Daavlin ClearLink 4 Series User manual

ClearLink™Home-Control
Operation Manual
Modes of Operation
•Guided Mode
•Dosimetric Mode
•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 4
4.0 Site Selection 4
4.1 Electrical Requirements 4
5.0 Unpacking and Assembly 4
6.0 Lamp Inspection 5
6.1 Lamp Specification Guide 5
7.0 Precautions and Warnings 5
8.0 Operating Specifications 7
9.0 Labels and Symbols 8
10.0 General Instructions (All Modes of Operation) 11
10.1 Pre-treatment Preparations 11
10.2 Special instructions –4 Series with 20 Lamps Only 11
10.3 How to Position Yourself 11
10.4 Unlocking the Device 12
10.5 Common ClearLink™Functions 12
10.6 Post-Treatment 12
10.7 FlexRx™12
11.0 Guided Mode 13
11.1 Features of the ClearLinkTM Guided Home-Control System 13
11.2 Running a Treatment 14
12.0 Dosimetric Mode 15
12.1 Features of the ClearLink™Dosimetric Home-Control System 15
12.2 Running a Treatment 15
13.0 Timed Mode 16
13.1 Running a Treatment 16
14.0 Care of the Unit 17
14.1 Recommended Maintenance Schedule 17
14.2 Uploading FlexRx™Refill Prescriptions 17
14.3 Changing or Disabling the Unlocking Code 17
14.4 Downloading Treatment History 17
14.5 Cleaning/Disinfection 18
14.5.1 General Cleaning 18
14.5.2 Low-Level Disinfection 18
14.5.3 High-Level Disinfection 18
14.6 Calibration (Applicable to Guided and Dosimetric Units Only) 19
14.7 Accuracy/Range (Applicable to Guided and Dosimetric Units Only) 19
14.8 Lamp Removal and Replacement 19
14.8.1 Lamp Replacement 19
14.8.2 Resetting Lamp Hours 20
15.0 Environmental Specifications 20
16.0 Warranty 22
16.1 Limited Warranty Policy 22
16.2 Warranty Coverage 22
16.3 Customer Responsibility 22
16.4 Warranty Service 23
16.5 Disposal 23
16.6 Other Services 23
16.7 Contact Information 24

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Dear Valued Customer,
Thank you for selecting a Daavlin 4 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 be sold by or on the order of a physician
or other practitioner licensed by the law of the state in which he or she practices.
1.0 Control Type
Your 4 Series phototherapy unit is equipped with Daavlin’s ClearLinkTM Control System. The device was
prescribed by your doctor to function in one of the three modes listed below:
● Guided: The system controls the beginning dose and all subsequent does depending upon how your skin
responds to the therapy. See pages 13 and 14 for operating instructions that are specific to this mode of
operation.
● Dosimetric: You control the doses which are delivered in either Joules or Millijoules. The system
automatically adjusts the length of each treatment depending on the power of the lamps. The doses you
take will be based on instructions from your doctor. See page 15 for operating instructions that are specific
to this mode of operation.
● Timed: You control the length of each treatment, based on instructions from your doctor. See page 16
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 4 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
physician will determine the light spectrum (ultraviolet to visible), the energy or duration of the treatment,
as well as the treatment environment. The population may range from pediatric, when accompanied by a
responsible adult to operate it, to geriatric.

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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.
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 bein 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 4 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 to be used
overseas will be equipped with a country appropriate electrical cord and plug.
All 4 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 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 box and grasp each side of the device. Pull it, along with the foam packers, up and out of the
box. Remove the foam packers.
Note: Be sure to remove all the accessories such as the manual, power cord, eyewear, and feet before
discarding the box.
2. Set the unit on a table so that the lamps are facing up and the end opposite the controller is hanging
over the edge of the table.
3. On each side of the unit, you will find four thumb screws. Remove them. They will be used to attach
the feet to the sides of the unit.
4. Take one of the feet and align the four precut holes with the four holes on the side of the device that
were created by removing the thumb screws.

