Aspiration and Injection Instrument set 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 written permission of Richard Wolf GmbH. Copyright © RICHARD WOLF GmbH

Subject to technical changes! Due to the constant further development of the products, descriptions, illustrations and technical data may deviate from the current state. For further information about our products please contact Richard Wolf GmbH or our representa­ tives.

Manufacturer RICHARD WOLF GmbH Pforzheimerstr. 32 75438 Knittlingen DEUTSCHLAND Phone: +49 70 43 35-0 Fax: +49 70 43 35-4300 www.richard-wolf.com

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Contents 1 1.1 1.2

General information... Structure of safety instructions... Symbol...

4 4 4

2

General safety instructions and guidance for use...

6

3

Product description...

7

4

Intended purpose...

7

5

Indications...

8

6 6.1 6.2

Contraindications and side effects... Contraindications... Side effects...

8 8 8

7 7.1

Combinations... Overview of permissible combinations and corresponding requirements...

8 8

8

Illustration...

9

9 9.1 9.2 9.3

Checks... Visual check... Function check... Service life...

10 10 11 11

10 10.1 10.1.1 10.1.2 10.1.3

12 13 13 14

10.1.4 10.2 10.2.1 10.2.2 10.2.3 10.2.4

Use... Preparation / Setup... Inserting endoscope in working element... Inserting working element (3) in urethro-cystoscope sheath (2)... Inserting cannula with proximal extension (4a) /semirigid cannula (4b) in working element (3)... Installing the instrument port... Additional guidance for use... Electricity... Irrigation / suction... HF applications... Laser application...

11 11.1

Reprocessing and maintenance... 19 Reprocessing sequence - Adapter element... 22

12 12.1

Technical description... 26 Operating, storage, transport and shipping conditions... 26

13

Spare parts... 26

14

Disposal... 26

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14 15 16 16 16 17 17

3

1

General information

1.1

Structure of safety instructions WARNING! This signal word is used to indicate a potentially dangerous situa­ tion. Not avoiding this situation can result in death or extremely serious injuries. CAUTION! This signal word is used to indicate a potentially dangerous situa­ tion. Not avoiding this situation can result in minor or limited in­ juries. CAUTION! This signal word without warning sign is used to indicate the po­ tential danger of material damage. NOTE: This signal word refers to additional information useful for the reader as well as easier operation and cross-references.

1.2

Symbol Symbol

Designation Follow the instructionsfor use

MD

Medical device

REF

Item number

SN

Serial numbmer

LOT

Lot code Manufacturer

Manufacturing date Number, amount Datamatrix Code CE identification in conformity with Directive 93/42/EEC on medical products or EU regulation 2017/745 on medical products. Is only valid if the product and/or the packaging is marked with this identification. Products as of category IIa, sterile products and products of class I, products with measuring function of class I, as well as reusable surgical instruments are additionally marked with the four-digit code number of the competent authority. The CE identification on the title page of these instructions for use relates exclusively to the Richard Wolf main product or, if serveral identical products are described, to the Richard Wolf product with the highest classification.The CE identification of the other Richard Wolf products and, if applicable, of products made by other manufacturers, described in these instructions for use results exclusively from the identification on the product and/or packaging.

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Do not reuse!

Do not resterilize

Use by

STERILE EO Sterilized with ethylene oxide Do not use if packaging is damaged

Keep away from sunlight Store in a dry place XX° XX° XX% XX%

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Temperature limitation

Humidity limitation

5

2

General safety instructions and guidance for use

The product must only be used as intended and in accordance with the instruc­ tions for use by adequately trained and qualified medical expertsMaintenance and repair must only 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. Other combinations, accessories and wear and tear parts may only be used if these are explicitly designated for the intended use and do not impair the performance criteria or safety require­ ments.Do not alter the product. Reprocess the products in accordance with the manual before every use and be­ fore return shipment to protect the patient, user and third parties. These instructions for use are an integral part of the product and must be stored in such a way that they are accessible at any time during the product's entire life cycle. This manual must be passed on to any subsequent owner or user. Immediately upon receipt,check the product with the accessories for complete­ ness and possible damage. Please inform the manufacturer or supplier immedi­ ately should the shipment give rise to complaints Any severe incident occurring in conjunction with this product must be reported to the manufacturer and the competent authority of the country where the user and/ or patient resides.

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3

Product description

4

Intended purpose

These instructions for use describe cystoscope working inserts for aspiration and injection in conjunction with a dia. 4mm telescope and further pertaining instru­ ments and accessories. The instrument set is suitable for inserting flexible auxiliary instruments and can­ nulas via the transurethral passage into the lower urinary tract.

