Cysto-urethroscope small children and infants 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

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.

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 information ...

4

1.1

Safety instructions and levels of danger...

4

1.2

Symbols...

4

2

General safety instructions and guidance for use ...

6

3

Product description...

7

4

Intended use... 10

5

Indications ... 11

6

Contraindications and side effects ... 11

6.1

Contraindications... 11

6.2

Side effects... 11

7

Combinations ... 12

7.1

Overview of permissible combinations and requirements ... 12

8

Illustration ... 13

9

Checks... 15

9.1

Visual checks ... 15

9.2

Function check ... 16

9.3

Service life ... 16

10

Use ... 17

10.1 10.1.1 10.1.2 10.1.3 10.1.4

Preparation / Commissioning ... 17 Inserting the obturator ... 18 Inserting the obturator into the sheath with automatic lock ... 19 Inserting the endoscope ... 20 Inserting the adapter / insert... 21

10.2 10.2.1 10.2.2 10.2.3 10.2.4

General notes and instructions for use... 22 Power ... 22 HF application ... 23 Laser application ... 24 Inserting auxiliary instruments ... 25

11

Reprocessing and maintenance ... 26

11.1

Reprocessing sequence – Adapter ... 29

11.2

Reprocessing sequence – Working insert ... 34

11.3

Reprocessing sequence – Obturator ... 41

11.4

Reprocessing sequence – Sheath... 44

12

Technical description... 49

12.1

Use, storage, transport, and shipping conditions ... 49

13

Spare parts ... 50

13.1

Spare parts ... 50

14

Disposal... 52

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1

General information

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.

1.2

Symbols

Symbols

Designation Follow the manual Medical device Product number Serial Number Lot code Manufacturer Manufacturing date Number, amount

Data Matrix Code

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Symbols

Designation CE identification with code number of the competent authority in conformity with Directive 93/42/ EEC on medical products or EU regulation 2017/745 on medical products. Only valid if the product and/or the packaging is marked with this identification. Products where a notified body is not involved in the conformity assessment procedure are marked with the CE-identification without the code number of the notified body. The CE identification on the title page of these instructions for use relates exclusively to the Richard Wolf main product or, if serveal 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. Do not reuse! Do not resterilize Expiry date Sterilized with ethylene oxide Do not use if package is damaged Keep away from sunlight!

Store in a dry place!

Temperature, limitation

Humidity, limitation

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General safety instructions and guidance 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 products 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. 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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Product description These instructions for use describe the cysto-urethroscope for Ø 1.9 mm and Ø 2.7 mm telescopes with corresponding additional instruments and accessories. Different adapters and are available for the cysto-urethroscope.

Fig. 1 SHEATH FOR CYSTOSCOPE 8686.0145 SHEATH FOR CYSTOSCOPE 7.5 FR. Color code blue, SL 146 mm, round, distal end oblique, compatible with telescopes Ø 1.9 mm, 0°, with 2 irrigation valves, quick-release mechanism, reusable 8686.0245 SHEATH FOR CYSTOSCOPE 8.5 FR. Color code red, SL 145 mm, round, distal end oblique, compatible with telescopes Ø 1.9 mm, with 2 irrigation valves and 1 instrument port, quick-release mechanism, reusable 8686.0345 SHEATH FOR CYSTOSCOPE 9.5 FR. Color code yellow, SL 145 mm, round, distal end oblique, compatible with telescopes Ø 1.9 mm, with 2 irrigation valves and 1 instrument port, quick-release mechanism, reusable 8672.0145 SHEATH FOR CYSTOSCOPE 11 FR. Color code red, SL 149 mm, round, distal end oblique, compatible with telescopes Ø 2.7 mm, with 2 irrigation valves, bayonet lock, reusable 8672.0245 SHEATH FOR CYSTOSCOPE 12 FR. Color code green, SL 150 mm, round, distal end oblique, compatible with telescopes Ø 2.7 mm, with 2 irrigation valves and 1 instrument port, bayonet lock, reusable

