Storz TELECAM C3 User manual

Instructions for use
TELECAM C3 TC100
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.
02-2022

Table of contents
Instructions for use • TELECAM C3 TC100 • LZA600_EN_V2.0_02-2022_IFU_CE-MDR 3
Table of contents
1 General information .................................................................................................................. 6
1.1 Read the instructions for use........................................................................................... 6
1.2 Read the instructions for use of compatible products .................................................... 6
1.3 Scope .............................................................................................................................. 6
1.4 General signs and symbols ............................................................................................. 6
1.5 Description of warning messages ................................................................................... 7
2 Normal use ............................................................................................................................... 8
2.1 Intended use.................................................................................................................... 8
2.2 Indications ....................................................................................................................... 8
2.3 Contraindications ............................................................................................................ 8
2.4 Patient groups ................................................................................................................. 8
2.5 Target user populations................................................................................................... 8
3 Safety and warning................................................................................................................... 9
3.1 Serious incidents ............................................................................................................. 9
3.2 Observing ambient condition .......................................................................................... 9
3.3 Combination with other components .............................................................................. 9
3.4 Damage due to ingress of liquid in electrical components ............................................. 9
3.5 Dangers from electrical current ....................................................................................... 9
3.6 Electromagnetic interference........................................................................................... 10
3.7 Product not clean ............................................................................................................ 10
3.8 Failure of devices............................................................................................................. 10
4 Product description.................................................................................................................. 11
4.1 Product overview............................................................................................................. 11
4.2 Possible combinations .................................................................................................... 12
4.3 Technical data ................................................................................................................. 15
4.4 Symbols employed .......................................................................................................... 16
4.4.1 Symbols on the packaging ................................................................................. 16
4.4.2 Symbols on the product ..................................................................................... 17
4.4.3 Symbols on the user interface ............................................................................ 18
4.4.4 Symbols on the type plate .................................................................................. 21
4.5 Ambient conditions.......................................................................................................... 21
5 Preparation ............................................................................................................................... 22
5.1 Unpacking the product.................................................................................................... 22
5.2 Inspecting the product .................................................................................................... 22
5.3 Setting up the product..................................................................................................... 22
5.4 Connecting the product................................................................................................... 22
5.4.1 Connecting the potential equalization ................................................................ 22
5.4.2 Connecting the monitor ...................................................................................... 23
5.4.3 Connecting USB devices.................................................................................... 23
5.4.4 Connecting the camera head or videoendoscope ............................................. 24
5.4.5 Connecting the power supply............................................................................. 24
5.5 Putting the product into operation .................................................................................. 24
5.5.1 Switching the product on and off ....................................................................... 25
5.5.2 Performing the white balance ............................................................................. 25
5.5.3 Performing the function test ............................................................................... 26

Table of contents
Instructions for use • TELECAM C3 TC100 • LZA600_EN_V2.0_02-2022_IFU_CE-MDR 4
6 Application................................................................................................................................ 27
6.1 Camera head buttons...................................................................................................... 27
6.2 User interface .................................................................................................................. 28
6.3 Quick menu ..................................................................................................................... 28
6.3.1 Performing functions via the Quick menu........................................................... 28
6.3.2 Quick menu configuration................................................................................... 28
6.4 Function Space................................................................................................................ 29
6.5 Setup menu ..................................................................................................................... 29
6.5.1 Accessing the Setup menu................................................................................. 29
6.5.2 Changing the general product settings .............................................................. 30
6.6 Information area............................................................................................................... 30
6.6.1 Opening the information area ............................................................................. 30
6.6.2 Accessing information on the system status or on the connected accessories 30
6.6.3 Changing the camera head button assignment.................................................. 31
6.7 Patient area...................................................................................................................... 32
6.8 Patient management ....................................................................................................... 32
6.8.1 Patient handling .................................................................................................. 32
6.8.2 Labeling .............................................................................................................. 34
6.8.3 Export Mode ....................................................................................................... 34
6.9 Access and security concept .......................................................................................... 35
6.9.1 Password encryption .......................................................................................... 35
6.9.2 Role-based access system with user accounts ................................................. 35
6.9.3 Configuring a role-based access system ........................................................... 36
6.10 Storage functions ............................................................................................................ 36
6.10.1 Storing recordings .............................................................................................. 36
6.10.2 Transferring recording from internal storage to USB storage device................. 36
7 Maintenance, servicing, repairs, and disposal ......................................................................... 37
7.1 Maintaining the product................................................................................................... 37
7.2 Maintenance .................................................................................................................... 37
7.3 Safety inspection in accordance with IEC 62353............................................................ 37
7.3.1 Visual inspection................................................................................................. 37
7.3.2 Electric measurements ....................................................................................... 37
7.3.3 Functional test .................................................................................................... 37
7.4 Repairing the product...................................................................................................... 37
7.5 Disposing of the product ................................................................................................. 38
8 Accessories and spare parts.................................................................................................... 39
8.1 Accessories ..................................................................................................................... 39
9 Electromagnetic compatibility .................................................................................................. 40
9.1 General notes on the operating environment .................................................................. 40
9.2 Accessories and cables................................................................................................... 40
9.3 Table 1 – Compliance level for immunity tests................................................................ 41
9.4 Table 2 – Test levels for proximity fields from HF wireless communications equipment 42
9.5 Table 3 – Test levels for radiated and conducted immunity tests................................... 43
9.6 Table 4 – Emission class and group................................................................................ 44
9.7 Table 5 – Recommended separation distances between portable and mobile HF
communications devices and the product ...................................................................... 45
10 Errors and messages................................................................................................................ 46
10.1 Troubleshooting............................................................................................................... 46

