IMAGE1 S including TC 20x , TC30x and TC015 Instruction Manual Ver 2.1 March 2022

03-2022 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 ... 1.1 Read the instructions for use ... 1.2 Read the instructions for use of compatible products ... 1.3 Scope ... 1.4 General signs and symbols ... 1.5 Description of warning messages ...

5 5 5 5 5 6

2 Normal use ... 2.1 Intended use ... 2.2 Indications ... 2.3 Contraindications ... 2.4 Target user populations ... 2.5 Patient groups ...

7 7 7 7 7 7

3 Safety and warning ... 8 3.1 Serious incidents ... 8 3.2 Observing ambient condition ... 8 3.3 Combination with other components ... 8 3.4 Damage due to ingress of liquid in electrical components ... 8 3.5 Dangers from electrical current ... 9 3.6 Risk of explosion and fire ... 9 3.7 Electromagnetic interference ... 9 3.8 Product not clean ... 10 3.9 Failure of products ... 10 4 Product description ... 11 4.1 Description of operation ... 11 4.2 Product overview ... 11 4.3 Technical data ... 14 4.4 Possible combinations ... 16 4.4.1 Installation overview of IMAGE1 S CONNECT ... 16 4.4.2 Installation overview of IMAGE1 S CONNECT II ... 17 4.5 Symbols employed ... 18 4.5.1 Symbols on the packaging ... 18 4.5.2 Symbols on the product ... 19 4.5.3 Symbols on the user interface ... 20 4.6 Ambient conditions ... 23 5 Preparation ... 24 5.1 Unpacking the product ... 24 5.2 Inspecting the product ... 24 5.3 Setting up the product ... 24 5.4 Connecting the product ... 24 5.5 Putting the product into operation ... 27 5.6 Performing the white balance ... 29 6 Application ... 30 6.1 Dashboard ... 30 6.2 Live menu ... 31 6.2.1 Enhance (S-Technologies) ... 34

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Table of contents

6.2.2 OPAL1 ... 34 6.2.3 Display (Live menu) ... 35 6.3 Setup menu ... 36 6.3.1 Display (Setup menu) ... 39 6.3.2 Network ... 40 6.4 Patient data privacy ... 42 6.5 Switching off the product ... 45 7 Maintenance, servicing, repairs, and disposal ... 46 7.1 Maintenance ... 46 7.2 Safety inspection in accordance with IEC 62353 ... 46 7.2.1 Visual inspection ... 46 7.2.2 Electric measurements ... 46 7.3 Repairing the product ... 46 7.4 Disposing of the product ... 46 8 Accessories and spare parts ... 48 8.1 Accessories ... 48 9 Electromagnetic compatibility ... 56 9.1 General notes on the operating environment ... 56 9.2 Accessories and cables ... 56 9.3 Table 1 – Compliance level for immunity tests ... 57 9.4 Table 2 – Test levels for proximity fields from HF wireless communications equipment 58 9.5 Table 3 – Test levels for radiated and conducted immunity tests ... 59 9.6 Table 4 – Emission class and group ... 60 9.7 Table 5 – Recommended separation distances between portable and mobile HF communications devices and the product ... 61 10 Subsidiaries ... 62

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General information

1 General information 1.1 Read the instructions for use If the instructions for use are not followed, patients, users, and third parties may be injured or the product may be damaged. Read the instructions for use carefully and follow all the safety notes and warnings. Read the reprocessing instructions carefully and follow all the safety notes and warnings. The reprocessing instructions can be downloaded from www.karlstorz.com/ifu by entering the item number. Keep the instructions for use and reprocessing instructions in a safe place.

1.2 Read the instructions for use of compatible products If the instructions for use of compatible products are not followed, patients, users, and third parties may be injured or the product may be damaged. Read the instructions for use of the compatible products carefully and follow all the safety notes and warnings. Read the reprocessing instructions of the compatible products carefully and follow all the safety notes and warnings.

1.3 Scope These instructions for use apply to the following products up to and including software version 4.3: Product name

Item number

IMAGE1 S CONNECT

TC200

IMAGE1 S CONNECT II

TC201

IMAGE1 S H3-LINK

TC300

IMAGE1 S X-LINK

TC301

IMAGE1 S D-LINK

TC302

IMAGE1 S 4U-LINK

TC304

IMAGE1 S D3-LINK extension cable

TC015

The products listed here may not yet be available in all countries due to differences in approval requirements.