Cystoscope working inserts for aspiration and injection 8652.781

WORKING ELEMENT FOR CYSTOSCOPE 30

The products serve to insert auxiliary instruments and cannulas as well as a tele­ scope into the sheath. Cystoscope insertion stopcock 8652.788

INSTRUMENT PORT 4FR

The products serve to insert flexible auxiliary instruments. Rubber caps 88.01

RUBBER CAP, CAPACITY 0.8MM

88.005

RUBBER CAP, CAPACITY 0.5MM

The products serve to seal working channels, suction channel and irrigation chan­ nels thus preventing uncontrolled spillage of liquides or gasses. User This product is exclusively intended for use by specialized medical experts and may only be used by medically qualified or adequately trained persons.

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5

Indications The products are used in urology in the lower urinary tract for the following indica­ tions: Therapeutic cystoscopy Incontinence therapy Reflux therapy Patient group There is no limitation for the intended patient group with regard to ethnicity, age, sex, body size or weight. Before use, the attending physician must make sure that in view of its dimensions or settings the product can be used safely in the patient.

6

Contraindications and side effects

6.1

Contraindications In urology contraindications directly related to the products are are presently not known. If there are medical contraindications for the aforementioned interven­ tions, any use of the products concerned is excluded.

6.2

Side effects

7

Combinations

Side effects directly related to the products are are not known if the products are used as intended.

CAUTION! Do not combine the products incorrectly! Danger of injury due to wrong combination of products or possible damage to the products. Follow the instructions for use of the products used in combination with these products. Different products should only be used jointly if their intended purpose and rele­ vant technical data (working length, diameter, peak voltage, etc.) are the same. Follow the instructions for use of the products used in combination with these products. In addition the instructions for use for the urethro-cystoscope sheaths (order no.: GA-D321) and endoscopes (order no.: GA-S001) must be observed.

7.1

Overview of permissible combinations and corresponding requirements The instrument set is used in conjunction with flexible light cables and light sources, video cameras and objective lenses as well as endoscopic accessories such as grasping forceps, syringes, cannulas). Via instrument port 8652.788, de­ pending on the indication, flexible auxiliary instruments up to 4 FR can be in­ serted.

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Illustration

# 1

2

3.4

# 3.1

3.3

3.6 3.5

3.7 3.8

3

3.9

#

3.10

3.2 4.2 4.3 4.4

4.6

4.5

4a

4.1

#

4.5 4.6

4b 5.1 5.2 5.3

4.2 4.3

#

5.4

5

5.5 Legend and identification Item

Designation

Item

1

PANOVIEW-PLUS Endoscope

4b

Semi-rigid cannula

2

Urethro-cystoscope sheath with obturator

4.1

Cannula tip

3

Working element

4.2

Guide nose

3.1

Telescope guide tube

4.3

O-ring

3.2

Cannula guide tube

4.4

Adapter element

3.3

Locking cone

4.5

Locking collar

3.4

Handle

4.6

Luer connector

3.5

Lock body

5

Instrument port

3.6

Spring

5.1

Guide nose

3.7

Clamping toggle

5.2

O-ring

3.8

Clamping mechanism

5.3

Locking collar

3.9

Cannula port

5.4

Rubber cap, red

3.10

Thumb ring

5.5

Stopcock

4a

Flexible cannula with proximal extension

#

Product no.

GA-D322

Designation

9

9

Checks WARNING! Loss of sterility! In case of a damaged sterile barrier system the sterility of the product is no longer guaranteed. Unsterile products can cause infections. Do not open the sterile barrier system until immediately before using the sterile product. WARNING! Injuries due to damaged or incomplete products! Do not use the products if they are damaged, incomplete or have loose parts. Run through the checks before and after each use. CAUTION! Send in damaged or inomplete products together with any loose parts for repair. Repair only by authorized specialized personnel. CAUTION! Be careful if products are damaged or incomplete! Injuries of the patient, user and others are possible. Run through the checks before and after each use. Do not use products that are damaged and incomplete or have loose parts. Return damaged products together with any loose parts for repair. Do not attempt to do any repairs yourself.

9.1

Visual check

o.k.

Fig. 8

10

defective (blunt/bent)

Check instruments and accessories for damage, sharp edges, loose or missing parts and rough surfaces. Check rubber cap (5.4) and O-rings (4.3)/(5.2) for damage and replace if necessary. Do not use damaged or kinked cannulas. Replace. Inscriptions and identifications necessary for the safe and intended use must be legible. Any missing or illegible lettering or identification leading to wrong handling an reprocessing must be reinstated..

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9.2

Function check

9.3

Service life

Check the individual products for easy assembly and proper functioning of the locking mechanisms. Replace the instruments if the connection although locked is not secure. Replace the instruments if the connection cannot be locked or is difficult to lock. Check the cannulas for patency using a sterile irrigation solution. Check the irrigation and suction flow. Check the image quality.

