Storz 11272 VN User manual

Flexible Video-Urethro-Cystoscope

11272 VN/VNU

Instruction

Manual

Thank you for placing confidence in the KARL STORZ brand name. As with all of our other products, this product is

the result of years of experience and great care in manufacture. You and your organization have chosen a modern,

high-quality item of equipment from KARL STORZ.

These instructions are intended to assist you in the proper handling, cleaning and sterilization of the Flexible Video-

Urethro-Cystoscope. Read them carefully. 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.

CAUTION: Do not mix sterilization methods as it will accelerate product deterioration.

CAUTION: Federal (U.S.) 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

deduced from the information, figures and descriptions in this manual.

Important Information

for Users of KARLSTORZ

Instruments

Important information for users of KARL STORZ instruments ___________________________________________________ 2

Illustrated description _____________________________________________________________________________________ 5

Controls, displays, connectors and their uses_________________________________________________________________ 6

Specifications__________________________________________________________________________________________ 6

General information for the safe use of the Flexible Video-Urethro-Cystoscope ____________________________________ 7

User qualification _______________________________________________________________________________________ 7

Warnings and cautions __________________________________________________________________________________ 7

Definitions_____________________________________________________________________________________________ 7

Device description______________________________________________________________________________________ 8

Indications for use______________________________________________________________________________________ 8

Safety precautions when using the Flexible Video-Urethro-Cystoscope _________________________________________ 9

Warnings and cautions __________________________________________________________________________________ 9

Unpacking the device __________________________________________________________________________________ 12

Basic equipment ______________________________________________________________________________________ 12

Operating conditions___________________________________________________________________________________ 12

Electromagnetic compatibility ___________________________________________________________________________ 12

Handling instructions ____________________________________________________________________________________ 13

Handling _____________________________________________________________________________________________ 13

Operating ____________________________________________________________________________________________ 13

Holding the Flexible Video-Urethro-Cystoscope correctly ____________________________________________________ 13

Handling the shaft _____________________________________________________________________________________ 13

Directions for use _______________________________________________________________________________________ 14

Handling the deflection mechanism ______________________________________________________________________ 14

Handling the accessories _______________________________________________________________________________ 15

Compatible camera control units/light sources _____________________________________________________________ 16

Connection to the Tele Pack™ __________________________________________________________________________ 17

Connection to the light source __________________________________________________________________________ 18

Connection to the camera control unit TELECAM®DX II/SL II ________________________________________________ 19

Connection to the camera control unit Image 1 and Image 1 HUB ____________________________________________ 20

User button __________________________________________________________________________________________ 20

Inspecting the surfaces ________________________________________________________________________________ 21

Checking the deflection ________________________________________________________________________________ 22

Inspecting the light source ______________________________________________________________________________ 23

Inspecting the camera control unit _______________________________________________________________________ 23

Inspecting the instruments and the instrument channel______________________________________________________ 24

Cleaning and sterilization instructions_______________________________________________________________________ 25

General information____________________________________________________________________________________ 25

Contents

Water quality requirements______________________________________________________________________________ 26

Cleaning equipment and accessories_____________________________________________________________________ 27

Bedside pre-cleaning __________________________________________________________________________________ 28

Leakage testing _________________________________________________________________________________________ 29

Cleaning and sterilization instructions_______________________________________________________________________ 32

Manual cleaning_______________________________________________________________________________________ 32

Detergent cleaning ____________________________________________________________________________________ 32

Water rinsing _________________________________________________________________________________________ 34

Drying _______________________________________________________________________________________________ 35

Inspection____________________________________________________________________________________________ 35

Sterilization ___________________________________________________________________________________________ 36

Sterilization methods___________________________________________________________________________________ 37

STERIS Amsco V-PRO maX sterilization __________________________________________________________________ 37

References for cleaning and sterilization __________________________________________________________________ 38

Storage________________________________________________________________________________________________ 39

