Storz TL410US User manual

INSTRUCTION MANUAL
TL410US Cold Light Fountain powerLEDsaphira

III
Thank you for your expression of condence in the KARL STORZ brand name. Like all of our other products, this product is the result
of years of experience and great care in manu facture. You and your organization have decided in favor of a modern, high-quality item of
equipment from KARL STORZ.
This instruction manual is intended to serve as an aid in the proper setup, installation, and ope r a tion of the cold light fountain
power LED saphira. All essential details of the equipment and all actions required on your part are clearly presented and explained.
We thus ask that you read this manual carefully before proceeding to work with the equipment. Insert this manual in its protective wallet and
keep it available for ready reference in a convenient and conspicuous location near the equipment.
KARL STORZ is constantly working on the further development of all products. Please appreciate that changes to the scope of supply in
form, equipment and technology may occur for this reason. Therefore, no claims may be derived from the information, illustrations, and
descriptions in this manual.
© All product pictures, photos and descriptions and texts are the intellectual property of KARL STORZ SE & Co. KG
Utilization and reproduction by third parties require express authorization by KARL STORZ SE & Co. KG.
All rights reserved.
Rx only Federal (USA) law restricts this device to sale by or on the order of a physician.
96286016 US Version 1.0 – 02/2022
It is recommended to check the suitability of the product for the intended procedure prior to use.

IV
Images of the device
1. Images of the device
2 3 5 8761 4 90

V
Controls, displays,
connectors, and their uses
2. Controls, displays, connectors, and their uses
1 Standby button
2 Touch screen
3 Light outlet, can be unscrewed
4 Footswitch connector
5 Potential equalization connector
6 External sync interface (inactive)
7 Power cord socket
8 Line fuses (fuse holder)
9 USB connector
0 KS HIVE connection (only in combination with KARL STORZ devices)
Abbreviations used
WL = White Light
PDD = Photodynamic diagnosis
The application of the TL410US performs Fluorescence Contrast Imaging (FCI) according to IEC60601-2-75.
The designation of the procedure applied with the TL410US as Photodynamic Diagnosis (PDD) is therefore not in accordance with the denition
of the term ‘Photodynamic Diagnosis’ from IEC60601-2-75. However, for historical reasons, the term Photodynamic Diagnosis persists in the
technical literature as well as in general usage as a synonym for FCI. In reference to TL410US, the established term PDD is therefore still used.

VI
Symbols employed
3. Symbols employed
3. 1 Symbols on the device
Follow instructions for use
Standby/ON/OFF
Potential equalization connector
Type CF applied part according to IEC 60601-1
Alternating current
Fuse
Ethernet
USB
Connection socket for footswitch
Electronic information product pollution control (China RoHS)
This device has been labelled in accordance with the European Directive on
waste electrical and electronic equipment (WEEE).
Manufacturer
PDD
OPAL1 PDD icon
Warning; Hot surface
Warning; Visible radiation

VII
Symbols employed
3. 2 Label and packaging symbols
Manufacturer
Catalogue number
Serial number
Number of products in the product packaging
Keep dry
Fragile, handle with care
Consult instructions for use

VIII
Symbols employed
White light
Mode display for white light and PDD applications
Footswitch (only shown if the footswitch is connected)
Menu (only shown if the light source on stand-by)
ON/OFF (white = Off)
ON/OFF (orange = On)
Manual light intensity regulation
Light intensity (only shown if manual light intensity regulation is active)
Automatic light intensity regulation (can only be used if the light source is connected
with the IMAGE1 S via KS HIVE).
Lower light intensity manually
Increase light intensity manually
Slide control for manual light intensity regulation
3. 3 User interface symbols
A
A
B
B
E
E
C
F
G
D
D
AB
H

