Storz 11272 VA User manual

Flexible CMOS Video-Cysto-Urethroscope
Models 11272 VA/VUA, 11272 V/VU
Monitor 8402 ZX
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 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, where required, steriliza-
tion of the Flexible CMOS Video-Cysto-Urethroscope. 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 available for ready reference.
Warning: KARL STORZ instruments are provided non-sterile, and must be cleaned and sterilized prior to the initial
use and before each subsequent use.
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
deduced from the information, figures and descriptions in this manual.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
Important Information
for Users of KARLSTORZ
Instruments

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Symbol Description
Symbol Description
Follow the instruction manual
White balance
Single image capture
Video recording
This device has been marked in accordance with the European Directive 2012/19/EU
on waste electrical and electronic equipment (WEEE)
Device type BF
Electronic information product pollution control (China RoHS)
Manufacturer



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Illustrated Description
①
②
⑥
⑤
⑧
13242 XL Leakage Tester
11025 E Pressure Compensation Cap
㉔
㉓
㉒
⑱
⑲
⑳
㉑
⑩
⑪⑫⑬
⑭ ⑮ ⑯ ⑰
⑨
②
⑦
③
④

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Controls, Displays, Connectors
and Their Uses
① Connecting cord
② Connection for leakage tester or pressure compensation cap (vent port)
③ Instrument channel/Luer port
(the 11272 VA/VUA (11272 V/VU) Flexible CMOS Video-Cysto-Urethroscope is equipped with a T-Luer)
④ Shaft
⑤ Handle
⑥ Deflection lever
⑦ Distal tip
⑧ Leakage tester (P/N 13242 XL)
⑨ Pressure compensation cap (P/N 11025 E)
⑩ Monitor
⑪ Power supply connection
⑫ Video output for connecting an external monitor
⑬ CMOS Video-Cysto-Urethroscope connection
⑭ Reset button
⑮ Holder for SD memory card
⑯ Function symbols
⑰ Soft keys
⑱ Charge state
⑲ Pilot lamp (orange) charging process
⑳ Power button
㉑ Pilot lamp (green) power button
㉒ Video recording
㉓ White balance
㉔ Single image capture

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Important Information for Users of KARLSTORZ Instruments _______________________________________________ 2
Symbol Description ___________________________________________________________________________________ 3
Illustrated Description__________________________________________________________________________________ 4
Controls, Displays, Connectors and Their Uses ___________________________________________________________ 5
Safety Instructions ____________________________________________________________________________________ 9
Indications for Use __________________________________________________________________________________ 9
User Qualification ___________________________________________________________________________________ 9
Warnings and Cautions _____________________________________________________________________________ 10
Safety Precautions _________________________________________________________________________________ 10
Installation and Operating Instructions __________________________________________________________________ 13
Unpacking the Device ______________________________________________________________________________ 13
Basic Equipment___________________________________________________________________________________ 13
Operating Conditions _______________________________________________________________________________ 14
Electromagnetic Compatibility _______________________________________________________________________ 14
External System Components _______________________________________________________________________ 14
Handling __________________________________________________________________________________________ 15
Operating _________________________________________________________________________________________ 15
Holding Correctly __________________________________________________________________________________ 15
Handling the Shaft _________________________________________________________________________________ 15
Handling the Deflection Mechanism __________________________________________________________________ 16
Handling the Working Channel _______________________________________________________________________ 17
Handling the Accessories (Forceps, Cleaning Brushes, etc.) _____________________________________________ 18
Inspecting the Surfaces _____________________________________________________________________________ 19
Checking the Deflection_____________________________________________________________________________ 19
Connection to the Monitor 8402 ZX __________________________________________________________________ 20
Using the Video Output _____________________________________________________________________________ 21
Focus ____________________________________________________________________________________________ 23
Function Buttons of the Endoscope __________________________________________________________________ 23
Function Keys for the Monitor________________________________________________________________________ 23
Main Menu ________________________________________________________________________________________ 24
Second Level Functions Play Back Menu______________________________________________________________ 25
Level 2a: Selecting the Recorded Videos ______________________________________________________________ 25
Contents

