Instruction For Use

OR1™. avm
WO301
 Table of contents

Table of contents
1 General information............................................................................................................................................  5
1.1 Important information ..................................................................................................................................... 5
1.2 Other applicable documents........................................................................................................................... 5
1.3 Guarantee ....................................................................................................................................................... 5
1.4 Typographical conventions............................................................................................................................. 5
1.4.1 General signs and symbols .................................................................................................................  5
1.4.2 Hazard levels .......................................................................................................................................  5
1.5 Abbreviations .................................................................................................................................................. 6
1.6 Contact details................................................................................................................................................ 6
2 Safety .................................................................................................................................................................  7
2.1 Proper use....................................................................................................................................................... 7
2.2 Contraindications............................................................................................................................................ 7
2.3 Target group ................................................................................................................................................... 7
2.4 General safety instructions ............................................................................................................................. 7
2.4.1 Risk of infection ...................................................................................................................................  7
2.4.2 Potentially explosive atmosphere ........................................................................................................  7
2.4.3 Electricity supply..................................................................................................................................  8
2.4.4 Site.......................................................................................................................................................  8
2.4.5 Technical state.....................................................................................................................................  8
2.4.6 Liquid ingress ......................................................................................................................................  9
2.4.7 Combination with other devices and accessories...............................................................................  9
2.4.8 Qualification of the user.......................................................................................................................  9
2.4.9 Maintenance and repair .......................................................................................................................  9
2.4.10 Electromagnetic compatibility ...........................................................................................................  10
2.4.11 Data transfer ......................................................................................................................................  10
2.5 Standards and directives .............................................................................................................................. 10
3 Device description ...........................................................................................................................................  11
3.1 Functions ...................................................................................................................................................... 11
3.2 Product overview .......................................................................................................................................... 11
3.2.1 Front of device...................................................................................................................................  11
3.2.2 Back panel .........................................................................................................................................  12
3.3 Device identification...................................................................................................................................... 12
3.3.1 Shipping label ....................................................................................................................................  12
3.3.2 Product identification number ...........................................................................................................  13
3.3.3 Name plate ........................................................................................................................................  13
3.3.4 Symbols for product identification ....................................................................................................  13
3.4 Scope of supply ............................................................................................................................................ 14
3.5 Technical specifications................................................................................................................................ 15
4 Transport..........................................................................................................................................................  17
5 Operation .........................................................................................................................................................  18
5.1 Starting the Program..................................................................................................................................... 18
5.2 User interface................................................................................................................................................ 19
5.2.1 User interface symbols ......................................................................................................................  20
5.3 Streaming Videos.......................................................................................................................................... 21
5.4 Stopping video transmission in the OP ........................................................................................................ 22
5.5 Capturing videos........................................................................................................................................... 22
5.6 Creating image compositions ....................................................................................................................... 23
5.7 Selecting access status ................................................................................................................................ 25
5.8 Streaming videos .......................................................................................................................................... 26
5.9 Invite participant ........................................................................................................................................... 27
5.9.1 Access with URL and password........................................................................................................  27
5.9.2 Access via email ................................................................................................................................  27
5.10 Commenting on videos................................................................................................................................. 28
5.11 Setting playback volume............................................................................................................................... 28

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 Table of contents

5.12 Adjusting microphone ................................................................................................................................... 29

6 Service, repair, and disposal............................................................................................................................  30
6.1 Changing a fuse ............................................................................................................................................ 30
6.2 Manual wipe disinfection .............................................................................................................................. 30
6.3 Servicing and repair ...................................................................................................................................... 31
6.4 Repair program ............................................................................................................................................. 31
6.5 Disposal ........................................................................................................................................................ 31
7 Appendices ......................................................................................................................................................  32
7.1 Electromagnetic compatibility (EMC)............................................................................................................ 32
7.1.1 Table 200 ...........................................................................................................................................  32
7.1.2 Table 201 ...........................................................................................................................................  33
7.1.3 Table 202 ...........................................................................................................................................  33
7.1.4 Table 203 ...........................................................................................................................................  34
7.1.5 Table 204 ...........................................................................................................................................  35
7.1.6 Table 206 ...........................................................................................................................................  36
7.2 Regulatory information on telecommunications ........................................................................................... 37
7.2.1 USA....................................................................................................................................................  37
7.2.2 Canada ..............................................................................................................................................  37
7.2.3 European Union .................................................................................................................................  37

Instruction For Use • OR1™. avm • BA • 96296660EN 4

 General information

1 General information
1.1 Important information
Thank you for your expression of confidence in the name KARL STORZ. Like all of our products,
this product too is the result of years of experience and careful manufacturing. You and your
organization have decided in favor of a system based on modern, high-quality software as well as
hardware from KARL STORZ.
These instructions for use provide basic understanding of the functions of the OR1™. avm and
must be read carefully before operating the device. Special attention should be given to the safety
instructions and warning notices.

1.2 Other applicable documents

The following documents are a part of the product and must be observed:
– AIDA® Instructions for use

1.3 Guarantee
For information concerning the guarantees provided, please see the Standard Conditions of
Business of KARL STORZ. The medical device must always be sent to your local subsidiary, even
during the warranty period.
Opening the equipment or performing any repairs or modifications to the components of the
device by unauthorized persons shall relieve KARL STORZ of any liability for the operational safety
of the device. Any such opening, repair, or modification performed during the warranty period shall
void all warranty.

1.4 Typographical conventions

Signs and symbols used in the instructions for use are described below.

1.4.1 General signs and symbols

The signs and symbols used in the instructions for use identify the following:
ü Prerequisite that must be met before carrying out an action.
4 An action to be carried out
1. Step 1 of an action to be carried out by several steps.
2. Step 2
ð Interim result of an action
ð Result of a complete action
1. Numbered list
– Unnumbered list, 1st level
– Unnumbered list, 2nd level
This sign refers to useful and important information.

