H1 Camera Head Instructions for Use

12-2020 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 Unsterile product ... 6 3.3 Dangers from electrical current... 6 3.4 High light intensity ... 6 3.5 Failure of devices ... 6 4 Product description ... 7 4.1 Product overview ... 7 4.2 Possible combinations... 7 4.3 Technical data... 7 4.4 Symbols on the packaging ... 8 4.5 Ambient conditions ... 8 5 Preparation... 10 5.1 Unpacking the product ... 10 5.2 Testing the product... 10 5.3 Assembling the product... 10 5.4 Connecting the light cable ... 10 6 Application ... 11 6.1 Adjusting the focus ... 11 7 Maintenance, servicing, repairs, and disposal... 12 7.1 Repairs to the product ... 12 7.2 Disposing of the product ... 12 8 Accessories and spare parts ... 13 8.1 Accessories... 13 9 Electromagnetic compatibility... 14 9.1 General notes on the operating environment ... 14 9.2 Table 1 – Compliance level for immunity tests ... 14 9.3 Table 2 – Test levels for proximity fields from HF wireless communications equipment ... 15 9.4 Table 3 – Test levels for radiated and conducted immunity tests ... 16 9.5 Table 4 – Emission class and group ... 17 9.6 Table 5 – Recommended separation distances between portable and mobile HF communications devices and the product ... 18 10 Subsidiaries... 19

Instructions for use • H1 Camera Head • VYQ413_EN_V1.0_12-2020_IFU_CE-MDR

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 This instruction manual is valid for: Product

Item number

H1 camera head one-chip HD camera head

TH130

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 • H1 Camera Head • VYQ413_EN_V1.0_12-2020_IFU_CE-MDR

4

Normal use

2 Normal use 2.1 Intended use In combination with the corresponding camera control unit, light source, monitor, and telescopes or microscopes, camera heads are used to display the endoscopic or open operating field in diagnostic or surgical procedures. Camera heads do not have body contact.

2.2 Indications In combination with appropriate accessories, camera heads can be used to display the endoscopic or open operating field in diagnostic or surgical procedures.

2.3 Contraindications No contraindications relating directly to the medical device are currently known. The responsible physician must decide whether the anticipated application is admissible based on the general condition of the patient.

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 • H1 Camera Head • VYQ413_EN_V1.0_12-2020_IFU_CE-MDR

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 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.

3.3 Dangers from electrical current An improper power supply may cause an electric shock and injure patients, users, or third parties. Make sure that the plug is completely clean and dry. Never allow HF devices to come into contact with the product or system.

3.4 High light intensity The high level of light intensity produced by the light source may lead to permanent eye damage or blindness, and may cause tissue and items facing the light output to heat up. Do not look into the light output. Set the light source output to a level that is just high enough to ensure optimal illumination of the operating area. Make sure the light output is sufficiently far away from tissue and operating accessories.

3.5 Failure of devices The product may fail during use. Have a replacement product ready for each application or plan for an alternative surgical technique.

Instructions for use • H1 Camera Head • VYQ413_EN_V1.0_12-2020_IFU_CE-MDR

6

Product description

4 Product description 4.1 Product overview 1

2

3

4

5

TH130 1

Instrument coupler

4

2

Focus ring/Focus wheel

5

3

Scroll down

Scroll up Activate camera function Call up menu Select

Activate camera function

4.2 Possible combinations The product can be combined with the following camera control units (CCU): –

TELE PACK + (TP101)

–

C-MAC® Monitor (8403ZX)

–

C-HUB® II (20290320)

The product can be connected to endoscopes or adaptors via the following connections: –

Eyepiece connection

4.3 Technical data Description

Value

Image sensor

1x 1/3" CMOS

Image format

4:3

Image refresh rate

25/30 Hz

Focal length

19 mm

Dimensions (L x H x W)

99 x 42 x 44 mm

Weight (without cable)

180 g

Instructions for use • H1 Camera Head • VYQ413_EN_V1.0_12-2020_IFU_CE-MDR

7

Product description

4.4 Symbols on the packaging Symbol

Meaning Manufacturer

Date of manufacture

Medical device

Article no.