CAUTION! For the service life of the products, careful and gentle handling during use and during the entire reprocessing process is essential. Eine Limitierung der Lebensdauer der Medizinprodukte ist bei bestimmungs­ gemäßer Verwendung und unter Beachtung der Angaben in der Gebrauchsan­ weisung des Herstellers nicht erforderlich. When used as intended and following the instructions in the manufacturer's instructions for use, it is not necessary to limit the service life of the medical products. If one or several criteria of the checks described below are not met, the medical product must be replaced or returned for repair (by the original manufacturer or repair facility authorized by the original manufacturer) if necessary.

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10

Use WARNING! The products have only limited strength! Applying excessive force will cause damage, impair the function and thus endan­ ger the patient. Do not use the products if they are damaged or incomplete or have loose parts. WARNING! Make sure that no missing parts remain in the patient! Immediately before and after each use, check the products for damage, loose parts and completeness. CAUTION! The products have only limited strength! Carry out a visual check before and after every use. Do not use damaged prod­ ucts. WARNING! Introduce the product only under visual control and x-ray control if necessary and approach the operating area in the same way. CAUTION! Due to their flexibility and dimensions the cannulas have only a limited service life. Stop using the cannulas and replace after max. 10 uses. NOTE! We recommend always having two cannulas ready to allow trouble-free surgery.

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10.1

Preparation / Setup Install the rubber cap (5.4) (Fig. 1). Perform a visual check (Sections 9 and 9.1)

5.4

Fig. 1 10.1.1

Inserting endoscope in working element Clamping toggle (3.7) in in position “I". Insert the endoscope (1) into the working element (3). The nose (a) engages in the groove (b). Turn clamping toggle (3.7) to position “II". The two instrument are locked together.

3

1

II I 3.7

a

B

Fig. 2

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10.1.2

Inserting working element (3) in urethro-cystoscope sheath (2) Insert the working element (3) in the urethro-cystoscope sheath (2) in such a way that the groove (c) and the pin (d) are aligned, and push together until the connection engages automatically. (Fig. 3)

NOTE! If the connection won't lock automatically, push the tab (2.1) as far as it will go and repeat the procedure. Unlocking (Fig. 3a): Push tab (2.1) and remove working element (3).

c d

2.1 2.1 2

3

Fig. 3a

Fig. 3 10.1.3

Inserting cannula with proximal extension (4a) /semirigid cannula (4b) in working element (3)

NOTE! During insertion the sheath tube of the cannulas (4a/4b) is slightly bent. Be sure not to kink the sheath tube during insertion. Insert cannula (4a/4b) in the cannula port (3.9). The guide nose (4.2) must engage in groove (a) (Fig. 4a). Screw on the locking collar (4.5) as far as it will go (Fig. 4b). The connection is locked (secured).

3.9 a

Fig. 4

14

4.2

Fig. 4a

4.5

fig. 4b

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10.1.4

Installing the instrument port Same procedure as described in Section 10.1.3 “Inserting flexible cannula with proximal extension (4a)/semi-rigid cannula (4b)" and Fig. 5.

1

2

Fig. 5 Connect the supply units (light, supply line, drain line, video camera) Carry out a function check (see section 9.2).

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10.2

Additional guidance for use

The inserted cannulas can be rotated in steps of 90 degrees without changing the position of the working element (3). For this purpose: Release the locking collar (4.5) by pulling and turn to the next snap-in position (cw or ccw).Fig. 6

2. 90

Fig. 6

10.2.1

90

90

90 4.5

1.

Electricity

WARNING! Danger of electric shock! Patient leakage currents can add up if the endoscope is operated with powered endoscopic accessories or combined with other electrically energized products. Make sure that the combinations do not exceed the permissible patient leakage currents. Before use check the combination for leakage currents. 10.2.2

Irrigation / suction

CAUTION! Due to the different anatomical conditions it is not possible to quantify the irriga­ tion and suction performance. The user must adapt these parameters to the pre­ vailing conditions.

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10.2.3

HF applications

WARNING! Activate the HF instruments only, if the instruments are visible through the scope and tissue contact is made. CAUTION!

2

5 mm Fig. 7

Danger of HF arcing! Insufficient distance between parts carrying high-frequency current and other conductive parts can lead to unintended tissue and instrument damage. In the home position of the working element (3), parts of HF instruments carrying high-frequency current must project at least 5 mm from the sheath (2) to guaran­ tee the necessary safety distance. In the case of unintended HF arcing: replace the HF instrument immediately, check the instument set for damage and return for repair if necessary to avoid consequential damage. NOTE! Follow the "Notes and instructions on HF applications" (GA-S 002), as well as the HF device manufacturer's instructions.

