Richard Wolf Logic HD PENDUAL Camera Head green 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 ... 11

6.1

Contraindications... 11

6.2

Side effects... 11

7

Combinations ... 12

7.1 7.1.1

Requirements of the products / components of a combination ... 13 Checking the installed software version ... 13

7.2

Electromagnetic compatibility (EMC) – IEC 60601-1-2:2014 ... 13

7.3

Connection diagram for product ... 13

8

Illustration ... 14

9

Checks... 15

9.1

Visual check ... 15

9.2

Function check ... 15

9.3

Service life ... 16

10

Preparation / Setup ... 17

10.1 10.1.1 10.1.2 10.1.3

Connection ... 18 Cleaning the glass surfaces of the objective lens ... 18 Inserting the endoscope ... 18 Removing the endoscope... 19

11

Operating instructions ... 20

11.1 11.1.1

Additonal guidance for use ... 20 Operating principle ... 20

11.2 11.2.1

Control elements and modes ... 20 Function assignment of camera head buttons ... 20

11.3 11.3.1 11.3.2 11.3.3

Operation of the product... 21 Focusing the image ... 21 Special Imaging Modes ... 21 Taking out of service ... 21

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Reprocessing and maintenance ... 22

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 HD camera head green ... 25 Machine reprocessing ... 26 Manual reprocessing ... 28 Checks and maintenance ... 29 Packaging... 29 Sterilization ... 29 Storage ... 30 Validation... 31

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12.2

Maintenance ... 31

13

Technical description... 32

13.1

Technical Data ... 32

13.2

Performance characteristics ... 32

13.3

Operating, storage, transport and shipping conditions ... 32

14

Replacement parts ... 33

15

Disposal... 33

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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

6

Description

ICG

Indocyanine green

NIR

Near infrared

VIS

Visible range

W/D

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 85525812

LOGIC HD CAMERA HEAD GREEN

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, and to optically filter the excitation light within the scope of the "ICG fluorescence imaging" diagnostic procedure. 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 the following indications in various medical disciplines: Endoscopic interventions (white light endoscopy) Visualization of the visceral blood flow n Lymph node mapping The products are used for fluorescence cholangiography, especially in laparoscopy. n n

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. With regard to fluorescence endoscopy (this relates to the indications visceral blood flow, lymph node mapping and fluorescence cholangiography), follow the fluorescence dye manufacturer's instructions. Please note that for the use of fluorescence imaging there are no clinical data for patients under 18 years. In such cases the attending physician must decide whether a safe use is possibe.

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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. With regard to fluorescence endoscopy (this relates to the indications visceral blood flow, lymph node mapping and fluorescece cholangiography), follow the fluorescence dye manufacturer's instructions. Please note that for the use of fluorescence imaging there are no clinical data during pregnacy or breast feeding. In such cases the attending physician must decide whether or not a safe use is possibe.

6.2

Side effects Side effects directly related to the product are unknown if the product is used as intended. With regard to fluorescence endoscopy (this relates to the indications visceral blood flow, lymph node mapping and fluorescece cholangiography), follow the fluorescence dye manufacturer's instructions.

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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.

CAUTION Operation in the corresponding fluorescence diagnostic method must only the carried out in conjunction with the components intended for this purpose. For this mode a suitable light source such as ENDOLIGHT LED green 5165002 must be used.

NOTE The Logic HD camera head green must only be used following the instruction for use GA-A282 from version 12.0 for model series ENDOCAM Logic HD Camera Controller 552510X and ENDOCAM Logic 4K Camera Controller 5525301. The Logic HD camera head green is not compatible with ENDOCAM Logic HD lite Camera Controller 5525201.

NOTE For operation in fluorescence mode (ICG fluorescence imaging) observe instructions for use GA-A344 for the system green.

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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.

The Logic HD camera head green is compatible with camera controllers of the Logic HD Camera Controller 552510X series and Logic 4K Camera Controller 5525301 from software version V2.0.9 or higher. The Logic HD camera head green ist not compatible with ENDOCAM Logic HD lite Camera Controller 5525201. If a higher software version than installed on the camera controller is necessary for operation, the Logic HD camera head green is not recognized. The color bar test image remains on screen. 1. Check the installed software version. 2. Contact the service department if a software update is necessary. The Logic HD camera head green is used for diagnostic and therapeutic interventions with white light and near infrared light. When operated in combination with further products of the "green" model line, the Logic HD camera head green can be used for visualizing the fluorescence of a dye in the near infrared (NIR) range such as indocyanine (ICG).

7.1.1

Checking the installed software version For calling up the installed software version, proceed as follows in the menu on the device front panel of the camera controller: n

7.2

/Menu/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 1

1.8

2

1.7

1.3

1.4

1.5 1.6

1.9

Fig. 1 1

Camera head

1.6

Product no.

1.1

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

1.7

Focusing ring

1.2

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

1.8

Snap-on lock

1.3

GTIN no.

1.9

Camera plug plus+

1.4

Manufacturing date

2

Cover plate

1.5

Serial no.

-

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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 CAUTION Soiled glass surfaces Soiled glass surfaces on the endoscope and lens can yield a stained or blurred image. n Before assembling the endoscope please check that the glass surfaces on the endoscope and objective lens are dry and dust-free. n Remove contaminants with a cotton swab soaked with alcohol (70% isopropanol, the swab carrier must be wood or plastic, 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 erros 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 cameras of the ENDOCAM Logic HD 552510X und ENDOCAM Logic 4K Camera Controller 5525301 model series in accordance with instructions for use GAA282 . 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 The applied part is not protected against explosions Explosion hazard. 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 CAUTION Soiled glass surfaces Soiled glass surfaces on the endoscope and lens can yield a stained or blurred image. n Before assembling the endoscope please check that the glass surfaces on the endoscope and objective lens are dry and dust-free. n Remove contaminants with a cotton swab soaked with alcohol (70% isopropanol, the swab carrier must be wood or plastic, not metal).

10.1.1

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.

Inserting the endoscope 1. Pull the snap-on locking mechanism backwards to the release position. 2. Remove the protection cap from the snap-on locking mechanism on the camera head.

Fig. 3

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3. 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 . 4. Place the endoscope onto the objective lens. • The snap-on locking mechanism is in the open and pretensioned position. 5. Attach the endoscope. • The snap-on locking mechanism locks automatically locking the endoscope in place. 6. Check that the components are securely connected.

Fig. 4

10.1.3

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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11

Operating instructions

11.1

Additonal guidance for use

11.1.1

Operating principle The Logic HD camera head green with integrated objective lens converts the image generated by the attached endoscope into an electronic signal which can be fed into a suitable camera controller. The Logic HD camera head green is equipped with an image sensor for visualizing the visible (VIS) portion of the light spectrum and can be used in conjunction with the corresponding products suitable for white light endoscopy. Furthermore the Logic HD camera head green is equipped with a second image sensor which receives light in the near infrared range (NIR) via a special filter device.This allows the use of the Logic HD camera head green in combination with other suitable products, e.g. for the detection of the fluorescence of a dye in this NIR spectral range (e.g. indocyanine green (ICG)) and thus for the "fluorescence imaging with ICG" diagnostic procedure.

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 ENDOCAM Logic HD camera controller 552510X or ENDOCAM Logic 4K camera controller 5525301 camera model series.

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