Daavlin 1 Series User manual

MNL-00049 [1] Proprietary and Confidential Page 1of 19
DT Home-Control
Operation Manual
Modes of Operation
•Timed Mode

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Table of Contents
1.0 Control Type........................................................................................................ 3
2.0 Indications for Use ............................................................................................. 3
3.0 Delivery and Inspection ..................................................................................... 3
4.0 Site Selection ...................................................................................................... 4
4.1 Electrical Requirements...................................................................................................................4
5.0 Unpacking and Assembly .................................................................................. 4
5.1 Swivel Stand ....................................................................................................................................4
6.0 Lamp Inspection ................................................................................................. 4
6.1 Lamp Specification Guide................................................................................................................4
7.0 Precautions and Warnings ................................................................................ 5
8.0 Operating Specifications ................................................................................... 7
9.0 Labels and Symbols........................................................................................... 7
10.0 General Instructions........................................................................................... 9
10.1 Pre-treatment Preparations..............................................................................................................9
10.2 Unlocking the Device .......................................................................................................................9
10.3 How to Position Yourself................................................................................................................10
11.0 Setting Up a Treatment Time ........................................................................... 10
12.0 Viewing Device Code for Flex Rx .................................................................... 11
13.0 Enable/Disable/Refill FlexRX ........................................................................... 11
13.1 Refill FlexRx...................................................................................................................................12
14.0 Special Notes .................................................................................................... 12
15.0 Care of the Unit................................................................................................. 12
15.1 Recommended Maintenance Schedule.........................................................................................12
15.2 Cleaning/Disinfection .....................................................................................................................13
15.2.1 General Cleaning ................................................................................................. 13
15.2.2 Low-Level Disinfection ........................................................................................ 13
15.2.3 High-Level Disinfection........................................................................................ 13
15.3 Lamp Removal and Replacement..................................................................................................13
15.3.1 Lamp Replacement.............................................................................................. 14
15.3.2 Resetting Lamp Hours......................................................................................... 14
16.0 Environmental Specifications ......................................................................... 14
17.0 Warranty ............................................................................................................ 18
17.1 Limited Warranty Policy .................................................................................................................18
17.2 Warranty Coverage........................................................................................................................18
17.3 Customer Responsibility ................................................................................................................18
17.4 Warranty Service............................................................................................................................18
17.5 Disposal .........................................................................................................................................19
17.6 Other Services ...............................................................................................................................19
17.7 Contact Information........................................................................................................................19

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Dear Valued Customer,
Thank you for selecting a Daavlin 1 Series phototherapy unit. The use of
light for the treatment of photoresponsive skin disorders has been our business since
1981. We are proud of our tradition of innovation in the field of phototherapy and are
honored that you have chosen us for your phototherapy needs. Let’s be clear. Our
commitment to you starts…Now!
Sincerely,
The Daavlin Staff
CAUTION: Federal law restricts this device to sale by or on the order of a
physician or other practitioner licensed by the law of the state in which they
practice.
1.0 Control Type
Your 1 Series phototherapy unit is equipped with Daavlin’s DT Control System. The device was
prescribed by your doctor to function in the mode listed below:
● Timed: You control the length of each treatment, based on instructions from your doctor. See
page 14 for operating instructions that are specific to this mode of operation.
FlexRx™Your physician may have prescribed your device with FlexRx, a system that limits the
total number of exposures the device will deliver. Specific information about these systems is
provided in this manual.
2.0 Indications for Use
The 1 series Phototherapy Devices are indicated for use to treat diagnosed skin
disorders such as but not limited to, psoriasis, vitiligo, and atopic dermatitis (eczema)
under the direction of a physician. The population may range from pediatric to geriatric.
3.0 Delivery and Inspection
Upon delivery, inspect the box and its contents. If damage is discovered, save all packing
materials and call Daavlin immediately to begin the claims process. If it’s not possible to inspect
the unit before the driver leaves, we recommend that you write “Concealed damage possible.
Further inspection required” on the delivery receipt.
As part of the claims process, the delivering carrier may require that a damage inspection be
conducted. They may conduct the inspection at your home, or they may decide to collect the
package for inspection at their facilities.
Note: In addition to notifying Daavlin, the delivering carrier must also be notified of any shipping
damage within twenty-four (24) hours to protect your right to an insurance claim.

