Storz IMAGE1 PILOT User manual

Instructions for use
IMAGE1 PILOT
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.
11-2021

Table of contents
Instructions for use • IMAGE1 PILOT • HLI417_EN_V2.0_11-2021_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 compatible products .................................................... 4
1.3 Scope .............................................................................................................................. 4
1.4 General signs and symbols ............................................................................................. 4
1.5 Description of warning messages ................................................................................... 5
2 Normal use ............................................................................................................................... 6
2.1 Intended use.................................................................................................................... 6
2.2 Indications ....................................................................................................................... 6
2.3 Contraindications ............................................................................................................ 6
2.4 Target user populations................................................................................................... 6
2.5 Patient groups ................................................................................................................. 6
3 Safety ....................................................................................................................................... 7
3.1 Serious incidents ............................................................................................................. 7
3.2 Observing ambient conditions......................................................................................... 7
3.3 Damage due to ingress of liquid in electrical components ............................................. 7
3.4 Combination with other components .............................................................................. 7
3.5 Failure of devices............................................................................................................. 7
4 Product description.................................................................................................................. 8
4.1 Product overview............................................................................................................. 8
4.2 Possible combinations .................................................................................................... 8
4.3 Technical data ................................................................................................................. 8
4.4 Symbols on the packaging .............................................................................................. 9
4.5 Ambient conditions.......................................................................................................... 9
5 Preparation ............................................................................................................................... 11
5.1 Unpacking the product.................................................................................................... 11
5.2 Assembling the product .................................................................................................. 11
5.3 Attaching a sterile drape.................................................................................................. 12
6 Application................................................................................................................................ 14
6.1 Using the 3D wheel.......................................................................................................... 14
6.2 Controlling the IMAGE1S camera platform .................................................................... 15
6.3 Using the function keys ................................................................................................... 15
7 Disassembly ............................................................................................................................. 17
7.1 Disassembling the product.............................................................................................. 17
8 Maintenance, servicing, repairs, and disposal ......................................................................... 18
8.1 Repairs to the product..................................................................................................... 18
8.2 Disposing of the product ................................................................................................. 18
9 Accessories and spare parts.................................................................................................... 19
9.1 Accessories ..................................................................................................................... 19
10 Subsidiaries .............................................................................................................................. 20

General information
Instructions for use • IMAGE1 PILOT • HLI417_EN_V2.0_11-2021_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.
Read the reprocessing instructions carefully and follow all the safety notes and warnings.
The reprocessing instructions can be downloaded from www.karlstorz.com/ifu by entering
the item number.
Keep the instructions for use and reprocessing instructions in a safe place.
1.2 Read the instructions for use of compatible products
If the instructions for use of compatible products are not followed, patients, users, and third
parties may be injured or the product may be damaged.
Read the instructions for use of the compatible products carefully and follow all the safety
notes and warnings.
Read the reprocessing instructions of the compatible products carefully and follow all the
safety notes and warnings.
1.3 Scope
This instruction manual is valid for:
Product name Item number
IMAGE1 PILOT TC014
1.4 General signs and symbols
The signs and symbols used in this document have the following meaning:
Practical tip
This sign refers to useful and important information.
Actions to be performed
Action to be carried out by several steps:
üPrerequisite that must be met before carrying out an action.
1. Step 1
ðInterim result of an action
2. Step 2
ðResult of a completed action
Actions in safety notes or in the case of a single step:
Step 1
Lists
1. Numbered list
– Unnumbered list, 1st level

General information
Instructions for use • IMAGE1 PILOT • HLI417_EN_V2.0_11-2021_IFU_CE-MDR 5
– Unnumbered list, 2nd level
1.5 Description of warning messages
To prevent any injury to persons or damage to property, the warnings and safety notes in the
instructions for use must be observed. The warnings use the following levels of danger:
WARNING
WARNING
Designates a possible imminent risk. If this is not avoided, it could lead to death or serious
injuries.
CAUTION
CAUTION
Designates a possible imminent risk. If this is not avoided, it could lead to minor injuries.
NOTICE
NOTICE
Designates a possibly harmful situation. If this is not avoided, the products could be damaged.

