Richard Wolf

Rigid Uretero-Renoscopes Instructions for Use

50 Pages

Instructions for use Fiber Ureterorenoscopes/ Continuous Irrigation Ureterorenoscopes GA-D352 / en / EU / V1.0 / 2022-01 / PK22-0356

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File Name: Richard Wolf - GA-D352 - Rigid Uretero-Renoscopes Instructions for Use - 2022-01 - V1.0.pdf

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Instructions for use

Fiber Ureterorenoscopes/ Continuous Irrigation Ureterorenoscopes

GA-D352 / en / EU / V1.0 / 2022-01 / PK22-0356

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.

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

GA-D352

Contents 1

General information ...

1.1

Safety instructions and levels of danger...

1.2

Symbols...

1.3

Explanation of acronyms used ...

General safety instructions and guidance for use ...

Product description...

Intended use... 12

Indications ... 14

Contraindications and side effects ... 15

6.1

Contraindications... 15

6.2

Side effects... 15

Combinations ... 15

7.1

Overview of permissible combinations and requirements ... 15

Illustration ... 16

8.1

E-Line fiber ureterorenoscopes with automatic valve... 16

8.2

E-Line fiber ureterorenoscopes with straight eyepiece ... 18

8.3

Removable stopcocks ... 19

Checks... 20

9.1

Visual check ... 20

9.2 9.2.1 9.2.2

Function check ... 21 Ureterorenoscope... 21 Stopcock plug ... 22

9.3

Service life ... 22

Application ... 23

10.1 10.1.1 10.1.2 10.1.3 10.1.4

Preparation / Commissioning ... 24 Preparing the fiber ureterorenoscope... 24 Connecting the fiber ureterorenoscope to system components ... 25 Assembling handle 8702.261 for E-Line fiber ureterorenoscopes (optional) ... 26 Assembling the guide element ... 27

10.2 10.2.1 10.2.2 10.2.3 10.2.4 10.2.5 10.2.6 10.2.7 10.2.8

General notes and instructions for use... 28 Light... 28 Power ... 29 Image quality ... 29 Irrigation fluid ... 29 Inserting auxiliary instruments ... 29 Lithotripsy application ... 31 HF application ... 33 Laser application ... 34

Reprocessing and maintenance ... 35

11.1 11.1.1 11.1.2 11.1.3 11.1.4 11.1.5

Reprocessing sequence – fiber ureterorenoscope ... 39 Machine reprocessing ... 41 Manual reprocessing ... 44 Checks and maintenance ... 45 Packaging... 46 Sterilization ... 47

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11.1.6 11.1.7

Storage ... 47 Validation... 47

Technical description... 48

12.1

Technical data ... 48

12.2

Use, storage, transport, and shipping conditions ... 48

Spare parts ... 49

Disposal of product, packaging material and accessories ... 50

GA-D352

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

Designation Follow the manual Medical device Product number Serial Number Lot code Manufacturer Manufacturing date Do not reuse! Do not resterilize Number, amount

GA-D352

Symbols

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

Temperature, limitation

Humidity, limitation

Single-use sterile barrier system (sterilized with ethylene oxide)

Data Matrix Code

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.

1.3

Explanation of acronyms used

Acronym W/D

Description Washer-disinfector device

GA-D352

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.

Product description The fiber ureterorenoscope is available in three versions with a straight, laterally offset, or lateral eyepiece. The instruments are equipped with an atraumatically shaped tip, a fiber image guide, an oval irrigation and probe channel, and an automatic valve. The continuous irrigation ureterorenoscope is available in two versions with a straight and a lateral eyepiece. Both instrument versions are equipped with an atraumatically shaped tip, a fiber image guide, and two channels that enable the continuous irrigation function. The handle makes the semi-rigid ureterorenoscopes easy to handle, while the guide elements are used to mount the LithoClast handpiece and US transducer. The universal sealing valve can be used as an option for introducing auxiliary instruments through the working channel.

