ENDOLIGHT LED blue Instructions for Use V1.0 April 2020

Instructions for Use

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Instructions for use

ENDOLIGHT LED blue 5165001

GA-A309 / en / EU / V1.0 / 2020-04 /

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.

Subject to technical changes! Due to ongoing development, the product descriptions, figures, and technical data may deviate slightly from the current state. For further information about our products, please contact Richard Wolf GmbH or a local 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

GA-A309-en-EU V1.0

Contents 1

General information ...

1.1

Safety instructions and levels of danger...

1.2

Symbols...

1.3

Explanation of acronyms used ...

General safety notes and instructions for use ...

Product description...

Intended purpose ...

4.1

Operation with white light ...

4.2

Operation with blue light ...

Indications ... 10

Contraindications and side effects ... 11

6.1

Contraindications... 11

6.2

Side effects... 11

Combinations ... 12

7.1

Requirements for the products/components of a combination ... 13

7.2 7.2.1 7.2.2

Electromagnetic compatibility (EMC) ... 15 Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2014 ... 15 Electromagnetic compatibility (EMC) – IEC 60601-1-2:2007 ... 18

7.3

Equipotentality ... 20

7.4

Connection diagram – light source in video mode... 21

Illustration ... 22

8.1

Front view ... 22

8.2

Rear view... 23

Checks... 24

9.1

Visual check ... 24

9.2

Function check ... 24

Preparation / Commissioning ... 25

10.1

Connecting to the core nova system ... 27

10.2

Preparation ... 28

Use ... 29

11.1 11.1.1

General notes and instructions for use... 30 Operating principle ... 30

11.2 11.2.1 11.2.2 11.2.3 11.2.4 11.2.5

Control elements and operating modes ... 30 Dialog function... 30 Automatic switch-on of the device, i.e., "Safe start" (e.g., after power failure) ... 31 Manual brightness adjustment ... 31 LAN (Ethernet) system connection... 31 Temperature protection circuit... 31

11.3 11.3.1 11.3.2 11.3.3 11.3.4 11.3.5

Operating the light source ... 32 General notes on operation within the core nova system ... 32 Notes and instructions for blue light mode ... 32 Device function after switching on the device ... 32 Manual brightness adjustment ... 33 Automatic brightness adjustment using the dialog function ... 33

GA-A309-en-EU V1.0

11.3.6 11.3.7 11.3.8 11.3.9 11.3.10 11.3.11

Brightness control in video mode ... 33 Switching the LED on and off ... 33 White light/blue light switchover ... 34 Selecting white light mode/blue light mode ... 34 Error messages displayed on device ... 34 Taking out of service ... 35

11.4 11.4.1 11.4.2 11.4.3 11.4.4 11.4.5 11.4.6

Overview of system messages... 35 Structure of system messages ... 35 Message types ... 35 Functionality of control elements ... 35 LOW error (turquoise)... 36 MEDIUM error (yellow) ... 37 HIGH error (red) ... 37

Reprocessing and maintenance ... 38

12.1

Reprocessing ... 38

12.2 12.2.1

Maintenance ... 39 Maintenance intervals ... 39

Operation in the core nova system... 40

13.1

Operating principle in the core nova system ... 40

13.2

Combination and device operation ... 40

13.3

Connecting to the core nova system ... 41

Technical description... 42

14.1 14.1.1 14.1.2 14.1.3 14.1.4

Troubleshooting... 42 Device errors ... 42 LED function error ... 42 Fault in video mode ... 43 Error in the core nova system ... 43

14.2 14.2.1

Technical data ... 43 Technical data for LED ... 44

14.3

Interfaces... 44

14.4

Performance characteristics ... 44

14.5

Operating, storage, transport, and shipping conditions ... 44

Spare parts ... 44

15.1

Spare parts ... 44

15.2 15.2.1

Replacing parts ... 45 Device fuses ... 45

Disposal... 45

GA-A309-en-EU V1.0

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.

