Daavlin ML24000 Operation manual

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OPERATION AND SERVICE MANUAL

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Table of Contents
1.0 Introduction ......................................................................................................................................4
2.0 Indications for Use............................................................................................................................5
3.0 Classifications....................................................................................................................................5
4.0 Operating Specifications...................................................................................................................5
5.0 Transport and Storage Specifications ...............................................................................................6
6.0 EMC Precautions...............................................................................................................................6
7.0 Electrical Specifications.....................................................................................................................6
8.0 Site Selection.....................................................................................................................................6
9.0 UVA-1 Output Spectrum ...................................................................................................................7
9.1 Irradiance Specifications...............................................................................................................7
9.2 Labels and Symbols.......................................................................................................................7
10.0 Training Requirements....................................................................................................................10
11.0 Warnings & Cautions ......................................................................................................................10
11.1 Electrical Shock Hazards..............................................................................................................10
11.2 Ultraviolet Light Exposure & Bodily Injury Hazards....................................................................11
11.3 Equipment & Property Damage Hazards....................................................................................11
12.0 Unlocking the Device ......................................................................................................................12
13.0 Changing or Disabling the Key Code ...............................................................................................12
14.0 Flex Timer Instructions....................................................................................................................12
14.1 Determining a Treatment Time ..................................................................................................12
14.2 Partial UVA, UVA-1 Time Chart...................................................................................................13
14.3 Setting Up a Treatment Time......................................................................................................13
14.4 Special Functions of the Digital Timer ........................................................................................14
14.5 Special Notes...............................................................................................................................14
14.6 Flex Timer Range and Accuracy ..................................................................................................14
15.0 Treatment Protocols .......................................................................................................................15
15.1 MED Testing................................................................................................................................15
15.2 MED Testing Procedure ..............................................................................................................15
15.3 Daavlin Dose Patch (sold separately)..........................................................................................16
15.4 General Instructions for MED Testing.........................................................................................16
15.5 RECOMMENDED PROTOCOL FOR UVA-1....................................................................................16
16.0 Care of Your Phototherapy Unit .....................................................................................................17
16.1 Recommended Maintenance Schedule......................................................................................17
16.2 Cleaning.......................................................................................................................................17

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16.3 Cleaning of the Filter...................................................................................................................17
16.4 Relamping ...................................................................................................................................17
16.5 Removing and Fitting Lamps.......................................................................................................18
16.6 Resetting Your Lamp Hours.........................................................................................................18
16.7 Troubleshooting..........................................................................................................................19
16.8 Spare Parts and Accessories .......................................................................................................19
17.0 Warranty.........................................................................................................................................20
17.1 Limited Warranty Policy..............................................................................................................20
17.2 Warranty Coverage.....................................................................................................................20
17.3 Customer Responsibility .............................................................................................................20
17.4 Warranty Service.........................................................................................................................20
17.5 Disposal.......................................................................................................................................21
17.6 Other Services.............................................................................................................................21
17.7 Contact Information....................................................................................................................21

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1.0 Introduction
Thank you for purchasing a Daavlin Phototherapy Unit. The use of light for the treatment of
photoresponsive skin disorders has been our passion since 1981. From the beginning we have been
devoted to providing our customers with the highest quality products coupled with industry leading
customer service.
At Daavlin, we are always keeping track of new developments and are doing our best to implement the
latest findings in our products. We appreciate receiving feedback from the medical community and
patients, so we can further improve our products. If you have any comments or suggestions, please
contact our Customer Service department and your input will be channeled to the appropriate person.
The purpose of this manual is to instruct users on the proper methods of operation and general
maintenance. In addition to this, the manual also addresses important information regarding device
specifications, warnings, treatment protocols and warranty information. Please take a moment to read
the entire operation manual before operating your Daavlin phototherapy unit.
Here at Daavlin we are proud of our tradition of development and innovation in the field of
phototherapy and we are honored that you have chosen us for your phototherapy needs. Let’s be clear.
Our commitment to you starts…Now!
Sincerely,
The Daavlin Distributing Company
205 West Bement Street
P.O. Box 626
Bryan, OH 43506-0626
Phone: [phone]
Fax: [phone]
Email: [email protected]m
Website: www.Daavlin.com

