EYE MAX CCD Endoscopes Instructions Manual

Important general instructions for use Ensure that this product is used only as intended and described in this instruction manual, by adequately trained and qualified personnel, and that maintenance and repair is only carried out by authorized specialized technicians. Use this product only with the combinations and with the accessories and spare parts listed in this instruction manual. Use other combinations, accessories and replacement parts only if they are expressly intended for this use and if the performance and safety requirements are met. Reprocess the products before every application and before returning them for repair as required by the instruction manual in order to protect the patient, user or third parties. Subject to technical changes! Due to continuous development of our products, illustrations and technical data may deviate slightly from the data in this manual. CAUTION -- USA only: Federal law restricts this device to sale by or on the order of a physician.

Safety instructions and levels of danger Symbol

Level of danger WARNING! Failure to observe can result in death or serious injury. CAUTION! Failure to observe can result in slight injury or damage to the product. 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--300 MANUFACTURER [email protected] www.richard--wolf.com

USA RICHARD WOLF Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Telephone: +1 84 79 13 11 13 Telefax: +1 84 79 13 14 88 sales&[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

FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette 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 1160 Vienna Telephone: +43 14 05 51 51 Telefax: +43 1405 51 51 45

[email protected]

[email protected] www.richard--wolf.at

[email protected] www.richard--wolf.be 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

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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

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Contents 1

Technical description...

1

2

Intended use...

1

3

Indications and field of use...

1

4

Contraindications...

1

5

Combinations...

1

6 6.1

Illustration... Legend and identification...

3 3

7 7.1 7.1.1 7.2 7.2.1 7.2.2 7.2.3 7.2.4 7.2.5 7.3

Use... Preparation... Connect the CCD endoscope to the system components... Additional notes and instructions for use... Horizontal image alignment... Light... Current... Image quality... HF application... Function assignment of remote--control buttons (3)...

5 5 6 7 7 8 8 8 9 9

8 8.1 8.2

Checks... 9 Visual check... 9 Functional check... 10

9 9.1 9.2 9.3 9.3.1 9.4 9.5 9.6 9.6.1 9.6.2 9.6.3

Reprocessing and maintenance... Disassembly before cleaning... Manual reprocessing... Machine reprocessing... Loading the reprocessing basket... Checks... Assembly before sterilization... Sterilization... Loading the reprocessing basket... Steam sterilization... STERIS and STERRAD sterilization procedures...

10

Technical data and order data... 14

11

Spare parts and accessories... 14

12 12.1

Operating, storage, transport and shipping conditions... 14 Disposal of product, packaging material and accessories... 14

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11 11 12 12 12 12 12 13 13 13 13

I

1

Technical description CCD endoscopes consisting of: distal external tube internal light cable and CCD proximal light connector female jack for video cable remote control buttons rotary ring (only CCD endoscope (B), direction of view 30° )

2

Intended use The CCD endoscopes are used to visualize the inside of a patient via natural or surgically created passages. Rotary ring (only CCD endoscope (B), direction of view 30° ) for mechanical image alignment to obtain horizontal images on the monitor when rotating the CCD endoscope around its longitudinal axis.

3

Indications and field of use For examination, diagnosis and/or therapy in conjunction with endoscopic accessories in laparoscopy. CAUTION ! Video signal processing may fail ! As a result, the operation may either be delayed or may have to be terminated. Make sure that a comparable or conventional system ready to use is available to make sure that the user can complete the operation should the video image fail.

4

Contraindications Contraindications directly related to the product are presently unknown. On the basis of the patient’s general condition the physician/surgeon in charge must decide whether the planned use is possible or not. For further information see the latest medical literature.

5

Combinations CCD endoscopes with camera cable (removable) are used in conjunction with: 1 CCD--ENDOCAM 5520.xxx Light sources and flexible light cables Endoscopic accessories, e.g. trocar sleeves IMPORTANT ! When using the CCD endoscope make sure you follow the instruction manual GA--A 190 for the 1 CCD ENDOCAM 5520. The CCD endoscope can be connected to the following camera controllers:

1

Camera controllers

Can be used from series no.:

5520.102

03 0101

5520.201

03 0151

5520.210

03 0145

5520.702

03 0101

5520.810

03 0108

5520.801

03 0106

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CAUTION ! Caution if products are incorrectly combined ! Possible injury of the patient, user or others as well as possible damage to the product. Different products should only be used in combination if their intended uses and relevant technical data (working length, diameter, etc.) are the same. Follow the instruction manuals of the products used in conjunction with this product.

5

The cold--light connector (5) can be unscrewed and replaced by suitable adapters in order to connect flexible light cables made by other manufacturers (Fig.1). For order data please refer to the latest catalog sheet.