Table of contents
Instructions for use • TELECAM C3 TC100 • LZA600_EN_V2.0_02-2022_IFU_CE-MDR 5
11 Subsidiaries .............................................................................................................................. 47

General information
Instructions for use • TELECAM C3 TC100 • LZA600_EN_V2.0_02-2022_IFU_CE-MDR 6
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
TELECAM C3 TC100
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 • TELECAM C3 TC100 • LZA600_EN_V2.0_02-2022_IFU_CE-MDR 7
– 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 • TELECAM C3 TC100 • LZA600_EN_V2.0_02-2022_IFU_CE-MDR 8
2 Normal use
2.1 Intended use
The TELECAM C3 is a camera control unit for use with camera heads or videoendoscopes and
is used for visualizing and documenting endoscopic and microscopic procedures. The
TELECAM C3 has no direct contact with the human body.
2.2 Indications
The camera control units do not come into direct contact with the patient; instead, they are
used in conjunction with the corresponding accessories (videoendoscopes, camera, light
source, and monitor) and the applied parts for the purpose of visualizing and documenting
endoscopic and exoscopic procedures. Use is not restricted to certain medical disciplines.
2.3 Contraindications
No contraindications relating directly to the medical device are currently known. The
responsible physician must decide whether the foreseen application is admissible based on
the general condition of the patient.
2.4 Patient groups
There are no restrictions in terms of patient groups for this product.
2.5 Target user populations
The medical device may only be used by doctors and medical assistants with a relevant
specialist qualification.

Safety and warning
Instructions for use • TELECAM C3 TC100 • LZA600_EN_V2.0_02-2022_IFU_CE-MDR 9
3 Safety and warning
WARNING
Danger due to non-observance of warnings and safety notes
This chapter contains warnings and safety notes structured according to hazards and risks.
1. Carefully read and observe all warnings and safety notes.
2. Follow the instructions.
3.1 Serious incidents
A ‘serious incident’ includes incidents which, directly or indirectly, had, could have had or
could have any of the following consequences:
– Death of a patient, user, or another person
– Temporary or permanent serious deterioration in the medical condition of a patient, user,
or another person
– A serious threat to public health
The manufacturer and appropriate authority must be notified of all serious incidents.
3.2 Observing ambient condition
If the device is operated in an environment which is not suitable, patients, users and third
parties may be injured.
Always store and operate the product in the prescribed ambient conditions.
3.3 Combination with other components
The use of unauthorized devices and components or unauthorized changes to the product can
result in injuries.
Only combine the product with devices and components that are approved for combined
use by the manufacturer.
Do not modify this equipment without authorization of the manufacturer.
3.4 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.
3.5 Dangers from electrical current
An improper power supply may cause an electric shock and injure patients, users, or third
parties. All electrical installations in the operating room in which the product is connected and
used must meet applicable IEC standards.
Do not touch the output jacks of the product and the patient at the same time during use
Do not open the product.

