Tele Pack

en Instructions for use
TELE PACK +
08-2022
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.
Table of contents
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
Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 3

Table of contents
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
10.1 Troubleshooting ......................................................................................................................... 51

11 Overview of mitigating warnings ........................................................................................................ 52
12 Subsidiaries ........................................................................................................................................ 53

General information
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:
ü Prerequisite that must be met before carrying out an action.
1. Step 1
ð Interim result of an action
2. Step 2
ð Result 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
– 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
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
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
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
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
4 Product description
4.1 Product overview
1 2 3
8 7 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
1 2
4
5
6
7
13 12 11 10 9
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
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
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
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 11272VUE-R
only)
Video-uretero-renoscope FLEX-XC1 091271-01
C1
Video-uretero-renoscope FLEX-X 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
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
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
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
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
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.

Product description
Symbol Meaning
Patient management
Manages the settings for handling patient data.
Module information
Calls up the all the necessary information on the system and the connected
camera heads and videoendoscopes.
Quick menu settings

Configures the Quick menu.
Network settings
Specifies the settings and the user-defined storage location. The network func-
tion can be used in FileShare mode or in Worklist mode.
In FileShare mode, the generated data is automatically moved to an FTP server.
The Local and FileShare tab must be configured.
In Worklist mode, patient data can be retrieved from the worklist server, se-
lected, and then stored on the worklist server again.
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 either via USB or the selected FTP
server.
Via Audit logs, you can view the audit log and export it via either USB or the se-
lected FTP server.
Factory settings
Resets the product to its factory settings.
Access and security

Manages access to sensitive areas of the system.
Image viewing
Displays a captured still image.
The image does not correspond to the live image.

Product description
Symbol Meaning
Video viewing
Shows a recorded video.
The video does not correspond to the live image.
Network connection active
Network connection disconnected
Camera
Footswitch
Printer
USB storage
Internal storage
Adds new functions to the Quick menu.
Moves the selected function upward in the Quick menu.

Product description
Symbol Meaning
Pressing the Delete button removes the selected function from the Quick menu.
Pressing the Replace button replaces the selected function with a different
function.
Moves the selected function downward in the Quick menu.
4.5 Ambient conditions

Storage and transport conditions
Temperature -18°C ... +60°C (-0.4°F ... 140°F)
Relative humidity 5–85%
(non-condensing)
Air pressure 600–1,080 hPa
Operating conditions
Temperature 0°C ... 40°C (32°F ... 104°F)
Relative humidity 15–80%
(non-condensing)
Max. operating altitude 3,000 m
Air pressure 700–1,080 hPa

Preparation
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 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 Setting up the product

WARNING
Blocked air inlets and air outlets! Risk of fire!
If the air inlets and outlets are blocked, the product may overheat. This can cause the product to fail
and start a fire. Users, patients, and third parties may be injured.
Remove any blockages in the air inlets and outlets when setting up the product.
CAUTION
Breakable glass! Risk of injury!
The front glass will break if the product is dropped or sustains a significant impact. Patients, users, or
third parties can injure themselves on broken glass.
Do not touch broken glass.
Do not continue to use the product.
Do not touch the glass parts of the product.
Remove small glass parts from the product.
Have the product repaired by qualified service personnel.
The product can be operated free-standing, on a video cart, or in a rack.

1. Place the product on a horizontal, flat surface.
2. Keep the product out of reach of patients.
3. Keep air inlets and outlets clear.
4. Ensure adequate air circulation.

Preparation
5.3 Connecting the product

1. Connect the potential equalization cable.
2. Connect the potential equalization cable to the outlet in the treatment room.
3. Connect the power cord. Push the power plug fully into the power socket.
4. Connect the other end of the power cord to the mains socket.
5. Connect the network cable.

Preparation
5.4 Connecting external devices

1. Connect the required peripheral devices to the USB interfaces.
2. Connect the camera head. Push the connector fully into the respective socket.
3. Connect the microphone cable.

Preparation
4. Connect an external monitor to the DVI D-video output.
5.5 Connecting the light cable

WARNING
Hot light connections! Risk of burns!
The high level of light intensity produced by the light source may cause the light connections and
adjacent components to heat up. This can cause burns to users and third parties.
Switch off the light source before changing the light cable.
Allow the product to cool down before changing the light cable.
1. Insert the light cable into the light connection until the light cable engages. Hold the light cable
only by the handle, never by the cable.
5.6 Mounting the camera head holder

Using the camera head holder (TP002), the camera head can be stored between two interventions,
and a light cable can be attached to the mount provided.
1. Make sure that the light source is switched off.
2. Connect the light cable to the camera head holder.

Preparation
3. Remove the screws on the rear left side of the product using a screwdriver.
4. Place the mount for the camera head holder on the product.
5. Turn the screws into the two holes using a screwdriver.
6. Place the camera head holder on the mount. The holder can be placed in 2 positions to ensure
proper function and to stow the holder for transport in case of mobile use.
5.7 Functional test

1. Check the product and the camera head or videoendoscope for external damage.
2. Ensure that the camera head cable or videoendoscope cable is not damaged or kinked.
3. Switch on the product.
4. Press the Light button in the menu.
5. Start the light source.
6. Point the camera head or videoendoscope toward an object and check the quality of the
display.
ð The product can be used after a successful functional test.

Application
6 Application
6.1 Switching the product on and off
1. Press and hold the ON/OFF for 2.4 seconds button to start the product.
2. Press and hold the ON/OFF button for 2.4 seconds to switch off the product.
6.2 Camera head buttons

All compatible camera heads and X-Line videoendoscopes feature three buttons for retrieving
programmed functions and for menu control:
– Scroll down: Scrolls down the menus or options.
– Scroll up: Scrolls up the menus or options.
– Menu/selection: Access to the Quick menu. A highlighted option is activated.
1 2 3
1 Scroll down 3 Menu/selection

2 Scroll up
6.3 Keyboard and mouse

The following external peripheral devices are required to work with the device:
Action Peripheral device

Entering patient data Keyboard
Navigating in menus Keyboard or mouse
Connect the peripheral device to the USB interface on the device.
6.4 User interface

The user interface is subdivided into the following areas:

