What does a safe, consistent treatment space look like?
Use a stable location that meets your exact manual’s placement, space, electrical, ventilation, and storage requirements and your clinical plan’s positioning and protection boundaries. Do not copy a setup from a photograph, another device, or a general checklist. Evidence Evidence Evidence
Why this item matters
- Sources cited, not yet graded
A consistent space keeps the device, approved protective equipment, support information, and prescribed setup together without blocking safe movement or exits. Larger equipment may need more deliberate room and access planning.
Check before moving on
- Depends on you
Ask the manufacturer or an appropriately qualified local professional to check any room, electrical, floor, or installation question the manual does not clearly resolve.
Questions for the device company or your care team
Which requirements in the current manual apply to the room I plan to use?
Saving keeps this on your device and needs JavaScript, which is off in this browser.Who should check what the manual does not answer?
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How do I keep children, pets, and visitors away from the equipment?
Keep children, pets, and untrained visitors outside the treatment area while the device is in use. When it is not in use, secure the device, keys, controls, cables, lamps, and accessories exactly as the manual directs. Locks or access controls do not replace supervision or manufacturer safeguards. Evidence Evidence Evidence
Why this item matters
- Sources cited, not yet graded
A simple household plan can identify who may access the equipment, where keys and approved protective items are kept, and how the area stays clear. If a child is receiving care, caregivers also need age-appropriate boundaries that protect the child’s safety and agency.
Check before moving on
- Depends on you
Locking and storage features differ by device. Do not assume that a key, app control, or lockout is tamper-proof or use it for anything beyond its documented purpose.
Questions for the device company or your care team
How should I secure this device when it is not in use?
Saving keeps this on your device and needs JavaScript, which is off in this browser.Who in my household needs to know the safety rules?
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How should I store the device and its protective equipment?
Follow the exact manufacturer instructions for storing the device, approved eye protection, keys, cables, manual, and accessories. Keep them protected from unauthorized use, damage, moisture, and mix-ups with similar-looking items. Evidence Evidence Evidence
Why this item matters
- Sources cited, not yet graded
Keeping the current manual and official support contacts with the equipment makes it easier to find help. Keep labels and unit identifiers readable and connected to the correct records.
Check before moving on
- Depends on you
Temperature, orientation, transport, cleaning, and long-term storage requirements can be specific to the model. Ask the manufacturer when the current manual does not answer a storage question.
Questions for the device company or your care team
What storage conditions does my exact manual require?
Saving keeps this on your device and needs JavaScript, which is off in this browser.How should I store the approved eye protection?
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When should I stop using the device and call support?
Stop using the device if it is damaged, unstable, wet, or missing required parts. Also stop if it acts differently from the manual or shows an alert you do not understand. Contact official support. Do not keep testing it, open it, bypass a control, or improvise a repair. Evidence Evidence Evidence
Why this item matters
- Sources cited, not yet graded
The current manual and manufacturer are the first sources for hardware questions. If you also experienced a skin or health concern, follow your personal action plan and report that separately to the treating team.
Check before moving on
- Depends on you
The same device behavior can have different causes. Keep the device unused while official support uses the exact identifiers and, when needed, an inspection to advise you.
Questions for the device company or your care team
Does the current manual explain this exact message or behavior?
Saving keeps this on your device and needs JavaScript, which is off in this browser.What should I do with the device while I wait for support?
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What information should I have ready when I call support?
Have the manufacturer, exact model and unit identifiers, current manual revision, purchase or service record if available, displayed message, and a factual description of what happened. This helps the support conversation; it does not identify the fault or mean you should keep using the device. Evidence Evidence Evidence Evidence
Why this item matters
- Sources cited, not yet graded
Separating the device facts from what happened to your skin or health can help each concern reach the right place. The manufacturer handles equipment support, the treating team handles clinical effects, and the FDA provides a United States route for reporting device problems.
Check before moving on
- Depends on you
Your records may be incomplete, and the support team may need more information or an inspection. Send the report directly through the manufacturer’s or regulator’s official route.
Questions for the device company or your care team
Which official support route handles my exact model?
Saving keeps this on your device and needs JavaScript, which is off in this browser.What should I tell my clinician about the problem, and how soon?
Saving keeps this on your device and needs JavaScript, which is off in this browser.Should I report the problem to the FDA?
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Applicability check
Who was studied?
These fields show what the cited evidence reports about the people and body sites behind outcome or safety claims. “Not reported” means the reviewed source omitted the field; “Pending exact source review” means SteadySkin has not made that determination yet.
Use a stable location that meets your exact manual’s placement, space, electrical, ventilation, and storage requirements and your clinical plan’s positioning and protection boundaries. Do not copy a setup from a photograph, another device, or a general checklist.