1.4 General signs and symbols The signs and symbols used in this document have the following meaning: Practical tip This sign refers to useful and important information. Actions to be performed Action to be carried out by several steps: ü

Prerequisite that must be met before carrying out an action.

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General information

1.

Step 1 ð Interim result of an action

2.

Step 2

ð Result of a completed action Actions in safety notes or in the case of a single step: Step 1 Lists 1.

Numbered list

–

Unnumbered list, 1nd level – Unnumbered list, 2nd level

1.5 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 warnings use 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. NOTICE NOTICE Designates a possibly harmful situation. If this is not avoided, the products could be damaged.

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Normal use

2 Normal use 2.1 Intended use IMAGE1 S The IMAGE1 S is a camera control unit for use with camera heads or videoscopes and is used for visualizing and documenting endoscopic and microscopic procedures. The IMAGE1 S has no direct contact with the human body. Extension cable The extension cable is used for extending the camera head cable for connection to the IMAGE1 S camera control unit. The extension cable has no direct contact with the human body.

2.2 Indications The camera control units do not come into direct contact with the patient; instead, they are used in conjunction with the corresponding accessories (videoendoscopes, camera, light source, and monitor) and the applied parts for the purpose of visualizing and documenting endoscopic and exoscopic procedures. Use is not restricted to certain medical disciplines.

2.3 Contraindications No contraindications relating directly to the medical device are currently known. The responsible physician must decide whether the foreseen 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.

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Safety and warning

3 Safety and warning WARNING Danger due to non-observance of warnings and safety notes This chapter contains warnings and safety notes structured according to hazards and risks. 1. Carefully read and observe all warnings and safety notes. 2. Follow the instructions.

3.1 Serious incidents A ‘serious incident’ includes incidents which, directly or indirectly, had, could have had or could have any of the following consequences: –

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 Observing ambient condition If the device is operated in an environment which is not suitable, patients, users and third parties may be injured. Always store and operate the product in the prescribed ambient conditions.

3.3 Combination with other components The use of unauthorized devices and components or unauthorized changes to the product can result in injuries. Additional devices connected to electrical medical equipment must comply with the relevant IEC or ISO standards. Furthermore, all configurations must comply with the requirements for medical electrical systems. Only combine the product with devices and components that are approved for combined use by the manufacturer. Only use devices and components that have standardized interfaces and do not breach the normal use of the product. Do not modify this equipment without authorization of the manufacturer.

3.4 Damage due to ingress of liquid in electrical components In the case of electrical products, individual components or the product itself may be live. Liquid ingress into an electrical product may result in a short circuit or an unintentional transfer of current. The product is damaged as a result and patients, users and third parties may be injured. Do not store liquids near the product or on the product. If liquid has entered the product, pull out the plug and allow the product to dry completely.

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Safety and warning

3.5 Dangers from electrical current An improper power supply may cause an electric shock and injure patients, users, or third parties. All electrical installations in the operating room in which the product is connected and used must meet applicable IEC standards. Do not touch the output jacks of the product and the patient at the same time during use Do not open the product. Use either the power cord supplied by KARL STORZ or a power cord which has the same properties and which bears a national mark of conformity. Make sure that the plug is completely clean and dry. Do not use more than one extension cable. The product’s ground line should be installed by a qualified electrician. Ensure potential equalization according to the applicable national rules and regulations. To ensure reliable protective earth grounding, connect the product to a properly installed socket that is approved for use in the operation room. Routinely inspect the electrical plug and cord and do not use if the inspection reveals damage. To avoid the risk of electric shock, this product must only be connected to a supply mains with protective earth. If several products supplied with energy are used simultaneously, the patient leakage currents accumulate. These leakage currents can exceed the limit values and injure patients. The patient applied parts of the simultaneously used products must be type BF or type CF.

3.6 Risk of explosion and fire The product can generate sparks, which cause combustible or flammable gases and liquids to ignite or explode. This may cause injuries to patients, users, and third parties. When using explosive narcotic gases: Operate the product outside of the hazard zone.

Do not use the product in the presence of flammable anesthetics. The product must not be operated in oxygenated environments. Only connect or disconnect the power plug to or from the power supply outside explosive atmospheres.