Application
1 2
3
1 Patient area 3 Function space (access to the Setup
menu)
2 Information panel 4 Quick menu
Patient area
Depending on the configuration, the patient area allows one or several patient data sets to be entered
manually or patient data sets to be retrieved and selected from a patient worklist. In order to
successfully create a patient, the Last name and (in the case of network storage) the Date of birth
fields have to be filled in. After the treatment, images and videos of the current treatment can be
viewed, see chapter Viewing image material [p. 34].
Quick menu
Camera functions can be selected and settings changed in the Quick menu. Functions that are
unavailable are grayed out. If the product is operated using the camera head buttons or the keyboard,
the Quick menu can be accessed by pressing ENTER on the keyboard or the Menu button on the
camera head or videoendoscope. The configuration of the icons in the Quick menu can be changed in
the Setup menu. Some icons in the Quick menu are grayed out until a camera head is connected.
Function space
Camera functions can be selected and settings changed using the function space. The function space
contains all functions that were not configured in the Quick menu. Some icons in the function space
are grayed out until a camera head is connected.
Setup menu
The general settings can be changed in the Setup menu.
Information area
The information area consists of the Information bar and the Information panel. The information bar
provides an overview of the system status. More information on the system status and the connected
accessories can be found in the information panel. The information panel can be accessed via the i-
icon.

Application
6.5 Quick menu configuration

The configuration menu is divided into 3 columns. The functions can be moved, replaced, added, or
removed. Up to 8 functions can be added in total. The configuration is saved by restarting the
product.
1 2 3
1 Quick Menu 3 Select Function

2 Command
To change the configurations, press the Quick Menu button in the Setup menu.

Application
6.6 Connected accessories

6.6.1 Camera head and videoendoscope
The camera head button assignment is shown true to original.
1. Connect a camera head or videoendoscope.
2. Select the connected device from Connected Devices in the info panel.
3. Press the Settings button to change the button assignment.
The camera head button assignment cannot be changed on all videoendoscopes. This depends on
whether the camera head button assignment is fixed on the videoendoscope.
If two camera heads/videoendoscopes are used, it must be ensured that the correct source was
selected for the application concerned.
6.6.2 Footswitch
The following information can be retrieved using the footswitch:
– Article no.
– Article name
– Button assignment
6.6.3 Storage medium

If the internal storage option is used, the recorded data can be transferred to a USB storage medium.
Internally stored data are deleted after successful transfer in order to create space for new recordings.
6.6.4 Printer
The following functions can be configured if a printer is connected:
– Number of images per page
– Number of copies
– Print images during the current treatment

Application
6.7 Performing a stroboscopy

In stroboscopy mode, the integrated LED light source is activated at the same time as the
microphone's audio signal.
1 2 3 4
1 Voice frequency in hertz (Hz) 3 Volume in decibels (dB)

2 Notation 4 Delta frequency (Δ Hz) in slow motion
mode
1. Plug the stroboscopy microphone (20140030) into the microphone input socket on the side.
2. Connect the stroboscopy footswitch (40160033) to the USB interface to activate the
stroboscopy function.
3. Press the footswitch in the presence of a microphone signal to start stroboscopy mode
automatically.
ð The stroboscopy-specific parameters will appear.
4. Release the footswitch to close stroboscopy mode and return to steady light mode.
5. Press the stroboscopy footswitch twice in quick succession to start or stop the video recording.
The freeze frame function is active in the upper area of the pedal movement range, meaning that the
vibration of the vocal cords appears as a static image. The respective phase or the position of the
vocal cords can be adjusted within the range of 0 to 360 degrees using the footswitch.
Pressing the footswitch down beyond the pressure point activates the slow motion function. The
vocal cords appear at the preset slow motion frequency.
6. Press the footswitch down beyond the pressure point to active the slow motion function.
ð The vocal cords appear at the preset slow motion frequency.
7. Select Settings > Stroboscopy > Slow motion to set the slow motion frequency to between 0.2
and 2.5 Hz.

Application
6.8 Viewing image material

After the treatment, recorded images and videos can be viewed before the current treatment is
completed. An overview of the recorded images and videos can be found in the patient area.
1. Open the Patient area menu to retrieve the recorded images and videos.
2. Select one of the following options:
– Display images in full screen mode
– Display and play videos in full screen mode
– Create screenshots
– View frames and scenes individually
– Select images for printing
– Delete images or videos
6.9 Access and security concept

There are two options for protecting the product and the sensitive areas of the menu from access by
unauthorized parties: Access via a password or via user accounts. One option must be selected
during the configuration process.
If the password is lost, the product's factory settings have to be restored. This will delete all settings
and patient data and the product will be returned to the default patient data privacy settings.
6.9.1 Password encryption

Selecting this option protects certain menus with a password.
The default password is [90290245] and must be changed.
6.9.2 Role-based access system with user accounts

When this option is selected, the user account has only limited access to sensitive areas.
1. Create an Administrator account.

Application
2. Define the password rules.

ð The password rules apply to all further passwords.
3. Create a new password.
4. Configure all further settings.
The following roles can be selected:
– Administrator: Full access to all functions and settings
– Operating room personnel: Access to patient data. No access to patient data security or storage
medium
– Technician: Access to device settings, e.g., updates. No access to patient data or other
sensitive areas.
All safety-relevant actions are recorded and saved by the system. KARL STORZ assumes no
legal liability or responsibility for the loss, accuracy, damage, or disclosure of patient data that
has been managed using the TELE PACK+.
6.9.2.1 Configuring a role-based access system

Additional user accounts can be created and existing ones can be edited or deleted. The maximum
number of user accounts is limited.
1. A name, the corresponding role, and a password have to be defined for each user account.
2. Under Login Message, enter a customized message to be shown in the login area before the
system grants access to sensitive areas.
3. Under Password Rules, specify whether and which rules are to be applied when passwords are
assigned.
4. Under Automatic Logout, specify whether the system is to log out a user after an individually
definable period of inactivity has expired.
ð Once the role-based access system has been activated, a further menu item with the name
Login appears in the main screen next to the information area.
5. Press Deactivate to deactivate the role-based access system.
ð The encryption of sensitive menus via password is activated automatically.
Under Login, all system users can log in using their user account and password. If no users are
logged in, certain areas such as the patient area and the settings for patient data security and memory
cannot be called up.
6.9.3 Memory functionality

The product comprises the following options:
– Internal storage
– USB storage
– Network storage
Depending on the configuration of the recording and storage options in the Setup menu under Access
and security, images and videos with patient data can be captured. The storage method can be
selected. For storage on the USB and the network, the internal storage is used for buffering. This
means data is first buffered in the internal storage and then transferred to the USB or network
directory. The transfer status of the data can be checked in the information area.
In order to store recordings without any loss of data, the Complete treatment button in the patient
area has to be pressed. The pending data is then transferred and saved properly. If no network
storage location has been configured or no USB storage medium is available, the internal storage
option can also be used. Approx. 50 GB of storage space are available for internal storage.