1.4.2 Hazard levels

To prevent any injury to persons or damage to property, the warnings and safety instructions in
the instructions for use must be observed. The warnings are marked as follows.
WARNING
WARNING
Designates a possible imminent risk. If this is not avoided, it could lead to death or serious injuries.

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 General information

CAUTION
CAUTION
Designates a possible imminent risk. If this is not avoided, it could lead to minor injuries.

  ATTENTION  
ATTENTION
Designates a possibly harmful situation. If this is not avoided, the devices could be damaged.

1.5 Abbreviations
Abbreviation Meaning
EMC Electromagnetic compatibility
GTIN Global item number
OR Operating room
PiP Picture in Picture
PaP Picture and Picture
UDI Product identification number

1.6 Contact details

Manufacturer
KARL STORZ SE & Co. KG
Dr.-Karl-Storz-Straße 34
Postfach 230
78503 Tuttlingen
Germany
Tel.: +49 7461 708-0
Fax: +49 7461 708-105
E-mail: info@karlstorz.com
Internet: www.karlstorz.com

Repair service
KARL STORZ SE & Co. KG
Abt. Reparaturservice
Take-off Gewerbepark 83
78579 Neuhausen
Service hotline: +49 7461-708 980
E-mail: technicalsupport@karlstorz.com

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 Safety

2 Safety
The instructions for use are an integral part of the device and must be read carefully before use as
well as be available at all times.
The device may only be used for the intended purpose. Misuse of any kind is not allowed.

2.1 Proper use

OR1™. avm is a system for controlling the distribution of video data from integrated signal sources
to signal targets within the operating room with an integrated teleconference function.

2.2 Contraindications
Use is contraindicated if, in the opinion of the attending physician, the device is not compatible
with successful completion of the planned intervention due to its technical design.

2.3 Target group

The instructions for use are intended for medical staff, particularly for nursing staff in the OP.

2.4 General safety instructions

2.4.1 Risk of infection
Patents, users or third parties can be infected by contaminated medical devices.
4 Country specific national laws and regulations must be observed.
4 Observe the guidelines of the Employer's Liability Insurance Association and equivalent
organizations.
4 Follow the manual for "Cleaning, disinfection, care and sterilization of KARL STORZ
instruments" and the accompanying documentation, see www.karlstorz.com.
4 Observe the instructions for use of the components.
4 Take suitable personal protection measures.
4 Clean as required before putting into service for the first time and after each application of the
product and accessories.
4 Perform cleaning as described in the instructions for use. The procedure was validated by the
manufacturer.
4 In the case of any varying procedure, ensure the effectiveness of the cleaning.
4 In the case of any varying procedure, exclude any possible harmful consequences.

2.4.2 Potentially explosive atmosphere

Electrical sparks in the product can result in explosions or fire.
4 Do not operate the product in the demarcated hazard zone when highly inflammable inhalation
anesthetics and their mixtures are used.
4 Do not operate the product in explosive atmospheres.
4 Do not operate the product in an oxygen-enriched environment.
4 Do not operate the product in environments with combustible gases.
4 Connect or disconnect the power plug to or from the power supply only outside of explosion
hazard areas.

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 Safety

2.4.3 Electricity supply

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 operated
must meet the applicable IEC standards. Input and output devices connected to the OR1™. avm
must comply with IEC 60601-1.
4 Only operate the product with the power cord supplied by KARL STORZ or a similar power
cord with the national test seal.
4 Have the device installed and put into service by authorized and trained electricians of KARL
STORZ SE & Co. KG or by an authorized distributor.
4 Do not use any additional multiple socket outlets or extension cables.
4 To ensure reliable protective earth grounding, connect the product to a properly installed
socket that is approved for use in the operating room; see figure Back panel [} 12].
4 Carry out potential equalization according to the applicable national rules and regulations.
4 Only use fuses of the correct rating and replace any defective fuses immediately.
4 Connect the power cord only to grounded safety power sockets that meet the respective
national rules and regulations.
4 Do not touch device output sockets and patients at the same time.
4 Only operate the product at the line voltage stated on the manufacturer's nameplate; see
Name plate [} 13].
4 Have a replacement cable ready in case of failures and defects.
4 Position the product appropriately so that the power cord can be unplugged at any time.
The product can only be disconnected from the power supply when the power cord is
unplugged.

2.4.4 Site
Insufficient ventilation can cause an internal build-up of heat, resulting in a safety shut-down.
4 Keep the product out of reach of patients.
4 The product should be placed on a flat surface or in a video cart.
4 Keep air inlets and outlets free.
4 Ensure that there is sufficient air circulation.
4 Observe the defined environmental conditions for operation; see Technical specifications
[} 15].

2.4.5 Technical state

A damaged product can injure patients, users, or third parties. A damaged power cord or missing
protective conductor may cause an electric shock.
4 Check the routing function after installation of the product. Make sure that the designation of
the sources and targets is correct. Check to make sure that all possible connections are
functional.
4 Make sure that the device is safe and operating properly before every use.
4 Only operate the product if it has no external damage.
4 Never operate the product if the touchscreen or the control elements are defective.
4 Inspect the power cord before use.
4 Have parts with breakage or surface changes tested by an authorized person.
4 In the event of sudden failures, have a replacement device ready or use alternative
technologies.
4 Have a safety inspection performed by an authorized person.
4 In the event of malfunctions, stop working and commission an employee of KARL STORZ to
carry out the repair.

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 Safety

2.4.6 Liquid ingress

Using the product in humid or electrically conductive environments can cause an electric shock
and injure the patient, user, and third parties.
4 Only use the product in a dry environment.
4 Only use the product in an environment that is not electrically conductive.
4 Protect the product against ingress by liquids.
4 If you detect any liquid on the power cord, immediately unplug the product from the power
supply and do not touch it.
4 Make sure that the product surface is completely dry before you reinsert the power cord.
4 After maintenance work, interventions, and repairs on the product and before putting it back
into service, have an authorized person carry out a safety inspection of the product.