- Age range
- Not reported
- Condition subtype
- Not reported
- Severity or extent
- Not reported
- Sample size
- Not reported
- Geography and care setting
- Three first-party records for named home phototherapy products: the Phothera manuals index, one SolRx E-Series spec sheet, and Zerigo Health terms. None is a study or reports a population.
- Skin tone or phototype
- Not reported
- Race
- Not reported
- Ethnicity
- Not reported
- Body sites
- Not reported
What that means for this page: The Phothera record is an index to model-specific manuals. The Solarc record is one spec sheet. It lists model, lamp, electrical, and fuse facts. It has no installation, maintenance, or support sections. Zerigo’s terms describe its prescription device and service. They do not document room placement or storage. These sources do not set one room rule for every device or report results for any household.
Keep children, pets, and untrained visitors outside the treatment area while the device is in use. When it is not in use, secure the device, keys, controls, cables, lamps, and accessories exactly as the manual directs. Locks or access controls do not replace supervision or manufacturer safeguards.
- Age range
- Not reported
- Condition subtype
- Not reported
- Severity or extent
- Not reported
- Sample size
- Not reported
- Geography and care setting
- Three first-party records for named home phototherapy products: the Phothera manuals index, one SolRx E-Series spec sheet, and Zerigo Health terms. None is a study or reports a population.
- Skin tone or phototype
- Not reported
- Race
- Not reported
- Ethnicity
- Not reported
- Body sites
- Not reported
What that means for this page: The Phothera record is an index to model-specific manuals. The Solarc record is one spec sheet. It has no access-control or storage instructions. Zerigo’s terms describe its service and app. They do not describe locks, key storage, or household controls. None tests access controls, reports incidents, describes a group of households, or sets one control for every device. Exact requirements remain in the current device documents, not in this source set.
Stop using the device if it is damaged, unstable, wet, or missing required parts. Also stop if it acts differently from the manual or shows an alert you do not understand. Contact official support. Do not keep testing it, open it, bypass a control, or improvise a repair.
- Age range
- Not reported
- Condition subtype
- Not reported
- Severity or extent
- Not reported
- Sample size
- Not reported
- Geography and care setting
- Three first-party records for named home phototherapy products: the Phothera manuals index, one SolRx E-Series spec sheet, and Zerigo Health terms. None is a study or reports a population.
- Skin tone or phototype
- Not reported
- Race
- Not reported
- Ethnicity
- Not reported
- Body sites
- Not reported
What that means for this page: The Phothera record is an index to model-specific manuals. The Solarc record is one spec sheet. It has no maintenance or support section. Zerigo’s terms separate technical support from medical advice. They name its Member and Care Guides but give no steps for alerts or damage. None reports how often faults happen, why one happened, or one rule for every device. The current device documents and official support remain necessary.
Evidence behind this page
Sources
Each evidence badge opens the source and its limits. The full list stays available here.
- Phothera PhototherapyManufacturer document · Manufacturer, tier 4Independence not established
- Published
- SteadySkin last checked
What this source can and cannot tell you
What this source supports
Supports the current first-party route to Phothera device and accessory manuals and shows that instructions are model- and controller-specific.
What it does not support
It does not establish clinical suitability, comparative benefit, the condition of an individual unit, or that one manual applies to a related or legacy model; each exact linked manual and revision still requires verification.
Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.
- Solarc Systems Inc.Manufacturer document · Manufacturer, tier 4Independence not established
- Published
- SteadySkin last checked
What this source can and cannot tell you
What this source supports
Supports one page of the named SolRx E-Series manual revision, its specifications page. That page carries the models covered, the narrowband waveband, the bulb type and count, the nominal irradiance figures with their stated caution, and the per-device electrical and fuse ratings. It does not support another SolRx family, confirm that this is the newest revision for an individual unit, establish clinical suitability, or prove comparative safety or effectiveness; the owner must verify the exact current manual with Solarc.
What it does not support
The linked file is that one page, not the whole manual. It does not carry the installation, protective-equipment, maintenance or support sections that the rest of the manual holds.
Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.
- Zerigo Health, Inc.Manufacturer document · Manufacturer, tier 4Independence not established
- Published
- SteadySkin last checked
What this source can and cannot tell you
What this source supports
Supports Zerigo’s current first-party description of its United States prescription device, required mobile application, Member Guide, Care Guide support, data-enabled service model, transfer restrictions, and distinction between technical support and medical advice.
What it does not support
It does not independently establish comparative benefit, coverage, privacy quality, clinical suitability, or that the program terms will remain unchanged.
Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.
- U.S. Food and Drug AdministrationRegulatory · Regulatory / guideline, tier 1Independent source
- Published
- SteadySkin last checked
What this source can and cannot tell you
What this source supports
Supports that patients, consumers, and health professionals can use FDA MedWatch to report serious reactions, product-quality problems, product-use errors, and other serious problems involving human medical products, including medical devices.
What it does not support
It does not determine whether a report is required, prove causation, replace clinical care, or replace the manufacturer’s equipment-support route.
Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.