Application
Internally stored recordings can be removed from the internal storage only via USB export. If large
volumes of data are to be stored, a correspondingly large USB storage medium has to be available.
The current status of data transfer can be checked in the information area.
6.10 Patient data security

The system does not contain patient data as standard. The functions for managing patient data must
be activated first, e.g., input, access, display.
Upon activating the functions, the user assumes responsibility for all patient-related data that
are managed in accordance with the applicable national data protection laws.
In the Patient Data Privacy settings, all settings concerning patient information can be configured.
Patient information is available only if the corresponding settings have been made. The configuration
of the Patient Data Privacy menu is password-protected by default.
The Patient Data Privacy menu is divided into 3 areas:
– Patient handling
– Labeling
– Export mode
6.10.1 Patient handling
Worklist setup
The worklist setup specifies whether patient data is allowed to be used and how the patient data can
be processed on the TELE PACK+, whether this is via manual entry, patient worklist, or network
worklist providers.
Select the worklist setup:
– No Worklist / Patient Entry (selected by default)
– Local Worklist
– Worklist Provider
When working without entering patient data, the data in the information panel must be exported via
Transfer to USB.
Capture tools
Whether and how images and videos are to be recorded is defined in the capture tools:
– No Capture
– Capture Allowed (selected by default)
If Capture Allowed is selected, the following settings are available:
– Recording of images and videos with patient information
– Anonymous recording
Storage Limit
The storage limit specifies the period during which data sets are stored on the device. Patient data
sets in the worklist and media files are deleted if this is configured. The data cannot be recovered.
Select storage limit:
– Infinite
– Power cycle
– 1 day (selected by default)
– 7 days

Application
– 30 days
– 90 days
6.10.2 Labeling
1. Specify whether the digital recordings or prints are to be labeled with patient information or not.
2. Select one of the following options:
– No patient data in the patient folder (selected by default)
– Patient data in the patient folder
– Patient data on prints
6.10.3 Export mode

Export mode specifies the permitted form of data export. The data can be saved on the USB storage
medium or transferred to a network storage path. The two storage options can also be permitted in
parallel.
Select Export mode:
– No export
– USB (or USB anonymous) export (selected by default)
– Network export
– Network and USB export
6.11 Network communication

The product can be operated in network mode in order to place recorded data at a user-defined
storage location.
The data can be stored on an FTP server or on a worklist server.
The data generated are temporarily stored in the internal memory with encrypted assignment and
transferred to the defined server. If the network is not available, all data remain stored internally. The
data are automatically sent to the selected server as soon as the network becomes available.
6.11.1 FileShare mode

In FileShare mode, a new patient data set is created in the patient area or selected from an existing
list. The video data and images generated during the treatment are automatically transferred to the
defined server directory.
A sub-directory is created for each patient. As soon as a file has been successfully transferred from
the internal memory to the server directory and the treatment is complete, the local copy is deleted. If
the network connection is interrupted during treatment, all data are automatically transferred as soon
as the network connection becomes available again.

Application
6.11.2 FileShare settings
1. In order to define the storage location, save the configuration for the server in FileShare mode
and in Worklist mode.
2. Press the Connect button to test the configuration.
ð The test report confirms successful configuration.
ð The network function is activated.
FileShare Directory name on the FTP server.

Host name/IP address IP address or host name of the FTP server.
Port The port number used to reach the FTP server.
User If the FTP server requires access, the access
data will need to be stored.
Password
Timeout Maximum period of time during which attempts
can be made to establish a connection with the
FTP server.
KARL STORZ recommends creating a separate user for the product on the FTP server.
6.11.3 Worklist mode

In Worklist mode, a patient can be selected from a prepared list. The list is provided by the defined
worklist server.
The current treatment list can be accessed using the Worklist function from the Patient menu. The list
can be filtered based on a range of different criteria.

Application
6.11.4 Worklist settings
1. If a worklist server is to be used as a user-defined storage location, save the configuration for
the server in the Worklist tab.
2. Configure the FTP/FileShare tab and enter the required data.
3. Press the Connect button to test the configuration.
ð The network function is activated in Worklist mode.

Application
Max. worklist items count Maximum number of entries received.

Too high a value can noticeably impact perfor-
mance. A maximum value of 1,000 is recom-
mended.
Device Identity Unique name
Hostname/IP address IP address or host name of the worklist server.
Port The port number used to reach the worklist
server. Usually 443.
User If the worklist server requires access, the access
data will need to be stored.
Password
Timeout Maximum period of time during which attempts
can be made to establish a connection with the
FTP server.
6.11.5 Network dialog

The network dialog can be called up via the Network settings Setup menu. The settings can be
changed and the user-defined storage location can be specified in the network dialog.
The network function can be used in FileShare mode and Worklist mode. The generated data is
automatically moved to an FTP server. This requires the LAN and the FTP/FileShare tabs to be
configured.
In Worklist mode, patient data can be retrieved from the worklist server, selected, and then stored on
the worklist server again.
Because data can be saved and retrieved on two different worklist servers, all three tabs (LAN,
Worklist server, FTP/FileShare) have to be configured.
In order to use the worklist functionality, a connection to the KARL STORZ server software
SCENARA.connect (StreamConnect for US customers) is required.

Application
6.11.6 Local settings
The network configuration is defined on the LAN tab. The configuration is performed automatically via
DHCP or manually.
Press the Connect button to test the set configuration if the data is entered manually.
ð The network function is activated.
The device supports only IP version 4.