Normal use
Instructions for use • IMAGE1 PILOT • HLI417_EN_V2.0_11-2021_IFU_CE-MDR 6
2 Normal use
2.1 Intended use
The IMAGE1 PILOT is an input device and is used for operating the IMAGE1 camera control
unit and connected devices / camera heads. The IMAGE1 PILOT has no direct contact with the
human body.
2.2 Indications
The indication is defined by the device that is controlled using the additional operating
elements or for which the additional accessories are used.
2.3 Contraindications
The contraindication is defined by the device that is controlled using the additional operating
elements.
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 • IMAGE1 PILOT • HLI417_EN_V2.0_11-2021_IFU_CE-MDR 7
3 Safety
3.1 Serious incidents
A ‘serious incident’ includes incidents which, directly or indirectly, had, could have had or
could have any of the following consequences:
– Death of a patient, user, or another person
– Temporary or permanent serious deterioration in the medical condition of a patient, user,
or another person
– A serious threat to public health
The manufacturer and appropriate authority must be notified of all serious incidents.
3.2 Observing ambient 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.
3.3 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.
3.4 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 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 combined
use by the manufacturer.
Only use devices and components that have standardized interfaces and do not breach
the intended use of the product.
Observe the instruction manuals and interface specifications of the devices and
components used in combination.
Comply with national and local regulations.
Only make changes to the product if these changes are approved by KARLSTORZ.
3.5 Failure of devices
The product may fail during use.
Have a replacement product ready for each application.

Product description
Instructions for use • IMAGE1 PILOT • HLI417_EN_V2.0_11-2021_IFU_CE-MDR 8
4 Product description
4.1 Product overview
4
12
3
6 5
1 Control buttons 1–4 for programmed
functions
4 KSLOCK quick release coupling (male)
for connection to a KARLSTORZ hold-
ing system
2 LED for operating status display 5 Right control button: canceling, jump-
ing back from a menu, and ESC
3 3D wheel for controlling the zoom, fo-
cus, and ROI as well as navigating
through the menu
6 Left control button: opening the cam-
era menu, Setup menu, selection
4.2 Possible combinations
It is recommended that the suitability of the products for the intended procedure be checked
prior to use. Please note that the products listed here may not yet be available in all countries
due to differences in approval requirements.
The IMAGE1PILOT is an accessory to the IMAGE1Scamera platform.
The product can be combined with camera heads, articulated stands, and rotation sockets,
e.g.:
– VITOM3D (TH200)
– Articulated stand (28272HB)
– Rotation socket (28172HR)
4.3 Technical data
Description Value
Dimensions (LxHxW) 123x61x92mm
Weight 355g

Product description
Instructions for use • IMAGE1 PILOT • HLI417_EN_V2.0_11-2021_IFU_CE-MDR 9
4.4 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
Keep dry
Federal (USA) law restricts this device to sale by or on the order of a
physician.
CE marking
With this marking, the manufacturer declares the conformity of the prod-
uct with the applicable EU directives. A code number after the CE mark
indicates the responsible notified body.
The EU legislation relevant to the product can be found in the EU Decla-
ration of Conformity, which can be requested from KARL STORZ.
4.5 Ambient conditions
Storage and transport conditions
Temperature -10°C...+60°C (14°F...140°F)
Relative humidity, non-
condensing
20–85%
Air pressure 700–1,060hPa

Product description
Instructions for use • IMAGE1 PILOT • HLI417_EN_V2.0_11-2021_IFU_CE-MDR 10
Operating conditions
Temperature 0°C...40°C (32°F...104°F)
Relative humidity, non-
condensing
20–95%
Air pressure 700–1,060hPa

Preparation
Instructions for use • IMAGE1 PILOT • HLI417_EN_V2.0_11-2021_IFU_CE-MDR 11
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 Assembling the product
The product is attached to the operating table using a KARLSTORZ articulated stand.
Two IMAGE1PILOT products can be connected at the same time, enabling the product
to be operated in both sterile and unsterile environments.
1. Fasten the articulated stand onto the operating table and position it.
2. Open the KSLOCK quick release coupling (female) on the articulated stand by turning it in
the “OPEN” direction.
3. Insert the KSLOCK quick release coupling (male) on the bottom of the IMAGE1PILOT
until it audibly clicks into place.
4. Make sure that the product is inserted properly.

Preparation
Instructions for use • IMAGE1 PILOT • HLI417_EN_V2.0_11-2021_IFU_CE-MDR 12
5. Lock the KSLOCK quick release coupling (female) on the articulated stand by turning it in
the “CLOSE” direction.
6. Using the articulated stand, position the product so that the control unit can be accessed
conveniently. CAUTION!To prevent injury to the patient and third parties, hold the
product when the fixation screws on the articulated stand are open.
7. Connect the USB cable of the control unit to a USB socket on the IMAGE1SCONNECT
or IMAGE1SCONNECTII.
ðThe message “IMAGE1 PILOT connected” appears on the display.
ðThe LED indicating the function status lights up.
5.3 Attaching a sterile drape
The product cannot be sterilized and must be fitted with a sterile drape (041150-20) in a sterile
environment for the duration of the procedure.
1. Remove the sterile drape from its packaging.

