Instructions for Use
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Instructions for use IMAGE1 S
06-2021 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... 5 1.1 Read the instructions for use ... 5 1.2 Read the instructions for use of combinable products... 5 1.3 Scope... 5 1.4 Description of warning messages... 5 2 Normal use... 7 2.1 Intended use ... 7 2.2 Indications... 7 2.3 Contraindications... 7 2.4 Target user populations ... 7 2.5 Patient groups... 7 3 Safety ... 8 3.1 Serious incidents ... 8 3.2 Observing ambient conditions ... 8 3.3 Combination with other components ... 8 3.4 Damage due to ingress of liquid in electrical components... 9 3.5 Dangers from electrical current... 9 3.6 Electromagnetic interference ... 9 3.7 Unsterile product ... 10 3.8 Failure of devices ... 10 4 Product description ... 11 4.1 Description of operation ... 11 4.2 Product overview ... 11 4.3 Technical data... 14 4.4 Possible combinations... 16 4.4.1 Installation overview of IMAGE1 S CONNECT ... 16 4.4.2 Installation overview of IMAGE1 S CONNECT II ... 17 4.5 Symbols employed ... 18 4.5.1 Symbols on the packaging ... 18 4.5.2 Symbols on the user interface ... 19 4.6 Ambient conditions ... 22 5 Preparation... 24 5.1 Unpacking the product ... 24 5.2 Inspecting the product... 24 5.3 Setting up the product ... 24 5.4 Connecting the product ... 24 5.5 Putting the product into operation... 27 5.6 Performing the white balance ... 28 6 Application ... 30 6.1 Dashboard ... 30 6.2 Live menu... 31 6.2.1 Enhance (S-Technologies)... 34 6.2.2 OPAL1 ... 34 6.2.3 Display (Live menu)... 35 6.3 Setup menu... 36 6.3.1 Display (Setup menu)... 39 6.3.2 Network ... 40 6.4 Patient data privacy ... 42 6.5 Switching off the product ... 45 7 Maintenance, servicing, repairs, and disposal... 46 7.1 Maintenance ... 46
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Table of contents
7.2
Safety inspection in accordance with IEC 62353 ... 46 7.2.1 Visual inspection... 46 7.2.2 Electric measurements ... 46 7.3 Repairing the product ... 46 7.4 Disposing of the product ... 46 8 Accessories and spare parts ... 48 8.1 Accessories... 48 9 Electromagnetic compatibility... 56 9.1 General notes on the operating environment ... 56 9.2 Table 1 – Compliance level for immunity tests ... 56 9.3 Table 2 – Test levels for proximity fields from HF wireless communications equipment ... 57 9.4 Table 3 – Test levels for radiated and conducted immunity tests ... 58 9.5 Table 4 – Emission class and group ... 59 9.6 Table 5 – Recommended separation distances between portable and mobile HF communications devices and the product ... 60 10 Subsidiaries... 61
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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 combinable 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 These instructions for use apply to the following products up to and including software version 4.2: Product name
Item number
IMAGE1 S CONNECT
TC200
IMAGE1 S CONNECT II
TC201
IMAGE1 S H3-LINK
TC300
IMAGE1 S X-LINK
TC301
IMAGE1 S D-LINK
TC302
IMAGE1 S 4U-LINK
TC304
IMAGE1 S D3-LINK extension cable
TC015
1.4 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 warning messages describe 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.
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General information
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 IMAGE1 S The IMAGE1 S is a camera control unit for use with camera heads or videoscopes and is used for visualizing and documenting endoscopic and microscopic procedures. The IMAGE1 S has no direct contact with the human body. Extension cable The extension cable is used for extending the camera head cable for connection to the IMAGE1 S camera control unit. The extension cable has no direct contact with the human body.
2.2 Indications The camera control units do not come into direct contact with the patient; instead, they are used in conjunction with the corresponding accessories (videoendoscopes, camera, light source, and monitor) and the applied parts for the purpose of visualizing and documenting endoscopic and exoscopic procedures. Use is not restricted to certain medical disciplines.
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 groups There are no restrictions in terms of patient groups for this product.
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Safety
3 Safety 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 Observing ambient conditions If the device is operated in an environment which is not suitable, patients, users and third parties may be injured. Always operate the product in the prescribed ambient conditions. 2.
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.
3.3 Combination with other components The use of unauthorized devices and components or unauthorized changes to the product can result in injuries. Additional devices connected to electrical medical equipment must comply with the relevant IEC or ISO standards. Furthermore, all configurations must comply with the requirements for medical electrical systems (see Clause 16 of IEC 60601-1). Only combine the product with devices and components that are approved for joint use by the manufacturer. Perform regular checks to ensure that only authorized devices are connected to the product. Only use devices and components that have standardized interfaces and do not breach the intended use of the product. Observe the instruction manuals and interface specifications of the devices and components used in combination. Comply with national and local regulations. Only make changes to the product if these changes are approved by KARL STORZ.
