Instructions for Use
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Instructions for use POWER LED 300
12-2020 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 Scope... 5 1.3 Description of warning messages... 5 2 Normal use... 6 2.1 Intended use ... 6 2.2 Indications... 6 2.3 Contraindications... 6 2.4 Target user populations ... 6 2.5 Patient groups... 6 2.6 Intended conditions of use ... 6 3 Safety ... 7 3.1 Serious incidents ... 7 3.2 Correct reprocessing ... 7 3.3 Contaminated products ... 7 3.4 Combination with other components ... 7 3.5 Damaged products ... 7 3.6 Dangers from electrical current... 8 3.7 Damage due to ingress of liquid in electrical components... 8 3.8 High light intensity ... 8 3.9 Electromagnetic interference ... 9 3.10 Failure of devices ... 9 3.11 Observing ambient conditions ... 9 3.12 Functionality of the touch screen... 10 4 Product description ... 11 4.1 Description of operation ... 11 4.2 Product overview ... 11 4.3 Possible combinations... 12 4.4 Technical data... 13 4.5 Symbols employed ... 13 4.5.1 Symbols on the packaging ... 13 4.5.2 Symbols on the product ... 14 4.5.3 Symbols on the type plate... 15 4.5.4 Symbols on the user interface ... 15 4.6 Ambient conditions ... 16 5 Preparation... 17 5.1 Unpacking the product ... 17 5.2 Testing the product... 17 5.3 Setting up the product ... 17 5.4 Connecting the product ... 17 5.5 Connecting the light cable ... 18 5.6 Assembling the three-way adaptor (option)... 19 5.7 Putting the product into operation... 22 6 Application ... 23 6.1 User interface... 23 6.2 Switching the light on and off ... 23 6.3 Manual light adjustment... 24 6.4 Automatic light control... 24 6.5 Settings ... 24 6.5.1 Service ... 25
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Table of contents
6.5.2 Setting the language... 25 6.5.3 Event protocol ... 25 6.5.4 Product information ... 26 6.5.5 Audio settings ... 26 6.6 Switching off the product ... 27 6.7 Information signals... 27 6.7.1 Visual information signal... 27 6.7.2 Acoustic information signal ... 27 6.7.3 Availability signal ... 28 7 Maintenance, servicing, repairs, and disposal... 29 7.1 Maintaining the product ... 29 7.1.1 Maintenance ... 29 7.2 Changing a fuse ... 29 7.3 Safety inspection in accordance with IEC 62353 ... 30 7.3.1 Visual inspection... 31 7.3.2 Electric measurements ... 31 7.3.3 Functional test ... 31 7.4 Repairing the product ... 31 7.5 Disposing of the product ... 31 8 Accessories and spare parts ... 32 8.1 Accessories... 32 8.2 Spare parts ... 33 9 Electromagnetic compatibility... 34 9.1 General notes on the operating environment ... 34 9.2 Accessories and cables ... 34 9.3 Table 1 – Compliance level for immunity tests ... 34 9.4 Table 2 – Test levels for proximity fields from HF wireless communications equipment ... 36 9.5 Table 3 – Test levels for radiated and conducted immunity tests ... 36 9.6 Table 4 – Emission class and group ... 38 9.7 Table 5 – Recommended separation distances between portable and mobile HF communications devices and the product ... 38 10 Faults and messages ... 40 10.1 Troubleshooting ... 40 11 Subsidiaries... 41
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General information
1 General information 1.1 Read the instructions for use These instructions for use are intended to aid you in the proper installation, connection, and operation of this product. If the instructions for use are not followed, patients, users, or third parties may be injured. In addition, the product may be damaged. 1.
Read the instructions for use carefully and follow them completely.
2.
Keep the instructions for use clearly visible next to the product.
It is recommended to check the suitability of the products for the planned procedure prior to use.
