Storz IMAGE1 PILOT Bedienungsanleitung
Instructions for use
IMAGE1 PILOT
en
Copyright ©
All product illustrations, product descriptions, and texts are the intellectual property of
KARLSTORZSE&Co.KG.
Their use and reproduction by third parties require the express approval of
KARLSTORZSE&Co.KG.
All rights reserved.
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 IMAGE1S 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 KARLSTORZ.
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 KARLSTORZ 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 IMAGE1PILOT is an accessory to the IMAGE1Scamera platform.
The product can be combined with camera heads, articulated stands, and rotation sockets,
e.g.:
– VITOM3D (TH200)
– Articulated stand (28272HB)
– Rotation socket (28172HR)
4.3 Technical data
Description Value
Dimensions (LxHxW) 123x61x92mm
Weight 355g
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 700–1,060hPa
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 700–1,060hPa
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