Cystoscope 12° / Cannula for injection Instructions for Use

Richard Wolf reserves all rights in this document, in particular relating to reproduction, distribution, public communication and public dissemination. This document may not be modified, and texts and images must not be reproduced or translated without the express prior permission of Richard Wolf GmbH.

Copyright © RICHARD WOLF GmbH

Manufacturer RICHARD WOLF GmbH Pforzheimer Straße 32 75438 Knittlingen GERMANY Telephone: +49 70 43 35-0 Telefax: +49 70 43 35-4300

www.richard-wolf.com

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Contents 1

General notes and instructions for use...

5

1.1

Safety instructions and levels of danger...

5

2

Technical description...

6

3

Intended use...

6

4

Indications and field of use ...

6

5

Contraindications, patient selection and side effects ...

7

5.1

Contraindications...

7

5.2

Patient selection ...

7

5.3

Side effects...

7

6

Combinations ...

8

7

Illustration ...

9

7.1

Legend and identification ...

9

7.2

Symbols... 10

8

Application ... 11

8.1 8.1.1 8.1.2 8.1.3 8.1.4

Preparation ... 12 Preparing the cystoscope ... 12 Connect the supply and drain stopcocks ... 12 Connection to a light source ... 13 Assembly of handle 8702.261 (option) ... 14

8.2 8.2.1 8.2.2 8.2.3 8.2.4

Additonal notes and instructions for use ... 14 Light... 14 Electrical current... 15 Image quality ... 15 Irrigation fluid ... 15

8.3 8.3.1 8.3.2

Auxiliary instruments ... 16 General information ... 16 Inserting the cannula into the working channel ... 16

8.4 8.4.1 8.4.2

Lithotripsy application ... 17 Additional notes and instructions on electro-hydraulic lithotripsy (EHL)... 18 Additional notes and instructions on laser lithotripsy... 19

8.5

HF applications... 20

8.6

Laser application ... 20

9

Checks... 21

9.1

Visual check ... 21

9.2 9.2.1 9.2.2

Function check ... 22 Image quality and light output ... 22 Stopcock plug ... 23

10

Reprocessing and maintenance ... 24

10.1

Reprocessing procedure ... 25

10.2 10.2.1 10.2.2 10.2.3

Reprocessing sequence - cystoscope... 25 Machine reprocessing ... 27 Manual reprocessing ... 29 Sterilization ... 30

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10.3 10.3.1 10.3.2 10.3.3

Reprocessing sequence - cannula for injection... 33 Machine reprocessing ... 33 Manual reprocessing ... 34 Sterilization ... 34

11

Technical data and order data... 35

12

Spare parts and accessories ... 36

13

Operating, storage, transport and shipping conditions ... 37

13.1

Disposal of product, packaging material and accessories ... 37

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General notes and instructions for use The product must only be used as intended following the instruction manual by adequately trained and qualified medical personnel. Maintenance and repair must be carried out by authorized experts. Use the product only in the combinations and with the accessories and spare parts specified in this instruction manual. Use other combinations, accessories and replacement parts only if they are expressly intended for the planned application and if the performance characteristics and safety requirements are met. The product must not be altered in any way. Reprocess the product in accordance with the manual before every use and before return shipment to protect the patient, user and third parties. This manual is an integral part of the product and must be stored in such a way that it is accessible at any time during its entire life cycle. This manual must be passed on to any subsequent owner or user. Immediately on receipt, check the product and its accessories for completeness and possible damage. Should the shipment give rise to complaints, please inform the manufacturer or supplier immediately. Subject to technical changes! Due to ongoing development, the product descriptions, illustrations and technical data may deviate slightly from the current state. For further information about our products please contact Richard Wolf GmbH or your representative.

1.1

Safety instructions and levels of danger WARNING This signal word is used to indicate a potentially dangerous situation. Not avoiding this situation can result in death or extremely serious injuries.

CAUTION This signal word is used to indicate a potentially dangerous situation. Not avoiding this situation can result in minor or moderate injury.

ATTENTION This signal word without warning sign is used to indicate a potential danger of material damage.

NOTE This signal word indicates additional useful information for the reader, such as hints for easier operation as well as cross references.

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2

Technical description Cystoscope The cystoscope consists of: n n n n n n

Sheath tube, integrated light guide, optical system and working channel Coldlight connector Adapter, endoscope side (light cable to endoscope, can be unscrewed) Obliquely offset eyepiece with eyecup Supply and drain stopcocks Automatic valve – Option: Sterile universal sealing valve (for single use)

Cannula for injection The cannula for injection consists of: n n n n

3

Cannula tip Cannula tube Stabilizer ring Luer connector (proximal)

Intended use Cystoscope The cystoscope is used for visualizing the lower urinary tract (urethra or bladder) via natural or surgically created passages. Cannula for injection The cannula for injection is used for aspirating and injecting viscuous media (e.g. collagen, deflux). Universal sealing valve The sterile universal sealing valve available as an option is used for inserting auxiliary instruments through the working channel. These products are exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately instructed persons.