D
DG
BA

1
Contents
1. Images of the device ..................................................................................................... IV
2. Controls, displays, connectors, and their uses ............................................................V
3. Symbols employed ........................................................................................................ VI
3. 1 Symbols on the device ................................................................................................................. VI
3. 2 Label and packaging symbols ......................................................................................................VII
3. 3 User interface symbols ................................................................................................................VIII
4. General information .........................................................................................................3
4. 1 System description ........................................................................................................................ 3
4. 2 Device description ......................................................................................................................... 3
5. Safety instructions ...........................................................................................................4
5. 1 Explanation of warnings and cautions ............................................................................................ 4
5. 2 Normal use .................................................................................................................................... 9
5. 3 Intended use .................................................................................................................................. 9
5. 4 Indications for use ......................................................................................................................... 9
5. 5 Contraindication ............................................................................................................................. 9
5. 6 User qualification ......................................................................................................................... 10
5. 7 Patient profile ............................................................................................................................... 10
5. 8 User profile .................................................................................................................................. 10
5. 9 Intended conditions of use........................................................................................................... 11
5. 9. 1 Use .............................................................................................................................................. 11
5. 9. 2 Other intended conditions ............................................................................................................ 11
5. 10 User position ............................................................................................................................... 11
5. 11 Safety precautions at the site of installation ................................................................................. 12
5. 12 Safety features ............................................................................................................................. 12
5. 12. 1 Self-test ....................................................................................................................................... 12
6. KARL STORZ D-Light C Photodynamic Diagnostic (PDD) System ..........................13
6. 1 Saphira Rigid PDD Cystoscope System....................................................................................... 13
7. Installation and operating instructions ........................................................................14
7. 1 Unpacking the equipment ............................................................................................................ 14
7. 2 Basic equipment .......................................................................................................................... 14
7. 3 Installation .................................................................................................................................... 14
7. 3. 1 Connecting the ground line .......................................................................................................... 15
7. 3. 2 Connecting the power cord ......................................................................................................... 15
7. 3. 3 KS HIVE....................................................................................................................................... 15
7. 3. 4 Connecting light cable ................................................................................................................. 16
7. 3. 5 Connecting the light cable to the endoscope ............................................................................. 16
7. 3. 6 Connecting the footswitch ........................................................................................................... 17
7. 4 Powering on the power LED saphira light source ......................................................................... 17
7. 4. 1 Switching the light on and off ...................................................................................................... 18
7. 4. 2 Using the automatic light source control ...................................................................................... 19

2
Contents
7. 4. 3 Using manual light intensity regulation ......................................................................................... 19
7. 4. 4 Changing the light mode.............................................................................................................. 20
7. 4. 5 Switching off the device (decommissioning) ................................................................................. 20
7. 5 Settings ....................................................................................................................................... 21
7. 5. 1 Service ........................................................................................................................................ 21
7. 5. 2 Language .................................................................................................................................... 21
7. 5. 3 Event protocol ............................................................................................................................. 22
7. 5. 4 Device Info ................................................................................................................................... 22
7. 5. 5 Audio settings .............................................................................................................................. 22
8. Maintenance ...................................................................................................................23
8. 1 Fuse replacement ........................................................................................................................ 23
8. 2 Reprocessing ............................................................................................................................... 24
8. 2. 1 General warnings for medical devices .......................................................................................... 24
8. 2. 2 Wipe-down disinfection of device ................................................................................................ 24
8. 3 Maintenance and safety check ................................................................................................... 25
8. 3. 1 Maintenance ................................................................................................................................ 25
8. 3. 2 Safety checks/repeat inspections as per IEC 62353 .................................................................... 25
8. 4 Servicing and repair ..................................................................................................................... 26
8. 5 Disposal ....................................................................................................................................... 26
8. 6 Repairing devices ........................................................................................................................ 26
8. 7 Infection prevention...................................................................................................................... 26
8. 8 Limitation of liability ...................................................................................................................... 27
8. 9 Manufacturer’s warranty ............................................................................................................... 27
9. Technical description ....................................................................................................28
9. 1 Information signals ....................................................................................................................... 28
9. 1. 1 Configuration ............................................................................................................................... 28
9. 1. 2 Visual signals ............................................................................................................................... 28
9. 1. 3 Acoustic signals ........................................................................................................................... 29
9. 1. 4 Information signals (general) ......................................................................................................... 29
9. 1. 5 Availability signal .......................................................................................................................... 29
9. 2 Troubleshooting ........................................................................................................................... 30
9. 3 Technical data .............................................................................................................................. 33
9. 4 Technical documentation ............................................................................................................. 35
9. 5 Software ownership and licensing ................................................................................................ 35
10. Spare parts, recommended accessories ....................................................................36
10. 1 Spare parts .................................................................................................................................. 36
10. 2 Recommended accessories ........................................................................................................ 36
11. Electromagnetic Compatibility (EMC) Information .....................................................37
12. Subsidiaries ....................................................................................................................43

