D Camera Controller Instructions for Use V2.0 Sept 2020

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 1.2.1

Symbol... Symbols manual remote control (option)...

5 7

1.3

Explanation of acronyms used ...

7

2

General safety instructions and guidance for use ...

8

3

Product description... 10

4

Intended purpose ... 10

5

Indications ... 11

6

Contraindications and side effects ... 11

6.1

Contraindications... 11

6.2

Side effects... 11

7

Combinations ... 12

7.1

Requirements for the products / components of a combination ... 14

7.2

Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2014 ... 16

7.3

Equipotentality ... 18

8

Connection diagram for camera controller ... 19

9

Illustration ... 20

9.1

Front view ... 20

9.2

Illustration of rear panel ... 21

9.3

Illustration of manual remote control unit (option) ... 22

10

Checks... 23

10.1

Visual check ... 23

10.2

Function check ... 23

11

Preparation/Setup ... 25

11.1

Connection ... 26

11.2 11.2.1 11.2.2 11.2.3 11.2.4 11.2.5

Preparation ... 26 Selecting the video format ... 26 Setting date and time ... 27 Color bar test chart ... 27 Adjusting LCD monitors... 27 Carry out a function check... 27

12

Use ... 28

12.1 12.1.1

Additonal notes and guidance for use ... 28 Operating principle ... 28

12.2 12.2.1 12.2.2 12.2.3 12.2.4

Control elements and operating modes ... 29 Electronic zoom ... 29 Image capture and video recording functions ... 29 Status display ... 31 Signal sounds when using the product... 33

12.3 12.3.1 12.3.2 12.3.3

Operation of the product... 33 Operating time limitation for applied parts with limited usage time ... 33 Automatic white balance (AWB) ... 33 Automatic brightness control (ELC)... 33

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12.3.4 12.3.5

Temperature protection circuit... 34 Taking out of service ... 34

13

Reprocessing and maintenance ... 35

13.1

Reprocessing ... 35

13.2 13.2.1

Maintenance ... 36 Maintenance intervals ... 36

14

License conditions ... 37

15

Technical description... 38

15.1 15.1.1

Troubleshooting... 38 Device error ... 38

15.2

Technical Data ... 39

15.3

Interfaces... 40

15.4

Performance characteristics ... 40

15.5

Operating, storage, transport and shipping conditions ... 40

16

Replacement parts ... 41

16.1

Replacement parts ... 41

16.2 16.2.1

Replacing parts ... 42 Device fuses ... 42

17

Disposal... 43

18

Lithium button cell ... 43

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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.

1.2

Symbol

Symbols

Designation Follow the instruction manual OFF (power supply is switched off) ON (power supply is switched on) Equipotentality Fuse Alternating current (AC) USB interface Data output Type BF applied part Camera head connector

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Symbols

Designation Power supply input Product number Serial Number Manufacturer Manufacturing date Recycle the product separately. Do not discard together with other waste.

Data Matrix Code

Medical product 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.

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1.2.1

Symbols manual remote control (option) Termination or Back

Up

Left or Minus

Right or Plus

Down

OK button for confirmation

Function key I

Function key II

1.3

Explanation of acronyms used

Acronym

Description

OSD

On-Screen Display

ELC

Electronic Light Control (automatic brightness control)

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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.

WARNING Temperature adaptation of electrical devices Before the setup allow the device to adapt to the temperature of the working environment. In particular when changing from cold to warm environments and high humidity this is imperative.

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 n

n

The product must only be used as intended following the instruction manual by adequately trained and qualified medical personnel. Maintenance and repair must be carried out by authorized experts.

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 Contamination by unsterile control terminal Possible contamination by touching the control terminal. n Operate the control terminal only in the unsterile area.

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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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3

Product description The product is used in combination with sensor endoscopes. The electrical signals provided by the sensor endoscope are processed and adequately converted to render a visible image of the endoscopic scene on a connected display device for the user. The product is controlled directly via the control panel on the device front panel.

4

Intended purpose D CAMERA CONTROLLER 5522101

D CAMERA CONTROLLER

The products are used for displaying an image of the inside of the body generated via a rigid or flexible endoscope. MANUAL REMOTE CONTROL USB 5525401

MANUAL REMOTE CONTROL USB

As cable-linked hand-held control panels the products are used to control the control menu of a medical technical device. User This product is designed exclusively for use by specialized medical personnel and may only be applied 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 Patient population The intended patient population is not restricted to ethnics, age, gender, body height and weight. Before use the doctor in charge must ensure that the product can be safely used in terms of its dimensions or settings.

6

Contraindications and side effects

6.1

Contraindications Contraindications directly related to the product are presently unknown. On the basis of the patient’s general condition, the attending physician must decide whether the planned use is possible or not.

6.2

Side effects No side effects relating to the product are known if the product is used as intended.

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7

Combinations WARNING Danger of electric shock If the camera system is used in conjunction with electrosurgical devices an electric shock may be felt.

CAUTION n

n

n

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.

