Storz OR1 SCB CONTROL User manual

Instructions for use
OR1 SCB CONTROL
Rel. 3.0
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.
09-2022

Table of contents
Instructions for use • OR1 SCB CONTROL • SBC231_EN_V3.0_09-2022_IFU_CE-MDR 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 Other applicable documents...................................................................................................... 5
1.5 General signs and symbols........................................................................................................ 5
1.6 Description of warning messages.............................................................................................. 6
2 Normal use ......................................................................................................................................... 7
2.1 Intended purpose....................................................................................................................... 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 Correct handling and product testing ........................................................................................ 8
3.3 Product not clean....................................................................................................................... 8
3.4 Combination with other components......................................................................................... 8
3.5 Risks from electric current ......................................................................................................... 9
3.6 Damage due to ingress of liquid in electrical components........................................................ 9
3.7 Risk of explosion and fire........................................................................................................... 9
3.8 Observing ambient conditions ................................................................................................... 10
3.9 Electromagnetic interference ..................................................................................................... 10
4 Product description............................................................................................................................ 11
4.1 Technical description ................................................................................................................. 11
4.2 Device overview ......................................................................................................................... 11
4.3 Possible combinations ............................................................................................................... 12
4.4 Technical data............................................................................................................................ 13
4.5 Symbols employed .................................................................................................................... 14
4.5.1 Symbols on the packaging ........................................................................................... 14
4.5.2 Symbols on the device ................................................................................................. 15
4.5.3 Symbols on the type plate ............................................................................................ 16
4.6 Ambient conditions .................................................................................................................... 16
5 Preparation......................................................................................................................................... 17
5.1 Unpacking the product .............................................................................................................. 17
5.2 Setting up the product ............................................................................................................... 17
6 Operation ........................................................................................................................................... 18
6.1 Switching on the product........................................................................................................... 18
6.2 User interface............................................................................................................................. 18
6.2.1 Icons on the user interface ........................................................................................... 19
6.3 Equipment list ............................................................................................................................ 20
6.4 Checking the functioning of the user interface .......................................................................... 21
6.5 Widgets (compact menus) ......................................................................................................... 21
6.5.1 Hiding and displaying widgets...................................................................................... 23
6.5.2 Setting the set value ..................................................................................................... 23

Table of contents
Instructions for use • OR1 SCB CONTROL • SBC231_EN_V3.0_09-2022_IFU_CE-MDR 4
6.6 Opening presets......................................................................................................................... 24
6.7 Messages................................................................................................................................... 25
6.7.1 Information.................................................................................................................... 25
6.7.2 Warnings....................................................................................................................... 26
6.8 Setting equipment to standby.................................................................................................... 28
6.9 Switching off the product........................................................................................................... 28
7 Equipment .......................................................................................................................................... 29
7.1 Equipment overview................................................................................................................... 29
7.2 Equipment views........................................................................................................................ 30
7.2.1 Camera systems ........................................................................................................... 31
7.2.2 Light sources ................................................................................................................ 32
7.2.3 Insufflators .................................................................................................................... 33
7.2.4 Pumps........................................................................................................................... 34
7.2.5 Motor systems .............................................................................................................. 36
7.2.6 HF equipment ............................................................................................................... 38
7.2.7 Smoke extraction systems ........................................................................................... 42
7.2.8 Operating lights and OR camera systems.................................................................... 43
7.2.9 Operating tables ........................................................................................................... 45
8 Maintenance, servicing, repairs, and disposal................................................................................... 47
8.1 Maintaining the product ............................................................................................................. 47
8.1.1 Maintenance ................................................................................................................. 47
8.2 Repairs to the product ............................................................................................................... 47
8.3 Disposing of the product ........................................................................................................... 47
9 Accessories and spare parts.............................................................................................................. 48
9.1 Accessories................................................................................................................................ 48
10 Errors and messages ......................................................................................................................... 49
10.1 General faults ............................................................................................................................. 49
10.2 Troubleshooting ......................................................................................................................... 49
11 Electromagnetic compatibility............................................................................................................ 50
11.1 General information on the operating environment ................................................................... 50
11.2 Cables ........................................................................................................................................ 50
11.3 Table 1 – Compliance level for immunity tests .......................................................................... 51
11.4 Table 2 – Test levels for proximity fields from HF wireless communications equipment .......... 52
11.5 Table 3 – Test levels for radiated and conducted immunity tests ............................................. 53
11.6 Table 4 – Emission class and group .......................................................................................... 54
11.7 Table 5 – Recommended separation distances between portable and mobile HF
communications equipment and the product............................................................................ 55
12 Subsidiaries........................................................................................................................................ 56