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8672.0345 SHEATH FOR CYSTOSCOPE 13 FR. Color code blue, SL 149 mm, round, distal end oblique, compatible with telescopes Ø 2.7 mm, with 2 irrigation valves and 2 instrument ports, quick-release mechanism, reusable 8672.0445 SHEATH FOR CYSTOSCOPE 14 FR. Color code white, SL 119 mm, oval, distal end oblique, compatible with telescopes Ø 2.7 mm, with 2 irrigation valves, quick-release mechanism, reusable ADAPTER FOR CYSTOSCOPE 8672.264 ADAPTER FOR CYSTOSCOPE TL 55 mm, compatible with sheath 86720445, compatible with telescopes Ø 2.7 mm, 0°/30°/70°, with instrument port, bayonet lock, reusable WORKING INSERT FOR CYSTOSCOPE 8672.214 WORKING INSERT FOR CYSTOSCOPE 0/30/70 With Albarran deflector, compatible with sheath 86720445, compatible with telescopes Ø 2.7 mm, 0°/30°/70°, with instrument port, bayonet lock, reusable 8672.224 WORKING INSERT FOR CYSTOSCOPE 0/30/70 SL 132 mm, with Albarran deflector, compatible with sheath 86720445, compatible with telescopes Ø 2.7 mm, 0°/30°/70°, with 2 instrument ports, bayonet lock, reusable OBTURATOR FOR CYSTOSCOPE 8686.0147 OBTURATOR FOR CYSTOSCOPE 7.5 FR. Color code blue, SL 183 mm, round, distal end rounded, compatible with sheath 86860145, reusable 8686.0247 OBTURATOR FOR CYSTOSCOPE 8.5 FR. Color code red, WL 180 mm, round, distal end rounded, compatible with sheath 86860245, reusable 8686.0347 OBTURATOR FOR CYSTOSCOPE 9.5 FR. Color code yellow, WL 180 mm, round, distal end rounded, compatible with sheath 86860345, reusable 8672.0147 OBTURATOR FOR CYSTOSCOPE 11 FR. Color code red, WL 184 mm, round, distal end rounded, compatible with sheath 86720145, reusable

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8672.0247 OBTURATOR FOR CYSTOSCOPE 12 FR. Color code green, WL 184 mm, round, distal end rounded, compatible with sheath 86720245, reusable 8672.0347 OBTURATOR FOR CYSTOSCOPE 13 FR. Color code blue, WL 184 mm, round, distal end rounded, compatible with sheath 86720345, reusable 8672.0447 OBTURATOR FOR CYSTOSCOPE 14 FR. Color code white, WL 137 mm, oval, distal end rounded, compatible with sheath 86720445, reusable

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Intended use Cystoscope sheaths 8686.0145

SHEATH FOR CYSTOSCOPE 7.5 FR.

8686.0245

SHEATH FOR CYSTOSCOPE 8.5 FR.

8686.0345

SHEATH FOR CYSTOSCOPE 9.5 FR.

8672.0145

SHEATH FOR CYSTOSCOPE 11 FR.

8672.0245

SHEATH FOR CYSTOSCOPE 12 FR.

8672.0345

SHEATH FOR CYSTOSCOPE 13 FR.

8672.0445

SHEATH FOR CYSTOSCOPE 14 FR.

The products are used for access to the operating field and the supply and drainage of irrigation fluids. Cystoscope adapters 8672.264

ADAPTER FOR CYSTOSCOPE

The products are used for connecting sheaths to telescopes and for inserting auxiliary instruments. Cystoscope working inserts 8672.224

WORKING INSERT FOR CYSTOSCOPE 0/30/70

8672.214

WORKING INSERT FOR CYSTOSCOPE 0/30/70

The products are used for inserting auxiliary instruments and a telescope into the sheath. Cystoscope obturators 8686.0147

OBTURATOR FOR CYSTOSCOPE 7.5 FR.

8686.0247

OBTURATOR FOR CYSTOSCOPE 8.5 FR.

8686.0347

OBTURATOR FOR CYSTOSCOPE 9.5 FR.

8672.0147

OBTURATOR FOR CYSTOSCOPE 11 FR.

8672.0247

OBTURATOR FOR CYSTOSCOPE 12 FR.

8672.0347

OBTURATOR FOR CYSTOSCOPE 13 FR.

8672.0447

OBTURATOR FOR CYSTOSCOPE 14 FR.

The products are used for atraumatic introduction of sheaths. User The product is exclusively intended for use by specialized medical personnel and may only be used by medically qualified and adequately trained persons.

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Indications The products are used in lower urinary tract urology for the following indications: n n

Diagnostic cystoscopy Therapeutic cystoscopy including tumor removal in the bladder, foreign body removal, and lithotripsy in the bladder, for example

Patient group The use of the products is limited to patients with small anatomies. There is no restriction regarding ethnicity, gender, or body weight. Before use, the attending physician must make sure that the product in view of its dimensions or settings can be used safely in the patient.

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Contraindications and side effects

6.1

Contraindications There are currently no known contraindications in urology directly related to the products. If there are medical contraindications for the interventions listed, use with the products concerned is excluded.

6.2

Side effects When used as intended, there are no known side effects directly related to the products.