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Safety
3.4 Damage due to ingress of liquid in electrical components In the case of electrical products, individual components or the product itself may be live. Liquid ingress into an electrical product may result in a short circuit or an unintentional transfer of current. The product is damaged as a result and patients, users and third parties may be injured. Do not store liquids near the product or on the product. If liquid has entered the product, pull out the plug and allow the product to dry completely.
3.5 Dangers from electrical current An improper power supply may cause an electric shock and injure patients, users, or third parties. All electrical installations in the operation room in which the product is connected and used must meet applicable IEC standards. Do not touch the output jacks of the product and the patient at the same time during use. Do not open the product. 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. 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. Make sure that the plug is completely clean and dry. Do not use more than one extension cable. Ensure potential equalization according to the applicable national rules and regulations. The product’s ground line should be installed by a qualified electrician. To ensure reliable protective earth grounding, connect the product to a properly installed socket that is approved for use in the operation room. Routinely inspect the electrical plug and cord and do not use if the inspection reveals damage. If several products supplied with energy are used simultaneously, the patient leakage currents accumulate. These leakage currents can exceed the limit values and injure patients. Only use products of the same type, for example, endotherapy device and application part of type CF.
3.6 Electromagnetic interference Medical electrical products are subject to special precautions regarding electromagnetic compatibility and must be installed and commissioned according to the tables on electromagnetic compatibility. If other products (e.g. for MRT, CT, diathermy, electrocautery or RFID) emit electromagnetic radiation, the function of the product may be impaired. Highfrequency communication equipment can affect electrical medical products and impair their performance. Do not use the product next to or together with other devices. If such use is required, monitor the product and the other devices, and follow the relevant instructions for use in the event of malfunctions. Portable RF communications equipment including peripheral devices (e.g., antenna cables and external antennas) should be used no closer than 30 cm from the product, including cables specified by the manufacturer. The discharge of a defibrillator can cause image loss. If the image has not reappeared after 4 seconds, switch the camera control unit off and on again.
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Safety
3.7 Unsterile product The product is not sterile when delivered. The use of non-sterile products 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.
3.8 Failure of devices The product may fail during use. If the image fails during the procedure, remove the camera from the endoscope and continue the procedure optically. Have a replacement system ready for each application.
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Product description
4 Product description 4.1 Description of operation The product offers the following functions: –
IMAGE1 SVisualization modes to support the user with contrast enhancement and/or consistent brightness perception.
–
Light Source Control for automatic adjustment of the light source.
–
Integrated image and video capture for simple documentation.
4.2 Product overview 1
2
3
10
4
9
8 5
7 6 IMAGE1 S CONNECT, front 1
Power switch
6
D3-LINK camera connection
2
White balance
7
IMAGE1 S D-LINK (TC302)
3
USB port
8
IMAGE1 S X-LINK (TC301)
4
H3-LINK camera connection
9
IMAGE1 S H3-LINK (TC 300)
5
X-LINK camera connection
10
IMAGE1 S CONNECT (TC200)
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Product description
1
2
3
4
5
6
7
8
10
9
Rear side of IMAGE1 S CONNECT 1
LINK input ports
6
HD DVI-D video output sockets
2
Potential equalization connector
7
3G-SDI video output
3
SCB input/output sockets (KARL STORZ Communication Bus)
8
Mains sockets
4
LAN interface, KS HIVE interface
9
Potential equalization connector
5
USB interface
10
LINK output
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Product description
1
2
3
10 4
9
8
5 7 6 IMAGE1 S CONNECT II, front 1
Power switch
6
D3-LINK camera connection
2
White balance
7
IMAGE1 S D-LINK (TC302)
3
USB port
8
IMAGE1 S X-LINK (TC301)
4
4U-LINK camera connection
9
IMAGE1 S 4U-LINK (TC304)
5
X-LINK camera connection
10
IMAGE1 S CONNECT II (TC201)
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Product description
1
3
2
4
5
6
7
12