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4.0 Site Selection
A location for the device should be chosen within reach of a standard, grounded electrical outlet.
Extension cords are not recommended. It is important that the unit be properly grounded. It
should not be in a location where there is foot traffic or where water or moisture might collect. It
should be protected from access by children. Exposure to ultraviolet light over extended periods
of time may cause carpets, wall coverings and furnishings to fade.
4.1 Electrical Requirements
In the United States and Canada, the 1 Series is shipped with a standard three-pronged plug and
can be plugged into any grounded household electrical outlet installed on a standard, non-
Residual Current Device (RCD) or ground fault circuit interrupter (GFCI) breaker. Devices that
will be used overseas will be equipped with a country appropriate electrical cord and plug.
All 1 Series devices are equipped with an onboard fuse. The fuse holder is a part of the power
cord receptacle that is located on the lower left-hand side of the device. If an onboard fuse fails,
call Daavlin’s service department to determine an appropriate replacement.
5.0 Unpacking and Assembly
1. Open the top of the box and grasp both sides of the device. Pull it out of the box along
with the foam packers on each end. Remove the foam packers.
Note: Be sure to remove all of the accessories, such as the manual, power cord and
eyewear before discarding the box.
2. Plug the “D” shape male fixture into the corresponding receptacle on the lower left-hand
side of the device. Plug the unit into any grounded, household electrical outlet. The unit
is now ready for use.
5.1 Swivel Stand
An optional Swivel stand is available that facilitates the treatment of both sides of your hands, or
feet or other parts of your body. Installation instructions for this optional accessory are separate
from this manual.
6.0 Lamp Inspection
1 Series devices can be equipped with different types of lamps, each with its own effect on the
skin. It is important to check that the proper lamps are installed. Consult the Lamp Specification
Guide in section 6.1 Lamp Specification Guide. If there is any question that the device is not
equipped with the lamps that you have been prescribed, contact Daavlin immediately. Lamp code
numbers are generally located at the base of the lamp.
6.1 Lamp Specification Guide
UVA
UVA-1
Narrowband
UVB
Broadband
UVB
Blue (405)
PLL-36W/09
PLL-36W/10
PLL-36W/01
PLL-36W/-06
PLL-36W/03

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7.0 Precautions and Warnings
•To protect the eyes during operation, the operator and anyone in view of the device must wear
the provided UV blocking glasses or goggles designed to block 100% of all UVA and UVB
light from the eye area when worn. Always use Daavlin approved eyewear.
•Do not remove protective eyewear, or any other protective equipment, during treatment.
•If psoralens (photosensitizing drugs) are being used as part of your treatment (“PUVA”), your
eyes should be protected from exposure to ultraviolet (sunlight) for 24 hours after taking the
drug. Ultraviolet blocking glasses are provided with devices equipped with UVA lamps.
•Do not use over skin eruptions without express consent from the attending physician.
•If a patient experiences burning, never treat the patient until the noticeable effects of burning
subside, and always reduce the subsequent treatment time.
•To protect unaffected skin during operation, the operator, patient, and anyone in view of the
device must generously apply UV blocking skin protection to all exposed skin that the
physician does not intend to treat.
•During extremely long treatments, some surfaces may become hot. Remove any body parts
from those surfaces if it becomes uncomfortable. The unit should have a 50% duty cycle of
10 minutes on, 10 minutes off.
•Erythema can result in as little as 15 seconds of exposure, or approximately 200 millijoules of
dose to UVB light. Prior to using your home phototherapy unit, contact your prescribing
physician for specific treatment instructions and dosing information.
•Center patients between the lamps during treatment to avoid over exposure to isolated areas
of the body.
•All people and pets should leave the treatment area to avoid exposure to ultraviolet light.
•Ask your doctor about protecting areas of the body that have not been exposed to sunlight.
•Do not use this device for anything other than its intended purpose.
•This device is only to be used by authorized users.
•Do not operate this device with a damaged cord or plug.
•If appliance coupler or mains plug is used as the mains disconnect, do not position the ME
equipment so that it is difficult to operate the disconnection device.
•To avoid the risk of electric shock, this equipment must only be connected to a supply main
with protective earth.
•To prevent electric shock, remove power to the device prior to cleaning and servicing.

