3D Telescopes 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

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

2

GA-A338

Contents 1

General notes and instructions for use...

4

1.1

Safety instructions and levels of danger...

4

2

Technical description...

5

3

Intended use...

5

3.1

Intended purpose ...

5

3.2

Intended use...

5

4

Indications and field of use ...

6

5

Contraindications and side effects ...

6

5.1

Contraindications...

6

5.2

Side effects...

6

6

Combinations ...

7

7

Illustration ...

8

7.1 7.1.1

3D telescopes... Legend and identifications...

8 8

7.2 7.2.1

Reprocessing basket ... Legend and identifications...

9 9

7.3

Symbols... 10

8

Application ... 11

8.1 8.1.1 8.1.2

Preparation ... 11 Connecting the 3D telescope to the system components ... 12 Attaching camera head to 3D telescope ... 13

8.2 8.2.1 8.2.2 8.2.3 8.2.4

Notes and instructions for use ... 14 Light... 14 Electrical current... 15 Image quality ... 15 HF applications... 15

9

Checks... 16

9.1

Visual check ... 16

9.2

Function check ... 17

10

Reprocessing and maintenance ... 18

10.1

Reprocessing procedure ... 19

10.2

Reprocessing process ... 19

11

Technical data and order data... 25

12

Spare parts and accessories ... 25

13

Operating, storage, transport and shipping conditions ... 26

13.1

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

GA-A338

3

1

General notes and instructions 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 product 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. 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.

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.

4

GA-A338

2

Technical description 3D telescopes 0°/30° Ø10 mm with suitable reprocessing basket comprise the following: 3D telescopes n n n n n

Sheath tube, integrated light guide, optical lens system Proximal guide sleeve Guide pins for attaching the camera head Cold-light connector, adapter endoscope end (can be unscrewed) Code number (numerical) and color coding ring for identifying the fiber bundle diameter

Reprocessing basket n n n n

Basket cover Basket bottom Spring lock Set of silicone chains

3

Intended use

3.1

Intended purpose 3D telescopes The non-active reusable 3D telescopes are used for short-term invasive surgical visual examination of the abdominal cavity/retroperitoneal cavity (laparoscopically), the thorax and their organs. Reprocessing basket The reprocessing basket houses the 3D telescope safely and gently during machine reprocessing, sterilization, transport and storage.

3.2

Intended use The patient selection for the application of the medical product herein described is not limited with regard to gender, origin, anamnesis and other framework conditions. On the basis of the medical state of the art and depending on the patient's condition, the attending physician must decide whether or not the planned application is possible. This product is designed exclusively for use by specialized medical personnel and may only be applied by medically qualified and adequately trained persons. The product is intended for use in the operating room.

GA-A338

5

4

Indications and field of use For examination and diagnosis in conjunction with endoscopic accessories. The product is used in the following medical disciplines: n n n n

Laparoscopic surgery Laparoscopic gynaecology Laparoscopic urology Thoracoscopy

5

Contraindications and side effects

5.1

Contraindications CJD

Creutzfeldt-Jakob Disease or a

vCJD

Variant of the Creutzfeldt-Jakob Disease

BSE

Bovine Spongiform Enzephalopathy; so-called mad cow disease (e.g. Creutzfeldt-Jakob Disease)

TSE

Transmissible Spongiform Enzephalopathy

On the basis of the patient's general condition the doctor in charge must decide whether the planned use is possible or not. 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.

5.2

Side effects No side effects are known if the system is used as intended.

6

GA-A338

6

Combinations 3D telescopes are used in conjunction with: n n n n n n n

Light source and fiber light cable Camera head Camera controller Monitor Video recorder (option) Printer (option) Endoscopic accessories, such as: – Trocar sleeves – Forceps – etc.

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.

The adapter, endoscope side, can be unscrewed and replaced by a suitable adapter to connect fiber light cables by other manufacturers. For order data please refer to the latest catalog sheets.

Fig. 1

NOTE For further information on fiber light cables please refer to the following instructions for use: n Fiber light cable sets: GA-A287 n Light cable: GA-A009

GA-A338

7

7

Illustration

7.1

3D telescopes 1

4

5 6

#

2 3

7 8

9

A 1 2 13 12 11 10 9

B

13 12 11 10 Fig. 2

7.1.1

8

Legend and identifications

Item

Designation

Item

Designation

A

3D telescope 0°

B

3D telescope 30°

1

Light exit

8

Serial no.

2

Objective window

9

Telescope channel

3

Indication of direction of view

10

Adapter, endoscope end

4

Specification of outer diameter of sheath tube

11

External thread for connecting suitable adapters

5

3DHD Identification for 3D high definition

12

Color coding ring Identification for fiber bundle diameter

6

Data matrix code

13

Numerical identification number identification of fiber bundle diameter

7

Guide pin

#

Product no.

