Storz OR1 SCB CONTROL User manual

Installation instructions
OR1 SCB CONTROL
Rel. 3.0
en

Copyright ©
All product illustrations, product descriptions, and texts are the intellectual property of
KARLSTORZSE&Co.KG.
Their use and reproduction by third parties require the express approval of KARLSTORZSE&Co.KG.
All rights reserved.
04-2022

Table of contents
Installation instructions • OR1 SCB CONTROL • SBC232_EN_V2.0_04-2022_II_CE-MDR 3
Table of contents
1 General information............................................................................................................................ 5
1.1 Read the installation instructions ............................................................................................... 5
1.2 Other applicable documents...................................................................................................... 5
1.3 Scope......................................................................................................................................... 5
1.4 General signs and symbols........................................................................................................ 5
1.5 Description of warning messages.............................................................................................. 6
2 Safety and warning ............................................................................................................................ 7
2.1 Combination with other components......................................................................................... 7
2.2 Correct handling and product testing ........................................................................................ 7
2.3 Risks from electric current ......................................................................................................... 7
2.4 Damage due to ingress of liquid in electrical components........................................................ 8
2.5 Risk of explosion and fire........................................................................................................... 8
2.6 Observing ambient conditions ................................................................................................... 8
2.7 Electromagnetic interference ..................................................................................................... 8
3 Product description............................................................................................................................ 10
3.1 Technical description ................................................................................................................. 10
3.2 Device overview ......................................................................................................................... 10
3.3 Possible combinations ............................................................................................................... 11
3.3.1 Basic configurations ..................................................................................................... 12
3.4 Technical data............................................................................................................................ 14
3.5 Symbols employed .................................................................................................................... 15
3.5.1 Symbols on the packaging ........................................................................................... 15
3.5.2 Symbols on the device ................................................................................................. 16
3.5.3 Symbols on the type plate ............................................................................................ 17
3.6 Ambient conditions .................................................................................................................... 17
4 Preparation......................................................................................................................................... 18
4.1 Unpacking the product .............................................................................................................. 18
4.2 Setting up the product ............................................................................................................... 18
4.3 Connecting the device ............................................................................................................... 18
5 Installation and commissioning.......................................................................................................... 20
5.1 Switching on the product........................................................................................................... 20
5.2 User interface............................................................................................................................. 20
5.2.1 Icons on the user interface ........................................................................................... 22
5.3 User roles and access rights...................................................................................................... 22
5.4 Settings ...................................................................................................................................... 23
5.4.1 Setting the language..................................................................................................... 23
5.4.2 Opening Maintenance Manager ................................................................................... 24
5.4.3 Device Setup................................................................................................................. 26
5.4.4 Identical equipment ...................................................................................................... 27
5.5 Presets ....................................................................................................................................... 29
5.5.1 Saving Presets .............................................................................................................. 30
5.5.2 Deleting Presets............................................................................................................ 32
5.6 HIVE certificates......................................................................................................................... 33
5.7 Configuration.............................................................................................................................. 34
5.7.1 Autologon ..................................................................................................................... 34
5.7.2 Starting VNC server service.......................................................................................... 35

Table of contents
Installation instructions • OR1 SCB CONTROL • SBC232_EN_V2.0_04-2022_II_CE-MDR 4
5.8 Switching off the product........................................................................................................... 37
6 Equipment .......................................................................................................................................... 38
6.1 Equipment overview................................................................................................................... 38
6.2 Universal OR-Light, OR-Light Cam............................................................................................ 39
6.2.1 Setting the OR camera and operating light .................................................................. 39
6.3 Operating tables......................................................................................................................... 41
6.3.1 Configuration of operating tables ................................................................................. 41
6.4 HF devices ................................................................................................................................. 42
6.4.1 Configuration — VIO3................................................................................................... 42
7 Data backup and reorganization ........................................................................................................ 44
7.1 Data backup............................................................................................................................... 44
8 Maintenance, servicing, repairs, and disposal................................................................................... 45
8.1 Maintaining the product ............................................................................................................. 45
8.1.1 Maintenance ................................................................................................................. 45
8.2 Repairs to the product ............................................................................................................... 45
8.3 Disposing of the product ........................................................................................................... 45
9 Accessories and spare parts.............................................................................................................. 46
9.1 Accessories................................................................................................................................ 46
10 Errors and messages ......................................................................................................................... 47
10.1 Troubleshooting ......................................................................................................................... 47
11 Software user rights ........................................................................................................................... 48
12 Subsidiaries........................................................................................................................................ 49