Endoscope return instructions_____________________________________________________________________________ 40

Maintenance ___________________________________________________________________________________________ 41

Storage/transport conditions ____________________________________________________________________________ 41

Directive compliance___________________________________________________________________________________ 41

Important information __________________________________________________________________________________ 41

Disposal _____________________________________________________________________________________________ 41

Troubleshooting _________________________________________________________________________________________ 42

Accessories ____________________________________________________________________________________________ 43

Shipping _______________________________________________________________________________________________ 44

Return policy ___________________________________________________________________________________________ 44

Repair program _________________________________________________________________________________________ 45

Warranty policy _________________________________________________________________________________________ 45

Limitation of liability ______________________________________________________________________________________ 46

Software ownership and licensing _________________________________________________________________________ 47

Contents

Illustrated Description

①

②

③

④

⑤

⑧

⑦

⑥

⑩⑫Pressure Compensation Cap

⑪Leakage Tester

⑨

Controls, Displays, Connectors and Uses

① User buttons

② Light source connector

③ Video connector

④ Connection for Leakage Tester or pressure compensation cap

⑤ Protective cap for video connector

⑥ Distal tip

⑦ Shaft

⑧ Handpiece

⑨ Working channel with Luer lock connectors

⑩ Deflection lever

⑪ Leakage tester 13242 XL

⑫ Pressure compensation cap 11025E

Specifications: 11272 VN/VNU

Direction of view: 0˚

Field of view: 120˚

Depth of field: 3–50 mm

Tip deflection: 210˚ up

140˚ down

Tip diameter: 5.5 mm

Working shaft diameter: 5.3 mm

Working channel diameter: 2.2 mm

Working shaft length: 370 mm

Total length: 635 mm

General Information for the Safe Use

of the Flexible Video-Urethro-Cystoscope

User Qualification

The KARL STORZ Flexible Video-Urethro-Cystoscope may only be used by persons with an appropriate medical

qualification and who are acquainted with the cystoscopic technique. The information given in these instructions only

serves to instruct in the correct handling and preparation of the Flexible Video-Urethro-Cystoscope.

It is not intended as an introduction to the technique of cystoscopy.

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.

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. Close attention to all warnings, precautions and notes is necessary for safe

and effective operation of the Flexible Video-Urethro-Cystoscope.

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.

General Information for the Safe Use

of the Flexible Video-Urethro-Cystoscope

Device Description

The KARL STORZ Flexible Video-Urethro-Cystoscope has a working shaft, equipped with a distal tip, which houses

the CCD video module, and can be deflected up or down. The handle houses the deflection lever and the video

control buttons, which can be programmed to perform functions such as white balance, image capture, zoom, and

provide access to the set up menu. The Flexible Video-Urethro-Cystoscope also features a working channel with a T-

Luer fitting, to accommodate the use of small diameter flexible instruments, electrodes and/or laser fibers. The KARL

STORZ Flexible Video-Urethro-Cystoscope is connected to the camera control unit and light source via an integrated

umbilical cord and a plug. This plug is inserted directly into a KARL STORZ compatible light source. The connection

to the camera control unit is made with a detachable connector cord, which allows for compatibility with multiple

KARL STORZ camera control units.

Opening the equipment or performing any repairs or modifications to the equipment by unauthorized persons shall

release KARL STORZ from any liability for its performance. Any such opening, repair, or modification performed dur-

ing the warranty period shall void all warranties.

Indications for Use

The KARL STORZ Video-Urethro-Cystoscope System is intended for use by physicians in the visual examination and

treatment of a variety of urological endoscopic procedures. The Video-Urethro-Cystoscope is intended to provide

optical visualization via a video monitor and therapeutic access.

Contraindications

The KARL STORZ Video-Urethro-Cystoscope is contraindicated for use when, in the opinion of a qualified physician,

such use would create a condition that would be dangerous for the patient.