3.7 Electromagnetic interference Medical electrical products are subject to special precautions regarding electromagnetic compatibility and must be installed and commissioned according to the tables on electromagnetic compatibility. If other products (e.g. for MRT, RFID) emit electromagnetic radiation, the function of the product may be impaired. Highfrequency communication equipment can affect electrical medical products and impair their performance. Observe the information on electromagnetic compatibility, see chapter Electromagnetic compatibility [p. 56].

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Safety and warning

The discharge of a defibrillator can cause image loss. If the image has not recovered after 4 seconds, switch the camera control unit off and on again.

3.8 Product not clean The product is not clean when delivered. The use of products that have not been cleaned 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.

3.9 Failure of products The product may fail during use. Perform an equipment test before use, see chapter Preparation [p. 24]. If the image fails during the procedure, remove the camera from the endoscope and continue the procedure optically. If the surgery cannot be continued optically, determination of how to further the procedure is at the physician's discretion based on the surgical circumstances. Have a replacement system ready for each application.

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Product description

4 Product description 4.1 Description of operation The product offers the following functions: –

IMAGE1 S Visualization modes to support the user with contrast enhancement and/or consistent brightness perception.

–

Light Source Control for automatic adjustment of the light source.

–

Integrated image and video capture for simple documentation.

4.2 Product overview 1

2

3

10

4

9

5

8

7 6 IMAGE1 S CONNECT, front 1

Power switch

6

D3-LINK camera connection

2

White balance

7

IMAGE1 S D3-LINK (TC302)

3

USB port

8

IMAGE1 S X-LINK (TC301)

4

H3-LINK camera connection

9

IMAGE1 S H3-LINK (TC 300)

5

X-LINK camera connection

10

IMAGE1 S CONNECT (TC200)

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Product description

1

2

3

4

5

6

7

8

10

9

Rear side of IMAGE1 S CONNECT 1

LINK input ports

6

HD DVI-D video output sockets

2

Potential equalization connector

7

3G-SDI video output

3

SCB input/output sockets (KARL STORZ Communication Bus)

8

Mains sockets

4

LAN interface, KS HIVE interface

9

Potential equalization connector

5

USB interface

10

LINK output

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Product description

1

2

3

10

9

4

8

5

7 6 IMAGE1 S CONNECT II, front 1

Power switch

6

D3-LINK camera connection

2

White balance

7

IMAGE1 S D-LINK (TC302)

3

USB port

8

IMAGE1 S X-LINK (TC301)

4

4U-LINK camera connection

9

IMAGE1 S 4U-LINK (TC304)

5

X-LINK camera connection

10

IMAGE1 S CONNECT II (TC201)

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Product description

1

3

2

4

5

6

7

12

11 10

9

8

Rear side of IMAGE1 S CONNECT II 1

LAN interface, KS HIVE interface

7

Mains sockets

2

LINK input ports

8

Potential equalization connector

3

SCB input/output sockets (KARL STORZ Communication Bus)

9

USB interface

4

12G/3G SDI video output

10

Potential equalization connector

5

DisplayPort video output sockets

11

EXT SYNC connection

6

HD DVI-D video output socket

12

LINK output

4.3 Technical data IMAGE1 S CONNECT Description

Value

HD video outputs

2x DVI-D 1x 3G-SDI

Signal output format

1,920 x 1,080p, 50/60 Hz

LINK input ports

3x

KS HIVE interface

RJ45

USB interface

4x USB

Image format

JPEG

Video format

MPEG 4

SCB interface

2x 6 pin Mini DIN

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Product description

IMAGE1 S CONNECT II Description

Value

4K and HD video outputs

2x DP 1x 12G/3G SDI 1x DVI-D

Signal output format

3,840 x 2,160p, 50/60 Hz for DP and 12G-SDI 1,920 x 1,080p, 50/60 Hz for 3G-SDI and DVID

LINK input ports

3x

KS HIVE interface

RJ45

USB interface

4x USB

Image format

JPEG

Video format

MPEG 4

SCB interface

1x 6 pin Mini DIN

Power supply (AC) and frequency requirements

Value

IMAGE1 S CONNECT

100–120 V, 50/60 Hz 200–240 V, 50/60 Hz

IMAGE1 S CONNECT II

100–240 V, 50/60 Hz

IMAGE1 S H3-LINK

100–240 V, 50/60 Hz

IMAGE1 S X-LINK

100–240 V, 50/60 Hz

IMAGE1 S D3-LINK

100–240 V, 50/60 Hz

IMAGE1 S 4U-LINK

100–240 V, 50/60 Hz

Dimensions

Value (W x H x D)