Maintenance, servicing, repairs, and disposal
7 Maintenance, servicing, repairs, and disposal

7.1 Maintaining the product
If they are not described in more detail here, maintenance activities may only be performed by
KARL STORZ or by a company authorized by KARL STORZ.
7.1.1 Maintenance
The following maintenance intervals are recommended:
Interval Activity To be performed by

annually Safety test KARL STORZ service techni-
cians
Check the device configuration after every software update.
7.2 Safety inspection in accordance with IEC 62353

WARNING
Risk of injury due to product degradation!
Patients, users and third parties may be injured as a result of product and accessory degradation.
Shut down the product.
Have the deficiencies repaired by persons authorized by KARL STORZ.
Regardless of the national accident prevention regulations and testing intervals for medical devices,
for this device safety checks must be performed as repeat inspections according to IEC 62353 and
recorded by a qualified electrician at least once a year. Detailed specifications regarding the scope
and execution of the safety inspection can be found in the service manual.
7.2.1 Visual inspection

1. Check the product and accessories for any mechanical damage.
2. Check labels for readability.
7.2.2 Electric measurements

Limit values for electrical measurements can be found in the current IEC 62353.
1. Measure the protective ground resistance.

2. Measure the earth leakage current.
3. Measure the touch current.
4. Measure the patient leakage current.
7.2.3 Functional test

1. Perform a functional test in line with the instructions for use.
2. Document the results of the safety inspection.
7.3 Repairing the product

Repair work may only be performed by KARL STORZ or by a company authorized by KARL STORZ.
The interventions described in this instruction manual are exempt from this rule.

Maintenance, servicing, repairs, and disposal
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.
7.4 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
8 Accessories and spare parts

8.1 Accessories
Not all articles are available in all regions.
Article Order no.

Videoendoscope adaptor 0° TC001
Videoendoscope adaptor 90° TC013
USB to ACC adaptor TC009
Camera head holder, irrigation bottle holder TP002
ACC connecting cable, to control peripheral devices, length 180 cm 20221070
Power cord, length 300 cm 400F
DVI connecting cable, length 200 cm 20040086
DVI connecting cable, length 300 cm 20040089
Power cord, US version, 200 cm 400B
USB silicone keyboard with touchpad 20040240XX
USB flash drive, 32 GB 20040282
USB color printer 549M
Headset W21341
Light source
Article Order no.

Three-way adaptor for light source TL005
Stroboscopy
Article Order no.

Stroboscopy footswitch 40160033
Microphone set, consisting of: 40160031
Microphone 20140030
Microphone holder 20140030MH
Connector for microphone membrane 20140030T
Microphone membrane 20140030MB

Electromagnetic compatibility
9 Electromagnetic compatibility
9.1 General notes on the operating environment
The product is suitable for use in professional healthcare settings. Professional healthcare facilities
include physician offices, dental offices, limited care facilities, freestanding surgical centers,
freestanding birth centers, multiple treatment facilities, hospitals (emergency rooms, patient rooms,
intensive care, surgical rooms, outside the HF-shielded room of an ME system for MRT).
The emission characteristics of this product make it suitable for use in industrial areas as well as
in hospitals (CISPR 11 Class A) and other professional healthcare environments. If it is used in a
residential environment (for which CISPR 11 Class B is normally required), the product may not
offer sufficient protection for radio transmission operation. The user might need to take
mitigation measures, such as relocating or re-orienting the product.
WARNING
Electromagnetic interferences! Malfunction!
Use of this equipment adjacent to or stacked with other equipment could result in improper operation.
Avoid this situation.
If such use is necessary: Ensure that this equipment and the other equipment are operating
normally.
9.2 Accessories and cables

Accessories and cables for EMC compliance
Type Shield Length [m] Ferrite Use
Mains cord No 3 No Power supply
Two-pedal Yes 2 No Device control,
footswitch socket rear
USB keyboard Yes 2 No Data input
with touchpad
Microphone No 2 No Speech recording
Camera Yes 3 No Image transmis-
sion
DVI cable Yes 3 No Signal transmis-
sion
WARNING
Reduced immunity or increased emissions! Malfunction!
Use of the product with accessories, transducers and cables other than those specified in this manual
may result in increased emissions or decreased immunity.
Only use the accessories specified in the manual.
WARNING
Degradation of performance! Malfunction!
Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) could result in degradation of the performance of the product.
Do not use portable communications equipment closer than 30 cm (12 inches) to any part of the
product, including cables.

9.3 Table 1 – Compliance level for immunity tests

Guidelines and manufacturer’s declaration – electromagnetic immunity
The product is intended for use in the electromagnetic environment specified below. The user of the
product should make sure that it is used in such an environment.
Immunity tests EN/IEC 60601 test level Compliance level Electromagnetic envi-
ronment – guidelines
Electrostatic dis- ± 8 kV contact discharge ± 8 kV contact discharge Floors should be made of
charge (ESD) acc. ± 15 kV air discharge ± 15 kV air discharge wood, concrete, or cov-
to IEC 61000-4-2 ered with ceramic tiles. If
floors are covered with
synthetic material, the rel-
ative humidity must be at
least 30%.
Electrical fast tran- ± 2 kV for power lines ± 2 kV for power lines The power supply quality
sients/bursts acc. ± 1 kV for input and out- ± 1 kV for input and out- should be that of a typical
to IEC 61000-4-4 put lines put lines commercial or hospital
environment.
100 kHz repetition 100 kHz repetition
Surges acc. to IEC ±1 kV voltage outer con- ±1 kV voltage outer con- The power supply quality
61000-4-5 ductor – outer conductor ductor – outer conductor should be that of a typical
±2 kV voltage outer con- ±2 kV voltage outer con- commercial or hospital
ductor – ground ductor – ground environment.
Voltage dips, short Voltage dip: Voltage dip: The power supply quality
interruptions, and Dip to 0% for 1 cycle at Dip to 0% for 1 cycle at should be that of a typical
voltage variations 0° phase angle 0° phase angle commercial or hospital
acc. to environment. If the user
IEC 61000-4-11 Dip to 70% for 25/30 cy- Dip to 70% for 25/30 cy- of the product requires
cles at 0° phase angle cles at 0° phase angle continued operation in
Dropout to 0% for 0.5 Dropout to 0% for 0.5 the event of interruptions
cycles @ 0°, 45°, 90°, cycles @ 0°, 45°, 90°, to the power supply net-
135°, 180°, 225°, 270°, 135°, 180°, 225°, 270°, work, it is recommended
and 315° phase angles and 315° phase angles that the product be oper-
ated with an uninterrupt-
Voltage interruption: Voltage interruption:
ible power supply or a
100% for 250/300 cy- 100% for 250/300 cy- battery.
cles cles
Magnetic field at 30 A/m at 50 Hz / 60 Hz 30 A/m at 50 Hz / 60 Hz If image distortion occurs,
the power fre- it may be necessary to in-
quency (50/60 Hz) stall the product further
acc. to IEC from sources of electro-
61000-4-8 magnetic fields or to in-
stall magnetic shielding.
Before the product is in-
stalled, the electromag-
netic field should be mea-
sured to ensure that it is
sufficiently low.
Immunity test acc. 3 V/m 80 MHz to 3 V/m 80 MHz to
to IEC 61000-4–3 2.7 GHz 2.7 GHz
for radiated, radio-
frequency electro-
magnetic fields

