This document describes the Daavlin ML24000 Phototherapy Unit, an ultraviolet light-emitting device intended for the therapeutic treatment of photoresponsive skin disorders. It is designed for use by or under the direction of a physician.
Function Description
The Daavlin ML24000 is a phototherapy unit that utilizes ultraviolet or visible radiation for treating diagnosed skin disorders. Its primary function is to deliver controlled doses of UVA-1 radiation to the patient's skin. The device is designed for intermittent operation, not continuous use, with specific cool-down periods recommended for treatments exceeding 20 minutes.
Important Technical Specifications
The device is classified as a Class II Device by FDA, Class IIa Device by 93/42/EEC, and Class I Device by IEC 60601-1. It operates with a Pollution Degree of Class II and a non-continuous mode of operation. The UV Risk Group is 2 (Moderate-Risk) according to IEC/EN 62471:2006.
Operating Specifications:
- Ambient Temperature: 15°C to 30°C (59°F to 86°F)
- Relative Humidity: 10% to 95%, non-condensing
- Liquid Ingress Rating: IPX0 (no protection against water ingress)
- Ocular Hazard Distance: 3 Meters (9.84 Feet)
- Altitude: ≤ 2000m
Transport and Storage Specifications:
- Ambient Temperature: -40°C to 70°C (-40°F to 158°F)
- Relative Humidity: 10% to 95%, non-condensing
- Atmospheric Pressure: 50 kPa to 106 kPa
- Altitude: ≤ 2000m
Electrical Specifications:
The device is manufactured in several electrical configurations.
- Mains Input: 230V, 3~, 60Hz, 100A (Operating = 230V, 3~, phase to phase)
- Mains Input: 400V, 3N~, 50Hz, 100A (Operating = 230V~, single-phase to neutral)
UVA-1 Output Spectrum:
The light treatment is generated by 24 1000 Watt High Intensity Discharge Metal Halide Lamps. The UV emission range is 350-400nm.
- Minimum Output (9" Away): 60 mW/cm² (+/- 10%)
- Maximum Output (9" Away): 100 mW/cm² (+/- 10%)
Irradiance measurements are taken with a GigaHertz-Optik P-9710-1 Optometer.
Usage Features
Safety and Warnings:
- Federal law restricts this device to sale by or on the order of a physician.
- Not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide.
- All treatments must be administered under the direction of a licensed physician.
- UV blocking glasses or goggles must be worn by the operator, patient, and anyone in view of the device during operation to prevent eye injury.
- Serious injury can be caused by exposure in excess of the recommended dose.
- Do not treat over skin eruptions without physician consent or when the patient has noticeable burns.
- If burning occurs, reduce subsequent treatment time and do not treat until effects subside.
- Trained personnel must monitor all treatments.
- UV blocking skin protection should be generously applied to unaffected skin areas.
- Patients should be centered between lamps to avoid overexposure to isolated body areas.
- Electrical wiring must be done by a qualified, licensed electrician according to national and local codes.
- Before each use, verify the device is in correct working order and that components are not worn or damaged.
- Faulty components must be replaced by factory-authorized service personnel.
- Disconnect from power source before opening casing for maintenance.
- Never directly expose the device to liquids. If exposed, it must be tested for safe function.
- No modifications are permitted; unauthorized modifications void the warranty and may cause hazardous operation.
Training Requirements:
Staff operating the phototherapy unit must have appropriate training, knowledge, and clinical skills. This includes being a physician, nurse, or other licensed practitioner, with training and experience in dermatology covering anatomy, physiology, skin diseases, skin assessment, photoresponsive diseases, and theoretical knowledge of phototherapy. A supervised practice period of approximately 3 months is recommended.
Unlocking the Device:
The device "self-locks" after 20 minutes of idle time.
- Press any key to awaken.
- "CODE" will display.
- Enter the factory preset key code "0007" by pressing the ▲ key seven times.
- Press "ENTER" to unlock.
The key code can be disabled or personalized by contacting Daavlin service.