Fig. 1

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2

6

Illustration

A 1 2

6.3

B #7 4.1

3

#

6.3

6.1

6 4

5

#8

7 6.3

6.2

#2 #4 #1 #3 #5 #6

Fig. 2 6.1

Legend and identification Item A B

CCD Endoscope, direction of view 0° without rotating ring (4)

CCD Endoscope, direction of view 30° with rotating ring (4)

Item

Designation

5

Cold--light connector

6

Camera cable, removable Camera plug

1

Light exit

6.1

2

End window

6.2

3

Remote control buttons

6.3

Reference dots

Rotating ring

7

Protection cap for camera plug (6.2)

4 4.1

(for connection to CCD endoscope)

Camera plug (for connection to CCD ENDOCAM)

Alignment pin (for horizontal image alignment)

#

Further identifications:

#1

Product no.

#5

Serial number

#2

Follow instructions for use

#6

Trash can

#3

CE 0124

#7

Direction of view / AUTOCLAVE

#8

Writing: eyeMAX

#4

3

Designation

IPX7 (protected aginst the effects of permanent immersion)

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Symbols

Designation Caution! Attention!

Follow instructions for use

REF

Order number

SN

Serial number

Do not place product in general waste bin. Recycle separately

IPX7

protected aginst the effects of permanent immersion Identification in conformity with Medical Devices Directive 93/42/EEC only valid if the product and/or packaging are marked with this symbol. Products of category IIa and above, as well as sterile products or products with measuring function in category I, are additionally marked with the code number of the notified body (0124).

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4

7

Use CAUTION ! The products have only limited strength ! Exerting excessive force will cause damage, impair the function and therefore endanger the patient. Immediately before and after each use, check the products for damage, loose parts and completeness. Ensure that no missing instrument parts remain in the patient. Do not use products which are damaged, incomplete or have loose parts.

7.1

Preparation Unscrew the protection cap (7) from the camera plug (6.2) (Fig. 3). Run through the checks: Sections 8 and 8.1

6.2

7

Fig. 3

A

Plug the camera plug (6.1) into the CCD endoscope as far as it will go. Do not apply excessive force (Fig. 4). The reference dot (6.3) of the camera plug (6.1) must be aligned with the dot on the CCD endoscope.

6.3

6.1 Fig. 4

5

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7.1.1

Connect the CCD endoscope to the system components Fig. 5 Connect the CCD endoscope via a flexible light cable to a suitable light source. NOTE ! Optimum light efficiency with minimum heating of the connection is achieved if the effective diameter of the fiber core of the flexible light cable and that of the endoscope are the same. We recommend using the following Richard Wolf flexible light cables: For CCD Endoscopes 8934.xxx flexible light cable, high temperature resistant 8063.353 or 8061.456 For CCD Endoscopes 8935.xxx flexible light cable 8061.356 CAUTION ! Intense heat due to high light energy! In the case of unfavorable combinations, the use of the high temperature resistant flexible light cable 8063.353 together with the CCD Endoscopes 8935.xxx can lead to increased temperatures at the coupling point between the flexible light cable and the endoscope. The user may suffer burns and the endoscope may become damaged. Use the recommended flexible light cables or reduce the light output. Plug the camera plug (6.2) into the 1 CCD ENDOCAM 5520.xxx as far as it will go. Do not apply excessive force. The reference dot (6.3) of the camera plug (6.2) must be aligned with the reference dot of the 1 CCD--ENDOCAM.

Light source

6.2

6.3

1 CCD ENDOCAM

Fig. 5

Carry out a function check: Section 8.2

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6

7.2

Additional notes and instructions for use The CCD endoscope (B) -- direction of view 30 is equipped with mechanical image alignment. After rotating the CCD endoscope around its longitudinal axis, this feature allows horizontal alignment of the image on the monitor by means of the rotating ring (4).

7.2.1

Horizontal image alignment CCD endoscope (B), direction of view 30 Position of the alignment pin (4.1) (Fig. 6) The alignment pin (4.1) is facing upward.

B

4 4.1

Fig. 6

The rotating ring (4) can be rotated through 360 and has 2 snap--in positions (0 and 180 ). NOTE ! Handling options to achieve horizontal image alignment: Hold the rotating ring (4) keeping the image aligned horizontally [alignment pin (4.1) is facing upward] while turning the CCD endoscope (B) to the required position. Turn the CCD endoscope (B) to the required position and hold it in this position. Align the image horizontally using rotating ring (4). CCD endoscope (A), direction of view 0 Position of remote--control buttons (3) (Fig. 7) The remote--control buttons (3) are facing upward.

