Richard Wolf Logic 4K Camera Head Instruction Manual

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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Contents 1

General information ...

5

1.1

Safety instructions and levels of danger...

5

1.2

Symbols...

6

1.3

Explanation of acronyms used ...

6

2

General safety instructions and guidance for use ...

7

3

Product description...

9

4

Intended purpose ...

9

5

Indications ... 10

6

Contraindications and side effects ... 10

6.1

Contraindications... 10

6.2

Side effects... 10

7

Combinations ... 11

7.1 7.1.1

Requirements of the products / components of a combination ... 11 Checking the installed software version. ... 12

7.2

Electromagnetic compatibility (EMC) – IEC 60601-1-2:2014 ... 12

7.3

Connection diagram for product ... 12

8

Illustration ... 13

9

Checks... 14

9.1

Visual check ... 14

9.2

Function check ... 14

9.3

Service life ... 15

10

Preparation / Setup ... 16

10.1 10.1.1 10.1.2 10.1.3 10.1.4

Connection ... 17 Cleaning the glass surfaces of the objective lens ... 17 Connecting a C-mount objective lens... 17 Inserting the endoscope ... 18 Removing the endoscope... 18

11

Operating instructions ... 19

11.1 11.1.1

Additional guidance for use ... 19 Operating principle ... 19

11.2 11.2.1

Control elements and modes ... 19 Function assignment of camera head buttons ... 19

11.3 11.3.1

Operating the product ... 19 Taking out of service ... 19

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Reprocessing and maintenance ... 20

12.1 12.1.1 12.1.2 12.1.3 12.1.4 12.1.5 12.1.6 12.1.7

Reprocessing sequence for Logic 4K camera head ... 23 Machine reprocessing ... 24 Manual reprocessing ... 26 Checks and maintenance ... 27 Packaging... 27 Sterilization ... 27 Storage ... 28 Validation... 29

12.2

Maintenance ... 29

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Technical description... 30

13.1

Technical Data ... 30

13.2

Performance characteristics ... 30

13.3

Operating, storage, transport and shipping conditions ... 30

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Replacement parts ... 31

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Disposal... 31

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1

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 Follow the manual

Medical device Product number Serial Number Manufacturer Manufacturing date Number, amount

Protected against the effects of temporary immersion in water Recycle the product separately. Do not discard together with other waste.

Data Matrix Code

CE marking in conformity with Directive 93/42/EEC on medical products or EU Regulation 2017/745 on medical devices. Only valid, if the product and/or packaging is marked with this identification. Products as of category IIa, sterile products and products of class I, products with measuring function of class I, as well as reusable surchical instruments are additionally marked with the four-digit code number of the competent authority. The CE identification on the title page of these instructions for use relates exclusively to the Richard Wolf main product or, if serveal identical products are described, to the Richard Wolf product with the highest classification. The CE identification of the other Richard Wolf products and, if applicable, of products made by other manufacturers, described in these instructions for use results exclusively from the identification on the product and/or packaging.

1.3

Explanation of acronyms used

Acronym W/D

6

Description Washer-disinfector device

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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 serves as a link between the endoscope and the camera controller. The image generated by the attached endoscope is passed on via the camera head to the corresponding camera controller where it is processed.

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Intended purpose Camera head 85525942

LOGIC 4K CAMERA HEAD

The product serves to convert the image of the inside of the body generated by an endoscope into an electronic signal which is passed on to the camera controller. Lenses 5261504

ZOOM LENS 13-29MM

85261144

LENS F 14MM

85261244

LENS F 24MM

85261504

ZOOM LENS F 13-29MM

The product serves to image the endoscopic image onto the sensor of a camera head and to focus the image. User The product is exclusively intended for use by specialized medical personnel and may only be used by medically qualified and adequately trained persons.

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Indications CAUTION Product failure during therapeutic use Interruption of therapeutic use n In therapeutic applications a second product with the same features should be available as a backup.

NOTE We recommend reading relevant literature for the planned application.

The products are used for endoscopic interventions across all disciplines On the basis of the patient’s general condition, the user in charge must decide whether the planned use is possible. For further notes and instructions please refer to the latest medical literature. Patient population The intended patient population is not restricted to ethnics, age, gender, body height and weight. Before use the attending physician must ensure that the product can be safely used in terms of its dimensions or settings.

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Contraindications and side effects

6.1

Contraindications Contraindications directly related to the product are presently unknown. Medical contraindications for the aforementioned operations exclude the use of the products concerned. On the basis of the patient's general condition the attending physician must decide whether or not the planned application is possible.

6.2

Side effects No side effects directly related to the product are known if the system is used as intended.

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Combinations CAUTION Be careful not to combine products incorrectly! Injuries of the patient, user or others as well as damage to the product are possible. n The products must only be used jointly if the intended use and the relevant technical data such as working length, diameter, etc. are the same. n Also follow the instruction manuals of the products used in conjunction with this product.

NOTE The Logic 4K camera head must only be used following Instructions for Use GAA282 from version 9.0 for the ENDOCAM Logic HD Camera Controller 552510X and ENDOCAM Logic 4K Camera Controller 5525301. The Logic 4K Camera Head is not compatible with ENDOCAM Logic HD lite Camera Controller 5525201.

7.1

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

CAUTION Patient leakage currents Patient leakage current can add up when endoscopy systems are used in combination with electrically operated devices.This is particularly the case when using Class CF devices (Cardiac Floating).

CAUTION Possible electromagnetic or other interference that may occur between the product and other products can cause faults or malfunctions.

