Logic HD lite Camera Control Unit Instructions for Use V1.0 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 ...

6

1.1

Safety instructions and levels of danger...

6

1.2 1.2.1

Symbols... Symbols on manual remote control (optional) ...

6 8

1.3

Explanation of acronyms used ...

9

2

General safety notes and instructions for use ... 10

3

Product description... 12

4

Intended purpose ... 12

5

Indications ... 13

6

Contraindications and side effects ... 13

6.1

Contraindications... 13

6.2

Side effects... 13

7

Combinations ... 14

7.1

Requirements for the products / components of a combination ... 15

7.2

Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2014 ... 18

7.3

Equipotentality ... 21

7.4

Connection diagram – camera control unit in video mode ... 22

8

Illustration ... 23

8.1

Front view ... 23

8.2

Rear view... 24

8.3

Illustration of manual remote control unit (optional) ... 25

9

Checks... 26

9.1

Visual checks ... 26

9.2

Function check ... 26

10

Preparation / Commissioning ... 28

10.1

Connecting to the core nova system ... 30

10.2 10.2.1 10.2.2 10.2.3 10.2.4 10.2.5

Preparation ... 31 Selecting the menu language ... 33 Setting the keyboard layout ... 33 Setting the date and time ... 33 Color bar test image ... 33 Adjusting LCD monitors... 33

11

Use ... 34

11.1 11.1.1

General notes and instructions for use... 34 Operating principle ... 34

11.2 11.2.1 11.2.2 11.2.3 11.2.4 11.2.5

Control elements and operating modes ... 35 "dialog" function... 35 Special Imaging Mode (SIM) ... 36 Automatic brightness control (ELC)... 37 Temperature protection circuit... 37 Documentation ... 38

11.3 11.3.1 11.3.2

Operating the product... 38 Controlling the device via the buttons on the front panel + 2nd menu level ... 38 Menu control via monitor with manual remote control (optional) ... 39

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11.3.3

Menu control via monitor with PC keyboard (optional) ... 39

11.4

Menu levels ... 40

11.5 11.5.1 11.5.2 11.5.3 11.5.4 11.5.5 11.5.6 11.5.7 11.5.8 11.5.9 11.5.10

Menu control via monitor with manual remote control or PC keyboard ... 40 Overview – menu structure – "Operation" main menu... 40 Overview – menu structure – "Settings" main menu... 41 Overview – menu structure – "Image archive" menu... 42 Description – "Settings" submenu ... 43 Patient data input ... 45 Status display for camera head button actions ... 45 Symbols in status line... 46 HDR on-screen display and white light modes (SIM) ... 47 On-screen display of run time for applied parts with limited usage time ... 47 Display of function button assignment... 47

11.6 11.6.1 11.6.2

Operating the camera control unit via the buttons on the front panel... 48 Overview – button functions on the different control levels ... 48 Description – button functions on the device front panel ... 48

11.7 11.7.1 11.7.2 11.7.3 11.7.4 11.7.5 11.7.6 11.7.7 11.7.8 11.7.9 11.7.10

Operation of the camera control unit ... 49 General notes on device operation in the core system ... 49 Automatic white balance (AWB) ... 50 Displaying and editing profiles... 51 Image brightness ... 51 Detail ... 51 Electronic zoom ... 51 Measurement window (endoscopic image adaptation) ... 52 Connecting the USB storage medium ... 52 USB printer ... 52 Taking out of service ... 52

11.8 11.8.1 11.8.2 11.8.3 11.8.4

Overview of system messages... 53 Structure of system messages ... 53 Message types ... 53 Functionality of control elements ... 53 Operating messages (green)... 53

12

Reprocessing and maintenance ... 57

12.1

Reprocessing of the device ... 57

12.2

Reprocessing applied parts ... 58

12.3

Reprocessing adapters ... 58

12.4 12.4.1

Maintenance ... 58 Maintenance intervals ... 58

13

License agreements ... 59

14

Operation in the core nova system... 60

14.1

Operating principle in the core nova system ... 60

14.2

Combination and device operation ... 60

14.3

Connecting to the core nova system ... 61

15

Technical description... 62

15.1 15.1.1 15.1.2 15.1.3 15.1.4 15.1.5

Troubleshooting... 62 Device errors ... 62 Error in video mode ... 63 Error in the core nova system ... 64 Error in adapter connection ... 64 Monitor display error... 64

15.2

Technical data ... 66

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15.3

Output interfaces ... 67

15.4

Performance characteristics ... 67

15.5 15.5.1

Operating, storage, transport, and shipping conditions ... 67 Operating time limitation for applied parts with limited usage time ... 68

16

Spare parts ... 69

16.1

Spare parts ... 69

16.2 16.2.1

Replacing parts ... 70 Device fuses ... 70

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Disposal... 70

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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

Symbols

Symbols

Designation Caution Follow the instruction manual Medical device Off (no power supply, disconnected from line power) On (power supply, connected to line power) Equipotentality Fuse Alternating current (AC) Type CF applied part Camera head connector

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Automatic white balance (AWB)

Brightness control

Brightness "+"

Brightness "-"

Profiles

Detail levels

Zoom levels

USB interface Data input Data output Local Area Network (LAN) Manufacturer Manufacturing date Maximum temperature range for shipment, transport, and storage

Temperature, limitation

Atmospheric pressure, limitation

Humidity, limitation

Do not immerse in liquids

Recycle the product separately. Do not discard together with other waste.

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A registered trademark of a recognized testing laboratory, confirms compliance with the Medical Electrical Equipment CAN/CSA C22.2 No.60601-1 (C) and ANSI/AAMI ES60601-1 (US) standards A Registered Trademark of a Recognized Testing Laboratory, confirms the compliance to the standard of Medical Electrical Equipment CAN/CSA C22.2 No.60601-1 (c) and ANSI/AAMI ES60601-1 (US) 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.