Immunity tests EN/IEC 60601 test level Compliance level Electromagnetic envi-
ronment – guidelines
* Refer to Table 2 for
wireless proximity RF
field test levels
Immunity to con- 3 Vrms on 150 kHz to 3 Vrms on 150 kHz to
ducted distur- 80 MHz 80 MHz
bances, induced by 1 kHz 80% AM modula- 1 kHz 80% AM modula-
radio-frequency tion tion
fields acc. to IEC
61000-4-6 6 Vrms in ISM band 6 Vrms in ISM band
9.4 Table 2 – Test levels for near fields from HF wireless

communications equipment
Test frequency Frequency Radio service Modulation Immunity Compliance
MHz band test level level
MHz V/m V/m
385 380 – 390 TETRA 400 Pulse modula- 27 27
tion 18 Hz
450 430 – 470 GMRS 460, FM ± 5 kHz de- 28 28
FRS 460 viation
1 kHz sine
wave
710 704 – 787 LTE band 13 Pulse modula- 9 9
and 17 tion
745
217 Hz
780
810 800 – 960 GSM 800/900, Pulse modula- 28 28
TETRA 800, tion
870
iDEN 820, 18 Hz
930 CDMA 850,
LTE band 5
1720 1700 – 1990 GSM 1800, Pulse modula- 28 28
CDMA 1900, tion
1845
GSM 1900, 217 Hz
1970 DECT,
LTE band 1, 3,
4, 25,
UMTS
2450 2400 – 2570 Bluetooth, Pulse modula- 28 28
WLAN 802.11 tion
b/g/n, 217 Hz
RFID 2450,
LTE Band 7
5240 5100 – 5800 WLAN 802.11 Pulse modula- 9 9
a/n tion
5500
217 Hz
5785

9.5 Table 3 – Test levels for radiated and conducted immunity

tests
Guidelines and manufacturer’s declaration – electromagnetic immunity
The product is intended for use in the electromagnetic environment specified below. The user of the
product should make sure that it is used in such an environment.
Immunity tests EN/IEC 60601-1-2 test Compliance Electromagnetic environ-

level level ment – guidelines
Conducted RF distur- 3 Vrms 3 Vrms Portable and mobile HF
bances acc. to IEC 150 kHz to 80 MHz communications equipment
61000-4-6 should be used no closer to
any part of the product, in-
Radiated RF disturbances 3 V/m 3 V/m
cluding cables, than the rec-
acc. to IEC 61000-4-3 80 MHz to 2.7 GHz ommended separation dis-
6 V for ISM frequency tance calculated from the
bands equation applicable to the
frequency of the transmitter.
Recommended safety dis-
tances:
d = 1.2 √P
Where P is the rated power
of the transmitter in watts
[W] according to the infor-
mation provided by the
transmitter manufacturer and
d is the recommended sepa-
ration distance in meters [m].
Field strengths from fixed HF
transmitters as determined
by an electromagnetic site
survey a should be less than
the compliance level in each
frequency range b.
d = 1.2 √P
80 MHz to 800 MHz
d = 2.3 √P
800 MHz to 2.7 GHz
Interferences may occur in
the vicinity of equipment
marked with the following
symbol:
Note: At 80 MHz and 800 MHz, the higher frequency range applies.
Note: These guidelines may not apply in all situations. The propagation of electromagnetic waves is
affected by absorptions and reflections of buildings, objects, and people.
a
The field strength of stationary transmitters, e.g., base stations for radio (cellular/cordless) tele-
phones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast can-
not be predicted theoretically with accuracy. To assess the electromagnetic environment due to

Immunity tests EN/IEC 60601-1-2 test Compliance Electromagnetic environ-

level level ment – guidelines
fixed transmitters, an electromagnetic site survey should be considered. If the measured field
strength at the location where the device is used exceeds the above compliance levels, the device
should be monitored to ensure proper function. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the device.
b
Over the frequency range from 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
9.6 Table 4 – Emission class and group

Guidelines and manufacturer’s declaration – Electromagnetic emissions
The product is intended for use in such an environment as specified below. The customer or user of
the product should ensure that it is used in such an environment.
Interference emission measure- Compliance Electromagnetic environment –

ments guidelines
RF emissions acc. to CISPR 11 Group 1 The device uses RF energy only for its
internal function. Therefore, its RF
emissions are very low and are not
likely to cause any interference in
nearby electronic equipment.
RF emissions acc. to CISPR 11 Class A The device is suitable for use in all es-
tablishments other than domestic and
Emission of harmonic oscillations Class A
those directly connected to the public
acc. to IEC 61000-3-2
low voltage power supply network that
Voltage fluctuations/flicker emissions Complies supplies buildings used for domestic
acc. to IEC 61000-3-3 purposes.
9.7 Table 5 – Recommended separation distances between

portable and mobile HF communications devices and the
product
The product is intended for use in an electromagnetic environment in which HF disturbances are
controlled. The customer or user of the product can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile HF communications equipment
(transmitters) and the product as recommended below, according to the output energy of the
communications equipment.