2.4.7 Combination with other devices and accessories

The use of unauthorized devices and accessories or unauthorized changes to the product can
result in injuries.
Additional devices connected to electrical medical equipment must comply with the relevant IEC
or ISO standards (e.g. IEC 60950 for data processing equipment). Furthermore, all configurations
must comply with the requirements for medical electrical systems (see IEC 60601-1-1 or clause 16
of the 3rd edition of IEC 60601-1).
4 Only use the product in combination with AIDA®, software version 1.5.1.
4 Only use the product with accessories that have been approved by the manufacturer for
combination with the product and meet the standard requirements for medical electrical
systems.
4 Only use devices and accessories that have standardized interfaces and do not breach the
intended use of the product.
4 Only use devices with display capability that are identified as "display".
4 Observe the instruction manuals and interface specifications of other devices and
accessories.
4 Comply with national and local regulations.
4 Only make changes to the product if these changes are approved by KARL STORZ.

2.4.8 Qualification of the user

The KARL STORZ OR1™. avm may only be operated by qualified staff who have a corresponding
specialized qualification and who have been instructed in the use of the system. Use of the device
by untrained staff can injure the patient, user, and third parties.
4 Make sure that the user has read and understood the instructions for use.
4 Comply with national and local regulations.

2.4.9 Maintenance and repair

Repair, maintenance and safety inspections may only be carried out by authorized and trained
persons.
4 Always unplug the device from the mains supply before maintenance work.
4 Have maintenance services and audit tasks performed in accordance with the German
Medical Device Operator Ordinance.
4 Have a safety inspection of the device performed by an authorized person after maintenance
work, interventions and repairs to the device and before putting back into service.
4 Check the functions and configuration of the device after every software update.
4 Have safety inspections performed and recorded by an electrician at least once a year in
accordance with IEC 62353.

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 Safety

2.4.10 Electromagnetic compatibility

WARNING
Risk of injury from high-frequency communication equipment!
High-frequency communication equipment can affect electrical medical equipment and impair the
performance of the device. This may lead to injury of the patient, user, and third parties.
Place the product and its components, such as the cables used, at a distance of at least 30
cm from high-frequency communication equipment.
Position portable high-frequency communication devices and their peripheral devices, e.g.,
antenna cables and external antennae, spaced at a distance of at least 30 cm from the device
and its components, including the cables specified by the manufacturer.

  ATTENTION  
Damage due to electromagnetic waves!
Based on its emission properties, the product is suitable for use in industrial areas, hospitals, and
other professional healthcare facilities (CISPR 11 class A). If the product is used in a residential
environment for which CISPR 11 Class B is usually required, the product may not provide
adequate protection for high-frequency communication services.
Undertake mitigating actions, such as repositioning or realigning the product.

Medical electrical devices are subject to special precautions regarding electromagnetic

compatibility and must be installed and commissioned according to the tables on electromagnetic
compatibility; see Electromagnetic compatibility (EMC) [} 32].
4 During installation and when putting into service, consult the electromagnetic compatibility
tables.
4 Avoid integrating other devices into the system; otherwise check for fault-free operation.
4 Do not stack the product directly next to or on other equipment. Otherwise, monitor the
system to ensure normal operation in line with the intended use.
4 To prevent increased electromagnetic emissions or reduced electromagnetic immunity of the
product, only use accessories, transducers, and cables recommended or supplied by the
manufacturer.

2.4.11 Data transfer

If incompatible signal types are connected to the video connections of the OR1™. avm, image
errors and malfunctions may occur. Sudden system shutdown leads to data loss.
4 Only connect the specified signal types and test the system before use.
4 Take measures that prevent any sudden system shutdown.

2.5 Standards and directives

During development and validation of the product, the following standards were applied and
observed:

IEC 60601-1 3.1rd Medical electrical equipment

th
IEC 60601-1-2: 2015, 4 edition Medical electrical equipment
CAN/CSA C22.2 No. 60601-1 Medical electrical equipment
ANSI/AAMI ES60601-1 Medical electrical equipment
MDD 93/42/EEC Medical Devices Directive
GDPR 2016/679 General Data Protection Regulation
RED 2014/53/EU Radio Equipment Directive
The device has been tested for its compatibility with high-frequency surgical devices in
accordance with IEC 60601-2-2 Appendix BB.

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 Device description

3 Device description
3.1 Functions
The OR1™. avm allows up to 8 image sources and image targets to be selected for transmission
within the OP. Furthermore, "Picture in Picture“ (PiP) as well as "Picture and Picture" (PaP)
displays are possible. Streaming allows videos to be transmitted externally, audio comments to be
sent bidirectionally and videos to be commented visually. The drawings in the OP are only
displayed in the preview and disappear after approx. 10 seconds.
Streaming is an optional function and is set during installation of the OR1™. avm, see
installation instructions.

3.2 Product overview

3.2.1 Front of device

1 2 3 4

1 Switch for standby and ON status 3 LED, green, ON status

2 LED, orange, standby 4 USB port

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 Device description

3.2.2 Back panel

1 2

10 9 8 7 6 5 4 3

1 Video outputs 6 ACC connections

2 Video inputs 7 LAN connections
3 Audio In 8 DP connections
4 Audio Out 9 Potential Equalization Conductor
5 USB ports This symbol appears next to the
Potential Equalization Conductor on
the device
10 AC Input Receptacle and Fuse

3.3 Device identification

3.3.1 Shipping label
2

3
1

1 Catalog number 4 Symbols

2 Manufacturer 5 Product identification number (unique
device identification, UDI)
3 Serial number

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 Device description

3.3.2 Product identification number

The product identification number (unique device identification, UDI) is used for uniform
identification of medical devices throughout the world.