3
General information
4. General information
4. 1 System description
The KARL STORZ D-Light C Photodynamic Diagnostic (PDD) System consists of the Saphira Rigid PDD Cystoscope System (Power LED
Saphira Light Source, PDD Rigid Cystoscopes, IMAGE1 S HX-P Saphira Camera Head, IMAGE1 S Saphira Camera Control Unit, and Fiber
Optic Light Cable), the Rigid PDD Cystoscope System (D-Light C Light Source, PDD Rigid Cystoscopes, Tricam® Camera Head, Tricam® SL
II Camera Control Unit, and Fluid Light Cable), and the Flexible PDD Video Cystoscope System (D-Light C Light Source, PDD Flexible Video
Cystoscopes, Telecam® SL II-FI Camera Control Unit, and Video Endoscope Adaptor).
The system has two modes of operation: an attenuated white light (WL) mode (Mode 1) for use during uorescence examinations and a
PDD or blue light (Mode 2) mode for identication of uorescent images.
The Saphira Rigid PDD Cystoscope System is a subsystem of the KARL STORZ D-Light C PDD System. Refer to Chapter 6.1 Saphira Rigid
PDD Cystoscope System for system conguration diagram.
4. 2 Device description
The cold light fountain power LED saphira is a high-performance cold light source for diagnostic and therapeutic interventions in endoscopy.
The device offers numerous functions and features. These include:
•White light and PDD: High and constant light intensity with low current consumption thanks to LED technology.
•PDD: Fluorescent mode to assist the user by displaying the uorescent signal.
•Comfortable working environment: Innovative cooling concept for minimal noise emission.
•Durable: No costs or effort required to change the lamp if used properly.
•Clear: Direct operation via a color screen with touch-sensitive surface (touchscreen)
•Integration: The KS HIVE function enables the light source to be controlled remotely and the system status information to be retrieved, while
providing simple conguration during initialization.
•Up-to-date: Software updates can be installed easily and conveniently via an interface.

4
Safety instructions
5. 1 Explanation of warnings and cautions
Please read this manual and follow its instructions carefully. The words Warning, Caution, and Note convey special meanings. Wherever they
are used in this manual, they should be carefully reviewed to ensure the safe and effective opera tion of this product. To make the words stand
out more clearly, they are accompanied by a pictogram.
3WARNING: A Warning indicates that the personal safety of the patient or physician may be involved. Disregarding a Warning could
result in injury to the patient or physician.
2CAUTION: A Caution indicates that particular service procedures or precautions must be followed to avoid possible damage to the
product.
1NOTE: A Note indicates special informa tion about operating the product, or clar ies important information.
1NOTE: Any damage to the device resulting from incorrect operation is not covered by the manufacturer’s warranty.
5. Safety instructions
Safety instructions are measures intended to protect the user and patients from the risks which could arise through the use of the system.