Rated maximum out- Separation distance d [m] according to frequency of transmitter

put power of the
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz
transmitter [W]
d = 1.2 √P d = 1.2 √P d = 2.3 √P
0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters whose maximum rated power is not listed in the table above, the recommended
separation distance d in meters (m) can be estimated using the equation from the respective col-
umn, whereby P is the maximum rated power of the transmitter in watts (W) according to the trans-
mitter manufacturer.
Note: At 80 MHz and 800 MHz, the separation distance for higher frequency range applies.
Note: These guidelines may not apply in all situations. The propagation of electromagnetic waves is
affected by absorptions and reflections of buildings, objects, and people.
The product was tested for compatibility with HF surgical devices in accordance with IEC
60601-2-2 Appendix BB.

Errors and messages
10 Errors and messages

10.1 Troubleshooting
Symptom Possible causes Actions
Loss of image for longer than Defibrillator discharged. Switch the device off and
4 seconds back on again.
LED temperature above 80°C Lamp overheated Allow the lamp to cool
down (to below 75°C)
LED temperature above 90°C Lamp overheated Allow the lamp to cool
Lamp is switching off after a few down (to below 80°C)
minutes
LED temperature above 100°C Lamp overheated Turn off the lamp and let it
cool down (to below 75°C)
Device will not start up Fan malfunction Contact Service
Device temperature above 80°C Device overheated Allow the device to cool
The device switches itself off at down (to below 75°C)
temperatures above 90°C Contact Service
Update failed Restart the device
Repeat the procedure
Contact Service
Incompatible camera head Replace the camera head

Overview of mitigating warnings
11 Overview of mitigating warnings

The original English warning text is as follows:
To avoid the risk of electric shock, this equipment must only be connected to a sup-
ply mains with protective earth.
WARNING
Portable RF communications equipment (including peripherals such as antenna ca-
bles and external antennas) should be used no closer than 30 cm (12 inches) to any
part of the [ME EQUIPMENT or ME SYSTEM], including cables specified by the man-
ufacturer. Otherwise, degradation of the performance of this equipment could result.
WARNING
Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are oper-
ating normally.
WARNING
Use of accessories, transducers and cables other than those specified or provided
by the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in im-
proper operation.
WARNING
No modification of this equipment is allowed.
WARNING

Subsidiaries
12 Subsidiaries
KARL STORZ SE & Co. KG KARL STORZ Endoskopi Danmark A/S
Dr.-Karl-Storz-Straße 34, 78532 Tuttlingen/Germany Skovlytoften 33, 2840 Holte, Denmark
Postfach 230, 78503 Tuttlingen/Germany Phone: +45 45162600, Fax: +45 45162609
Phone: +49 7461 708-0, Fax: +49 7461 708-105 E-mail: marketing@karlstorz.dk
E-mail: info@karlstorz.com
KARL STORZ Endoscopy (UK) Ltd.
KARL STORZ Endoskope Berlin GmbH 415 Perth Avenue, Slough, Berkshire, SL1 4TQ, United Kingdom
Scharnhorststr. 3, 10115 Berlin/Germany Phone: +44 1753 503500, Fax: +44 1753 578124
Phone: +49 30 30 69090, Fax: +49 30 30 19452 E-mail: info-uk@karlstorz.com
KARL STORZ Endoscopy Canada Ltd. KARL STORZ Endoscopie Nederland B.V.
7171 Millcreek Drive, Mississauga, Ontario L5N 3R3 Canada Displayweg 2, 3821 BT Amersfoort, Netherlands
Phone: +1 905 816-4500, Fax: +1 905 816-4599 Phone: +31 (0)33 4545890
Toll free phone: 1-800-268-4880 (Canada only), Fax: 1-800-482-4198 (Canada E-mail: info-nl@karlstorz.com
only)
E-mail: info-canada@karlstorz.com KARL STORZ Endoscopy Belgium N.V.
Phone: +31 (0)33 4545890
KARL STORZ Endoscopy America, Inc. E-mail: info-be@karlstorz.com
2151 East Grand Avenue, El Segundo, CA 90245-5017, USA
Phone: +1 424 218-8100, Fax: +1 424 218-8525 KARL STORZ Endoscopie France S.A.S.
Toll free phone: 800 421-0837 (USA only), Fax: 800 321-1304 (USA only) 12, rue Georges Guynemer, Quartier de l’Europe, 78280 Guyancourt, France
E-mail: communications@ksea.com Phone: +33 1 30484200, Fax: +33 1 30484201
E-mail: marketing-fr@karlstorz.com
KARL STORZ Veterinary Endoscopy America, Inc.
1 South Los Carneros Road, Goleta, CA 93117, USA KARL STORZ Endoskop Austria GmbH
Phone: +1 805 968-7776, Fax: +1 805 685-2588 Landstraßer Hauptstr. 148/1/G1, 1030 Vienna, Austria
E-mail: info@karlstorzvet.com Phone: +43 1 71 56 0470, Fax: +43 1 71 56 0479
E-mail: storz-austria@karlstorz.com
KARL STORZ Endoscopia Latino America, Inc.
815 N. W. 57th Avenue, Suite 480, Miami, FL 33126-2042, USA KARL STORZ Endoscopia Ibérica S.A.
Phone: +1 305 262-8980, Fax: +1 305 262-8986 Parque Empresarial San Fernando, Edificio Munich – Planta Baja, 28830 Madrid,
E-mail: info@ksela.com Spain
Phone: +34 91 6771051, Fax: +34 91 6772981
KARL STORZ Endoscopia México S.A. de C.V. E-mail: info-es@karlstorz.com
Av. Ejercito Nacional No. 453 Piso 2, Colonia Granada, Alcaldia Miguel Hidalgo,
C.P. 11520 Ciudad de México KARL STORZ Endoscopia Italia S.r.l.
Phone: +52 (55) 1101 1520 Via dell’Artigianato, 3, 37135 Verona, Italy
E-mail: mx-info@karlstorz.com Phone: +39 045 8222000, Fax: +39 045 8222001
E-mail: info-ita@karlstorz.com
KARL STORZ Marketing América Do Sul Ltda.
Rua Joaquim Floriano, nº. 413, 20º andar – Itaim Bibi, CEP-04534-011 São Paulo, KARL STORZ Croatia d.o.o.
Brazil Capraška 6, 10000 Zagreb, Croatia
Phone: +55 11 3526-4600, Fax: +55 11 3526-4680 Phone: +385 1 6406 070, Fax: +385 1 6406 077
E-mail: br-info@karlstorz.com E-mail: info@karlstorz.hr
KARL STORZ Endoscopia Argentina S.A. KARL STORZ Endoskopija d.o.o.

