ENDOCAM Logic HD 8552590x Instruction Manual V1.0 July 2012

Important general notes and instructions for use Make sure that this product is used only as intended and described in this instruction manual, by adequately trained and qualified medical personnel, and that maintenance and repair are only 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 not impaired. Do not alter the product in any way. Reprocess the products before every application and before returning them for repairs as required by the instruction manual in order to protect the patient, user and others. Immediately upon receipt, check the product and its accessories for completeness and possible damage. Should the shipment give right 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 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 !

.

NOTE !

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

BB-A 282-01

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 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

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

[email protected]

[email protected] www.richard-wolf.com

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

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

0

Contents 1 1.1 1.2 1.3 1.4 1.4.1 1.4.2 1.5

General information... Symbol... Intended use... Indications and field of application... Contraindications and side effects... Contraindications... Side effects... Combinations...

1 1 1 1 2 2 2 2

2 2.1

Illustration... Camera head...

3 3

3 3.1

Preparation... Connecting the objective lenses and endoscopes to the camera head...

4 4

4 4.1 4.2

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

6 6 6

5 5.1

Use... Function assignment of the camera head buttons...

6 6

6 6.1 6.2 6.2.1 6.2.2 6.3 6.4 6.5

Reprocessing and maintenance... Overview: reprocessing of camera heads... Reprocessing of camera heads... Checks... Contaminated camera plug... Reprocessing procedures... Low-temperature sterilization... Maintenance intervals...

7 7 7 7 7 8 9 9

7 7.1 7.2 7.3

Technical data... Operating, storage, transport and shipping... Spare parts and accessories... Disposal of product, packaging material and accessories...

10 10 11 11

BB-A 282-01

I

1

General information

1.1

Symbol Symbol

Designation Follow the instruction manual Recycle the product separately. Do not discard together with other waste. 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).

1.2

Intended use In conjunction with the ENDOCAM Logic HD Controller 552510x camera the 1-Chip HD ENDOCAM Logic HD 8552590x Camera Head is used for diagnostic and therapeutic interventions. This product is designed exclusively for use by specialized medical per­ sonnel and may only be applied by medically qualified and adequately trained doctors.

1.3

Indications and field of application This product is used for diagnostics and therapy in conjunction with endo­ scopic accessories. On the basis of the patient’s general condition, the user in charge must decide whether the planned use is possible or not. For further notes and instructions please refer to the latest medical literature.

CAUTION! Possible failure of the camera head. For therapeutic applications a second camera head with the same spe­ cifications should be available.

1

BB-A 282-01

1.4

Contraindications and side effects

1.4.1

Contraindications Contraindications directly related to the product are presently unknown. On the basis of the patient's general condition the doctor in charge must decide whether the planned use is possible or not. For further notes and instructions please refer to the latest medical litera­ ture.

1.4.2

Side effects

1.5

Combinations

Side effects directly related to the product are currently unknown.

CAUTION! For a joint use of the different products it is necessary that the intended use and the relevant technical data such as working length, diameter etc. are the same. Follow the instruction manuals of the products used in conjunction with this product. When inserting the camera head, the manual GA-A282 for the EN­ DOCAM Logic HD Controller 552510x camera must be followed.

BB-A 282-01

2

2.1

Camera head 1.4 1.5

SN XXXX

Illustration

8552590X

2

1.1 1.2 1

2 1.3

1.7

1.6

Legend 1

Camera head

1.1

Head button 1 (bright) for remote control (for button configuration see GA-A 282)

1.2

Head button 2 (dark) for remote control (for button configuration see GA-A 282)

1.3

C-mount thread for objective lens

1.4

Serial no.

1.5

Product no.

1.6

Camera plug

1.7

Plug protection cap

2

Protection cap

3

BB-A 282-01

3

Preparation WARNING! The applied part is not protected against explosions. Explosion hazard. Do not operate the applied part in ignitable atmospheres.

3.1

.

IMPORTANT! Never direct the camera head at the sun or bright light sources in the vi­ cinity. High-energy radiation in the visible and ultrviolet wavelength ranges can damage the CCD chip surface. This may result in color dis­ tortions and image noise. When the camera head is not used, the protection cap must be installed.

.

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

Connecting the objective lenses and endoscopes to the camera head

.

IMPORTANT! If the image is to dark, grainy or if there is image noise this may be due to an excessively large focal length of the objective lens or a zoom lens which has been adjusted to an extensively large focal length. Check the focal length of the objective length or the zoom setting in case of a zoom lens.

.