Flex Timer Instructions (Determining a Treatment Time):
Treatment time can be determined by starting at a prescribed time and increasing incrementally or by percentage, or by using factory power output levels to estimate "time equivalents" for desired Joule doses (UVA-1).
Partial UVA, UVA-1 Time Chart:
A chart is provided to determine Joules based on mW/cm² and time. For example, 1.0 mW/cm² for 03:20 (mm:ss) equals 02:47 Joules.
Setting Up a Treatment Time:
- Press any key to awaken the unit. "CODE" will appear.
- Enter the key code (factory preset is 0007).
- Once the key code is entered, the display shows 00:00.
- Press the ▲ key until the first digit of your desired time is displayed. For 10 minutes and ten seconds (04:10), the first digit will be a "4".
- Press the ◄ key to move the "4" one space to the left. The display should read 00:40.
- Press the ▲ key until the next desired number is displayed ("1" in this case). The display should read 00:41.
- Press the ◄ key to move the "4" one space to the left. The display will now read 04:10.
- When the desired time is displayed, press the ENTER key to lock in your treatment time.
- Begin treatment by pressing ENTER.
To repeat the same dose, press END to clear the display, then press MODE and POWER keys simultaneously. Press ENTER to start.
The Digital Timer beeps three times and flashes the treatment time at the end of a treatment.
Special Functions of the Digital Timer:
- Pause: Press END or ENTER. "HOLD" will display. Press ENTER to resume.
- End/Cancel: Press END twice.
- Correcting Entry Mistakes: Repeatedly press ◄ until all zeros are displayed.
- Check Lamp Hours: With lamps off, press and release MODE and ◄ keys simultaneously.
- Maximum Time: 59 minutes and 59 seconds (cannot enter 60 seconds, use 1:00 minute).
- Beeps: Short beep for valid key, long beep for invalid key.
- Power Outage: If power goes off during treatment, the system remembers elapsed time. Upon power restoration, the device will be on "HOLD". Press START to continue, END to cancel.
- Treatment Indicator: A small orange light above the display is lit during treatment and blinks when paused.
MED Testing (Minimum Erythemal Dose):
This method determines the minimal dose of UVB that causes marked erythema. It provides a more accurate starting point than skin-typing quizzes. Starting at a higher dose, if tolerated, can prevent excessive tanning and reduce cumulative UV dose.
For UVA-1, the first treatment is a percentage of the MED. Subsequent treatments are a percentage of the preceding dose.
MED Testing Procedure:
- Determine the patient's skin type using a table (e.g., Skin Type I: Always burns, never tans; Skin Type VI: Black).
- Use the Daavlin Dose Patch (sold separately), a disposable adhesive MED/MPD test panel with six 2cm x 2cm exposure windows.
- Apply the patch to a non-exposed area (arms, buttocks, back), ensuring it's stretched tightly. Use multiple patches if more than six exposure levels are needed.
- Protect eyes and non-tested areas with UV blocking clothing or sunscreen.
- Determine test doses. Open exposure window #1. Expose the entire patch area to UV light. Open subsequent windows in consecutive order as each dose level is reached. The last window opened receives the lowest dose, the first receives the highest.
- Patient returns in 48 hours for UVA-1 test results. The resulting MED is the initial MED for treatment setup.
Recommended Protocol for UVA-1:
- Irradiation 5 times a week for 3 weeks (15 exposures).
- Determine UVA-1 MED prior to treatment.
- Start with 1 MED if MED < 70 J/cm².
- Increase dose by 20% each time if no erythematous reaction and good tolerability, up to a maximal dose of 70 J/cm².
- Reference applicable time charts for dosing times.
Maintenance Features
Recommended Maintenance Schedule:
- Dusting of unit and lamps: Once a month.
- Fully clean all internal reflectors, lamps, and protective acrylic: Annually.
- Power Output Measurement (Timer Only): Every 100 hours of use and when lamps are replaced (meters available from Daavlin).
- Replace lamps (UVA): Every 500-800 hours of use.
Cleaning:
- Exterior Cleaning: Use "Monk" Brand Wipes (available from Daavlin) for disinfection without harming UV transmitting surfaces. For dusting, use a feather duster or non-abrasive device.