1.2.1

Symbols on manual remote control (optional)

Symbols

Designation Termination or Back

Up

Left or Minus

Right or Plus

Down

OK button for confirmation

Function key I

Function key II

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1.3

Explanation of acronyms used

Acronym

Description

PDD

Photodynamic diagnostics

SIM

Special Imaging Mode

HDR

High Dynamic Range

ELC

Electronic Light Control (automatic brightness control)

OSD

On-Screen Display

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2

General safety notes and instructions 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 Contamination by unsterile control terminal Possible contamination by touching the control terminal. n Operate the control terminal only in the unsterile area.

CAUTION n

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

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 to the patient, user, and others are possible. Run through the checks before and after each use. Do not use products that 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.

CAUTION The operator is responsible for limiting the physical access of non-authorized persons to the product.

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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. The instruction manual is an integral part of the product and must be stored in such a way that it is accessible at all times during the entire life cycle. It 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 products are used for displaying the image of natural or artificial hollow spaces obtained by an endoscope within the scope of diagnostic or therapeutic endoscopy. The Logic HD lite camera control unit has different output ports (USB, HDMI, etc.) for the connection of USB storage media, image storage devices, and other video devices for recording and storing video images and video sequences.

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Intended purpose Camera controller 5525201

LOGIC HD LITE CAMERA CONTROLLER

The products are used for displaying the image of the inside of the body obtained by a rigid or flexible endoscope. Manual remote control, USB 5525401

MANUAL REMOTE CONTROL, USB

The products are used as a cable-connected manual control unit for controlling the control menu of a medical device. User The product is intended exclusively for use by medical experts and may only be used by adequately qualified and trained medical personnel.

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Indications CAUTION Device may fail For therapeutic applications, a second camera with the same specifications should be available.

NOTE We recommend reading relevant literature for the planned application.

The products are used for endoscopic procedures 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.

6

Contraindications and side effects

6.1

Contraindications Contraindications directly related to the products are presently unknown. Medical contraindications for the endoscopic procedures to be performed exclude the use of the products concerned. The responsible physician must decide on the basis of the patient's general condition whether the intended use is possible or not. For further information, please refer to the most recent medical literature.

6.2

Side effects No side effects related to the products are known if the products are used as intended.

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7

Combinations CAUTION The installation of the entire product including the configuration setting via the core nova system must be carried out by an authorized and trained expert.

CAUTION Do not connect the device to other networks (e.g., hospital network) via the LAN (Ethernet) interface. Connect the device via the LAN (Ethernet) interface only within the core nova system.

ATTENTION The OR network must be galvanically isolated from the hospital network, e.g. by: n Optical network cable(s) with the corresponding optical transceiver(s) for the network switch. n Network isolator for medical devices.

ATTENTION Close any LAN (Ethernet) sockets in the network switch that are not used with the corresponding plastic caps. The camera ENDOCAM Logic HD Lite 5525201 may only be used in combination with the camera heads, sensor endoscopes, and adapters approved by Richard Wolf, and following the corresponding instruction manual: 85525922

LOGIC HD CAMERA HEAD CABLE 3M

85525923

LOGIC HD CAMERA HEAD CABLE 5M

85525902

LOGIC HD CAMERA HEAD CABLE 3M

5525933

LOGIC HD PENDUAL CAMERA HEAD CABLE 3 M

7355071

SENSOR URETERORENOSCOPE 8.7FR WL 680MM

7355076

SENSOR URETERORENOSCOPE 8.7FR WL 680MM

7356071

SENSOR URETERORENOSCOPE 9.9FR WL 680MM

7356076

SENSOR URETERORENOSCOPE 9.9FR WL 680MM

7315001

SENSOR CYSTOSCOPE 16.2FR WL 400MM

7235011

SENSOR BRONCHOSCOPE Ø 3.3 MM WL 680 MM

473572076

SENSOR URETERORENOSCOPE 9FR WL 600MM

5592201

CORE.BROWSER

5651051

DIGITAL COLOR PRINTER SONY UP-DR80MD

5525410

ADAPTER FOR CONTROLLER 5525

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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 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, etc.) and the patient at the same time.

CAUTION Safety distance from portable 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 may impair the device’s performance.

CAUTION In loop-through operation with interconnected devices, the image display may be negatively affected.

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

CAUTION In addition to this instruction manual, follow the latest instruction manual for the products used in combination with this product. Only components approved for the core system may be connected to the device. For further information please contact Richard Wolf or your representative.

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CAUTION 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 still fulfilled. Only components approved for the integration solution may be connected to the device. For further information please contact Richard Wolf or your representative. The product must not be altered in any way.

CAUTION Device operation may be jeopardized by other devices located in the immediate vicinity or if devices are stacked. Other devices located in the immediate vicinity or stacked devices may interfere with each other and cause malfunctions, in particular if devices give off energy (e.g., HF surgical devices). If devices have to be arranged in this way, make sure that they work properly.

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

CAUTION 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.

ATTENTION 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, etc.) and the patient at the same time.

NOTE Should a higher software version than installed on the camera control unit be required for the operation, the applied part will not be detected. The color bar test image appears on the screen. Check the installed software version. If a software update is required: contact the service department.

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The general requirements depend on whether the products/components are inside or outside the patient environment.

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

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

additional isolating device to IEC/ EN 60601-1

Multi-socket strip*

----

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

*

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"

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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

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%.

Electrical fast transients / bursts to IEC 61000-4-4

± 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.

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.

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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. 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.

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