IFU LED battery light source with fast screw thread Instructions For Use

11-2020 Copyright © All product illustrations, product descriptions, and texts are the intellectual property of KARL STORZ SE & Co. KG. Their use and reproduction by third parties require the express approval of KARL STORZ SE & Co. KG. All rights reserved.

Table of contents

Table of contents 1 General information... 4 1.1 Read the instructions for use ... 4 1.2 Scope... 4 1.3 Description of warning messages... 4 2 Normal use... 5 2.1 Intended use ... 5 2.2 Indications... 5 2.3 Contraindications... 5 2.4 Target user populations ... 5 2.5 Patient groups... 5 3 Safety ... 6 3.1 Serious incidents ... 6 3.2 Correct handling ... 6 3.3 Correct reprocessing ... 6 3.4 Contaminated products ... 6 3.5 Unsterile product ... 6 3.6 Damaged products ... 7 3.7 Failure of systems ... 7 3.8 Combination with other components ... 7 3.9 Risk of explosion... 7 4 Product description ... 8 4.1 Product overview ... 8 4.2 Possible combinations... 8 4.3 Technical data... 8 4.4 Symbols employed ... 9 4.4.1 Symbols on the packaging ... 9 4.4.2 Symbols on the product ... 10 4.5 Ambient conditions ... 10 5 Preparation... 11 5.1 Unpacking the product ... 11 5.2 Testing the product... 11 5.3 Assembling the product... 11 6 Application ... 12 6.1 Using the product ... 12 6.2 Activating and deactivating BOOST mode ... 12 7 Maintenance, servicing, repairs, and disposal... 13 7.1 Changing the batteries... 13 7.2 Repairing the product ... 13 7.3 Disposing of the product ... 14 8 Electromagnetic compatibility... 15 8.1 General notes on the operating environment ... 15 8.2 Table 1 – Compliance level for immunity tests ... 15 8.3 Table 2 – Test levels for proximity fields from HF wireless communications equipment ... 16 8.4 Table 3 – Test levels for radiated and conducted immunity tests ... 17 8.5 Table 4 – Emission class and group ... 18 8.6 Table 5 – Recommended separation distances between portable and mobile HF communications equipment and the product ... 19 9 Subsidiaries... 20

Instructions for use • LED battery light source with fast screw thread • KCC914_EN_V1.0_11-2020_IFU_CEMDR

3

General information

1 General information 1.1 Read the instructions for use If the instructions for use are not followed, patients, users, or third parties may be injured. In addition, the product may be damaged. 1.

Read the instructions for use of the product carefully and follow them completely.

2.

Keep the instructions for use clearly visible next to the product.

3.

Observe the instructions for use of products used in combination.

It is recommended to check the suitability of the products for the planned procedure prior to use.

1.2 Scope These instructions for use are valid for the following products: Product

Article number

LED battery light source

11301D4

1.3 Description of warning messages To prevent any injury to persons or damage to property, the warnings and safety notes in the instructions for use must be observed. The warning messages describe the following levels of danger. WARNING WARNING Designates a possible imminent risk. If this is not avoided, it could lead to death or serious injuries. CAUTION CAUTION Designates a possible imminent risk. If this is not avoided, it could lead to minor injuries. ATTENTION ATTENTION Designates a possibly harmful situation. If this is not avoided, the products could be damaged.

Instructions for use • LED battery light source with fast screw thread • KCC914_EN_V1.0_11-2020_IFU_CEMDR

4

Normal use

2 Normal use 2.1 Intended use Battery light sources are mobile light sources and are used for generating and transmitting light to KARL STORZ endoscopes in ENT medicine. Battery light sources are non-invasive and are designed for transient use in invasive procedures through a body orifice

2.2 Indications The use of the instrument set is indicated if it is indicated in the opinion of the attending physician. This includes, amongst other things: –

Rhinology, rhinoplasty

–

Sinus surgery and transnasal access for skull base surgery

–

Ear diagnostics and ear surgery

–

Adenotomy, tonsillectomy, tracheotomy

–

Laryngoscopy, endolaryngeal microlarynx and transoral microsurgery

–

Esophagoscopy, diverticuloscopy

2.3 Contraindications The use of the basic instrument set is contraindicated if, in the opinion of the responsible physician, the surgical method is contraindicated or the patient is not able to undergo surgery or anesthesia due to his or her general condition. The basic instrument set must not be used for procedures in direct contact with the central nervous system (CNS) and central cardiovascular system.