GA-A309-en-EU V1.0

1.2

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 Cold light Licht ein/aus

Brightness setting (maximum) Brightness setting (minimum) Increase brightness Decrease brightness

White light/blue light switchover

Footswitch Local Area Network (LAN) Manufacturer Manufacturing date Recycle the product separately. Do not discard together with other waste.

GA-A309-en-EU V1.0

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) 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 Not applicable.

GA-A309-en-EU V1.0

General safety notes and instructions for use WARNING The product and its accessories 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 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. The product must not be altered in any way.

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.

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. Immediately upon 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. 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.

GA-A309-en-EU V1.0

Product description The light source is used for diagnostic and therapeutic endoscopic interventions. Using LED lamps, light is generated, which is transported from the light source to the endoscope via a light cable, thereby ensuring that the operation area is sufficiently lit. The light source is used together with a suitable camera control unit, a camera head, and an endoscope specifically for photodynamic diagnostics (PDD).

Intended purpose Light source 5165001

LED BLUE LIGHT SOURCE

2030.105

TOGGLE SWITCH

The products are used for providing white light and blue light for diagnostic and therapeutic applications, particularly in endoscopy. User The product is exclusively intended for use by specialized medical personnel and may only be used by medically qualified and adequately trained persons.

4.1

Operation with white light The ENDOLIGHT LED blue light source supplies white light for examinations, as well as diagnostic and therapeutic applications, particularly in endoscopy.

4.2

Operation with blue light ATTENTION The blue light modes may only be operated in combination with the components intended for this purpose. The ENDOLIGHT LED blue light source supplies blue light for diagnostic applications requiring fluorescent light.

GA-A309-en-EU V1.0

Indications WARNING Product failure during therapeutic use. Interruption of therapeutic use. n For therapeutic use, 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 in various medical disciplines (white light mode). n Used in urology for photodynamic diagnostics (PDD) (blue light mode). For use in blue light mode, follow instruction manual GA-A324 for the blue system. n

Patient population The intended patient population is not restricted to ethnics, age, gender, body height and weight. Before use the attending physician must ensure that the product can be safely used in terms of its dimensions or settings.

GA-A309-en-EU V1.0

Contraindications and side effects

6.1

Contraindications There are currently no known contraindications directly related to the products for white light mode. If there are any medical contraindications for the endoscopic interventions to be performed, the products concerned may not be used. Blue light mode is contraindicated for patients who: Have been treated with chemotherapy or immune therapy within the previous three months n Have undergone intravesical therapy or a tissue resection in the area to be examined in the previous three months n Have a florid urinary tract infection n Have already shown an immunological reaction to one of the photosensitizers used in photodynamic diagnostics When using a photosensitizer, observe the package insert. n

The ENDOLIGHT LED blue light source must not be used on patients not suitable for white light endoscopy. For operation in blue light mode, observe the contraindications in instruction manual GA-A324 for the blue system.

6.2

Side effects There are currently no known side effects directly related to the blue system. For side effects relating to the photosensitizer, please refer to the package insert.

GA-A309-en-EU V1.0

Combinations WARNING Do not combine products incorrectly! This could cause injuries to the patient, user, or others, as well as damage to the product. The various products must only be used together if the intended use and the relevant technical data such as working length, diameter, etc. are the same. Observe the instruction manuals of the products used in combination with this product.

WARNING This product must only be applied in combination with the devices approved by Richard Wolf and following the corresponding device instruction manual.

ATTENTION For use in blue light mode, follow instruction manual GA-A324 for the blue system.

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

NOTE In addition to this manual be sure to observe the latest instructions for use of the products used in combination with this product. Connect only components to the product that have been approved for the core nova system. For further information please contact Richard Wolf or our representatives.

NOTE The OR network must be galvanically isolated from the hospital network, e.g., by: n Optical network cables with the corresponding optical transceiver for the network switch. n A network isolator for medical devices.

NOTE Do not connect the device to other networks, such as the hospital in-house network via the LAN (Ethernet) interface. Only connect the device via the LAN (Ethernet) interface within the core nova system.

