Logic HD PENDUAL 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

Distributor

RICHARD WOLF GmbH Pforzheimer Straße 32 75438 Knittlingen GERMANY Telephone: +49 70 43 35-0 Telefax: +49 70 43 35-4300

RICHARD WOLF Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 USA Toll Free: 001 (800) 323-9653 Phone: 001 (847) 913-1113 Fax: 001 (847) 913-1488

www.richard-wolf.com

www.richardwolfusa.com

2

BB-A282-02

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

Indications for use ... 10

4.1

Statement ... 10

4.2

User ... 10

4.3

Additional information ... 10

5

Contraindications and side effects ... 10

5.1

Contraindications... 10

5.2

Side effects... 10

6

Combinations ... 11

6.1

Requirements on the products / components of a combination ... 11

6.2

Electromagnetic compatibility (EMC) – IEC 60601-1-2:2014 ... 11

6.3

Connection diagram for product ... 11

7

Illustration ... 12

8

Checks... 13

8.1

Visual check ... 13

8.2

Function check ... 13

8.3

Service life ... 14

9

Preparation / Setup ... 15

9.1 9.1.1 9.1.2 9.1.3

Connection ... 16 Cleaning the glass surfaces of the objective lens ... 16 Inserting the endoscope ... 16 Removing the endoscope... 17

10

Operating instruction ... 18

10.1 10.1.1

Additional guidance for use ... 18 Operating principle ... 18

10.2 10.2.1

Control elements and modes ... 18 Function assignment of the camera head buttons ... 18

10.3 10.3.1 10.3.2 10.3.3 10.3.4 10.3.5

Operating the product... 18 Locking the snap-on lock... 18 Unlocking the snap-on lock ... 18 Focusing the image ... 19 Angling the camera head ... 19 Taking out of service ... 19

11

Reprocessing and maintenance ... 20

11.1 11.1.1 11.1.2 11.1.3 11.1.4

Reprocessing sequence for Logic HD pendual camera head ... 23 Machine reprocessing ... 24 Manual reprocessing ... 26 Checks and maintenance ... 27 Packaging... 27

BB-A282-02

3

11.1.5 11.1.6 11.1.7

Sterilization ... 28 Storage ... 28 Validation... 29

11.2

Maintenance ... 29

12

Technical description... 30

12.1

Technical Data ... 30

12.2

Performance characteristics ... 30

12.3

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

13

Replacement parts ... 31

14

Disposal... 31

15

Warranty and Customer Service ... 32

4

BB-A282-02

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.

BB-A282-02

5

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

Federal law restricts this device to sale by or on the order of a physician. 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

BB-A282-02

2

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

BB-A282-02

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

7

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.

CAUTION Federal law restricts this device to sale by or on the order of a physician.

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.

8

BB-A282-02

3

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. The Logic HD PENDUAL camera head with integrated objective lens can be used preferably as a straight camera head (0°) or as an angled variant (90°). A simple mechanism allows the angle of the housing to be changed to any required position between 0° and 90° depending on the operating method used or the personal preferences of the user. For certain applications, e.g. scraping of the prostate, the locking device of the snap-on locking mechanism can be unlocked allowing the endoscope to rotate freely. Free rotation and self-alignment result in a correctly positioned endoscopic image.

NOTE The new camera plugs are delivered without a plug protection cap. This has no negative effect on the tightness of the camera plug so that if used as intended the contacts of the PCB are not damaged. The land (y) guarantees a protection against damage of the inner contacts (z) of the PCB and represents the latest state of the art. The plug protection caps can still be used.

z

y

Fig. 1

BB-A282-02

9

4

Indications for use

4.1

Statement The product is used for applications in conjunction with an ENDOCAM LOGIC 5525 Camera Controller for diagnostic and therapeutic interventions.

4.2

User User These products are exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately instructed persons.

4.3

Additional information 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.

5

Contraindications and side effects

5.1

Contraindications Contraindications directly related to the product are presently unknown. If medical contraindications for the mentioned indications are known, the use of the products is not permitted. On the basis of the patient's general condition the doctor in charge must decide whether or not the planned use is possible.

5.2

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

10

BB-A282-02

6

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 camera head must only be used in accordance with instructions for use GAA282 or GA-A293 for the camera controllers of the ENDOCAM Logic camera controller 5525 model series.

6.1

Requirements on 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.

6.2

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

6.3

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

BB-A282-02

11

7

Illustration 2

1.3

1.6

1.1

1.2 1.4

1

1.7

1.5

1.8

Fig. 2 1

Camera head

1.5

Product no.

1.1

Head button 1 (light) for remote control (for button assignment please see GA-A282 or GAA293)

1.6

Focusing lever

1.2

Head button 2 (dark) for remote control (for button assignment please see GA-A282 or GAA293)

1.7

Locking lever for rotating snap-on lock

1.3

Snap-on lock (rotatable)

1.8

Camera plug

1.4

Serial no.

2

Cover plate (cap)

12

BB-A282-02

8

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.

8.1

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.

8.2

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 Camera Controller 5525 model series in accordance with instructions for use GA-A282 or GA-A293. 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.

BB-A282-02

13

8.3

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.

14

BB-A282-02

9

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. 3

BB-A282-02

15

9.1

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).

9.1.1

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

9.1.2

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 cap from the snap-on lock on the lens.

Fig. 4

16

BB-A282-02

3. Check that the glass surfaces of the endoscope and objective lens are clean and dry. ð Please refer to section 9.1.1 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. 5

9.1.3

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

Fig. 6

BB-A282-02

17

10

Operating instruction

10.1

Additional guidance for use

10.1.1

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.

10.2

Control elements and modes

10.2.1

Function assignment of the camera head buttons NOTE The camera head buttons support functionalities of the camera controller on a remote control basis (e.g. switching to the SIM, starting white-balance procedure, taking images or starting video recording). The buttons are configurable by the user.

10.3

Operating the product

10.3.1

Locking the snap-on lock The locking lever is in position I. ¯ Turn the locking lever to position II. ð The snap-on locking mechanism is locked. The endoscope no longer rotates freely.

Fig. 7

10.3.2

Unlocking the snap-on lock The locking lever is in position II. ¯ Turn the locking lever to position I. ð The snap-on locking mechanism is no longer locked in place, the endoscope can rotate freely.

Fig. 8

18

BB-A282-02

10.3.3

Focusing the image ¯ Turn the focusing lever until the image on the monitor is in focus.

Fig. 9

10.3.4

Angling the camera head ¯ The camera head can be angled between 0° and 90° as required (preferrably it is used as a straight camera head or at an angle of 90°)

Fig. 10

10.3.5

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

BB-A282-02

19

11

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.

20

BB-A282-02