Richard Wolf Performance Camera Head 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, 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.

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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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 instruction manual Type CF applied part Medical device Product number Serial Number Manufacturer Manufacturing date Recycle the product separately. Do not discard together with other waste.

CE marking in compliance with directive 93/42/EEC on medical products. Is only valid if the product and/or packaging is identified with this marking . Products of category IIa and above, as well as sterile products or products with measuring function of category I, are additionally identified with the 4-digit code number of the notified body. The CE marking on the title page of this instruction manual relates exclusively to the Richard Wolf main product or, if several equivalent products are described, to the Richard Wolf product with the highest classification. The CE marking of the other Richard Wolf products described in this manual and of other manufacturers, if applicable, results exclusively from the identification on the product and/or its packaging.

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General safety instructions and guidance for use WARNING Danger of explosion The device is not protected against explosions. n Do not operate this device in areas where there is a danger of explosion.

CAUTION n

n

In the case of failure or interruption of the surgery image or inacceptable impairment of the reproduction quality during therapeutic use: Disconnect the camera from the endoscope and view the operating area directly through the eyepiece. In the case of therapeutic use a second product with the same features should be available as a backup.

CAUTION The camera cable has only limited strength. Applying excessive force or high mechanical loads can cause damage to the camera cable or wiring resulting in image interference or image failure. n Do not pinch, squeeze or excessively bend the camera cable. n Do not pull on the camera cable.

CAUTION n

n

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.

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 or incomplete or have loose parts. n Return damaged products together with any loose parts for repair. n Do not attempt do to any repairs yourself.

CAUTION n

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The products must only be used as intended following the instruction manual by adequately trained and qualified medical personnel.

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CAUTION n

Reprocess the products in accordance with the manual before every use and before return shipment to protect the patient, user and third parties.

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. 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. 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 camera head is the link between the endoscope and the camera controller. The image generated by the connected endoscope is transmitted to the associated camera controller via the camera head and processed there.

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Intended use Camera heads 5514901

PERFORMANCE CAMERA HEAD CABLE 4 M

5514961

PERFORMANCE CAMERA HEAD CABLE 4 M

The products are used to convert an image of the inside of the body produced by the endoscope into an electronic signal for transmission to the camera controller. Lenses 5257271

ANGLED LENS BEAM SPLITTER F 27 MM

85261322

LENS F 32 MM

85261501

ZOOM LENS F 21–36 MM

85261272

LENS F 27 MM

The products are used to map the endoscopic image onto the sensor of a camera head and to focus the image. User The product is intended exclusively for use by medical experts and may only be used by adequately qualified and trained personnel.

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5

Indications CAUTION Possible failure of the camera head. For therapeutic applications, a second camera head with the same specifications should be available.

The products are used for endoscopic interventions in various medical disciplines. Patient group The intended patient group is not limited with regard to ethnicity, age, sex, height, or weight. Before use, the attending physician must make sure that the product in view of its dimensions or settings can be used safely in the patient.

NOTE We recommend reading relevant literature for the appropriate application.

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Contraindications and side effects

6.1

Contraindications There are currently no known contraindications directly related to the products. If there are medical contraindications for the endoscopic interventions to be performed, use with the products concerned is excluded. The responsible physician must decide on the basis of the patient's general condition whether the intended use is possible or not.

6.2

Side effects When used as intended, there are no known side effects related to the products.

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Combinations CAUTION The different products may only be used jointly if their intended use and the relevant technical data (working length, diameter, etc.) are the same. The instructions for use of the products used in the product combination must be observed.

7.1

Requirements for the products/components of a combination WARNING If the camera system is used in combination with electrosurgical devices, the sensation of an electric shock may be felt.

CAUTION If endoscopy systems are used in combination with electrically operated devices, patient leakage currents may add up. This is particularly the case when using class CF (cardiac floating) devices.

CAUTION Possible electromagnetic or other interference that may occur between the product and other products can cause faults or malfunctions. The camera head may only be used in compliance with the instructions for use GA-A280 for the Performance HD camera controller 5514.

7.2

Electromagnetic compatibility (EMC) – IEC 60601-1-2:2014 The electromagnetic data specified in the instructions for use of the camera controller apply.

7.3

Product connection diagram The connection to a camera controller is described in the instructions for use of the camera controller.