Serial number

Number of products in the product packaging

Unique Device Identifier

Consult instructions for use

Note for the user to consult the instructions for use for important cautionary information such as warnings and precautions. Unsterile

Fragile, handle with care

Federal (USA) law restricts this device to sale by or on the order of a physician. CE marking With this mark, the manufacturer declares the compliance of the devices with the applicable standards and directives The device must not be modified in any way

4.5 Ambient conditions Storage/transport conditions Temperature

-10 °C ... 60 °C

Relative humidity

20–95%

Instructions for use • H1 Camera Head • VYQ413_EN_V1.0_12-2020_IFU_CE-MDR

8

Product description

Operating conditions Temperature

5 °C ... 35 °C

Relative humidity (non-condensing)

20–95%

Instructions for use • H1 Camera Head • VYQ413_EN_V1.0_12-2020_IFU_CE-MDR

9

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 The product has an integrated instrument coupler and an integrated telescope. 1.

Rotate the outer ring of the coupler clockwise and insert the endoscope eyepiece.

2.

Rotate the outer ring of the instrument coupler counterclockwise to tighten it.

5.4 Connecting the light cable Tighten the knurled screw on the light cable by a quarter turn to connect the light cable.

Instructions for use • H1 Camera Head • VYQ413_EN_V1.0_12-2020_IFU_CE-MDR

10

Application

6 Application 6.1 Adjusting the focus The image display can be impaired by intense laser light. 1.

Ensure that the correct video image is displayed on the monitor before starting the procedure.

2.

Turn the focus ring/focus wheel to adjust the image sharpness on the camera lens.

Instructions for use • H1 Camera Head • VYQ413_EN_V1.0_12-2020_IFU_CE-MDR

11

Maintenance, servicing, repairs, and disposal

7 Maintenance, servicing, repairs, and disposal 7.1 Repairs to the product Repair work may only be performed by KARL STORZ or by a company authorized by KARL STORZ. 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.

7.2 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 • H1 Camera Head • VYQ413_EN_V1.0_12-2020_IFU_CE-MDR

12

Accessories and spare parts

8 Accessories and spare parts 8.1 Accessories Not all articles are available in all regions. Article

Order no.

Adaptor, autoclavable

533TVA

Dust cap for camera heads

6349190

Sterile covers for KARL STORZ cameras

040113-01, 040114-01, 040115-01, 040112-01

Instructions for use • H1 Camera Head • VYQ413_EN_V1.0_12-2020_IFU_CE-MDR

13

Electromagnetic compatibility

9 Electromagnetic compatibility 9.1 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 industrial areas as well as in hospitals (CISPR 11 Class A) and other professional healthcare environments. If it is used in a residential environment (for which CISPR 11 Class B is normally required), the product may not offer sufficient protection for radio transmission operation. The user might need to take mitigation measures, such as relocating or re-orienting the product.

9.2 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

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, concrete, or covered with ceramic tiles. If floors are covered with synthetic material, the relative humidity must be at least 30%.

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

± 2 kV for power lines

± 2 kV for power lines

± 1 kV for input and output lines

± 1 kV for input and output lines

100 kHz repetition

100 kHz repetition

Surges acc. to IEC 61000-4-5

± 1 kV voltage outer ± 1 kV voltage outer The power supply qualconductor – outer con- conductor – outer con- ity should be that of a ductor ductor typical commercial or hospital environment. ± 2 kV voltage outer ± 2 kV voltage outer

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

EN/IEC 60601 test level

± 15 kV air discharge

conductor – ground

conductor – ground

Voltage dip:

Voltage dip:

Dip to 0% for 1 cycle at 0° phase angle

Dip to 0% for 1 cycle at 0° phase angle

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

The power supply quality should be that of a typical commercial or hospital environment. If Dip to 70% for 25/30 Dip to 70% for 25/30 the user of the product cycles at 0° phase an- cycles at 0° phase an- requires continued opgle gle eration in the event of Dropout to 0% for 0.5 Dropout to 0% for 0.5 interruptions to the cycles @ 0°, 45°, 90°, cycles @ 0°, 45°, 90°, power supply network, 135°, 180°, 225°, 270°, 135°, 180°, 225°, 270°, it is recommended that and 315° phase angles and 315° phase angles the product be oper-

Instructions for use • H1 Camera Head • VYQ413_EN_V1.0_12-2020_IFU_CE-MDR

14

Electromagnetic compatibility

Interference immunity tests

EN/IEC 60601 test level

Compliance level

Electromagnetic environment – guidelines

Voltage interruption:

Voltage interruption:

100% for 250/300 cycles

100% for 250/300 cycles

ated with an uninterruptible power supply or a battery.

Magnetic field at 30 A/m at 50 Hz / the power fre60 Hz quency (50/60 Hz) acc. to IEC 61000-4-8

30 A/m at 50 Hz / 60 Hz

If image distortion occurs, it may be necessary to install the product further 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.

