TP101 TELE PACK + Instruction Manual V3.0

11-2023 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 ... 1.1 Read the instructions for use ... 1.2 Read the instructions for use of compatible products ... 1.3 Scope ... 1.4 General signs and symbols ... 1.5 Description of warning messages ...

6 6 6 6 6 7

2 Normal use ... 2.1 Intended use ... 2.2 Indications ... 2.3 Contraindications ... 2.4 Target user populations ... 2.5 Patient population ...

8 8 8 8 8 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 ... 11 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 Reprocessing the product ... 24 5.3 Setting up the product ... 24 5.4 Connecting the product ... 25 5.5 Connecting external devices ... 26 5.6 Connecting the light cable ... 27 5.7 Mounting the camera head holder ... 27

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Table of contents

5.8 Functional test ... 28 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 ... 36 6.10 Patient data security ... 36 6.10.1 Patient handling ... 37 6.10.2 Labeling ... 37 6.10.3 Export mode ... 37 6.11 Network communication ... 38 6.11.1 FileShare mode ... 38 6.11.2 FileShare settings ... 38 6.11.3 Worklist mode ... 39 6.11.4 Worklist settings ... 40 6.11.5 Network dialog ... 40 6.11.6 Local settings ... 41 7 Maintenance, servicing, repairs, and disposal ... 43 7.1 Maintaining the product ... 43 7.1.1 Maintenance ... 43 7.2 Safety inspection in accordance with IEC 62353 ... 43 7.2.1 Visual inspection ... 43 7.2.2 Electric measurements ... 43 7.2.3 Functional test ... 43 7.3 Repairing the product ... 43 7.4 Disposing of the product ... 44 8 Accessories and spare parts ... 45 8.1 Accessories ... 45 9 Electromagnetic compatibility ... 46 9.1 General notes on the operating environment ... 46 9.2 Accessories and cables ... 46 9.3 Table 1 – Compliance level for immunity tests ... 47 9.4 Table 2 – Test levels for near fields from HF wireless communications equipment ... 48 9.5 Table 3 – Test levels for radiated and conducted immunity tests ... 49 9.6 Table 4 – Emission class and group ... 50 9.7 Table 5 – Recommended separation distances between portable and mobile HF communications devices and the product ... 51 Instructions for use • TELE PACK + • CQH848_EN_V3.0_11-2023_IFU_CE-MDR

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Table of contents

10 Errors and messages ... 52 10.1 Troubleshooting ... 52 11 Overview of mitigating warnings ... 53 12 Subsidiaries ... 54

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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

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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.

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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.

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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; see Disposing of the product.

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.

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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. To ensure reliable protective earth grounding, connect the product to a properly installed socket that is approved for use in the operation room. 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 unplug the device before carrying out any cleaning and maintenance work and disconnect any connected applied parts as well as the USB stick or hard disk.

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.

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Safety and warning

3.9 Failure of products The product may fail during use. 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.

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Product description

4 Product description 4.1 Product overview 2

1

3

4 5

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

2

1

3 4 5 6 7 8

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

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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 described products in this medium may not be available in all countries due to different regulatory requirements. Do not connect network devices (Ethernet, Bluetooth, or WiFi dongles) to the USB port of the product. The connection may impair operation of the product.

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

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

Flexible HD video cystoscope

11272VHU

Flexible HD Video Choledochoscope

11292VH

Video bronchoscope

11900BP

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Product description

Item

Order no.

Video bronchoscope HD

11910T

Video bronchoscope HD

11910D

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

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

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Product description

Item

Order no.

CMOS Video Rhino-Laryngoscope SSU

091330-01

CMOS Video Cysto-Urethroscope

11272VE

CMOS Video Cysto-Urethroscope

11272VUE

CMOS Video Cystoscope-Urethroscope (US only)

11272VUE-R

Video-uretero-renoscope FLEX-XC1

091271-01

Video-uretero-renoscope FLEX-XC1

091279-01

4.3 Technical data Description

Value

Power supply (AC)

100–240 V

Operating frequency

50/60 Hz

Power input

140 VA

Electrical protection class

I

Applied part type according to IEC 60601-1

CF

Dimensions (L x H x W)

209 x 388 x 469 mm

Weight

8.9 kg

Light source Lamp

LED

Color temperature

5,700 K

Display Screen size

18.5"

Contrast

1,200 : 1

Resolution

1,920 x 1,080 p

Speaker Power

3.2 W

Memory device Memory interface

USB

Image format

JPEG

(Audio)/video format

MPEG-4

Interfaces Network interface

RJ-45 x Gbit

Video interface

1x DVI-D

Audio

3.5 mm jack (in/out – rear), KARL STORZ stroboscopy microphone (1 x lateral)

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Product description

Description

Value

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 information such as warnings and precautions. Fragile, handle with care

Keep dry

Temperature limit

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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 packaging label. Ready/standby button

Network connection

USB

Applied part type BF

Applied part type CF defibrillation protection

Potential equalization connector

Line out

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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.

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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 righthand corner of the monitor. Zoom If Adaptive Zoom has been activated, the system detects the size of the endoscopic image. The endoscopic image is enlarged digitally until the vertical height is completely filled, without losing any image information. 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 relatively 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.

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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 specifically 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 language 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.

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