2.4 Target user populations The medical device may only be used by doctors and medical assistants with a relevant specialist qualification.

2.5 Patient groups There are no restrictions in terms of patient groups for this product.

Instructions for use • LED battery light source with fast screw thread • KCC914_EN_V1.0_11-2020_IFU_CEMDR

5

Safety

3 Safety 3.1 Serious incidents According to the Medical Device Regulation (MDR), a “serious incident” includes incidents that directly or indirectly had, could have had, or could have any of the following consequences (MDR, Art. 2, No. 65 [1]): –

Death of a patient, user, or another person

–

Temporary or permanent serious deterioration in the medical condition of a patient, user, or another person

–

A serious threat to public health The manufacturer and appropriate authority must be notified of all serious incidents.

3.2 Correct handling If the product is not handled correctly, patients, users, and third parties may be injured. Only persons with the necessary medical qualification and who are acquainted with the application of the product may work with it. Check that the product is suitable for the procedure prior to use. Do not overload the product with mechanical stress. Check the product for the following points before and after every use: –

Completeness

–

Good working order

–

Rough surfaces left inadvertently

–

Sharp corners

–

Burred edges

–

Correct assembly of the components

–

Functionality

3.3 Correct reprocessing Incorrectly reprocessed products expose patients, users, and third parties to a risk of infection. Reprocess the product before use. A validated reprocessing procedure must be followed and the product must be reprocessed in line with the reprocessing instructions.

3.4 Contaminated products Contaminated products pose a risk of infection for users, patients, and third parties. Comply with national laws and regulations. Observe the guidelines of the Employer’s Liability Insurance Association and equivalent organizations.

3.5 Unsterile product The product is not sterile when delivered. The use of non-sterile products poses a risk of infection for patients, users, and third parties. Reprocess the product in line with the reprocessing instructions before initial use and every subsequent use.

Instructions for use • LED battery light source with fast screw thread • KCC914_EN_V1.0_11-2020_IFU_CEMDR

6

Safety

3.6 Damaged products Damaged products can result in injury to patients, users, or third parties. Before each use, check all components of the products for damage. Do not use damaged instruments.

3.7 Failure of systems The system may fail during use. Have a replacement system ready for each application.

3.8 Combination with other components Combination of the product with non-suitable instruments and devices can result in uncontrolled behavior and injury to patients, users, and third parties. Only combine the device with instruments and equipment that are approved for joint use. Only use approved accessories.

3.9 Risk of explosion The product can generate sparks, which cause combustible or flammable gases and liquids to ignite or explode. This may cause injuries to patients, users, or third parties. The product must not be operated in oxygenated environments. Do not operate the product in explosive atmospheres. Do not operate the product in environments with combustible gases such as inhalation anesthetics and mixtures thereof. Observe the hazard zones:

Instructions for use • LED battery light source with fast screw thread • KCC914_EN_V1.0_11-2020_IFU_CEMDR

7

Product description

4 Product description 4.1 Product overview 3

4

7

8

1 5 6

2 D4 battery light source 1

Light outlet

5

Lid lock

2

Switch (On/Off)

6

Lid

3

Screw connection on endoscope/fiberscope

7

Marker pin: Locked

4

Housing

8

Batteries 2 x 3 V / CR123A

4.2 Possible combinations The battery light sources can be used with the following components: –

Batteries: – Panasonic CR123A with UL Recognized Component Mark (UR) – Duracell DL123A with UL Recognized Component Mark (UR)

–

Endoscopes/fiberscopes: – All KARL STORZ telescopes with light connection

4.3 Technical data Property

Value

Dimensions (L x H x W)

95 x 40 x 20 mm

Weight

80 g (without battery)

Color temperature

6,000–6,700 K

Drip-water protection

None, wipeable, disinfectable

Protection class

Internal voltage supply

Power supply (DC)

3V

Battery

2 x CR123A 3 V lithium

Instructions for use • LED battery light source with fast screw thread • KCC914_EN_V1.0_11-2020_IFU_CEMDR

8

Product description

4.4 Symbols employed 4.4.1 Symbols on the packaging Symbol

Meaning Number of products in the product packaging

Article no.