- Cleaning of the Filter: A trained technician should clean internal filters and cavities annually. Do not attempt without proper training, as certain solutions may damage filters. Only Daavlin authorized personnel should perform this function. Allow filters to cool, then use a vacuum to remove dust from black filters on both sides of each lamp column. Dirt accumulation can impair UV intensity.
Relamping:
- Only Daavlin authorized personnel may carry out lamp replacement.
- Lamps typically degrade after 500-800 hours. Use only specified replacement lamps. Other lamps may fit but could produce harmful UVB levels.
- Return lamp filters to original position after relamping.
- Dispose of discarded lamps according to federal and local regulations.
- Measure lamp intensity before and after replacement. Notify relevant personnel as patient exposure times may need adjustment.
Removing and Fitting Lamps:
- Measure lamp intensity.
- Switch off the lamp, allow to cool.
- Turn off at the breaker.
- Remove air filter brackets and acrylic from each column.
- Wear latex gloves when handling filters and lamps.
- Remove the three clear filters from each column and place in a safe location.
- Remove the six colored filters from each column and place in a safe location.
- Grasp the end of the lamp and pull from the lamp socket.
- Insert new lamps into lamp sockets.
- Replace filters in reverse order.
- Replace air filter brackets and acrylic.
- Reconnect the unit.
- Switch on the unit and measure UV intensity to redefine necessary exposure times.
Patient exposure times may need adjusting after lamp replacement.
Resetting Your Lamp Hours:
To reset lamp hours to zero when installing new lamps:
- Press MODE, then ▲ and ENTER all at the same time.
- Press ▲.
- Press ENTER.
- Press MODE and ◄ at the same time.
- Press END.
Troubleshooting:
- Deposits in glass cylinder of lamp: Normal for deposits to collect after lamps have been switched off. These are metal halide precipitating inside the lamp. They will disappear when the lamp is switched on and warms up.
- Lamp does not ignite:
- Main switch is on.
- Unit is properly plugged in.
- All fuses in unit and building are checked.
- If lamp is defective, change the lamp.
- If ignition unit is defective, contact Daavlin Service Department.
- If it's impossible to ignite the lamp or if the lamp produces a weak, bluish light, switch the device off immediately to prevent damage to the ignition units. Contact Daavlin Service Department.
- Filters slipped or defective: Never operate the unit if filters have slipped or are defective. Switch the device off. Contact Daavlin Service Department.
Spare Parts and Accessories:
- Metal Halide High Pressure Lamp, 1000 W: 101MLMLAMP
- Colored Filter (260mm x 230mm): 100MLFTRGLSRD
- Clear Filter Filter (639mm x 292mm): 100MLFTRGLSCLR
- UVA-1 Irradiance Meter: 925GOX97
- Dose Patch (box of 100): 101MTDP100
- Cleaning Wipes: 90BWPDISMNK
- UV Safety Glasses – Fit Over Green: 905GR
- UV Safety Goggles with Elastic Band – Red: 101RDG
Warranty:
- New Equipment: 1 Year
- Remanufactured Equipment: 90 Days
- Lamps: 90 Days
The warranty covers defective materials and workmanship. It does not apply to equipment purchased for rental or altered outside the factory. Daavlin is not responsible for incidental, indirect, punitive, or consequential damages. Warranty is void if non-qualified technicians perform repairs without prior written authorization. Daavlin may bill for labor/expenses if requested "warranty" service trips are not covered by the warranty (e.g., tripped circuit breaker, unplugged machine, blown fuse).
Disposal:
Contact Daavlin for disposal instructions for the unit, cabinet, and accessories.
Other Services:
Extended warranties are available.
Contact Information:
- USA & Canada: 1-800-322-8546
- Overseas: 1-419-636-6304
- Fax: 1-419-636-1739
- Email: service@daavlin.com
- Website: www.daavlin.com
- Address: Daavlin, 205 W. Bement Street, PO Box 626, Bryan, Ohio 43506 USA
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