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Illustration 1.1

1

1.6 2

1.5

1.4

1.2

3

1.3

Fig. 1 1

Camera head

1.1

Buttons for remote control (see GA-A 280 for button assignments)

1.2

C-Mount lens thread

1.3

Camera plug

1.4

Serial no.

1.5

Product no.

1.6

Type CF applied part

2

Protective cap for camera head

3

Plug protection cap

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Checks ATTENTION 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.

9.1

Visual checks CAUTION Before assembling the endoscope and lens, check that the glass surfaces on the endoscope, lens, and camera head are dry and dust-free. 1. Check the camera head and accessories for damage, sharp edges, loose or missing parts, and rough surfaces before and after each use. 2. Check the connection cable and connection pieces for damage. 3. Any inscription, lettering, or labeling necessary for the safe intended use must be legible. ð Any inscription, lettering, or labeling leading to handling or reprocessing errors must be reinstated. 4. Liquid penetration can be detected by fogging or functional impairment.

9.2

Function check ¯ Perform the function checks of the camera head together with the Performance HD camera controller 5514 in accordance with the instructions for use GA-A280.

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Preparation / Commissioning ATTENTION Never point the camera head at the sun or nearby bright light sources. High-energy radiation in the visible and ultraviolet wavelength range can damage the CCD chip surface. This may result in color distortion and image noise. If the camera head is not in use, the protective cap must be in place.

10.1

Connection

10.1.1

Cleaning the glass surfaces of the lens NOTE Before assembling the endoscope, check that the glass surfaces on the endoscope and lens are dry and dust-free. Remove contamination with a cotton swab soaked in alcohol (wood or plastic swab carrier, no metal). ¯ Clean the glass surfaces of the lens with a cotton swab soaked in alcohol (70% isopropanol) until no residue is visible on the glass surface. Requirements for the cotton swab: 1. 2. 3. 4.

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Solvent resistant Head made from 100% pure cotton Swab carrier made from wood or plastic, no metal Head diameter 3–5 mm

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10.1.2

Connecting the lens and endoscope to the camera head For a detailed description and overview of the lens, see instructions for use GAS022. Connecting the C-Mount lens: 1. Remove the covering caps from the camera head and lens. 2. Screw the C-Mount lens onto the camera head in the direction of the arrow.

Fig. 2 Connecting the endoscope: 1. Place the endoscope on the lens: ð Press the handle part and the tab together in the "open" arrow direction – Insert the endoscope – Release the tab. 2. Fix the endoscope (so that it is no longer rotatable): ð Press the tab in the "fix" arrow direction while holding the handle part. 3. Remove the endoscope: ð Press the handle part and the tab together in the direction of the "open" arrow – Remove the endoscope – Release the tab.

Fig. 3

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11

Use CAUTION Risk of microorganisms being transmitted. To prevent contamination of the camera plug when disconnecting it from the camera controller during the course of the operation, screw on the plug protection cap immediately after disconnecting the plug. A contaminated camera plug must be cleaned, disinfected, and then rinsed with sterile water, and the contacts must be sufficiently dried before putting on the plug protection cap. Residual moisture in the contacts can impair the signal transmission (e.g., interruptions, poor contact).

ATTENTION The camera heads cannot be used for photodynamic diagnostics application.

11.1

General notes and instructions for use

11.1.1

Operating principle The camera head converts the image generated by a connected endoscope into an electronic signal for transmission to the associated camera controller.

11.2

Control elements and operating modes

11.2.1

Function assignment of the camera head keys ¯ See the instructions for use GA-A280 (Performance HD camera controller 5514) for the function assignment of the camera head keys.

11.3

Operating the product

11.3.1

Taking out of service ¯ To take the camera out of service, remove the camera head from the camera controller.

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Reprocessing and maintenance 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.

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.

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

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 Do not sterilize the products in hot-air sterilizers.

NOTE Brand-new products. Before reprocessing or commissioning, remove all protective films and transport guards 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 n

www.richard-wolf.com/en/solutions/reprocessing/

Required equipment Image

-

Product no.

