Rigid Endoscopes Instruction Manual

Important general notes and instructions Make sure that this product is used only as intended and described in this instruction manual and 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 appli­ cation 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 pa­ tient, 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 upon 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 developments the illustrations and technical data may deviate slightly.

Safety instructions and levels of danger Symbols

Level of danger

WARNING!

Failure to observe can result in death or extremely serious injuries.

CAUTION!

Failure to observe can result in slight injury or damage to the product.

. .

0

IMPORTANT!

Failure to observe can result in damage to the product or surroundings.

NOTE!

Tips for optimum use and other useful information. GERMANY RICHARD WOLF GmbH 75438 Knittlingen Pforzheimerstr. 32 Telephone: +49 70 43 35-0 Telefax: +49 70 43 35-4300 MANUFACTURER [email protected] www.richard-wolf.com

USA RICHARD WOLF Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Toll Free: 001 (800) 323 - 9653 Phone: 001 (847) 913 - 1113 Fax: 001 (847) 913 - 1488 [email protected] www.richardwolfusa.com

UK RICHARD WOLF UK Ltd. Waterside Way Wimbledon SW17 0HB Telephone: + 44 20 89 44 74 47 Telefax: + 44 20 89 44 13 11 [email protected] www.richardwolf.uk.com

BELGIUM / NETHERLANDS N.V. Endoscopie RICHARD WOLF Belgium S.A. Industriezone Drongen Landegemstraat 6 9031 Gent Drongen Telephone: +32 92 80 81 00 Telefax: +32 92 82 92 16 [email protected] www.richard-wolf.be

FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette F-51100 Reims Telephone: +33 3 26 87 02 89 Telefax: +33 3 26 87 60 33

AUSTRIA RICHARD WOLF Austria Ges.m.b.H. Wilhelminenstraße 93 a A-1160 Vienna Telephone: +43 14 05 51 51 Telefax: +43 14 05 51 51 45

[email protected]

[email protected] www.richard-wolf.com

Marketing Office U.A.E RICHARD WOLF Middle East P.O. Box 500283 AL Thuraya Tower 1 9th Floor, Room 904, Dubai Telephone: + 9 71 43 68 19 20 Telefax: + 9 71 43 68 61 12 [email protected] www.richard-wolf.com

INDIA RICHARD WOLF India Private Ltd. JMD Pacific Square No. 211 A, Second Floor Behind 32nd Milestone Gurgaon - 122 001 National Capitol Region Telephone: + 91 12 44 31 57 00 Telefax: + 91 12 44 31 57 05 [email protected] www.richard-wolf.com

GA-S001

Contents 1

Technical description...

1

2

Intended use...

1

3

Indications and field of use...

1

4 4.1 4.2

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

2 2 2

5

Combinations...

2

6 6.1 6.2 6.3

Illustration... Legend and identification... Symbols... Explanation of acronyms used...

5 6 8 8

7 7.1 7.1.1 7.1.2 7.2 7.2.1 7.2.2 7.2.3 7.3 7.4

Use... Preparation... Identification of fiber bundle diameter on endoscope... Connecting the fiber light cable to the endoscope and the system components... Additonal notes and instructions for use... Light... Electricity... Image quality... HF applications... Laser application...

9 9 9 11 12 12 12 12 13 13

8 8.1 8.2 8.3

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

14 14 14 14

9 9.1

Reprocessing and maintenance... 16 Reprocessing procedure... 16

10

Spare parts and accessories... 19

11 11.1

Operating, storage, transport and shipping conditions... 19 Disposal of product, packaging material and accessories... 19

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I

1

Technical description

The rigid endoscopes / blue endoscopes are available in different product variants and consist of the following: Z Endoscope with fixed eyecup ' with sheath tube, integrated light guide, optical system ' with locking cone ' cold-light connector ' with adapter (can be unscrewed) ' with color coding ring indicating the direction of view with plug-on eyecup ' with sheath tube, integrated light guide, optical system ' with locking cone ' cold-light connector ' with adapter (can be unscrewed) ' with color coding ring indicating the direction of view ' with plug-on connector Possible identification of the fiber bundle diameter on the endoscope: ' The product is marked with the code number and a color coding ring (new design). ' Only the code number (numerical) is on the product. ' there is no code number and no coding ring

2

Intended use

The rigid endoscopes / blue endoscopes are used for visualizing the inside of the patient via natural or surgically created passages. These products are exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately instructed persons.