General information
Instructions for use • OR1 SCB CONTROL • SBC231_EN_V3.0_09-2022_IFU_CE-MDR 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.
1.3 Scope
This instruction manual is valid for:
Product name Item number
OR1 SCB CONTROL WU300
1.4 Other applicable documents
The following documents are a part of the product and must be observed:
– SCB installation instructions
– SCB reprocessing instructions
– Regulatory information on Intel Corporation radio receiver
1.5 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

General information
Instructions for use • OR1 SCB CONTROL • SBC231_EN_V3.0_09-2022_IFU_CE-MDR 6
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
1.6 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 • OR1 SCB CONTROL • SBC231_EN_V3.0_09-2022_IFU_CE-MDR 7
2 Normal use
2.1 Intended purpose
The KARLSTORZ SCB device control serves to centrally display and enable remote control of the
parameters of both the SCB devices and the designated device from other manufacturers which is
connected to the KARLSTORZ SCB during diagnostic and therapeutic interventions. The device
control can be operated via sterile input on touch-sensitive LCD monitors (touch screens) and has no
direct contact with the patient.
The KARLSTORZ SCB hardware is used to provide a computer system in order to enable use of the
KARLSTORZ SCB software. The KARLSTORZ SCB hardware does not come into direct contact with
the patient.
The KARLSTORZ SCB software is used to display and enable central and sterile remote control of
the parameters of both of the SCB devices connected to the KARLSTORZ SCB control and the
device from other manufacturers intended for this purpose. The KARLSTORZ SCB software does not
come into direct contact with the patient.
The SCB PC card is used as a master node (administration) in the KARLSTORZ SCB bus and thus
enables the KARLSTORZ SCB control software to control and visualize the SCB device. Furthermore,
the SCB PC card is used as an independent watchdog for the SCB Security Task. The SCB PC card
does not come into contact with the patient.
2.2 Indications
The KARLSTORZ OR1 SCB CONTROL and the corresponding accessories are, based on their
intended use, suitable for all diagnostic and therapeutic procedures that are compatible with them
and for which it is possible to use them in the opinion of the responsible physician.
2.3 Contraindications
Use is contraindicated if, in the opinion of the responsible physician, the device is not compatible with
successful completion of the planned procedure due to its technical design.
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.
The product does not come into direct contact with the patient.The product does not come into direct
contact with the patient.

Safety and warning
Instructions for use • OR1 SCB CONTROL • SBC231_EN_V3.0_09-2022_IFU_CE-MDR 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 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.
3.3 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.
3.4 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.

Safety and warning
Instructions for use • OR1 SCB CONTROL • SBC231_EN_V3.0_09-2022_IFU_CE-MDR 9
3.5 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
IEC60601-1.
Have the device installed and put into service by authorized and trained electricians of
KARLSTORZSE&Co.KG or by companies authorized by KARLSTORZ.
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.
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.
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 KARLSTORZ or a company authorized by KARLSTORZ. 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.
3.6 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.
3.7 Risk of explosion and fire
During use, explosive anesthetic gases are used. If sparks occur, this may trigger explosions.

Safety and warning
Instructions for use • OR1 SCB CONTROL • SBC231_EN_V3.0_09-2022_IFU_CE-MDR 10
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.
3.8 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.
3.9 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.
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 30cm from the product, including cables
specified by the manufacturer.
Observe the information on electromagnetic compatibility, See section Electromagnetic
compatibility [p.50].
In case of uncertainties, seek expert advice from KARLSTORZ.
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
Instructions for use • OR1 SCB CONTROL • SBC231_EN_V3.0_09-2022_IFU_CE-MDR 11
4 Product description
4.1 Technical description
The SCB 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 SCB.
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
4.2 Device overview
4
123 5
SCB - front panel
1 ON/OFF rocker switch
Standby and operating state
4 LED, red, hard disk access
2 LED, yellow, Standby 5 USB port
3 LED, green, ON status

Product description
Instructions for use • OR1 SCB CONTROL • SBC231_EN_V3.0_09-2022_IFU_CE-MDR 12
16
4
123 5 67
89
101112131415
SCB - 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.
4.3 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
KARLSTORZ Touch Screen 21.5" WM100
KARLSTORZ Touch Screen 24" WM101
KARLSTORZ Touch Screen 21.5" 20090621
KARLSTORZ Touch Screen 24" 20090624
OR1 Panel PC 21.5'', InWall W22168-W
OR1 Panel PC 21.5'', Stand-Alone W22168-S

