FlexSys

The device FlexSys is a multi-modality skin surface treatment. Depending on the chosen modules the intended use and the mode of operation varies.

Module MultiLite:

• Blue 420 nm light: The GME FlexSys with Blue 420 MultiLite is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
• Yellow 585 nm light: The GME FlexSys with module Yellow 585 is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides.
• Red 635 nm Light: The GME FlexSys with Red 635 MultiLite is indicated in general to treat dermatological conditions and specifically indicated to treat superficial, benign vascular, and pigmented lesions.

Module Green 532:

The GME FlexSys with module Green 532 (wavelength: 532nm) is intended for vaporization and photocoagulation of benign vascular and benign pigmented lesions in soft tissue.
Module Yellow 577:

The GME FlexSys with module Yellow 577 (wavelength: 577nm) is intended for treatment of benign vascular and benign pigmented lesions.

The device FlexSys is a multi-modality skin surface treatment. Depending on the chosen modules the intended use and the mode of operation varies. Module MultiLite: The intended use of the device FlexSys with MultiLite module is: Blue 420 nm light: The GME FlexSys with Blue 420 MultiLite is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. Yellow 585 nm light: The GME FlexSys with module Yellow 585 is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides. Red 635 nm Light: The GME FlexSys with Red 635 MultiLite is indicated in general to treat dermatological conditions and specifically indicated to treat superficial, benign vascular, and pigmented lesions. Module Green 532: The GME FlexSys with module Green 532 (wavelength: 532nm) is intended for vaporization and photocoagulation of benign vascular and benign pigmented lesions in soft tissue. Module Yellow 577: The GME FlexSys with module Yellow 577 (wavelength: 577nm) is intended for treatment of benign vascular and benign pigmented lesions.

The device FlexSys consists of a base unit with up to two installed internal laser modules, handpieces and/or scanners for these modules and attachable applicators. All applicators, handpieces, and scanners are connected by an electrical cable. The base unit contains most of the controls, such as the touch-screen, the on / off switch or the emergency stop button. In addition the power cord, foot switch, and the door plug are connected to the base unit. The touch-screen serves as the main control panel. The applicators, handpieces, and scanners direct the light onto the skin. Some applicators contain a hand switch on the front of the handle by which light emission can be triggered. The scanners and handpieces of the internal modules are connected to the base unit by an electric signal cable and by an optical fiber which guides the aiming beam and working beam laser light to the handpiece/scanner in its core. The light is then guided onto the skin via several mirrors and lenses. Due to the round shape of the fiber core the resulting laser spot on the skin is circular. The size of the working beam spot corresponds to the nominal value when the distance tip touches the skin. For larger distances the spot size will increase, i.e. the laser beam is divergent. During development and manufacturing applicable directives, legal requirements and standards for medical devices were considered. Our product complies to them. If you turn on the device, then the unit performs several tests automatically. Thereby the proper functioning of the device - according to the specifications - is ensured. As soon as these tests have been completed successfully, the device is ready for parameter selection and patient treatment. In addition to the initial tests a number of device functions and parameters are monitored continuously. If the unit detects abnormalities or defects, then it reacts depending on the nature and importance by a notice, a warning or error message. This message needs to be confirmed by the user. Depending on the message one of the following cases is possible: • the user needs to perform an action to eliminate the cause of the message (Example: The user has to take his foot off the foot switch or order a device service) • the user must wait for a change of parameters (Example: the temperature of the device is too low, the user must wait until the unit has warmed up sufficiently.) • the device attempts to resolve the cause of the error and performs a re-test (Examp