Zufriategui 627 6° Piso, B1638 CAA - Vicente Lopez, Provincia de Buenos Aires, Cesta v Gorice 34b, 1000 Ljubljana, Slovenia
Argentina Phone: +386 1 620 5880, Fax: + 386 1 620 5882
Phone: +54 11 4718 0919, Fax: +54 11 4718 2773 E-mail: pisarna@karlstorz.si
E-mail: info@karlstorz.com.ar KARL STORZ Polska Sp. z o.o.
KARL STORZ Endoskopi Norge AS ul. Bojkowska 47, 44-100 Gliwice, Poland
Stamveien1, 1483 Hagan, Norway Phone: +48 32 706 13 00, Fax: +48 32 706 13 07
Phone: +47 6380 5600, Fax: +47 6380 5601 E-mail: info-pl@karlstorz.com
E-mail: post@karlstorz.no KARL STORZ Endoszkóp Magyarország Kft.
KARL STORZ Endoskop Sverige AB Toberek utca 2. fsz. 17/b, HU-1112 Budapest, Hungary
Storsätragränd 14, 127 39 Skärholmen, Sweden Phone: +36 195 096 31, Fax: +36 195 096 31
Phone: +46 8 505 648 00 E-mail: info-hu@karlstorz.com
E-mail: kundservice@karlstorz.se KARL STORZ Endoscopia Romania srl
KARL STORZ Endoscopy Suomi OY Str. Prof. Dr. Anton Colorian, nr. 74, Sector 4, 041393 Bucharest, Romania
Taivaltie 5, 01610 Vantaa, Finland Phone: +40 (0)31 4250800, Fax: +40 (0)31 4250801
Phone: +358 (0)96824774, Fax: +358 (0)968247755 E-mail: info-ro@karlstorz.com
E-mail: asiakaspalvelu@karlstorz.fi KARL STORZ Endoskope Greece M.E.P.E.*
KARL STORZ SE & Co. KG Patriarhou Grigoriou E’ 34, 54248 Thessaloniki, Greece
Representative Office Phone: +30 2310 304868, Fax: +30 2310 304862
Žalgirio St. 94, LT9300 Vilnius, Lithuania E-mail: info-gr@karlstorz.com
Phone: +370 5 272 0448, Mobile: +370 685 67 000 *Repair & Service Subsidiary
E-mail: info-lt-lv@karlstorz.com KARL STORZ Industrial**
Gedik Is Merkezi B Blok, Kat 5, D 38-39, Bagdat Cad. No: 162, Maltepe Istanbul,
Turkey
Phone: +90 216 442 9500, Fax: +90 216 442 9030
**Sales for Industrial Endoscopy

