HD Autoclavable Camera Head 8555091x Instruction 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

Symbols...

1

2

Intended use...

1

3

Indications and field of use...

1

4

Contraindications...

1

5

Combinations...

1

6 6.1 6.1.1

Illustration... Autoclavable camera head... Legend...

2 2 2

7 7.1

Preparation... Connecting the endoscopes to the camera head...

3 3

8 8.1 8.2

Checks... Visual check... Function check...

4 4 4

9 9.1 9.2

Use... Function assignment of camera head buttons... Additional notes and instructions for use...

5 5 5

10 10.1 10.2 10.2.1 10.2.2 10.2.3 10.3 10.4

Reprocessing... Overview of camera head reprocessing... Reprocessing of steam--sterilizeable camera head... Manual reprocessing... Checks... Contaminated camera plug... Sterilization... Maintenance intervals...

6 6 6 6 6 6 7 7

11

Technical data...

8

12

Spare parts and accessories...

8

13 13.1

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

8 8

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1

Symbols Symbols

Meaning Attention, consult ACCOMPANYING DOCUMENTS TYPE BF APPLIED PART

Do not place product in general waste bin. Recycle separately. 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 marked with the code number of the notified body (0124)

2

Intended use The HD camera head 85550911/85550912 is designed for use in conjunction with the 3 CCD HDTV ENDOCAM 5550101 for diagnostic and therapeutic interventions. CAUTION! There is the possibility of camera head failure. For therapeutic applications a second camera head of the same type should be available.

3

Indications and field of use The product may only be used by adequately qualified and trained medical personnel.

.

4

NOTE! We recommend reading relevant literature on the planned application.

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 CAUTION! Different products may only be combined if their intended use and the relevant technical data (working length, diameter, etc.) are the same. Make sure you observe the instruction manuals of the products used in combination with this product. The camera head may only be used if the corresponding instruction manual for the 3 CCD HDTV ENDOCAM 5550101 (GA--A 253) is followed.

1

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6

Illustration

6.1

Autoclavable camera head

3

2 IPX7

4

#

1

85550xxx

3.1

5 6

6.1.1

Legend Item

Designation

1

Camera head

2

Buttons for remote control (For button assignment, see GA--A 253)

3

Integrated lens with locking mechanism

3.1

Focusing ring

4

Protection cap for locking mechanism

5

Camera plug

6

Plug protection cap

#

Product no.

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2

7

Preparation .

IMPORTANT! Never direct the camera head at the sun or bright light sources in the vicinity. High--energy radiation in both the visible and ultraviolet wavelength ranges can damage the surface of the CCD chip which may result in wrong color rendition and image noise. If the camera head is not used, the lens protection cap must be in place.

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IMPORTANT! Never pull at the camera cable. Never squeeze, pinch and/or excessively bend the camera cable as this may damage the leads and therefore cause image failure.

Connecting the endoscopes to the camera head

7.1

.

NOTE! Before mounting the lens, check that the glass surfaces of the lens and the camera head are dry and dust--free. Remove any deposits with a cotton swab soaked with alcohol (wooden or plastic swab carrier, not metal). Z Remove the protection cap from the objective lens. Z Attaching the endoscope to the objective lens: ' Push together the locking collar tab (B) and the nose(A) -- insert the endoscope (Fig. 3) -- and let go of tab (B) (Fig. 1). Z Locking the endoscope in place: ' Push locking collar tab (B) in the direction indicated by the arrow marked ”fix” while holding nose (A) in position (Fig. 2).

A

A

Fig. 2

Fig. 1

B

B

Fig. 3

3

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8

Checks .

8.1

IMPORTANT! Run through the checks before and after each use. Do not use products which 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.

Visual check Z Before and after each use, check the camera head and accessories for damage, sharp edges, loose or missing parts and rough surfaces. Z Check the connection cables and connectors for damage. Z 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. Z Check the function of the locking mechanism.

8.2

Function check Z Carry out the function check of the camera head which is used together with the 3 CCD HDTV ENDOCAM 5550, see GA--A 253.

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9

Use CAUTION! Risk of transmitting microorganisms! To prevent contamination of the camera plug when removing it from the camera controller during the surgical procedure, screw on the protection cap immediately after removing the plug. The contaminated camera plug must be thoroughly cleaned, disinfected and then rinsed with sterile water before the protection cap is attached, and the contacts must be adequately dried. Any residual moisture in the contacts can impair signal transmission (e.g. interruptions, poor contact).

. 9.1

IMPORTANT! The camera heads cannot be used for PDD applications.