Batch code

Medical device

US Federal law (21 CFR 801.109) restricts this device to sale to or on the order of a licensed physician

Manufacturer

Date of manufacture

Unique Device Identifier

CE conformity mark With this mark, the manufacturer declares the compliance of the products with the applicable regulation (EU) 2017/745. A code number after the CE mark indicates the responsible notified body. Fragile, handle with care

Not MR safe

Keep dry

Instructions for use • LED battery light source with fast screw thread • KCC914_EN_V1.0_11-2020_IFU_CEMDR

9

Product description

4.4.2 Symbols on the product Symbol

Meaning Follow instructions for use

Heat emission

Applied part type BF

Article no.

Batch code

Separate collection of electrical and electronic devices. Do not dispose of in household refuse. CE conformity mark With this mark, the manufacturer declares the compliance of the products with the applicable regulation (EU) 2017/745. A code number after the CE mark indicates the responsible notified body. Observe the correct battery polarity Power supply

4.5 Ambient conditions Storage/transport conditions Temperature

-20°C ... +60°C

Relative humidity

10–90%

Air pressure

700–1,080 hPa

Operating conditions Temperature

10°C ... 30°C

Relative humidity

30–70%

Air pressure

700–1,080 hPa

Instructions for use • LED battery light source with fast screw thread • KCC914_EN_V1.0_11-2020_IFU_CEMDR

10

Preparation

5 Preparation 5.1 Unpacking the product 1.

Carefully remove the product and accessories from the packaging.

2.

Check the delivery for missing items and evidence of shipping damage.

3.

In the case of damage, hidden defects, and short deliveries, document their nature and extent and contact the manufacturer or supplier immediately.

5.2 Testing the product 1.

Inspect the product for visible contamination. Do not use if contaminated.

2.

Inspect the product for the following characteristics:

–

Good working order

–

Functionality

–

Correct assembly of the components

–

Completeness

5.3 Assembling the product Use a suitable adaptor (495G) to screw the product onto the endoscope/fiberscope light inlet:

Instructions for use • LED battery light source with fast screw thread • KCC914_EN_V1.0_11-2020_IFU_CEMDR

11

Application

6 Application 6.1 Using the product WARNING High energy! Risk of injury! The light source transmits high-energy light that can lead to high surface temperatures. The user or a third party may be startled if they come into contact with the hot light source and then injure the patient by jerking the endoscope/fiberscope. Do not touch the hot light source. Only use the light source with an endoscope/fiberscope. Always switch off the light source before putting it down, and never place it in the vicinity of the patient. WARNING High energy! Risk of fire! The light source transmits high-energy light that can lead to high surface temperatures. Do not cover the light source with cloths or similar objects immediately after use. WARNING High light intensity! Danger of glare! The high light intensity of the light source can permanently damage eyes and cause blindness. Never look directly into the light outlet of the light source. 1.

Use the switch (On/Off) to switch the product on.

2.

Use the switch (On/Off) to switch the product off after use.

The LED flashes several times to signal the end of the battery service life. The flashing repeats at 2-minute intervals until the battery is completely discharged after 5–10 minutes: Model

Operating time

11301D4

2h

Comment –

2 batteries

–

Rechargeable batteries must not be used.

6.2 Activating and deactivating BOOST mode The brightness can be increased in BOOST mode. ü

The product is switched on.

1.

To activate BOOST mode, press and hold the switch (On/Off). ð The brightness is increased.

2.

To deactivate BOOST mode, press and hold the switch (On/Off) once again. BOOST mode is then automatically deactivated after a certain amount of time.

ð The nominal brightness is reset.

Instructions for use • LED battery light source with fast screw thread • KCC914_EN_V1.0_11-2020_IFU_CEMDR

12

Maintenance, servicing, repairs, and disposal

7 Maintenance, servicing, repairs, and disposal 7.1 Changing the batteries 1.

Place your thumb on the lid lock.