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•To eliminate the risk of fire when replacing the fuse, replace ONLY with a fuse of the same
type and rating.
•NO MODIFICATION OF THIS EQUIPMENT IS PERMITTED. Unauthorized modification will
void the warranty and may result in hazardous or improper device operation.
•DANGER - ULTRAVIOLET RADIATION. As with natural sunlight, overexposure can cause
eye and skin injury, and allergic reactions. Repeated exposure may cause premature aging
of the skin and/or skin cancer. ALWAYS WEAR PROTECTIVE EYEWEAR: FAILURE TO
DO SO MAY RESULT IN SEVERE ERYTHEMA OR LONG-TERM INJURY TO THE EYES.
Medications or cosmetics may increase skin sensitivity to ultraviolet radiation. Inform your
physician before using this device if you are using medications or have a history of skin
problems or sensitivity to light.
•This device should be a minimum of 12 inches (30 cm) away from RF generating equipment.
•If the device malfunctions, cease operation immediately. If the device is placed close to other
equipment, it is possible that the cause is interference by external noise sources and fields,
in which case you should follow the remedies found under section 16.0 Environmental
Specifications. If the device continues to malfunction cease operation and contact the
Daavlin Service Department.
•If necessary, operation of equipment may beterminated by disconnecting unitfrom ACmains.
This can be accomplished by unplugging the device or, if hard wired, turning off quick
disconnect.
•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.
•The device should be placed a minimum of 1 inch (2.5 cm) away from surrounding walls,
devices, and furniture to ensure proper cooling airflow.
•The room that the deviceis placed in should be vented to allow free air displacement to ensure
the device and surroundings remain cool.
•Only original components and accessories should be used with the device to avoid damage.
•Before opening the device casing to perform maintenance or service, disconnect the device
from the power source.
•The device must never be directly exposed to flowing or splashing liquids of any kind. If the
device is inadvertently exposed to liquid, it must be tested for safety before being placed in
operation again.
•The device contains glass lamps. Avoid excessive force to the device to prevent lamp
damage.
•The device control system display is susceptible to damage from excessive force. Avoid
excessive force to the control system to prevent damage.

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•All treatments must be administered under the direction of a licensed physician only.
•Device is not to be used in MR environments that may include MRI, diathermy, electrocautery,
or other high frequency equipment.
•Do not treat if the lamps fail to ignite. Consult with doctor and/or contact Daavlin customer
service. (See page 21)
•If lamps turn on without treatment being started/resumed, or if lamps do not turn off when
treatment is completed, unplug the device. Contact doctor and/or Daavlin customer service.
(See page 21)
•DT Controlled Phototherapy Devices are considered CISPR Group 1, Class A devices, to be
used for prescription use only.
8.0 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)
Ambient
Luminance:
250 –500 lux
WARNING: Equipment not suitable for use in the presence of a flammable anesthetic mixture
with air or with oxygen or nitrous oxide.
9.0 Labels and Symbols
If the unit is equipped with FlexRx™exposure limiting software, there will be a label similar to the
one shown below (Figure 1 FlexRx Label) below informing you that your unit has been equipped
with this feature.
Figure 1 FlexRx Label

