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Technical Support

The following information is for Lumicell DVS.

IssueAction to Take

Warning! Signal below/ above expected limit

This is normal when the handheld probe is outside the lumpectomy cavity, but these warnings should not appear while inside the cavity. If one of thesewarning appears, follow these steps for correctiveaction:

a)   Confirm light source is on.

b)   Confirm surgical lights are pointed away fromthe table and that the surgeon is using the blue surgical towel to minimize light disruption.

If the problem persists after completing steps a and b,cancel current session, then start a new session andworkflow starting at Section 3.7b.

Bright/dark plate fail

Error Codes 9002/9003/90001/2048/2049: Calibrate bright/dark plate failed. Ensure calibration tool is snapped onto probe with bright/dark side facing in/ Confirm light guide is clicked into light source. Retry with new calibration tool. If error persists, contact Lumicell support.

a)    Ensure that the calibration plate is properly secured on the handheld probe.

b)    For bright plate calibration, ensure the white side of the calibration plate is facing toward the probe.

c)    For dark plate calibration, ensure the black side of the calibration plate is facing toward the probe.

d)    Confirm that the light source is turned on and the probe’s optical light guide is securely clicked into the light source.

e)    Retry calibration with the same plate. If calibration fails, try again with a different calibration plate.

f)      If repeated attempts to calibrate the system are unsuccessful, discontinue use of the probe and contact Lumicell.

Probe Connection

The touchscreen might display a camera or framing error if there are any issues with the imaging feed, or if the USB 3 cable is disconnected from the touchscreen.

Error Codes:

1050: PROBE DISCONNECTED.  Check USB connections at USB Hub then “Continue”.

1052: PROBE DISCONNECTED.  Check USB connections at USB Hub  and touch ‘Check Devices’.

2005: SYSTEM ERROR. YOU WILL BE LOGGED OUT. Log in to retry.

a)    Unplug the gray, probe USB cable from the USB hub.

b)    Unplug the black, touchscreen cable from the USB hub. Note: do not unplug cables from the back of the touchscreen.

c)    Wait 10 seconds.

d)    Replug the black touchscreen cable into the USB hub.

e)    Replug the gray, USB cable into the USB hub.

f)      Wait for 5 seconds, then tap “Retry”.

g)    If the issue persists, check the USB connection in the back of the touchscreen, then contact Lumicell at 1‑833‑4LUMDVS (1‑833‑458‑6387).

Light Source Errors

 

The touchscreen might display the following errors when the light source is off or disconnected:

1046: LIGHT SOURCE POWER OFF. Switch light source power ON and ‘Continue’. If error persists, touch “End Session”.

1047: LIGHT SOURCE DISCONNECTED. check 2 USB connections (1 at Touchscreen and 1 at Light source) and Continue. If error persists, touch “End Session”.

a)    Switch light source to the “On” position as detailed in Section 3.5c.

b)    Ensure cables are secure in the light source and back of the touchscreen.

Light Source Idle Errors

Error Codes:

1048: LIGHT SOURCE POWER OFF. Before starting a new session, switch light source power ON, and touch ‘Check Devices’ to establish connection.

1049: LIGHT SOURCE DISCONNECTED. Before starting a new session, check 2 USB connections (1 at Touchscreen and 1 at Light source), and touch ‘Check Devices’ to establish connection.

See the previous section “Light Source Errors” for action to take.

Light Source Disconnected

 

Error Codes 2016/17: LIGHT SOURCE DISCONNECTED. Ensure light source power ON, check USB connection at touchscreen and at light source then touch ‘Continue’. If error persists, touch “End Session” and contact Lumicell support.

See the previous section “Light Source Errors” for action to take.

Camera Overheating

Error Codes 1051/1053: PROBE OVERHEATING. Remove any towels covering probe, disconnect from USB Hub for 5 seconds, reconnect and touch Continue. (or before starting a new session, touch ‘Check Devices’).

Remove gray cable from USB hub for 5-10 seconds.

Reseat gray cable in USB hub and tap “Retry”.

Contact Lumicell at 1‑833‑4LUMDVS (1‑833‑458‑6387) to report the error.

Computer Disk Full

Error code 2004: DISK SPACE FULL.  Manage saved sessions to create space prior to new session.

Work with the surgeon or IT department to delete sessions and free space on the hard drive. Use the administrator resource guide (MKT00206) for instructions on managing data.

Start Session Failure

Error Codes 2031/2032: RESUME SESSION ERROR. Check USB connections at USB Hub then retry.

See “Probe Connection” section for troubleshooting steps.

If the issue persists, see “Light Source Errors” troubleshooting steps.

What is LumiSystem™?

LumiSystem is the combination of the following FDA approved products – LUMISIGHT™ (pegulicianine) and Lumicell™ DVS. These products are used as an adjunct by surgeons to intraoperatively detect residual breast cancer, in real-time, during lumpectomy surgery.

IMPORTANT SAFETY INFORMATION

What is LUMISIGHT (pegulicianine) and Lumicell DVS?

  • LUMISIGHT (pegulicianine) is an optical imaging agent and Lumicell Direct Visualization System (DVS) is a fluorescence imaging device. LUMISIGHT and Lumicell DVS, in combination, are indicated for adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery.

What is the most important information I should know about LUMISIGHT?