Safety and warning
Instructions for use • TELECAM C3 TC100 • LZA600_EN_V2.0_02-2022_IFU_CE-MDR 10
Use either the power cord supplied by KARLSTORZ or a power cord which has the same
properties and which bears a national mark of conformity.
Make sure that the plug is completely clean and dry.
To ensure reliable protective earth grounding, connect the product to a properly installed
socket that is approved for use in the operation room. Routinely inspect the electrical plug
and cord and do not use if the inspection reveals damage.
Connect the product to a power supply with protective conductor.
If several products supplied with energy are used simultaneously, the patient leakage currents
accumulate. These leakage currents can exceed the limit values and injure patients
The patient applied parts of the simultaneously used products must be type BF or type CF.
3.6 Electromagnetic interference
The discharge of a defibrillator can cause image loss.
If the image has not recovered after 4seconds, switch the camera control unit off and on
again.
3.7 Product not clean
The product is not clean when delivered. The use of products that have not been cleaned
poses a risk of infection for patients, users, and third parties.
Reprocess the product in line with the reprocessing instructions before initial use and
every subsequent use.
3.8 Failure of devices
The product may fail during use.
Perform an equipment test before use.
If the image fails during the procedure, remove the camera from the endoscope and
continue the procedure optically.
If the surgery cannot be continued optically, determination of how to further the procedure
is at the physician's discretion based on the surgical circumstances.
Have a replacement system ready for each application.

Product description
Instructions for use • TELECAM C3 TC100 • LZA600_EN_V2.0_02-2022_IFU_CE-MDR 11
4 Product description
4.1 Product overview
The TELECAM C3 is a camera control unit for endoscopic image display and documentation.
An intuitive user interface ensures simple and quick access as well as rapid understanding of
menu navigation. Click here for a detailed description of the functions see chapter User
interface [p.28].
4
1235
1On/Off switch 4 X-Line camera connection
2 White balance 5 USB 2.0 (1x)
3 C-Line camera connection

Product description
Instructions for use • TELECAM C3 TC100 • LZA600_EN_V2.0_02-2022_IFU_CE-MDR 12
12 2 3 3 45
1 Potential equalization 4 LAN interface
2 DVI output (2x) 5 Power cord socket
3 USB 2.0 (4x)
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.
Compatible camera heads for X-Line connection
Item Order no.
IMAGE1 S HX TH110
IMAGE1 S HX-P TH111
IMAGE1 S D1 TH115
IMAGE1 S D1 TH116
Compatible camera heads for C-Line connection
Article Order no.
H1 Camera head TH130
Compatible videoendoscopes for X-Line connection
ENT

Product description
Instructions for use • TELECAM C3 TC100 • LZA600_EN_V2.0_02-2022_IFU_CE-MDR 13
Article Order no.
CCD Video Rhino-Laryngoscope 11101VP/VN
Strobo video rhino-laryngoscope 11101VPS, 11101VNS
HD Video Rhino-Laryngoscope 11101 HD
Urology
Item Order no.
Video uretero-renoscope FLEX-XC 11278VSU, 11278VSUE
Video uretero-renoscope FLEX-XC 11278VS, 11278VSU
Flexible video urethro-cystoscope 11272VP, 11272VN
Flexible video urethro-cystoscope 11272VPU, 11272VNU
Flexible video cystoscope 11272VH, 11272VHU
Broncho
Item Order no.
Video bronchoscope 11900BP, 11900BN
Video bronchoscope HD 11910T, 11910D
Video bronchoscope 11910P, 11910S
Video mediastinoscope 10973HD
Surgery
Item Order no.
Flexible video choledochoscope 11292VP, 11292VPU
Flexible video choledochoscope 11292VS, 11292VSU
Gastroscopy
Item Order no.
Slim gastroscope, 5.9/2/1100/PAL
Slim gastroscope, 5.9/2/1100/NTSC
13820PKS, 13820NKS
Gastroscope 9.3/2.8/1100 PAL
Gastroscope 9.3/2.8/1100 NTSC
13821PKS, 13821NKS
Duodenoscope 12.6/4.2/1260 PAL
Duodenoscope 12.6/4.2/1260 NTSC
13885PKS, 13885NKS
Standard colonoscope 3.8/1400 PAL
Standard colonoscope 3.8/1400 NTSC, set
13924PKS, 13924NKS
Standard colonoscope 3.8/1600 PAL
Standard colonoscope 3.8/1600 NTSC
13925PKS, 13925NKS
Medium gastroscope 7.8/2.8/1100 PAL
Medium gastroscope 7.8/2.8/1100 NTSC
13823PKS, 13823NKS
Slim colonoscope 11.2/3.4/1330 PAL
Slim colonoscope 11.2/3.4/1330 NTSC
13926PKS/NKS

