Richard Wolf Fiber Light Cable Sets Instruction manual

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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Table of contents 1

General information ...

5

1.1

Safety instructions and levels of danger...

5

1.2

Symbol...

5

2

General safety instructions and guidance for use ...

7

3

Product description...

8

4

Intended purpose ... 10

5

Indications ... 12

6

Contraindications and side effects ... 13

6.1

Contraindications... 13

6.2

Side effects... 13

7

Combinations ... 14

7.1 7.1.1

Overview of permissible combinations and requirements ... 15 Connection with fiber light cable (RICHARD WOLF) to light sources and endoscopes (RICHARD WOLF) ... 15 Connection with fluid light cable (RICHARD WOLF) to light sources and endoscopes (RICHARD WOLF) ... 16 Connection with special fiber light cable (RICHARD WOLF) to light sources (RICHARD WOLF) and endoscopes (OTHER MANUFACTURERS)... 17 Connection with fiber light cable (RICHARD WOLF) to light sources and endoscopes (OTHER MANUFACTURERS) ... 18 Connection with fluid light cable (RICHARD WOLF) to light sources and endoscopes (OTHER MANUFACTURER)... 19 Connection with fiber light cable (OTHER MANUFACTURER) to light sources and endoscopes (RICHARD WOLF) ... 20

7.1.2 7.1.3 7.1.4 7.1.5 7.1.6 8

Illustration ... 21

9

Checks... 23

9.1

Visual check ... 23

9.2

Function check ... 23

9.3

Service life ... 24

10

Application ... 25

10.1 10.1.1 10.1.2

Preparation ... 25 Attaching the adapter (1) (6) to the light cable (3) (7) ... 25 Identification of fiber bundle diameter on fiber light cable (1) (7) ... 26

10.2 10.2.1 10.2.2

Indications for Use... 27 Replacing the color coding ring (2) on the light cable connector facing the light source (only if required). 28 Light... 29

11

Reprocessing and maintenance ... 30

11.1

Reprocessing sequence – Fiber light cable set [ A ], Fusion fiber light cable set [ B ], Special fiber light cable set [ C ] ... 32 Machine reprocessing ... 33 Manual reprocessing ... 33 Checks and maintenance ... 35 Packaging... 35 sterilization... 35 Storage ... 36 Validation... 36

11.1.1 11.1.2 11.1.3 11.1.4 11.1.5 11.1.6 11.1.7

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11.2 11.2.1 11.2.2 11.2.3 11.2.4 11.2.5 11.2.6 11.2.7

Reprocessing sequence for fluid light cable [ D ] ... 36 Machine reprocessing ... 37 Manual reprocessing ... 37 Checks and maintenance ... 38 Packaging... 39 sterilization... 39 Storage ... 40 Validation... 40

12

Technical description ... 41

12.1 12.1.1 12.1.2 12.1.3

Technical data ... 41 Endoscopes without identification of the fiber bundle diameter ... 41 Fiber Light Cable Sets ... 42 Fluid light cable [ D ] ... 45

12.2

Operating, storage, transport and shipping conditions ... 45

13

Spare parts ... 46

14

Disposal of product, packaging material and accessories ... 46

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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

Symbol

Symbols

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

Data Matrix Code

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Symbols

Designation CE marking in conformity with Directive 93/42/EEC on medical products or EU Regulation 2017/745 on medical devices. Only valid, if the product and/or 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 surchical 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 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.

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2

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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3

Product description The fiber light cable sets are available in different product versions: n n n n

Fiber light cable set with color coding [ A ] Fusion fiber light cable set, high temperature resistant [ B ] Special fiber light cable set [ C ] Fluid light cable [ D ]

The products described differ in the following features: Fiber light cable set with color coding [ A ] n

n

n n

on projector side – with replaceable color coding ring (standard color black). This color coding ring is available in different colors. on endoscope side – with color coding ring and numeric code for fiber bundle diameter. Adapter, projector side, can be unscrewed Adapter, endoscope side, can be unscrewed – with "snap" quick-release coupling (ring actuation)

Fusion fiber light cable set, high temperature resistant [ B ] n

n

n n

on projector side – with identification: fusion – with replaceable color coding ring (standard color black). This color coding ring is available in different colors. on endoscope side – with color coding ring and numeric code for fiber bundle diameter Adapter, projector side, can be unscrewed Adapter, endoscope side, can be unscrewed – with "snap" quick-release coupling (ring actuation)

