Storz OR1 SmartScreen User manual

Instructions for use
OR1 SmartScreen
WM200
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.
04-2021

Table of contents
Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR 3
Table of contents
1 General information.......................................................................................................................................4
1.1 Read the instructions for use....................................................................................................................4
1.2 Read the instructions for use of combinable products.............................................................................4
1.3 Scope........................................................................................................................................................4
1.4 Description of warning messages.............................................................................................................4
2 Normal use....................................................................................................................................................5
2.1 Intended use .............................................................................................................................................5
2.2 Indications.................................................................................................................................................5
2.3 Contraindications......................................................................................................................................5
2.4 Target user populations ............................................................................................................................5
2.5 Patient groups...........................................................................................................................................5
3 Safety............................................................................................................................................................6
3.1 Serious incidents ......................................................................................................................................6
3.2 Damaged products ...................................................................................................................................6
3.3 Unsterile product ......................................................................................................................................6
3.4 Contaminated products ............................................................................................................................6
3.5 Risks from electric current........................................................................................................................6
3.6 Damage due to ingress of liquid in electrical components.......................................................................7
3.7 Electromagnetic interference....................................................................................................................7
3.8 Combination with other components .......................................................................................................7
4 Product description ......................................................................................................................................9
4.1 Product overview ......................................................................................................................................9
4.2 Possible combinations..............................................................................................................................9
4.3 Technical data.........................................................................................................................................10
4.4 Symbols employed .................................................................................................................................11
4.4.1 Symbols on the packaging .......................................................................................................... 11
4.4.2 Symbols on the type plate........................................................................................................... 12
4.5 Ambient conditions .................................................................................................................................12
5 Preparation..................................................................................................................................................13
5.1 Unpacking the product ...........................................................................................................................13
5.2 Inspecting the device..............................................................................................................................13
5.3 Setting up the product............................................................................................................................13
5.4 Connecting the product..........................................................................................................................13
5.5 Connecting the product to AIDA.............................................................................................................14
5.6 Putting the product into operation..........................................................................................................15
6 Maintenance, servicing, repairs, and disposal............................................................................................16
6.1 Maintaining the product..........................................................................................................................16
6.2 Maintenance ...........................................................................................................................................16
6.3 Repairing the product .............................................................................................................................16
6.4 Disposing of the product ........................................................................................................................16
7 Accessories and spare parts ......................................................................................................................17
7.1 Accessories.............................................................................................................................................17
8 Electromagnetic compatibility.....................................................................................................................18
8.1 General notes on the operating environment .........................................................................................18
8.2 Accessories and cables ..........................................................................................................................18
8.3 Table 1 – Compliance level for immunity tests .......................................................................................18
8.4 Table 2 – Test levels for proximity fields from HF wireless communications equipment .......................20
8.5 Table 3 – Test levels for radiated and conducted immunity tests ..........................................................20
8.6 Table 4 – Emission class and group .......................................................................................................22
9 Subsidiaries.................................................................................................................................................23

General information
Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR 4
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.
Keep the instructions for use clearly visible next to the product.
1.2 Read the instructions for use of combinable products
If the instructions for use of combinable 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 combinable products carefully and follow all the safety
notes and warnings.
1.3 Scope
This instruction manual is valid for:
Product name Item number
SmartScreen WM200
1.4 Description of warning messages
To prevent any injury to persons or damage to property, the warnings and safety notes in the
instructions for use must be observed. The warning messages describe the following levels of
danger.
WARNING
WARNING
Designates a possible imminent risk. If this is not avoided, it could lead to death or serious
injuries.
CAUTION
CAUTION
Designates a possible imminent risk. If this is not avoided, it could lead to minor injuries.
NOTICE
ATTENTION
Designates a possibly harmful situation. If this is not avoided, the products could be damaged.