5
Safety instructions
Warnings and cautions
WARNING: Read this instruction manual thoroughly before putting the device into operation. Read the section on safety instructions carefully
to avoid putting your patients, personnel, or yourself at risk.
WARNING: The electrical installation of the operating room in which the device is connected and operated must comply with the applicable
IEC standards.
WARNING: Keep device out of reach of patients.
WARNING: For safety reasons, do not simultaneously touch the device output sockets and the patient.
WARNING: The instruction manuals and interface specications for medical devices and/or system components used in combination must be
observed precisely.
WARNING: Combinations of medical devices are only assured to be safe if
• they are identied as such in the respective instruction manuals or
• the intended use and interface specications of the devices used in combination permit this (cf. Clause 16 of IEC 60601‑1).
WARNING: Additional devices which are connected to electrical medical devices must comply with the relevant IEC or ISO standards (e.g.,
IEC 60950 for data processing devices). Furthermore, all configurations must comply with the requirements for medical electrical systems
(see Clause 16 of the 3rd Ed. of the IEC 60601‑1). Anybody connecting additional devices to electrical medical devices is configuring a
medical system, and is therefore responsible for ensuring that the system complies with the standard requirements for medical electrical
systems. It should be noted that the local legal regulations have priority over the above‑mentioned requirements. If in doubt, contact your
representative on site or the technical customer service. Use KARLSTORZ model UG300 (included on UG130U Cor cart) or UG890 Isolation
Transformer when configuring the IMAGE1S Saphira TC205US, TC305US with the TL410US light source. Alternatively, use an equivalent
isolation transformer that is NRTL certified to ANSI IEC 60601‑1 and rated for minimum 800VA. An additional Multiple Socket Outlet
(PowerTap) or extension cord should NOT be connected to the system.

6
Safety instructions
Warnings and cautions
WARNING: Grounding reliability can only be achieved when the unit is connected to a properly installed ‘Hospital Only’ or ‘Hospital Grade’
receptacle (i.e. approved for use in an operating room environment). Routinely inspect electrical plug and cord. Do not use if inspection reveals
damage.
WARNING: To avoid risk of electric shock, this equipment must only be connected to supply mains with protective earth.
WARNING: At the end of its useful operating life, dispose of the unit as electronic scrap.
WARNING: Avoid allowing uids to penetrate the device. Do not store liquids on or directly above the device.
If liquid penetrates the device, in spite of the precautions, sufcient time should be allowed for evaporation (this also applies for the formation of
condensation).
WARNING: Ensure sufcient air circulation for the device.
WARNING: It is not permitted to press more than one touch point simultaneously.
WARNING: Only operate the device with the voltage stated on the manufacturer's identication plate.
WARNING: DO NOT use the device in the presence of ammable anesthetics.
WARNING: Servicing may only be performed by specialists authorized by KARL STORZ.
WARNING: Test this device prior to each surgical procedure to ensure that it is functioning correctly. It should not be used if any damage is
evident.
WARNING: The device may only be operated with the power cable delivered by KARL STORZ or a similar power cable which has a national
inspection seal.
WARNING: Do not use the device if the input controls or the displays are defective.
WARNING: The device must not be used in oxygenated environments.
WARNING: The device may be subject to sudden failures. Keep a spare device at hand or alternate procedures in mind.
WARNING: Applied parts of devices used in combination with this device must be of type BF or CF.
WARNING: Patient leakage currents may be additive when energized endoscopes are used with energized endotherapy devices. This is
particularly important if a CF applied part endoscope is used, in which case a type CF applied part energized endotherapy device should be
used in order to minimize total patient leakage current.

7
Safety instructions
Warnings and cautions
WARNING: The compatibility of this device with any accessories and/or energized endotherapy devices should be checked in the individual
instructions for use.
WARNING: The line voltage to the device is only denitively disconnected once the power plug has been unplugged.
WARNING: The signal input and signal output parts of this device are designated by the manufacturer for exclusive connection to equipment
which complies with IEC 60601‑1.
WARNING: To avoid the risk of electrical shock, do not open the unit. Refer servicing to the manufacturer or to personnel authorized by the
manufacturer. Removal of covers by unauthorized personnel will void the equipment’s warranty.
WARNING: Always use the lowest possible settings for your intervention.
WARNING: Danger of glare! Never look into the light outlet when the light system is switched on.
WARNING: Danger of glare! The device can emit small amounts of UV light which can be dangerous for the retina. Never look into the light
outlet when the light system is switched on.
WARNING: The light source is transmitting high energy light leading to high temperatures at the light window of the endoscope. Tissue
damage is possible.
WARNING: Insufcient ventilation of the unit can cause an internal build‑up of heat which leads to a safety shut‑off.
WARNING: The device may only be operated within specied environmental conditions.
WARNING: The correct conguration of the device must be checked after each software update.
WARNING: Certain devices or accessories can cause danger in lower power settings. For example, the risk of gas embolism in argon assisted
coagulation rises if the HF power is insufcient for the fast creation of an impenetrable eschar layer on the target tissue.
1NOTE: The Power LED Saphira light source is marked with the OPAL1 PDD icon for purposes of identification.
UV Warning label
Ultraviolet hazard – Avoid eye and skin exposure to unshielded product.
Retinal blue light hazard – Do not look at the operating lamp. Eye injury may result.
Do not exceed exposure times of 1 hour of PDD light to the inner urinary bladder tissue.
PDD

