Safety and performance information for:
FloNaviTM Open Field Fluorescence Imaging System
IPU: OPTO-CAM214K
Camera Head: OPTO-CHD214KH/OPTO-CHD214KE
Light Source: OPTO-LED214K
FloNavi Endoscopic Fluorescence Imaging System (hereafter referred to as FloNavi System) consists of FloNavi Image Processing Unit (hereafter referred to as IPU), FloNavi Endoscopic Fluorescence Camera Head, and FloNavi Light Source, which is designed to observe the fluorescence images from Indocyanine Green (ICG) in the patient body.
Upon injection of the imaging agent (ICG), the ICG binds to specific proteins in the blood or lymph. The light transmitted from the Light Source illuminates the surgical field with invisible, infrared light and visible white light through a flexible light guide cable. The ICG fluoresces under the infrared light. The Camera Head captures both the visible and invisible image signals and transmits the signals to the Image Processing Unit for processing. Then the Image Processing Unit outputs the video image to a medical grade monitor and/or video recorder.
FloNavi System is used to provide near infrared fluorescence imaging.
During minimally invasive surgery, FloNavi System is used in conjunction with ICG, enabling surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, lymph nodes, and at least one of the major extra-hepatic bile ducts, using near-infrared imaging.
Fluorescence imaging should not be used during surgical procedures with patients who are known to be sensitive to iodides or iodinated contrast agents.
The equipment should not be used on patients who do not need or are not suitable for endoscopic surgery.
FloNavi System may only be used by physicians and medical assistants who have a specialized qualification and who have been instructed in the use of the FloNavi System.
FloNavi is indicated for patients who need endoscopic examination and/or intervention and do not have medical contraindications to endoscopy.
The attending physician must evaluate patient’s physical condition to decide if the patient needs or is suitable for fluorescence imaging.
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This manual does not explain or discuss clinical surgical procedures. It is the surgeon’s responsibility to be familiar with the appropriate surgical techniques prior to using this equipment. Anaphylactic or urticarial reactions have been reported in patients with or without history of allergy to iodides. If such reactions occur, immediate treatment with appropriate agents, for example, epinephrine, antihistamines, and corticosteroids should be administered. Resuscitative measures may also be required. A backup equipment is necessary in case the equipment loses function during surgery and the operation cannot be continued. A backup equipment may also help terminate the surgery safely. Test the equipment prior to each procedure to ensure it functions correctly. Do not use the equipment if any component is damaged or functions improperly. Failure to follow this warning may lead to injury. Risk of injury and damage to persons and the products! Failure to observe and follow this instruction manual and all the instruction manuals of the products used in combination can result in injury to patients, users and third parties as well as damage to the product. Please carefully read all relevant instruction manuals prior to use and always follow the instructions given precisely. Check the functioning of the products used in combination. Grounding reliability can only be achieved when the equipment is connected to a 'Hospital Only’ or 'Hospital Grade' outlet (i.e., approved for use in an operating room environment). There may be potential difficulties in ensuring electromagnetic compatibility if the equipment is used in domestic establishments and connected to the public mains network. The power plug and cord should be routinely inspected. Do not use if damaged. Danger of electrical shock! The equipment is a Class I ME equipment and may only be connected to a socket with protective earthing. To reduce the risk of electrical shock, keep the system out of reach of patients. The AC inlet of the equipment is means to isolate its circuits electrically from the supply mains. To prevent electrical shock, do not disassemble the equipment. There are no user-serviceable parts. Dismantling the equipment voids the warranty. Make sure the equipment is completely disconnected from the power supply prior to any reprocessing, maintenance, and service. Any service and maintenance to the equipment is prohibited while it is being used on the patient. The assembly and modification of the equipment should meet the requirements of IEC 60601-1 and should be carried out by experienced professionals designated by OptoMedic. Unauthorized assembly or modification is not allowed. The equipment has not been tested in conjunction with high frequency (HF) surgical equipment (e.g., electrocautery, MRI, electrosurgical units, and diathermy devices) and should not be used with such equipment. The equipment is not suitable for use in the presence of flammable anesthetics mixed with air or with oxygen or nitrous oxide. Connect only items that have been specified as being compatible with the equipment. Use of unspecified accessories and/or devices may deteriorate the safety and performance of the equipment. Consult and follow the storage, transport, and operating conditions specified in the accompanying document precisely to avoid equipment damage. The equipment should be placed on a flat surface or on a surgical cart. Do not block the air inlets/outlets of the equipment as overheating may result in fire hazard or device failure during procedure. The equipment is shipped non-sterile and should be cleaned and disinfected before the first use and after every subsequent use. Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. |
