Operating Laparoscopes 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, figures, and technical data may deviate slightly from the current state. For further information about our products, please contact Richard Wolf GmbH or a local 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...

5

2

General safety instructions and guidance for use ...

6

3

Product description...

7

4

Intended purpose ...

7

5

Indications ...

8

6

Contraindications and side effects ...

8

6.1

Contraindications...

8

6.2

Side effects...

8

7

Combinations ...

9

7.1

Overview of permissible combinations and requirements ...

9

8

Illustration ... 10

8.1

Operating laparoscope ... 10

9

Checks... 12

9.1

Visual check ... 12

9.2

Function check ... 12

9.3

Service life ... 13

10

Use ... 14

10.1

Preparation / Commissioning ... 14

10.2

Connecting the automatic instrument valve 8911.318 ... 14

10.3 10.3.1 10.3.2 10.3.3 10.3.4

General notes and instructions for use... 15 Light... 15 Power ... 15 HF application ... 16 Irrigation / suction ... 17

11

Reprocessing and maintenance ... 18

11.1

Reprocessing sequence ... 21

12

Technical description... 25

12.1

Technical data ... 25

12.2

Usage, storage, transport, and shipping conditions ... 25

13

Spare parts ... 26

13.1

Spare parts ... 26

14

Disposal of product, packaging material and accessories ... 26

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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.

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1.2

Symbols

Symbols

Designation Follow the manual Medical device Product number Serial Number 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.

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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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Product description The operating laparoscopes are used for visualizing the inside of the patient via surgically produced access points.

4

Intended purpose Telescope, rigid, with working channel 8914.402

OPERATING LAPAROSCOPE Ø 12.5 MM WL 267 MM

8915.501

OR ENDOSCOPE 0° Ø 10 MM WL 188 MM

The products are used for visualizing the inside of the body and for introducing auxiliary instruments through the working channel. Instrument valves 8911.318

INSTRUMENT VALVE

The products are used to seal the operating endoscope working channel when inserting 5 mm auxiliary instruments.

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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5

Indications The products are used in urology, gynecology, and abdominal surgery for laparoscopic interventions and laparoscopic diagnostics. The products are used for endoscopic tumor treatment (esophagectomy). The products are used in thoracoscopy for tumor treatment, pleurectomy, lung biopsy, and endoscopic transthoracic sympathectomy (ETS). 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.

6

Contraindications and side effects

6.1

Contraindications Contraindications directly related to the product are presently unknown. If medical contraindications for the mentioned indications are known, the use of the products is not permitted. On the basis of the patient's general condition the doctor in charge must decide whether or not the planned use is possible.

6.2

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

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Combinations CAUTION Be careful not to combine products incorrectly! Injuries of the 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: ⊳ Light sources and flexible light cables ⊳ Video cameras ⊳ Lenses ⊳ Accessories for endoscopic use, e.g., trocar sleeves, forceps, electrodes The endoscope-side adapter (1.8) can be unscrewed and removed to allow the connection of a flexible light cable from a different manufacturer, using an appropriate adapter.

Fig. 1 Accessories for endoscopic use with 5 mm, 7 mm, and 8 mm, corresponding to the working channel in question and the working length. Lenses with C-Mount threads for working via the monitor. Ordering information can be found on the current catalog page.

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8

Illustration

8.1

Operating laparoscope

Item Designation

Item Designation

Meaning

A

Operating laparoscope; angled view

1.9

B

Operating laparoscope; oblique view

1.10 Autoclave

Possible steam sterilization with a fractionated procedure at 134°C (272°F)

1.1

Sheath tube

1.11 Raised ring

Increased object field, high detail resolution

1.2

Working channel

1.3

Insufflation stopcock

1.12 Color ring

1.4

Eyecup

Blue: Direction of view 0° Green: Direction of view 10°

1.5

Serial no.

1.13

Instrument port / instrument valve symbol

1.6

Model no.