Subsidiaries
OOO KARL STORZ Endoskopy – WOSTOK KARL STORZ Endoscopy (Shanghai) Ltd., Shenyang Branch
Derbenyevskaya nab. 7, building 4, 115114 Moscow, Russia Room 2001-2005, 20F N-MEDIA International Center, No. 167 Youth Avenue,
Phone: +7 495 983 02 40, Fax: +7 495 983 02 41 Shenhe District, 110014, Shenyang, People‘s Republic of China
E-mail: Info-ru@karlstorz.com Phone: +86 24 23181118, Fax: +86 24 23181119
E-mail: info@karlstorz.com.cn
TOV LLC KARL STORZ Ukraine
Avenue Geroyiv Stalingrada Str. 2D, office 717 Kiev, 04210/Ukraine KARL STORZ Endoscopy (Shanghai) Ltd., Guangzhou Branch
Phone: +38 095 000-895-0, +38-097-000-895-0, +38 073 000-895-0 Room 02B & 03 & 04A, 35F Teem Tower, No. 208 Tianhe Road, Tianhe District,
E-mail: marketing@karlstorz.com.ua 510620, Guangzhou, People’s Republic of China
Phone: +86 20 87321281, Fax: +86 20 87321286
KARL STORZ SE & Co. KG Representation Office E-mail: info@karlstorz.com.cn
Sabit Orudschow 1184, apt. 23, 1025 Baku, Azerbaijan
Phone: +99 450 613 30 60 KARL STORZ Endoscopy Asia Marketing Pte.
E-mail: info-az@karlstorz.com No. 8 Commonwealth Lane #03-02, Singapore 149555, Singapore
Phone: +65 69229150, Fax: +65 69229155
KARL STORZ ENDOSKOPE – East Mediterranean and Gulf (Offshore) S.A.L. E-mail: infoasia@karlstorz.com
Spark Tower 1st floor Charles Helou St., Horch Tabet – Sin El Fil, Beirut, Lebanon
Phone: +961 1 501105, Fax: +961 1 501950 KARL STORZ Endoscopy Singapore Sales Pte Ltd
E-mail: info@karlstorz-emg.com No. 8 Commonwealth Lane #03-02, Singapore 149555, Singapore
Phone: +65 69229150, Fax: +65 69229155
KARL STORZ Endoscopy (South Africa) (Pty) Ltd. E-mail: infoasia@karlstorz.com
P.O. 6061, Roggebaai, 8012 Cape Town, South Africa
Phone: +27 21 417 2600, Fax: +27 21 421 5103 KARL STORZ SE & Co. KG Representative Office Indonesia
E-mail: info@karlstorz.co.za Sinarmas MSIG Tower Level 37, Jl. Jend. Surdirman No. Kav. 21, South Jakarta
DKI Jakarta 12920
TOO KARL STORZ Endoskopy Kasachstan E-mail: infoindonesia@karlstorz.com
Saryarka, 6, BC “Arman“, off. 910, 010000 Astana, Republic of Kazakhstan
Phone: +7 7172 552-549, 552-788, Fax: -444 KARL STORZ Endoscopy Korea Co. Ltd.
E-mail: info@karlstorz.kz 9F Hyowon-Building, 97, Jungdae-ro, Songpa-gu, 05719 Seoul, Korea
Phone: +82-70-4350-7474, Fax: +82-70-8277-3299
KARL STORZ ENDOSKOPE East Mediterranean & Gulf (branch) E-mail: infokorea@karlstorz.com
Building West Side 7A – Unit 7WA – 3008, Dubai Airport Free Zone, P.O. Box
54983, Dubai - United Arab Emirates KARL STORZ Endoscopy Taiwan Ltd.
Phone: +971 (0)4 2958887, Fax: +971 (0)4 3205282 12F, No. 192, Sec. 2, Chung Hsin Rd., Sindian District, New Taipei City, Taiwan
Service Hotline: +971 (0)4 3415882 Phone: +886 933 014 160, Fax: +886 2 8672 6399
E-mail: info-gne@karlstorz-emg.com E-mail: info-tw@karlstorz.com
KARL STORZ Endoscopy India Private Limited KARL STORZ SE & Co. KG Representative Office Philippines
11th Floor, Dr. Gopal Das Bhawan, 28, Barakhamba Road, New Delhi 110001, 1901 Picadilly Star Bldg., 4th Avenue, BGC, Taguig City 1636, Philippines
India Phone: +63 2 317 45 00, Fax: +63 2 317 45 11
Phone: +91 11 4374 3000, Fax: +91 11 4374 3010 E-mail: phillippines@karlstorz.com
E-mail: corporate@karlstorz.in
KARL STORZ Endoscopy Japan K. K.
KARL STORZ SE & CO. KG Stage Bldg. 8F, 2-7-2 Fujimi, Chiyoda-ku, Tokyo 102-0071, Japan
Interchange 21 Tower, Level 33, 399 Sukhumvit Road, North Klongtoey, Wattana, Phone: +81 3 6380-8622, Fax: +81 3 6380-8633
10110 Bangkok, Thailand E-mail: info@karlstorz.co.jp
Phone: +84 28 3823 8000 Fax: +84 28 3823 8039
E-mail: infovietnam@karlstorz.com KARL STORZ Endoscopy New Zealand
Ltd. 31 Morningside Drive Mt Albert Auckland, 1025, New Zealand PO Box 56 511,
KARL STORZ SE & Co. KG Dominion Rd Auckland, 1446, New Zealand
Resident Representative Office Phone: +64 9 846 6044
14th Floor, MPlaza Saigon, 39 Le Duan, District 1, Ho Chi Minh City, Vietnam Toll free: +64 508 84 84 84 (New Zealand only)
Phone: +84 28 3823 8000, Fax: +84 28 3823 8039 Email: sales-nz@karlstorz.com
E-mail: infovietnam@karlstorz.com
KARL STORZ Endoscopy Australia Pty. Ltd .
KARL STORZ Endoscopy China Ltd. 68 Waterloo Road, Macquarie Park NSW 2113, P O Box 50 Lane Cove NSW 1595,
Room 2503-05, 25F AXA Tower, Landmark East, No. 100 How Ming Street, Kwun Australia
Tong, Kowloon, Hong Kong, People’s Republic of China Phone: +61 (0)2 9490 6700, Fax: +61 (0)2 9420 0695
Phone: +852 28 65 2411, Fax: +852 28 65 4114 Toll free: 1800 996 562 (Australia only)
E-mail: inquiry@karlstorz.com.hk E-mail: info@karlstorz.au
KARL STORZ Endoscopy (Shanghai) Ltd., Beijing Branch www.karlstorz.com

Room 1805-1807, Building B, 18F Beijing IFC, No. 8, Jianguomenwai Street,
Chaoyang District, 100022, Beijing, People’s Republic of China
Phone: +86 10 5638188, Fax: +86 10 5638199
KARL STORZ Endoscopy (Shanghai) Ltd., Shanghai Branch

Room 701A Building 5 & Room 501 Building 7, No. 3000 Longdong Avenue, Pilot
Free Trade Zone, 201203, Shanghai, People’s Republic of China
Phone: +86 21 60339888, Fax: +86 21 60339808
KARL STORZ Endoscopy (Shanghai) Ltd., Chengdu Branch

Room 803-805, 8F Jin Jiang International Building, No. 1 West Linjiang Road,
Wuhou District, 6100414, Chengdu, People’s Republic of China
Phone: +86 28 86587977, Fax: +86 28 86587975

Subsidiaries

CQH848 • EN • V2.0 • 08-2022 • IFU • CE-MDR
KARL STORZ SE & Co. KG

Dr.-Karl-Storz-Straße 34
78532 Tuttlingen
Postfach 230
78503 Tuttlingen
Germany
Phone: +49 7461 708-0

Fax: +49 7461 708-105
E-mail: info@karlstorz.com
www.karlstorz.com

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en Instructions for use

Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 3

Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 4

10.1 Troubleshooting ......................................................................................................................... 51

Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 5

1.2 Read the instructions for use of compatible products

Product name Item number

1.4 General signs and symbols

Actions in safety notes or in the case of a single step:

Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 6

– Unnumbered list, 2nd level

1.5 Description of warning messages

Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 7

2.4 Target user populations

2.5 Patient population

Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 8

3 Safety and warning

3.1 Serious incidents

3.2 Product not clean

3.3 Correct handling and product testing

3.4 Combination with other components

Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 9

3.5 Dangers from electrical current

3.6 Electromagnetic interference

3.7 High light intensity

3.8 Hot components

3.9 Failure of products

Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 10

3.10 Observing ambient conditions

3.11 Risk of explosion and fire

Do not use the product in the presence of flammable anesthetics.

3.12 Image failure during HF application

Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 11

Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 12

5 USB 2.0 (4x) 12 Cable manager

4.2 Possible combinations

4.2.1 Camera heads

Item Order no.

Article Order no.

Item Order no.

Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 13

Item Order no.

Item Order no.

Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 14

Item Order no.

4.3 Technical data

Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 15

4.4 Symbols employed

Number of products in the product packaging

Unique Device Identifier

Consult the printed or electronic instructions for use

Fragile, handle with care

Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 16

4.4.2 Symbols on the product

Applied part type BF

Applied part type CF defibrillation protection

Potential equalization connector

Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR 17

Lateral stroboscopy microphone input