1.2 Scope This instruction manual is valid for: Product name
Article number
POWER LED 300
TL300
1.3 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. NOTICE ATTENTION 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 power LED 300, Xenon Nova 300, and Xenon 300 SCB white light sources are used for illumination in diagnostic and therapeutic procedures in endoscopy, microscopy, and open surgery.
2.2 Indications The power LED 300, XENON NOVA® 300, and XENON 300 SCB white light sources are designed for generating light in endoscopic and microscopic diagnostic examinations and in surgical procedures.
2.3 Contraindications White light sources are contraindicated for ophthalmologic procedures. For other procedures, the responsible physician must decide whether the prescribed 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.
2.6 Intended conditions of use The product may only be used in hospitals and doctors’ offices in suitable ambient conditions. Condition
Application
Frequency of use
One or more times a day
Length of use
Several minutes to several hours a day
Place of installation
Positioning on a level, vibration-free surface
Mobility
Can be moved if placed on a cart.
Combination
Can be used on the patient at the same time as other devices.
Control
Can be controlled via the KARL STORZ SCB.
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Safety
3 Safety 3.1 Serious incidents According to the Medical Device Regulation (MDR), a “serious incident” includes incidents that directly or indirectly had, could have had, or could have any of the following consequences (MDR, Art. 2, No. 65 [1]): –
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 Correct reprocessing Incorrectly reprocessed products expose patients, users, and third parties to a risk of infection. Reprocess the product before use. A validated reprocessing procedure must be followed and the product must be reprocessed in line with the reprocessing instructions.
3.3 Contaminated products Contaminated products pose a risk of infection for users, patients, and third parties. Comply with national laws and regulations. Observe the guidelines of the Employer’s Liability Insurance Association and equivalent organizations.
3.4 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 IEC 60601-1-1 or Clause 16 of the 3rd edition of IEC 60601-1). Only combine the product with devices and components that are approved as medical devices. Comply with national and local regulations. Observe the instruction manuals and interface specifications of the devices and components used in combination. Only use devices and components that have standardized interfaces and do not breach the intended use of the product. Only make changes to the product if these changes are approved by KARL STORZ.
3.5 Damaged products Damaged products can result in injury to patients, users, or third parties. Before each use, check all components of the product for damage. Do not use damaged products.
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Safety
3.6 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. 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. Only use BF or CF type devices and components. 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. Always pull out the mains plug before carrying out any cleaning and maintenance work. Connect the product to a power supply with protective conductor. 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. Routinely inspect the electrical plug and cord and do not use if the inspection reveals damage. 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, or third parties. Do not open the product. Have servicing carried out by KARL STORZ or a company authorized by KARL STORZ. Failure to observe this will void the guarantee. 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. During operations, explosive anesthetic gases are used. If sparks occur, this may trigger explosions. Only connect or disconnect the power plug to or from the power supply outside explosive atmospheres. 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.
3.7 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.
3.8 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. Always select the lowest possible light setting during use.
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Safety
Make sure the light output is sufficiently far away from tissue and operating accessories. Never look into the light output when the light system is switched on. Switch off the light source before changing the light cable connection (adapter). Allow the product to cool down before changing the light cable connection (adapter).
3.9 Electromagnetic interference Medical electrical devices are subject to special precautions regarding electromagnetic compatibility and must be installed and commissioned according to the tables on electromagnetic compatibility. If other devices (e.g. MRI, CT, diathermy, electrocautery or RFID equipment) emit electromagnetic radiation, the product’s function may be impaired. Highfrequency (HF) communications equipment can affect electrical medical equipment and impair the performance of the device. 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. Observe the information on electromagnetic compatibility; see chapter Electromagnetic compatibility [p. 34]. The use of accessories and cables other than those specified in the instruction manual may result in increased emissions or decreased immunity of the product. When using other accessories and cables, the operator is responsible for checking compliance with IEC 60601-1-2 for this particular product. To prevent increased electromagnetic emissions or reduced electromagnetic immunity of the product, only use accessories, transducers, and cables recommended or supplied by the manufacturer.