3

Indications and field of use Rigid endoscopes are designed for examination, diagnosis and / or therapy in conjunction with endo­ scopic accessories in the various medical disciplines. Blue endoscopes Optimized for the transmission of blue light for applications with fluorescence diag­ nostics ' For detailed information, please refer to the corresponding system manuals. Endoscopes for NIR fluorescence diagnosis Optimized for the transmission of light in the near infrared spectrum for NIR fluo­ rescence diagnosis using indocyanine green (ICG). The endoscopes suitable for NIR fluorescence diagnosis are marked with two continuous rings around both sides of the serial number (see illustration in section 6). ' For detailed information please refer to the corresponding system manuals. The availability of the system components is based on the market-specific approval / certification. ' Endoscopes for standard white light applications which are also suitable for NIR fluorescence diagnosis are marked with two rings around both sides of the serial number (see section 6).

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4

Contraindications and side effects

4.1

Contraindications

CJD - Creutzfeldt Jakob Disease or a vCJD - Variant of the Creutzfeldt-Jakob Disease BSE - Bovine Spongiform Encephalopathy; so-called mad cow disease (e.g. Creutzfeldt-Jakob Disease) TSE - Transmissible Spongiform Encephalopathy On the basis of the patient's general condition the attending physician must decide whether or not the planned application is possible. 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 For limitations regarding the Blue light mode, please refer to the corresponding system manuals.

4.2

Side effects

5

Combinations

No side effects are known if the system is used as intended. Rigid endoscopes / blue endoscopes are used in conjunction with: Rigid endoscopes Z Light sources and fiber light cables / fusion fiber light cable Z Video cameras and objective lenses Z Mirror reflex cameras Z Endoscopic accessories, e.g. ' Trocar sleeves, forceps and scissors, electrodes Blue endoscopes Z ENDOLIGHT LED blue and fiber light cable special Z Video cameras and objective lenses Z Endoscopic accessories, e.g. ' Trocar sleeves, forceps and scissors, electrodes Endoscopes for NIR fluorescence diagnosis Z ENDOLIGHT LED green and fiber light guide (high-temperature resistant) Z Camera controller suitable for NIR fluorescence diagnosis Z Logic HD camera head green Z Endoscopic accessories, e.g. ' Trocar sleeves, forceps and scissors, electrodes

CAUTION! Danger if the products are incorrectly combined! Injuries of the patient, user or others as well as damage to the product are possi­ ble. The different products can only be used together if their intended uses and rele­ vant technical data (such as working length, diameter, peak voltage, etc.) are the same. Follow the instructions for use or the corresponding system manuals of the prod­ ucts used in combination with this product. Follow the "Notes and instructions on HF applications", order no.: GA-S 002 as well as the HF device manufacturer's instructions.

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4

Fig. 1 Z The adapter (4) on the endoscope can be unscrewed and replaced by the cor­ responding adapters to connect fiber light cables of other manufacturers. ' For order data, please follow the latest catalog sheets. ' For this, see GA-A287 and GA-A009

Fig. 1

3

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Fig. 2 Z Objective lenses with C-mount thread for working via the monitor or under di­ rect view. ' For order data, please follow the latest catalog sheets. ' For this, see GA-S022

Fig. 2 Fig. 3

clo­ se

ope­ n

Z Objective lenses with RW-mount thread for working via the monitor or under direct view. ' For order data, please follow the latest catalog sheets. ' For this, see GA-S022

Fig. 3 Fig. 4 Z Plug-on eyecup (18) for the connection of objective lenses with C-mount thread to endoscopes with plug-on eyepiece adapter (14). Plug-on eyecup, rotatable, special design for video TUR. ' For order data, please follow the latest catalog sheets. ' For this, see GA-S022

open close

14

18

Fig. 4

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4

6

Illustration

2 3

1

45 7 6 8

9

xx

A

10 11 4

XXXXX*8XXX.

13 12

6 8

2

1

9

7

B

xx

10 11

XXXXX*8XXX.

