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