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Note: The feet will only fit one way. Be sure that the widest part of the foot is level with the bottom of the
unit and that the lip or rail faces away from the unit. For a picture of the proper foot alignment please see
the cover of this manual.
5. To secure the foot, thread the four thumb screws through the holes in the foot and into the side of the
unit, tightening each of them lightly. Be sureto insert all thethumb screws before fully tightening them.
Note: Tighten the thumb screws using your thumb and index finger. If necessary, the screws can
be tightened with a flathead screwdriver.
6. Repeat steps 4-5 to install the other foot.
7. Stand the unit up vertically and check all the screws to be sure they are tight.
8. Insert the “D” shaped male plug into the corresponding receptacle on the lower left side of the device.
Plug the unit into any standard, electrical outlet.
6.0 Lamp Inspection
4 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 (see section
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
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.

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•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 your 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 a
protective earth.
•To prevent electric shock, remove power to the device prior to cleaning and servicing.
•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.

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•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 EMC Precautions. If the device continues to
malfunction cease operation and contact the Daavlin Service Department.
•If necessary, operation of equipment may be terminated by disconnecting unit from AC mains. This
can be accomplished by unplugging 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.
•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 safe function 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.
•All treatments must be administered under the direction of a licensed physician 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.

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9.0 Labels and Symbols
A removable label (Figure 1 Unlocking Code) located near the keypad provides information on how to
unlock the unit.
Figure 1 Unlocking Code
If the unit is equipped with FlexRx™exposure limiting software, there will be a label similar to the one
shown below (Figure 2 FlexRx Label) informing you that your unit has been equipped with this feature.
Figure 2 FlexRx Label

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A warning label (Figure 3 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 3 Warning Label
Figure 4 Identification Label

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The following table lists all the symbols located on the device along with their meaning.
Table 1 Symbols
SYMBOL
DESCRIPTION
DANGEROUS VOLTAGE
NON-IONIZING RADIATION
EARTH (ground)
PROTECTIVE EARTH (ground)
OPERATING INSTRUCTIONS
KEEP DRY
CAUTION, CONSULT ACCOMPANYING DOCUMENTS
FUSE IDENTIFICATION LABEL

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10.0 General Instructions (All Modes of Operation)
10.1 Pre-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.
The ClearLink Controller will track your treatment data. However, 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.
10.2 Special instructions – 4 Series with 20 Lamps Only
If you have a ten-lamp unit, treatments should only be taken from a distance of 9 inches!
Your 4 Series twenty lamp unit has been designed to deliver accurate and effective treatments from two
distinct treatment distances. If you have been prescribed a 20-lamp unit, 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 22
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, you must 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 aretelling the system how it should calculate thelength
of the treatment based on the distance from the lamps.
10.3 How to Position Yourself
Large Area Treatments: The recommended distance from the lamps for treatment is 9 inches (22
centimeters). We also recommend that you mark that distance on the floor in some manner. Your torso
should not be closer to the lamps than this line. Standing closer to the lamps will cause localized streaking
or burning.
Small Area Treatments at the Acrylic Surface (20 lamp 4 series only): Place the area being treated
directly on the acrylic lamp guard. For best results you should position the area being treated as close as
possible to the center of the fixture.
Note: When treating, be careful to not place too much weight or pressure on the acrylic surface. Excess
pressure can cause the acrylic surface to crack and break.

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10.4 Unlocking the Device
To prevent unauthorized use, the device will self-lock when left idle
for twenty (20) minutes.
1. Tap the blank screen. The Daavlin logo will appear.
2. Tap the logo. The Lock Screen will appear (unless disabled)
3. Using the keypad, enter the number 7 (unlocking code)
4. Press the Enter key to unlock.
10.5 Common ClearLink™ Functions
The system beeps to signal the end of the treatment and displays the
delivered dose with the elapsed time.
If power goes off during a treatment, the system will track how much of the treatment has elapsed and
will allow the treatment to resume when power is restored.
10.6 Post-Treatment
After a treatment, you may protect any areas that feel sunburned with sunscreen for the next several
treatments or until they appear normal. (Make a note in your notebook.) You should see your physician at
the intervals he or she requests when actively using the unit. Always take the notebook with you when you
see your physician.
10.7 FlexRx™
If your unit was prescribed with FlexRx™, a screen (Figure 7 FlexRx Screen) will tell you how many
exposures remain before you need a refill prescription. See Section Uploading FlexRx™Refill
Prescriptions for refill instructions.
Figure 7 FlexRx Screen
Figure 5 Logo Screen
Figure 6 Lock Screen