General information
Installation instructions • OR1 SCB CONTROL • SBC232_EN_V2.0_04-2022_II_CE-MDR 5
1 General information
1.1 Read the installation instructions
These installation instructions should help you with the proper installation and connection of the
OR1SCBCONTROL. They also describe the configuration of the software to allow users to
subsequently operate the system with presets and in their desired language.
Installation and putting into service must only be performed by authorized, electrotechnically qualified
specialists from KARLSTORZSE&Co.KG or by an authorized contractual partner.
Configurations can only be carried out by administrators with a special administrator login.
1.2 Other applicable documents
The following documents must also be observed:
– OR1SCBCONTROL instructions for use
– OR1SCBCONTROL reprocessing instructions
1.3 Scope
This installation manual is valid for:
Product name Item number
OR1SCBCONTROL WU300
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.
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

General information
Installation instructions • OR1 SCB CONTROL • SBC232_EN_V2.0_04-2022_II_CE-MDR 6
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.

Safety and warning
Installation instructions • OR1 SCB CONTROL • SBC232_EN_V2.0_04-2022_II_CE-MDR 7
2 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.
2.1 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 devices 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.
Observe the instruction manuals and interface specifications of the devices and components
used in combination.
2.2 Correct handling and product testing
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 the product for visible damage before and after every use.
Do not continue to use damaged products.
Dispose of the product properly.
2.3 Risks from electric current
An improper power supply may cause an electric shock and injure patients, users, or third parties. All
electrical installations of the operation room in which the product is connected and used must meet
the applicable IEC standards. Input and output devices connected to the product must comply with
IEC60601-1.
Have the device installed and put into service by authorized and trained electricians of
KARLSTORZSE&Co.KG or by companies authorized by KARLSTORZ.
Use either the power cord supplied by KARLSTORZ or a power cord which has the same
properties and which bears a national mark of conformity.
The product may only be operated with the line voltage stated on the rating plate.
Position the product appropriately so that the power cord can be unplugged at any time. The
product is only voltage-free when the mains plug has been disconnected.
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.
Connect the product to a power supply with protective conductor.
If several devices are connected to the product, note the maximum leakage current.
Do not use any additional multiple socket outlets or extension cables.
Do not use freely accessible multiple socket outlets.

Safety and warning
Installation instructions • OR1 SCB CONTROL • SBC232_EN_V2.0_04-2022_II_CE-MDR 8
In the case of electrical products, individual components or the product itself may be live. Live parts
can cause electric shocks in the event of contact and injure patients, users and third parties.
Do not open the product.
Have servicing carried out by KARLSTORZ or a company authorized by KARLSTORZ. Failure to
do so will void the guarantee.
Do not touch the output jacks of the product and the patient at the same time during use
Always pull out the mains plug before carrying out any cleaning and maintenance work.
2.4 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.
2.5 Risk of explosion and fire
During use, explosive anesthetic gases are used. If sparks occur, this may trigger explosions.
Do not operate the product in environments with combustible gases such as inhalation
anesthetics and mixtures thereof. Observe the hazard zones:
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.
2.6 Observing ambient conditions
If the device is stored, transported, operated or reprocessed under unsuitable conditions, patients,
users or third parties may be injured and the device can be damaged.
Observe the ambient conditions listed in the instructions for use and reprocessing.
2.7 Electromagnetic interference
Medical electrical devices 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 RFID) emit electromagnetic radiation,
the function of the product may be impaired. High-frequency communication equipment can affect
medical electrical devices and impair their performance.

Safety and warning
Installation instructions • OR1 SCB CONTROL • SBC232_EN_V2.0_04-2022_II_CE-MDR 9
Do not use the product in the vicinity of a magnetic resonance tomograph (MRT).
Do not use the product next to or together with other devices. If such use is required, monitor the
product and the other devices, and follow the relevant instructions for use in the event of
malfunctions.
Portable RF communications equipment including peripheral devices (e.g., antenna cables and
external antennas) should be used no closer than 30cm from the product, including cables
specified by the manufacturer.
Observe the information on electromagnetic compatibility, Electromagnetic compatibility.
In case of uncertainties, seek expert advice from KARLSTORZ.
Before use, a clinical/biomedical engineer or an EMC specialist should carry out an ad-hoc test of
the electromagnetic radiation.
To prevent increased electromagnetic emissions or reduced electromagnetic immunity of the
product, only use accessories, transducers, and cables recommended or supplied by the
manufacturer.
In order to avoid exposing patients, users, or third parties to harmful electromagnetic interference,
the product must not be operated outside of its intended EMC environment. Furthermore, the
product must not be operated if the housing, cable, or electromagnetic shielding equipment is
damaged.

