How To Operate the DermaSensor

Follow these steps to properly use the DermaSensor to assess a lesion.

Preparing for Use

1. Verify the DermaSensor is ready for use:
   • The Handheld Unit should be powered on and seated in a charging state on the Base.
   • The Base should display a solid white LED light and the Handheld Unit battery icon should display as solid white. See Charging
   • The Handheld unit has been setup with WiFi, and is activated and registered online.
   • All DermaSensor device updates are installed.
   • The entire DermaSensor device is fully cleaned and disinfected. See Cleaning and Maintenance.
   • The DermaSensor device is located and operated in a patient treatment room with floors made of wood, concrete, or ceramic tile. Floors in this room can be made of other synthetic material if the present relative humidity of the room is 30% or higher. The DermaSensor device is not operated under direct focused light, such as a surgical or examination light or headlamp. (Review Warnings & Precautions)
2. Position the patient in the treatment room and put on disposable gloves. (Review Contraindications ensure lesion is appropriate for assessment.)
3. Completely clean all lesion areas for examination.
   • Remove all makeup, sunscreen and other topical solutions, powders, and any residue.
   • If any area of the lesion is crusted or scaled, place the tip to areas of the lesion not covered by the crusts or scale. Removal of crust or scale is advised when such removal does not cause bleeding or any other liquid discharge. If such discharge occurs, device is not indicated for use.
   • Wait for the surface of the lesion to fully dry before use on a lesion.
4. The Handheld Unit must complete a calibration procedure prior to each first use on a patient. The Handheld Unit must be placed in the Base to begin calibration. While theHandheld Unit is in the Base, press the START NEW PATIENT button on the Handheld Unit display. The calibration process will start automatically.
   
   • If the Handheld Unit is removed from the Base before calibration is complete, it will display, “Place device in Base to calibrate”.  Return Handheld Unit to the Base and repeat the process until the display indicates calibration is complete.
   • When calibration is complete, the Handheld Unit will display, “Move to location 1 and press record.”

Tip Placements on Lesion 

Keep these guidelines in mind when taking lesion recordings:

• Hold the Handheld Unit so the tip touches the lesion at a 90-degree angle to the surface of the lesion (see Figure 7).
• Touch the Handheld Unit tip to the lesion completely and gently so that the tip does not significantly depress the tissue (e.g. similar pressure to marking the skin with a marking pen, see Figure 8). 
  
• The Handheld Unit requires five recordings to be made for each lesion on five distinct points within the lesion border including the center of the lesion, as shown in Figure 9.
  
• The placement of the Handheld Unit tip for each recording should be made after careful clinical assessment of the lesion to decide if there are any lesion areas that exhibit especially concerning clinical properties, as the tip placement should be adjusted to include lesion areas that have especially concerning clinical properties as shown in Figure 10.
  
• Avoid recording on or outside the border of the lesion, or on any crusted or scaled area of the lesion, as shown  in Figure 11. 
  
• When using the DermaSensor device on a small lesion of around 2.5-4mm in diameter, for each location recording lift the Handheld Unit tip and place the Handheld Unit tip back on the lesion, even if the recordings overlap or appear to overlap partially or fully with previous recordings. See Figure 12.
  

Recording a Lesion

Wipe the tip with an alcohol wipe prior to use on every lesion to ensure accurate recordings.

1. Remove the calibrated and charged Handheld Unit from the Base in preparation of taking a series of recordings for a specific lesion.
2. Take one recording at a time of the lesion tissue.
   • Press either of the Side buttons on the Handheld Unit (see Figure 13) or the RECORD button on the Handheld Unit display to record while the Handheld Unit tip is touching the lesion. 
   • There will be multiple flashes, tones, and clicks during the recording process, which may be audible and visible.  DO NOT LIFT THE TIP OFF OF THE LESION OR MOVE THE TIP WHILE A RECORDING IS IN PROGRESS.
   • When the recording of a location is complete, you will be prompted to continue recording in a new location on the same lesion until five recordings are made. 
   • If the DermaSensor does not capture a usable recording (e.g., if the DermaSensor detects that the tip is not in contact with a lesion), you will be prompted to repeat the last individual recording.
3. Lift the tip of the Handheld Unit off sampled tissue when the Handheld Unit displays “Move to location 2 and press record.” (Figure 9)
4. If any of the five individual recordings is taken in error (e.g. tip placement error) or with suboptimal positioning, press CANCEL to be prompted to restart the lesion recordings.
5. Repeat the steps above when prompted to move to locations 3, 4 and 5 on the same lesion. 

Understanding Results

After all five recordings for a specific lesion have been acquired, the Handheld Unit will assign and display a unique Device Record Number (DRN) for the lesion. The Handheld Unit will also analyze the spectral data from the five recordings and provide a result as follows:

Output	Results
	“Investigate Further”   The Handheld Unit will display “Investigate Further” for lesions found to contain recorded properties associated with malignant lesions, such as melanoma, squamous cell carcinoma, and basal cell carcinoma.  Spectral Score For lesions with an “Investigate Further” result, the Handheld Unit will display a score from 1 through 10 to indicate the degree of similarity the lesion's spectral recordings are to malignant lesions in studies (the "spectral similarity", e.g., 1 indicating the least similar to malignant lesions and 10 indicating the most similar to malignant lesions). A pivotal clinical trial showed that higher scores had greater positive predictive value for malignancy. However, low scores are still classified as "Investigate further" and should be considered as positive output when the device is used in referral decisions in addition to clinically relevant information.
	“Monitor” The Handheld Unit will display “Monitor” for lesions found to contain recorded properties associated with benign lesions.  No Spectral Score is shown when the result is “Monitor”.

See INDICATED LESION TYPES AND PERFORMANCE

Device melanoma sensitivity has been observed to be slightly lower than overall skin cancer sensitivity, which is thought to be due to the heterogeneity of melanoma pathology as documented in literature. Given the high mortality rate of melanoma and that the device sensitivity was observed to be slightly lower for melanoma, for darkly pigmented lesions of concern for melanoma, it is important to consider referring these lesions for any “Investigate Further” device result, regardless of the 1-10 spectral score.

Additional Lesion Recordings

1. Wipe the tip with an alcohol wipe prior to use on every lesion to ensure accurate recordings.
2. Press the NEW LESION option on the Handheld Unit and repeat the above steps (Preparing for Use, Tip Placements on Lesion, and Recording a Lesion) for each lesion to be recorded on the same patient.

Recordings Complete

1. Press the PATIENT COMPLETE option on the Handheld Unit when all lesions for this patient have been assessed.
2. Thoroughly clean and disinfect the DermaSensor. See Cleaning and Maintenance
3. Reseat the Handheld Unit in the Base to store and charge until next use.
4. Wipe areas contacted on the patient with a lint-free wipe saturated with water. 

For operating and storage information, see TECHNICAL DATA, GUIDANCE, AND MANUFACTURER’S DECLARATIONS

IFU 40-0001 v7