  • Hypersensitivity Reactions: LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred in 4/726 (0.6%) of patients in clinical studies. Before LUMISIGHT administration, assess all patients for any history of hypersensitivity reaction to contrast media or products containing polyethylene glycol (PEG). Always have emergency resuscitation drugs, equipment, and trained personnel available during the use of LUMISIGHT. Monitor all patients for hypersensitivity reactions. If a hypersensitivity reaction is suspected, immediately discontinue the injection and initiate appropriate therapy.
  • LUMISIGHT is contraindicated in patients with a history of hypersensitivity reactions to pegulicianine.

What are the most common side effects of LUMISIGHT?

  • The most common side effects (≥1%) include hypersensitivity and an abnormal color in urine.

What additional important information should I know about LUMISIGHT and Lumicell DVS?

  • Adjunctive Use: Lumicell DVS is for adjunctive use and is not a replacement for the standard of care lumpectomy procedure and pathology. Before use, physicians must be trained in breast-conserving surgery and the proper use of Lumicell DVS. Lumicell DVS detection of breast cancer may not be generalizable to all subpopulations at increased risk for positive margins.
  • Risk of Misdiagnosis: The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in non-cancerous tissue.
  • Interference from Dyes Used for Sentinel Lymph Node Mapping: Avoid administration of dyes before imaging the lumpectomy cavity in patients who have received LUMISIGHT.
  • Tissue Perforation or Damage: Avoid excessive pressure or torque with the Lumicell DVS handheld probe while inside the cavity as it can cause tissue perforation or damage.
  • Infection Risk: To avoid infection risk when using reusable equipment, properly and completely disinfect and reprocess the Lumicell DVS handheld probe and cables after each use. To avoid infection risk when using sterile single-use equipment, ensure to use the Lumicell DVS sterile probe cover properly.
  • Eye Discomfort: Avoid direct eye exposure to the Lumicell DVS handheld light probe as it may cause discomfort.

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. Please see the LUMISIGHT Prescribing Information, including Boxed Warning, and Lumicell DVS Instructions for Use. For complete product information www.LumiSystem.com.

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What is LumiSystem™?

LumiSystem is the combination of the following FDA approved products – LUMISIGHT™, an optical imaging agent, and Lumicell™ DVS, a fluorescence imaging device. These products are used as an adjunct by surgeons to intraoperatively detect residual breast cancer, in real-time, during lumpectomy surgery.

Indications for Use (Test)

LUMISIGHT, an optical imaging agent, and Lumicell DVS, a fluorescence imaging device, are indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery.

IMPORTANT SAFETY INFORMATION FOR LUMICELL™ DVS and LUMISIGHT™

LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred in 4/726 (0.6%) of patients in clinical studies. Tell your doctor if you have any history of hypersensitivity reactions to pegulicianine or to contrast media or products containing polyethylene glycol (PEG).

Your healthcare provider should have emergency resuscitation drugs, equipment, and trained personnel available during use of LUMISIGHT. Healthcare providers should monitor all patients for hypersensitivity reactions and if one is suspected, immediately discontinue the injection and initiate appropriate therapy.

LUMISIGHT™ (pegulicianine) Important Safety Information

What is LUMISIGHT (pegulicianine)?

LUMISIGHT (pegulicianine) is an optical fluorescence imaging agent used in adults with breast cancer to help detect any remaining cancerous tissue at the surgical site following removal of the primary specimen during a lumpectomy procedure.

Important Safety Information

  • Risk of Misdiagnosis: The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in non-cancerous tissue.
  • Interference from Dyes Used for Sentinel Lymph Node Mapping: Your healthcare provider should avoid using dyes before imaging with LUMISIGHT.

What are the most common side effects of LUMISIGHT?

The most common side effects (≥1%) include hypersensitivity and an abnormal color in urine.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. Please see full Prescribing Information, including Boxed Warning.

Lumicell™ Direct Visualization System (DVS) Important Safety Information

What is the Lumicell™ DVS?

The Lumicell™ Direct Visualization System (DVS) is for use in patients with breast cancer to help detect cancerous tissue within the lumpectomy cavity after the removal of the primary specimen during surgery. The Lumicell DVS is used with LUMISIGHT™ (pegulicianine), an imaging agent to visualize the lumpectomy cavity.

Important Safety Information

  • Adjunctive use: Lumicell DVS is for use as part of the lumpectomy procedure and is not a replacement for the standard of care procedures and pathology. Your healthcare provider must be trained on proper use of the Lumicell DVS, and breast conserving surgery prior to performing any procedures.
  • Risk of Misdiagnosis: The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in non-cancerous tissue.
  • Interference from Dyes Used for Sentinel Lymph Node Mapping: Your healthcare provider should avoid use of dyes before imaging the lumpectomy cavity who have received LUMISIGHT.
  • Tissue perforation or damage: During the procedure, your healthcare provider should avoid excessive pressure or torque with the handheld probe while inside the cavity as it can cause tissue perforation or damage.
  • Infection risk: To avoid infection risk, the reusable handheld probe and cables should be properly and completely disinfected and reprocessed after each use by your healthcare provider. Your healthcare provider should also ensure proper use of the sterile, single-use probe cover.
  • Eye discomfort: Your healthcare provider should avoid direct eye exposure to handheld light probe as it may cause pain.

Please see the LUMISIGHT Prescribing Information, including Boxed Warning, and Lumicell DVS Instructions for Use.  For complete product information visit www.LumiSystem.com.