Normal use
Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR 5
2 Normal use
2.1 Intended use
The KARLSTORZ SMARTSCREEN is designed for use by qualified personnel in practices and
operating rooms. The SMARTSCREEN is used for controlling the allocated, compatible
KARLSTORZ medical devices (such as the KARLSTORZ AIDA® WD300) from within an
unsterile area and should be positioned under the compatible KARLSTORZ equipment.
The combination of the two medical devices enables a non-sterile user to view and
preoperatively use the connected medical device within the medical area. Data and images are
shown on the FULL HD display of the SMARTSCREEN and can be processed using the 10-
finger multi-touchscreen. For other important and fundamental information on safe use of the
medical device, the user must pay attention to the software description and the instructions for
use for the compatible KARLSTORZ equipment.
2.2 Indications
Display of video signals between signal sources and signal destinations in the case of medical
procedures. Control inputs for controlling connected devices.
2.3 Contraindications
None
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
Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR 6
3 Safety
3.1 Serious incidents
According to the Medical Device Regulation (MDR), a “serious incident” includes incidents that
directly or indirectly had, could have had, or could have any of the following consequences
(MDR, Art.2, No.65[1]):
– Death of a patient, user, or another person
– Temporary or permanent serious deterioration in the medical condition of a patient, user,
or another person
– A serious threat to public health
The manufacturer and appropriate authority must be notified of all serious incidents.
3.2 Damaged products
Damaged products can result in injury to patients, users, or third parties.
Before each use, check all components of the product for damage.
Do not use damaged products.
3.3 Unsterile product
The product is not sterile when delivered. The use of non-sterile products poses a risk of
infection for patients, users, and third parties.
Reprocess the product in line with the reprocessing instructions before initial use and
every subsequent use.
3.4 Contaminated products
Contaminated products pose a risk of infection for users, patients, and third parties.
Comply with national laws and regulations.
Observe the guidelines of the Employer’s Liability Insurance Association and equivalent
organizations.
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 operating room in which the product is connected and
used must meet the applicable IEC standards. Input and output equipment 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.

Safety
Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR 7
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 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 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 chapter Electromagnetic
compatibility [p.18].
To prevent increased electromagnetic emissions or reduced electromagnetic immunity of
the product, only use accessories, transducers, and cables recommended or supplied by
the manufacturer.
The use of accessories and cables other than those specified in the instructions for use may
result in increased emissions or decreased immunity of the product. When using other
accessories and cables, the operator is responsible for checking compliance with
IEC60601-1-2 for this particular product.
To prevent increased electromagnetic emissions or reduced electromagnetic immunity of
the product, only use accessories, transducers, and cables recommended or supplied by
the manufacturer.
3.8 Combination with other components
The use of unauthorized devices and components or unauthorized changes to the product can
result in injuries.

Safety
Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR 8
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 (see Clause 16 of IEC 60601-1).
Only combine the product with devices and components that are approved for joint use by
the manufacturer.
The product should not be used immediately adjacent to or stacked with other equipment.
If adjacent or stacked use is necessary, the product should be observed to verify normal
operation in the configuration in which it will be used.
Comply with national and local regulations.
Only make changes to the product if these changes are approved by KARLSTORZ.

Product description
Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR 9
4 Product description
4.1 Product overview
Front
12345
Rear
1 Potential equalization connection 4 12V direct current input socket
2 DisplayPort video output sockets 5 Transport lock
3 USB-B port
4.2 Possible combinations
It is recommended that the suitability of the products for the planned 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 product can be combined with the following components:
Product name Item number
Cable set WO10042
Power supply unit WM20001
DisplayPort cable WA1000C
USB-A to USB-B cable 20090179

Product description
Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR 10
4.3 Technical data
Description Value
Display
Colors 16.7million colors (8bits)
Response time (Tr + Tf) 25–35ms
Life span At least 12,000 operating hours
Panel AHVA
Backlight type LED
Visible diagonal 21.5“
Brightness 300cd/m2
Native resolution 1,920x1,080pixels
Pixel pitch 0.144x0.144mm
Viewing angle Horizontal 170° / vertical 170°
Contrast ratio, nominal 700:1
Power supply
Average energy consumption <6W
Maximum energy consumption <8W
Input voltage (DC) 12V
Inputs
Video input DisplayPort1.2
Power connection 8-pin connection
Touch signal input USB-B2.0
Other Potential equalization connection (POAG)
Touchscreen
Technology PCAP
Driver No installation required in Windows
Support Windows
Linux kernel 3.x.x and 4.x.x
Number of points of contact Max.10
General
Dimensions (LxWxH) 305x355x46mm
Weight 6.6kg

Product description
Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR 11
4.4 Symbols employed
4.4.1 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
Federal (USA) law restricts this device to sale by or on the order of a
physician.
CE marking
With this mark, the manufacturer declares the compliance of the devices
with the applicable standards and directives
The device must not be modified in any way

Product description
Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR 12
4.4.2 Symbols on the type plate
Symbol Meaning
Manufacturer
Date of manufacture
Medical device
Serial number
Prevention of pollution by electronic devices
Separate collection of electrical and electronic devices.
Do not dispose of in household refuse.
TÜV SÜD
CE conformity mark
With this mark, the manufacturer declares the compliance of the prod-
ucts with the applicable regulation (EU) 2017/745. A code number after
the CE mark indicates the responsible notified body.
4.5 Ambient conditions
Storage/transport conditions
Ambient temperature -20°C...+60°C
Relative humidity Max.90%
Operating conditions
Ambient temperature 0°C...50°C
Relative humidity Max.80%