2.

Turn the lock counterclockwise and remove the lid.

3.

Remove the old batteries and insert two new batteries. Both batteries must always be replaced at the same time.

4.

Replace the lid and turn the lock clockwise as far as it will go.

5.

Check that the battery light source is functioning properly and then switch it off.

7.2 Repairing the product Repair work may only be performed by KARL STORZ or by a company authorized by KARL STORZ. The interventions described in this instruction manual are exempt from this rule.

Instructions for use • LED battery light source with fast screw thread • KCC914_EN_V1.0_11-2020_IFU_CEMDR

13

Maintenance, servicing, repairs, and disposal

Please contact your local KARL STORZ subsidiary or authorized dealer (see the list of subsidiaries). Contaminated devices may not be shipped. To prevent contact infections and airborne infections, products must first be decontaminated. KARL STORZ reserves the right to send back contaminated products.

7.3 Disposing of the product The product meets the requirements of the Directive on Waste Electrical and Electronic Equipment (WEEE). Within the scope of application of this directive, KARL STORZ SE & Co. KG is responsible for the proper disposal of this product. 1.

The product must be disposed of in accordance with the applicable national laws and regulations at a suitable collection point for the reprocessing of electrical and electronic equipment.

2.

Contact KARL STORZ SE & Co. KG, a KARL STORZ branch or an authorized dealer to find out the address of the collection point in your area.

Instructions for use • LED battery light source with fast screw thread • KCC914_EN_V1.0_11-2020_IFU_CEMDR

14

Electromagnetic compatibility

8 Electromagnetic compatibility 8.1 General notes on the operating environment The product is suitable for use in professional healthcare settings. Professional healthcare facilities include physician offices, dental offices, limited care facilities, freestanding surgical centers, freestanding birth centers, multiple treatment facilities, hospitals (emergency rooms, patient rooms, intensive care, surgical rooms, outside the HF-shielded room of an ME system for MRT). The emission characteristics of this product make it suitable for use in professional healthcare facilities as well as in a residential environment (CISPR 11 Class B). This product offers adequate protection to radio communication service. In the rare event of interference to the radio transmission operation, the user might need to take mitigation measures, such as relocating or re-orienting the product.

8.2 Table 1 – Compliance level for immunity tests Guidelines and manufacturer’s declaration – Electromagnetic immunity The product is intended for use in the electromagnetic environment specified below. The user of the product should make sure that it is used in such an environment. Interference immunity tests

EN/IEC 60601 test level

Compliance level

Electromagnetic environment – Guidelines

Electrostatic dis- ± 8 kV contact discharge (ESD) acc. charge to IEC 61000-4-2 ± 15 kV air discharge

± 8 kV contact discharge

Floors should be made of wood or concrete, or covered with ceramic tiles. If floors are covered with synthetic material, the relative humidity should be at least 30%.

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

± 2 kV for power lines

N/A

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

Surges acc. to IEC 61000-4-5

± 1 kV voltage outer N/A conductor – outer conductor

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

± 15 kV air discharge

± 1 kV for input and output lines 100 kHz repetition

± 2 kV voltage outer conductor – ground Voltage dips, short interruptions, and voltage variations acc. to IEC 61000-4-11

Voltage dip: Dip to 0% for 1 cycle at 0° phase angle Dip to 70% for 25/30 cycles at 0° phase angle Dip to 0% for 0.5 cycles @ 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315° phase angles

N/A

The power supply quality should be that of a typical commercial or hospital environment. If the user of the product requires continued operation in the event of interruptions to the power supply network, it is recommended that the product be oper-

Voltage interruption:

Instructions for use • LED battery light source with fast screw thread • KCC914_EN_V1.0_11-2020_IFU_CEMDR

15

Electromagnetic compatibility

Interference immunity tests

EN/IEC 60601 test level

Compliance level

100% for 250/300 cycles

Electromagnetic environment – Guidelines ated with an uninterruptible power supply or a battery.