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2.0 Indications for Use
The Daavlin ultraviolet light emitting device contained in this manual are intended for use, by or under
the direction of a physician, for the therapeutic treatment for individuals who require ultraviolet or
visible radiation for diagnosed skin disorders.
WARNING: Do not use these devices for anything other than their intended purposes.
CAUTION: Federal law restricts this device to sale by or on the order of a physician or any other
practitioner licensed by the law of the state in which he/she practices.
3.0 Classifications
FDA:
Class II Device
93/42/EEC:
Class IIa Device
IEC 60601-1:
Class I Device
Pollution Degree:
Class II
Mode of Operation:
Non-continuous
IEC/EN 62471:2006
UV Risk Group:
Risk Group 2 (Moderate-Risk)
WARNING: This device is designed for intermittent operation only and not for continuous use. The
device should not be cycled continuously. For treatments greater than 20 minutes in duration the device
should be either turned off or left idling for a minimum of 50% of the administered treatment time, e.g.
a treatment lasting 40 minutes in duration should be followed by a cool down period of 20 minutes.
4.0 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 (This device does not have protection against
ingress of water.)
Ocular Hazard
Distance:
3 Meters (9.84 Feet)
Altitude:
≤ 2000m
WARNING: Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or
with oxygen or nitrous oxide.

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5.0 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
6.0 EMC Precautions
The devices contained in this manual have been tested and found to comply with the EMC limits of the
international standard IEC 60601-1-2. These limits are designed to provide reasonable protection
against interference in a typical medical installation. The system can radiate radio frequency energy if
not installed in accordance with the instructions, and may cause harmful interference to other devices in
the vicinity. There is no guarantee that interference will not occur in a particular installation. If the
system does cause interference with other devices, which can be determined by turning the system off
and on, the user is encouraged to try to correct the interference by one or more of the following
measures:
•Re-orient or relocate the receiving device
•Increase the separation between the equipment
•Connect the System into an outlet on a circuit different from that to which the other device(s) is
connected
Consult the manufacturer or field service technician for help
7.0 Electrical Specifications
The device is manufactured in the following electrical configurations. Always refer to the identification
label of the device to determine which electrical configuration the device is manufactured to.
•Mains input = 230V, 3~, 60Hz, 100A Operating = 230V, 3~, phase to phase
•Mains input = 400V, 3N~, 50Hz, 100A Operating = 230V~, single-phase (phase to neutral)
8.0 Site Selection
A site should be chosen within reach of the specified electrical connection (refer to the Facility
Requirements Guide) and where the unit can be left in place without obstructing traffic flow. It is
important that the unit be properly grounded. The site should not be in any area where water or
moisture might collect and should be protected from access by children and other unintended users.
WARNING: To avoid the risk of electric shock this equipment must only be connected to a supply mains
with a protective earth.
CAUTION: This device is a Class A Medical Device suitable for use in all establishments other than
domestic and those directly connected to the public low voltage power supply network that supplies
buildings used for domestic purposes.