13 12

C xx

1

7

2 10

14

4 15

D

16

0

15

7

0

AUTOCLAVE

0

AUTOCLAVE

AUTOCLAVE

0

AUTOCLAVE

1 2 0

17

18

3 6

7

0

E

13 0

F

3 6

Fig. 5 5

12

F19

7

G

13 12

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6.1

Legend and identification Item

Designation

A

Endoscope (new design) - with fixed eyecup - with color coding ring and code number (numeri­

Item

Endoscope (new design) B

cal)

identification of fiber bundle diameter

C

E

Endoscope (new telescope design) - with plug-on eyecup - with code number (numerical) identification of fiber bundle diameter Endoscope - with plug-on eyecup

D

G

- with fixed eyecup - with code number (numerical) identification of fiber bundle diameter

Endoscope - with fixed eyecup

Endoscope (PANOVIEW F

blue endoscope - with fixed eyecup - with color coding ring and code number (numeri­

Designation

- with fixed eyecup - with color coding ring and code number (numerical) identification of fiber bundle diameter

F19

Endoscopes for standard white light applications, which are also suitable for NIR fluorescence diagnosis, are marked with two rings (A) on both sides of the serial number.

cal)

identification of fiber bundle diameter

1

Sheath tube

10

Product no.

2

Locking cone

11

Serial no.

12

Numerical indication of direction of view

13

Sheath tube diameter

14

Connection for plug-on connector (plug-on eyecup)

3 4 5

6

7

8 9

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Color coding ring identification of fiber bundle diameter

Adapter External thread for connecting suitable adapters Numerical identification number identification of fiber bundle diameter

Color coding ring Identification of direction of view

HD Identification of high definition

Fixed eyecup

15

16

17 18

Color coding ring, red Identification of steam sterializability using the fraction­ ated prevacuum process at 134 °C (273 °F)

Convex ring only on PANOVIEW- *PLUS* Identification of increased object field; high detail resolution

AUTOCLAVE Identification of steam-sterilizability

plug-on connector (plug-on eyecup)

6

Item

3

6

7

7

Explanations for items 3, 6 and 7

Code num­ ber

Color

Fiber bundle diameter in [mm] Fiber light cable / special fiber light cable FUSION

blue

blue

-

1.6

-

-

Color coding ring

green

-

2.5

-

-

Identification of fiber bundle diameter

orange

-

3.5

-

3.5

gray

-

5.0

5.0

-

-

16

1.6

-

-

-

25

2.5

-

-

-

35

3.5

-

3.5

-

45

-

50

5.0

5.0

-

Numerical identification number Identification of fiber bundle diameter

Color coding ring Identification of direction of view

Color

Direction of view []

blue

0

0

green

5

-

orange

12/ 45 - 50

12

red

30

30

gray

50

-

purple

60

-

yellow

70

70

brown

90

-

white

110

-

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6.2

Symbols Symbols

Designation Follow the instruction manual

MD

Medical device/product

REF

Order number

SN

Series no.

LOT

Lot code Manufacturer

Manufacturing date Number, amount 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.

6.3

Explanation of acronyms used Acronym

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Designation

ICG

Indocyanine green

NIR

Imaging in the near infrared range

8

7

Use CAUTION! The products have only limited strength! Applying excessive force will lead to damage, impair the function and therefore endanger the patient. Immediately before and after each use, check the products for damage, loose parts and completeness. Make sure that no missing parts remain in the patient. Do not use the products if they are damaged or incomplete or have loose parts.

7.1

Preparation

Z Carry out a check: see section 8 Fig. 6

4

Z Screw the adapter (4) to the endoscope.

Fig. 6

7.1.1

Identification of fiber bundle diameter on endoscope

.

IMPORTANT! To achieve optimum light transmission, the fiber bundle diameters of the endo­ scope and fiber light cable must match. If there is a mismatch, possible consequences are: Z Fiber light cables with excessively large fiber bundle diameter (cross-section) cause ' excessive heating at the coupling point with the endoscope Z Fiber light cables with excessively small fiber bundle diameter (cross-section) cause ' reduced light output CAUTION! Intense heat due to high light energy! Unfavorable combinations can cause a temperature increase at the coupling point of the fiber light cable and at the light outlet of the endoscope. Burns on the patient, user and others as well as damage to the endoscope are possible. Reduce the light output or adapt the light cable cross section. Due to the different product variants, the identification of the fiber bundle diameter on the endoscope differs. Possible identification on the endoscope: Z The product is marked with the code number and a color coding ring (new de­ sign). Z Only the code number (numerical) is on the product. Z No code number and no color coding ring is found on the product. The fiber bundle diameter of the fiber light cable / fusion fiber light cable / special fiber light cable is marked with a color coding ring and a code number on the endo­ scope connector of the light cable.

9

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A code number and color coding ring are found on the endoscope. Fig. 7

6

The code number (6) and the color coding ring (3) on the endoscope and on the endoscope connector of the fiber light cable must be the same.