3.10 Failure of devices The product may fail during use. Have a replacement product ready for each application or plan for an alternative surgical technique.
3.11 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. 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.
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Safety
3.12 Functionality of the touch screen If the functionality of the touch screen is limited, the product cannot be used correctly. Patients, users, and third parties may be injured. Do not use the product if the touch screen is defective. Do not tap the touch screen in several places at the same time.
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Product description
4 Product description 4.1 Description of operation The cold light fountain POWER LED 300 is a high-power cold light source for diagnostic and therapeutic endoscopic applications. The POWER LED 300 has the following characteristics: –
Efficiency: High light intensity combined with low power consumption.
–
Comfortable working environment: Intelligent 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 screen.
–
Integrated SCB function: Enables the light source to be controlled remotely and the system status information to be retrieved, while providing simple configuration during initialization.
–
Up-to-date: Software updates can be installed easily via an interface.
4.2 Product overview
1
2
3
POWER LED 300 – Front view 1
Power switch
2
TFT touch screen
3
Light outlet point
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Product description
4 3
1
2
POWER LED 300 – Back view 1
Grounding plug
3
Power fuse holder
2
Power cord socket
4
SCB connectors
4.3 Possible combinations The basic system consists of the following components: –
POWER LED 300
–
Camera control unit (CCU), IMAGE1 S™ system
–
Light cable with endoscope or videoendoscope
The system can be used for flexible or rigid endoscopic procedures. Adapters can also be used in combination with light cables from other manufacturers. Compatibility with light cables Series 495xx light cables are compatible with the standard adapter. The three-way adaptor (TL005) can be combined with the light cables from the following manufacturers: –
Olympus
–
Stryker
–
Richard Wolf Only KARL STORZ Hopkins telescopes are recommended in combination with KARL STORZ light cables.
The compatibility with the light cables of the listed third-party manufacturers does not take the degree of protection into account. The defibrillation protection is not guaranteed. Compatibility with camera control units (CCU) The POWER LED 300 is connected to the KARL STORZ camera control unit and a LINK module (modular CCU) via the KARL STORZ communication bus (SCB). The light intensity can be controlled automatically via the SCB with the modular CCU.
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Product description
The following CCUs can be combined: –
IMAGE1 S CONNECT® (TC200)
–
IMAGE1 S CONNECT® II (TC201)
–
IMAGE1 S™ H3-LINK (TC300)
–
IMAGE1 S™ X-LINK (TC301)
–
IMAGE1 S D3-LINK® (TC302)
–
IMAGE1 S™ 4U-LINK (TC304)
4.4 Technical data Description
Value
Power supply (AC)
100 – 240 V
Operating frequency
50/60 Hz
Line fuse
2 x T 4.0 AH 250 V
Power input
175 VA
Electrical protection class
I
Applied part type according to IEC 60601-1
CF
Dimensions (L x H x W)
313 x 155 x 305 mm
Weight
8.6 kg
4.5 Symbols employed 4.5.1 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
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Product description
Symbol
Meaning 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
Federal (USA) law restricts this device to sale by or on the order of a physician. CE marking With this mark, the manufacturer declares the compliance of the devices with the applicable standards and directives The device must not be modified in any way
4.5.2 Symbols on the product Symbol
Meaning Follow instructions for use
ON
OFF
Potential equalization connector
Applied part of the type CF
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Product description
4.5.3 Symbols on the type plate Symbol
Meaning Manufacturer
Date of manufacture
Medical device
In accordance with US federal law (21 CFR 801.109), this product may only be sold to or on prescription from a licensed physician. Prevention of pollution by electronic devices
Separate collection of electrical and electronic devices. Do not dispose of in household refuse. CE conformity mark With this mark, the manufacturer declares the compliance of the products with the applicable regulation (EU) 2017/745. A code number after the CE mark indicates the responsible notified body.