GA-A338

7.2

Reprocessing basket

14.2

14

14.3 14.4

14.1

14.6 # 14.5

Fig. 3

7.2.1

Legend and identifications

Item

Designation

Item

Designation

14

Reprocessing basket

14.1

Basket cover

14.5

Spring lock

14.2

Retaining hooks

14.6

Spring lock latch

14.3

Silicone chains

#

Product no.

14.4

Basket bottom

GA-A338

9

7.3

Symbols

Symbols

Designation Follow the instruction manual Follow instructions for use Product number Lot code Manufacturer Manufacturing date Number, amount

Identification in conformity with medical devices directive 93/42/EEC only valid if the product and/ or packaging is marked with this symbol. Products of category IIa and above, as well as sterile products or products with measuring function of category I, are additionally identified with the code no. of the notified body (0124).

10

GA-A338

8

Application WARNING The products have only limited strength! Excessive force will cause damage, impair the function and therefore endanger the patient. n Immediately before and after use, check the products for damage, loose parts and completeness. Make sure that no missing instrument parts remain in the patient. n Do not use products which are damaged or incomplete or have loose parts.

8.1

Preparation 1. Carry out checks. ð Please refer to section 9 Checks ð Please refer to section 9.1 Visual check 2. Fasten adapter to 3D telescope.

Fig. 4

GA-A338

11

8.1.1

Connecting the 3D telescope to the system components ¯ Connect the fiber light cable to the adapter and to a suitable light source.

Fig. 5

ATTENTION To achieve optimum light transmission, the fiber bundle diameters of the endoscope and fiber light cable must match. Possible consequences if there is a mismatch: n Fiber light cables with excessively large fiber bundle diameter (cross-section) cause ð excessive heating at the coupling point with the endoscope n Fiber light cables with excessively small fiber bundle diameter (cross-section) cause ð reduced light output The suitable fiber bundle diameter can be recognized by the color coding ring and the code number on the endoscope. The color coding ring and the code number on the fiber light cable connector (side of the endoscope) must be the same.

CAUTION Intense heat due to high light energy! Unfavourable conditions can cause an increase in temperature at the coupling point of the fiber light cable and the light exit of the endoscope. Burns on the patient, user and others as well as damage to endoscope are possible. n Reduce the light output or choose a fiber light cable with suitable diameter.

12

GA-A338

8.1.2

Attaching camera head to 3D telescope ATTENTION Attach the camera head to the 3D telescope only in dry condition. There must be no moisture in the connection.

NOTE The snap-on locking mechanism of the camera head is unlocked and pre-tensioned. The 3D telescope can be locked in the camera head in either one of the two positions (0° and 180°). Locking 1. Plug the 3D telescope onto the camera head. ð The snap-on locking mechanism of the camera head locks automatically. ð The 3D telescope is locked in place. 2. Check for secure connection

Fig. 6 Unlocking 1. Turn the snap-on locking mechanism in direction of arrow and remove the 3D telescope.

Fig. 7 2. Carry out a function check. ð Please refer to section 9.2 Function check

GA-A338

13

8.2

Notes and instructions for use

8.2.1

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 - When using high performance light sources n Do not touch the light exit area and avoid direct contact with the tissue. n Remove any soiling

CAUTION 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. n Store the endoscope in a safe place. n Switch off the light source if you do not use the endoscope for a period of time.

CAUTION Danger of burns! Due to the high energy of the light source, the adapter and glass surfaces on 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. n Do not touch the adapter or the glass surface of the fiber light cable. n Allow the fiber light cable to cool down.

CAUTION Danger of injury due to dazzling! Danger of impaired sight. n Do not look into the light exit area or into the free end of an endoscope or fiber light cable that is connected to a light source.

14

GA-A338

8.2.2

Electrical current ATTENTION Use only products with type CF applied parts in conjunction with this instrument.

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.

8.2.3

Image quality WARNING Increased risk potential if the image is blurred! Danger of injuring the patient. n Stop the intervention for safety reasons if the image is blurred. n Check the image quality of the endoscope before use.

8.2.4

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

WARNING Danger of injury! Danger of injury if the HF instrument is not visible through the endoscope! Inadvertent tissue injury as well as damage to the distal end of the endoscope can occur. n Activate HF instruments only after the live part carrying HF current is fully visible through the scope and makes contact with the application area.

WARNING HF sparking! Danger of injury if there is insufficient distance between the part of the HF product carrying high frequency and other conductive parts. During HF current activation, the parts of HF products carrying HF current must have a safe distance of at least 10 mm from other conductive parts.

GA-A338

15

9

Checks CAUTION Injury due to damaged or incomplete products! Injuries of the patient, user and others are possible. n Run through the checks before and after each use. n Do not use the products if they are damaged, incomplete or have loose parts. n Return damaged products together with any loose parts for repair. n Do not attempt to do any repairs yourself.