1
2
3

1 Global item number (GTIN) 3 Item number

2 Serial number

3.3.3 Name plate

The nameplate is situated on the underside of the device.

1
3

1 Information for operation 3 Symbols

2 Manufacturer 4 Serial number

3.3.4 Symbols for product identification

Symbol Meaning
Follow the instructions for use

Manufacturer

Serial number

Item number

Number of products in the product packaging

Date of manufacture

FCC label

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 Device description

Symbol Meaning
Non-ionizing radiation
The IC identification code refers to the internal Wi-Fi adaptor

Separate collection of electrical and electronic devices.

Do not dispose of in household refuse.

Test mark for electromagnetic compatibility

Prevention of pollution by electronic devices

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
Consult the instructions for use

Keep dry

Fragile, handle with care

US Federal law (21 CFR 801.109) restricts this device to sale to or on the
order of a licensed physician

3.4 Scope of supply

The scope of supply of the OR1™. avm comprises the following:
– OR1™. avm system (WO 301)
– OR1 connecting cable HDMI high-speed 0.5 m (WO10198)
– CABLE, FTP PATCH CABLE ASSEMBLED, CAT. 5E, 0 (4800163)
– CONNECTING CABLE 2.5 m (4802051)

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 Device description

3.5 Technical specifications

Interfaces
Video inputs 5x 12G SDI
3x HDMI 2.0
Video outputs 6x 12G SDI
2x HDMI 2.0
USB 4x USB 3.0
1x USB 2.0
LAN 2x Ethernet
AUDIO 1x Audio in
1x Audio out
Remote control 2x ACC
Table 1: Interfaces

Power supply
Input voltage 100 – 240 V AC
Input frequency 50 – 60 Hz
Max. input current 2.5 A (@100 V AC), 1 A (@ 240 V AC)
Operating mode Continuous
Table 2: Power supply

Housing
Degree of protection IPx0
Protection class I
Dimensions 305 x 74.5 x 355 mm (W x H x D)
Weight 4 kg
Table 3: Housing

Ambient conditions
Transport and storage Temperature: -10 °C – 60 °C
Humidity: 10 % ... 90%, non-condensing
Max. altitude above sea level: 10,000 m
Operation Temperature: 0 °C – 40 °C
Humidity: 10 % ... 90% non-condensing
Max. altitude above sea level: 3000 m
Table 4: Ambient conditions

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 Device description

Radiofrequency transmission
Frequency bands in 2.4 GHz and 5 GHz bands
operation
Operating frequency 2400 – 2485 MHz
5150 – 5250 MHz
5250 – 5350 MHz
5470 – 5725 MHz
5725 – 5875 MHz
Channel spacing/band 2.4 GHz: 802.11 b/g/n: 5MHz / BT: 1MHz
width 5 GHz: 802.11 a/n/ac: 20, 40, 80, 160 MHz
Radiofrequency output 20 dBm (2400 – 2485 MHz) IEEE 802.11 b/g/n & BT
energy 10 dBm (2400 – 2485 MHz) BLE
23 dBm (5150 – 5725 MHz) IEEE 802.11 a/n/ac
13.98 dBm (5725 – 5875 MHz) IEEE 802.11 a/n/ac
Type of modulation 2.4 GHz: DSSS/OFDM/FHSS
5 GHz: OFDM
Table 5: Radiofrequency transmission

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 Transport

4 Transport
The products from KARL STORZ are optimally protected against damage in transit by appropriate
packaging. KARL STORZ reserves the right to make partial shipments on any order. Invoices for
partial shipments are payable upon receipt. KARL STORZ is not liable for any damages caused by
or attributable to delays and/or non-delivery.
1. Carefully check delivery upon arrival.
2. In the case of damage, hidden defects and short deliveries, document their nature and extent
and contact KARL STORZ Tuttlingen immediately.
3. Keep packaging for any possible returns.

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 Operation

5 Operation
5.1 Starting the Program
The OR1™ .avm is used in combination with the AIDA® system and can be started from the start
screen of the AIDA® system or from the Workflow bar.
When the AIDA® system is switched off, the OR1™. avm automatically shuts down, and
routed video signals are switched off.

1. Switch on the OR1™ .avm.

ð The start screen of the AIDA® system appears.

2. In the Control area, select the Routing view. If Routing is gray, the OR1™. avm is not available.

ð The user interface of the OR1™ .avm appears.

3. If any other screen appears, tap on the Routing button in the Workflow bar.

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 Operation

ð The user interface of the OR1™ .avm appears.

5.2 User interface

The user interface of the OR1™. avm is subdivided into the following areas:
4

1 5

1 Sources 4 Preview
2 Image composition 5 Destinations
3 Streaming

Sources
Up to 8 image sources can be connected to the OR1™. avm. Only connected devices appear as
sources in the user interface.
The following devices, for example, can be sources:
– Endoscopic camera
– Room camera
– PC

Image composition
In the image composition area, videos from 2 sources can be displayed as PiP and PaP. The
composite image appears in the preview.

Streaming
A source transmitted outside the OR can be selected for the streaming. The transmitted image can
be commented on with the aid of a drawing function and details can be highlighted with an arrow
function. Drawings disappear automatically after approx. 10 seconds and are not saved. Audio
comments can be sent bi-directionally with the streaming. The streaming can be defined as a
target in order to capture and archive the video e.g. with the
AIDA® system.

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 Operation

Preview
WARNING
Risk of injury due to wrong diagnosis!
The components and monitors of the OR1™. avm are not diagnostic or therapeutic devices.
The preview of the OR1™. avm is not to be used for diagnostic or therapeutic purposes.

A selected source, the image composition or the streaming can appear in the preview.