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11.0 Guided Mode
11.1 Features of the ClearLinkTM Guided Home-Control System
The ClearLink Guided Home-Control System automatically performs many safety checks on your behalf,
as well as calculating dose increases based on your treatment schedule and how your skin responds to
treatment.
For example, each time you use the device, the ClearLink Controller will check the date of your last
treatment. If you are on schedule, it will automatically proceed. However, if you have missed a treatment
or treatments, the system will adjust accordingly to keep your dose at a safe level. A screen will appear
advising you of the adjustment (See Figure 8 below).
Figure 8
Integrating dosimetry, another feature, uses a built-in sensor to monitor the amount of light energy being
produced by the device. The system then automatically adjusts your treatment time to account for variations
in light energy caused by changes in room temperature or the aging of the lamps.
Finally, before each treatment, the ClearLink Controller will ask about the current condition of your skin,
such as whether or not there is any redness, mild or otherwise. It will use this information to calculate the
next dose. Keep in mind, it is normal to experience some “redness” within 8 – 12 hours of a treatment but
it is typically gone before it is time for the next treatment.

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11.2 Running a Treatment
Note: The first time you use the device, your dose will automatically appear, based on your doctor’s
prescription. After your first treatment, the screen will display the next scheduled treatment, but will ask if
you experienced any pain or redness after your last treatment. Based on your response, the system will
adjust the treatment according to your prescription.
1. After unlocking the device, the Treatment Screen will appear with the scheduled dose.
2. You will be asked, “Were you in pain or red after your last treatment?”
3. You must choose one of the following responses:
No, or < 24 Hrs (“Not at all, or it was gone in less than 24 hours”)
24 –48 Hrs (“I was in pain or red for 24-48 hours after the treatment”)
> 48 Hrs (“I was in pain or red for more than 48 hours”)
Still red / pain (“I am currently still red or have pain”)
Note: Selection of the “Still red / pain” option will lock the device until one treatment has been skipped.
This prevents treating the skin until the erythema (redness) has resolved.
4. Once you have highlighted your response, press the Enter key.
5. Choose the treatment distance by pressing either the “9 in” button or the “0 in” button (Only for
20 lamp units)
6. The Treatment Confirmation screen will appear and will display the dose and an estimated time
for the treatment. If changes need to be made, press the back arrow. To cancel, press the
Cancel key.
Put on your goggles and position yourself 9 inches from the front of the device or on the surface of the
acrylic, as appropriate. See Section Error! Reference source not found. for guidance.
7. Press the Enter key to begin the treatment. A 3 second countdown will begin; the lamps
will turn on and the screen will track your progress. The lamps will shut off when the treatment is
over.
8. To repeat the same dose for exposure to another part of your body, touch the Repeat button.
Note: Repeats will not be available after leaving the treatment screen.
9. To pause an active treatment, press the Pause button. To resume, press the Play button.
To end or cancel an active treatment, first pause the treatment and then press the Cancel button