Fiber ureterorenoscope 8701517 URETERORENOSCOPE 5° 4.5/6.5 FR, WL 330 MM semi-rigid, with straight eyepiece, working channel 3 Fr., atraumatically shaped tip, TL 465mm, fiber image guide 8701518 URETERORENOSCOPE 5° 4.5/6.5 FR, WL 430 MM semi-rigid, with straight eyepiece, working channel 3 Fr., atraumatically shaped tip, TL 565mm, fiber image guide

GA-D352

8701.533 URETERORENOSCOPE 5° 4.5/6.5 FR, WL 315 MM semi-rigid, with lateral eyepiece, working channel 3 Fr., atraumatically shaped tip, TL 440 mm, fiber image guide 8701.534 URETERORENOSCOPE 5° 4.5/6.5 FR, WL 430 MM semi-rigid, with lateral eyepiece, working channel 3 Fr., atraumatically shaped tip, TL 555mm, fiber image guide 8702.513 URETERORENOSCOPE 5° 6/7.5 FR, WL 330 MM semi-rigid, with straight eyepiece, working channel 1x4 (2x2.2) Fr., atraumatically shaped tip, TL 458 mm, fiber image guide 8702.514 URETERORENOSCOPE 5° 6/7.5 FR, WL 430 MM semi-rigid, with straight eyepiece, working channel 1x4 (2x2.2) Fr., atraumatically shaped tip, TL 558mm, fiber image guide 8702.523 URETERORENOSCOPE 5° 6/7.5 FR, WL 315 MM semi-rigid, with laterally offset eyepiece, working channel 1x4 (2x2.2) Fr., atraumatically shaped tip, TL 484mm, fiber image guide 8702.524 URETERORENOSCOPE 5° 6/7.5 FR, WL 430 MM semi-rigid, with laterally offset eyepiece, working channel 1x4 (2x2.2) Fr., atraumatically shaped tip, TL 599mm, fiber image guide 8702.533 URETERORENOSCOPE 5° 6/7.5 FR, WL 315 MM semi-rigid, with lateral eyepiece, working channel 1x4 (2x2.2) Fr., atraumatically shaped tip, TL 448mm, fiber image guide 8702.534 URETERORENOSCOPE 5° 6/7.5 FR, WL 430 MM semi-rigid, with lateral eyepiece, working channel 1x4 (2x2.2) Fr., atraumatically shaped tip, TL 563mm, fiber image guide

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8703.514 URETERORENOSCOPE 12° 8/9.8 FR, WL 430 MM semi-rigid, with straight eyepiece, working channel 1x5 (2x3) Fr., atraumatically shaped tip, TL 558 mm, fiber image guide 8703.523 URETERORENOSCOPE 12° 8/9.8 FR, WL 315 MM semi-rigid, with laterally offset eyepiece, working channel 1x5 (2x3) Fr., atraumatically shaped tip, TL 484mm, fiber image guide 8703.524 URETERORENOSCOPE 12° 8/9.8 FR, WL 430 MM semi-rigid, with laterally offset eyepiece, working channel 1x5 (2x3) Fr., atraumatically shaped tip, TL 599mm, fiber image guide 8703.533 URETERORENOSCOPE 12° 8/9.8 FR, WL 315 MM semi-rigid, with lateral eyepiece, working channel 1x5 (2x3) Fr., atraumatically shaped tip, TL 448mm, fiber image guide 8703.534 URETERORENOSCOPE 12° 8/9.8 FR, WL 430 MM semi-rigid, with lateral eyepiece, working channel 1x5 (2x3) Fr., atraumatically shaped tip, TL 563mm, fiber image guide 8704.523 URETERORENOSCOPE 12° 8.5/11.5 FR, WL 315 MM semi-rigid, with laterally offset eyepiece, working channel 1x6 (2x4) Fr., atraumatically shaped tip, TL 484mm, fiber image guide 8704.524 URETERORENOSCOPE 12° 8.5/11.5 FR, WL 430 MM semi-rigid, with laterally offset eyepiece, working channel 1x6 (2x4) Fr., atraumatically shaped tip, TL 599mm, fiber image guide