NOTE! Before assembling the endoscope and objective lens, check that the glass surfaces on the endoscope, objective lens and camera head are dry and dust-free. Any soiling can be removed with a cotton swab soaked with allcohol (wooden or plastic swab carrier, not metal). For a detailed description and overview of the objective lenses, see in­ struction manual GA-S 022.

BB-A 282-01

4

Connecting the C-mount objective lens: Z Remove the protection caps from the camera head and objective lens (Fig.1). Z Screw the C-mount objective lens onto the camera head by turning clockwise (Fig. 2). Connecting the endoscope: Z Place the endoscope onto the objective lens: ' The snap-on locking mechanism is open and spring loaded (fig. 3) insert the endoscope (fig. 4) - the snap-on mechanism locks auto­ matically holding the endoscope in place. Z To remove the endoscope pull back the snap-on mechanism until it is unlocked (fig.3).

Fig. 1

Fig. 3

Fig. 2

Fig. 4

5

BB-A 282-01

4

Checks .

4.1

IMPORTANT! Run through the checks before and after each use. Do not use the products if they are damaged or 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 the accessor­ ies for damage, sharp edges, loose or missing parts and rough sur­ faces. Z Check the connection cables and adapters for damage. Z Any inscriptions, lettering or labeling necessary for the safe intended use must be legible. ' Missing inscriptions, lettering or labeling leading to wrong handling or reprocessing must be reinstated. Z Fogging or functional impairment may indicate the ingress of liquid.

4.2

Function check Z Carry out the function check of the camera head together with the EN­ DOCAM Logic HD Controller 552510x camera in accordance with in­ struction manual GA-A282.

5

Use .

5.1

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

Function assignment of the camera head buttons Z For the function configuration of the camera head buttons, see instruc­ tion manual GA-A282 of the ENDOCAM Logic HD Controller 552510x camera.

BB-A 282-01

6

6

Reprocessing and maintenance .

IMPORTANT! Follow the latest notes and instructions in manual GA-J 020, “Reproces­ sing of RICHARD WOLF heat-stable instruments“. Do not use disinfectants containing peracetic acid without corrosion protection, phenols or chlorine components for the reprocessing of Ri­ chard Wolf products. Strictly adhere to the maximum immersion time in the disinfectants used, as described by the manufacturers.

6.1

Overview: reprocessing of camera heads

Product no. Camera head

Cleaning Manual

Machine

Disinfection Ultrasound

Manual

Machine

Sterilization High Level

Steam

STERIS SYSTEM 1, STERIS SYSTEM 1Et

8552590x

+

+ = recommended ,

6.2

+

-

+

+

+

+

Gas

STERRAD

FA, V-PRO™ 1

STERRAD 50 / 100S / 200 / NXt / 100 NXt, PLASMASTER 40 / 80 / 140

+

+

- = must not be used!

Reprocessing of camera heads

.

6.2.1

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

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

6.2.2

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

7

BB-A 282-01

6.3

Reprocessing procedures

.

IMPORTANT! Due to the product design and the materials used it is not possible to define a specific limit of the number of possible reprocessing cycles. The service life of medical products is defined by their function and careful handling. Before returning defective products for repair, these products must have gone through the entire reprocessing cycle. The user is obliged to make sure that the reprocessing process including the ressources, material and per­ sonnel is suited to reach the required reprocessing results. The state of the art and national laws require that validated processes be followed.

Reprocessing instructions Product

Camera heads - heat-resistant

Preparation at the point of use

Directly after use, remove any coarse soiling from the camera head. Do not use fixing agents or excessively hot water (max. 40 C) as this will bake any residues to the surfaces and may have a negative impact on the cleaning success.

Transport

Store safely in a closed container, then transport the camera head to the reprocessing location, to prevent damage and contamination.

Ultrasonic cleaning

Ultrasonic cleaning is not permissible.

Cleaning

Manual cleaning

Machine cleaning

1.Immerse in a cleaning solution for at least 5 minutes. 2.Brush with a soft brush for at least 5 seconds to remove any residues. 3.Clean the buttons on the camera head with a soft brush. Make sure that no contaminant residues re­ main on and around the pushbuttons. 4.Rinse the camera head and the camera cable with demineralized water. 5.Carefully dry with a cloth. 6.Clean the glass surfaces on the objective lens with a cotton swab soaked with alcohol (wooden or plastic swab carrier, not metal).

1.Place the camera head into the sieve tray of the automatic washer-disinfector.

