LEICA FL800
Leica Microsystems (Schweiz) AG · Model 000000000010448748
A non-sterile, mains electricity (AC-powered) device assembly designed for viewing intraoperative blood flow in the cerebral vascular area, in bypass grafts during coronary artery bypass graft (CABG) surgery, and during plastic and reconstructive surgery. It enables a surgical microscope to produce excitation light and resolve fluorescence from the fluorescent agent indocyanine green (ICG). Fluorescent signals depict the distribution of the infrared dye in the patient's blood vessels during the operation. The system is attached to a compatible surgical microscope and typically includes an ICG filter, a near infrared (NIR) charge-coupled device (CCD) video camera, and connecting cables.
Key tips
- ·When no category-specific guidance fits, default to the manufacturer's own service manual and the general troubleshooting method in the Engineer's Guide.
- ·Run an incoming and annual electrical safety test regardless of how niche the device is.
PM Checklist
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
- ·Follow the manufacturer's PM schedule
- ·Perform incoming and annual electrical safety testing per facility biomedical program
Technical Specs
- Handling Environment Humidity
- 10 Percent (%) Relative Humidity to 100 Percent (%) Relative Humidity
- Storage Environment Temperature
- -30°C to 70°C
- Handling Environment Atmospheric Pressure
- 500 millibar to 1060 millibar
- Storage Environment Atmospheric Pressure
- 500 millibar to 1060 millibar
- Storage Environment Humidity
- 10 Percent (%) Relative Humidity to 100 Percent (%) Relative Humidity
- Handling Environment Temperature
- -30°C to 70°C
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- No
- Single use
- No
- Prescription use
- Rx only
- FDA distribution status
- Not in Commercial Distribution
- Device type (GMDN)
- Surgical microscope fluorescent angiography system
- FDA product classification
- System, x-ray, angiographic
- Manufacturer support
- +1(984)7105152 · Iris.Pohl@leica-microsystems.com
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- Varies by device - check the unit's own manual for facility placement guidance
Documents & Manuals
Troubleshoot this device with Bio
Describe a symptom or error code. Bio answers from this device's own documented error codes, failure modes, parts, and guides.
Ask Bio →