cleaning __________________________________________________________________________________ 24
Water rinsing _______________________________________________________________________________________ 25
Drying ____________________________________________________________________________________________ 26
Inspection__________________________________________________________________________________________ 26
Sterilization _________________________________________________________________________________________ 26
STERRAD® sterilization ______________________________________________________________________________________________________ 27
Amsco V-PRO maX sterilization _______________________________________________________________________ 28
STERIS System 1/1E (SS1/SS1E) Liquid Chemical Sterilant Processing System_______________________________________ 28
Reference for cleaning and sterilization _________________________________________________________________ 29
Storage___________________________________________________________________________________________________________________________ 30
Endoscope return instructions __________________________________________________________________________________________________ 31
Appendix _________________________________________________________________________________________________________________________ 32
Troubleshooting _____________________________________________________________________________________________________________ 32
Shipping__________________________________________________________________________________________________________________________ 33
Return policy _____________________________________________________________________________________________________________________ 33
Repair program __________________________________________________________________________________________________________________ 34
Warranty policy___________________________________________________________________________________________________________________ 34
Limitation of liability ______________________________________________________________________________________________________________ 35
Software ownership and licensing ______________________________________________________________________________________________ 36
Contents

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⑨ Leakage Tester
⑩ Pressure Compen sation Cap
①
②
③
④
⑤
⑧
⑦
⑥
Illustrated Description

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General Information for the Safe Use of
the Flexible Video-Uretero-Renoscope
① Control Buttons
② Supply Connector
③ Connection for Leakage Tester or Pressure Compensation Cap
④ Distal Tip
⑤ Shaft
⑥Handpiece
⑦ Working Channel with Luer Lock Connectors
⑧ Deflection Lever
⑨ Leakage Tester 13242 XL
⑩ Pressure Compensation Cap 11025E
Specifications: 11278 VU/VSU
Direction of view: 0°
Field of view: 90°
Depth of field: 4–50 mm
Tip deflection: 270° up
270° down
Working shaft diameter: 2.9 mm
Working channel diameter: 1.2 mm
Working shaft length: 675 mm
Total length: 980 mm
Operating Conditions
Ambient temperature: 15° C – 37° C (59° F – 98.6° F)
Humidity: 15% – 80%
Equipment Classification
Type of protection against moisture: Ordinary
Degree of protection against electric shocks: CF-type
Mode of operation: Continuous

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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.
User Qualification
The KARLSTORZ Flexible Video-Uretero-Renoscopes may only be used by persons with an appropriate medical qualifi-
cation and who are acquainted with the technique of uretero-renoscopy. The information given in these instructions only
serves to instruct in the correct handling and preparation of the Flexible Video-Uretero-Renoscope.
It is not intended as an introduction to the technique of renoscopy.
Please read these safety instructions carefully before using this instrument and ensure that you are very familiar with its
operation and control.
Warnings 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.
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General Information for the Safe Use of
the Flexible Video-Uretero-Renoscope