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Level 2aa: Playing Back and Deleting a Recorded Video Stream__________________________________________ 26
Level 2b: Selecting the Saved Images_________________________________________________________________ 26
Level 2bb: Viewing and Deleting a Saved Image ________________________________________________________ 27
Third Level Functions _______________________________________________________________________________ 27
Fourth Level Functions______________________________________________________________________________ 28
Fifth Level Functions________________________________________________________________________________ 28
Sixth Level Functions _______________________________________________________________________________ 29
Switching the Flexible CMOS Video-Cysto-Urethroscope On/Off _________________________________________ 30
Video Recording ___________________________________________________________________________________ 30
Single Image Capture_______________________________________________________________________________ 30
Inspecting the Image Quality ________________________________________________________________________ 31
Switching off the Monitor____________________________________________________________________________ 31
Energy Management _______________________________________________________________________________ 32
Attaching the Monitor to a Stand _____________________________________________________________________ 33
System Reset _____________________________________________________________________________________ 33
Cleaning, Sterilization and Care ________________________________________________________________________ 34
General Information ________________________________________________________________________________ 34
Water Quality Requirements _________________________________________________________________________ 35
Cleaning Equipment and Accessories_________________________________________________________________ 36
Bedside Pre-cleaning (at point of use)_________________________________________________________________ 37
Leakage Test ______________________________________________________________________________________ 38
Manual Cleaning ___________________________________________________________________________________ 40
Detergent Cleaning_________________________________________________________________________________ 40
Water Rinsing _____________________________________________________________________________________ 42
Drying ____________________________________________________________________________________________ 43
Inspection_________________________________________________________________________________________ 43
Sterilization________________________________________________________________________________________ 43
Sterilization Methods _______________________________________________________________________________ 44
STERIS V-PRO maX Sterilization _____________________________________________________________________ 44
STERRAD Systems Sterilization ______________________________________________________________________ 44
Reference for Cleaning and Sterilization _______________________________________________________________ 46
Storage_____________________________________________________________________________________________ 47
Contents

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Endoscope Return Instructions ________________________________________________________________________ 48
System Description __________________________________________________________________________________ 49
Technical Data_______________________________________________________________________________________ 49
Maintenance ________________________________________________________________________________________ 51
Servicing and Repair _______________________________________________________________________________ 51
Maintenance ______________________________________________________________________________________ 51
Directive Compliance _______________________________________________________________________________ 52
Important Information_______________________________________________________________________________ 52
Disposal __________________________________________________________________________________________ 52
Troubleshooting____________________________________________________________________________________ 53
Accessories _________________________________________________________________________________________ 54
Electromagnetic Compatibility (EMC) Information for KARL STORZ NPU System______________________________ 55
Shipping ____________________________________________________________________________________________ 60
Return Policy ________________________________________________________________________________________ 60
Repair Program______________________________________________________________________________________ 61
Warranty Policy ______________________________________________________________________________________ 61
Limitation of Liability__________________________________________________________________________________ 62
Software Ownership and Licensing_____________________________________________________________________ 63
Contents

9
Safety Instructions
Please read these safety instructions carefully before using the device. Before using the instrument on the patient it is
imperative that you be acquainted with how the instrument operates and is controlled.
Indications for Use
The Flexible CMOS Video-Cysto-Urethroscope is used to provide visualization and operative access during diagnos-
tic and therapeutic endoscopic procedures of the lower urinary tract, including the bladder and urethra.
Contraindications:
There are no known contraindications relating directly to the product. The Flexible CMOS Video-Cysto-Urethroscope
must not be used if, in the opinion of a qualified physician, such an application would endanger the patient, e.g. due
to the patient’s general condition, or if the endoscopic method as such is contraindicated.
User Qualification
The KARL STORZ Flexible CMOS Video-Cysto-Urethroscope may only be used by persons with an appropriate medi-
cal qualification and who are acquainted with the cystoscopy technique. The information given in these instructions
only serves to instruct in the correct handling and preparation of the Flexible CMOS Video-Cysto-Urethroscope.
It is not intended as an introduction to the technique of cystoscopy.