Destinations
Up to 8 image targets can be defined for transmission in the OR. Only output devices configured
in the settings appear as targets in the user interface. Videos can be recorded in the AIDA ®
system with the targets Recording 4K and Recording HD.
Settings are carried out during the installation of the OR1™. avm and are outlined in the
installation instructions.

Recording functions are described in the AIDA® instructions for use.

5.2.1 User interface symbols

The following symbols identify functions of the OR1™. avm:

General Meaning
symbols
Access status private or public

Settings, see installation instructions

Streaming Meaning
symbols
Show

Draw

Invite participant

Switch playback volume off

Switch microphone off

All other symbols of the user interface designate functions of the AIDA® system and are
described in the corresponding instructions for use.

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 Operation

5.3 Streaming Videos

WARNING
Risk of injury due to transmission of wrong video!
If the operation screen is defined as a target, the selected image source replaces the local live
view of the operation screen. This could result in injury to the patient.
Make sure that the correct video appears on the operation screen.

Image sources must be assigned to the image targets in order to transmit videos to different
output devices within the OP. Image compositions and streamings can also be transferred to
output devices in the OP.
1. In the Sources area, tap on an image source, the Image composition or the Streaming.

ð The image source appears in the Preview.

2. In the Targets area, tap on an image target.

ð The image source, image composition or the streaming is assigned to the image target.
The video is transmitted within the OP.
3. Repeat step 2 to assign the selected image source to other image targets.
If a selected image source is not compatible with the image target, the image target is set to
inactive.

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 Operation

5.4 Stopping video transmission in the OP

The video transmission can be stopped during the OP.
1. In the Targets area, tap on an image target and hold for approx. 3 seconds.

ð The screen of the image target appears black.

2. Tap on the image target again and hold for approx. 3 seconds.
ð The video is streamed once again.

5.5 Capturing videos

Videos can be captured and archived using the AIDA® functions.
Recording functions are described in the AIDA® instructions for use.

1. In the Sources area, tap on an image source, the Image composition or the Streaming.

ð The image source appears in the Preview.

2. In the Targets area, tap on the image target Recording 4K or Recording HD.

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 Operation

ð The video can be recorded by the AIDA®.

5.6 Creating image compositions

An image composition can be created as a PiP or PaP with the videos of 2 sources.
1. In the Image composition area, tap on the following button and select the desired depiction.

2. In the Sources area, tap an image source.

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 Operation

3. In the Image composition area, tap on a hotspot.

ð The source appears in the selected hotspot.

4. In the Sources area, tap on a second image source.

5. In the Image composition area, tap on the second hotspot.

ð The second source appears in the selected hotspot.

6. If necessary, tap on the marked button in a PiP representation to replace the sources in the
hotspots.

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 Operation

7. Tap on the Image composition area at the top.

ð The Image composition appears in the Preview.

5.7 Selecting access status

The access status can be private or public. If the access status is public, videos can be streamed
and audio comments can be transmitted. In the case of a private access status, the streaming and
audio transmission are interrupted.
1. In the toolbar of the AIDA®, tap on the following symbol.

2. Select the desired access status.

Instruction For Use • OR1™. avm • BA • 96296660EN 25

 Operation

5.8 Streaming videos

WARNING
Risk of injury due to wrong diagnosis!
The components and monitors of the OR1™. avm are not diagnostic or therapeutic devices.
Do not use compressed image and video streaming for diagnostic or therapeutic purposes.

The Streaming function of the OR1™. avm allows videos to be transmitted outside the OR.
1. In the Sources area, tap on an image source or on the Image composition.

ð The image source appears in the Preview.

2. Tap on the Streaming area.

ð The image source or Image composition is assigned to the Streaming and the video is
transmitted externally.
3. Tap on the Streaming area at the top.

ð The video appears in the Preview and can be transmitted to a monitor in the OR, see
Streaming Videos [} 21], e.g. in order to display visual comments of the external participants
in the OR. A warning notice is shown during the transmission to indicate that the picture must
not be used for diagnostic or therapeutic purposes.
The streaming can be interrupted at any time if the private access status is selected, see
Selecting access status [} 25].

The user in the OP is responsible to ensure that images and possibly sensitive data are
streamed only in accordance with the valid data protection guidelines of the country or
hospital. After the operation, the transmissions must be disconnected by selecting the private
access status and reestablished for the next case. The connection is disconnected
automatically once a case is completed in the AIDA®.

Instruction For Use • OR1™. avm • BA • 96296660EN 26

 Operation

5.9 Invite participant

Up to 4 participants can access a stream and all participants see the same streamed video. To
ensure that only authorized participants can see the streaming, an authentication must be
performed. Depending on the configuration during installation, the authentication is done by a URL
and a password or via e-mail.

5.9.1 Access with URL and password

The URL and password are transmitted by phone and can be reset by selecting the private access
status, see Selecting access status [} 25].
The URL can be requested only in compatible browsers such as Google Chrome, Opera and
Mozilla Firefox.

ü An image source from the Sources or Image composition area is assigned in the Streaming
area.
1. Tap on the Streaming area at the top.

ð The video appears in the Preview.

2. Tap on the following button.

ð The URL and the password appear in the Preview.

3. Transmit the displayed URL and password by phone to the participant.

5.9.2 Access via email

If authentication takes place via e-mail, the participant is to receive an e-mail containing a link and
access authorization.
ü An image source from the Sources or Image composition area is assigned in the Streaming
area.
1. Tap on the Streaming area at the top.

ð The video appears in the Preview.

2. Tap on the following button.

ð The input field for the email of the participant appears in the Preview.
3. Enter the e-mail address of the participant in the field and send it.

Instruction For Use • OR1™. avm • BA • 96296660EN 27

 Operation

ð The link and access authorization are generated automatically.