Product description
Instructions for use • TELECAM C3 TC100 • LZA600_EN_V2.0_02-2022_IFU_CE-MDR 14
Item Order no.
Slim colonoscope 11.2/3.4/1530 PAL
Slim colonoscope 11.2/3.4/1530 NTSC
13927PKS, 13927NKS
Sigmoidoscope 11.2/3.4/800 PAL
Sigmoidoscope 11.2/3.4/800 NTSC
13920PKS, 13920NKS
Gastroscope 12/2.8–3.8/1100 PAL
Gastroscope 12/2.8–3.8/1100 NTSC
13826PKS, 13826NKS
FRIMBERGER duodenoscope, PAL
FRIMBERGER duodenoscope, NTSC
13885FPKS, 13885FNKS
Colonoscope 12.9/3.8/1400 PAL
Colonoscope 12.9/3.8/1400 NTSC
13924HPKS, 13924HNKS
Colonoscope 12.9/3.8/1600 PAL
Colonoscope 12.9/3.8/1600 NTSC
13925HPKS, 13925HNKS
Proctology
Item Order no.
TROIDL rectoscope, flexible, PAL
TROIDL rectoscope, flexible, NTSC
13912PKS, 13912NKS
Veterinary
Item Order no.
FLEX-XC Veterinary 60278VS, 60278VSU
Veterinary videoendoscope PV-SG 28-140 60714PKS, 60714NKS
Veterinary videoendoscope PV-G 28-140 60914PKS, 60914NKS
Veterinary videoendoscope PV-G 28-180 60118PKS, 60118NKS
Veterinary videoendoscope PV-G 28-250 60125PKS, 60125NKS
Veterinary videoendoscope PV-G 28-300 60130PKS, 60130NKS
Veterinary videoendoscope PV-G 34-325 60332PKS, 60332NKS
Veterinary videoendoscope PV-SG 20-110 60511PKS, 60511NKS
Compatible videoendoscopes for C-Line connection
Anesthesia
Item Order no.
C-MAC S Imager 8403XS
C-MAC S Imager 8403XSI
C-MAC S Pediatric Imager 8403XSP
C-MAC Video laryngoscope MAC #0 8403EXC
C-MAC Video laryngoscope MAC #2 8403KXC
C-MAC Video laryngoscope MAC #3 8403AX
C-MAC Video laryngoscope MAC #3 8403AXC

Product description
Instructions for use • TELECAM C3 TC100 • LZA600_EN_V2.0_02-2022_IFU_CE-MDR 15
Item Order no.
C-MAC Video laryngoscope MAC #4 8403BX
C-MAC Video laryngoscope MAC #4 8403BXC
C-MAC Video laryngoscope D-BLADE 8403HX
C-MAC Video laryngoscope D-BLADE, Ped. 8403HXP
C-MAC Video laryngoscope MIL #0 8403DXC
C-MAC Video laryngoscope MIL #1 8403GXC
C-MAC Video laryngoscope MIL #2 8403MXC
Flex. Intubation Videoscope 11301ABX
Flex. Intubation Videoscope 11302BDX
Flex. Intubation Videoscope 11303BNX
Flex. Intubation Videoscope 11304BCX
C-MAC VS 10331BX
ENT
Article Order no.
CMOS Video Rhino-Laryngoscope 11102CM
Video Esophagoscope 13303E
Urology
Article Order no.
CMOS Video Cystoscope-Urethroscope 11272VE/VUE
Compatible disposable videoendoscopes for C-Line connection
Item Order no.
FIVE S 3.5x65, sterile, for single use 091361-01
CMOS Video Esophagoscope SSU 091370-01
CMOS Video Rhino-Laryngoscope SSU 091330-01
FIVE S 5.3x65, sterile for single use 0915612-01
Video-uretero-renoscope FLEX-XC1 091271-01
Video-uretero-renoscope FLEX-XC1 091279-01
4.3 Technical data
TELECAM C3 TC100
Power supply (AC) 100–240V
Operating frequency 50/60Hz
Power input 100–135VA
Electrical protection class I