Function assignment of camera head buttons Z The function assignment of the camera head buttons is carried out as described in the manual of the 3 CCD HDTV ENDOCAM 5550, GA--A 253.

9.2

Additional notes and instructions for use CAUTION! Loss of image information if you set the camera lens to full image format! If you choose full image format (Fig. 5), some parts of the endoscopic image (grey surface) won’t show on the monitor.

Focusing: Z Turn the focusing ring (3.1) until the image on the monitor is properly focused. ' For the close range, turn as indicated by the arrow marked (Fig. 4). ' For the long range, turn as indicated by the arrow marked (Fig. 4).

Fig. 5 3.1

Fig. 4

5

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Reprocessing .

IMPORTANT! Follow the latest notes and instructions in the GA--J020 Manual on the “Reprocessing of RICHARD WOLF Thermally Stable Instruments“. Do not use disinfectants containing peracetic acid without corrosion protection agents, phenols or chlorine components for the reprocessing of Richard Wolf products. Do not exceed the maximum exposure time specified by the manufacturer of the disinfectants used.

10.1

Overview of camera head reprocessing Cleaning

85550911 85550912

Manual

Machine

Ultrasound

Manual disinfection

+

+

--

+

Sterilization Steam

Gas

STERIS

STERRAD

+

+

--

+

+ = Recommended , -- = must not be used! 10.2

Reprocessing of steam--sterilizeable camera head

.

10.2.1

IMPORTANT! Only immerse and sterilize the camera plug with the protective cap in place. If liquid enters the camera plug (e.g. because you forgot to put the cap on) carefully rinse the plug out with clear water and dry carefully (with compressed air if necessary).

Manual reprocessing Wet preparation at the point of use: Z For wet preparation at the point of use and subsequent reprocessing, do not attach the protection cap for the objective lens. Manual cleaning: Z Rinse the camera head and cable under the tap. Z Manually clean the camera head buttons with a soft brush. ' Check that there are no contaminant residues left on the buttons. Z After cleaning thoroughly rinse with demineralized water and carefully dry with cloth. Z Clean the glass surfaces on the objective lens with a cotton swab soaked with alcohol (swab carrier made of wood or plastic material, not metal). Disinfection: Z Immerse the camera head in a disinfectant solution. ' For the exposure time and concentration, strictly adhere to the disinfectant manufacturer’s instructions. Z Then thoroughly rinse with demineralized water and dry with sterile swabs and cloths. Z Clean the glass surfaces with a cotton swab soaked with alcohol.

10.2.2

Checks Z Check all parts for damage and replace, if necessary.

10.2.3

Contaminated camera plug Z Clean and disinfect the contaminated camera plug, then rinse with sterile water. Thoroughly dry the contacts. ' Any residual moisture in the contacts can impair signal transmission (e.g. interruptions, poor contact).

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6

10.3

Sterilization

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IMPORTANT! When loading the sterilizer, follow the sterilizer manufacturer’s instructions. Do not overload the sterilizer. Z For sterilization, wrap the reprocessing basket in a sterilize packaging as required by the country--specific regulations, e.g. EN 868, or use a suitable sterilization container. Steam sterilization: Z Steam--sterilize the camera head and camera cable using the pre--vacuum method at 134C (273 F). Gas sterilization: Z Gas--sterilize the camera head and camera cable using formaldehyde (FA) or ethylene oxide (EtO). STERRAD sterilization procedures

.

10.4

NOTE! The STERRAD  sterilization procedures have been approved for use on our endoscopes and endoscopic accessories only with regard to material compatibility.

Maintenance intervals

.

7

IMPORTANT! To avoid any incidents or damage caused by aging and wear it is necessary to service the product and the accessories at adequate intervals. Depending on the frequency of use, but at least once a year, have an expert check the functional and operational safety of the equipment.

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Technical data Camera head

for camera controller

Autoclavable (camera head)

5550101

yes

85550911 85550912 Classification of applied part

BF

Degree of protection against the ingress of liquids

IP X7

Weight -- camera head

0.230 kg (0.505 lbs)

Weight with camera cable

0.460 kg (1.001 lbs)

Dimensions of camera head

Camera housing, W x H approx. 38 x 50 mm Length of anti--kink sleeve approx. 130 mm strain relief 25_

dia of locking mechanism approx. 47 mm

Length of camera cable

approx. 3.0 m

Integrated objective lens with locking mechanism:

12

85550912

f = 18.5 mm

85550911

f = 13 mm

Spare parts and accessories Product no.

Designation

15135.248

Protection cap for locking mechanism ' Further accessories on request

13

Operating, storage, transport and shipping conditions

.

13.1

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 the transport or shipment of the products we recommend using the original packaging material.

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

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