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9.0 UVA-1 Output Spectrum
The treatment light is generated by 24 1000 Watt High Intensity Discharge Metal Halide Lamps. The light
emitted is in the UVA band with a primary emission range of 350-400 nanometers. The output spectrum
of the system is shown in Figure 1.4. Some of the light outside the 350-400nm peak emission range is
typical for these types of systems and does not affect safety or efficiency.
Figure 1
9.1 Irradiance Specifications
The power output of your unit is dependent on the style and quantity of lamps contained within the
device. The power output of your unit is fixed and cannot be altered by the user. The power output
value of your device, as measured at the factory, is shown on the Power Output Certificate included with
your device literature. The table below represents the possible output range of your unit.
Lamp Style:
High Intensity Discharge
Minimum
Output:
9" Away: 60 mW/cm2(+/- 10%)
Maximum
Output:
9" Away: 100 mW/cm2(+/- 10%)
Note: Irradiance measurements taken with Gigahertz-Optik P-9710-1 Optometer.
9.2 Labels and Symbols
A warning label is affixed to your device in a prominent and easily readable position. Please read the
label carefully as it contains important safety information for you. According to IEC/EN 62471:2006,
sources of optical radiation are classified into risk groups subject to their potential photobiological
hazard. This device falls under Risk Group 2 (Moderate-Risk) and does not pose a severe hazard due to
the natural aversion response to bright light or thermal discomfort. A Risk Group 2 warning label, which

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also includes the primary emission range and potential output range, is affixed to your device in a
prominent and easily readable position. In addition to the warning labels mentioned above, an
identification label indicates the serial number and date of manufacture that is specific to your device.
The ML24000 features a Data Connection port located on the Device. This port is only to be used as a
data only connection to the ML24000 Flex Controller Box. This data port is identified by the following
label.
The ML24000 Flex Controller Box comes affixed with two additional labels containing important
information regarding the Flex Controller Box model number, system rating, and DC input jack rating.
This information is identified by the following labels.

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The following is a chart detailing all symbols located on the cabinet and their definitions:
DANGEROUS VOLTAGE
!
ATTENTION, CONSULT ACCOMPANYING DOCUMENTS
NON-IONIZING RADIATION
EARTH (ground)
PROTECTIVE EARTH (ground)
ALTERNATING CURRENT
THREE-PHASE ALTERNATING CURRENT WITH NEUTRAL CONDUCTOR
OPERATING INSTRUCTIONS
REFER TO INSTRUCTION MANUAL/BOOKLET
DATA ONLY ETHERNET PORT
L1, L2, L3
PHASE CONDUCTORS

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10.0 Training Requirements
Phototherapy services require staff that have appropriate training, knowledge, and clinical skills in order
to ensure effective outcomes and quality care for patients. Staff must be assessed as being competent
and safe in order to provide phototherapy treatments that maximize benefit and minimize adverse
effects. Recommended training requirements include:
•Staff should be either a physician, nurse, or any other practitioner licensed by the law of the
state or country in which he/she practices
•Training and experience in dermatology is important to provide holistic patient care. This
knowledge includes:
oAnatomy and the Physiology of the skin
oRecognition and understanding of skin diseases
oSkin assessment
oUnderstanding of photoresponsive diseases
•Theoretical knowledge of phototherapy and its use
•A period of supervised practice for approximately 3 months with a competent practitioner
•Managers should ensure that staff members have, or are provided with, the appropriate level of
training and education needed prior to administering phototherapy services.
11.0 Warnings & Cautions
11.1 Electrical Shock Hazards
•Warning: A qualified, licensed electrician must wire the service for this device in accordance
with all national and local codes and the electrical instructions provided in the accompanying
Service & Installation Instructions manual. Unauthorized personnel should not open the panels.
The Daavlin Service Department should be consulted before any service is performed.
•Warning: Prior to each use, always verify that the device is in correct working order and
operating condition and plugs, sockets, lamps, and electrical cables and connections are not
worn or damaged.
•Warning: Upon detection or discovery of faulty, worn, or damaged component(s), factory
authorized service personnel must replace the component(s) in accordance with the
accompanying Service & Installation Instructions manual and test the device for proper
functionality prior to placing the device in use again.
•Warning: Before opening the device casing to perform maintenance or service, read,
understand, and follow all warnings, cautions, and instructions in this and the accompanying
Service & Installation Instructions manual, both of which are provided with the device.
•Warning: Before opening the device casing to perform maintenance or service, disconnect the
device from the power source.
•Warning: The device must never be directly exposed to liquids of any kind. If the device is
inadvertently exposed to liquid, it must be tested for safe function before being placed in
operation again.