Preparation
Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR 13
5 Preparation
5.1 Unpacking the product
1. Carefully remove the product and accessories from the packaging.
2. Check the delivery for missing items and evidence of shipping damage.
3. In the case of damage, hidden defects, and short deliveries, document their nature and
extent and contact the manufacturer or supplier immediately.
5.2 Inspecting the device
1. Inspect the device for visible contamination. Do not use if contaminated.
2. Inspect the device for the following characteristics:
– Good working order
– Functionality
– Correct assembly of the components
– Completeness
5.3 Setting up the product
This product and connected components may only be used in medical rooms with electrical
installations that conform to applicable national regulations.
1. Set the product on a horizontal, flat surface. Make sure that the power cord can be
unplugged at any time.
2. Install the product out of reach of patients.
3. Ensure adequate air circulation.
5.4 Connecting the product
1. Connect the DisplayPort cable to the video output socket.
2. Connect the USB cable to the USB-B port.
3. Connect the power cord to the direct current input socket.

Preparation
Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR 14
5.5 Connecting the product to AIDA
1. Connect the DisplayPort cable to the video output socket.
2. Connect the other end of the DisplayPort cable to the AIDA (WD300) video output socket.
3. Connect the USB cable to the USB-B port.
4. Connect the other end of the USB cable to the AIDA (WD300) USB-A port.
5. Connect the AIDA (WD300) serial interface to the direct current input socket using the
RS232 to DC connector.

Preparation
Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR 15
5.6 Putting the product into operation
1. Press gently on the front panel of the monitor and turn the screw lock at the rear of the
product counterclockwise.
2. Press in the monitor front panel to release the monitor guide.
3. Pull out the monitor.
4. Move the monitor into the required position.
Image signals that do not originate from a KARLSTORZ device may only be used for
information purposes.

Maintenance, servicing, repairs, and disposal
Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR 16
6 Maintenance, servicing, repairs, and disposal
6.1 Maintaining the product
If they are not described in more detail here, maintenance activities may only be performed by
KARLSTORZ or by a company authorized by KARLSTORZ.
6.2 Maintenance
The following maintenance intervals are recommended:
Interval Activity To be performed by
annually Safety test KARLSTORZ service techni-
cians
6.3 Repairing the product
Repair work may only be performed by KARLSTORZ or by a company authorized by
KARLSTORZ. The interventions described in this instruction manual are exempt from this rule.
Please contact your local KARLSTORZ subsidiary or authorized dealer (see the list of
subsidiaries).
Contaminated devices may not be shipped. To prevent contact infections and airborne
infections, products must first be decontaminated. KARLSTORZ reserves the right to send
back contaminated products.
6.4 Disposing of the product
The product meets the requirements of the Directive on Waste Electrical and Electronic
Equipment (WEEE).
Within the scope of application of this directive, KARLSTORZSE&Co.KG is responsible for
the proper disposal of this product.
1. The product must be disposed of in accordance with the applicable national laws and
regulations at a suitable collection point for the reprocessing of electrical and electronic
equipment.
2. Contact KARLSTORZSE&Co.KG, a KARLSTORZ branch or an authorized dealer to
find out the address of the collection point in your area.

Accessories and spare parts
Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR 17
7 Accessories and spare parts
7.1 Accessories
Item Order no.
Power supply unit WM20001
KARLSTORZ OR1 FUSION CONTROL, 19” WO200-02

Electromagnetic compatibility
Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR 18
8 Electromagnetic compatibility
8.1 General notes on the operating environment
The product is suitable for use in professional healthcare settings. Professional healthcare
facilities include physician offices, dental offices, limited care facilities, freestanding surgical
centers, freestanding birth centers, multiple treatment facilities, hospitals (emergency rooms,
patient rooms, intensive care, surgical rooms, outside the HF-shielded room of an ME system
for MRT).
The emission characteristics of this product make it suitable for use in industrial areas as
well as in hospitals (CISPR 11 Class A) and other professional healthcare environments.
If it is used in a residential environment (for which CISPR 11 Class B is normally
required), the product may not offer sufficient protection for radio transmission operation.
The user might need to take mitigation measures, such as relocating or re-orienting the
product.
8.2 Accessories and cables
Accessories and cables for EMC compliance
Type Shield Length [m] Ferrite Use
External adaptor Yes 1.9 ??? Power supply
USB cable Yes 0.2 ??? USB connection
DisplayPort ca-
ble
Yes 0.2 ??? DisplayPort con-
nection
Power supply
unit
Yes 0.2 ??? Power supply
8.3 Table 1 – Compliance level for immunity tests
Guidelines and manufacturer’s declaration– electromagnetic immunity
The product is intended for use in the electromagnetic environment specified below. The user
of the product should make sure that it is used in such an environment.