4.5.4 Symbols on the user interface Symbol
Meaning Settings
Standby
Start/stop
Increase value
Decrease value
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Product description
Symbol
Meaning Confirm
Cancel
Remove
Scroll back
Scroll forward
Audio signals on/off
4.6 Ambient conditions Storage/transport conditions Temperature
-10 °C ... +60 °C
Relative humidity (non-condensing)
5 – 95 %
Air pressure
500 – 1,080 hPa
Operating conditions Temperature
10 °C ... 40 °C
Relative humidity (non-condensing)
20 – 85 %
Max. operating altitude
3,000 m
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Preparation
5 Preparation 5.1 Unpacking the product 1.
Carefully remove the product and accessories from the packaging.
2.
Check the delivery for missing items and evidence of shipping damage.
3.
In the case of damage, hidden defects, and short deliveries, document their nature and extent and contact the manufacturer or supplier immediately.
4.
Keep packaging for further transport.
5.2 Testing the product 1.
Inspect the product for visible contamination. Do not use if contaminated.
2.
Inspect the product for the following characteristics:
–
Good working order
–
Functionality
–
Correct assembly of the components
–
Completeness
5.3 Setting up the product WARNING Overheating! Risk of fire! Insufficient ventilation can cause an internal build-up of heat, resulting in a safety shut-down. If the product overheats, there is a risk of fire. Patients, users, and third parties may be injured. Ensure that there is sufficient air circulation. Keep air inlets and outlets free. This product and connected components may only be used in medical rooms with electrical installations that conform to applicable national regulations. When the product is installed, the position of the user must be taken into account. When operating the product, the user stands within a viewing cone with an angle of view of ±45° at a distance of approx. 30 – 70 cm from the front panel. 1.
Set the product down on a horizontal, flat surface or a video cart.
2.
Position the product so that it is in the user’s field of vision.
3.
Keep the product out of the reach of patients.
5.4 Connecting the product 1.
Connect the potential equalization cable.
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Preparation
2.
Connect the power cord. Push the power plug fully into the power socket.
3.
Connect the SCB cable.
4.
Connect the other end of the SCB cable to a KARL STORZ control device or other SCB devices; see the instruction manual for the KARL STORZ SCB control NEO system.
5.
To remove the SCB cable, pull on the plug (the SCB cable is equipped with a protection device to prevent if from being pulled out accidentally).
5.5 Connecting the light cable WARNING High energy! Risk of burns! The light source transmits high-energy light at high surface temperatures which can damage tissue. Keep the light source away from tissue. The light outlet point is provided with an antiglare flap, which does not allow any direct outlet of light. Light only appears when the light cable is attached.
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Preparation
We recommend using original KARL STORZ light cables, because light cables from other manufacturers may not be optimized for light transmission. The degree of protection against electric shock at the applied part as type CF according to IEC 60601-1 (defibrillation-protected) is guaranteed using KARL STORZ light cables, see chapter Accessories [p. 32]. 1.
Insert the light cable into the light outlet point until it engages. Hold the light cable only by the handle, never by the cable.
2.
Connect the light cable by twisting the knurled screw on the endoscope screw base through a quarter turn.
5.6 Assembling the three-way adaptor (option) WARNING High energy! Risk of burns! Switch off the light source before changing the light cable connection (adapter).
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Preparation
The three-way adaptor (TL005) can be used for the light cables from the following manufacturers: –
KARL STORZ, Richard Wolf
–
Stryker (Position II)
–
Olympus (Position III)
ü
The light source is switched off.
1.
Turn the standard adaptor counterclockwise and remove it.
2.
Insert the three-way adapter into the thread and turn it counterclockwise until it clicks into place.
3.
Then screw in the three-way adaptor in a clockwise direction until hand-tight.
4.
Check whether the dot marking on the front of the adaptor is in the 12 o'clock position.
5.
If not, undo the screw at the edge of the adaptor using a Phillips screwdriver.
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