Immunity test acc. to IEC 61000-4–3 for radiated, radio-frequency electromagnetic fields

3 V/m 80 MHz to 2.7 GHz

3 V/m 80 MHz to 2.7 GHz

Immunity to conducted disturbances, induced by radio-frequency fields acc. to IEC 61000-4-6

3 Vrms on 150 kHz to 80 MHz

3 Vrms on 150 kHz to 80 MHz

1 kHz 80% AM modulation

1 kHz 80% AM modulation

6 Vrms in ISM band

6 Vrms in ISM band

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

9.3 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 • H1 Camera Head • VYQ413_EN_V1.0_12-2020_IFU_CE-MDR

15

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

9.4 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 3 V/m

80 MHz to 2.5 GHz

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 • H1 Camera Head • VYQ413_EN_V1.0_12-2020_IFU_CE-MDR

16

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.

9.5 Table 4 – Emission class and group Guidelines and manufacturer’s declaration – electromagnetic emissions The device is intended for use in such an environment as specified below. The customer or user of the device 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 device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions acc. to CISPR 11

Class A

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

Class A

The device is suitable for use in all establishments other than domestic and those directly connected to the

Instructions for use • H1 Camera Head • VYQ413_EN_V1.0_12-2020_IFU_CE-MDR

17

Electromagnetic compatibility

Interference emission measurements

Compliance

Electromagnetic environment – guidelines

Voltage fluctuations/flicker emissions acc. to IEC 61000-3-3

Complies

public low voltage power supply network that supplies buildings used for domestic purposes.

9.6 Table 5 – Recommended separation distances between portable and mobile HF communications devices and the product The device is intended for use in an electromagnetic environment in which HF disturbances are controlled. The customer or user of the device 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 maximum output power of the communications device. Rated power of the transmitter [W]

Separation distance d [m] according to frequency of transmitter 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. The product was tested for compatibility with HF surgical devices in accordance with IEC 60601-2-2 Appendix BB.

Instructions for use • H1 Camera Head • VYQ413_EN_V1.0_12-2020_IFU_CE-MDR

18

Subsidiaries

10 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 • H1 Camera Head • VYQ413_EN_V1.0_12-2020_IFU_CE-MDR

19

Subsidiaries

KARL STORZ Industrial** Gedik Is Merkezi B Blok, Kat 5, D 38-39, Bagdat Cad. No: 162, Maltepe Istanbul, Turkey Phone: +90 216 442 9500, Fax: +90 216 442 9030 **Sales for Industrial Endoscopy

KARL STORZ Endoscopy (Shanghai) Ltd., Chengdu Branch Room 803-805, 8F Jin Jiang International Building, No. 1 West Linjiang Road, Wuhou District, 6100414, Chengdu, People’s Republic of China Phone: +86 28 86587977, Fax: +86 28 86587975 Email: [email protected]

OOO KARL STORZ Endoskopy – WOSTOK Derbenyevskaya nab. 7, building 4, 115114 Moscow, Russia Phone: +7 495 983 02 40, Fax: +7 495 983 02 41 Email: [email protected]

KARL STORZ Endoscopy (Shanghai) Ltd., Shenyang Branch Room 2001-2005, 20F N-MEDIA International Center, No. 167 Youth Avenue, Shenhe District, 110014, Shenyang, People‘s Republic of China Phone: +86 24 23181118, Fax: +86 24 23181119 Email: [email protected]