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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.

7.1

Overview of permissible combinations and requirements The products are used with: n n n n n n

12

Endoscopic cameras and light sources Endoscopic devices Suction and irrigation pumps Endoscopic instruments and accessories HF surgical generators Lithotripsy devices

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Illustration

For diagnostics

Single

Double Single

Double Automatic lock

Fig. 2 Removable stopcocks Contrary to the illustrations in the instructions for use, the stopcocks can now be removed. The following figure shows the products with the removable stopcocks.

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Fig. 3 Legend and labeling A Endoscope B Sheath with color coding C Obturator with color coding D Adapter E Insert with Albarran deflector Item

Designation

Item

Designation

1

Distal sheath tip

6.1

Stopcock insert

1a

Beveled

6.2

Stopcock housing

1b

With window

6.3

Luer connector

2

Inlet tap

6.4

Capacity indicator stopcock housing and stopcock insert

2.1

Stopcock insert

7

Rubber cap

2.2

Stopcock housing

8

Automatic lock

2.3

Luer connector

9

Tab with color coding

2.4

Capacity indicator stopcock housing and stopcock insert

10

Albarran deflector

3

Outlet tap

11

Drive wheels

4

Clamping handle with color coding

12

Product no.

5

Locking mechanism

13

Specification: Capacity (Fr.)

6

Instrument port

14

Specification: Diameter (Fr.)

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Checks WARNING Loss of sterility! In the case of a damaged sterile barrier system or if the date of expiry is exceeded, product sterility is no longer guaranteed. Unsterile products can cause infections. Open the sterile barrier system only directly before using the sterile product.

WARNING Injuries by damaged or incomplete products! Injuries of the patient, user and others are possible. n Do not use the products if they are damaged, incomplete or have loose parts. n Run through the checks before and after each use.

ATTENTION Send in damaged or incomplete products together with any loose parts for repair. Repair only by authorized experts.

9.1

Visual checks ¯ Check products and accessories for: ð Damage ð Sharp edges ð Loose or missing parts ð Raw surfaces Any inscription, lettering, or labeling necessary for the safe and intended use must be legible.

Fig. 4

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9.2

Function check 1. Check the compatibility of the individual components. 2. Check that the individual connections are fitted securely. 3. Check the easy mounting of the individual components. Replace products if the connection does not hold or is difficult to assemble or screw. 4. Check image quality. 5. Check the angular position of the Albarran deflector (10), see Fig. 5. ð The Albarran deflector (10) is angled by turning the drive wheels (11). 6. Check the entire system for leaks and continuity. 7. Check the irrigation and suction function.

Fig. 5

9.3

Service life ATTENTION For the service life of the products, careful and gentle handling during use and during the entire reprocessing process is essential 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 described checks are not passed, the medical product must be replaced or returned for repair (by the OEM or a repair facility authorized by the OEM) if necessary.

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Use WARNING The products have only limited strength! Exerting excessive force will cause damage, impair the function, and therefore endanger 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! Run through visual checks before and after each use. Do not use damaged products.

WARNING Only use the product under visual control and, if necessary, under X-ray control, or bring it to the surgical site.

10.1

Preparation / Commissioning 1. Check assembly 2. Perform a visual check: Section 9.1 Visual checks 3. Put on the rubber caps (7).

Fig. 6

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10.1.1

Inserting the obturator CAUTION Do not insert the sheath without the obturator! This may result in unintentional tissue damage. Only insert the sheath atraumatically with the obturator in place. In medically indicated cases, the sheath can also be inserted under endoscopic control. 1. Turn the clamping handle (4) to position "I". 2. Insert the obturator (C) into the sheath (B). ð The nose (a) engages in the groove (b). 3. Turn the clamping handle (4) to position "II". ð Both components are locked together.

Fig. 7

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10.1.2

Inserting the obturator into the sheath with automatic lock ¯ Insert the obturator (C) into the sheath (B) so that the groove (c) and pin (d) are in the same plane, and push together until the connection automatically engages.

Fig. 8

NOTE If the connection does not lock automatically, press the tab (9) as far as it will go and repeat the process, see Fig. 8.

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10.1.3

Inserting the endoscope NOTE Insertion of the endoscope (A) is explained using the adapter (D). The endoscope (A) is inserted into the sheath (B) and the insert (E) using the same procedure. 1. Turn the clamping handle (4) to position "I". 2. Insert the endoscope (A) into the adapter (D). ð The nose (e) engages in the groove (f). 3. Turn the clamping handle (4) to position "II". ð Both components are locked together.

Fig. 9

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