5.10 Commenting on videos

Streamed videos can be commented on in the Preview and on external output devices using a
drawing function and arrow function. All visual comments can be seen by all participants.
ü An image source from the Sources or Image composition area is assigned to the Streaming
area.
1. Tap on the Streaming area at the top.

ð The video and buttons for Show and Draw appear in the Preview.
2. Tap on the following button and create drawings in the video.

ð The drawings only appear in the Preview, disappear automatically after approx. 10
seconds, and are not saved.
3. Tap on the following button and display details in the video with the arrow.

5.11 Setting playback volume

WARNING
Risk of injury due to high sound volume!
A high sound volume can startle the surgeon. This can result in injury to the patient, surgeon, or
third parties.
Before each surgery, check the volume and set it to an appropriate level. The volume of the
external loudspeaker must not exceed 95 dB.

During streaming, external audio comments can be transmitted to the OR. Transmission from
connected audio playback devices in the OR is feasible. If the playback volume is switched off, no
transmission takes place.
ü An image source from the Sources or Image composition area is assigned in the Streaming
area.
1. Tap on the Streaming area at the top.

ð The video and buttons for setting the playback volume and microphone appear in the
Preview.

Instruction For Use • OR1™. avm • BA • 96296660EN 28

 Operation

2. Adjust the playback volume using the slider.

3. Tap on the following button to switch off the playback volume.

5.12 Adjusting microphone

During streaming, audio comments can be transmitted from the operating room to the outside,
and audio comments from the external participants can be received using the microphone. All
audio comments can be heard by all participants. If the microphone is switched off, no
transmission takes place.
ü An image source from the Sources or Image composition area is assigned to the Streaming
area.
1. Tap on the Streaming area at the top.

ð The video and buttons for setting the playback volume and microphone appear in the
Preview.
2. Adjust the volume of the microphone using the slider.

3. Tap on the following button to switch off the microphone.

Instruction For Use • OR1™. avm • BA • 96296660EN 29

 Service, repair, and disposal

6 Service, repair, and disposal

6.1 Changing a fuse
The OR1™. avm requires two T 5A 250 V, 5 x 20 mm fuses (BK/S506-5-R or equivalent); see Back
panel [} 12] Section 10 "Power plug and potential equalization conductor".
1. Unplug the power cord from the device.
2. Use a suitable screwdriver to unscrew the fuse box.
3. Replace the fuse by the following or an equivalent fuse:
T 5A 250 V, 5 x 20 mm BK/S506-5-R.
4. Fasten the fuse box in the device again.

6.2 Manual wipe disinfection

  ATTENTION  
Damage due to incorrect exposure times!
Incorrect exposure times and incorrect concentration of chemicals can cause damage to the
product.
Comply with the chemical manufacturer's specifications concerning concentration, exposure
time, and life span.
Bear in mind the microbiological range of action of the chemicals used.

  ATTENTION  
Damage due to alcohol-based reprocessing agents!
Alcohol-based agents are protein-fixing and can damage materials.
Do not use alcohol-based agents.
Comply with the chemical manufacturer's specifications regarding material compatibility.

  ATTENTION  
Damage due to ingress of liquid!
Any ingress of liquid can cause damage to the product.
Do not directly spray the product with disinfectants.

  ATTENTION  
Damage from disinfectants!
When disinfectants penetrate into the connections on the front and back of the product, residues
can form during drying that interfere with the conductivity of the contacts.
Never allow the connections on the front and back of the product to come into contact with
disinfectant.

Required materials:
– Disposable cloth and disinfectant, alternatively: ready-to-use disinfectant cloth
– Dry, low-lint cloth
ü The product is disconnected from the power grid.
1. Use a disposable cloth moistened with disinfectant or a ready-to-use disinfectant cloth to
wipe the external surfaces of the product.
2. Allow disinfectant to take effect according to the manufacturer's specifications.
3. After the required exposure time, wipe the surfaces with a dry, lint-free cloth.

Instruction For Use • OR1™. avm • BA • 96296660EN 30

 Service, repair, and disposal

6.3 Servicing and repair

WARNING
Risk of injury from inadvertent flow of current!
Live parts of the device can cause severe injuries due to electric shock.
Do not open the housing.
Make sure that the connection to the power supply is disconnected.
Request a KARL STORZ service technician for service work.

Defective devices must be serviced and repaired by authorized KARL STORZ personnel only. Only
parts approved by KARL STORZ may be used.
4 After the repair, have an electrician carry out and record a safety check in accordance with
IEC 62353.

6.4 Repair program

In Germany you can contact the following address in the case of repairs:
KARL STORZ SE & Co. KG
Repair Service Department
Take-Off Gewerbepark 83
78579 Neuhausen, Germany
Service hotline: +49 7461-708 980
E-mail: technicalsupport@karlstorz.com
In other countries, the respective KARL STORZ branches or specialist dealers are responsible.
After repair work on the unit, the default settings may be activated for safety reasons. All user-
specific values must be reset by an authorized person.

6.5 Disposal
The product meets the requirements of Directive 2011/65/EU RoHS (on the restriction of the use of
certain hazardous substances in electrical and electronic equipment) and Directive 2012/19/EU on
waste electrical and electronic equipment.
Within the scope of application of this directive, KARL STORZ SE & Co. KG is responsible for the
proper disposal of this device.
1. The product must be disposed of in accordance with the applicable national regulations and
laws at a suitable collection point for the reprocessing of electrical and electronic equipment.
2. To prevent damage to the environment and personal injury, contact KARL STORZ SE & Co.
KG, a KARL STORZ branch, or an authorized dealer and find out the address of the collection
point in your area.