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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. To further emphasize the words Warning, CAUTION and Note, they are preceded
by a pictogram.
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.
Safety Precautions
The Flexible CMOS Video-Cysto-Urethroscope must be used according to the recognized medical rules and proce-
dures of endoscopy.
Warning: Every time the Flexible CMOS Video-Cysto-Urethroscope is used, you must first check that it, and any
accessories used in combination with it, is in perfect condition. Damaged Flexible CMOS Video-Cysto-Urethroscopes
or damaged accessories must not be used.
Warning: Combinations of medical devices are only then assured to be safe if
• they are identified as such in the respective instruction manual or
• 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 products used in combination.
Warning: The Flexible CMOS Video-Cysto-Urethroscope is delivered non-sterile and must be cleaned and sterilized
before initial and subsequent use.
Warning: The pressure compensation cap (P/N 11025 E) ⑨must be removed from the vent port ②for:
• endoscopic interventions
• immersing in liquid.
Warning: Not intended for use with electro surgical instruments. Use of the Flexible CMOS Video-Cysto-
Urethroscope with HF electrodes may cause interference with the image.

Safety Instructions

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Warning: The pressure compensation cap (P/N 11025 E) ⑨must be in place on the vent port ②for:
• plasma sterilization
• shipping
Warning: Do not point the light beam of the Flexible CMOS Video-Cysto-Urethroscope into the patient's and/or other
healthcare provider's eyes. Looking into the light beam may cause eye damage.
Warning: Danger of explosion if flammable gases are used in the immediate proximity of the Flexible CMOS Video-
Cysto-Urethroscope. The Flexible CMOS Video-Cysto-Urethroscope must not be used in the presence of flammable or
combustible media.
Warning: The Flexible CMOS Video-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 CMOS Video-Cysto-Urethroscopes that are repaired by unauthorized
personnel.
Warning: Always unplug the Flexible CMOS Video-Cysto-Urethroscope before carrying out any maintenance and
cleaning work on it.
Warning: The Flexible CMOS Video-Cysto-Urethroscope must not be used during the discharge of a cardiac defibrilla-
tor. Remove the Flexible CMOS Video-Cysto-Urethroscope from the operation area before discharge takes place.
Warning: When in operation, the integrated LED light source heats up the Flexible CMOS Video-Cysto-
Urethroscope. Switch off the CMOS Video-Cysto-Urethroscope before putting it down and do not place it in the prox-
imity of the patient (as per IEC 60601-1-1).
Warning: Only KARL STORZ devices (monitor 8402 ZX) may be used. Disregarding this warning can endanger the
patient and user.
Warning: If the Flexible CMOS Video-Cysto-Urethroscope should malfunction during application on a patient, stop the
application immediately. Place the distal tip of the Flexible CMOS Video-Cysto-Urethroscope in the neutral, nondeflect-
ed position and remove the Flexible CMOS Video-Cysto-Urethroscope.
CAUTION: Do not steam sterilize (autoclave) the Flexible CMOS Video-Cysto-Urethroscope under any conditions.
CAUTION: Do not allow any electrically live components or instruments to come into contact with the Flexible CMOS
Video-Cysto-Urethroscope.
CAUTION: Do not expose the Flexible CMOS Video-Cysto-Urethroscope to direct sunlight or excessive heat, to
avoid damage to the device.
Safety Instructions

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CAUTION: Flexible CMOS Video-Cysto-Urethroscopes must never be exposed to X-rays, to avoid damage.
CAUTION: Do not hit the distal tip of the Flexible CMOS Video-Cysto-Urethroscope against hard objects, and never
use a sharp object to remove dirt.
CAUTION: Never lay heavy objects on the Flexible CMOS Video-Cysto-Urethroscope.
CAUTION: To avoid damaging the monitor, do not remove the SD card or connecting cord while a video is recording.
CAUTION: To avoid damaging the monitor, always switch it off before replacing the SD card.
Safety Instructions