8
Safety instructions
Warnings and cautions
Safety warnings when using the KARL STORZ D-Light C PDD System and Cysview®
1NOTE: The instruction manual for optical imaging agent Cysview®used in combination must be observed precisely.
3WARNING: Cysview®Contraindications for Use: The physician should refer to the Cysview® (hexaminolevulinate hydrochloride)
for Intravesical Solution Package Insert contraindications before selecting patients to receive Cysview®and to identify the Cysview®full
prescribing information.
3WARNING: The KARL STORZ D‑Light C PDD System must be used in combination with the optical imaging agent Cysview®
(Photocure) as an adjunct to white light to view tissue specic uorescent images. If the drug is not used uorescent images will not be
present. The light source blue light mode is not indicated as a stand‑alone product.
3WARNING: The safety and effectiveness of use of the KARL STORZ D‑Light C PDD System in combination with Cysview®in pediatric
patients has not been established.
3WARNING: Do not use the KARL STORZ D‑Light C PDD System to determine the histology of tissue. The uorescent images may also
result from inammation, scope trauma, scar tissue, the presence of immunotherapy or chemo‑preventive agents. Images that appear
negative may not always accurately indicate the absence of abnormal tissues, i.e., not all abnormal bladder tissue will be detected.
3WARNING: The KARL STORZ D‑Light C PDD System is restricted to use only by physicians who have completed appropriate training
in cystoscopy, and who have been trained in the use of the KARL STORZ D‑Light C PDD System and the optical imaging agent
Cysview®. The physician should use his/her judgment and experience in interpreting the uorescence images.
3WARNING: False‑positive and false‑negative results may occur with the PDD assisted tissue characterization after treatment with
Cysview®. The KARL STORZ D‑Light C PDD System is only to be used as an adjunct to white light (WL) cystoscopy.
CYSVIEW® WARNINGS & Precautions
Anaphylaxis – Anaphylaxis, including anaphylactoid shock, has been reported following administration of Cysview®. Prior to and during use of
the Cysview®, have trained personnel and therapies available for the treatment of anaphylaxis.
Adverse Reactions – Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably
estimate their frequency or establish a causal relationship to drug exposure.
Anaphylactoid shock, hypersensitivity reactions, bladder pain, cystitis and abnormal urinalysis have been reported during use of Cysview®.

9
Safety instructions
Before using the device on the patient, it is impera tive that you be acquainted with how the device operates and is controlled.
5. 2 Normal use
It is only allowed to use the power LED saphira light source in combination with approved accessories from KARL STORZ or with equipment
that is approved as safety-related uncritical.
Use of the device in elds other than those indicated above is not allowed for safety reasons.
3WARNING: No modication of this equipment is allowed.
5. 3 Intended use
The KARL STORZ D-Light C Photodynamic Diagnostic (PDD) System is intended to provide photodynamic blue light cystoscopy as an adjunct
to white light cystoscopy for the detection of non-muscle invasive bladder cancer.
The Power LED Saphira light source is intended for white light illumination and excitation during uorescence imaging in the blue and UV
spectral range, in endoscopic procedures.
5. 4 Indications for use
The KARL STORZ D-Light C Photodynamic Diagnostic (PDD) System for use in combination with the optical imaging drug Cysview®
(hexaminolevulinate hydrochloride) for Intravesical Solution is indicated for photodynamic blue light cystoscopy, as an adjunct to white light
cystoscopy for the detection of non-muscle invasive bladder cancer, including carcinoma in situ (CIS), in patients suspected or known to have
the lesion on the basis of a prior cystoscopy, or in patients undergoing surveillance cystoscopy for bladder cancer.
5. 5 Contraindication
When using PDD uorescent light sources, the medical contraindications that are listed for the suitable marker substance that may be used
apply, and use is contraindicated if endoscopic or microscopic examination techniques contradict the latest state of scientic knowledge.
PDD uorescent light sources are contraindicated for ophthalmologic interventions. For other interventions, the responsible physician must
decide whether the prescribed application is admissible based on the general condition of the patient.

