5
+1-215-667-8990
• Dedicated video card (optional, but strongly recommended)
OPERATING SYSTEM REQUIREMENTS
• Microsoft
- Windows 10 or later
• Apple
- MacOS 10.12 Sierra or later
1.5. SAFETY CLASSIFICATION AND REGULATIONS
SAFETY CLASSIFICATION
•
Protection against electric shock:
Determined by the electric
shock protection type of the computer connected to the USB
•
Classification of applied part:
Type BF applied part (cushion)
•
Method(s) of sterilization:
No requirement for sterilization
•
Protection against harmful ingress of water or particulate matter:
IP20
•
Mode of operation:
Continuous
•
Suitable for use in an oxygen rich environment:
No
STANDARDS
The Insight Video Goggles complies with the following standards:
• IEC 60601-1: Medical Electrical Equipment. Part 1: General requirements for safety
• IEC 60601-1-2: Medical Electrical Equipment. Part 2: Electrical Safety
• IEC 62471-1: Photobiological safety of lamps and lamp systems
• ISO 10993-1: Biological Evaluation of Medical Devices - Part 1: Evaluation
and Testing Within a Risk Management Process. (Biocompatibility)
• ISO 10993-10: Biological evaluation of medical devices -
part 10: tests for irritation and skin sensitization
• ISO 10993-5: Biological evaluation of medical devices
- part 5: tests for in vitro cytotoxicity
External equipment intended for connection to USB complies with the applicable
standards of the IEC 60601 series. In addition, all such combinations of systems
comply with the IEC 60601-1 safety requirements for medical electrical systems.
Any person who connects external equipment to USB has formed a system and is
therefore responsible for the system to comply with the requirements of IEC 60601-1.
If in doubt, contact a qualified technician or the manufacturer’s representative.