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Unpacking the Device
Check for missing items and evidence of shipping damage.
File any complaints immediately with KARL STORZ or the supplier.
Basic Equipment
The following accessories are provided with the Flexible CMOS Video-Cysto-Urethroscope
11272 VA/VUA (11272 V/VU):
1 Carrying case 27677 FV
1 Instruction manual Z18446US
1 Leakage tester 13242 XL
1 Pressure compensation cap 11025 E
1 Flat cleaning brush 27652/3
1 Short cleaning brush 9990/50
1 Long cleaning brush 110910/50
1 Luer plug 29100-BK
The following accessories are provided with the Monitor 8402 ZX:
1 Cleaning cap 8403 YZ
1 VESA 75 Quick clip 8401 YCA
1 Ultra II SD card 2 GB 8401 YSD
1 Power supply and charging unit 40150031
Installation and Operating
Instructions

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Operating Conditions
Flexible CMOS Video-Cysto-Urethroscope:
Ambient temperature: 15° — 37° C (59° — 98.6° F)
Humidity: 15% — 80%
Monitor 8402 ZX:
Ambient temperature: 0° — 40° C (32° — 104° F)
Humidity: 30% — 70% relative humidity
Electromagnetic Compatibility
This device has been tested and is found to comply with the EMC limits of EN/IEC 60601-1-2 :2007 CISPR 11 Class B.
External System Components
Charger
Using the medically approved charger (ANR 40150031), the Li-Ion battery of the monitor can be recharged extremely
quickly.
Moreover, this charger enables the monitor to be operated with a discharged Li-Ion battery.
The charger has a green LED display ㉖, which indicates that the output voltage is correct.
Country specific configuration
The charger features interchangeable primary adapters ㉗, ㉘, ㉙, which allow the system to be adapted to the coun-
try-specific power supply outlets.
Primary adapter for Europe: 1530290
Primary adapter for UK: 1530390
Primary adapter for US/Japan: 1530490
Primary adapter for Australia: 1530690
Installation and Operating
Instructions
㉖
㉗㉘㉙

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Handling
CAUTION: In order to avoid damage to the exterior, do not store the CMOS Video-Cysto-Urethroscope together with
sharp objects.
Operating
The following instructions outline the correct operation of the Flexible CMOS Video-Cysto-Urethroscope and the cor-
responding accessories. This is not an introduction to the techniques of cystoscopy. Instructions on the endoscopic
technique can be found in the relevant medical literature.
Holding Correctly
Grip the handle of the Flexible CMOS Video-Cysto-Urethroscope in your left or right hand, as shown in the picture.
With this kind of control grip, the Flexible CMOS Video-Cysto-Urethroscope can be operated with one hand.
Handling the Shaft
CAUTION: Do not carry the Flexible CMOS Video-Cysto-Urethroscope by the shaft. Do not pull, clamp or twist the
shaft of the Flexible CMOS Video-Cysto-Urethroscope.
CAUTION: The shaft of the Flexible CMOS Video-Cysto-Urethroscope must never be kinked or coiled up too tightly.
Warning: Do not apply lubricant to the lens, to avoid clouding the image and thus posing a risk to the patient!
Use a suitable water-soluble lubricant (e.g. Surgilube) for the distal section of the insertion shaft.
Installation and Operating
Instructions

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Handling the Deflection Mechanism
Note: The neutral position of the distal tip is straight, without any deflection whatsoever.
Warning: When introducing the CMOS Video-Cysto-Urethroscope into the patient, the distal tip must be in a straight,
nondeflected position.
Warning: The deflection lever must never be operated with force or abruptly to avoid perforation and injury to the
patient or damaging the device irreparably.
Warning: Before removing the Flexible CMOS Video-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 (sticking etc.) via the deflection lever, or if the deflection
mechanism develops any other fault, the Flexible CMOS Video-Cysto-Urethroscope must not be used.
Warning: If a functional defect occurs with the Flexible CMOS Video-Cysto-Urethroscope during use on the patient,
discontinue use immediately. Put the distal tip of the Flexible CMOS Video-Cysto-Urethroscope into the neutral, non-
deflected position and remove the Flexible CMOS Video-Cysto-Urethroscope 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 and carefully, without any sudden or jerky movements, as far as
the limit stop.
The distal tip is deflected by actuating the deflection lever slowly.
The distal end will deflect in accordance with the direction of actuation (forward or backward).