GA-D352

E-Line continuous irrigation ureterorenoscope 8708.517 URETERORENOSCOPE 5° 6.5/8.5 FR, WL 330 MM semi-rigid, with straight eyepiece, working channel 1: 1x4 (2x2.2) Fr., working channel 2: 2.4 Fr., atraumatically shaped tip, TL 473mm, fiber image guide 8708.518 URETERORENOSCOPE 5° 6.5/8.5 FR, WL 430 MM semi-rigid, with straight eyepiece, working channel 1: 1x4 (2x2.2) Fr., working channel 2: 2.4 Fr., atraumatically shaped tip, TL 572 mm, fiber image guide 8708.533 URETERORENOSCOPE 5° 6.5/8.5 FR, WL 315 MM semi-rigid, with lateral eyepiece, working channel 1: 4.2 Fr., working channel 2: 2.4 Fr., atraumatically shaped tip, TL 448mm, fiber image guide 8708.534 URETERORENOSCOPE 5° 6.5/8.5 FR, WL 430 MM semi-rigid, with lateral eyepiece, working channel 1: 4.2 Fr., working channel 2: 2.4 Fr., atraumatically shaped tip, TL 563mm, fiber image guide 8706534 URETERORENOSCOPE 5° 8.5/11.5 FR, WL 430 MM semi-rigid, with lateral eyepiece, working channel 5 Fr., irrigation channel 2.4 Fr., atraumatically shaped tip, TL 563mm, fiber image guide

Guide element for ureterorenoscope 8702.251 GUIDE ELEMENT FOR URETERORENOSCOPE for LITHOCLAST handpiece for ureterorenoscopes, reusable 8702.271 GUIDE ELEMENT FOR URETERORENOSCOPE for US transducer, for ureterorenoscopes, reusable

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Handle for E-Line surgical fiber ureterorenoscope 8702.261 HANDLE FOR E-LINE URETERORENOSCOPES TL 67 mm, compatible with E-Line ureterorenoscopes, reusable

Universal sealing valve 1–6 Fr. 4712348 UNIVERSAL SEALING VALVE 1–6 FR. for inserting auxiliary instruments of 1–6 Fr., PU = 5 pcs, sterile, disposable

