1. Device Overview

The Phothera 400 is a medical phototherapy device intended for home or clinical use. It utilizes the advanced ClearLink™ Control System and offers multiple treatment modes: Guided, Dosimetry, and Timed. The device is suitable for various skin conditions and is prescription-only. Exposure-limiting software may be included as directed by your physician:contentReference[oaicite:0]{index=0}.

2. Indications for Use

The Phothera 400 is intended for therapeutic ultraviolet treatment of diagnosed skin disorders (such as psoriasis, vitiligo, atopic dermatitis) under the direction of a physician. When equipped with blue lamps, it is indicated for the treatment of mild to moderate acne vulgaris:contentReference[oaicite:1]{index=1}.

3. Control Type (ClearLink)

• Guided Mode: System controls doses and adjusts for missed treatments and skin response.
• Dosimetry Mode: User/physician sets dose in Joules or mJ; system automatically adjusts treatment time based on lamp power.
• Timed Mode: User/physician sets treatment time directly. All modes include on-screen safety checks and reminders.
• Exposure Limiting: If enabled, the device will require a physician-provided refill code after a set number of exposures:contentReference[oaicite:2]{index=2}.

4. Warnings & Safety Precautions

• Prescription Use Only: Use only under physician supervision.
• Always wear UV-blocking goggles: Required for anyone in view of the device. Only use Phothera-approved eyewear:contentReference[oaicite:3]{index=3}.
• Cover untreated skin: Use SPF 30+ sunscreen on all areas not being treated.
• No use over skin eruptions or burns.
• Do not use if device, cord, or goggles are damaged. Keep away from water.
• DANGER – Ultraviolet Radiation: Overexposure can cause burns, premature aging, and eye injury. See the full warning label on the device and in the manual:contentReference[oaicite:4]{index=4}.
• Device must never be modified. Use only original components and accessories.
• Remove pets and people from the treatment area.

5. Setup & Assembly

1. Unpack and inspect the device and accessories. Report any shipping damage immediately.
2. Set the unit on a stable table with lamps facing up. Attach feet using thumb screws as shown in the manual (wide part level with the unit bottom, rail facing away):contentReference[oaicite:5]{index=5}.
3. Repeat for the other foot. Stand the unit up and ensure all screws are tight.
4. Insert the “D” shaped plug, then plug the device into a grounded outlet.
5. Check that the correct lamps are installed (see Lamp Specification Guide in the manual for codes/compatibility).

6. Operating Instructions

1. Unlock the device: Tap the blank screen, tap the Phothera logo, enter code 0007, and press Enter (see label on device or page 10 in the manual):contentReference[oaicite:6]{index=6}.
2. Pre-treatment: Apply sunscreen, remove jewelry from treatment area, and put on goggles.
3. For 20-lamp models: Select treatment distance (0 in: on acrylic surface, 9 in: 22 cm away).
4. Press Play to begin treatment. The controller tracks dose/time and progress. Follow on-screen prompts.
5. If interrupted, resume with Play. If still red or in pain after a treatment, device may lock until skipped session (see section 11.2 in manual):contentReference[oaicite:7]{index=7}.
6. After treatment, record in your log or export data to USB if required by your physician.

7. Treatment Modes

Guided Mode

• Device adjusts for missed sessions and skin response, increasing safety and accuracy.
• System asks if redness or pain occurred; if “still red/pain” is selected, device locks until skipped session.
• Automatically calculates dose adjustments and provides reminders.

Dosimetry Mode

• User sets dose in Joules or mJ as prescribed. System calculates exposure time using built-in sensor.
• On-screen distance selection (0 in or 9 in for 20-lamp models).
• Press Enter to begin and track dose/time on screen.

Timed Mode

• User sets treatment time with arrows. Device calculates and tracks elapsed time.
• Timer is accurate within ±5% for 10-minute treatments.
• See manual for use of time charts or web calculator (link in Resources section).

8. Cleaning & Maintenance

• Unplug device before cleaning.
• Clean exterior with mild dish soap and a non-abrasive cloth. For disinfecting, use Monk wipes or 70% isopropyl alcohol (3 min contact time):contentReference[oaicite:8]{index=8}.
• High-level disinfection for multi-user devices: Use FDA-cleared product such as Steris Resert XL-HLD.
• Annual calibration (or every 100 hours/lamp change) recommended. Phothera offers meters for calibration.
• Lamp replacement: Contact Phothera for service and reset instructions.
• Do not use paper towels or abrasives on acrylic surfaces.

9. Troubleshooting

• Device won’t turn on? Check power, outlet, and fuse. Contact support if problem continues.
• Lamps not lighting? Ensure correct code and settings, check lamp status, contact support if needed.
• Device locked? Use code 0007 or request reset from provider.
• Refill code needed? Contact your physician and provide the code displayed on screen.
• Export treatment history via USB if required by your physician.
• See manual or contact Phothera support for additional help.

10. Warranty & Support

• Warranty: 1 year (device), 90 days (lamps):contentReference[oaicite:9]{index=9}.
• Contact:
  • Phone: 1-216-831-0600 (Press 1 for Daavlin)
  • Email: service@phothera.com
  • Website: www.phothera.com

11. Frequently Asked Questions

• How do I unlock the device? Tap blank screen, tap logo, enter 0007, press Enter.
• What goggles should I use? Only Phothera-provided or doctor-approved UV goggles.
• Can I treat twice in one day? No, only as directed by your physician.
• What if I miss a treatment? Device will adjust dosing; resume as prescribed, consult your doctor if unsure.
• How do I order replacement parts? Contact Phothera support.
• Device says refill needed? Contact provider for new code, provide the device code shown on screen.

12. Downloadable Resources

• Full Operation Manual (PDF)
• Treatment Log Sheet (PDF)
• Treatment Time Calculator