Product description
Installation instructions • OR1 SCB CONTROL • SBC232_EN_V2.0_04-2022_II_CE-MDR 10
3 Product description
3.1 Technical description
The OR1SCBCONTROL forms a communication interface between the connected devices and a
central control panel in the operation room. The central display and control of the parameters of
connected devices in sterile and non-sterile areas is possible via the graphic user interface of the
OR1SCBCONTROL.
A touch screen with a sterile disposable cover is required for operation in sterile areas. Outside the
sterile area, a keyboard or mouse can optionally be used.
The product is characterized by the following criteria:
– Safety and reliability
– Simple operation
– Hot plug-and-play (active systems)
– User-specific and application-specific "Presets" (preprogramming)
– Central control
– Modular design
– Possibility of later extensions
3.2 Device overview
4
123 5
OR1SCBCONTROL - front panel
1 Rocker switch ON/OFF 4 LED, red, hard disk access
2 LED, yellow, Standby 5 USB port
3 LED, green, ready for use

Product description
Installation instructions • OR1 SCB CONTROL • SBC232_EN_V2.0_04-2022_II_CE-MDR 11
16
4
123 5 67
89
101112131415
OR1SCBCONTROL - back panel
1 Mains socket 9 Phoenix 2-pin*
2 Potential equalization connector 10 Mini jack (audio OUT)*
3 Serial interface (DE 9) 11 4x USB 3.0
4 2x LAN (RJ-45) 12 Monitor (DVI)
5 Mini jack (audio IN)* 13 2x monitor (digital port)
6 SCB PC card with 2 connections 14 4x USB 2.0
7 Serial interface (DE 9) 15 Keyboard (PS/2)
8 Remote switch (Phoenix 4-pin) 16 Mouse (PS/2)
* No accessories may be connected here.
3.3 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.
Touch screen models
Product name Item number
KARLSTORZ Touch Screen 21.5" WM100
KARLSTORZ Touch Screen 24" WM101
KARLSTORZ Touch Screen 21.5" 20090621
KARLSTORZ Touch Screen 24" 20090624
OR1 Panel PC 21.5'', InWall W22168-W
OR1 Panel PC 21.5'', Stand-Alone W22168-S

Product description
Installation instructions • OR1 SCB CONTROL • SBC232_EN_V2.0_04-2022_II_CE-MDR 12
OR1 software
Product name Item number
KARLSTORZ AIDA from software release 1.6 WD300
KARLSTORZ OR1 FUSION from software re-
lease 1.4.2
WO300
KARLSTORZ OR1 NEO from release 50 WS112
3.3.1 Basic configurations
The OR1SCBCONTROL can be configured freely depending on the extension. A number of basic
configurations are shown schematically below. Other system configurations are generally possible,
but these must always be considered and planned separately. Additional costs may be incurred here.
Any changes to the hardware or software which are not authorized by KARLSTORZ void the approval
for medical use, the guarantee, and the manufacturer’s warranty. If necessary, contact your
KARLSTORZ staff member to enquire about available and compatible hardware and software
components.

Product description
Installation instructions • OR1 SCB CONTROL • SBC232_EN_V2.0_04-2022_II_CE-MDR 13
OR1SCBCONTROL connection diagram
2
1
3
654
OR1SCBCONTROL connection diagram with touch monitor
1 KARLSTORZ touch monitor 4 HIVE device (e.g. PowerLED Rubina TL400)
2 OR1SCBCONTROL 5 OR1 table interface
3 KARLSTORZ SCB device with STORZ Commu-
nication Bus
6 RF device (e.g. AUTOCONIII 300, 400, BOWA
Arc 400, ERBEVIO3)

Product description
Installation instructions • OR1 SCB CONTROL • SBC232_EN_V2.0_04-2022_II_CE-MDR 14
OR1SCBCONTROL connection diagram with integration
2
1
543
6
OR1SCBCONTROL connection diagram with integration
1 OR1SCBCONTROL 4 KARLSTORZ AV NEO, OR1 FUSION or
AIDA
2 KARLSTORZ SCB device with STORZ
Communication Bus
5 OR1 table interface
3 HIVE device (e.g. PowerLED Rubina
TL400)
6 RF device (e.g. AUTOCONIII 300, 400,
BOWA Arc 400, ERBEVIO3)
3.4 Technical data
Power supply
Power supply (AC) 100–240V
Operating frequency 50–60Hz
Power input 5–2A
Operating mode Continuous operation

Product description
Installation instructions • OR1 SCB CONTROL • SBC232_EN_V2.0_04-2022_II_CE-MDR 15
Housing
Degree of protection acc. to
IEC60259
IP20
Protection class I
Dimensions (LxHxD) 355x74.5x305mm
Weight 6kg
Device
Hard disk capacity 2TB
RAM 16GB
Operating system Windows 10 IoT
The OR1SCBCONTROL contains a lithium battery that needs to be checked and replaced
regularly.
3.5 Symbols employed
3.5.1 Symbols on the packaging
Symbol Meaning
Manufacturer
Date of manufacture
Medical device
Article no.
Serial number
Number of products in the product packaging
Unique Device Identifier
Consult the printed or electronic instructions for use
Fragile, handle with care

