Karl Storz TELE PACK + User manual

Instructions for use
TELE PACK +
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.
08-2022

Table of contents
Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_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 Target user populations ............................................................................................................. 8
2.5 Patient population ...................................................................................................................... 8
3 Safety and warning ............................................................................................................................ 9
3.1 Serious incidents........................................................................................................................ 9
3.2 Product not clean....................................................................................................................... 9
3.3 Correct handling and product testing ........................................................................................ 9
3.4 Combination with other components......................................................................................... 9
3.5 Dangers from electrical current.................................................................................................. 10
3.6 Electromagnetic interference ..................................................................................................... 10
3.7 High light intensity...................................................................................................................... 10
3.8 Hot components ........................................................................................................................ 10
3.9 Failure of products ..................................................................................................................... 10
3.10 Observing ambient conditions ................................................................................................... 11
3.11 Risk of explosion and fire........................................................................................................... 11
3.12 Image failure during HF application ........................................................................................... 11
4 Product description............................................................................................................................ 12
4.1 Product overview ....................................................................................................................... 12
4.2 Possible combinations ............................................................................................................... 13
4.2.1 Camera heads............................................................................................................... 13
4.2.2 Videoendoscopes ......................................................................................................... 13
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 type plate ............................................................................................ 18
4.4.4 Symbols on the user interface ...................................................................................... 19
4.5 Ambient conditions .................................................................................................................... 23
5 Preparation......................................................................................................................................... 24
5.1 Unpacking the product .............................................................................................................. 24
5.2 Setting up the product ............................................................................................................... 24
5.3 Connecting the product ............................................................................................................. 25
5.4 Connecting external devices...................................................................................................... 26
5.5 Connecting the light cable ......................................................................................................... 27
5.6 Mounting the camera head holder ............................................................................................. 27
5.7 Functional test............................................................................................................................ 28

Table of contents
Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 4
6 Application ......................................................................................................................................... 29
6.1 Switching the product on and off .............................................................................................. 29
6.2 Camera head buttons ................................................................................................................ 29
6.3 Keyboard and mouse................................................................................................................. 29
6.4 User interface............................................................................................................................. 29
6.5 Quick menu configuration.......................................................................................................... 31
6.6 Connected accessories ............................................................................................................. 32
6.6.1 Camera head and videoendoscope.............................................................................. 32
6.6.2 Footswitch .................................................................................................................... 32
6.6.3 Storage medium ........................................................................................................... 32
6.6.4 Printer ........................................................................................................................... 32
6.7 Performing a stroboscopy ......................................................................................................... 33
6.8 Viewing image material .............................................................................................................. 34
6.9 Access and security concept..................................................................................................... 34
6.9.1 Password encryption .................................................................................................... 34
6.9.2 Role-based access system with user accounts ........................................................... 34
6.9.3 Memory functionality .................................................................................................... 35
6.10 Patient data security .................................................................................................................. 36
6.10.1 Patient handling ............................................................................................................ 36
6.10.2 Labeling ........................................................................................................................ 37
6.10.3 Export mode ................................................................................................................. 37
6.11 Network communication ............................................................................................................ 37
6.11.1 FileShare mode............................................................................................................. 37
6.11.2 FileShare settings ......................................................................................................... 38
6.11.3 Worklist mode............................................................................................................... 38
6.11.4 Worklist settings ........................................................................................................... 39
6.11.5 Network dialog.............................................................................................................. 40
6.11.6 Local settings................................................................................................................ 41
7 Maintenance, servicing, repairs, and disposal................................................................................... 42
7.1 Maintaining the product ............................................................................................................. 42
7.1.1 Maintenance ................................................................................................................. 42
7.2 Safety inspection in accordance with IEC 62353 ...................................................................... 42
7.2.1 Visual inspection........................................................................................................... 42
7.2.2 Electric measurements ................................................................................................. 42
7.2.3 Functional test .............................................................................................................. 42
7.3 Repairing the product ................................................................................................................ 42
7.4 Disposing of the product ........................................................................................................... 43
8 Accessories and spare parts.............................................................................................................. 44
8.1 Accessories................................................................................................................................ 44
9 Electromagnetic compatibility............................................................................................................ 45
9.1 General notes on the operating environment ............................................................................ 45
9.2 Accessories and cables ............................................................................................................. 45
9.3 Table 1 – Compliance level for immunity tests .......................................................................... 46
9.4 Table 2 – Test levels for near fields from HF wireless communications equipment .................. 47
9.5 Table 3 – Test levels for radiated and conducted immunity tests ............................................. 48
9.6 Table 4 – Emission class and group .......................................................................................... 49
9.7 Table 5 – Recommended separation distances between portable and mobile HF
communications devices and the product................................................................................. 49
10 Errors and messages ......................................................................................................................... 51