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Indications and field of use For examination, diagnosis and therapy in conjunction with endoscopic accessories in the following applications: n n n n

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transurethral extraction or lithotripsy of bladder stones tumor diagnostics withdrawal / removal of foreign bodies incontinence and reflux therapy

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Contraindications, patient selection and side effects

5.1

Contraindications CJD

Creutzfeldt-Jakob Disease or a

vCJD

Variant of the Creutzfeldt-Jakob Disease

BSE

Bovine Spongiform Enzephalopathy; so-called mad cow disease (e.g. Creutzfeldt-Jakob Disease)

TSE

Transmissible Spongiform Enzephalopathy

On the basis of the patient's general condition the doctor in charge must decide whether the planned use is possible or not. The laws and regulations valid in your country must be complied with. For further notes and instructions please refer to the latest medical literature. Contraindications directly related to the product are presently unknown.

5.2

Patient selection The patient selection for the application of the medical product herein described is not limited with regard to gender, origin, anamnesis and other framework conditions.

5.3

Side effects No side effects are known if the system is used as intended.

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Combinations CAUTION Do not combine products incorrectly! Injuries of the patient, user or others as well as damage to the product are possible. n Combine the different products only if the intended use and the relevant technical data (working length, diameter, peak voltage, etc.) are the same. n Follow the instructions for use of the products used in combination with this product. n Observe the "Notes and instructions on HF applications", order no.: GA-S002 as well as the HF device manufacturer's instructions. Combinable products The cystoscope is used in conjunction with: n

n n n n n

Cannula for injection (can also be used together with endoscopes with a 5 Fr. working channel) Intracorporeal lithotripsy systems Suction and irrigation devices light sources and fiber light guides Video cameras and objective lenses Endoscopic accessories, e.g. – Grasping forceps – Stone extractors – Probes – Laser fibers – Syringes

Adapter, endoscope side The adapter, endoscope side, can be unscrewed and replaced by a suitable adapter to connect fiber light cables by other manufacturers. For order data please refer to the latest catalog sheets.

8

Fig. 1

NOTE For further information on fiber light cables please refer to the following instructions for use: n Fiber light cable sets: GA-A287 n Light cable: GA-A009

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Illustration 11 1

8

3

2

9 #

10

14 4

5

6

7

13

15.1 15.2 12.1 12.2

15 17 18.5 18.4

12

16

18.1

18.3 18.2

# 18

Fig. 2

7.1

Legend and identification

Item

Designation

Item

Designation

1

Objective lens

13

Rubber cap

2

Light exit

14

Sterile universal sealing valve (option)

3

Working channel

15

Supply/drain stopcock with removable stopcock plug

4

Endoscope tip

15.1

Stopcock plug

5

Sheath tube

15.2

Stopcock housing

6

Identification: Diameter of endoscope tip in Fr.

16

Identification: max. passage in Fr.

7

Identification: Sheath tube diameter in Fr.

17

Identification: Indication of direction of view

8

Adapter, endoscope side

18

Cannula for injection

9

Identification: Fiber bundle diameter in mm

18.1

Luer connector

10

Color coding ring, orange: Identification of direction of view 12°

18.2

Stabilizer ring

11

Fixed eyecup

18.3

Cannula tube

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Item

Designation

Item

Designation

12

Automatic valve

18.4

Marking: Identification of maximum puncture depth of injection cannula

12.1

Seal

18.5

Cannula tip

12.2

Valve holder

#

Product no.

7.2

Symbols

Symbols

Designation Follow instructions for use Product number Serial Number Lot code Manufacturer Manufacturing date Do not reuse! Do not resterilize Number, amount

Expiry date Sterilized with ethylene oxide Do not use if package is damaged Keep away from sunlight!

Temperature, limitation

Humidity, limitation

Identification in conformity with medical devices directive 93/42/EEC only valid if the product and/ or packaging is marked with this symbol. Products of category IIa and above, as well as sterile products or products with measuring function of category I, are additionally identified with the code no. of the notified body (0124).

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Application WARNING Do not reprocess a single-use product! If a single-use product is reprocessed for further use, the product properties can be impaired and/or changed, endangering the patient, user and others. Possible dangers / risk factors: - Strength problems - Severely impaired function - Damage to the product - Substantially increased risk of infection - Biocompatibility problems This single-use product is only designed for one single use on one single patient. If a single-use product is reprocessed, the product responsibility lies with the user or with the person reprocessing the product. In this case the manufacturer can no longer guarantee the safety and performance of the product. n It is not permissible to reprocess a disposable (i.e. single-use) product. n Discard a single-use product after use in accordance with the country-specific regulations.