Special fiber light cable set [ C ] n

n n

on endoscope side – with color coding ring and numeric code for fiber bundle diameter Adapter, projector side, fixed Adapter, endoscope side, can be unscrewed – with "snap" quick-release coupling (ring actuation)

Fluid light cable [ D ] n n n

8

projector side and endoscope side, straight Adapter, projector side, can be unscrewed Adapter, endoscope side, can be unscrewed – with tab, long version

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NOTE The fiber light cables are also available without adapter. The color coding ring system on both the projector and the endoscope sides allows easy and quick allocation of the fiber light cable. n Color coding ring projector side (replaceable): Hospital-specific identification of fiber light cables (e.g., for different disciplines) n Color coding ring endoscope side: Fiber bundle diameter of fiber light cable matches the endoscope diameter See section Technical data and order data

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4

Intended purpose NOTE For detailed information regarding fluorescence diagnostic applications, please refer to the corresponding system instruction manuals.

Light cable 80655023

FIBER LIGHT CABLE Ø 5 MM TL 2.3 M

80655030

FIBER LIGHT CABLE Ø 5 MM TL 3 M

80655035

FIBER LIGHT CABLE Ø 5 MM TL 3.5 M

80661618

FIBER LIGHT CABLE Ø 1.6 MM TL 1.8 M

80661623

FIBER LIGHT CABLE Ø 1.6 MM TL 2.3 M

80661630

FIBER LIGHT CABLE Ø 1.6 MM TL 3 M

80662518

FIBER LIGHT CABLE Ø 2.5 MM TL 1.8 M

80662523

FIBER LIGHT CABLE Ø 2.5 MM TL 2.3 M

80662530

FIBER LIGHT CABLE Ø 2.5 MM TL 3 M

80663518

FIBER LIGHT CABLE Ø 3.5 MM TL 1.8 M

80663523

FIBER LIGHT CABLE Ø 3.5 MM TL 2.3 M

80663530

FIBER LIGHT CABLE Ø 3.5 MM TL 3 M

80663535

FIBER LIGHT CABLE Ø 3.5 MM TL 3.5 M

80665023

FIBER LIGHT CABLE Ø 5 MM TL 2.3 M

80665030

FIBER LIGHT CABLE Ø 5 MM TL 3 M

80665035

FIBER LIGHT CABLE Ø 5 MM TL 3.5 M

80673523

FIBER LIGHT CABLE BLUE Ø 3.5MM

4070.253

FLUID LIGHT CABLE Ø 3.0MM TL 2.3MM

The products are used to transmit light in the visible spectral range from the light source to the application-specific instrument set. Adapter for light cable

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807001

ADAPTER, ENDOSCOPE SIDE

807002

ADAPTER, ENDOSCOPE SIDE

808801

ADAPTER, ENDOSCOPE SIDE

8070.00

ADAPTER, ENDOSCOPE SIDE

8087.00

ADAPTER, ENDOSCOPE SIDE

8088.00

ADAPTER, ENDOSCOPE SIDE

8088.80

ADAPTER, ENDOSCOPE SIDE

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8088.81

ADAPTER, ENDOSCOPE SIDE

8091.00

ADAPTER, ENDOSCOPE SIDE

8095.05

ADAPTER, ENDOSCOPE SIDE

809506

ADAPTER, ENDOSCOPE SIDE

8095.07

ADAPTER, PROJECTOR TO LIGHT CABLE

809509

ADAPTER, ENDOSCOPE SIDE

8096.811

ADAPTER, PROJECTOR TO LIGHT CABLE

The products are used to connect light guides to light sources or endoscopes. 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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5

Indications The products are used in endoscopic procedures in various medical disciplines.

NOTE For detailed information regarding the blue light mode, please refer to the corresponding system instruction manuals.

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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6

Contraindications and side effects

6.1

Contraindications There are currently no known contraindications directly related to the product. Medical contraindications for the endoscopic procedures to be performed exclude the use of the products concerned. The responsible physician must decide on the basis of the patient's general condition whether the intended use is possible or not.

NOTE For any limitations regarding the blue light mode, please refer to the corresponding system instruction manuals.

6.2

Side effects No side effects related to the products are known if the products are used as intended.

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7

Combinations CAUTION Incorrect combination of products! Injuries to the patient, user, or others, as well as damage to the product are possible. n The different 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 Follow the instruction manuals and the system instruction manuals of the products used in combination with this product.