3

50

Fig. 7

If there is only the code number on the endoscope

6

Fig. 8 The code number (6) on the endoscope and on the endoscope connector of the fiber light cable must be the same.

Fig. 8

.

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NOTE! Please contact RICHARD WOLF GmbH if there is no identification number and no color coding ring on the endoscope and ask for the fiber light cable to be used.

10

7.1.2

Connecting the fiber light cable to the endoscope and the system components Connecting the fiber light cable Fig. 9 Z Connect the fiber light cable (x) or (y) to the adapter (4) on the endoscope and to a suitable light source. ' Fiber light cable (x) - adapter, endoscope-to-light cable (tab) ' Fiber light cable (y) / fusion fiber light cable / special fiber light cable - adapter, endoscope-to-light cable (quick-release coupling with actuation ring)

(x)

(y)

4

4 50

Fig. 9 Removing the fiber light cable Fig. 10 Z Fiber light cable (x): Push the tab in direction of arrow and remove the fiber light cable (x). Z Fiber light cable (y) / fusion fiber light cable / special fiber light cable push the fiber light cable (y) slightly against the endoscope, slide the quick-re­ lease coupling (ring actuation) in the direction indicated by the arow and re­ move the fiber light cable (y).

(x)

(y)

50

Fig. 10

.

11

NOTE! For further information and notes on the fiber light cables please refer to the de­ scriptions in manuals GA-A287 and GA-A009.

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7.2

Additonal notes and instructions for use WARNING! Danger of electric shock due to leakage currents! Use endoscopes only with supply units (light sources) with type BF or CF insu­ lated light cable output plug (light connection socket).

7.2.1

Light

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 ' if high performance sources are used Do not touch the light exit area and avoid direct contact with the tissue. Remove any soiling. In neurosurgery use only halogen light sources up to a maximum of 250 W or other light sources (e.g. gas discharge lamps, xenon) up to a maximum of 180 W. Do not use fluid light cables. WARNING! 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. Store the endoscope in a safe place. Switch off the light source if the endoscope is not used for a period of time. CAUTION! Danger of burns! Due to the high energy output of the light source the adapters and the glass sur­ face of 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. Do not touch the adapter and the glass surface of the fiber light cable. Allow the fiber light cable to cool down. CAUTION! Danger of dazzling! Danger of impaired vision. Do not look into the light exit area / free end of an endoscope / fiber light cable which is connected to a light source. 7.2.2

Electricity

WARNING! Danger of electric shock! Patient leakage currents can add up if the endoscopes are combined with other energetically operated endoscopic accessories. Make sure that the combinations do not exceed the permissible patient leakage currents. 7.2.3

Image quality

CAUTION! Increased risk potential if the image is blurred! Danger of injuring the patient. Stop the intervention for safety reasons if the image is blurred. Check the image quality of the endoscope before use (section 8.3).

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7.3

HF applications

Follow the "Notes and instructions on HF applications", order no.: GA-S 002 as well as the HF device manufacturer's instructions.

CAUTION! If high-frequency current is used, leakage currents may cause burns! This may result in burns around the user's eye. Use the endoscope only with the eyecup connected.

7.4

Laser application

When applying a laser make sure you follow the laser device manufacturer's in­ structions as well as the general regulations on the use of lasers. Wear the required personal protection gear.

CAUTION! Highly coherent laser beam! This may result in injuries from laser energy in the user's face around the eye. Wear the required personal protection gear when using this product in conjunc­ tion with laser devices. An additional suitable filter attachment is required when using lasers and working with endoscopes under direct view.

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8

Checks 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 the products if they are damaged, incomplete or have loose parts. Return damaged products together with any loose parts for repair. Do not attempt to do any repairs yourself!

8.1

Service life

.

8.2

NOTE! When used as intended and following the instructions in manufacturer's manual, it is not necessary to limit the service life of the medical products. Careful and gentle handling of medical products during the entire reprocessing process has an essential influence on the service life of the 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).

Visual check Z Check the endoscopes in particular in the distal area and the accessories for: ' damage ' sharp edges ' loose or missing parts ' rough surfaces Z Any inscriptions, labeling and identifications necessary for the safe intended use must be legible. ' Any lettering or identification necessary for the safe intended use must be legi­ ble. To prevent wrong handling or reprocessing, any missing or illegible letter­ ing or identification must be reinstated.