TOV LLC KARL STORZ Ukraine Avenue Geroyiv Stalingrada Str. 2D, office 717 Kyiv, 04210/Ukraine Phone: +38 095 000-895-0, +38-097-000-895-0, +38 073 000-895-0 Email: [email protected] KARL STORZ SE & Co. KG Representation Office Sabit Orudschow 1184, apt. 23, 1025 Baku, Azerbaijan Phone: +99 450 613 30 60 Email: [email protected] KARL STORZ ENDOSKOPE – East Mediterranean and Gulf (Offshore) S.A.L. Spark Tower 1st floor Charles Helou St., Horch Tabet – Sin El Fil, Beirut, Lebanon Phone: +961 1 501105, Fax: +961 1 501950 Email: [email protected] KARL STORZ Endoscopy (South Africa) (Pty) Ltd. P.O. 6061, Roggebaai, 8012 Cape Town, South Africa Phone: +27 21 417 2600, Fax: +27 21 421 5103 Email: [email protected] TOO KARL STORZ Endoskopy Kasachstan Saryarka, 6, BC “Arman“, off. 910, 010000 Astana, Republic of Kazakhstan Phone: +7 7172 552-549, 552-788, Fax: -444 Email: [email protected] KARL STORZ ENDOSKOPE East Mediterranean & Gulf (branch) Building West Side 7A – Unit 7WA – 3008, Dubai Airport Free Zone, P.O. Box 54983, Dubai - United Arab Emirates Phone: +971 (0)4 2958887, Fax: +971 (0)4 3205282 Service Hotline: +971 (0)4 3415882 Email: [email protected] KARL STORZ Endoscopy India Private Limited 11th Floor, Dr. Gopal Das Bhawan, 28, Barakhamba Road, New Delhi 110001, India Phone: +91 11 4374 3000, Fax: +91 11 4374 3010 Email: [email protected] KARL STORZ SE & CO. KG Interchange 21 Tower, Level 33, 399 Sukhumvit Road, North Klongtoey, Wattana, 10110 Bangkok, Thailand Phone: +84 28 3823 8000 Fax: +84 28 3823 8039 Email: [email protected] KARL STORZ SE & Co. KG Resident Representative Office 14th Floor, MPlaza Saigon, 39 Le Duan, District 1, Ho Chi Minh City, Vietnam Phone: +84 28 3823 8000, Fax: +84 28 3823 8039 Email: [email protected] KARL STORZ Endoscopy China Ltd. Room 2503-05, 25F AXA Tower, Landmark East, No. 100 How Ming Street, Kwun Tong, Kowloon, Hong Kong, People’s Republic of China Phone: +852 28 65 2411, Fax: +852 28 65 4114 Email: [email protected]

KARL STORZ Endoscopy (Shanghai) Ltd., Guangzhou Branch Room 02B & 03 & 04A, 35F Teem Tower, No. 208 Tianhe Road, Tianhe District, 510620, Guangzhou, People’s Republic of China Phone: +86 20 87321281, Fax: +86 20 87321286 Email: [email protected] KARL STORZ Endoscopy Asia Marketing Pte Ltd. No. 8 Commonwealth Lane #03-02, Singapore 149555, Singapore Phone: +65 69229150, Fax: +65 69229155 Email: [email protected] KARL STORZ Endoscopy Singapore Sales Pte Ltd No. 8 Commonwealth Lane #03-02, Singapore 149555, Singapore Phone: +65 69229150, Fax: +65 69229155 Email: [email protected] KARL STORZ SE & Co. KG Representative Office Indonesia Sinarmas MSIG Tower Level 37, Jl. Jend. Surdirman No. Kav. 21, Jakarta Selatan DKI Jakarta 12920 Email: [email protected] KARL STORZ Endoscopy Korea Co. Ltd. 9F Hyowon-Building, 97, Jungdae-ro, Songpa-gu, 05719 Seoul, Korea Phone: +82-70-4350-7474, Fax: +82-70-8277-3299 Email: [email protected] KARL STORZ Endoscopy Taiwan Ltd. 12F, No. 192, Sec. 2, Chung Hsin Rd., Sindian District, New Taipei City, Taiwan Phone: +886 933 014 160, Fax: +886 2 8672 6399 Email: [email protected] KARL STORZ SE & Co. KG Representative Office Philippines 1901 Picadilly Star Bldg., 4th Avenue, BGC, Taguig City 1636, Philippines Phone: +63 2 317 45 00, Fax: +63 2 317 45 11 Email: [email protected] KARL STORZ Endoscopy Japan K. K. Stage Bldg. 8F, 2-7-2 Fujimi, Chiyoda-ku, Tokyo 102-0071, Japan Phone: +81 3 6380-8622, Fax: +81 3 6380-8633 Email: [email protected] KARL STORZ Endoscopy Australia Pty. Ltd . 68 Waterloo Road, Macquarie Park NSW 2113, P O Box 50 Lane Cove NSW 1595, Australia Phone: +61 (0)2 9490 6700, Fax: +61 (0)2 9420 0695 Toll free: 1800 996 562 (Australia only) Email: [email protected] www.karlstorz.com

KARL STORZ Endoscopy (Shanghai) Ltd., Beijing Branch Room 1805-1807, Building B, 18F Beijing IFC, No. 8, Jianguomenwai Street, Chaoyang District, 100022, Beijing, People’s Republic of China Phone: +86 10 5638188, Fax: +86 10 5638199 Email: [email protected] KARL STORZ Endoscopy (Shanghai) Ltd., Shanghai Branch Room 701A Building 5 & Room 501 Building 7, No. 3000 Longdong Avenue, Pilot Free Trade Zone, 201203, Shanghai, People’s Republic of China Phone: +86 21 60339888, Fax: +86 21 60339808 Email: [email protected]

Instructions for use • H1 Camera Head • VYQ413_EN_V1.0_12-2020_IFU_CE-MDR

20