Preparation
Instructions for use • IMAGE1 PILOT • HLI417_EN_V2.0_11-2021_IFU_CE-MDR 13
2. Pull the sterile drape over the product and the articulated stand.
3. Ensure that the elastic insert on the tip of the sterile drape is placed directly over the 3D
wheel. NOTICE!Do not pull the drape on too tightly as this may inadvertently
operate the 3D wheel.

Application
Instructions for use • IMAGE1 PILOT • HLI417_EN_V2.0_11-2021_IFU_CE-MDR 14
6 Application
6.1 Using the 3D wheel
NOTICE
Incorrect handling! Product damage!
The product calibrates the 3D wheel position as soon as it is switched on.
Do not press the 3D wheel or the buttons while establishing the USB connection.
Do not press the 3D wheel or the buttons while switching on the IMAGE1S camera
platform.
1. Push the 3D wheel to navigate through the IMAGE1 menu and operate a camera-specific
function.
2. Press the 3D wheel to confirm or select a function.
3. Pull the 3D wheel to exit a menu, cancel an action, or operate a camera-specific function.

Application
Instructions for use • IMAGE1 PILOT • HLI417_EN_V2.0_11-2021_IFU_CE-MDR 15
4. Turn the 3D wheel clockwise or counterclockwise to operate a camera-specific function.
6.2 Controlling the IMAGE1S camera platform
The product enables the IMAGE1Scamera platform menu to be accessed directly.
1. Press ENTER to access the menu.
2. Push the 3D wheel to navigate through the menu, adjust settings, or access functions.
3. Press ESC to exit the menu.
As long as the IMAGE1Smenu is active, the camera functions (e.g., zoom and focus with
VITOM® 3D) cannot be controlled.
6.3 Using the function keys
The four function keys can be programmed and functions can be assigned to them. Depending
on which camera system is connected, certain functions can be performed quickly, or rapid
access can be gained to menus.

Application
Instructions for use • IMAGE1 PILOT • HLI417_EN_V2.0_11-2021_IFU_CE-MDR 16
1. Select the button for the IMAGE1PILOT in the camera’s live menu.
2. Select the required function for the function key from the drop-down menu.

Disassembly
Instructions for use • IMAGE1 PILOT • HLI417_EN_V2.0_11-2021_IFU_CE-MDR 17
7 Disassembly
7.1 Disassembling the product
1. Remove the sterile drape.
2. Open the KSLOCK quick release coupling (female) on the articulated stand by turning it in
the “OPEN” direction.
3. Remove the product.

Maintenance, servicing, repairs, and disposal
Instructions for use • IMAGE1 PILOT • HLI417_EN_V2.0_11-2021_IFU_CE-MDR 18
8 Maintenance, servicing, repairs, and disposal
8.1 Repairs to the product
Repair work may only be performed by KARLSTORZ or by a company authorized by
KARLSTORZ.
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.
8.2 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 • IMAGE1 PILOT • HLI417_EN_V2.0_11-2021_IFU_CE-MDR 19
9 Accessories and spare parts
9.1 Accessories
Item Order no.
Drape, elastic tip 041150-20