Electromagnetic compatibility
Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR 19
Immunity tests EN/IEC60601 test
level
Compliance level Electromagnetic envi-
ronment – guidelines
Electrostatic dis-
charge (ESD) acc.
to IEC61000-4-2
±8kV contact dis-
charge
±15kV air discharge
±8kV contact dis-
charge
±15kV air discharge
Floors should be made
of wood, concrete, or
covered with ceramic
tiles. If floors are cov-
ered with synthetic ma-
terial, the relative hu-
midity must be at least
30%.
Electrical fast
transients/bursts
acc. to IEC
61000-4-4
±2kV ±2kV The power supply qual-
ity should be that of a
typical commercial or
hospital environment.
Surges acc. to
IEC 61000-4-5
±1kV voltage outer
conductor – outer con-
ductor
±2kV voltage outer
conductor – ground
±1kV voltage outer
conductor – outer con-
ductor
±2kV voltage outer
conductor – ground
The power supply qual-
ity should be that of a
typical commercial or
hospital environment.
Voltage dips,
short interrup-
tions, and voltage
variations acc. to
IEC61000-4-11
<5% UT*
(>95% dip in UT) for
1/2cycle
<5% UT*
(>95% dip in UT) for
1cycle
70% UT (30% dip in
UT)
for 25/30cycles
<5% UT
(>95% dip in UT) for
250/300cycles
<5% UT*
(>95% dip in UT) for
1/2cycle
<5% UT*
(>95% dip in UT) for
1cycle
70% UT (30% dip in
UT)
for 25/30cycles
<5% UT
(>95% dip in UT) for
250/300cycles
The power supply qual-
ity should be that of a
typical commercial or
hospital environment. If
the user of the product
requires continued op-
eration in the event of
interruptions to the
power supply network,
it is recommended that
the product be oper-
ated with an uninter-
ruptible power supply
or a battery.
Magnetic field at
the power fre-
quency (50/60Hz)
acc. to IEC
61000-4-8
30A/m 30A/m Magnetic fields at the
supply frequency
should correspond to
the values typically
found in commercial
and hospital environ-
ments.
*UT is the mains alternating voltage before applying the test levels.

Electromagnetic compatibility
Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR 20
8.4 Table 2 – Test levels for proximity fields from HF
wireless communications equipment
Test fre-
quency
MHz
Frequency
band
MHz
Radio service Modulation Immunity
test level
V/m
Compliance
level
V/m
385 380 – 390 TETRA 400 Pulse modula-
tion 18Hz
27 27
450 430 – 470 GMRS 460,
FRS 460
FM ±5kHz
deviation
1kHz sine
wave
28 28
710 704 – 787 LTE band 13 &
17
Pulse modula-
tion
217Hz
9 9
745
780
810 800 – 960 GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE band 5
Pulse modula-
tion
18Hz
28 28
870
930
1,720 1,700 – 1,990 GSM 1800,
CDMA 1900,
GSM 1900,
DECT,
LTE band 1, 3,
4, 25,
UMTS
Pulse modula-
tion
217Hz
28 28
1,845
1,970
2,450 2,400 – 2,570 Bluetooth,
WLAN 802.11
b/g/n,
RFID 2450,
LTE band 7
Pulse modula-
tion
217Hz
28 28
5,240 5,100 – 5,800 WLAN 802.11
a/n
Pulse modula-
tion
217Hz
9 9
5,500
5,785
8.5 Table 3 – Test levels for radiated and conducted
immunity tests
Guidelines and manufacturer’s declaration– electromagnetic immunity
The product is intended for use in the electromagnetic environment specified below. The user
of the product should make sure that it is used in such an environment.
Immunity tests EN/IEC60601 test
level
Compliance
level
Electromagnetic envi-
ronment – guidelines
Conducted RF distur-
bances acc. to IEC
61000-4-6
3Vrms
150kHz to 80MHz
3Vrms Portable and mobile HF
communications equip-
ment should be used no
closer to any part of the