Designation, Technical data

509.81

DISINFECTION BASIN W 400mm L 600mm for disinfection, incl. lid, without sieve basket, not steam-sterilizable, Outside dimensions: 600 x 400 x 140 mm Inside dimensions: 548 x 348 x 100 mm

38047111

REPROCESSING BASKET FOR CAMERA HEADS Outside dimensions: (L x W x H) 445 x 200 x 73 mm

8691

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

86.90

CLEANING BRUSH for surface cleaning, angled, reusable

-

LINT-FREE DISPOSABLE CLOTH

Manual cleaning 6199.00

-

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-

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

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

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12.1

Reprocessing CAUTION As a result of the product design and the materials used, it is not possible to determine a defined limit of possible reprocessing cycles. The service life of medical devices is determined by their function and gentle handling. Before returning defective products for repair, they must have been subjected to the entire reprocessing cycle. The user must ensure that the reprocessing process, including the resources, materials, and personnel, is suitable for achieving the required results. The state of the art and national laws require that validated processes be followed.

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

NOTE For immersion time and concentration, refer to the chemical manufacturer's specifications.

NOTE Prepare the cleaning and disinfecting solution according to the chemical manufacturer's instructions for use.

12.1.1

Camera head reprocessing overview

Model Camera head

Cleaning Manual Machine

Ultrasound

Manual Machine

High level STERIS SYSTEM 1®, STERIS SYSTEM 1E™

Steam

Gas FA, V-PRO™ 1

STERRAD STERRAD® 50 / 100S / 200 / NX™ / 100 NX™, PLASMASTER 40 / 80 / 140

5514901 5514961

+

−

+

+

−

+

+

Disinfection

+

+

Sterilization

+ = recommended − = do not use

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12.1.2

Initial treatment at the point of use Immediately after use, remove coarse soiling from the products. ⊳ Do not use cleaning agents (e.g., aldehyde) or hot water (> 40°C) for precleaning. These can bake contaminant residues to the surfaces. ⊳ Do not use physiological saline solution for rinsing. This may promote corrosion. Preparation for transport To avoid damage to the products and contamination towards the environment, safe storage in a closed container is required. ⊳ For safe transport, we recommend the reprocessing basket (model 38047111). Preparation before cleaning

ATTENTION Perform either machine or manual reprocessing. If machine reprocessing is possible, it is generally preferable to manual reprocessing. ⊳ See section 12.1.3 Machine reprocessing ⊳ See section 12.1.4 Manual reprocessing Contaminated camera plug

ATTENTION Only reprocess the camera plug with the protective plug cap fitted! If liquid enters the camera plug (e.g., because you forgot to put the cap on) carefully rinse out the camera plug with clean water and dry carefully.

A dirty camera plug must be manually reprocessed before screwing on the plug protection cap. 1. Place the camera plug in an approved, compatible cleaning solution and, if necessary, clean it with a cleaning brush or cotton swab until it appears clean. 2. Then rinse with sterile water. 3. Dry outer surfaces with a lint-free disposable cloth, and dry inside contacts with a cotton swab. ⊳ Residual moisture in the contacts can impair the signal transmission (e.g., interruptions, poor contact). 4. Screw the plug protection cap tightly onto the camera plug.

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12.1.3

Machine reprocessing

12.1.3.1

Precleaning for the machine cleaning process

ATTENTION Do not use metallic materials or equipment with sharp edges (e.g., metal brushes) to clean the product. 1. Rinse the product under cold, running tap water. 2. Immerse the product in a basin (e.g., model 509.81) filled with an approved cleaning solution for 6 minutes at room temperature. Make sure that the surfaces are completely covered by the cleaning solution. ⊳ Observe the manufacturer's application concentration and exposure time. 3. Brush the outer surfaces (camera head and buttons) with a cleaning brush (model 86.90 or 8691) under the liquid surface level for at least 40 seconds until the instrument appears clean. 4. Immerse the camera head with the camera cable in a basin (e.g., model 509.81) filled with demineralized water for 5 minutes at room temperature. 8691

86.90

Fig. 4

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12.1.3.2

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 processing can cause functional, material and biocompatible impairments on endoscopes and endoscopic accessories. Loading in the reprocessing basket 1. Put the camera head with camera cable in the reprocessing basket (model 38047111) and place it in the washer-disinfector.

Fig. 5 2. Start the washer-disinfector's cleaning program. Machine disinfection ♢ Carry out chemothermal machine disinfection at max. 60°C following the national requirements with regard to the A0 value (see DIN EN ISO 15883). Machine drying 1. Drying of the product via the washer-disinfector drying cycle – at max. 60°C. If necessary, additional drying can be achieved manually using a lint-free disposable cloth or, alternatively, a drying cabinet. 2. Dry hollow spaces with filtered compressed air. 3. Perform checks and maintenance. ⊳ See section 12.1.5 Checks and maintenance

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