IMAGE1 S CONNECT

320 x 54 x 305 mm

IMAGE1 S CONNECT II

320 x 54 x 305 mm

IMAGE1 S H3-LINK

320 x 54 x 305 mm

IMAGE1 S X-LINK

320 x 54 x 305 mm

IMAGE1 S D3-LINK

320 x 54 x 305 mm

IMAGE1 S 4U-LINK

320 x 54 x 305 mm

Weight

Value

IMAGE1 S CONNECT

2.1 kg

IMAGE1 S CONNECT II

3.1 kg

IMAGE1 S H3-LINK

1.86 kg

IMAGE1 S X-LINK

1.86 kg

IMAGE1 S D3-LINK

1.86 kg

IMAGE1 S 4U-LINK

1.86 kg

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Product description

Power input

Value

IMAGE1 S CONNECT

62 VA

IMAGE1 S CONNECT II

100–135 VA

IMAGE1 S H3-LINK

80 VA

IMAGE1 S X-LINK

80 VA

IMAGE1 S D3-LINK

80 VA

IMAGE1 S 4U-LINK

86 VA

4.4 Possible combinations It is recommended that the suitability of the products for the intended procedure be checked prior to use. Please note that the products listed here may not yet be available in all countries due to differences in approval requirements. The IMAGE1 S camera control unit (CCU) consists of the IMAGE1 S CONNECT (TC200) or IMAGE1 S CONNECT II (TC201) and 1–3 additional LINK modules. The various modules serve as interfaces to camera heads and videoendoscopes. The following LINK modules are available: –

IMAGE1 S H3-LINK (TC300)

–

IMAGE1 S X-LINK (TC301)

–

IMAGE1 S D3-LINK module (TC302)

–

IMAGE1 S 4U-LINK module (TC304) Only compatible products may be combined with the CONNECT modules and LINK modules, see chapter Accessories [p. 48]. KARL STORZ recommends combining only CONNECT modules and LINK modules with the same software version.

The following products are required for navigation and input: –

Keyboard

–

Mouse

The following products are available as options for navigation: –

Compatible camera heads and videoendoscopes

–

IMAGE1 PILOT (TC014)

–

Microscope footswitch (TC019)

Do not connect network devices (Ethernet, Bluetooth, or WiFi dongles) to the USB port of the IMAGE1 S. The connection may impair operation of the IMAGE1 S.

4.4.1 Installation overview of IMAGE1 S CONNECT If multiple KS HIVE-compatible peripheral devices are used, the OR1 HIVE router is required.

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Product description

4.4.2 Installation overview of IMAGE1 S CONNECT II To use OPAL1 fluorescence imaging, the IMAGE1 S 4U-LINK (TC304) and Power LED Rubina (TL400) must also be connected via a sync cable when using the TIPCAM1 Rubina. If multiple KS HIVE-compatible peripheral devices are used, the OR1 HIVE router is required.

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Product description

4.5 Symbols employed 4.5.1 Symbols on the packaging Symbol

Meaning Manufacturer

Date of manufacture

Medical device

Article no.

Serial number

Number of products in the product packaging

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Product description

Symbol

Meaning Unique Device Identifier

Consult the printed or electronic instructions for use

Fragile, handle with care

Keep dry

Temperature limit

Humidity limit

Not MR safe

Federal (USA) law restricts this device to sale by or on the order of a physician. CE marking With this marking, the manufacturer declares the conformity of the product with the applicable EU directives. A code number after the CE mark indicates the responsible notified body. The EU directives relevant to the product can be found in the EU Declaration of Conformity, which can be requested from KARL STORZ. This side up

4.5.2 Symbols on the product Symbol

Meaning Follow the instructions for use. The color may differ on the product. The symbol is black/white on the packaging label. ON/OFF (standby)

USB

White balance

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Product description

Symbol

Meaning Applied part type CF defibrillation protection

Potential equalization connector

Prevention of pollution by electronic devices

Separate collection of electrical and electronic devices. Do not dispose of in household refuse. Consult the printed or electronic instructions for use

4.5.3 Symbols on the user interface Symbol

Meaning H3-LINK The button appears once the H3-LINK module is correctly connected.

X-LINK The button appears once the X-LINK module is correctly connected.

D3-LINK The button appears once the D3-LINK module is correctly connected.

4U-LINK The button appears once the 4U-LINK module is correctly connected.

Insufflator

Printer

Light source

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