ENDOCAM PERFORMANCE HD 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 ...

5

1.1

Safety instructions and levels of danger...

5

1.2

Symbols...

5

1.3

Explanation of acronyms used ...

7

2

General safety notes and instructions for use ...

8

3

Product description... 10

4

Intended purpose ... 11

5

Indications ... 12

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 ... 14

7.2 7.2.1 7.2.2

Electromagnetic compatibility (EMC) ... 17 Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2014 ... 17 Electromagnetic compatibility (EMC) – IEC 60601-1-2:2007 ... 20

7.3

Equipotentality ... 22

7.4

Connection diagram – Video mode – optionally with documentation system ... 23

8

Illustration ... 24

8.1

Front view ... 24

8.2

Rear view... 25

9

Checks... 26

9.1

Visual checks ... 26

9.2

Function check ... 26

10

Preparation / Commissioning ... 27

10.1

Connection ... 29

10.2 10.2.1 10.2.2 10.2.3

Preparation ... 30 Setting the DIP switches ... 30 Color bar test image ... 30 Adjusting LCD monitors... 30

11

Use ... 31

11.1 11.1.1

General notes and instructions for use... 31 Operating principle ... 31

11.2

Control elements and operating modes ... 32

11.3 11.3.1 11.3.2 11.3.3 11.3.4 11.3.5 11.3.6 11.3.7 11.3.8

Operating the product... 32 White balance... 33 Automatic brightness control ... 33 Contour enhancement ... 34 Endoscopic image adjustment ... 34 Storage function on USB stick... 34 Directory structure on a USB stick ... 35 Functions and control via camera head ... 36 Taking out of service ... 36

12

Reprocessing and maintenance ... 37

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12.1

Reprocessing of the device ... 37

12.2

Reprocessing of the camera head ... 38

12.3 12.3.1

Maintenance ... 38 Maintenance intervals ... 38

13

Technical description... 39

13.1

Troubleshooting... 39

13.2

Technical data ... 41

13.3

Interfaces... 42

13.4

Performance characteristics ... 42

13.5

Operating, storage, transport, and shipping conditions ... 42

14

Spare parts ... 43

14.1

Spare parts ... 43

14.2 14.2.1

Replacing parts ... 44 Device fuses ... 44

15

Disposal... 45

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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, separation from grid) ON (power supply, connection to the grid) Equipotentality Fuse Alternating current (AC) APPLIED PART corresponding to the camera head connected

Camera head connector

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Automatic white balance (AWB)

Brightness control

Brightness preselection "PLUS"

Brightness preselection "MINUS"

Contour enhancement

Endoscopic image adjustment

USB interface Data output Recycle the product separately. Do not discard together with other waste.

Manufacturer Manufacturing date

Maximum temperature range for shipment, transport, and storage

Temperature, limitation

Atmospheric pressure, limitation

Humidity, limitation

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)

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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 ELC

GA-A280

Description Electronic Light Control (automatic brightness control)

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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

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

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

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.

CAUTION Access to patient data by staff trained in data protection law.

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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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 Performance HD camera control unit is equipped with various output sockets (USB, Video, S-Video, etc.) where USB storage media, image storage devices, and other video equipment for recording and storing video images and video sequences can be connected.

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Intended purpose Camera controller 5514101

PERFORMANCE HD CAMERA CONTROL UNIT

The products are used for displaying the image of the inside of the body obtained by a rigid or flexible endoscope. 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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5

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.

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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.

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 ATTENTION Do not connect the device to a network (e.g., hospital network) via the RJ45 or USB interfaces. The ENDOCAM Performance HD control unit may only be used in combination with the camera heads approved by Richard Wolf and following the instruction manual of the camera heads used.

7.1

5514901

PERFORMANCE CAMERA HEAD CABLE 4M

5514961

PERFORMANCE CAMERA HEAD CABLE 4M

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.

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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.

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. 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.

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) Note: The device or system referred to as the product always relates to the ENDOCAM Performance HD control unit.

7.2.1

Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2014 NOTE All instances of the word "product" in the context of a device/system in the following section of text refer to the product mentioned in the section on "Intended use".