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When in use, avoid placing the equipment in any place that blocks access to the AC wall outlet and hinders operation of the disconnection device. Do not use or store liquids on or around the equipment. If liquid enters the equipment, immediately disconnect the equipment from the power outlet. Do not store the system in direct sunlight. The equipment contains electrical printed circuit assemblies and should be disposed of in accordance with any applicable national or institution policy related to obsolete electronic equipment at the end of its service life. Do not put the equipment in a small and messy space that makes it difficult to remove the power supply cord. Use of accessories and other equipment other than those specified or provided by the manufacturer could result in product damage. |
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The following are known general warnings for ICG. Please refer to the ICG operator manual you purchase prior to use. |
Following intravenous injection, ICG is rapidly bound to plasma proteins, primarily lipoproteins with a lesser and variable binding to albumin (2-30% of total). Simultaneous arterial and venous blood estimations have shown negligible renal, peripheral, lung or cerebro-spinal uptake of the ICG. ICG is taken up from the plasma almost exclusively by the hepatic parenchymal cells and is secreted entirely into the bile. ICG does not undergo significant enterohepatic recirculation.
ICG has a half-life of 2.5-3.0 minutes.
ICG contains sodium iodide and should be used with caution in patients who have a history of allergy to iodides or iodinated imaging agents due to a risk of anaphylaxis.
The Imaging System should not be used for NIR imaging during surgical procedures with patients who are known to be sensitive to iodides or iodinated imaging agents.
Anaphylactic deaths have been reported following ICG administration during cardiac catheterization.
Radioactive iodine uptake studies should not be performed for at least a week following the use of ICG for injection.
Pregnancy Category C: Animal Reproduction studies have not been conducted with ICG. It is not known whether ICG can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ICG should be given to a pregnant woman only if clearly indicated.
Nursing Mothers: It is not known whether this drug is excreted in human milk.Because many drugs are excreted in human milk, caution should be exercised when ICG is administered to a nursing woman.
Anaphylactic or urticarial reactions have been reported in patients with or without history of allergy to iodides. If such reactions occur, immediate treatment with the appropriate agents, for example, epinephrine, antihistamines, and corticosteroids should be administered. Resuscitative measures may also be required.
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Feature |
Specification |
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Image Processing Unit |
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Outputs |
Video output signals: DVI, HDMI, 4×3G-SDI, 12G-SDI |
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Video resolution: 4096*2160/3840*2160/1920*1080 |
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Aspect ratio: 16:9 |
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Type of protection against electric shock |
Class I (as per IEC 60601-1) |
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Degree of protection against moisture |
Ordinary |
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Electrical Power |
Voltage: 110-240V~ |
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Frequency: 50/60 Hz |
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Power consumption: 150VA |
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Camera Head |
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Dimensions (L×H×W) |
176 mm × 55 mm × 50 mm |
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Weight |
600 ± 50 g |
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Cable length |
3.3 m ± 10% |
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Degrees of protection against moisture provided by enclosures |
IPX7 |
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Light Source |
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Light Sources |
Visible (VIS): Light-emitting diode array |
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Near infrared (NIR): NIR laser diode |
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