Product description
Instructions for use • OR1 SCB CONTROL • SBC231_EN_V3.0_09-2022_IFU_CE-MDR 13
OR1 software
Product name Item number
KARLSTORZ AIDA from software release 1.6 WD300
KARLSTORZ OR1 FUSION from software re-
lease 1.4.2
WO300
KARLSTORZ OR1 NEO from release 50 WS112
4.4 Technical data
Power supply
Power supply (AC) 100–240V
Operating frequency 50–60Hz
Power input 5–2A
Operating mode Continuous operation
Housing
Degree of protection acc. to
IEC60259
IP20
Protection class I
Dimensions (LxHxD) 355x74.5x305mm
Weight 6kg
Device
Hard disk capacity 2TB
RAM 16GB
CPU Intel® Core™ [email protected] GHz
Operating system Windows 10 IoT
The SCB contains a lithium battery that needs to be checked and replaced regularly.

Product description
Instructions for use • OR1 SCB CONTROL • SBC231_EN_V3.0_09-2022_IFU_CE-MDR 14
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
Unique Device Identifier
Consult the printed or electronic instructions for use
Fragile, handle with care
Keep dry
Temperature limit
Humidity limit
Air pressure limit

Product description
Instructions for use • OR1 SCB CONTROL • SBC231_EN_V3.0_09-2022_IFU_CE-MDR 15
Symbol Meaning
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 KARLSTORZ.
4.5.2 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 button
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
Instructions for use • OR1 SCB CONTROL • SBC231_EN_V3.0_09-2022_IFU_CE-MDR 16
4.5.3 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 KARLSTORZ.
4.6 Ambient conditions
Storage and Transport Conditions
Temperature -10°C...+60°C (14°F...140°F)
Relative humidity 5–95 %
Air pressure 500–1,080hPa
Operating conditions
Temperature 10°C...40°C (50°F...104°F)
Relative humidity 20–80 %
Air pressure 700–1,080hPa
Max. operating altitude 3,000m

Preparation
Instructions for use • OR1 SCB CONTROL • SBC231_EN_V3.0_09-2022_IFU_CE-MDR 17
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 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.
5.2 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.

Operation
Instructions for use • OR1 SCB CONTROL • SBC231_EN_V3.0_09-2022_IFU_CE-MDR 18
6 Operation
6.1 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. If you do not know the password, contact the administrator.
6.2 User interface
1
2
3
4
5
6
7
1 Messages 5 Exiting
2 Menu bar 6 Widgets (compact menus)
3 Device list 7 Navigation
4 Device window
Messages
The information and warnings for the connected device are shown in the header. The messages are
displayed as long as the situations prevail. More information, See section Messages [p.25].
Menu bar
The following functions are available in the menu bar:

Operation
Instructions for use • OR1 SCB CONTROL • SBC231_EN_V3.0_09-2022_IFU_CE-MDR 19
– Presets
– Help
Devices and their parameters for operations and surgeons can be saved in Presets. When a preset is
opened, the settings are transferred to the devices. More information, See section Opening presets
[p.24].
Information on the software is displayed in the Help menu.
Device list
The statuses of the connected devices are shown in the device list and active devices can be
selected.
Device window
A realistic view of a device selected in the device list is shown in the device window. The device can
be controlled via this view.
Exiting
The application is exited and the SCB shut down by pressing the Exit button.
If the Exit button is pressed for two seconds or longer, the user is logged off but the product
does not shut down.
Widgets (compact menus)
Widgets provide a compact view of the connected devices. The values shown can be changed
directly here. More information, See section Widgets (compact menus) [p.21].
Navigation
Depending on the configuration, other OR1 components can be accessed via the navigation, such as
KARLSTORZ AIDA, OR1 FUSION or AV system NEO. The widgets (compact menus) can be displayed
and hidden using the Overview button on the right-hand side of the navigation bar.
6.2.1 Icons on the user interface
Symbol Meaning
Confirm warning*
Mute warning*
Information on a warning*
Settings
Log in area of administrators
Exit
Overview
Hiding and displaying widgets

Operation
Instructions for use • OR1 SCB CONTROL • SBC231_EN_V3.0_09-2022_IFU_CE-MDR 20
*The availability of the function depends on the device.
6.3 Equipment list
Once the SCB has been started, the list of connected devices appears. Various frame colors and font
colors as well as symbols indicate the respective device status.
Font color Meaning
White The device is switched on and ready for use.
Gray The device cannot be operated in the current status.
Orange The device is displayed in the device window.
Symbol Meaning
Normal
The device is switched on and ready for use.
Standby
The device is in Standby mode.
Pumps and insufflators: The pumps are switched off.
Light sources: The emission of light is interrupted.
Out of operation
The device is not ready for use.