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

Compliance Electromagnetic environment – Guidelines

HF emissions to CISPR 11

Group 1

The product uses HF energy for its internal functions. 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 B

Harmonic emissions to IEC 61000-3-2

Class A

The product is suitable for use in all establishments, including domestic establishments. This also includes establishments directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

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 make sure that the product is used in such an environment. Immunity tests

IEC 60601 test level

Compliance Electromagnetic environment – Guidelines

Electrostatic discharge (ESD) to IEC 61000-4-2

± 8 kV contact discharge ± 15 kV air discharge

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 power caYes bles ± 1 kV for input/output cables

Line power quality should be that of a typical commercial or hospital environment.

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

± 1 kV line-to-line voltage ± 2 kV line-to-ground voltage

Yes

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 Yes 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 % UT * ; 250/300 periods

Line power quality should be that of a typical commercial or hospital environment. If the user of the product requires continued operation during power/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

30 A/m

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

Yes

* NOTE: UT is the line voltage prior to application of the test level.

Guidelines and manufacturer's declaration – Electromagnetic immunity for products that are not life-supporting

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The device is intended for use in the electromagnetic environment defined below. The user of the device must make sure that it is used in such an environment. Immunity tests

Test level acc. to IEC 60601

Compliance level

Electromagnetic environment – Guidelines

Conducted HF interference to IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms 150 kHz to 80 MHz

Portable and mobile RF communications equipment should be used no closer to any part of the device (including cables) than the recommended separation distance of 30 cm. The field strength from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the comb pliance level at all frequencies. Interference may occur in the vicinity of devices with the following symbol:

a

Radiated HF interference to IEC 61000-4-3

a

6 Vrms ISM frequency bands 150 kHz to 80 MHz

6 Vrms ISM frequency bands 150 kHz to 80 MHz

3 V/m 80 MHz to 2.7 GHz

3 V/m 80 MHz to 2.7 GHz

NOTES: These guidelines may not apply in all situations. The propagation of electromagnetic waves is affected by absorption and reflection 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 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz, and 40.66 MHz to 40.70 MHz. b) The field strength of fixed transmitters such as base stations for radio (cellular, cordless) telephones and land mobile radios, amateur radio, AM and FM radio, and TV transmitters cannot be predicted theoretically with accuracy. To assess the electromagnetic environment in terms of fixed transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location where the device is used exceeds the applicable compliance levels above, the device must be observed to verify it is functioning normally. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device.

Recommended separation distances between portable and mobile HF telecommunication devices and the product Definition for high-frequency wireless communication equipment Frequency band

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

800-960 1700-1990 2400-2570 5100-5800

810, 870, 930 1720, 1845, 1970 2450 5240, 5500, 5785

a

9

a

28

a

28

a

28

a

9

Pulse – 18 Hz Pulse – 217 Hz Pulse – 217 Hz Pulse – 217 Hz

NOTES: A minimum safety distance of 30 cm should be maintained between the product and portable HF communication devices emitting in the specified frequency band. This includes cell phones as well as WLAN, RFID, and Bluetooth devices, for example. Non-compliance may impair the product's performance. a) Pulse modulation is defined as a square-wave signal with a 50% duty cycle.

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7.2.2

Electromagnetic compatibility (EMC) – IEC 60601-1-2:2007 NOTE The device / system, in the following referred to as the product, always relates to the product mentioned in the section on "Intended use".

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

Conformity Electromagnetic environment – Guidelines

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 B

Harmonic emissions to IEC 61000-3-2

Class A

The product is suitable for use in all establishments, including domestic establishments. This also includes establishments directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

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 make sure that the product is used in such an environment. Immunity tests

IEC 60601 test level

Compliant

Electromagnetic environment – Guidelines

Electrostatic discharge (ESD) to IEC 61000-4-2

± 6 kV contact discharge ± 8 kV air discharge

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 power cables Yes ± 1 kV for input/output cables

Line power quality should be that of a typical commercial or hospital environment.

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

± 1 kV line-to-line voltage ± 2 kV line-to-ground voltage

Yes

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

Dip for 0.5 cycles > 95% UT * Dip for 5 cycles 60% UT * Dip for 25 cycles 30% UT * Dip for 5 s > 95% UT *

Yes

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

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