1.7

Viewing direction indication

1.8

Cold light connection part

10

Ring

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Item

Designation

2

Automatic instrument valve 8911.318

2.1

Locking collar

2.3

Sealing cover

2.2

Membrane seal

2.4

Sealing cap for instrument guide channel

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Item Designation

11

9

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

ATTENTION Return damaged or incomplete products together with any loose parts for repair. Repairs must be carried out by authorized experts only.

9.1

Visual check 1. Check products and accessories for: ð Damage ð Surface changes (e.g., corrosion, cracks) ð Sharp edges not compatible with the intended application ð Loose or missing parts ð Rough surfaces 2. Any inscription, lettering, or labeling necessary for safe use as intended must be legible. 3. Check sealing caps and membrane valves for integrity and replace if necessary.

9.2

Function check 1. Check the image quality and light output with the system components. 2. Check the glass surfaces for coatings. ð Coatings on the glass surfaces can cause a blotchy or cloudy field of view and reduce the light transmission considerably. ð Clean glass surfaces with a cotton swab (wood, no metal or plastic) soaked in alcohol (70% isopropanol) and clean stubborn coatings with a suitable instrument cleaner (e.g., 1001) if necessary.

Fig. 2 3. Check the image quality and light output without the system components. 4. Hold the distal end of the endoscope toward a light source.

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ð Coatings on the glass surfaces can cause a blotchy or cloudy field of view and reduce the light transmission considerably

Fig. 3

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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10

Use WARNING The products have only limited strength! Applying excessive force will cause damage, impair the function and therefore endanger the patient. n 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. n Do not use the products if they are damaged, incomplete or have loose parts.

10.1

Preparation / Commissioning NOTE Wet auxiliary instruments with a sterile liquid for better insertion.

1. Check assembly (section 11 Reprocessing and maintenance) 2. Perform checks (section 9 Checks)

10.2

Connecting the automatic instrument valve 8911.318 The integrated working channel allows 5 mm auxiliary instruments to be inserted without gas loss via the automatic instrument valve 8911.318 (2). ¯ Connect the automatic instrument valve (2) to the operating laparoscope (1) and fix by screwing on the union nut (2.1).

Fig. 4

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10.3

General notes and instructions for use ATTENTION For maximum light output, the glass fiber cross-section on the flexible light cable and on the surgical laparoscope must be the same size.

10.3.1

Light WARNING Heat generation due to high light energy! Risk of unintentional tissue damage ⊳ due to insufficient distance between the light emission area and tissue ⊳ due to soiling on the light emission area Do not touch the light emission area and avoid direct contact with tissue. Remove the soiling.

WARNING Risk of injury due to fire! The high heat generation at the area where light is emitted can lead to excessive heating or ignition when the endoscope is put down on heat-sensitive, flammable surfaces (dark cloths, etc.). ⊳ Place the endoscope in a safe place.

10.3.2

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

ATTENTION Use only products with type BF or CF applied parts in conjunction with the instrument.

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10.3.3

HF application Observe the "Notes on HF application", order no. GA-S002 and those of the HF device manufacturer.

WARNING There is a risk of injury if the HF instrument is not in the operator's field of vision! Unintentional tissue damage as well as damage to the distal end of the endoscope and to the instrument parts are possible. Use HF instruments within the scope of the predetermined specifications (dielectric strength, operating mode). Do not activate HF instruments until the part conducting high-frequency current appears fully in the field of view of the endoscope and the intended application area is being contacted.

Fig. 5

CAUTION Risk of HF arcing! Too small a distance between parts conducting high-frequency current and other conductive parts can lead to unintentional damage to the tissue and the instrument. When HF power is activated, parts of HF instruments conducting high-frequency current must have a safety distance of at least 10 mm from the distal end of the endoscope. In the event of HF arcing, replace the electrode immediately, check the endoscope for damage, and send it in for repairs if necessary to prevent subsequent damage.

NOTE In the case of HF applications, interferences may occur in the endoscopic image. This is a normal occurence and does not indicate any malfunction.