GA-A309-en-EU V1.0

NOTE 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.

NOTE Fluorescence mode can only be performed in conjunction with the components intended for this mode.

NOTE The device/system in the following called product always refers to the product mentioned in the chapter on "intended purpose".

Other combinable products: Model

Designation

80673523

FIBER LIGHT CABLE BLUE Ø 3.5MM

2030.105

TOGGLE SWITCH

72325378

PATCH CABLE, RJ45 SFTP, 0.5 M

72325429

PATCH CABLE, RJ45 HRS TM11 1.0 M Further accessories on request

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.

CAUTION Accessories such as light cables must not have a negative impact on the classification of the applied part and must not have a conductive connection between the light socket and the cold light connector.

GA-A309-en-EU V1.0

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

GA-A309-en-EU V1.0

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

= 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)

7.2.1

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

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"

GA-A309-en-EU V1.0

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.

GA-A309-en-EU V1.0

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 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

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:

Radiated HF interference to IEC 61000-4-3

6 Vrms ISM frequency bands 150 kHz to 80 MHz

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

430-470

450

FM ± 5 kHz deviation or a pulse – 18 Hz

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

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.

GA-A309-en-EU V1.0

7.2.2

Electromagnetic compatibility (EMC) – IEC 60601-1-2:2007

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

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

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

Voltage dip for 0.5 cycle > 95% UT * Voltage dip for 5 cycles 60% UT * Voltage dip for 25 cycles 30% UT * Voltage dip for 5 sec > 95% UT *

Yes

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

3 A/m

Yes

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

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

GA-A309-en-EU V1.0

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

Conducted HF interference 3 Vrms to IEC 61000-4-6 150 kHz to 80 MHz Radiated HF interference to IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

Compliance

Electromagnetic environment – Guidelines

Yes

Portable and mobile RF communications equipment should be used no closer to any part of the product, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: d = 1.2

d = 1.2

P for 80 MHz to 800 MHz

d = 2.3 P for 800 MHz to 2.5 GHz P = nominal power output rating of the transmitter in watts (W) (according to the transmitter manufacturer) d = recommended separation distance in meters (m) Field strengths from fixed RF transmitters, as determined by an electromagnetic site sur1 vey , should be less than the compliance level in each frequency range². Interference may occur in the vicinity of devices with the following symbol:

NOTES: At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. The propagation of electromagnetic waves is affected by absorption and reflection from buildings, objects, and people. 1 = The field strength of stationary transmitters (e.g., wireless phone base stations, radio devices, amateur radio stations, broadcasting and television transmitters) cannot be precisely predicted theoretically. To assess the EMC environment due to fixed transmitters, an electromagnetic site survey should be conducted. If the measured field strength in the location in which the product is used exceeds the applicable compliance level above, the product should be observed to verify normal operation. If abnormal performance is observed, additional measures may be required, such as reorienting or relocating the product. 2 = Over the frequency range between 150 kHz and 80 MHz, the field strength should be below 3 V/m.

GA-A309-en-EU V1.0

Recommended separation distances between portable and mobile HF telecommunication devices and devices which are not life-supporting The product is intended for use in an electromagnetic environment where HF interference is controlled. The user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile HF telecommunications equipment and the product. Rated nominal output power Separation distance as a function of transmitter frequency (m) of the transmitter (W) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz d = 1.2

d = 1.2

d = 2.3

0.01

0.12

0.23

0.1

0.38

0.73

1.2

2.3

3.8

7.3

100

For transmitters rated at a nominal output power not listed in the table above, the recommended separation distance (d) in meters (m) can be determined using the applicable equation (observe the frequency). P = nominal power of the transmitter in watts (W). NOTES: At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. The propagation of electromagnetic waves is affected by absorption and reflection from buildings, objects, and people.

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.

GA-A309-en-EU V1.0

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ENDOLIGHT LED blue Instructions for Use V1.0 April 2020