Installation and Operating
Instructions

17
Installation and Operating
Instructions
Handling the Working Channel
Do not use force when guiding the instruments and cleaning brushes through the channels. This can cause damage
to the interior, particularly if the tip of the instrument is deflected.
Note: When a rubber channel sealing cap is first used, the instrument is subjected to increased resistance. This
resistance will decrease the more often the sealing cap is used.
• When introducing an instrument into the instrument channel the flexible CMOS Video-Cysto-Urethroscope must
be in a straight, non-deflected position.
CAUTION: Only introduce the instruments from the proximal port of the flexible CMOS Video-Cysto-Urethroscope.
CAUTION: The resistance felt upon inserting the instrument increases with the degree of deflection. If the instru-
ments are introduced using force, this can result in damage to the Flexible CMOS Video-Cysto-Urethroscope or the
instrument channel.
CAUTION: If the resistance is too great upon inserting an instrument then the instrument must not be inserted with
force. Pull the instrument out and apply a water soluble lubricant to the tip thereof, then insert again. Before removing
the instrument from the patient, the distal tip must be in a straight position.
Forceps, scissors and other accessories whose jaws can be opened or closed must always be inserted into the
instrument channel with closed jaws. The jaws may only be opened when the distal tip of the instrument is com-
pletely clear of the channel. Opening the jaws in the instrument channel can cause damage to the Flexible CMOS
Video-Cysto-Urethroscope.


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Installation and Operating
Instructions
Handling the Accessories (Forceps, Cleaning Brushes, etc.)
CAUTION: Only use flexible accessories (forceps, cleaning brushes etc.) approved by KARL STORZ. Accessories
from other manufacturers may damage the flexible CMOS Video-Cysto-Urethroscope.
CAUTION: Inserting sharp-tipped accessories into the instrument channel may damage the flexible CMOS
Video-Cysto-Urethroscope.
CAUTION: Foreign bodies or parts to be extracted must not be removed through the instrument channel using
instruments. Instead, the entire flexible CMOS Video-Cysto-Urethroscope must be removed from the patient and the
foreign body extracted.

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Inspecting the Surfaces
CAUTION: Do not squeeze the distal tip of the Flexible CMOS Video-Cysto-Urethroscope too tightly.
Every time the flexible CMOS Video-Cysto-Urethroscope is used, you must first check that its surface, and above all
the surface of the sheath and distal tip, is in perfect condition and that there are no sharp edges. To prevent serious
injuries to the patient or the user, CMOS Video-Cysto-Urethroscopes with sharp edges must not be used.
Inspect the connecting cable for damage (such as breaks, cracks, twisted or squashed sections) and the connector
for loose connections. Inspect the shaft for cuffing. The scope should not be used if cuffing is observed.
Checking the Deflection
Warning: Before use, always check that the deflection lever and the distal tip connected to it function correctly.
Defective Flexible CMOS Video-Cysto-Urethroscopes must not be used.
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!
The distal end will deflect in accordance with the direction of actuation (forward or backward). If the distal end does
not deflect properly, contact KARL STORZ for repairs.
Installation and Operating
Instructions

20
Installation and Operating
Instructions
Connection to the Monitor 8402 ZX
The Flexible CMOS Video-Cysto-Urethroscope can be used together with the KARL STORZ Monitor 8402 ZX.
Insert the connecting cord ①of the Flexible CMOS Video-Cysto-Urethroscope into the connection socket ⑬on the
monitor.
Insert the cable from the power supply into the connection socket ⑪of the monitor and connect the power supply to
the mains.
The battery is charged automatically as soon as the monitor is connected to the power supply. This will be displayed
by the lighting up of the orange colored LEDs.
If required, an external monitor can be connected to the video output ⑫.
⑬ ⑫ ⑪