Description
Important Safety Information
This is a prescription full-body phototherapy device for professional clinical use. It must be operated only by qualified clinical physicians, or by trained, certified operators under the supervision of a qualified physician, strictly in accordance with the physician’s prescribed treatment plan. The patient’s Minimal Erythema Dose (MED) or Minimal Phototoxic Dose (MPD) must be determined before treatment begins.
Absolute contraindications (do not treat):
- Xeroderma pigmentosum; Bloom syndrome
- Systemic lupus erythematosus (SLE); dermatomyositis; solar dermatitis
- History of malignant melanoma; malignant tumors; dysplastic nevus syndrome
- Pregnancy
Relative contraindications (treat only under close physician monitoring):
- Porphyria; cataract; pemphigus
- Family history of malignant melanoma
- History of radiation or arsenic-agent therapy; significant hepatic dysfunction
During treatment:
- Patients and operators must wear UV-protective eyewear; never look directly at the light source
- Treat only affected skin where practical; cover unaffected skin to reduce exposure
- Adjust dose to the patient’s erythema response; overexposure can cause burns
- After 30 minutes of continuous operation, turn the lamps off for 10 minutes
- One patient at a time; monitor cumulative exposure dose
This product has not been evaluated to treat any condition other than those for which it is FDA-cleared. Statements herein are not intended to diagnose, treat, cure, or prevent any other disease.
Warranty Information
Kernel KN4001 Phototherapy Cabin – Warranty & Return
Product Warranty
- 1-year warranty on the device
- 1000-hour warranty on the UV light source
- Includes parts and support for manufacturer defects, arranged through Hey Med Supply
This warranty complies with the Magnuson–Moss Warranty Act.
Capital Equipment Returns
As installed capital medical equipment, the KN4001 Series is a made-to-order / freight item. Return eligibility, restocking, and freight terms are handled case-by-case; contact Hey Med Supply before ordering. Defective or damaged-in-transit units are repaired, replaced, or refunded per the Magnuson–Moss Warranty Act.
Regulatory Compliance
- FDA 510(k) K261775 (UV Phototherapy, KN-4001A/B/AB)
- FDA Quality System Regulation (21 CFR Part 820)
- 21 CFR Part 806 (device corrections/recalls)
Product Details
- Brand Name:
- Kernel
- Model:
- KN4001B
- Product Name:
- Full-Body NB-UVB Phototherapy Cabinet
- Application:
- Full-body Phototherapy Cabin
- Treatment Area:
- Whole body
- FDA 510(k):
- K261775
- Light Source:
- 40 × 100W Philips® NB-UVB lamps
- Wavelength:
- 311nm ± 3nm
- Light Intensity:
- 6.4 mW/cm²
- Treatment Size:
- 52.7 ft² ±10% (49,000 cm² +/-10%)
- Lamp Size:
- 23.7'' L x 1.54'' diameter
- Nominal Intensity Tolerance:
- ±20%
- Irradiation Uniformity:
- Within ±25%
- Output stability:
- Within ±5%
- Light Source Lifespan:
- 1,000 hours
- Working Distance:
- 7.9 in ±0.4 in
- Screen:
- 8'' LCD Touchscreem
- Power Source:
- AC 240V 50/60Hz, 5500VA
- Exterior Dimension:
- 48.4'' L × 48.4''W × 85.6''H (1,230 L × 1,230 W × 2,173 H mm)
- Exterior Footprint:
- 4.0 ft × 4.0 ft (1.23 × 1.23 m)
- Product Weight:
- 838 lb (380 kg)
- Interior Height:
- 6' 1'' (1,855 mm)
- Interior Shape:
- Hexagon
- Width between Parallel Wall:
- 38.4'' (975 mm)
- Maximum Interior Width:
- 41.7'' (1,060 mm)
- Delivery:
- 10-30 Days Delivery (Shipping Directly from the Manufacturer)