Magnetic field at power frequency (50/60 Hz) acc. to IEC 61000-4-8

30 A/m at 50 Hz /60 Hz

30 A/m at 50 Hz /60 Hz

Immunity test acc. to IEC 61000-4–3 for high-frequency electromagnetic fields

3 V/m 80 MHz to 2.7 GHz

3 V/m 80 MHz to 2.7 GHz

Immunity to conducted interference, induced by high-frequency fields acc. to IEC 61000-4-6

3 Vrms on 150 kHz to 80 MHz

If image distortion occurs, it may be necessary to install the product further away from sources of electromagnetic fields or to install magnetic shielding. Before the product is installed, the electromagnetic field should be measured to ensure that it is sufficiently low.

* Refer to Table 2 for wireless proximity RF field test levels N/A

1 kHz 80% AM modulation 6 Vrms in ISM band

8.3 Table 2 – Test levels for proximity fields from HF wireless communications equipment Test frequency MHz

Frequency band MHz

385

380 – 390

TETRA 400

450

430 – 470

GMRS 460, FRS 460

710

704 – 787

800 – 960

745

Radio service Modulation

Immunity test level V/m

Compliance level V/m

Pulse modulation 18 Hz

27

27

FM ± 5 kHz deviation 1 kHz sine wave

28

28

LTE band 13 & Pulse modula17 tion 217 Hz

9

9

GSM 800/900, Pulse modulaTETRA 800, tion iDEN 820, 18 Hz CDMA 850, LTE band 5

28

28

780 810 870 930

Instructions for use • LED battery light source with fast screw thread • KCC914_EN_V1.0_11-2020_IFU_CEMDR

16

Electromagnetic compatibility

Test frequency MHz

Frequency band MHz

Radio service Modulation

Immunity test level V/m

Compliance level V/m

1,700 – 1,990

GSM 1800, Pulse modulaCDMA 1900, tion GSM 1900, 217 Hz DECT, LTE band 1, 3, 4, 25, UMTS

28

28

2,450

2,400 – 2,570

Bluetooth, WLAN 802.11 b/g/n, RFID 2450, LTE band 7

Pulse modulation 217 Hz

28

28

5,240

5,100 – 5,800

WLAN 802.11 a/n

Pulse modulation 217 Hz

9

9

1,720 1,845 1,970

5,500 5,785

8.4 Table 3 – Test levels for radiated and conducted immunity tests Guidelines and manufacturer’s declaration – electromagnetic immunity The product is intended for use in the electromagnetic environment specified below. The user of the product should make sure that it is used in such an environment. Interference immunity tests

EN/IEC 60601 test level

Compliance level

Conducted HF disturbances acc. to IEC 61000-4-6

3 Vrms

3 Vrms

Radiated HF disturbances acc. to IEC 61000-4-3

3 V/m

150 kHz to 80 MHz

80 MHz to 2.5 GHz

3 V/m

Electromagnetic environment – guidelines Portable and mobile HF 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 distances: d = 1.2 √P Where P is the rated power of the transmitter in watts [W] according to the information provided by the transmitter manufacturer and d is the recommended separation distance in meters [m].

Instructions for use • LED battery light source with fast screw thread • KCC914_EN_V1.0_11-2020_IFU_CEMDR

17

Electromagnetic compatibility

Interference immunity tests

EN/IEC 60601 test level

Compliance level

Electromagnetic environment – guidelines Field strengths from fixed HF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b. d = 1.2 √P 80 MHz to 800 MHz d = 2.3 √P 800 MHz to 2.5 GHz Interferences may occur in the vicinity of equipment marked with the following symbol:

Note: At 80 MHz and 800 MHz, the higher frequency range applies. Note: These guidelines may not apply in all situations. The propagation of electromagnetic waves is affected by absorptions and reflections of buildings, objects, and people. a

Field strengths from fixed transmitters, e.g., 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 transmitters, an electromagnetic site survey should be considered. If the measured field strength at the location where the device is used exceeds the above compliance levels, the device should be monitored to ensure proper function. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the product. b

Over the frequency range from 150 kHz to 80 MHz, field strengths should be less than 3 V/ m.

8.5 Table 4 – Emission class and group Guidelines and manufacturer’s declaration – Electromagnetic emissions The product is intended for use in such an environment as specified below. The customer or user of the product should ensure that it is used in such an environment. Interference emission measurements

Compliance

Electromagnetic environment – Guidelines

RF emissions acc. to CISPR 11

Group 1

The product uses RF energy for its internal function only. Therefore, its RF emissions are very low and are not likely to cause any interference affecting nearby electronic equipment.