WARNING The products have only limited strength! Excessive force will cause damage, impair the function and therefore endanger the patient. n Immediately before and after use, check the products for damage, loose parts and completeness. Make sure that no missing instrument parts remain in the patient. n Do not use products which are damaged or incomplete or have loose parts.

NOTE The injection cannulas are delivered in unsterile condition and must be reprocessed before use (see section 10.3 Reprocessing sequence - cannula for injection).

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8.1

Preparation

8.1.1

Preparing the cystoscope 1. 2. 3. 4. 5.

Carry out a visual check, see section 9.1 Visual check. Screw on the adapter, endoscope side (8). Check that the seal (12.1) is in the valve holder (12.2). Tighten the valve holder (12.2). Install the rubber cap (13).

8

12.1

12.2

13

14

12

Fig. 3

NOTE Optionally, the universal sealing valve (14) can be installed instead of the automatic valve (12).

8.1.2

Connect the supply and drain stopcocks 1. Open the supply and drain stopcocks 2. Switch on the suction/irrigation system and check the suction/irrigation function. 3. Check the entire system for leak-tightness and free passage (patency).

Fig. 4

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8.1.3

Connection to a light source CAUTION Intense heat due to high light energy! Unfavourable conditions can cause an increase in temperature at the coupling point of the fiber light cable and the light exit of the endoscope. Burns on the patient, user and others as well as damage to endoscope are possible. n Reduce the light output or choose a fiber light cable with suitable diameter.

ATTENTION To achieve optimum light transmission, the fiber bundle diameters of the endoscope and fiber light cable must match. Possible consequences if there is a mismatch: n Fiber light cables with excessively large fiber bundle diameter (cross-section) cause ð excessive heating at the coupling point with the endoscope n Fiber light cables with excessively small fiber bundle diameter (cross-section) cause ð reduced light output Connection of light cable ¯ Connect the fiber light cable to the adapter and to a suitable light source. Fiber bundle diameter A suitable fiber bundle diameter can be recognized by the identification number on the endoscope. This number must be the same as the fiber bundle diameter on the fiber light cable where the endoscope is connected.

Fig. 5

NOTE For further information on fiber light cables please refer to the following instructions for use: n Fiber light cable sets: GA-A287 n Light cable: GA-A009

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8.1.4

Assembly of handle 8702.261 (option) 1. Unscrew the locking collar (a). 2. Insert the cystoscope from proximal into the handle 8702.261 as far as it will go. 3. Tighten the locking collar (a). ð The handle is locked in place. 4. Carry out a function check, see section 9.2 Function check.

a 3. 1.

2.

Fig. 6 For disassembly proceed in reverse order.

8.2

Additonal notes and instructions for use ATTENTION During use, an x-ray device should be available to allow intermediate fluoroscopy control.

8.2.1

Light ATTENTION Use only products with type BF applied parts in conjunction with the endoscope.

WARNING Intense heat due to high light energy! Danger of inadvertent tissue damage - due to insufficient distance between the light exit area and the tissue - due to soiling/contamination in the light exit area - When using high performance light sources n Do not touch the light exit area and avoid direct contact with the tissue. n Remove any soiling

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CAUTION Fire hazard! When placing the endoscope onto heat-sensitive flammable surfaces (dark drapes etc.) the high light energy at the light exit area of the endoscope can cause high temperatures or even ignition. n Store the endoscope in a safe place. n Switch off the light source if you do not use the endoscope for a period of time.

CAUTION Danger of burns! Due to the high energy of the light source, the adapter and glass surfaces on the fiber light cable are extremely hot when disconnected from the light source. This may cause burns if inadvertently the patient, user or others touch the parts. n Do not touch the adapter or the glass surface of the fiber light cable. n Allow the fiber light cable to cool down.

8.2.2

Electrical current WARNING Danger of electric shock! Patient leakage currents can add up if the endoscopes are combined with other energetically operated endoscopic accessories. n Make sure that the combinations do not exceed the permissible patient leakage currents.

8.2.3

Image quality WARNING Increased risk potential if the image is blurred! Danger of injuring the patient. n Stop the intervention for safety reasons if the image is blurred. n Check the image quality of the endoscope before use.

8.2.4

Irrigation fluid CAUTION Irrigation fluid can be electrically conductive! Depending on the application, a suitable low-conductivity irrigation fluid must be selected by the user. Do not use saline (NaCl) solution for HF applications.

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8.3

Auxiliary instruments

8.3.1

General information ATTENTION Use only auxiliary instruments with a maximum diameter of 5 Fr. and a working length of at least 250 mm.