Table of contents
Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 5
10.1 Troubleshooting ......................................................................................................................... 51
11 Overview of mitigating warnings ........................................................................................................ 52
12 Subsidiaries........................................................................................................................................ 53

General information
Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_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
TELE PACK + TP101
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 • TELE PACK + • CQH848_EN_V2.0_08-2022_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 • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 8
2 Normal use
2.1 Intended use
The TELE PACK + is a combination device comprising a light source for illumination, camera control
unit for image processing and documentation, as well as a monitor for visualization. It is designed for
endoscopic diagnostic and surgical procedures as well as for stroboscopy.
2.2 Indications
Compact devices with corresponding accessories are suitable for all diagnostic and therapeutic
procedures that, in order to be performed successfully, require the energy/materials/parameters
provided by the applicable device as per the "Technical data" section of the instruction manual.
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 Target user populations
The medical device may only be used by doctors and medical assistants with a relevant specialist
qualification.
2.5 Patient population
There are no restrictions in terms of patient groups for this product.

Safety and warning
Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_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 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.
3.3 Correct handling and product testing
If the product is not handled correctly, patients, users, and third parties may be injured.
Only persons with the necessary medical qualification and who are acquainted with the
application of the product may work with it.
Check that the product is suitable for the procedure prior to use.
Check the product for the following properties, for example, before and after every use:
– Functionality
– Damage
– Changes to the surface
– In the case of several components: completeness and correct assembly
Do not continue to use damaged products.
Dispose of the product properly.
3.4 Combination with other components
The use of unauthorized devices and components may result in injuries.
Ensure that any additional devices connected to electrical medical devices comply with the
relevant IEC or ISO standards.
Ensure that all configurations comply with the requirements for medical electrical systems.
Only combine the product with devices and components that the manufacturer has approved for
combined use, see chapter Possible combinations.
Only make changes to the product if these changes are approved by KARLSTORZ.

Safety and warning
Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 10
Only use devices and components that have standardized interfaces and do not breach the
normal use of the product.
3.5 Dangers from electrical current
An improper power supply may cause an electric shock and injure patients, users, or third parties.
Use either the power cord supplied by KARLSTORZ or a power cord which has the same
properties and which bears a national mark of conformity.
The product may only be operated with the line voltage stated on the rating plate.
Position the product appropriately so that the power cord can be unplugged at any time. The
product is only voltage-free when the mains plug has been disconnected.
Ensure potential equalization according to the applicable national rules and regulations.
Connect the product to a power supply with protective conductor.
In the case of electrical products, individual components or the product itself may be live. Live parts
can cause electric shocks in the event of contact and injure patients, users, and third parties.
Do not open the product.
Have servicing carried out by KARLSTORZ or a company authorized by KARLSTORZ.
Do not touch the output jacks of the product and the patient at the same time during use
Always pull out the mains plug before carrying out any cleaning and maintenance work.
3.6 Electromagnetic interference
Medical electrical devices are subject to special precautions regarding electromagnetic compatibility.
If other devices (e.g., MRT, CT, diathermy, electrocautery, or RFID) emit electromagnetic radiation, the
product’s functionality may be impaired. High-frequency (HF) communication equipment can affect
electrical medical devices and impair their performance.
During installation and operation of the product, please take note of the information on
electromagnetic compatibility, see chapter Electromagnetic compatibility.
3.7 High light intensity
The high level of light intensity produced by the light source may lead to permanent eye damage or
blindness, and may cause tissue and items facing the light output to heat up.
Do not look into the light output.
Set the output of the adjustable light sources to a level that is just high enough to ensure optimal
illumination of the operating area.
Make sure the light output is sufficiently far away from tissue and operating accessories.
3.8 Hot components
The high level of light intensity produced by the light source may cause the distal end, the light
connections, and adjacent components to heat up. This can cause burns to patients, users, and third
parties.
Set the output of the adjustable light sources to a level that is just high enough to ensure optimal
illumination of the operating area.
Prevent the distal end, light connections, and adjacent components from coming into contact
with tissue and operating room accessories.
3.9 Failure of products
The product may fail during use.