Instruction For Use • OR1™. avm • BA • 96296660EN 31

 Appendices

7 Appendices
7.1 Electromagnetic compatibility (EMC)
KARL STORZ OR1™. avm corresponds to IEC 60601-1-2 [CISPR 11 Class A] and therefore meets
the EMC requirements of Medical Device Directive (MDD) 93/42/EEC.
It is possible to check whether the device is suitable for the given electromagnetic environment
and which measures can be taken to operate the device as intended without interferences with
other medical and non-medical devices. If electromagnetic interference occurs, the following
measures can be taken:
1. Reorient or reposition the device.
2. Increase the distance between the individual devices.
3. Connect the equipment to an outlet on a circuit different from that on which the other devices
are connected.
If you have any further questions, please contact the corresponding KARL STORZ local
representative or the service department responsible.

7.1.1 Table 200

WARNING
Risk of injury due to reduced interference immunity!
The use of cables other than those specified in the KARL STORZ instructions for use may result in
increased emissions or decreased immunity of the OR1™. avm. The cables listed have been
shown to comply with the requirements of EN/IEC IEC 60601-1-2.
Using other cables, the operator is responsible for checking that they comply with IEC 60601
—1-2:2014.

Cables which have been shown to comply with EN/IEC 60601-1-2:

Interface Length Type Use

[m]
Number of Shielded Unshielde
wires d
AC power cord 3.0 3 x Main power
connection
PE 1.0 1 x POAG earth lead
ACC 1–2 2.0 3 x Camera head buttons
Line In/Out 1.8 3 x Audio In/Out
HDMI 4K 3.0 19 x In/Out
DP PC 3.0 20 x DP1/2
LAN1 5.0 8 x Ethernet
LAN2 5.0 8 x Ethernet
USB 2.0 (front) 1.8 4 x
USB 3.0 (back) 3.0 4 x
Table 6: Table 200

Instruction For Use • OR1™. avm • BA • 96296660EN 32

 Appendices

7.1.2 Table 201

Guidelines and manufacturer’s declaration – electromagnetic emissions

KARL STORZ OR1™. avm is intended for use in the electromagnetic environment specified below.
The user of KARL STORZ OR1™. avm must ensure that the device is used in such an
environment.

Interference emission Conformity Electromagnetic environment –

measurements
RF emissions acc. to CISPR 11
RF emissions acc. to CISPR 11
Harmonic emissions IEC
61000-3-2
Voltage fluctuations/flicker
emissions acc. to IEC 61000-3-3
Table 7: Table 201
guidelines
Complies The properties of this device which are
with Group 1 determined by emissions permit use of
the device in the industrial environment
Complies with
and in hospitals. If it is used in domestic
Class A
settings, this device may not provide
Complies with adequate protection of radio services. If
Class A necessary, the user must take remedial
measures such as relocating or
Complies reorienting the device.

7.1.3 Table 202

Guidelines and manufacturer’s declaration – electromagnetic immunity

KARL STORZ OR1™. avm is intended for use in the electromagnetic environment specified below.
The user of KARL STORZ OR1™. avm must ensure that it is used in such an environment. Applied
EMC standards and test methods – electromagnetic immunity – for the use of ME devices in
professional health care facilities.

Immunity tests IEC 60601-1-2:2007 IEC 60601-1-2:2014 Electromagnetic

(3rd Edition) test level (4th Edition) test level environment –
Guidelines
Electrostatic ± 6 kV contact discharge Complies Floors should be made
discharge (ESD) ± 8 kV air discharge ± 8 kV contact discharge of wood, concrete, or
acc. to IEC ± 2 kV, ± 4 kV, ± 8 kV, ceramic tile. If floors
61000-4-2 ± 15 kV air discharge are covered with
synthetic material, the
relative humidity must
be at least 30%.
Electrical fast ± 2 kV for power supply Complies The power supply
transients lines ± 2 kV for power supply quality should be that
± 1 kV for input/output lines of a typical
lines ± 1 kV for input and commercial or hospital
output lines environment.
Surges acc. to IEC ± 1 kV differential mode Complies The power supply
61000-4-5 ± 2 kV common mode ± 1 kV differential mode quality should be that
± 2 kV common mode of a typical
commercial or hospital
environment.
Voltage dips, short <5% UT* Complies The power supply
interruptions, and (>95% dip in UT) Voltage drop: quality should be that
fluctuations of the for 1/2 cycle Drop to 0% for 1 cycle of a typical
power supply acc. 40% UT at 0° phase angle commercial or hospital
to IEC 61000-4-11 (60% dip in UT) Drop to 70% for 25/30 environment.
for 5 cycles cycles at 0° phase angle If the user of the
70% UT Drop to 0% for 0.5 device requires
(30% dip in UT) continued operation
for 25 cycles even when the power

Instruction For Use • OR1™. avm • BA • 96296660EN 33

 Appendices

Immunity tests IEC 60601-1-2:2007 IEC 60601-1-2:2014 Electromagnetic

(3rd Edition) test level (4th Edition) test level environment –
Guidelines
<5% UT cycles at phase angles supply is interrupted,
(>95% dip in UT) of 0°, 45°, 90°, 135°, we recommend
for 5 seconds 180°, 225°, 270° & 315° powering the device
Voltage interruption: from an uninterruptible
100% for 250/300 cycles power supply.
Magnetic field at 3 A/m Complies Magnetic fields at the
the supply 30 A/m supply frequency
frequency (50/60 should correspond to
Hz) acc. to IEC the values typically
61000-4-8 found in commercial
and hospital
environments.
* NOTE: UT is the a.c. mains voltage prior to application of the test levels.
Table 8: Table 202

7.1.4 Table 203

Testing specifications for the interference immunity of coatings against high-frequency

wireless communication equipment (according to IEC 60601-1-2:2014)
KARL STORZ OR1™. avm is intended for use in the electromagnetic environment specified below.
The user of KARL STORZ OR1™. avm must ensure that it is used in such an environment.