8.3.2

Inserting the cannula into the working channel WARNING Danger of injury if the auxiliary instrument is not visible through the scope! Inadvertent tissue damage as well as damage to the distal end of the endoscope and instrument parts is possible. n Insert the auxiliary instrument only under visual control. n Carry out manipulations only once the auxiliary instrument is fully visible through the scope.

ATTENTION Discard the cannula for injection after use, as it is a single use item.

ATTENTION Observe the maximum puncture depth during reflux therapy The maximum puncture depth of the cannula for injection is 6 mm which is indicated by a marking (18.4) on the distal end of the cannula.

18.4

Fig. 7

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Inserting the cannula ¯ Insert the cannula for injection (18) via the automatic valve (12) into the working channel (3). ð The stabilizer ring (18.2) improves guidance of the cannula (18) in the working channel (3).

3

12

18.2

18

Fig. 8

8.4

Lithotripsy application NOTE Follow the sonotrode manufacturer's instructions.

CAUTION Danger of injury from kinked probes or probes with damaged insulation Danger of injuring the patient. n Interrupt the operation if necessary to replace the probe. n Carefully check the probes before each use.

CAUTION Danger of injury if the probes are inserted incorrectly Excessively fast and incorrect pushing of the probes can cause perforations or injuries when they project from the endoscope. n Insert the probes carefully under endoscopic control.

CAUTION Danger of injury when working outside the field of view When working outside the field of view, there is the risk of perforating tissue. n Always keep the tip of the probe within the field of view to avoid mechanical perforation.

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8.4.1

Additional notes and instructions on electro-hydraulic lithotripsy (EHL) CAUTION Premature activation of the EHL probe or insufficient distance of the EHL probe from unprotected tissue If the activated EHL probe makes direct contact with the mucuous membrane this can cause perforations and/or hematomas. n Pass the EHL probe to the concretion under endoscopic view and activate only if the probe tip is positioned freely and makes contact with the stone. n Trigger electrohydraulic shockwaves at least 10 mm away from unprotected tissue.

CAUTION Insufficient distance between the endoscope tip and the EHL probe During the intervention the endoscope tip may become damaged by electrohydraulic shockwaves. n Before activation the EHL probe must have a safety distance of 10 mm from the distal end of the endoscope sheath.

Fig. 9

NOTE Sorbite-mannite irrigation solutions are not suitable for electro-hydraulic lithotripsy. n Jammed stones can be crushed directly with an EHL probe and then extracted using a stone extractor or a grasping forceps.

Use of EHL probes EHL probes can be used for the fragmentation of ureter stones. A precondition for the above is the continuous supply of irrigation water while the probe tip contacts the stone as well a clear view of the concretion.

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8.4.2

Additional notes and instructions on laser lithotripsy NOTE When applying a laser make sure you follow the laser device manufacturer's instructions as well as the general regulations on the use of lasers. Wear the required personal protection equipment.

CAUTION Danger of injury! Do not work outside the scope's field of view! Inadvertent tissue damage as well as damage to the distal end of the instrument and to instrument parts are possible. n Activate the laser only after the tip of the laser fiber has become fully visible through the scope. n Activate the laser only after the pilot beam makes contact with the area to be treated.

CAUTION High temperatures due to highly coherent laser beam! The heat generated by the laser beam reduces the strength of instrument parts. n Do not direct the laser beam at instrument parts, in particular not at plastic parts. n Keep a safe distance.

CAUTION Danger of injury from high energy laser radiation There is the danger of eye injuries of the user if the endoscope is used without a filter attachment during laser applications. n Use a suitable filter attachment on the eyepiece of the endoscope.

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8.5

HF applications NOTE The notes and instructions on HF applications in instructions for use GA-S002 as well as the HF device manufacturers' instructions must be followed.

WARNING Danger of injury if the instrument is not visible through the scope! Inadvertent tissue damage and damage to the distal end of the endoscope and to instrument parts is possible. Activate the HF surgical device only after the live part carrying HF current has become fully visible through the scope and contact is made with the intended treatment area.

WARNING HF sparking! Danger of injury if there is insufficient distance between the part of the HF product carrying high frequency and other conductive parts. During HF current activation, the parts of HF products carrying HF current must have a safe distance of at least 10 mm from other conductive parts.

Fig. 10

CAUTION Wrong selection of HF output power! Injuries to the patient as well as damage to the product are possible. The power setting must be carried out based on the experience/training of the surgeon with regard to the current indication. To determine the optimum power setting we recommend starting at a low power setting.

8.6

Laser application For laser applications, the same notes and instructions apply as under section 8.4.2 Additional notes and instructions on laser lithotripsy.

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