Safety and warning
Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 11
Have a replacement product ready for each application or plan for an alternative surgical
technique.
3.10 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.
3.11 Risk of explosion and fire
The product can generate sparks, which cause combustible or flammable gases and liquids to ignite
or explode. This may cause injuries to patients, users, and third parties.
When using explosive narcotic gases: Operate the product outside of the hazard zone.
Do not use the product in the presence of flammable anesthetics.
The product must not be operated in oxygenated environments.
Only connect or disconnect the power plug to or from the power supply outside explosive
atmospheres.
3.12 Image failure during HF application
If the product is used together with a high frequency surgical unit, accidental contact between the
active electrode and the metal parts of the endoscope can cause the image to fail.
Make sure that the working part of the active electrode is in the user’s field of view.
Avoid contact between the active electrode and metal parts of the endoscope.
If the image has failed, proceed as follows:
Stop use immediately.
If the image has not reappeared after 4seconds, switch the camera control unit off and on again.

Product description
Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 12
4 Product description
4.1 Product overview
123
7
8
4
5
6
TELE PACK+ (TP101) – front view
1 Touch screen 5 Camera connection 2: X-Line
2 USB 2.0 (2x) 6 Lateral connection area
3 Connection for stroboscopy microphone 7 Light connection
4 Camera connection: 1 C-Line 8 ON/OFF button
12
3
4
5
6
7
8
9
10
11
12
13
TELE PACK+ (TP101) – rear view
1 Carrying handle 8 Mains socket
2 Speaker/headphone connection 9 Potential equalization connector
3 Microphone connection 10 Speaker
4 DVI Out (external monitor) 11 VESA 100 suspension

Product description
Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 13
5 USB 2.0 (4x) 12 Cable manager
6 Network socket 13 Mount for camera head holder
7 Kensington lock slot
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.
4.2.1 Camera heads
X-Line connection
Item Order no.
IMAGE1 S HX TH110
IMAGE1 S HX-P TH111
IMAGE1 S D1 TH115
IMAGE1 S D1 TH116
C-Line connection
Article Order no.
H1 Camera head TH130
4.2.2 Videoendoscopes
X-Line connection
Item Order no.
CCD Video Rhino-Laryngoscope 11101VP
CCD Video Rhino-Laryngoscope 11101VN
Strobo Video Rhino-Laryngoscope 11101VPS
Strobo Video Rhino-Laryngoscope 11101VNS
HD Video Rhino-Laryngoscope 11101HD
Video uretero-renoscope FLEX-X C 11278VSU
Video uretero-renoscope FLEX-X C 11278VSUE
Video uretero-renoscope FLEX-X C 11278VS
Video uretero-renoscope FLEX-X C 11278VSU
Flexible video urethro-cystoscope 11272VP
Flexible video urethro-cystoscope 11272VN
Flexible video urethro-cystoscope 11272VPU
Flexible video urethro-cystoscope 11272VNU
Flexible HD video cystoscope 11272VH

Product description
Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 14
Item Order no.
Flexible HD video cystoscope 11272VHU
Video bronchoscope 11900BP
Video bronchoscope HD 11910T
Video bronchoscope HD 11910D
Video bronchoscope 11910P
Video bronchoscope 11910S
Video choledochoscope 11292VP
Video choledochoscope 11292VPU
Video choledochoscope 11292VS
Video choledochoscope 11292VSU
Veterinary videoendoscope 60278VS
Veterinary videoendoscope 60278VSU
Video Mediastinoscope 10973HD
C-Line connection
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
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
CMOS Video Rhino-Laryngoscope 11102CM