9.1

Visual check 1. Check the 3D telescope, in particular the distal area as well as the reprocessing basket for: ð damage ð surface changes (e. g. 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 silicone chains for damage. ð Replace torn and overstretched silicone chains. ð We recommend replacing the silicone chains after 200 reprocessing cycles

16

GA-A338

9.2

Function check 1. Check for secure connections. 2. Check all components for easy assembly. Replace the products if the connection is not secure or is difficult to assemble or screw together. 3. Check the closing function of the spring lock latches. 4. Check image quality and light output in conjunction with the system components. ð Deposits on the glass surfaces can cause a stained or blurred field of view and may impair the light transmission considerably. ð Clean the glass surfaces with a swab soaked with alcohol (70% isopropanol) (wooden swab carrier, not metal or plastic). Clean hard-to-remove deposits with a suitable instrument cleaner (e.g. type 1001).

Fig. 8 5. Check image quality and light output without the system components. 6. Hold the distal end of the endoscope towards a light source. ð 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.

Fig. 9

GA-A338

17

10

Reprocessing and maintenance WARNING Creutzfeldt-Jakob Disease! n

n

If the patient is suspected of having Creutzfeldt-Jakob Disease (CJD) or a variant of the Creutzfeldt-Jakob Disease (vCJD) or the latter have been diagnosed, adequate measures must be taken to prevent possible transmission to other patients, users and third parties. The country-specific reprocessing guidelines and regulations must be adhered to.

NOTE For general notes and instructions on reprocessing please refer to the description in manual GA-J020 „Reprocessing of RICHARD WOLF heat-stable instruments“. n Disinfectants containing peracetic acid without corrosion protection, phenoles or chlorine components must not be used for the reprocessing of Richard Wolf products. n Adhere to the concentration and maximum immersion time of the different disinfectants specified by the manufacturer.

NOTE Water qualities n

n

n

Drinking water ð Drinking water is fresh water with a high degree of purity and suitable for human consumption. ð Drinking water must be free of pathogenic microorganisms and should contain a minimum concentration of minerals. ð The national guidelines of the Drinking Water Ordinance must be followed. Fully demineralized water (FD water) ð There is no standard for fully demineralized water. For this reason the boiler feed water quality defined in EN285, Appendix B and ISO17665 is also recommended for machine or manual reprocessing. ð By way of derogation from the requirements in these two standards, a conductivity of approx. 15 µS/cm is sufficient for machine and manual cleaning and disinfection. Also see the notes in the "Red Brochure" ð Instrument reprocessing - Reprocessing of Instruments to Retain Value www.a-k-i.org

NOTE Machine cleaning / disinfection should be preferred. Manual cleaning / disinfection can be carried out if there is no possibility of machine cleaning / disinfection.

18

GA-A338

10.1

Reprocessing procedure The following describes the reprocessing procedure used by Richard Wolf GmbH for the validation.

ATTENTION n

n

n

n

n

If the instrument is used as intended and provided that the manufacturer's manual is followed, it is not necessary to limit the number of possible reprocessing cycles. Careful and gentle handling during the entire reprocessing process has an essential influence on the service life of medical products. Before returning defective products for repair, they must have been subjected to the entire reprocessing cycle. The user is responsible for guaranteeing that the reprocessing process including the resources, material and personnel are suitable for obtaining the required results. The national and international requirements regarding the validation of the user's reprocessing process must be followed.

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

10.2

Reprocessing process ¯ Remove the fiber light cable from the 3D telescope.

Preparation at the point of use Immediately after use, remove coarse soiling from the products. If there are more than 6 hours between use and reprocessing, rinse out narrow hollow spaces with a 20 ml syringe filled with water. Do not use any agents (such as aldehyde) or hot water (> 40 °C) for precleaning, as they will bake residues to the surfaces. Transport To avoid product damage and contamination of the environment, safe storage in a closed container is necessary. Disassembly before cleaning 1. Remove the adapter, endoscope end, from the 3D telescope. 2. Remove the adapters on the endoscope end and projector end from the fiber light cable.

Fig. 10

GA-A338

19

Machine cleaning

ATTENTION Do not use care products or drying aids The application of care products as well as the use of chemical drying aids (e.g. rinse aid) during machine reprocessing can cause functional, material and biocompatible impairments on endoscopes and endoscopic accessories. 1. Place the reprocessing basket on a level surface and open the spring lock. 2. Lift off the basket cover.

Fig. 11 3. Place the 3D telescope with the cold-light connector between the silicone chains, 7- and 8-fold, into the basket bottom as shown in the figure. 4. Plug the adapter, endoscope end, of the 3D telescope as well as the adapters, endoscope end and projector end, of the fiber light cable onto the holders in the basket bottom.

Fig. 12

20

GA-A338