ATTENTION The special fiber light cable set is fitted with a fixed projector-side adapter and is only compatible with Richard Wolf light sources. The adapters (1) and (6) can be unscrewed and replaced by suitable adapters (a) and (b) for connection to the light source or endoscope (Fig. 1a). n

n

See section 7.1.1 Connection with fiber light cable (RICHARD WOLF) to light sources and endoscopes (RICHARD WOLF) See section 7.1.2 Connection with fluid light cable (RICHARD WOLF) to light sources and endoscopes (RICHARD WOLF)

Use of fiber light cable sets [ A ] [ B ] (RICHARD WOLF) (Fig. 1b) n

See section 7.1.4 Connection with fiber light cable (RICHARD WOLF) to light sources and endoscopes (OTHER MANUFACTURERS)

Use of special fiber light cable sets [ C ] (RICHARD WOLF) (Fig. 1c) n

See section 7.1.3 Connection with special fiber light cable (RICHARD WOLF) to light sources (RICHARD WOLF) and endoscopes (OTHER MANUFACTURERS)

Use of fluid light cables [ D ] (RICHARD WOLF) (Fig. 1d) n

See section 7.1.5 Connection with fluid light cable (RICHARD WOLF) to light sources and endoscopes (OTHER MANUFACTURER)

Use of fiber light cable (OTHER MANUFACTURER) n

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See section 7.1.6 Connection with fiber light cable (OTHER MANUFACTURER) to light sources and endoscopes (RICHARD WOLF)

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on projector side

on endoscope side

1

6

a

1

Fig. 1a

b

Fig. 1b

b

Fig. 1c

6

Fig. 1d

Fig. 1

7.1

Overview of permissible combinations and requirements

7.1.1

Connection with fiber light cable (RICHARD WOLF) to light sources and endoscopes (RICHARD WOLF)

Light source

Endoscope

Fiber light cable [ A ] [ B ]

Special fiber light cable [ C ]

Adapters

Adapters

projector side

endoscope side

8095.07

Adapter, fixed projector side

809509

Fig. 2

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7.1.2

Connection with fluid light cable (RICHARD WOLF) to light sources and endoscopes (RICHARD WOLF)

Light source

Endoscope

Fluid light cable [ D ]

Adapter

Adapter

projector side

endoscope side

8095.07

809506

8095.05

Fig. 3

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7.1.3

Connection with special fiber light cable (RICHARD WOLF) to light sources (RICHARD WOLF) and endoscopes (OTHER MANUFACTURERS)

Special fiber light cable [ C ]

Light source

Light source made by:

Adapter, fixed

Adapters

projector side

endoscope side

Other endoscope

Endoscope made by:

ACMI + Circon 807002

Henke-Sass-Wolf

Storz

Olympus

Stryker 807001

Fig. 4

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7.1.4

Connection with fiber light cable (RICHARD WOLF) to light sources and endoscopes (OTHER MANUFACTURERS)

Light source from other manufacturer

Light source made by:

Storz

Fiber light cable [ A ]

Endoscope from other manufacturer

Adapter

Adapter

projector side

endoscope side

ACMI + Circon

fits directly 807002

Olympus

Henke-Sass-Wolf

Storz

8096.811

Stryker

Endoscope made by:

Wolf adapter fits Olympus

Stryker 807001

Fig. 5

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7.1.5

Connection with fluid light cable (RICHARD WOLF) to light sources and endoscopes (OTHER MANUFACTURER)

Light source from other manufacturer

Light source made by:

Storz

Fluid light cable [ D ]

Endoscope from other manufacturer

Adapter

Adapter

projector side

endoscope side

fits directly

Endoscope made by:

Storz

Olympus 8096.811 Olympus Stryker

Wolf adapter fits

Stryker 8070.00

Fig. 6

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7.1.6

Connection with fiber light cable (OTHER MANUFACTURER) to light sources and endoscopes (RICHARD WOLF)

Light source

Fiber light cable from other manufacturer

Endoscope

Color coding ring? Yes / No?

Adapter projector side

Fiber light cable made by:

Adapter endoscope side

Storz, 3.5 mm

Storz, 4.8 mm

Olympus Standard 808801

Olympus WA032...A 8088.81 fits directly

ACMI + Circon 8087.00

Fig. 7

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