RF emissions acc. to CISPR 11

Class B

The product is suitable for use in all establishments including domestic establishments and those directly con-

Emission of harmonic oscillations Class A acc. to IEC 61000-3-2

Instructions for use • LED battery light source with fast screw thread • KCC914_EN_V1.0_11-2020_IFU_CEMDR

18

Electromagnetic compatibility

Interference emission measurements

Compliance

Voltage fluctuations/flicker emis- N/A sions acc. to IEC 61000-3-3

Electromagnetic environment – Guidelines nected to the public low voltage power supply network that supplies buildings used for domestic purposes.

8.6 Table 5 – Recommended separation distances between portable and mobile HF communications equipment and the product The product is intended for use in an electromagnetic environment in which HF disturbances are controlled. The customer or user of the product can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile HF communications equipment (transmitters) and the product as recommended below, according to the output energy of the communications equipment. Rated power of the transmitter [W]

Separation distance d [m] according to the transmitter frequency 150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

d = 1.2 √P

d = 1.2 √P

d = 2.3 √P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters whose maximum rated power is not listed in the table above, the recommended separation distance d in meters (m) can be estimated using the equation from the respective column, whereby P is the maximum rated power of the transmitter in watts (W) according to the transmitter manufacturer. Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note: These guidelines may not apply in all situations. The propagation of electromagnetic waves is affected by absorptions and reflections of buildings, objects, and people.

Instructions for use • LED battery light source with fast screw thread • KCC914_EN_V1.0_11-2020_IFU_CEMDR

19

Subsidiaries

9 Subsidiaries KARL STORZ SE & Co. KG Dr.-Karl-Storz-Straße 34, 78532 Tuttlingen/Germany Postfach 230, 78503 Tuttlingen/Germany Phone: +49 7461 708-0 , Fax: +49 7461 708-105 Email: [email protected]

KARL STORZ SE & Co. KG Representation Office Kęstučio st. 59 / Lenktoji st. 27, 08124 Vilnius, Lithuania Phone: +370 5 272 0448, Mobile: +370 685 67 000 Email: [email protected]

KARL STORZ Endoskope Berlin GmbH Scharnhorststr. 3, 10115 Berlin/Germany Phone: +49 30 3069090, Fax: +49 30 30 19452

KARL STORZ Endoskopi Danmark A/S Skovlytoften 33, 2840 Holte, Denmark Phone: +45 45162600, Fax: +45 45162609 Email: [email protected]

KARL STORZ Endoscopy Canada Ltd. 7171 Millcreek Drive, Mississauga, Ontario L5N 3R3 Canada Phone: +1 905 816-4500, Fax: +1 905 816-4599 Toll free (Canada only) Phone: 1-800-268-4880, Fax: 1-800-482-4198 (Canada only) Email: [email protected] KARL STORZ Endoscopy-America, Inc. 2151 East Grand Avenue, El Segundo, CA 90245-5017, USA Phone: +1 424 218-8100, Fax: +1 424 218-8525 Toll free (USA only) Phone: 800 421-0837, Fax: 800 321-1304 (USA only) Email: [email protected] KARL STORZ Veterinary Endoscopy-America, Inc. 1 South Los Carneros Road, Goleta, CA 93117, USA Phone: +1 805 968-7776, Fax: +1 805 685-2588 Email: [email protected] KARL STORZ Endoscopia Latino-America, Inc. 815 N. W. 57th Avenue, Suite 480, Miami, FL 33126-2042, USA Phone: +1 305 262-8980, Fax: +1 305 262-8986 Email: [email protected] KARL STORZ Endoscopia México S.A. de C.V. Edificio Atlantic, Oficina 3G, Calle D e/ 1ra y 3ra, 10400 Vedado, Havanna, Cuba Phone: +537 836 95 06, Fax: +537 836 97 76 Email: [email protected] KARL STORZ Endoscopia México S.A. de C.V. Av. Ejercito Nacional No. 453 Piso 2, Colonia Granada, Alcaldia Miguel Hidalgo, C.P. 11520 Ciudad de México Phone: +52 (55) 1101 1520 Email: [email protected] KARL STORZ Marketing América Do Sul Ltda. Rua Joaquim Floriano, nº. 413, 20º andar – Itaim Bibi, CEP-04534-011 São Paulo, Brasil Phone: +55 11 3526-4600, Fax: +55 11 3526-4680 Email: [email protected] KARL STORZ Endoscopia Argentina S.A. Zufriategui 627 6° Piso, B1638 CAA - Vicente Lopez, Provincia de Buenos Aires, Argentina Phone: +54 11 4718 0919, Fax: +54 11 4718 2773 Email: [email protected] KARL STORZ Endoskopi Norge AS Stamveien1, 1483 Hagan, Norway Phone: +47 6380 5600, Fax: +47 6380 5601 Email: [email protected] KARL STORZ Endoskop Sverige AB Storsätragränd 14, 127 39 Skärholmen, Sweden Phone: +46 8 505 648 00 Email: [email protected] KARL STORZ Endoscopy Suomi OY Taivaltie 5, 01610 Vantaa, Finland Phone: +358 (0)96824774, Fax: +358 (0)968247755 Email: [email protected]

