Do not use the DermaSensor™ device if:

  • Lesion surface is not accessible (e.g., inside ears, under nails, completely covered by a crust or scale); 
  • The lesion is on areas of crusts, psoriasis, eczema, or similar skin conditions; 
  • The lesion has erosion and/or ulceration with no area >2.5 mm intact; 
  • The lesion has foreign matter (e.g., tattoo, splinter, dermoscopy oils, makeup, sunscreen, or other medicated or non-medicated topical solutions or powders); 
  • The lesion has a targeted area <2.5 mm in diameter, where the device tip cannot be placed entirely within the border of the targeted area of the lesion; 
  • The lesion is greater than 15 mm in diameter at the widest point; 
  • The lesion is located on acral skin (e.g., sole or palms) 
  • The lesion is located within 1 cm of the eye; 
  • The lesion is on or adjacent to scars, areas previously biopsied, or areas subjected to any past surgical intervention; 
  • The lesion is located on mucosal surfaces (e.g. genitals, lips); or 
  • The lesion is located on acute sunburn.

WARNINGS


  • Use only by or under the supervision of a trained healthcare professional. 
  • Do not use for the direct diagnosis of skin cancers.
  • Do not point the tip of the handheld unit directly at the eye. 
  • Do not attempt to disassemble, repair, or modify the DermaSensor device in any way. 
  • Do not immerse the device in liquid. 
  • Do not use an autoclave or low temperature sterilizers to clean the device. 
  • Do not buff, scratch, or use an abrasive cream cleanser that would damage the tip of the handheld unit. 
  • Do not simultaneously contact the patient while touching or holding the base or power adapter. 
  • Do not use on lesion area that is under direct focused light, such as a surgical or examination light or headlamp. 
  • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the DermaSensor device, including cables specified by DermaSensor™ Inc.; otherwise, degradation of the performance of this equipment could result.

 PRECAUTIONS


  •     Other factors, such as visual analysis of the lesion, personal history of ultraviolet light exposure, and personal and      family history of skin cancer, should also be considered in making this decision. 
  • Protect the tip of the handheld unit by storing the handheld unit in the base when not in use. 
  • To maintain optimal device integrity, follow the cleaning and disinfection instructions before and after use. 
  • Use of accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. 
  • Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment, and the other equipment, should be observed to verify that they are operating normally. 
  • Monitor the device for any damage or wear. If you believe the device and or tip of the handheld unit has been scratched, damaged, or somehow compromised, please contact DermaSensor™. 
  • Only use the included components and accessories provided as part of the ME (Medical Equipment) system by DermaSensor
  • Always wear gloves during use (or examination). 
  • Makeup, sunscreen, and other topical solutions or powders must be completely removed, without any remaining residue, before use. 
  • Connection to IT networks including other equipment could result in previously unidentified risks to patients, operators, or third parties. The user should identify, analyze, evaluate and control these risks. 
  • Changes to the IT network (e.g., changes in network configuration, the connection of additional items, disconnection of items, an update of equipment, upgrade of equipment) could introduce new risks that require additional analysis. 
  • To avoid EMC disturbances, floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.