Fluobeam®
Fluobeam®
Medical Device
| Principle of action |
The system uses a near-infrared laser to image blood vessels, lymphatic vessels, tissue perfusion, and parathyroid glands. It consists of an optical head, a control box, a panel computer with software, and an accessory (Fluobox). It does not include indocyanine green (ICG). The near-infrared rays (NIR) generated from the light emitting module of this system are transmitted to the optical head through an optical fiber cable, and near-infrared rays are irradiated through the optical head above the patient’s interest area to be observed. Fluorescence that this system can capture includes exogenous elements such as ICG and endogenous agent such as autofluorescence in the body. In the case of imaging using exogeneous factors, when ICG is injected into the body, ICG rapidly binds to plasma proteins, circulates through lymphatic vessels and blood vessels, and perfusion of the capillary system of tissues. When the near-infrared laser is irradiated from the outside, the ICG inside the vessel becomes excited. It returns to its original state and generates a fluorescence light of 805 nm or more. In the case of imaging using endogenous agent, autofluorescence can be used. Unlike the surrounding tissues, the parathyroid gland has an optical property of autofluorescence in near-infrared light. Since autofluorescence of the parathyroid gland has a wavelength characteristic similar to that of ICG, it undergoes a fluorescence reaction by a near-infrared laser. The generated fluorescence passes through only the wavelength of 800nm or more by the CCD camera (charge-coupled device) of the imaging head and the filter, and selectively accepts the fluorescence of ICG and parathyroid gland (25 images/sec), and displays lymphatic vessels, blood vessels, tissue perfusion and parathyroid glands in real time. |
| Purpose of use |
The system assists in imaging of related tissue perfusion, blood flow in blood vessels and lymphatic vessels, and imaging of exposed parathyroid glands using a near-infrared laser. |
| Conditions of storage and transport |
Temperature : -20°C ~ 60°C Humidity : 10 ~ 90% Air pressure : 500 ~ 1060 hPa |
| Precautions for use |
1, Before use ① Before using FLUOBEAM 800, the user must have been trained by the Supplier and must have read this user guide. Caution : The system contains a laser source (class 1) and an LED light (RG-1 classification). Warning : The system must be kept away from strong magnetic fields. To ensure correct operation, place the fan located behind the control box in an unobstructed location. ② When used in a sterile area during surgery, the optical head can be used with a sterile cover. The control box is placed in a non-sterile area, and can only be operated by an operator remining in the non-sterile area of the operating theatre. Caution : Check that the patient does not react excessively to infrared light. The fluorescence system should not be used with patients whose medical treatment contains photosensitizing medication. Check that the patient is not taking any medication that could cause a photochemical reaction. ※ The sterile cover is not included in the product component. 2, During use ① The system must be used with a sterile cover during surgery. In pre- and post-operative procedures, this cover is not essential, the decision is left to the discretion of each practitioner. Caution : When used pre- or post-operatively, the operator must not touch the connector on the front panel of the case and the patient at the same time. ② Inject only the amount of fluorescent agent required to obtain optimum contrast. Do not inject more than the maximum administrable dose described in the product instructions provided by the supplier. ③ Under normal operating conditions, the optical head is held by hand and pointed downwards at a distance of 20cm from the patient so that it does not come into contact with the patient. Caution : Avoid keeping the laser switched on for prolonged periods at short distances (<5cm). ④ When using the system, the practitioner and/or operator must wear gloves and long sleeves. When it is time to view the fluorescent signal, the operating lights must be switched off and the laser switched on. Caution : Turn off the laser and LEDs when the system is not in use. When the optical head is not in use during surgery, it must be placed in a sterile area on the instrumentation table. In pre-and/or post-operative procedures, the optical head must be placed on a table when not in use. Warning : The optical head must be handled with care in order to avoid breaking the glass window. If a break occurs, the system must be returned to the manufacturer for maintenance. Caution : The control box must be placed on a horizontal support to avoid any impact during the movement of people or objects on wheels. No object other than the optical head should be placed on the control box. |