GA-D352

Intended use Fiber ureterorenoscope 8701517

URETERORENOSCOPE 5° 4.5/6.5 FR, WL 330 MM

8701518

URETERORENOSCOPE 5° 4.5/6.5 FR, WL 430 MM

8701.533

URETERORENOSCOPE 5° 4.5/6.5 FR, WL 315 MM

8701.534

URETERORENOSCOPE 5° 4.5/6.5 FR, WL 430 MM

8702.513

URETERORENOSCOPE 5° 6/7.5 FR, WL 330 MM

8702.514

URETERORENOSCOPE 5° 6/7.5 FR, WL 430 MM

8702.523

URETERORENOSCOPE 5° 6/7.5 FR, WL 315 MM

8702.524

URETERORENOSCOPE 5° 6/7.5 FR, WL 430 MM

8702.533

URETERORENOSCOPE 5° 6/7.5 FR, WL 315 MM

8702.534

URETERORENOSCOPE 5° 6/7.5 FR, WL 430 MM

8703.514

URETERORENOSCOPE 12° 8/9.8 FR, WL 430 MM

8703.523

URETERORENOSCOPE 12° 8/9.8 FR, WL 315 MM

8703.524

URETERORENOSCOPE 12° 8/9.8 FR, WL 430 MM

8703.533

URETERORENOSCOPE 12° 8/9.8 FR, WL 315 MM

8703.534

URETERORENOSCOPE 12° 8/9.8 FR, WL 430 MM

8704.523

URETERORENOSCOPE 12° 8.5/11.5 FR, WL 315 MM

8704.524

URETERORENOSCOPE 12° 8.5/11.5 FR, WL 430 MM

E-Line continuous irrigation ureterorenoscope 8708.517

URETERORENOSCOPE 5° 6.5/8.5 FR, WL 330 MM

8708.518

URETERORENOSCOPE 5° 6.5/8.5 FR, WL 430 MM

8708.533

URETERORENOSCOPE 5° 6.5/8.5 FR, WL 315 MM

8708.534

URETERORENOSCOPE 5° 6.5/8.5 FR, WL 430 MM

8706534

URETERORENOSCOPE 5° 8.5/11.5 FR, WL 430 MM

The products are used for visualizing the inside of the body, for supplying irrigation fluid, for draining fluids, secretions, and tissue residues, and for introducing auxiliary instruments through the working channel. Guide element for E-Line fiber and continuous irrigation ureterorenoscopes 8702.251

GUIDE ELEMENT FOR URETERORENOSCOPE

8702.271

GUIDE ELEMENT FOR URETERORENOSCOPE

The products are used for fastening LithoClast handpieces or US transducers to ureterorenoscopes.

GA-D352

Handle for E-Line fiber and continuous irrigation ureterorenoscopes 8702.261

HANDLE FOR E-LINE URETERORENOSCOPES

The products are used for handling rigid ureterorenoscopes. Universal sealing valve 1–6 Fr. 4712348

UNIVERSAL SEALING VALVE 1–6 FR. disposable

The products are used for sealing and, at the same time, for introducing 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 8701517

URETERORENOSCOPE 5° 4.5/6.5 FR, WL 330 MM

8701518

URETERORENOSCOPE 5° 4.5/6.5 FR, WL 430 MM

8701.533

URETERORENOSCOPE 5° 4.5/6.5 FR, WL 315 MM

8701.534

URETERORENOSCOPE 5° 4.5/6.5 FR, WL 430 MM

8702.513

URETERORENOSCOPE 5° 6/7.5 FR, WL 330 MM

8702.514

URETERORENOSCOPE 5° 6/7.5 FR, WL 430 MM

8702.523

URETERORENOSCOPE 5° 6/7.5 FR, WL 315 MM

8702.524

URETERORENOSCOPE 5° 6/7.5 FR, WL 430 MM

8702.533

URETERORENOSCOPE 5° 6/7.5 FR, WL 315 MM

8702.534

URETERORENOSCOPE 5° 6/7.5 FR, WL 430 MM

8703.514

URETERORENOSCOPE 12° 8/9.8 FR, WL 430 MM

8703.523

URETERORENOSCOPE 12° 8/9.8 FR, WL 315 MM

8703.524

URETERORENOSCOPE 12° 8/9.8 FR, WL 430 MM

8703.533

URETERORENOSCOPE 12° 8/9.8 FR, WL 315 MM

8703.534

URETERORENOSCOPE 12° 8/9.8 FR, WL 430 MM

8704.523

URETERORENOSCOPE 12° 8.5/11.5 FR, WL 315 MM

8704.524

URETERORENOSCOPE 12° 8.5/11.5 FR, WL 430 MM

8708.517

URETERORENOSCOPE 5° 6.5/8.5 FR, WL 330 MM

8708.518

URETERORENOSCOPE 5° 6.5/8.5 FR, WL 430 MM

8708.533

URETERORENOSCOPE 5° 6.5/8.5 FR, WL 315 MM

8708.534

URETERORENOSCOPE 5° 6.5/8.5 FR, WL 430 MM

8706534

URETERORENOSCOPE 5° 8.5/11.5 FR, WL 430 MM

The products listed above are used in urology for the following indications: Diagnosis (kidneys/ureter) Transurethral lithotripsy of kidney and ureteral stones n Removal of tumors (kidneys/ureter) n Slitting of the ureter n Endopyelotomy n Percutaneous nephrolithotomy (PCNL) The same indications apply to accessories of the listed medical devices. n n

Patient population The intended patient population is not restricted to ethnics, age, gender, body height and weight. Before use the attending physician must ensure that the product can be safely used in terms of its dimensions or settings.