Product description
Instructions for use • TELECAM C3 TC100 • LZA600_EN_V2.0_02-2022_IFU_CE-MDR 16
TELECAM C3 TC100
Applied part type according to IEC 60601-1 CF (X-Line)
BF (C-Line)
Dimensions (WxHxD): 305mm x 77mm x 339mm
Weight 2.75kg
Memory device
Memory interface USB
Image format JPEG
(Audio)/video format MPEG-4
Internal memory size 50GB
Interfaces
Service port RJ45
Video interface 2x DVI-D output
Footswitch connection USB
4.4 Symbols employed
4.4.1 Symbols on the packaging
Symbol Meaning
Manufacturer
Date of manufacture
Medical device
Article no.
Serial number
Number of products in the product packaging
Unique Device Identifier
Consult the printed or electronic instructions for use

Product description
Instructions for use • TELECAM C3 TC100 • LZA600_EN_V2.0_02-2022_IFU_CE-MDR 17
Symbol Meaning
Note for the user to consult the instructions for use for important cau-
tionary information such as warnings and precautions.
Fragile, handle with care
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 directives relevant to the product can be found in the EU Decla-
ration of Conformity, which can be requested from KARLSTORZ.
This side up
4.4.2 Symbols on the product
Symbol Meaning
Follow the instructions for use.
The color may differ on the product. The symbol is black/white on the
packaging label.
Ready/standby button
USB
Applied part type BF
White balance
Applied part type CF defibrillation protection
Potential equalization connector

Product description
Instructions for use • TELECAM C3 TC100 • LZA600_EN_V2.0_02-2022_IFU_CE-MDR 18
Symbol Meaning
Prevention of pollution by electronic devices
Separate collection of electrical and electronic devices.
Do not dispose of in household refuse.
Consult the printed or electronic instructions for use
4.4.3 Symbols on the user interface
Symbol Meaning
White Balance
Performs the white balance.
Freeze
Freezes the image. During this time, the live image is shown in the top
right-hand corner of the monitor.
Zoom
Digitally magnifies the display.
Orientation
Flips the displayed image vertically or horizontally or rotates it through
180°.
Enhance
Sets the digital fiberscope filter (anti-moiré filter or anti-grid filter) to two
levels (A, B). These filters reduce interfering artifacts, such as the moiré ef-
fect and display of the fiberscope grid.
Use filter A to reduce small honeycomb-like grids.
Use filter B to reduce larger honeycomb-like grids.
Light
Turns the light source on or off.
Close
Exits the Quick menu. Alternatively, exit the menu using the ESC button
on the keyboard.
The Close button appears only if a keyboard is used or the product is op-
erated via the camera head buttons.
Still
Captures a still image.

Product description
Instructions for use • TELECAM C3 TC100 • LZA600_EN_V2.0_02-2022_IFU_CE-MDR 19
Symbol Meaning
Video
Starts or stops a video recording.
Training Mode
Displays a circle in the center of the image. The training mode can be
used specifically for endoscopy training.
Brightness
Sets the brightness of the camera.
Print
Immediately prints all images in the print queue. This button appears only
if a printer is connected.
Swap Cameras
Toggles between two connected cameras.
Function Space
Selects various camera functions or changes the product settings.
Setup
Changes general product settings.
Display Language
Selects the language for the user interface.
Keyboard Language
Selects the language for the on-screen keyboard. The selected keyboard
language is used for an external keyboard.
DVI Signal Output
Selects the image refresh rate between 50 and 60Hz for the DVI output.
The product has to be restarted after the frequency is changed.
Date and time
Sets the date, time, and display format.
Patient Management
Manages the settings for handling patient data.

Product description
Instructions for use • TELECAM C3 TC100 • LZA600_EN_V2.0_02-2022_IFU_CE-MDR 20
Symbol Meaning
Module information
Calls up all the necessary information on the system and the connected
camera heads or videoendoscopes.
Quick menu settings
Configures the Quick menu.
Software Update
Updates the software of the product and of the connected camera heads
and videoendoscopes.
Software Licenses
A list of the open source software included in the product, and the open
source software license terms can be viewed here.
Logged Events
Displays the system log and exports it via USB.
Via Audit Logs, you can view the audit log and export it via USB.
Reset
Resets the product to its factory settings.
Access and Security
Manages access to sensitive areas of the system.
Camera
Calls up the item number, name, and camera head button assignment of a
connected compatible camera head.
Foot Switch
Calls up the item number, name, and button assignment of a connected
compatible footswitch.
Printer
Calls up the printer configuration of a connected compatible printer.
USB Storage
Calls up the storage space currently used as well as the free storage
space.
Internal Storage
Calls up the storage space currently used as well as the free storage
space. Transfers stored data to a USB storage device.