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12.0 Dosimetric Mode
12.1 Features of the ClearLink™ Dosimetric Home-Control System
The ClearLink Dosimetric Home-Control System uses a built-in sensor as part of a function called
integrating dosimetry to monitor the amount of light energy being produced by the device. The system then
automatically adjusts the length of each treatment to account for variations in light output caused by changes
in room temperature and aging of the lamps.
12.2 Running a Treatment
After unlocking the device, the Treatment Screen will appear.
1. Press the Treat Patient button, then
2. Choose the treatment distance by pressing either the “9 in” button or the “0 in” button (Only for 20
lamp units)
3. Touch the ▲/▼ arrows to set the desired dose in MilliJoules (UVB) or Joules if you have a
UVA device.
Note: UVB treatments are commonly dosed in MilliJoules. However, your doctor may have
requested that the UVB treatments be dosed in Joules. If so, your device will have been
programmed accordingly.
4. Press the Enter Arrow to enter the Treatment Confirmation screen.
5. Confirm the Dose and Estimated Treatment Time. If changes are needed to the dose, press the Return
Arrow and return to step 3.
Put on your goggles and position yourself 9 inches from the front of the device or on the surface of the
acrylic, as appropriate. See Section Error! Reference source not found. for guidance.
6. Press the Enter key to begin the treatment. A 3 second countdown will begin; the lamps will
turn on and the screen will track your progress. The lamps will shut off when the treatment is over.
7. To repeat the same dose for exposure to another part of your body, touch the Repeat button.
Note: Repeats will not be available after leaving the treatment screen.
8. To pause an active treatment, press the Pause button. To resume, press the Play button.
To end or cancel an active treatment, first pause the treatment and then press the Cancel button.

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13.0 Timed Mode
13.1 Running a Treatment
After unlocking the device, the Treatment Screen will appear with the scheduled dose.
1. Press the “Treat Patient” button.
2. Choose the treatment distance by pressing either the “9 in” button or the “0 in” button (Only for
20 lamp units)
3. Touch the ▲/▼ arrows to enter the desired treatment time. Note: It is not possible to enter a
time of 60 seconds. You must instead enter 1 minute.
4. Press the Enter Arrow to enter the Treatment Confirmation screen.
5. Confirm the Time. If a change is needed, press the Return Arrow and return to step 3.
Put on your goggles and position yourself 9 inches from the front of the device or on the surface of the
acrylic, as appropriate. See Section Error! Reference source not found. for guidance.
6. Press the Enter key to begin the treatment. A 3 second countdown will begin; the lamps
will turn on and the screen will track your progress. The lamps will shut off when the treatment is
over.
7. To repeat the same dose for exposure to another part of your body, touch the Repeat button.
Note: Repeats will not be available after leaving the treatment screen.
8. To pause an active treatment, press the Pause button. To resume, press the Play button.
To end or cancel an active treatment, first pause the treatment and then press the Cancel button
Calculating Increases: Phototherapy treatments usually start at a given time or dose and are increased
with each treatment. Your doctor may ask you to increase each treatment by a set amount of time or
may ask you to increase by a percentage, which is difficult when the treatment times are in minutes and
seconds. Google Daavlin treatment time calculator and bookmark it on your phone. In that app, simply
enter the time of your last treatment and the desired percentage increase and the calculator will give
you the new treatment time instantaneously.

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14.0 Care of the Unit
14.1 Recommended Maintenance Schedule
Item / Action
Frequency
Dusting of the unit and lamps
Once a month
Fully clean all internal reflectors, lamps
and protective acrylic
Annually (behind the lamps)
Unit calibration
Every 100 hours of use or once a year (whichever occurs first) and when
lamps are replaced. (Meters can be rented or purchased through Daavlin)
Replace lamps
*UVB –Approximately every 300 hours of use.
*UVA –Approximately every 500 hours of use.
*Blue –Approximately every 500 hours of use.
* Lamp life will vary significantly depending on average treatment time and other environmental conditions.
14.2 Uploading FlexRx™ Refill Prescriptions
When specified by your prescribing physician, Daavlin home phototherapy devices are equipped with
FlexRx exposure limiting software. For each sequence of exposures, the number of available treatments is
reduced by one. A treatment sequence consists of the primary exposure plus up to three repeat exposures,
if needed, for treating other areas of your body.
If the device is equipped with FlexRx, upon “waking up”, the screen will display reminders of how many
exposures are remaining. To ensure there are no interruptions in your therapy, we suggest that you contact
your physician for a “refill” when 5 to 10 exposures remain. Once you are completely out of exposures, the
controller will prompt you to upload a new FlexRx prescription.
To enter a FlexRx refill code, wake the controller from its sleep mode and enter the unlocking code. The
controller will ask you to enter a FlexRx code or you may press the Prescription button to begin.
Tap the screen and enter the code provided by your doctor by pressing the up arrows. Press the Enter
key once you have verified that the code is entered correctly. The controller will then display the number
of exposures that have been uploaded and you can then continue your normal routine.
14.3 Changing or Disabling the Unlocking Code
The unlocking code is a safety feature that prevents someone from accidentally turning on or tampering
with the device. It works just like a key. To remove the unlocking code feature or to change it to a number
that is easier to remember, contact Daavlin’s service department at 1-800-322-8546 for step-by-step
instructions. Hours of operation are Monday through Thursday 7:30am - 8:00pm EST and Friday 8:30am
- 5:00pm EST
14.4 Downloading Treatment History
Your doctor may require that you provide a treatment history file so he or she can monitor your progress.
To download your history files, insert a USB drive into the USB port. Press the “Export Data” button then