CAUTION In addition to these instructions for use, follow the latest instructions for use of the products used in combination with this product. For further information please contact Richard Wolf or one of our representatives.

CAUTION Patient leakage currents can add if endoscopes are combined with energetically operated, endoscopic devices. Make sure that the combinations do not exceed the permissible patient leakage currents.

CAUTION When operated in looped-through mode with interconnected devices, this may have a negative impac on image rendering.

CAUTION Wrong operation Do not operate the devices directly next to each other and do not stack them together with other devices. If the devices need to be stacked or if the devices are located directly next to each other and HF/RF interference is observed, follow the requirements for the intended use of the devices.

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CAUTION Separation distance from portable RF/HF communication devices Medical electrical devices can be influenced by mobile HF communication devices. Do not operate HF communication devices in the immediate vicinity of medical electrical devices. Non-compliance can cause the power characteristics of the device to be impaired.

CAUTION Influence on interference emissions and interference immunity. Use only accessories or cables specified or supplied by the manufacturer. n Other accessories and cables can cause increased electromagnetic interference or a reduced electromagnetic immunity of the device and lead to malfunctions.

CAUTION Interference and malfunctions Connect only USB accessories tested and approved by Richard Wolf to the USB interfaces. Otherwise interference or malfunction cannot be excluded.

The products are used with n n n n n n

Endoscopic cameras and sensor endoscopes Endoscopic devices Laser surgery devices Endoscopc instruments and accessories Surgical instruments and accessories Suction and irrigation pumps

Compatibility Product no.

Designation

473572076

SENSOR URETERORENOSCOPE 9CH WL 600MM

473572075

SENSOR URETERORENOSCOPE 9CH WL 600MM

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7.1

Requirements for the products / components of a combination WARNING Persons combining products to form a system are responsible for not impairing the system's compliance with performance and safety requirements, and for ensuring that the technical data and the intended use are adequately fulfilled. Possible electromagnetic or other interference that may occur between the product and other products can cause faults or malfunctions. When selecting system components, check that they meet the requirements for the medical environment in which they are to be used (IEC/EN 60601-1 in particular). In case of doubt, contact the manufacturer(s) of the system components. Do not touch connectors for electrical connections between various components (such as signal input connectors and signal output connectors for video signals, data exchange, controls) and the patient at the same time. The general requirements depend on whether the products/components are inside or outside the patient environment.

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Medically used room within the patient environment

outside the patient environment -------

Non-medically used room

Requirements / measures Leakage currents to IEC/EN 60601-1

-------

Measurement of leakage currents a) additional protective earth connection (to be clarified with the corresponding manufacturer), or b) additional isolating transformer **

-------

Measurement of leakage currents a) no plugs with metal housing, or b) additional separating device (to avoid voltage differentials) Verification of leakage currents a) joint protective earth connection, or b) additional protective earth connection at MP (verify with the corresponding manufacturer), or c) additional separating device (to avoid voltage differentials), or d) no plugs with metal housing in the patient environment

additional "isolating transformer with galcanic separation to IEC/EN 60601-1 **

additional isolating device to IEC/ EN 60601-1

----

Functional connection

Power supply grid

MP

= medical electrical device to IEC/ EN 60601-1, ANSI/AAMI es60601-1, CSA C22.2 No. 60601-1

NMP

= non-medical electrical device in accordance with product-specific IEC/EN/UL standards

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Multi-socket strip*

15

*

When connected via the same multiple socket strip under standard conditions, the earth leakage current of the socket strip must not exceed 5 mA.

**

e.g. Richard Wolf video cart with "isolating transformer"

Only connect devices with a safety extra-low voltage of no more than 60 V DC / 42.4 V AC peak to the connectors for electrical connections, i.e. the signal inputs and outputs.

7.2

Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2014 NOTE The device/system in the following called product always refers to the product mentioned in the chapter on "intended purpose".

Guidelines and manufacturer's declaration - Electromagnetic emissions The product is intended for use in the environment specified below. The user must assure that the product is used in such an environment. Emissions measurement / test

Compliance Electromagnetic environment - Guidelines with

HF emissions to CISPR 11

Group 1

The product uses HF energy for its internal function. The HF emission level is extremely low and is not likely to cause any interference in nearby electronic equipment.

HF emissions to CISPR 11

Class A

Harmonic emissions to IEC 61000-3-2

Class A

The product is suitable for use in buildings other than residential buildings and buildings that are immediately connected to the public power supply network that also supplies buildings used for residential purposes provided the following warning is observed: Warning: The product is only intended for use by specialized medical staff. In residential areas this product can cause radio interference which may require taking adequate remedial measures such as new alignment, new location or screening the product or filtering the connection to the installation site.