Product description
Installation instructions • OR1 SCB CONTROL • SBC232_EN_V2.0_04-2022_II_CE-MDR 16
Symbol Meaning
Keep dry
Humidity limit
Air pressure limit
Do not use if package is damaged.
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 KARLSTORZ.
3.5.2 Symbols on the device
Symbol Meaning
Follow the instructions for use.
The color may differ on the product. The symbol is black/white on the packag-
ing label.
Ready/standby
ON
Hard disk
USB
Attention
Here "Dangerous voltage
Danger of an electric shock!"
The potential equalization is responsible for equalizing the potentials of differ-
ent metal parts that can be touched at the same time, or for reducing potential
differences that could occur between the body, electromedical devices, and
external live parts during use.

Product description
Installation instructions • OR1 SCB CONTROL • SBC232_EN_V2.0_04-2022_II_CE-MDR 17
3.5.3 Symbols on the type plate
Symbol Meaning
Manufacturer
Serial number
Environmental protection use period of 10 years (China RoHS)
Separate collection of electrical and electronic devices.
Do not dispose of in household refuse.
CSA certification mark for the USA and Canada
With this mark, the manufacturer declares compliance with the certification re-
quirements.
Date of manufacture
Alternating current
Federal (USA) law restricts this device to sale by or on the order of a physician.
Medical device
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 KARLSTORZ.
3.6 Ambient conditions
Storage and Transport Conditions
Temperature -10°C...+60°C (14°F...140°F)
Relative humidity 5–95 %
Air pressure 500–1,080hPa
Operating conditions
Temperature 10°C...40°C (50°F...104°F)
Relative humidity 20–80 %
Air pressure 700–1,080hPa
Max. operating altitude 3,000m

Preparation
Installation instructions • OR1 SCB CONTROL • SBC232_EN_V2.0_04-2022_II_CE-MDR 18
4 Preparation
4.1 Unpacking the product
1. Carefully remove the product and accessories from the packaging.
2. Check the delivery for missing items and any possible damage.
3. In the case of damage, hidden defects, and short deliveries, document their nature and extent
and contact the manufacturer or supplier immediately.
4. Keep packaging for further transport.
4.2 Setting up the product
WARNING
Overheating! Risk of fire!
Insufficient ventilation can cause an internal build-up of heat, resulting in a safety shut-down. If the
product overheats, there is a risk of fire. Patients, users, and third parties may be injured.
Ensure that there is sufficient air circulation.
Keep air inlets and outlets free.
The product can be operated free-standing or in a rack.
1. Ensure that the ambient conditions are observed.
2. Observe the technical data.
3. Install the product out of reach of patients.
4.3 Connecting the device
OR1SCBCONTROL can be connected to other devices as per the connection diagram (See section
Basic configurations
[p.12]).
The instructions for use of the products used in combination must be followed.
üThe product is on an even surface.
üThe clearance dimensions are observed, Setting up the product.
1. Connect the potential equipotential cable.

Preparation
Installation instructions • OR1 SCB CONTROL • SBC232_EN_V2.0_04-2022_II_CE-MDR 19
2. Connect the power cord. Push the power plug fully into the power socket.
After connecting, a safety inspection must be performed by authorized, electrically trained specialists
from KARLSTORZSE&Co.KG or an authorized contractual partner.
If the product is connected to multiple devices via a portable multiple socket outlet on a cart, the
following measures apply:
3. Note the maximum permitted leakage current of the housing.
4. If necessary, use an isolation transformer.

Installation and commissioning
Installation instructions • OR1 SCB CONTROL • SBC232_EN_V2.0_04-2022_II_CE-MDR 20
5 Installation and commissioning
5.1 Switching on the product
NOTICE
Malfunction! Incorrect operation of the devices!
If the graphic user interface is not functioning properly, the connected equipment cannot be operated
correctly.
To ensure that the graphic user interface functions correctly, use the touchscreen to activate at
least one function for each connected item of equipment and check that the reaction is correct.
1. Switch on the connected devices.
2. Switch on the product via the rocker switch.
ðThe software will start up.
3. Log in with your username and password.
ðThe start screen appears.
4. Confirm by pressing OK and wait until the connected devices are visible in the list of devices.
5.2 User interface
1
2
3
4
7
5
6
1 Messages 5 Settings, exit
2 Menu bar 6 Widgets (compact menus)
3 Device list 7 Navigation
4 Device window
Messages
The information and warnings for the connected equipment are shown in the header. The warnings
continue to be displayed as long as they are relevant and must be noted. For more information see
chapter ‘Messages’ in the instructions for use.
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