Test Frequency Service Modulation Maximu Distance Interferen

frequenc band m output m ce
y MHz W immunity
MHz test level
V/m
385 380 to 390 TETRA 400 Pulse 1.8 0.3 27
modulation
18 Hz
450 430 to 470 GMRS 460, FM 2 0.3 28
FRS 460 ± 5 kHz stroke
1 kHz sine
710 704 to 787 LTE bands 13, Pulse 0.2 0.3 9
17 modulation
745
217 Hz
780
810 800 to 960 GSM 800/900, Pulse 2 0.3 28
TETRA 800, modulation
870
iDEN 820, 18 Hz
930 CDMA 850,
LTE band 5
1720 1700 to 1990 GSM 1800, Pulse 2 0.3 28
CDMA 1900, modulation
1845
GSM 1900, 217 Hz
1970 DECT,
LTE band 1, 3,
4, 25, UMTS
2450 2400 to 2570 Bluetooth, Pulse 2 0.3 28
WLAN 802.11 modulation
b/g/n, 217 Hz
RFID 2450,
LTE band 7

Instruction For Use • OR1™. avm • BA • 96296660EN 34

 Appendices

Test Frequency Service Modulation Maximu Distance Interferen

frequenc band m output m ce
y MHz W immunity
MHz test level
V/m
5240 5100 to 5800 WLAN 802.11 Pulse 0.2 0.3 9
a/n modulation
5500
217 Hz
5785
Table 9: Table 203

7.1.5 Table 204

Guidelines and manufacturer’s declaration – Electromagnetic immunity – For medical

electrical devices that are not life-supporting
KARL STORZ OR1™. avm is intended for use in the electromagnetic environment specified below.
The user of KARL STORZ OR1™. avm must ensure that it is used in such an environment.

Immunity tests IEC IEC Compliance Electromagnetic

60601-1- 2:2007 60601-1-2:2014 level environment –
test level test level Guidelines
Conducted HF 3 Vrms 3 Vrms 3 Vrms Portable and mobile
disturbances acc. 150 kHz to < 80 150 kHz to < 80 6 Vrms for ISM RF communications
to IEC 61000-4-6 MHz MHz bands equipment should
be used no closer
1kHz 80% to any part of the
amplitude KARL STORZ
modulation OR1™. avm,
6 Vrms for ISM including cables,
bands than the
recommended
Radiated HF 3 V/m 3 V/m 3 V/m safety distance
disturbance acc. 80 MHz to 2.5 80 MHz to 2.7 calculated from the
to IEC 61000-4-3 GHz GHz equation applicable
to the frequency of
the transmitter.
Recommended
safety distances:

150 kHz to < 80

MHz

80 MHz to < 800

MHz

800 MHz to 2.5

GHz
P is the
transmitter's rated
power in Watt [W]
as indicated by the
transmitter's
manufacturer, and
d is the

Instruction For Use • OR1™. avm • BA • 96296660EN 35

 Appendices

Immunity tests IEC IEC Compliance Electromagnetic

60601-1- 2:2007 60601-1-2:2014 level environment –
test level test level Guidelines
recommended
safety distance in
meters [m].
Field strengths from
fixed RF
transmitters as
determined by an
electromagnetic
site survey a should
be less than the
compliance level in
each frequency
range b.
Interferences may
occur in the vicinity
of equipment
marked with the
following symbol:

Table 10: Table 204

a The field strength of fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio stations, AM and FM radio and TV transmitters
cannot be predicted theoretically with accuracy. To determine the electromagnetic environment in
respect to the fixed transmitters, a site study should be carried out. If the measured field strength
exceeds the above compliance levels at the location where the device is used, the device should
be monitored to ensure proper function. If unusual performance characteristics are observed,
additional measures may be necessary, such as a modified orientation or a different location for
the device.
b Over the frequency range of 150 kHz to 80 MHz, the field strength should be less than 3 V/m.
These guidelines do not apply in all cases. The propagation of electromagnetic quantities is
affected by absorptions and reflections of buildings, objects, and persons.

7.1.6 Table 206

Recommended safety distances between portable and mobile RF communications

equipment and KARL STORZ OR1™. avm
KARL STORZ OR1™. avm is intended for use in an electromagnetic environment in which RF
disturbances are controlled.
The user of the device must help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the
device – as a function of the output power of the communication device, as shown below.

Instruction For Use • OR1™. avm • BA • 96296660EN 36

 Appendices

Rated maximum Safety distance d [m] according the transmitter frequency

output power of
150 kHz to < 80 MHz 80 MHz to < 800 MHz 800 MHz to 2.5 GHz
transmitter [W]

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
Table 11: Table 206
For transmitters rated at a maximum output power not listed above, the recommended safety
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
These guidelines do not apply in all cases. The propagation of electromagnetic quantities is
affected by absorptions and reflections of buildings, objects, and persons.

7.2 Regulatory information on telecommunications

7.2.1 USA
The device corresponds to Section 15 of the FCC Regulations. The application is subject to the
following two conditions:
– The device must not cause harmful interference.
– The device must be able to withstand harmful interference, including interference which may
lead to undesirable functions.
Includes FCC ID: PD99260NG

7.2.2 Canada
The device corresponds to Industry Canada’s license-free RSS standards. The application is
subject to the following two conditions:
– The device must not cause harmful interference.
– The device must be able to withstand harmful interference, including interference which may
lead to undesirable functions.
Includes IC: 10000M-9260NG

7.2.3 European Union

The device may only be used indoors.
Radio Equipment Directive (RED) 2014/53/EU

Instruction For Use • OR1™. avm • BA • 96296660EN 37

 KARL STORZ SE & Co. KG
Dr.-Karl-Storz-Straße 34
78532 Tuttlingen
Postfach 230
96296660EN • BA • 08/2019

78503 Tuttlingen
Germany

Telefon: +49 (0)7461 708-0

Telefax: +49 (0)7461 708-105
E-Mail: info@karlstorz.com
www.karlstorz.com