For the performance specifications of the HF instruments in the cutting or coagu­ lation mode please refer to the corresponding instructions for use. 10.2.4

Laser application

CAUTION! Laser applications! Do not direct the laser beam at instrument parts, in particular not at plastic parts. The heat generated by the laser beam can impair the strength of instrument parts. Keep a safe distance. The notes and instructions of the laser device manufacturer and the general reg­ ulations on the use of lasers must be observed. CAUTION! Laser applications may cause eye hazards! When using lasers a suitable filter attachment at the endoscope eyepiece and suitabe personal protection gear must be used. CAUTION! Laser applications can cause a hazard of inadvertent damage to the tissue, to the distal end of the endoscope and to instrument parts! Activate the laser only after the tip of the laser fiber has become visible through the scope and is directed at the tissue to be treated. Follow the notes and instructions of the laser device manufacturer and the gen­ eral regulations on laser applications. WARNING! Danger of eye damage when using lasers without filter attachment. Use a suit­ able filter attachment on the eyepiece of the panoview telescope. WARNING! Do not work outside the scope's field of view! Inadvertent tissue damage as well as damage to the distal end of the Panaview telescope and instrument parts are possible.Activate the laser only when the tip of the laser fiber is fully visible through the Panaview telescope and the pilot beam is aiming at the intended application area. Observe the notes and instructions of the laser device manufacturers and the general regulations on the use of lasers.

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WARNING! Laser application! Activate the laser beam only if the tissue to be destroyed has been positively identified and lies in the field of view. CAUTION! High temperatures due to highly coherent laser beam! The heat generated by the laser beam reduces the strength of instrument parts. Do not direct the laser beam at instrument parts, in particular not at plastic parts. Keep a safe distance.

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Reprocessing and maintenance WARNING! Danger of infection! The products and the accessories are delivered in unsterile condition. The use of unsterile products represents an infection hazard for patients, users and third parties. Reprocess the products at least once before their first use and then before every further use. The user is obliged to make sure that the reprocessing process including the re­ sources, material and personnel are suitable for achieving the required results. WARNING! Danger of infection! Clean, disinfect and sterilize the products before each return shipment as de­ scribed in the reprocessing instructions of the instructions for use to protect the users and third parties. WARNING! Danger of transmitting microorganisms! To protect the service staff please only send in products for repair that have been reprocessed in accordance with the state of the art in hygiene. Follow the instructions for use CAUTION! Damage to the products due to the use of non-authorized reprocessing proce­ dures. CAUTION! Use only cleaning agents and disinfectants whose efficacy and material com­ patibility with endoscopes and endoscopic accessories have been verified and approved by the chemicals manufacturer. Example of suitable active agents for chemical disinfection: ­ Ortho­phthalaldehyde ­ Ethandial, didecyldimethylammonium chloride ­ Formacedal, glutardialdehyde ­ Sodium carbonate peroxyhydrate Disinfectants fulfilling the test criteria of the VAH (Association for applied hygiene), FDA or other national certification bodies can also be used. Do not use disinfectants containing peracetic acid without corrosion pro­ tection, phenols or chlorine components for the reprocessing of RICHARD WOLF products. NOTE! New products from the factory Before reprocessing remove all protection foils and shipping locks or clips from the products and the accessories. NOTE! For a list of reprocessing chemicals approved by Richard Wolf in terms of material compatibility with RIchard Wolf products, please see document GA-J055. This doc­ ument can be requested from Richard Wolf or downloaded from our website. RICHARD WOLF on the Internet www.richard­wolf.com/en/solutions/processing

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NOTE! Please observe the following when cleaning the products: Products with long channels: Pull through the cleaning brush. Insert the cleaning brush into the channel with the brushless side first and pull out the brush on the other side of the channel. Other products/parts: Use a brush pass Move the cleaning brush forwards and backwards once. Example:

1 x pull through

1 brush pass

Required materials Illustration

Product no. Designation, Technical data

68603

BASIN (WXHXD) 548X100X348MM

DISINFECTION BASIN W 400MM L 600MM 509.81

68601

not steam-sterilizable, Outside dimensions: 600 x 400 x 140 mm Inside dimensions: 548 x 348 x 100 mm

BASIN (WXHXD) 432X100X150MM DISINFECTION BASIN W 200MM L 552MM

6860.901

not steam-sterilizable, Outside dimensions: 552 x 200 x 165 mm Inside dimensions: 432 x 150 x 100 mm

CLEANING BRUSH Ø 3MM TL 400MM 7970403

for Ø 1.6-2.5 mm channels, brush length 30 mm, PACK = 10 PCS, color: red, for single use

CLEANING BRUSH Ø 5MM TL 400MM 7970405

86.90

for Ø 3.6-4.5 mm channels, brush length 48 mm, PACK = 10 PCS, color: green, for single use

CLEANING BRUSH

for cleaning surfaces, angled, reusable

CLEANING BRUSH 8691

20

for cleaning surfaces, straight, PACK = 10 PCS, for single use

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