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press the Enter key. When the download is complete, remove the USB drive and take it to your
doctor.
14.5 Cleaning/Disinfection
14.5.1 General Cleaning
For general use, use a clean non-abrasive cloth, not paper towels, and a mild cleaning solution
such as Dawn Liquid Dishwashing Soap to gently wipe down the exterior of the device.
14.5.2 Low-Level Disinfection
To reduce micro-organisms on the patient-contacting surfaces, disinfect these surfaces between
uses of the device, including when the same patient has the device for use. For disinfection while
the same patient uses the device, we have tested several cleaners that do not degrade the Acrylic
and can be seen in Table 2 Daavlin Tested Cleaners.
Cleaner/Solution
Contact Time
Monk brand Wipes
Follow the contact time instructions
provided with the Monk brand Wipes
70% Isopropyl Alcohol
3 min
Table 2 Daavlin Tested Cleaners
1. Thoroughly wipe down the surfaces and allow contact time listed in Table 2 Daavlin Tested
Cleaners.
2. Allow to air dry and inspect for visible contaminants.
3. If contaminants remain repeat until no visible containments remain repeat steps 0 and 2.
14.5.3 High-Level Disinfection
Follow a high-level disinfection protocol between the use of the device on different patients. Use
a high-level disinfectant, such as Steris Corporation’s Resert XL-HLD, and follow the
manufactures guidelines. See also “FDA-Cleared Sterilants and High Level Disinfectants with
General Claims for Processing Reusable Medical and Dental Devices” available at:
https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices-information-
manufacturers/fda-cleared-sterilants-and-high-level-disinfectants-general-claims-processing-
reusable-medical-and.
We suggest using “Monk” Brand Wipes as they disinfect and will not harm any ultraviolet or light
transmitting surfaces. These wipes are available for purchase from Daavlin. When dusting the unit and the
lamps, we recommend using a feather duster or a similar non-abrasive cleaning device.
Note: Do not clean reflective surfaces with paper towels. They may scratch the surface.
At least once a year, we recommend that you remove the protective acrylic for a more thorough cleaning
of the lamps and reflectors. Refer to Lamp Replacement instructions on how to remove the acrylic and
lamps, as well as other important information on how to ensure that the lamps are safely and correctly
replaced.