3

A

Fig. 7

7

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7.2.2

Light IMPORTANT ! Use only products with type BF / CF applied parts in conjunction with this endoscope. WARNING ! Intense heat due to high light energy ! Danger of unintentional tissue damage - as a result of insufficient distance between the light exit area and the tissue - due to soiling in the light exit area. Do not touch the light exit area and avoid direct contact of that area with the tissue. Remove any soiling from the light exit area. WARNING ! Fire hazard ! The intense heat at the light exit area may cause excessive heating or even ignition if the endoscope is placed onto heat- sensitive flammable surfaces (such as dark drapes, etc.). Lay down the endoscope in a safe place. Switch off the light source if you do not intend to use the endoscope for a period of time. CAUTION ! Danger of burns ! Due to the high output of the light source, the cold light connector is extremely hot when disconnected. This may result in burns due to inadvertent contact. Do not touch the cold- light connection. Allow the cold light connector to cool down sufficiently.

7.2.3

Current WARNING ! Electric shock hazard ! Patient leakage currents can add up if endoscopes are combined with powered endoscopic accessories. Make sure that the combination won’t exceed the permissible patient leakage currents.

7.2.4

Image quality CAUTION ! Increased hazard potential if image is blurred ! Danger of injuring the patient. Interrupt the operation for safety reasons. Check the image quality before using the endoscope (Section 8.2).

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8

7.2.5

HF application Make sure you observe the “notes and instructions on HF applications, order no. GA--S 002 as well as the HF device manufacturer’s instructions. WARNING ! Danger of burns ! Plastic trocar sleeves do not guarantee a sufficiently large contact surface between the instrument and the patient. Inadvertent actuation of the HF instrument outside the body may generate stray or leakage currents which can cause unintended tissue coagulations. Note: Do not activate the HF instrument outside the body ! WARNING ! Danger of burns ! If the neutral electrode is connected but the HF instrument is not, the CCD endoscope may conduct HF current if the HF surgical device is activated during tissue contact. This can result in unintentional tissue coagulation. Make sure you do not activate the HF surgical device by unintentional actuation of the foot switch.

7.3

Function assignment of remote--control buttons (3). When connecting the CCD endoscope, the parameters defined for the button functions (pushbutton I + II or Left + Right ) are taken over. The assignment can be modified in accordance with Section 5.6 “setup menu” of Instruction Manual GA--A 190.

8

Checks CAUTION ! Be careful if products are damaged or incomplete ! Possible injury of patient, user or third persons. Run through the checks before and after each use. Do not use products which are damaged or incomplete or have loose parts. Return damaged products together with loose parts for repair. Do not attempt to do any repairs yourself.

8.1

Visual check Check the CCD endoscope, camera cable (removable) and the accessories for: damage sharp edges loose or missing parts rough surfaces Any lettering, labeling or identification necessary for the safe intended use must be legible. Missing or illegible lettering, labeling or identification which may lead to wrong handling and reprocessing must be restored. Check the pins in the CCD--Endoscope connector and camera plug (6.2) for correct alignment. Send in the CCD--Endoscope or camera cable (6) for repair, if necessary. Check the camera plugs (6.1) / (6.2) for deformations.

9

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8.2

Functional check Carry out the functional check in conjuction with the 1 CCD ENDOCAM 5520.xxx in accordance with Manual GA--A 190. Check the rotating ring (4) for easy rotation, snap--in positions and end stop. Check the connections for secure connection. Check the flexible light cable and camera cable (6) for compatibility. Check image quality and light output in conjunction with the system components. Check the glass surfaces for any deposits. Any deposits on the glass surfaces may result in a spotted or blurred field of vision and can considerably impair light transmission. Clean the glass surfaces with a swab soaked in alcohol (wooden swab carrier, not metal or plastic), remove hard--to--remove deposits with instrument cleaner* (Fig. 8).

*see instruction manual GA--J020 ”Reprocessing of RICHARD WOLF Heat--Stable Instruments”.

Fig.8 Check the light output without the system components. Hold the distal end of the endoscope towards a light source. Broken fibers appear as black dots in the cold--light connector. If approx. 30% of the fibers are broken, the light output is no longer sufficient (Fig. 9).

Fig. 9

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10

9

Reprocessing and maintenance IMPORTANT ! Further notes and instructions on reprocessing are described in manual GA--J020 ”Reprocessing of RICHARD WOLF Heat- Stable Instruments”, and these must be followed. IMPORTANT ! Do not clean the CCD endoscope in an ultrasonic bath ! IMPORTANT ! Reprocess the camera plug (6.2) only with the protection cap (7) in place. If inadvertently liquid gets into the camera plug (6.2) (e.g. because you forgot the protection cap), rinse the plug briefly with clear water, then dry carefully (with compressed air, if necessary). When drying the plug maintain a safe distance between the compressed air gun and the pins of the camera plug (6.2) to avoid damage to the pins.