10
Safety instructions
5. 6 User qualification
Only qualified doctors and medical assistant staffs are allowed to use the cold light fountain power LED saphira light source after training.
Training should only be provided by persons equipped to do so on the basis of their skills. Your local representative or responsible KARL STORZ
sales representative is available to provide training on your premises and to give you information about further training options.
5. 7 Patient profile
The use of the power LED saphira is not limited to a certain patient prole (sex, age, weight, etc.). The attending physician must assess a
patient’s health for the relevant application and declare it suitable.
5. 8 User profile
•Adequate and recognized skills in the relevant application
•Adequate powers of comprehension to rationally assess the surgical situation in hand
•Adequate language skills in at least one of the languages used on the device and in the instruction manual
•Be thoroughly trained in the operation and use of the device
•Knowledge of the contents of the instruction manual
•No physical impairments that could diminish perception of activation and alarm signals (visual and acoustic) and that cannot be compensated
using auxiliary means
•Physicians who have red/green color blindness should not attempt to use the KARL STORZ D-Light C PDD System, because they will not be
able to accurately judge the colors associated with normal and abnormal bladder tissue.
•The product is restricted to use only by physicians who have completed appropriate training in cystoscopy, and who have been trained in the
use of the KARL STORZ D-Light C PDD System and the optical imaging agent Cysview
®
. The physician should use his/her judgement and
experience in interpreting the uorescence images.

11
Safety instructions
5. 9 Intended conditions of use
5. 9. 1 Use
The device is intended for use in hospitals and doctors’ ofces. The technical data and ambient conditions are described in the instruction
manual.
It is the user’s responsibility to make sure the device is safe and operates properly before using it. During treatment using the power LED saphira
cold light fountain, the patient must be treated and kept under observation with the usual medical care. This includes keeping a check on the
progress of treatment, as well as monitoring the vital levels and the anesthetic.
3WARNING: Any treatment may only be performed if visual observation of the action of the device is ensured.
3WARNING: Risk of injury: Incorrectly assembled and damaged instruments can lead to injuries to the patient. Instruments and all of the
accessories used in combination with them must be checked immediately before and after every use to ensure that they are complete,
free from damage, and in full working order and have no unintentional rough surfaces, sharp corners, burred edges or projecting parts.
Care must be taken not to leave missing or broken‑off components inside the patient.
5. 9. 2 Other intended conditions
Frequency of use: one or more times a day
Length of use: from a few minutes to several hours a day.
Place of installation: Positioning on a level, vibration-free surface
Mobility: can be moved if positioned on a cart
Combination: can be used on the patient at the same time as other equipment required for the operations
Control: can be controlled via KS HIVE
5. 10 User position
For operation, the user should always be standing in front of the device within a ‘cone of vision’ with an opening angle of ±45° at a distance of
approx. 30 – 70 cm to the front panel.

12
Safety instructions
60°
5. 12 Safety features
The cold light fountain power LED saphira is equipped with the following safety features:
5. 12. 1 Self-test
A self-test is performed each time the device is switched on. If any of the tests is negative, a corresponding error message is displayed.
5. 11 Safety precautions at the site of installation
The device may only be used in medical rooms in which the electrical equipment has been installed in accordance with applicable national
regulations.
It is not intended for use in hazardous zones.
3WARNING: The device is not intended for use in potentially explosive zones. Do not operate the device within the demarcated hazard
zone while explosive anesthetic gases are in use.
This also applies to highly combustible and potentially explosive chemicals, e.g. skin disinfectants and fast-acting surface disinfectants.
The device is equipped with a connector for attaching a ground line. It should be connected up in accordance with national regulations.
3WARNING: The device should be placed on a at surface or a video cart. Do not block air inlets/outlets as overheating may result in re
hazard or device failure during procedure.