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As of camera controller software version V2.0.1 the Logic 4K Camera Head is also compatible with the ENDOCAM Logic HD Camera Controller 552510X model series, however with reduced resolution. The Logic 4K Camera Head is not compatible with ENDOCAM Logic HD lite Camera Controller 5525201. If a higher software version than installed in the camera controller is necessary for operation, the Logic 4K camera head is not recognized. In this case the color bar test image appears on the screen. 1. Check the installed software version. 2. If a software update is required, contact the service department.

7.1.1

Checking the installed software version. The currently installed software version is called up in the menu on the device front panel of the camera controller as follows: n

7.2

/Menü/Device Settings/Device Information

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

7.3

Connection diagram for product For connection to a camera controller please refer to the description in the instructions for use of the camera controller.

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Illustration

1.1 1.2

2

1

1.3

1.5

1.4

1.6

Fig. 1 1

Camera head

1.4

Product no.

1.1

Head button 1 (bright) for remote control (for button assignment see GA-A282)

1.5

C-mount thread for objective lens

1.2

Head button 2 (dark) for remote control (for button assignment see GA-A282)

1.6

Camera plug plus+

1.3

Serial no.

2

Cover plate

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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 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.

9.1

Visual check ATTENTION n

n

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 alcohol (wooden or plastic swab carrier, not metal).

1. Check the camera head and the accessories before and after each use for damage, sharp edges, loose or missing parts and rough surfaces. 2. Check the connection cables and adapters 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. Fogging or functional impairment may indicate the ingress of liquid.

9.2

Function check Preconditions for carrying out the function check are a technically perfect state and the correct setup of the devices. This must also be guaranteed within the scope of the visual check. 1. Carry out the function check of the camera head together with the camera controllers of the ENDOCAM Logic HD Camera Controller 552510X und ENDOCAM Logic 4K Camera Controller 5525301 series in accordance with instructions for use GA-A282. ð After connecting the camera head, an interference-free live image must appear on the monitor. 2. If the live image is poor (e.g. black, interference or color bars): disconnect the camera head and reconnect after 3 seconds. 3. If there still is no interference-free live image: Restart the camera controller.

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9.3

Service life When used as intended and following the instructions in manufacturer's instructions for use, it is not necessary to limit the service life of the medical products. If one or several criteria of the described checks are not passed, the medical product must be replaced or returned for repair (by the OEM or a repair facility authorized by the OEM) if necessary.

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Preparation / Setup WARNING Danger of explosion The applied part is not protected against explosions. n Do not operate the applied part in an ignitable atmosphere.

ATTENTION High-enery radiation from the sun or bright light sources High-energy radiation in the visible and ultraviolet wave length range can damage the image sensor surface. This may result in color distortions and image noise. n Never direct the camera head at the sun or bright light sources in the vicinity. n If the camera head is not used, always install the protection cap.

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.

Fig. 2

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10.1

Connection ATTENTION n

n

10.1.1

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 alcohol (wooden or plastic swab carrier, not metal).

Cleaning the glass surfaces of the objective lens ¯ Clean the glass surfaces of the objective lens with a cotton swab soaked with alcohol (70% isopropanol) until the glass surfaces look clean.

Specification of the cotton swab:

n n n n

10.1.2

Solvent resistant. Head made of 100 % pure cotton Wooden or plastic swab carrier, not metal. Head diameter 35 mm.

Connecting a C-mount objective lens NOTE For a detailed description and overview of the objective lenses, see instruction manual GA-S 022.

1. Pull the snap-on locking mechanism backwards to the release position. 2. Remove the protection caps from the camera head and objective lens. 3. Screw the C-mount lens in the direction indicated by the arrow onto the camera head.

Fig. 3

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10.1.3

Inserting the endoscope 1. Check that the glass surfaces of the endoscope and objective lens are clean and dry. ð See section10.1.1 Cleaning the glass surfaces of the objective lens 2. Place the endoscope onto the objective lens. • The snap-on locking mechanism is in the open and pretensioned position. 3. Attach the endoscope. • The snap-on locking mechanism locks automatically locking the endoscope in place. 4. Check that the components are securely connected.

Fig. 4

10.1.4

Removing the endoscope 1. Pull the snap-on locking mechanism backwards to the release position. 2. Remove the endoscope.

Fig. 5

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Operating instructions

11.1

Additional guidance for use

11.1.1

Operating principle The camera head converts the image generated by an attached endoscope into an electronic signal which is passed on to the corresponding camera controller.

11.2

Control elements and modes

11.2.1

Function assignment of camera head buttons NOTE For the function assignment of the camera head buttons see Instructions for Use GA-A282 for the camera controllers of the ENDOCAM Logic HD Camera Controller 552510X or ENDOCAM Logic 4K Camera Controller 5525301 model series.

11.3

Operating the product

11.3.1

Taking out of service ¯ To take the product out of service, pull the camera head off 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.

CAUTION Danger of infection! The products and the accessories are delivered in unsterile condition. The use of unsterile products represents an infection hazard for patients, users and third parties. The products must be reprocessed at least once before the first use and before every further use. The user is obliged to make sure that the reprocessing process including the resources, material and personnel are suitable for achieving the required results.

CAUTION Maximum number of reprocessing cycles Due to the product design and the materials used it is not possible to specify a defined limit of the maximum permissible reprocessing cycles. The service life of medical products is determined by their function and gentle handling. Before returning defective products for repair, they must have gone through the entire reprocessing cycle. The user is obliged to make sure that the reprocessing process including the resources, material and personnel are 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 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.

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