General Information for the Safe Use

of the Flexible Video-Urethro-Cystoscope

Safety Precautions When Using the Flexible Video-Urethro-Cystoscope

The Flexible Video-Urethro-Cystoscopes must be used according to the recognized medical rules and procedures of

endoscopy.

Note: The patient leakage current limit of the CF application part may be exceeded when CF application parts (appli-

cation on heart) are used in combination with other BF application parts.

In this case, the reduction of the patient leakage current should be effected using only CF application parts as far this

is possible.

Note: The Flexible Video-Urethro-Cystoscope 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 instru-

ments. Please read the instructions for use in the instruction leaflet supplied with the HF application part for more

information.

Warnings and Cautions

Warning: Read the following safety instructions carefully before using the Flexible Video-Urethro-Cystoscope to

avoid putting your patients, personnel or yourself at risk.

Warning: Inspect the Flexible Video-Urethro-Cystoscope prior to each surgical procedure to ensure that it functions

correctly and that it has been correctly cleaned and sterilized.

Warning: Every time the Flexible Video-Urethro-Cystoscope is used, you must first check that it, and any accesso-

ries used in combination with it, are in perfect condition. Damaged Flexible Video-Urethro-Cystoscopes or damaged

accessories must not be used.

Warning: Combinations of medical devices are only 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 Video-Urethro-Cystoscope is delivered non-sterile and must be cleaned and sterilized before

the initial use as well as before any further application.

Warning: The pressure compensation cap (P/N 11025E) must be removed from the vent port for:

• endoscopic interventions

• manual/machine preparation

General Information for the Safe Use

of the Flexible Video-Urethro-Cystoscope

Warning: Only use accessories (guide wire, cleaning brushes etc.) that are specifically suited for the intended pur-

pose and can be employed in line with generally accepted technical standards and safety guidelines.

Warning: Do not allow any electrically live components or instruments to come into contact with the Flexible

Video-Urethro-Cystoscope.

Warning: The Flexible Video-Urethro-Cystoscope must not be used during the discharge of a cardiac defibrillator.

Remove the Flexible Video-Urethro-Cystoscope from the operation area before discharge takes place.

Warning: Danger of explosion if flammable gases are used in the immediate proximity of the Flexible Video-Urethro-

Cystoscope. The Flexible Video-Urethro-Cystoscope must not be used in the presence of flammable or combustible

media.

Warning: High energy light radiated through Flexible Video-Urethro-Cystoscopes may give rise to high temperatures

in front of the light outlet, at the end faces of the light guide and at the tip of the Flexible Video-Urethro-Cystoscope.

Prolonged direct contact of light-emitting surfaces on tissue can lead to burns, this must therefore be avoided at all costs.

Warning: Even after the proximal connector is removed from the light source, surfaces will remain hot for a period of

time (Risk of user being burnt).

Warning: The pressure compensation cap (P/N 11025E) must be in place on the vent port for:

• plasma sterilization

• venting

• shipping

Warning: The “Cleaning, Sterilization and Care of KARL STORZ Instruments” section of this manual explains proce-

dures for cleaning and sterilization and these instructions must be followed.

Warning: The Flexible Video-Urethro-Cystoscope may only be repaired by personnel authorized by KARL STORZ.

Unauthorized repairs may impair the function and safety of the device, and are therefore strictly forbidden. KARL

STORZ does not warranty Flexible Video-Urethro-Cystoscopes that are repaired by unauthorized personnel.

Warning: Damage to the Flexible Video-Urethro-Cystoscope and injury to the patient or user resulting from incorrect

operation are not covered by the manufacturer’s warranty.

Warning: Always unplug the Flexible Video-Urethro-Cystoscope before carrying out any maintenance and cleaning.

Warning: Contaminated Flexible Video-Urethro-Cystoscopes can cause serious or fatal diseases during transporta-

tion or at the recipient’s premises. See “Endoscope Return Instructions” for return information.

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