11 10
9
8
Rear side of IMAGE1 S CONNECT II 1
LAN interface, KS HIVE interface
7
Mains sockets
2
LINK input ports
8
Potential equalization connector
3
SCB input/output sockets (KARL STORZ Communication Bus)
9
USB interface
4
12G/3G SDI video output
10
Potential equalization connector
5
DisplayPort video output sockets
11
EXT SYNC connection
6
HD DVI-D video output socket
12
LINK output
4.3 Technical data Description
Value
HD video outputs
2x DVI-D 1x 3G-SDI
Signal output format
1,920 x 1,080p, 50/60 Hz
LINK input ports
3x
KS HIVE interface
RJ45
USB interface
4x USB
Image format
JPEG
Video format
MPEG 4
SCB interface
2x 6 pin Mini DIN
Tab. 1: IMAGE1 S CONNECT
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Product description
Description
Value
4K and HD video outputs
2x DP 1x 12G/3G SDI 1x DVI-D
Signal output format
3,840 x 2,160p, 50/60 Hz for DP and 12G-SDI 1,920 x 1,080p, 50/60 Hz for 3G-SDI and DVID
LINK input ports
3x
KS HIVE interface
RJ45
USB interface
4x USB
Image format
JPEG
Video format
MPEG 4
SCB interface
1x 6 pin Mini DIN
Tab. 2: IMAGE1 S CONNECT II Power supply (AC) and frequency requirements
Value
IMAGE1 S CONNECT
100–120 V, 50/60 Hz 200–240 V, 50/60 Hz
IMAGE1 S CONNECT II
100–240 V, 50/60 Hz
IMAGE1 S H3-LINK
100–240 V, 50/60 Hz
IMAGE1 S X-LINK
100–240 V, 50/60 Hz
IMAGE1 S D3-LINK
100–240 V, 50/60 Hz
IMAGE1 S 4U-LINK
100–240 V, 50/60 Hz
Dimensions
Value (W x H x D)
IMAGE1 S CONNECT (TC200 and TC201)
320 x 54 x 305 mm
IMAGE1 S H3-LINK
320 x 54 x 305 mm
IMAGE1 S X-LINK
320 x 54 x 305 mm
IMAGE1 S D3-LINK
320 x 54 x 305 mm
IMAGE1 S 4U-LINK
320 x 54 x 305 mm
Weight
Value
IMAGE1 S CONNECT
2.1 kg
IMAGE1 S CONNECT II
3.1 kg
IMAGE1 S H3-LINK
1.86 kg
IMAGE1 S X-LINK
1.86 kg
IMAGE1 S D3-LINK
1.86 kg
IMAGE1 S 4U-LINK
1.86 kg
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Product description
Power input
Value
IMAGE1 S CONNECT
62 VA
IMAGE1 S CONNECT II
100–135 VA
IMAGE1 S H3-LINK
80 VA
IMAGE1 S X-LINK
80 VA
IMAGE1 S D3-LINK
80 VA
IMAGE1 S 4U-LINK
86 VA
4.4 Possible combinations It is recommended that the suitability of the products for the planned 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. The IMAGE1 S camera control unit (CCU) consists of the IMAGE1 S CONNECT (TC200) or IMAGE1 S CONNECT II (TC201) and 1–3 additional LINK modules. The various modules serve as interfaces to camera heads and videoendoscopes. The following LINK modules are available: –
IMAGE1 S H3-LINK (TC300)
–
IMAGE1 S X-LINK (TC301)
–
IMAGE1 S D3-LINK module (TC302)
–
IMAGE1 S 4U-LINK module (TC304) The compatibility list for the LINK modules must be respected.
The following products are required for navigation and input: –
Keyboard
–
Mouse
The following products are available as options for navigation: –
Compatible camera heads and videoendoscopes
–
IMAGE1 PILOT (TC014)
–
Microscope footswitch (TC019)
Do not connect network devices (Ethernet, Bluetooth, or WiFi dongles) to the USB port of the IMAGE1 S. The connection may impair operation of the IMAGE1 S.
4.4.1 Installation overview of IMAGE1 S CONNECT If multiple KS HIVE-compatible peripheral devices are used, the OR1 HIVE router is required.
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Product description
4.4.2 Installation overview of IMAGE1 S CONNECT II To use OPAL1 fluorescence imaging, the IMAGE1 S 4U-LINK (TC304) and Power LED Rubina (TL400) must also be connected via a sync cable when using the TIPCAM1 Rubina. If multiple KS HIVE-compatible peripheral devices are used, the OR1 HIVE router is required.
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Product description
4.5 Symbols employed 4.5.1 Symbols on the packaging Symbol
Meaning Manufacturer
Date of manufacture
Medical device
Article no.
Batch code
Number of products in the product packaging
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Product description
Symbol
Meaning Unique Device Identifier
Consult the printed or electronic instructions for use
Fragile, handle with care
Keep dry
Temperature limit
Humidity limit
Not MR safe
Federal (USA) law restricts this device to sale by or on the order of a physician. CE conformity mark: With this mark, the manufacturer declares the compliance of the products with the applicable standards and directives. A code number after the CE mark indicates the responsible notified body.
4.5.2 Symbols on the user interface Symbol
Meaning H3-LINK The button appears once the H3-LINK module is correctly connected.
X-LINK The button appears once the X-LINK module is correctly connected.
D3-LINK The button appears once the D3-LINK module is correctly connected.
4U-LINK The button appears once the 4U-LINK module is correctly connected.
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Product description
Symbol
Meaning Insufflator
Printer
Light source
Storage
Patient
Presets
Setup menu
Info
Brightness
Video
Image
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