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General Information for the Safe Use of
the Flexible Video-Uretero-Renoscope
Device Description
The KARL STORZ Flexible Video-Uretero-Renoscope has a working length of 675 mm with an outer diameter of 2.9 mm.
The shaft consists of a working channel, 1.2 mm in diameter, that can be used for insertion of various flexible instruments.
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 270 degrees in an UP/DOWN direction. The control buttons can be programmed to perform functions
such as white balance, Image Capture, zoom and to provide access to the setup menu.
The KARL STORZ Flexible Video-Uretero-Renoscope when used with compatible Camera Control Unit (CCU) and accesso-
ries from the KARL STORZ Flexible Ureteroscope System. There are three different system configurations possible. Please
refer to the system configuration matrix shown under Compatible Camera Control Units section of this instruction manual.
Please refer to the proper CCU manual for instructions on how to use the Camera Control Unit.
Videoscopes are applied parts which should only be used with supply units (camera control units) specified for this purpose
by KARL STORZ.
Indications for Use
The KARL STORZ Flexible Video-Uretero-Renoscope is indicated for endoscopic examination in the urinary tract and can
be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeu-
tic procedures.
Contraindications
There are no known contraindications relating directly to the product. The Flexible Video-Uretero-Renoscope must not be
used if, in the opinion of a qualified physician, such an application would endanger the patient, or if the endoscopic method
as such is contraindicated.
Safety Precautions When Using the Flexible Video-Uretero-Renoscope
The Flexible Video-Uretero-Renoscope must be used according to the recognized medical rules and procedures of endos-
copy.
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.
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General Information for the Safe Use of
the Flexible Video-Uretero-Renoscope
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.
Warnings and Cautions
Warning: Every time the Flexible Video-Uretero-Renoscope is used, it, and any accessories used in combination, must be
inspected to ensure that they are in perfect condition. A damaged Flexible Video-Uretero-Renoscope or damaged accesso-
ries 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 combination of devices permit this.
Pay careful attention to the instructions and interface specifications of medical devices used in combination.
Warning: The videoscope 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.
CAUTION: The pressure compensation cap must be removed from the vent port for:
• endoscopic interventions
• immersion in liquids
Warning: Do not point the light of the Flexible Video-Uretero-Renoscope into the eyes. Looking into the light may cause
eye damage.
Warning: Only use accessories (guide wires, cleaning brushes etc.) that are specifically intended for use with videoscopes
and can be operated with generally accepted technical standards and occupational safety guidelines.
Warning: Explosion may occur if flammable gases are used in the immediate proximity of the Flexible Video-Uretero-
Renoscope. The Flexible Video-Uretero-Renoscope must not be used in the presence of flammable or combustible media.
Warning: As a result of the light emitted by the Flexible Video-Uretero-Renoscope, the tip may heat up. Prolonged direct
contact of the light-emitting surfaces on tissue can lead to burns, and must therefore be avoided.
CAUTION: The pressure compensation cap must be in place on the vent port for:
• plasma sterilization
• shipping
Warning: Always unplug the Flexible Video-Uretero-Renoscope before carrying out any maintenance and/or cleaning.
Warning: The Flexible Video-Uretero-Renoscope may only be repaired by personnel authorized by KARL STORZ.
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Unauthorized repairs may impair functioning and safety, and are therefore strictly forbidden. KARL STORZ gives no warran-
ty for Flexible Video-Uretero-Renoscope that are repaired by unauthorized personnel.
Warning: If a malfunction should occur during application on a patient, stop the application immediately. Place the distal
tip of the videoscope in the neutral, nondeflected position and remove the video endoscope slowly and carefully from the
patient.
CAUTION: Do not expose the Flexible Video-Uretero-Renoscope to direct sunlight or excessive heat, to avoid damage to
the device.
CAUTION: Flexible Video-Uretero-Renoscopes must never be exposed to X-rays, to avoid damage.
CAUTION: Do not steam sterilize (autoclave) the Flexible Video-Uretero-Renoscope.
CAUTION: The maximum permissible temperature for decontamination, sterilization and storage is 65° C (149° F).
CAUTION: Do not hit the distal tip of the Flexible Video-Uretero-Renoscope against hard objects, and never use a sharp
object to remove dirt.
CAUTION: Never lay heavy objects on the Flexible Video-Uretero-Renoscope.
CAUTION: When using the Flexible Video-Uretero-Renoscope with the AIDA HD-Connect, a brief loss of video (2-3 sec)
may occur when the zoom function is used. The image will be restored without the need for additional user interaction.
Refer to the AIDA HD-Connect Instruction Manual for instructions for use.
Unpacking the Device
Check for missing items and evidence of shipping damage.
File any complaints immediately with KARL STORZ or the supplier.
Basic Equipment and Accessories
Flexible Video-Uretero-Renoscope 11278 VU/VSU
with the following accessories:
1 Short cleaning brush 9990/50
1 Long cleaning brush 11276CL2/10
1 Luer plug 29100-BK
1 Flat cleaning brush 27652/3
1 11025E Pressure Compensation Cap
General Information for the Safe Use of
the Flexible Video-Uretero-Renoscope