Disinfection

High Level disinfection

1.Immerse the camera head in a certified disinfectant solution, for exposure time refer to the manufacturer's specifications. 2.Rinse thoroughly with demineralized* water. 3.Clean the glass surfaces with a cotton swab soaked with alcohol. -------

2. Vario-TD program (without disinfection cycle): ' Pre-clean with cold water for 4 minutes ' Empty ' Wash for 6 min at 55C using an alkaline cleaner. ' Empty ' 3 min of neutralization*) using warm tap water (max. 40C) ' Empty ' 2 min of intermediate rinsing using warm tap wa­ ter (max. 40C) ' Empty *) depending on the quality of the neutralization solu­ tion, add an acid based on citric acid. Carry out thermal machine disinfection following the national requirements regarding the A0 value (see DIN EN ISO 15883).

Peracetic acid: STERIS SYSTEM 1/STERIS SYSTEM 1Et

Drying

Manual drying: Dry the camera head with a sterile lint-free disposable cloth or swab.

Dry the camera head using the washer-disinfector drying cycle (max. 60 C). If required, dry the camera head additionally using a lint-free disposable cloth or swab.

Care

After chemothermal manual / machine disinfection, no additional care is required.

Function test, maintenance

Visual check for cleanliness. If necessary repeat the reprocessing process until the camera head is visually clean.

Packaging

Package the camera head for sterilization as required by the standards for the sterilization procedure.

* = if there is no subsequent sterilization, thoroughly rinse with sterile water.

BB-A 282-01

8

Reprocessing instructions Product

Camera heads - heat-resistant

Sterilization

Steam sterilization: Sterilization of products using the fractional pre-vacuum method (ISO13060/ISO17665) taking into account the corresponding national requirements. ' Temperature exposure time: 4 min at 134 C +4 °C (273 F +7 °F), 4 min at 132 C +4 °C (270 F +7 °F) ' Drying time: 10 - 20 min ' Maximum sterilization temperature: 138 C Hydrogen peroxide plasma: STERRAD 50 / 100S / 200 / NXt und 100 NXt, PLASMASTER 40 / 80 / 140 Gas: Formaldehyde gas (FA), hydrogen peroxide (V-PRO™1)

Storage

Store the sterilized instruments in a dry, clean and dust-free environment at temperatures between 5 C and 40 C.

Validation

During validation, the following test instructions, materials and machines were used: ' Machine cleaning agent: alkaline cleaning agent 0.5% neodisher FA (Dr. Weigert) ' Manual cleaning agent: enzymatic cleaning agent 0.5% neodisher MediClean (Dr. Weigert) ' Manual disinfectant: Cidex (Advanced Sterilization Products) ' Automatic washer-disinfector: Miele G 7735 CD ' Washer-disinfector rack: Miele E 440/1

Additional notes and instructions

6.4

The user is obliged to validate his process in accordance with DIN EN ISO 17664.

Low-temperature sterilization

.

6.5

IMPORTANT! The low-temperature procedures using hydrogen peroxide and peracetic acid are approved for endoscopes and endoscopic accessories with re­ gard to their material compatibility. By no means must these low-temperature methods be used alternately. Possible interactions between these sterilization procedures may cause damage to the instruments.

Maintenance intervals

.

9

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.

BB-A 282-01

7

Technical data Camera head

Length of camera cable

Cable outlet

Compatible camera controller

Product no.

85525902 85525904 85525906

3.0 m 5.0 m 8.0 m

30°

ENDOCAM Logic HD Controller

552510x

IPX7

Degree of protection against the ingress of liquids

(protected against the effects of permanent submersion)

Cable length 3.0 m: 0.540 kg (1.19 lbs) Cable length 5.0 m: 0.660 kg (1.45 lbs)

Weight with camera cable and camera plug

Cable length 8.0 m: 0.840 kg (1.89 lbs) Diameter, horiz. approx. 34 mm Diameter, vertical approx. 36 mm Length approx. 114 mm

Dimensions of camera head Thread for objective lens

7.1

C-mount

Operating, storage, transport and shipping Operating conditions

+10C to +35C, 30% to 75% rel. humidity, atmospheric pressure 700 hPa to 1060 hPa

Storage, transport and shipping conditions

- 20C to +60C, 30% 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 packa­ ging material.

BB-A 282-01

10

7.2

Spare parts and accessories Product no.

Designation

15135463

Protection cap for camera head

85261143

RIWO objective lens, C-mount, f = 14 mm

85261243

RIWO objective lens, C-mount, f = 24 mm

85261172

RIWO objective lens, C-mount, f = 17 mm

85261212

RIWO objective lens, C-mount, f = 21 mm

85261242

RIWO objective lens, C-mount, f = 24 mm

85261504

RIWO zoom objective lens, C-mount, f = 13 to 29 mm ' Further accessories on request

7.3

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

11

BB-A 282-01