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14.6 Calibration (Applicable to Guided and Dosimetric Units Only)
The power output of the device was measured before it left Daavlin’s manufacturing facility. A
“Calibration Output Certificate” is included with the operating manual and contains the device’s factory
measured power output. The certificate for ten (10) lamp units will state the power output of the device at
a distance of nine (9) inches from the acrylic surface of the unit.
Because the 20 lamp 4 Series has been designed to deliver treatments from two specific distances, 0 inches
and 9 inches, the output certificate for 20 lamp units will have two outputs noted in the “Current Value”
box. The higher of the two values corresponds to the “0 inch” setting and the lower of the two corresponds
to the “9 inch” setting.
14.7 Accuracy/Range (Applicable to Guided and Dosimetric Units Only)
The integrating dosimeter will maintain a 5% level of accuracy if the device is calibrated at least annually
or whenever lamps are replaced or every one hundred (100) hours, whichever occurs sooner. The
calibration process involves taking an output reading with a hand-held meter (available for purchase or rent
from Daavlin) and checking it with the output reading from the integrating dosimetry system. Please
contact Daavlin for calibration assistance.
Dose Range:
UVA: 0.1 Joules - 999.9 Joules
UVB: 1 Millijoule - 9999 Millijoules
Accuracy:
+ / - 5%
Calibration:
1 year or every 100 hours of use or upon changing lamps
14.8 Lamp Removal and Replacement
Lamps may need to be replaced due to burnout or because their energy output has decreased to the point
that your treatments may have become excessively long.
DO NOT REPLACE LAMPS INDIVIDUALLY. ALL LAMPS SHOULD BE REPLACED AT THE
SAME TIME TO AVOID UNEVEN TREATMENTS OR BURNS. PLEASE CONTACT THE
DAAVLIN SERVICE DEPARTMENT PRIOR TO REPLACING THE LAMPS TO OBTAIN
IMPORTANT INFORMATION ON HOW THE OUTPUT OF THE UNIT WILL BE AFFECTED
BY THE CHANGE.
Because of differences between brands, always replace lamps with the same brand as originally installed.
Consult the Lamp Specification GuideError! Reference source not found. on page 5 for replacement
lamp guidance and contact the Daavlin service department for a lamp replacement quote. They can be
reached by dialing 1-800-322-8546 or via email at service@daavlin.com.
14.8.1 Lamp Replacement
1. First, unplug the unit and then remove both feet by unscrewing the four thumb screws on each side.
Once the feet have been removed lay the unit flat on a table with the lamps facing up.
2. Using a Phillips Head screwdriver, remove the four screws on each side of the unit. Once removed,
lift off the top of the device as you would remove the top from a gift box.

MNL-00004 [4] Proprietary and Confidential Page 20 of 24
3. On each lamp there are two clear plastic clasps that hold the lamps in position. To remove them,
position both thumbs on the top of the clasp and use your index fingers to pull the sides of the clasp
outward until it releases and can be removed.
4. On top of each lamp socket there will be a red button that, when pushed, will allow you to remove
the base of the lamp from its corresponding lamp socket. With one hand, firmly press and hold the
red button down while using your other hand to carefully lift the lamp up and out of the socket.
5. With one hand near the base of the lamp and the other at the opposite end, grasp the lamp and pull
both ends upward at the same time until it clears both clasps and the lamp holder/socket.
6. To replace the lamps in their lamp-holders, press them straight down. A distinctive snapping sound
will be heard which indicates that they are properly seated.
7. Once you have the new lamps in place, reassemble the 4 Series and reset the lamp hours to zero.
14.8.2 Resetting Lamp Hours
When changing lamps, it is important to reset the lamp age to zero so the operating hours of the new lamps
can be tracked. Pleasecontact the Daavlin service department for instructions onresetting the device’s lamp
hours.
15.0 Environmental Specifications
The 4 Series should be used in an electromagnetic environment as described below.
Table 3 Electromagnetic Emissions
Emissions Test
Conformity
EMC Environment Guide
RF Emission Following
CISPR 11 (EN 55011)
Group 1
Test unit only radiates RF energy for internal use in
powering lamps, and it seems unlikely that nearby medical
devices would be affected.
RF Emission Following
CISPR 11 (EN 55011)
Class B
The 4 Series device is suitable for healthcare environment
operation in hospitals and clinics
Limits for harmonic
current emissions
Following IEC 61000-3-
2
Class A
The 4 Series device is suitable for healthcare environment
operation in hospitals and clinics
Limitation of voltage
changes, voltage
fluctuations, and flicker
Following IEC 61000-3-
3
Compliant
The 4 Series device is suitable for healthcare environment
operation in hospitals and clinic
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