11
Handling Instructions
Handling
Note: Damage to the Flexible Video-Uretero-Renoscope resulting from incorrect operation is not covered by the manufac-
turer’s warranty.
Operating
The following instructions outline the correct operation of the Flexible Video-Uretero-Renoscope and the corresponding
accessories. Suitable accessories for your Flexible Video-Uretero-Renoscope, such as biopsy forceps, can be found in the
UROLOGY catalog or excerpts from this manual.
Holding the Flexible Video-Uretero-Renoscope Correctly
Grip the handle of the Flexible Video-Uretero-Renoscope in your left or right hand, as shown in the picture. With this kind of
control grip, the Flexible Video-Uretero-Renoscope can be operated with one hand.
Handling the Shaft
CAUTION: Do not carry the Flexible Video-Uretero-Renoscope by the shaft. Do not pull, clamp or twist the shaft of the
Flexible Video-Uretero-Renoscope.
CAUTION: The shaft of the Flexible Video-Uretero-Renoscope must never be kinked or coiled up too tightly. It is best to
suspend the shaft of the Flexible Video-Uretero-Renoscope by securely holding the handle in a vertical position.
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
entire 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, becomes blurred, or if vision in general is impeded, put the deflection mechanism
into the neutral position and slowly pull the shaft of the Flexible Video-Uretero-Renoscope out of the patient’s body. If the
Flexible Video-Uretero-Renoscope 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.
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Handling the Deflection Mechanism
Note: The neutral position of the distal tip is straight, without any deflection.
Warning: Accessories must only be inserted into the instrument channel of the Flexible Video-Uretero-Renoscope 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 Video-Uretero-Renoscope from the patient, the distal tip of the Flexible Video-
Uretero-Renoscope must be put into the neutral position, 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 devel-
ops any other fault, the Flexible Video-Uretero-Renoscope 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 Video-Uretero-Renoscope into the neutral, non-deflected position and remove the Flexible Video-Uretero-
Renoscope slowly and carefully from the patient.
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, without any sudden movements, as far as the limit stop allows.
CAUTION: Do not use force to actuate the deflection lever, to avoid either injuring the patient or damaging the instrument.
The distal tip can be deflected 270° upward or downward by continuously actuating the deflection lever slowly and careful-
ly. 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 feel for the deflection mechanism
and in particular for the neutral position.
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Handling Instructions

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Handling the Accessories
CAUTION: Only use flexible accessories (forceps, cleaning brushes etc.) from KARLSTORZ. Accessories from other man-
ufacturers may damage the Flexible Video-Uretero-Renoscope.
CAUTION: Only introduce the instruments into the proximal port of the Flexible Video-Uretero-Renoscope.
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 instrument channel and are in the user’s field of view, and the site of the operation is clearly
recognizable. Activation in the instrument channel may lead to serious injury to the patient and damage the Flexible Video-
Uretero-Renoscope.
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 Video-Uretero-Renoscope.
CAUTION: Do not force accessories through the working channel to avoid damaging the device. It should be possible to
move the accessory easily, without any hindrance through the entire channel.
CAUTION: Do not introduce any accessory into the Flexible Video-Uretero-Renoscope when the distal tip is deflected.
CAUTION: Inserting sharp-tipped accessories into the instrument channel may damage the Flexible Video-Uretero-
Renoscope.
CAUTION: The instrument channel is not designed for removal of tissue and/or foreign bodies. Remove the tissue or for-
eign bodies from the patient by removing the entire endoscope.
Handling Instructions

