Instruction Manual
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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 ... 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 ... 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
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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 Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR
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Table of contents
10.1 Troubleshooting ... 51 11 Overview of mitigating warnings ... 52 12 Subsidiaries ... 53
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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.
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. 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.
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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.
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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 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
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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
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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 only)
11272VUE-R
Video-uretero-renoscope FLEX-XC1
091271-01
C1
091279-01
Video-uretero-renoscope FLEX-X
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
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Product description
Description
Value
Video interface
1x DVI-D
Audio
3.5 mm jack (in/out – rear), KARL STORZ stroboscopy 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 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 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 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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