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A warning label (Figure 2 Warning Label) is affixed to your Daavlin phototherapy device in a
prominent and easily readable position. Please read the label carefully as it contains important
safety information.
Figure 2 Warning Label
Figure 3 Identification Label
The following table lists all of the symbols appearing on the device along with their meaning.
Table 1 Symbols
SYMBOL
DESCRIPTION
DANGEROUS VOLTAGE
NON-IONIZING RADIATION
EARTH (ground)
PROTECTIVE EARTH (ground)

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SYMBOL
DESCRIPTION
OPERATING INSTRUCTIONS
KEEP DRY
CAUTION, CONSULT ACCOMPANYING DOCUMENTS
MEDICAL DEVICE
10.0 General Instructions
10.1Pre-treatment Preparations
Before starting therapy, show your doctor these instructions. He or she is the final authority for
your treatment, and, depending upon your particular circumstances,may change these directions.
Always follow your physician’s instructions.
You may want a notebook or treatment log in which to record the date, dose, and duration of each
of your treatments along with any other notes regarding your treatment or treatment results. (For
example, forgot lip balm, put sunscreen on tender area, etc.)
Note: A free printable treatment log is available for download at www.Daavlin.com.
You will need to purchase lip balm and sunscreen with an SPF (Sun Protective Factor) of at least
30. Ask your doctor whether or not you should use an alcohol or cream-based sunscreen.
10.2Unlocking the Device
To prevent unauthorized use, the device will “self-lock” when it has not been used for three (3)
minutes. To unlock your unit:
1. Press any button to power on the device.
2. Your unit will now display the word “C0dE”.
3. The factory default key code is “0007”. Press the UP-ARROW button until your unit
displays “0007”.
4. Press the “PLAY/PAUSE” button to unlock the controller.

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10.3How to Position Yourself
Dual Point Calibration Selection: The 1 Series has been designed to deliver accurate and
effective treatments from two distinct treatment distances. Treatments can be administered
directly on the acrylic’s surface (0 inches) or at a distance of nine inches from the acrylic (9 inches
or 23 centimeters).
The intensity or power output of the device will be much greater when treating directly on the
acrylic surface versus treating from nine inches away. For this reason, youmust select the desired
treatment distance before administering a treatment. See specific instructions under Running a
Treatment.
By selecting the treatment distance, 0 in or 9 in, you are telling the system how it should calculate
the length of the treatment based on your distance from the lamps.
Hands and Feet: (Choose 0 inches position when starting your therapy). Position the device on
a flat surface with the lamps facing up. Place your hands or feet directly on top of the plastic lamp
guard. For the best results you should position your hands, or feet, as close as possible to the
center of the fixture.
Note: When treating the hands and feet be careful not to place too much weight or pressure on
the acrylic surface. Excess pressure can cause the acrylic surface to crack and break.
Larger Area Treatment: (Choose the 9 inches position when starting your therapy). Position
the 1 Series so that the lamps are perpendicular to the surface on which the device is standing
on. Position the part of your body that you wish to treat nine (9) inches away from the lamps.
11.0 Setting Up a Treatment Time
1. Enter in your key code. Unless you have changed it, the factory default key code is “0007.”
2. Once the key code has been entered, the display should read “00:00”.
3. The currently editable character will flash on and off to signal that it is the editable
character.
4. Press the UP-ARROW button to increase the value of the flashing character by one (1).
5. Press the LEFT ARROW button to move the flashing character over by one position.
6. Once the desired time is present on the display, press the PLAY/PAUSE button to lock-in
the treatment time.
7. Press the PLAY/PAUSE button to begin the treatment.
8. Press the PLAY/PAUSE button to pause the treatment.
9. While treatment is paused or completed, press the CANCEL button to return to the
treatment menu (“00:00” displayed with the right-most character flashing).
10. After a treatment is complete, the controller will enter Standby Mode. The controller will
flash the most recently completed treatment while in standby mode.
a. To repeat this treatment: press the PLAY/PAUSE button to re-enter Time Entry
Mode. The rightmost character should now be flashing.