NOTE We recommend starting at a lower power setting to determine the optimum power setting.

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10.3.4

Irrigation / suction WARNING Risk of injury due to excess irrigation fluid pressure! In order to avoid intraoperative injuries due to irrigation fluid overpressure, the irrigation fluid must flow away from the instrument set. Open the irrigation valve on the irrigation adapter and ensure that the instrument set is open proximally (do not put on a sealing cap).

CAUTION Due to the different anatomical conditions, it is not possible to quantify the irrigation power and suction power. These must be adapted by the user to the respective conditions.

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11

Reprocessing and maintenance WARNING Danger of infection! The products and accessories are delivered in unsterile condition. The use of unsterile products represents an infection hazard for patients, users and others. Products must be reprocessed at least once before the first use and each further use. The user must make sure that the reprocessing process including the resources, material and personnel yield the required results.

WARNING Danger of transmitting microorganisms! To protect the service staff, only send in products for repair that have been reprocessed according to the latest state of the art in hygiene. n Adhere to the reprocessing sequence described in the instructions for use.

ATTENTION n

n

n

Use only cleaning agents and disinfectants whose efficacy and material compatibility with endoscopes and endoscopic accessories has been tested and approved by the chemicals manufacturer. ð Examples of suitable active agents for chemical disinfection: - Ortho-phthalaldehyde - Ethandial, didecyldimethylammonium chloride - Formacedal, glutardialdehyde - Sodium carbonate peroxyhydrate Disinfectants meeting the test criteria of the VAH (Association for Applied Hygiene R.S.), FDA or other national certification bodies may also be used Do not use disinfectants containing peracetic acid without corrosion protection, phenols or chlorine components for the reprocessing of RICHARD WOLF products.

ATTENTION Product damage if non-released reprocessing processes are used.

ATTENTION Do not sterilize the products in hot-air sterilizers.

NOTE Brand new products. Before reprocessing, remove all protection foils and transport locks from the products and accessories.

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NOTE For chemicals whose material compatibility has been approved by Richard Wolf for the reprocessing of Richard Wolf products, please refer to the listing in document GA-J055. This document can be requested from Richard Wolf or downloaded from our website. RICHARD WOLF in the Internet www.richard-wolf.com/en/solutions/reprocessing/

n

NOTE When cleaning the products, follow these instructions: n

n

Products with long channels: Pull the cleaning brush through. ð Insert the bristle-free end of the cleaning brush into the channel and pull it out from the other end. Other products/components: Use brush strokes. ð Insert and remove the cleaning brush once.

See the diagram below:

1 x pull through

1 brush pass Required equipment Image

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Product no.

Designation, Technical data

68603

TRAY (WxHxD) 548x100x348MM

509.81

DISINFECTION BOX W 400 MM L 600 MM

7970407

CLEANING BRUSH Ø 7MM TL 400MM for Ø 4.6-6.5 mm channels, brush length 48 mm, PACK = 10 PCS, color: purple, for single use

7970409

CLEANING BRUSH Ø 9MM TL 400MM for Ø 6.6-8.5 mm channels, brush length 48 mm, PACK = 10 PCS, color: orange, for single use

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Image

Product no.

Designation, Technical data

8691

CLEANING BRUSH for surface cleaning, straight, PACK = 10 PCS, for single use

86.90

CLEANING BRUSH for surface cleaning, angled, reusable

6199.00

WATER JET CLEANING PISTOL (please note the pressure surge specifications)

-

-

LINT-FREE DISPOSABLE CLOTH

-

-

SYRINGE (20 ML)

-

-

ALCOHOL (70 % ISOPROPANOL)

-

-

COTTON SWABS Specifications: - sovent-resistent - head made of 100 % pure cotton - wooden or plastic swab carrier, not metal. - head diameter 35 mm

-

COLD TAP WATER (drinking water quality) 10 °C – 25 °C

For manual cleaning For sterilization

-

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33003

UNIVERSAL MESH BASKET 3

8584.1212

INSTRUMENT SIEVE BNDL

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