In conformity with IEC 61000-3-3 “Emission of voltage fluctuations / flicker"

Guidelines and manufacturer's declaration - Electromagnetic immunity The product is intended for use in the environment specified below. The user must assure that the product is used in such an environment. Immunity tests

IEC 60601 test level

Electrostatic discharge (ESD) ± 8 KV contact disto IEC 61000-4-2 charge ± 15 KV air discharge Electrical fast transients / bursts to IEC 61000-4-4

16

Compliance Electromagnetic environment - Guidelines Yes

Floors should be wood, concrete or ceramic tile. With floors made of synthetic material, the relative humidity of the ambient air must be at least 30%.

± 2 KV for mains power Yes lines ± 1 KV for input and output lines

Mains/line power quality should be that of a typical commercial or hospital environment.

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The product is intended for use in the environment specified below. The user must assure that the product is used in such an environment. Immunity tests

IEC 60601 test level

Compliance Electromagnetic environment - Guidelines

Surge voltage (surges) to IEC 61000-4-5

± 1 KV voltage Phase to phase ± 2 KV voltage phase to earth

Yes

Mains/line power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and supply voltage variations to IEC 61000-4-11

0% UT * ; 1/2 period at 0, 45, 90, 135, 180, 225, 270 and 315 degrees 0% UT * ; 1 period and 70% UT * ; 25/30 periods Single-phase: at 0 degrees 0% UT * ; 250/300 periods

Yes

Mains/line power quality should be that of a typical commercial or hospital environment. If the user of the product requires continued operation during power mains/line interruptions it is recommended that the product be powered from an uninterruptible power supply or battery.

Power frequency (50/60 Hz) magnetic field, to IEC 61000-4-8

30A/m

Yes

Power frequency magnetic fields should be at levels characteristic of a typical location in a commercial or hospital environment.

* REMARK: UT is the line / mains voltage prior to application of the test levels.

Guidelines and manufacturer's declaration - Electromagnetic immunity for products that are not life-supporting The device is intended for use in the electromagnetic environment defined below. The user must assure that the product is used in such an environment. Immunity tests

Test level to IEC 60601

Compliance level

HF conducted disturbances to IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms 150 kHz to 80 MHz

a

6 V rms in ISM frequency bands 150 kHz to 80 MHz

Radiated HF interference to IEC 61000-4-3

3 V/m 80 MHz to 2.7 GHz

Electromagnetic environment - Guidelines

Portable and mobile RF communications equipment should be used no closer to the device, including cables, than the recommended separation distance of 30 cm. a 6 Vrms in ISM freThe field strength of stationary radio quency bands transmitters determined within the scope 150 kHz to 80 of on-site investigations should be below b MHz the compliance level for all frequences. In the vicinity of devices with the folowing symbol interference is possible: 3 V/m 80 MHz to 2.7 GHz

REMARKS: These guidelines may not apply in all situations. The propagation of electromagnetic waves is affected by absorption and reflexion from buildings, objects and people.

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The device is intended for use in the electromagnetic environment defined below. The user must assure that the product is used in such an environment. Immunity tests

Test level to IEC 60601

Compliance level

Electromagnetic environment - Guidelines

a) The ISM frequency bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 to 13.567 MHz; 26.957 MHz to 27.283 MHz and 40.66 MHz to 40.70 MHz. b) The field strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the equipment is used exceeds the applicable RF compliance leve above, the equipment should be observed to verify normal operation. In the case of unusual behaviour during operation, additional measures may be necessary, such as a changed alignment or a different location of of the device.

Recommended safety distances between portable and mobile HF telecommunication devices and the producte Definition relative to high-frequency wireless communication devices Frequency band (MHz)

Test frequency (MHz)

Modulation a

Compliance level (V/m)

380–390

385

Pulse – 18 Hz

27

430–470

450

FM ± 5 kHz deviation or a pulse – 18 Hz

28

704–787

710, 745, 780

Pulse – 217 Hz

a

9

a

28

800–960

810, 870, 930

Pulse – 18 Hz

1700–1990

1720, 1845, 1970

Puls – 217 Hz

a

28

a

28

a

9

2400–2570

2450

Pulse – 217 Hz

5100–5800

5240, 5500, 5785

Pulse – 217 Hz

REMARKS: Between portable HF communication devices transmitting in the specified frequency band and the product, a minimum safety distance of 30 cm should be maintained. This comprises mobile phones, LAN, RFID and Bluetooth devices. Non-compliance can cause the power characteristics of the device to be impaired. a) Pulse modulation is defined as a square signal with a 50% duty cycle.

7.3

Equipotentality The potential equalization cable represents a direct connection between a medical electrical device and a potential equlization rail. It serves to equalize differences in potential between enclosures of electrical equipment and firmly installed conductive parts in the patient environment.

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Connection diagram for camera controller

Fig. 1 ------1

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Direct connection Video cable in accordance with the signal types of the camera controller used

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9

Illustration

9.1

Front view

x

6

4 7

x

5

3

2

1

17

Fig. 2 Item

20

Description

Item

Description

1

Selection of zoom level

5

USB 2.0 interface (for external storage media)

2

Selection of image capture

6

LED segmented ring

3

Selection of video recording Start/Stop

7

Camera socket (Type BF applied part)

4

USB status LED

17

Identification plate

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