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Contraindications and side effects

6.1

Contraindications There are currently no known contraindications directly related to the products in urology. Medical contraindications for the procedure, e.g., urinary tract infections, blood-clotting disorders, or anticoagulation therapy, exclude the use of the products concerned.

6.2

Side effects No side effects directly related to the product are known if the product is used as intended.

Combinations CAUTION Be careful not to combine products incorrectly! Injuries of the patient, user or others as well as damage to the product are possible. n The products must only be used jointly if the intended use and the relevant technical data such as working length, diameter, etc. are the same. n Also follow the instruction manuals of the products used in conjunction with this product.

7.1

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

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Endoscopic cameras and light sources Suction and irrigation pumps Lithotripsy systems Endoscopic instruments and accessories

Illustration

8.1

E-Line fiber ureterorenoscopes with automatic valve

Fig. 1 Since the ureterorenoscopes in this figure feature the same design, the positions of the individual components are illustrated using only the fiber ureterorenoscope [ A1 ].

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Item

Designation

Item

Designation

Fiber ureterorenoscope, laterally offset eyepiece

Continuous irrigation ureterorenoscope

Fiber ureterorenoscope, lateral eyepiece

Needle ureterorenoscope

Lens

Supply/drain stopcock

Light outlet

Rubber cap

Working channel

Instrument port

Endoscope tip

Indicator: max. capacity

Sheath tube

Indicator: viewing direction indication

Endoscope tip size indication

Automatic valve

Sheath tube size indication

17.1

Seal

Endoscope-sided adapter

17.2

Membrane holder

Indicator: fiber bundle diameter

Optional: sterile universal sealing valve

9.1

Color ring: marker for fiber bundle diameter

Color ring: viewing direction indication

Model no.

Eyecup

GA-D352

8.2

E-Line fiber ureterorenoscopes with straight eyepiece

Fig. 2 Item

Designation

Item

Designation

Fiber ureterorenoscope

Continuous irrigation ureterorenoscope

Lens

Color ring: viewing direction indication

Light outlet

Eyecup

Working channel

Supply/drain stopcock

Endoscope tip

Rubber cap

Sheath tube

Instrument port

Endoscope tip size indication in Fr.

Indicator: max. capacity in Fr.

Sheath tube size indication in Fr.

Indicator: viewing direction indication

Endoscope-sided adapter

Indicator: fiber bundle diameter

Model no.

9.1

Color ring: marker for fiber bundle diameter

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8.3

Removable stopcocks

See item 12 (supply and drain stopcock) and item 14 (instrument port)

Fig. 3 Item

Designation

Capacity

Stopcock insert

1.8 mm

Capacity indicator on stopcock housing

2 points

3 points

Capacity indicator on stopcock insert

2 nubs

3 nubs

Stopcock housing

LUER-LOCK connector

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2.5 mm

3.0 mm

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 check 1. Check the products, in particular their distal area, and the accessories for: ð Check for damage on the instrument tip (4) to prevent ureteral trauma. ð surface changes (such as corrosion) ð sharp edges ð loose or missing parts ð rough surfaces 2. Any inscriptions or identification necessary for the safe intended use must be legible. ð Missing or illegible inscriptions, labels and identifications that may lead to wrong handling or reprocessing must be reinstated. 3. Check the following parts for damage: ð Seal (17.1) ð Rubber cap (13) 4. Replace brittle and cracked parts. 5. When using the sterile universal sealing valve 1–6 Fr. (18): Check the sterile barrier system for damage.

Fig. 4

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