KARL STORZ Endoscopy (UK) Ltd. 415 Perth Avenue, Slough, Berkshire, SL1 4TQ, United Kingdom Phone: +44 1753 503500, Fax: +44 1753 578124 Email: [email protected] KARL STORZ Endoscopie Nederland B. V. Displayweg 2, 3821 BT Amersfoort, Netherlands Phone: +31 (0)33 4545890 Email: [email protected] KARL STORZ Endoscopy Belgium N. V. Phone: +31 (0)33 4545890 Email: [email protected] KARL STORZ Endoscopie France S. A. S. 12, rue Georges Guynemer, Quartier de l’Europe, 78280 Guyancourt, France Phone: +33 1 30484200, Fax: +33 1 30484201 Email: [email protected] KARL STORZ Endoskop Austria GmbH Landstraßer Hauptstr. 148/1/G1, 1030 Wien, Austria Phone: +43 1 71 56 0470, Fax: +43 1 71 56 0479 Email: [email protected] KARL STORZ Endoscopia Ibérica S. A. Parque Empresarial San Fernando, Edificio Munich – Planta Baja, 28830 Madrid, Spain Phone: +34 91 6771051, Fax: +34 91 6772981 Email: [email protected] KARL STORZ Endoscopia Italia S. r. l. Via dell’Artigianato, 3, 37135 Verona, Italy Phone: +39 045 8222000, Fax: +39 045 8222001 Email: [email protected] KARL STORZ Croatia d.o.o. Capraška 6, 10000 Zagreb, Croatia Phone: +385 1 6406 070, Fax: +385 1 6406 077 Email: [email protected] KARL STORZ Endoskopija d.o.o. Cesta v Gorice 34b, 1000 Ljubljana, Slovenia Phone: +386 1 620 5880, Fax: + 386 1 620 5882 Email: [email protected] KARL STORZ Polska Sp. z o.o. ul. Bojkowska 47, 44-100 Gliwice, Poland Phone: +48 32 706 13 00, Fax: +48 32 706 13 07 Email: [email protected] KARL STORZ Endoszkóp Magyarország Kft. Toberek utca 2. fsz. 17/b, HU-1112 Budapest, Hungary Phone: +36 195 096 31, Fax: +36 195 096 31 Email: [email protected] KARL STORZ Endoscopia Romania srl Str. Prof. Dr. Anton Colorian, nr. 74, Sector 4, 041393 Bukarest, Romania Phone: +40 (0)31 4250800, Fax: +40 (0)31 4250801 Email: [email protected] KARL STORZ Endoskope Greece M.E.P.E.* Patriarhou Grigoriou E’ 34, 54248 Thessaloniki, Greece Phone: +30 2310 304868, Fax: +30 2310 304862 Email: [email protected] *Repair & Service Subsidiary

Instructions for use • LED battery light source with fast screw thread • KCC914_EN_V1.0_11-2020_IFU_CEMDR

20