Product description
Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 15
Item Order no.
Video Esophagoscope 13303E
FIVE S 3.5x65, sterile, for single use 091361-01
FIVE S 5.3x65, sterile for single use 0915612-01
CMOS Video Esophagoscope SSU 091370-01
CMOS Video Rhino-Laryngoscope SSU 091330-01
CMOS Video Cysto-Urethroscope 11272VE
CMOS Video Cysto-Urethroscope 11272VUE
CMOS Video Cystoscope-Urethroscope (US
only)
11272VUE-R
Video-uretero-renoscope FLEX-XC1 091271-01
Video-uretero-renoscope FLEX-XC1 091279-01
4.3 Technical data
Description Value
Power supply (AC) 100–240V
Operating frequency 50/60Hz
Power input 140VA
Electrical protection class I
Applied part type according to IEC 60601-1 CF
Dimensions (LxHxW) 209x388x469mm
Weight 8.9kg
Light source
Lamp LED
Color temperature 5,700K
Display
Screen size 18.5"
Contrast 1,200 : 1
Resolution 1,920x1,080p
Speaker
Power 3.2W
Memory device
Memory interface USB
Image format JPEG
(Audio)/video format MPEG-4
Interfaces
Network interface RJ-45 x Gbit

Product description
Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 16
Description Value
Video interface 1x DVI-D
Audio 3.5mm jack (in/out – rear), KARLSTORZ stro-
boscopy microphone (1xlateral)
Footswitch connection USB
Printer connection USB
Printer languages PostScript
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
Note for the user to consult the instructions for use for important cautionary in-
formation such as warnings and precautions.
Fragile, handle with care
Keep dry
Temperature limit

Product description
Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 17
Symbol Meaning
Humidity limit
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 product
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 Declaration
of Conformity, which can be requested from KARLSTORZ.
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 packag-
ing label.
Ready/standby button
Network connection
USB
Applied part type BF
Applied part type CF defibrillation protection
Potential equalization connector
Line out

Product description
Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 18
Symbol Meaning
Microphone input
Lateral stroboscopy microphone input
Hot surface
4.4.3 Symbols on the type plate
Symbol Meaning
Manufacturer
Date of manufacture
Medical device
Article no.
Federal (USA) law restricts this device to sale by or on the order of a physician.
Separate collection of electrical and electronic devices.
Do not dispose of in household refuse.
Prevention of pollution by electronic devices
CE marking
With this marking, the manufacturer declares the conformity of the product
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 Declaration
of Conformity, which can be requested from KARLSTORZ.

Product description
Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 19
4.4.4 Symbols on the user interface
Symbol Meaning
Full screen
Displays the endoscopy image in full screen mode (the user interface no longer
appears).
White balance
Performs 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
The digital fiberscope filter (anti-moiré/anti-grid filter) can be set to two levels (A,
B). These filters are able to reduce interfering artifacts, such as the moiré effect
and display of the fiberscope grid. If the honeycombed grid structures are rela-
tively small in the image, Filter A is recommended. Filter B is recommended in
the case of larger honeycomb structures.
Light
Turns the light source on or off.
Light source
Displays and changes the light source settings. Turns the light source on and
off.
Exit
Exits the Quick menu. Alternatively, exit the menu using the ESC button on the
keyboard.
The button appears only if a keyboard is used or the product is operated via the
camera head buttons.
Image capture
Captures a still image.

Product description
Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 20
Symbol Meaning
Video recording
Starts or stops a video recording.
Training mode
Displays a circle in the center of the image. Training mode can be used specifi-
cally for endoscopy training.
Camera 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 and changes the product settings.
Setup menu
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 lan-
guage is used for an external keyboard.
Stroboscopy settings
Sets the speed of the visible vocal cord movement between 0.2 and 2.5Hz. The
setting is displayed in Δ Hz when slow motion mode is activated.
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.