8.3

Function check Fig. 11 Z Check image quality and light output in conjunction with the system compo­ nents. Z Check the glass surfaces for any deposits. ' Deposits on the glass surfaces can cause a spotted or blurred field of view and hence impair light transmission considerably. ' Clean the glass surfaces with a swab soaked with alcohol (wood, not metal or plastic) and hard-to-remove deposits with a suitable instrument cleaner.

xx

Fig. 11

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Fig. 12 Z Check the light output without the system components. Z Hold the distal end of the endoscope towards a light source. ' Broken fibers appear as black dots at the cold-light connector. If approx. 30% of the fibers are broken, the light output is no longer sufficient.

xx

Fig. 12

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9

Reprocessing and maintenance

.

NOTE! New products from the factory Before reprocessing remove all protection foils and shipping locks or clips from the products and the accessories. Reprocess the products and the accessories at least once before the first use. For the permissible processes please refer to the following sections. WARNING! Creutzfeldt-Jakob Disease! If the patient is suspected of having the Creutzfeldt-Jacob (CJD) disease or a vari­ ant of the latter (vCJD) has been diagnosed, take the necessary steps to prevent a possible transmission to other patients, the user or others. The country-specific reprocessing guidelines and regulations must be adhered to.

.

IMPORTANT! Never use metal or sharp-edged tools (e.g. metal brushes) for cleaning the prod­ ucts.

.

NOTE! For a listing of the Richard Wolf approved chemicals for the reprocessing of Richard Wolf products with regard to material compatibility, please see document GA-J055. This document can be requested from Richard Wolf or downloaded from our website. RICHARD WOLF in the Internet www.richard­wolf.com/en/solutions/processing

.

9.1

Reprocessing procedure

.

NOTE! Machine cleaning and disinfection is to be preferred. Manual cleaning / disinfection can be carried out if there is no possibility of ma­ chine cleaning/disinfection. The following describes the reprocessing procedure used by Richard Wolf GmbH for the validation.

IMPORTANT! ' If used as intended and following the manufacturer's instruction manual, it is

not necessary to limit the number of possible reprocessing cycles.

' Careful and gentle handling of medical products during the entire reprocessing

process has an essential influence on the service life of the products.

' Before returning defective products for repair, they must have been subjected

to the entire reprocessing cycle. ' It is the user's responsibility to make sure that the reprocessing process includ­ ing the resources, material and personnel, is suited to yield the required results. ' The national and international requirements regarding the validation of the re­ processing process established by the user must be observed.

.

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IMPORTANT! Do not sterilize the products in hot-air sterilizers.

16

Product:

Endoscopes (A) - (G)

Reprocessing sequence: Preparation at the point of use:

Immediately after use, remove coarse soiling from the products. Do not use any agents (e.g. aldehyde) or hot water above 40 °C for pre-cleaning, as this may bake residues to the surfaces.

Transport:

To avoid damage of the products and contamination of the environment, the products must be stored safely in a closed container.

Disassembly be­ fore cleaning:

Pre-cleaning:

4

Remove the adapter (4) from the endoscope.

No special requirements

Manual cleaning Cleaning:

1.Immerse the products in a certified cleaning solution for at least 5 minutes. ' For immersion time and concentration please refer to the manufacturer's specifications. 2.Brush the outer surfaces with a cleaning brush (86.90) until any visible residues have been removed. 3.At the end, thoroughly rinse the products with tap water for at least 20 seconds.

86.90

Disinfection:

1.Immerse the products in a certified disinfectant solution. ' For immersion time and concentration please refer to the manufacturer's specifications. 2.At the end, thoroughly rinse the products with tap water for at least 20 seconds.

Drying:

1.Dry the outer surfaces of the products using a lint-free disposable cloth or swab or, alternatively, dry in a drying cabinet. 2.Clean glass surfaces with a swab soaked in alcohol.

Machine cleaning Cleaning:

Place the endoscope and adapter (4) into the holders provided in the special reprocessing basket and connect to the washer-disinfector. Program parameters ' >4 min of prewashing with cold water**) ' Empty ' >6 min of washing with a cleaner at <55C ' Empty ' >3 min of neutralizing*) using cold FD water (<40C)***) ' Empty ' >2 min of intermediate rinsing using cold FD water (<40C)***) ' Empty

Disinfection:

Carry out thermal machine disinfection following the national requirements with regard to the A0 value (see DIN EN ISO 15883).

Drying:

Dry the products with the drying cycle of the washer-disinfector. If necessary, additional drying can be achieved manually using a lint-free disposable cloth or swab, or, alternatively, a drying cabinet. Clean glass surfaces with a swab soaked in alcohol.

17

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