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Compatible Camera Control Units
KARL STORZ Flexible Ureteroscope System Configurations
System Name Material Numbers Description
Flexible Video-Uretero-Renoscope with
IMAGE 1 S CCU System
11278 VSU Flexible Video-Uretero-Renoscope
TC-200/60250 & TC-301/60252 IMAGE 1 S (Modular CCU)
Flexible Video-Uretero-Renoscope with
Image 1 HD Hub CCU System
11278 VU Flexible Video-Uretero-Renoscope
22201011-U1, 22201011-U102,
22201011-U104, 22201011-
U110, 22201011-U112,
22201015-1, 22201015-102,
22201015-104, 22201015-110
or 22201015-112
Image 1 HD Hub CCU
TC002 Flex-Xc Adapter
Flexible Video-Uretero-Renoscope with
Image 1 HD Hub CCU System
11278 VU Flexible Video-Uretero-Renoscope
22201011-U1, 22201011-U102,
22201011-U104, 22201011-
U110, 22201011-U112,
22201015-1, 22201015-102,
22201015-104, 22201015-110
or 22201015-112
Image 1 HD Hub CCU
Warning: The KARLSTORZ Flexible Video-Uretero-Renoscope should not be used in combination with Camera Control
Units from other manufacturers. The use of non-compatible units may cause injury to the patient or damage to the instru-
ment. It must be ensured that parts of the endoscope that are not electrically insulated do not come into contact with con-
ductive surfaces or electrically live parts of other units, at any time.
Please refer to the IMAGE 1 CCU or IMAGE 1 S CCU instruction manual for complete instruction on how to use the
Camera Control Units.
Connection to the Camera Control Unit
Warning: The keyboard of the IMAGE1 HUB™ HD/IMAGE 1 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.
Directions for Use

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Directions for Use
1. Install the Camera Control Unit on a firm, level surface.
2. Plug the power cord into the specified power socket.
3. Plug the Flexible Video-Uretero-Renoscope supply cable into the HD socket of the Camera Control Unit.
4. Turn on the CCU to power up the endoscope imager and the integrated light source.
Control Buttons
The Flexible Video-Uretero-Renoscope has three control buttons which can be assigned specific functions in the camera
control unit’s device menu. The assignment is retained after switching off and on again.
• Left (Up)
• Right (Down)
• Select = Menu
Default Button Settings
The factory default button settings are:
• Left = Standby
• Right = Zoom
Program Head Buttons
Refer to the CCU Instruction Manual for instructions on programming the head buttons.
Select
Left (Up) Right (down)
IMAGE 1 HD HUB CCU
IMAGE 1S

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Directions for Use
Inspection Prior to Use
Warning: Every time the Flexible Video-Uretero-Renoscope is used, it, and any accessories used in combination, must be
inspected to ensure that they are in perfect condition. A damaged Flexible Video-Uretero-Renoscope or damaged accesso-
ries must not be used.
Inspecting the Surfaces
Warning: The surface of the Flexible Video-Uretero-Renoscope must be inspected visually and by carefully feeling it, to
detect any cracks, cuts, dents, foreign bodies, sharp edges or other forms of damage .
CAUTION: Do not squeeze the distal tip of the Flexible Video-Uretero-Renoscope too tightly.

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Directions for Use
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 oper-
ated with force or abruptly, to avoid injuring the patient or damaging the device!
Warning: Before use, always check that the deflection lever and the distal tip connected to it function correctly. Defective
Flexible Video-Uretero-Renoscopes 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 .

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Directions for Use
Inspecting the LED Function
Prepare the IMAGE 1 HD CCU or IMAGE 1 S CCU as described above and connect to the Flexible Video-Uretero-
Renoscope. Emission of light at the distal end should be recognizable. Light intensity is automatically regulated by the cam-
era control unit.
Verify that the scope will focus on objects at 5 mm and 50 mm away by pointing the Flexible Video-Uretero-Renoscope at
a nearby object (5 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 monitor remains con-
stant.
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 Video-Uretero-Renoscope from the patient’s body gently and carefully. If the Flexible Video-Uretero-
Renoscope is used in the patient after the image has failed or when there is interference, this may result in serious injury to
the patient.
CAUTION: The Camera Control Unit must be switched off before connecting the videoscope!
Inspecting the Instruments and the Instrument Channel
CAUTION: Accessories, such as biopsy forceps, which are bent or twisted, and/or difficult to pass through the channel,
may cause serious damage to the channel. Accessories in any of these conditions must be replaced before use.
Check the instrument channel by introducing the appropriate instrument into the Luer port. Verify that it passes through the
entire channel.

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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 contami-
nated 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: When preparing cleaning solutions, follow the manufacturer's instructions for proper exposure time, dilution and
temperatures.
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).
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