Storz Image1 S H3-Z FI TH 102 User manual

Instructions for use
IMAGE1 S
en

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.
05-2022

Table of contents
Instructions for use • IMAGE1 S • 705LZA_EN_V2.1_05-2022_IFU_FDA 3
Table of contents
1 General information .................................................................................................................. 5
1.1 Read the instructions for use........................................................................................... 5
1.2 Read the instructions for use of compatible products .................................................... 5
1.3 Scope .............................................................................................................................. 5
1.4 General signs and symbols ............................................................................................. 5
1.5 Description of warning messages ................................................................................... 6
2 Normal use ............................................................................................................................... 7
2.1 Intended use.................................................................................................................... 7
2.2 Indications ....................................................................................................................... 7
2.3 Contraindications ............................................................................................................ 7
2.4 Target user populations................................................................................................... 7
2.5 Patient groups ................................................................................................................. 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

Table of contents
Instructions for use • IMAGE1 S • 705LZA_EN_V2.1_05-2022_IFU_FDA 4
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 .................................................................................................. 53
9.1 General notes on the operating environment .................................................................. 53
9.2 Accessories and cables................................................................................................... 53
9.3 Table 1 – Compliance level for immunity tests................................................................ 54
9.4 Table 2 – Test levels for proximity fields from HF wireless communications equipment 55
9.5 Table 3 – Test levels for radiated and conducted immunity tests................................... 56
9.6 Table 4 – Emission class and group................................................................................ 57
9.7 Table 5 – Recommended separation distances between portable and mobile HF
communications devices and the product ...................................................................... 58
10 Subsidiaries .............................................................................................................................. 59

General information
Instructions for use • IMAGE1 S • 705LZA_EN_V2.1_05-2022_IFU_FDA 5
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 TC200US
IMAGE1 S CONNECT II TC201US
IMAGE1 S H3-LINK TC300US
IMAGE1 S X-LINK TC301US
IMAGE1 S D-LINK TC302US
IMAGE1 S 4U-LINK TC304US
IMAGE1 S D3-LINK extension cable TC015US
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:
üPrerequisite that must be met before carrying out an action.

General information
Instructions for use • IMAGE1 S • 705LZA_EN_V2.1_05-2022_IFU_FDA 6
1. Step 1
ðInterim result of an action
2. Step 2
ðResult of a completed action
Actions in safety notes or in the case of a single step:
Step 1
Lists
1. Numbered list
– Unnumbered list, 1st 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.

Normal use
Instructions for use • IMAGE1 S • 705LZA_EN_V2.1_05-2022_IFU_FDA 7
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.
2.2 Indications
IMAGE1S is a camera control unit (CCU) for use with camera heads or video endoscopes for
the visualization and documentation of endoscopic and microscopic procedures.
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.

Safety and warning
Instructions for use • IMAGE1 S • 705LZA_EN_V2.1_05-2022_IFU_FDA 8
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.

Safety and warning
Instructions for use • IMAGE1 S • 705LZA_EN_V2.1_05-2022_IFU_FDA 9
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 all 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. Grounding reliability can only be
achieved when the equipment is connected to a “Hospital Only” or “Hospital Grade”
outlet. 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, CT, diathermy, electrocautery or

Safety and warning
Instructions for use • IMAGE1 S • 705LZA_EN_V2.1_05-2022_IFU_FDA 10
RFID) emit electromagnetic radiation, the function of the product may be impaired. High-
frequency communication equipment can affect electrical medical products and impair their
performance.
Observe the information on electromagnetic compatibility, see chapter Electromagnetic
compatibility [p.53].
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.

Product description
Instructions for use • IMAGE1 S • 705LZA_EN_V2.1_05-2022_IFU_FDA 11
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
123
94
5
7
8
10
6
IMAGE1 S CONNECT, front
1 Power switch 6 D3-LINK camera connection
2 White balance 7 IMAGE1 S D3-LINK (TC302US)
3 USB port 8 IMAGE1 S X-LINK (TC301US)
4 H3-LINK camera connection 9 IMAGE1 S H3-LINK (TC300US)
5 X-LINK camera connection 10 IMAGE1 S CONNECT (TC200US)

Product description
Instructions for use • IMAGE1 S • 705LZA_EN_V2.1_05-2022_IFU_FDA 12
1
8
256
4
37
9
10
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

Product description
Instructions for use • IMAGE1 S • 705LZA_EN_V2.1_05-2022_IFU_FDA 13
13
10
9
8
7
4
2
5
6
IMAGE1 S CONNECT II, front
1 Power switch 6 D3-LINK camera connection
2 White balance 7 IMAGE1 S D-LINK (TC302US)
3 USB port 8 IMAGE1 S X-LINK (TC301US)
4 4U-LINK camera connection 9 IMAGE1 S 4U-LINK (TC304US)
5 X-LINK camera connection 10 IMAGE1 S CONNECT II (TC201US)

Product description
Instructions for use • IMAGE1 S • 705LZA_EN_V2.1_05-2022_IFU_FDA 14
123456
7
12 10 98
11
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

Product description
Instructions for use • IMAGE1 S • 705LZA_EN_V2.1_05-2022_IFU_FDA 15
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 DVI-
D
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 require-
ments
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

Product description
Instructions for use • IMAGE1 S • 705LZA_EN_V2.1_05-2022_IFU_FDA 16
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 (TC200US) or
IMAGE1S CONNECTII (TC201US) 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 (TC300US)
– IMAGE1S X-LINK (TC301US)
– IMAGE1S D3-LINK module (TC302US)
– IMAGE1S 4U-LINK module (TC304US)
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.

Product description
Instructions for use • IMAGE1 S • 705LZA_EN_V2.1_05-2022_IFU_FDA 17
4.4.2 Installation overview of IMAGE1 S CONNECT II
To use OPAL1* fluorescence imaging, the IMAGE1S 4U-LINK (TC304US) and Power
LED Rubina (TL400) must also be connected via a sync cable when using the TIPCAM1
Rubina.
* OPAL1 is NOT available for PDD in the USA.
If multiple KS HIVE-compatible peripheral devices are used, the OR1HIVE router is
required.

Product description
Instructions for use • IMAGE1 S • 705LZA_EN_V2.1_05-2022_IFU_FDA 18
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

Product description
Instructions for use • IMAGE1 S • 705LZA_EN_V2.1_05-2022_IFU_FDA 19
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 prod-
uct 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 Decla-
ration 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

Product description
Instructions for use • IMAGE1 S • 705LZA_EN_V2.1_05-2022_IFU_FDA 20
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