9.1

Disassembly before cleaning IMPORTANT ! The camera plug (6.1 / 6.2) can be damaged by external forces, such as inadvertent hard contact with an object or when it is dropped ! During assembly make sure that the camera plug (6.1 / 6.2) is handled with due care. IMPORTANT ! Do not pull the camera cable (6) ! Do not squeeze, compress and / or excessively bend the camera cable.This can damage the wiring and result in image failure. Disconnect the flexible light cable from the CCD endoscope and from the light source. Fig. 10 6.1

IMPORTANT ! The camera plug (6.1) may only be disconnected from the CCD endoscope by pulling on the knurled surface of the camera plug (6.1). Disconnect the camera plug (6.1) from the CCD endoscope and the camera plug (6.2) from the CCD ENDOCAM.

Fig. 10 Unscrew the cold--light connector (5) (Fig. 11).

5

Fig. 11

11

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9.2

Manual reprocessing Wet preparation at the point of use IMPORTANT ! Do not remove the removable camera cable (6) from the CCD endoscope during the entire reprocessing procedure. Disassembly before cleaning: see section 9.1 Manual cleaning / disinfection Clean the remote--control button (3) with a soft brush. Check that no contaminant residues remain on the buttons.

9.3

Machine reprocessing Screw the protection cap (7) onto the camera plug (6.2) (Fig. 12).

7

6.2

Fig. 12 NOTE ! Machine reprocessing should be carried out in the reprocessing basket. Dry preparation at the point of use Disassembly before cleaning: see section 9.1 9.3.1

Loading the reprocessing basket Place the CCD endoscope, cold--light connector (5) and removable camera cable (6) into the holders provided (fig. 13).

38045.211

5

6 Fig. 13 Machine cleaning / disinfection

9.4

Checks Perform a visual check (see section 8.1)

9.5

Assembly before sterilization NOTE ! Before sterilization, screw on the screw connections only loosely to allow-an adequate flow of the sterilization medium. Tighten all screw connection before use. Screw on the cold--light connector (5) 1--2 turns.

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9.6

Sterilization CAUTION ! Humidity in the area of the connectors of the camera cable (6) ! When sterilizing the CCD endoscope with the camera cable (6) plugged in, this may result in a loss of sterility as well as possible failure of functions during the operation, endangering the patient. Before sterilization, remove the camera cable (6) from the CCD endoscope. Loading the reprocessing basket Place the CCD endoscope and the removable camera cable (6) into the holders provided (Fig. 14).

38045.211

9.6.1

6 Fig. 14

For sterilization, wrap the reprocessing basket in a special packaging in accordance with the country--specific regulations, e.g. EN 868, or use a suitable sterilization container. 9.6.2

Steam sterilization

9.6.3

STERIS and STERRAD sterilization procedures

Steam sterilization at 134°C (273° F) using the fractional pre--vacuum method.

NOTE ! The STERIS  and STERRAD  sterilization procedures have been certified for endoscopes and endoscopic accessories only with regard to their material compatibility.

13

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10

Technical data and order data CCD endoscopes Model / type TV standard

Diameter mm

Working length mm

Direction of view [°]

8934.531

PAL

10

303.5

0

8934.532

PAL

10

303.3

30

8934.581

NTSC

10

303.5

0

8934.582

NTSC

10

303.3

30

8935.531

PAL

5,3

300

0

8935.532

PAL

5,3

302,7

30

8935.581

NTSC

5,3

300

0

8935.582

NTSC

5,3

302,7

30

85520.851

CAMERA HEAD CABLE 2.6M

Classification of applied part: See identification of camera jack on the camera controller used (5520.xxx)

11

Spare parts and accessories CCD Endoscope Product no.

Designation, technical data 8934.xxx

8061.456

FIBER LIGHT CABLE Ø 4.5MM TL 3M

8061.356

FIBER LIGHT CABLE Ø 3.5MM TL 3M

8063.353

FIBER LIGHT CABLE Ø 3.5MM TL 2.3M

38045.211

REPROCESS BASKET = recommended

8935.xxx

= not recommended

The products can be combined as required provided the relevant technical data and intended uses are observed. For the general overview please refer to the latest catalog sheets and brochures, or contact Richard Wolf or your Richard Wolf representative.

12

Operating, storage, transport and shipping conditions. Operating conditions

+10°C to +40°C , 30% to 75% rel. humidity, atmospheric pressure 700 hPa to 1060 hPa

Storage, transport and shipping conditions

-- 20°C to +60°C , 10% to 90% rel. humidity, atmospheric pressure 700 hPa to 1060 hPa

NOTE ! To prevent damage during transport or shipment of the products we recommend using the original packaging material.

12.1

Disposal of product, packaging material and accessories. For the disposal observe the regulations and laws valid in your country. For further information please contact the manufacturer.

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