Subsidiaries
Instructions for use • IMAGE1 PILOT • HLI417_EN_V2.0_11-2021_IFU_CE-MDR 20
10 Subsidiaries
KARLSTORZ SE & Co. KG
Dr.-Karl-Storz-Straße 34, 78532 Tuttlingen/Germany
Postfach 230, 78503 Tuttlingen/Germany
Phone: [phone], Fax: [phone]
E-mail: [email protected]
KARLSTORZ Endoskope Berlin GmbH
Scharnhorststr. 3, 10115 Berlin/Germany
Phone: [phone], Fax: [phone]
KARLSTORZ Endoscopy Canada Ltd.
7171 Millcreek Drive, Mississauga, Ontario L5N 3R3 Canada
Phone: [phone], Fax: [phone]
Toll free (Canada only) Phone: [phone], Fax: [phone]
(Canada only)
E-mail: [email protected]
KARLSTORZEndoscopyAmerica, Inc.
2151 East Grand Avenue, El Segundo, CA 90245-5017, USA
Phone: [phone], Fax: [phone]
Toll free (USA only) Phone: [phone], Fax: [phone] (USA only)
E-mail: [email protected]
KARLSTORZVeterinaryEndoscopyAmerica, Inc.
1 South Los Carneros Road, Goleta, CA 93117, USA
Phone: [phone], Fax: [phone]
E-mail: [email protected]
KARLSTORZEndoscopiaLatinoAmerica, Inc.
815 N. W. 57th Avenue, Suite 480, Miami, FL 33126-2042, USA
Phone: [phone], Fax: [phone]
E-mail: [email protected]
KARLSTORZEndoscopiaMéxicoS.A.deC.V.
Edificio Atlantic, Oficina 3G, Calle D e/ 1ra y 3ra, 10400 Vedado, Havanna,
Cuba
Phone: [phone], Fax: [phone]
E-mail: [email protected]
KARLSTORZEndoscopiaMéxicoS.A.deC.V.
Av. Ejercito Nacional No. 453 Piso 2, Colonia Granada, Alcaldia Miguel
Hidalgo, C.P. 11520, Mexico City, Mexico
Phone: [phone]
E-mail: [email protected]
KARLSTORZMarketingAméricaDoSulLtda.
Rua Joaquim Floriano, nº. 413, 20º andar – Itaim Bibi, CEP-04534-011 São
Paulo, Brazil
Phone: [phone], Fax: [phone]
E-mail: [email protected]
KARL STORZ Endoscopia Argentina S.A.
Zufriategui 627 6° Piso, B1638 CAA – Vicente Lopez, Provincia de Buenos
Aires, Argentina
Phone: [phone], Fax: [phone]
E-mail: [email protected]
KARL STORZ Endoskopi Norge AS
Stamveien1, 1483 Hagan, Norway
Phone: [phone], Fax: [phone]
E-mail: [email protected]
KARL STORZ Endoskop Sverige AB
Storsätragränd 14, 127 39 Skärholmen, Sweden
Phone: [phone]
E-mail: [email protected]
KARL STORZ Endoscopy Suomi OY
Taivaltie 5, 01610 Vantaa, Finland
Phone: [phone], Fax: [phone]
E-mail: [email protected]
KARLSTORZ SE & Co. KG
Representative Office
Žalgirio St. 94, LT9300 Vilnius, Lithuania
Phone: [phone], Mobile: [phone]
E-mail: [email protected]
KARL STORZ Endoskopi Danmark A/S
Skovlytoften 33, 2840 Holte, Denmark
Phone: [phone], Fax: [phone]
E-mail: [email protected]
KARL STORZ Endoscopy (UK) Ltd.
415 Perth Avenue, Slough, Berkshire, SL1 4TQ, United Kingdom
Phone: [phone], Fax: [phone]
E-mail: [email protected]
KARLSTORZ Endoscopie Nederland B.V.
Displayweg 2, 3821 BT Amersfoort, Netherlands
Phone: [phone]
E-mail: [email protected]
KARL STORZ Endoscopy Belgium N.V.
Phone: [phone]
E-mail: [email protected]
KARLSTORZ Endoscopie France S.A.S.
12, rue Georges Guynemer, Quartier de l’Europe, 78280 Guyancourt, France
Phone: [phone], Fax: [phone]
E-mail: [email protected]
KARL STORZ Endoskop Austria GmbH
Landstraßer Hauptstr. 148/1/G1, 1030 Vienna, Austria
Phone: [phone], Fax: [phone]
E-mail: [email protected]
KARLSTORZ Endoscopia Ibérica S.A.
Parque Empresarial San Fernando, Edificio Munich – Planta Baja, 28830
Madrid, Spain
Phone: [phone], Fax: [phone]
E-mail: [email protected]
KARLSTORZ Endoscopia Italia S.r.l.
Via dell’Artigianato, 3, 37135 Verona, Italy
Phone: [phone], Fax: [phone]
E-mail: [email protected]
KARLSTORZ Croatia d.o.o.
Capraška 6, 10000 Zagreb, Croatia
Phone: [phone], Fax: [phone]
E-mail: [email protected]
KARLSTORZEndoskopijad.o.o.
Cesta v Gorice 34b, 1000 Ljubljana, Slovenia
Phone: [phone], Fax: + 386 1 620 5882
E-mail: [email protected]
KARL STORZ Polska Sp. z o.o.
ul. Bojkowska 47, 44-100 Gliwice, Poland
Phone: [phone], Fax: [phone]
E-mail: [email protected]
KARLSTORZ Endoszkóp Magyarország Kft.
Toberek utca 2. fsz. 17/b, HU-1112 Budapest, Hungary
Phone: [phone], Fax: [phone]
E-mail: [email protected]
KARL STORZ Endoscopia Romania srl
Str. Prof. Dr. Anton Colorian, nr. 74, Sector 4, 041393 Bucharest, Romania
Phone: [phone], Fax: [phone]
E-mail: [email protected]
KARL STORZ Endoskope Greece M.E.P.E.*
Patriarhou Grigoriou E’ 34, 54248 Thessaloniki, Greece
Phone: [phone], Fax: [phone]
E-mail: [email protected]
*Repair & Service Subsidiary