Daavlin UV Series User manual

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ClearLink™Controlled Phototherapy Equipment
Clinical Operation Manual

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Table of Contents
1.0 Introduction ....................................................................................5
2.0 Indications for Use .........................................................................6
3.0 Classifications .................................................................................6
4.0 Operating Specifications................................................................7
5.0 Transport and Storage Specifications ..........................................7
6.0 EMC Precautions ...........................................................................7
7.0 Labels and Symbols........................................................................8
7.1 Domestic and International Units..................................................................................... 8
7.2 UV Risk Group 2 Labels (CE Devices Only) ................................................................ 10
8.0 Delivery and Inspection ...............................................................10
9.0 Lamp Inspection ...........................................................................11
10.0 Site Selection .................................................................................12
11.0 Training Requirements................................................................12
12.0 Important Safeguards and Warnings ........................................12
13.0 Unlocking the Device....................................................................15
14.0 Changing or Disabling the Key Code.........................................15
15.0 Checking the Power Output of Device .......................................15
16.0 Operating the ClearLink Controlled Phototherapy Equipment
Control Systems .....................................................................................16
16.1 Dosimeter Instructions: 3 Series NeoLux, UV Series, 7 Series, M Series, and 4 Series
16
16.1.1 Setting up a Treatment ............................................................................................ 16
16.1.2 Special Functions of the Integrated Dosimeter....................................................... 16
16.1.3 Special Notes .......................................................................................................... 16
16.1.4 ClearLink Controller Range and Accuracy............................................................. 17
16.2 Dosimeter Instructions: 1 Series................................................................................. 17
16.2.1 Setting Up a Treatment ........................................................................................... 17
16.2.2 Special Functions of the Integrated Dosimeter....................................................... 17
16.2.3 Special Notes .......................................................................................................... 18
16.2.4 Dosimeter Range and Accuracy.............................................................................. 18
16.3 Time Only Instructions: 3 Series NeoLux, UV Series, 7 Series, M Series, and 4 Series
18
16.3.1 Determining a Treatment Time............................................................................... 18
16.3.2 Setting Up a Treatment Time.................................................................................. 19
16.3.3 Special Functions of the Integrated Dosimeter....................................................... 19
16.3.4 Special Notes .......................................................................................................... 19
16.3.5 Timer Range and Accuracy .................................................................................... 20
16.4 Time Only Instructions: 1 Series ............................................................................... 20
16.4.1 Determining a Treatment Time............................................................................... 20
16.4.2 Setting Up a Treatment Time.................................................................................. 21

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16.4.3 Special Functions of the Integrated Dosimeter....................................................... 21
16.4.4 Special Notes .......................................................................................................... 21
16.4.5 Timer Range and Accuracy .................................................................................... 21
17.0 3 Series NeoLux Information ......................................................21
17.1 Available Models:....................................................................................................... 21
17.2 How to Position the Patient ........................................................................................ 22
17.3 Patient Control Buttons .............................................................................................. 22
17.4 3 Series NeoLux Lamp Removal and Replacement................................................... 22
18.0 UV Series CX and UV Series CT Information..........................23
18.1 Domestic and Non-CE Electrical Requirements ........................................................ 23
18.2 European CE Electrical Requirements ....................................................................... 24
18.3 Circuit Breaker ........................................................................................................... 24
18.4 Unpacking and Assembly........................................................................................... 24
18.5 How to Position the Patient ........................................................................................ 25
18.6 UV Series Lamp Removal and Replacement ............................................................. 25
19.0 7 Series CX and 7 Series CT Information .................................26
19.1 Electrical Requirements.............................................................................................. 26
19.2 Unpacking and Assembly........................................................................................... 27
19.3 How to Position the Patient ........................................................................................ 28
19.4 7 Series Lamp Removal and Replacement ................................................................. 29
20.0 M Series CX and M Series CT Information..............................29
20.1 Electrical Requirements.............................................................................................. 29
20.2 Unpacking and Assembly........................................................................................... 30
20.3 Special Notes .............................................................................................................. 31
20.4 How to Position the Patient ........................................................................................ 31
20.5 M Series Lamp Removal and Replacement ............................................................... 31
21.0 4 Series Information.....................................................................32
21.1 Electrical Requirements.............................................................................................. 32
21.2 Unpacking and Assembly........................................................................................... 32
21.3 How to Position the Patient ........................................................................................ 33
21.4 4 Series Lamp Removal and Replacement ................................................................. 34
22.0 1 Series CX and 1 Series CT Information .................................34
22.1 Electrical Requirements.............................................................................................. 34
22.2 Unpacking and Assembly........................................................................................... 35
22.3 How to Position the Patient ........................................................................................ 35
22.3.1 Hand and Foot Treatments:..................................................................................... 35
22.3.2 Larger Area Treatment:........................................................................................... 36
22.4 1 Series Lamp Removal and Replacement ................................................................. 36
22.5 Special Notes for 1 Series Units Equipped with Integrated Dosimetry ..................... 36
22.5.1 Treatment Distance ................................................................................................. 36
22.5.2 Calibration Output Certificate................................................................................. 37
22.6 Special Notes for 1 Series Units Equipped with the Digital Timer............................ 37
22.6.1 Treatment Distances and Your Calibration Output Certificate............................... 37
23.0 Treatment Protocols.....................................................................39

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23.1 UVA Clearing Phase Protocols (Skin Types I - III)................................................... 39
23.2 UVA Clearing Phase Protocols (Skin Types IV - VI)................................................ 41
23.3 UVA Maintenance Phase Protocols: .......................................................................... 43
23.4 UVA Treatment Limits for Maintenance & As Required Protocols .......................... 44
23.5 LO Dose Broad Band UVB Clearing Phase Protocols:.............................................. 44
23.6 LO Dose Broad Band UVB Maintenance Phase Protocols:....................................... 44
23.7 LO Dose Broad Band UVB Treatment Limits for Maintenance & As Required
Protocols ................................................................................................................................... 45
23.8 HI Dose Broad Band UVB Clearing Phase Protocols: 11011, 3/week, 2/week....... 45
23.9 HI Dose Broad Band UVB Maintenance Phase Protocols: 1/week ........................ 45
23.10 LO Dose Narrow Band UVB Clearing Phase Protocols: 11011, 3/week, 2/week .... 46
23.11 LO Dose Narrow Band UVB Maintenance Phase Protocols: 1/WEEK.................... 46
23.12 LO Dose Narrow Band UVB Treatment Limits for Maintenance & As Required
Protocols ................................................................................................................................... 46
23.13 HI Dose Narrow Band UVB Clearing Phase Protocols: ............................................ 46
23.14 HI Dose Narrow Band UVB Maintenance Phase Protocols: ..................................... 47
23.15 HI Dose Narrow Band UVB Treatment Limits for Maintenance & As Required
Protocols ................................................................................................................................... 48
24.0 Care of Your Phototherapy Unit ................................................49
24.1 Recommended Maintenance Schedule....................................................................... 49
24.2 Cleaning/Disinfection................................................................................................. 49
24.2.1 General Cleaning .................................................................................................... 49
24.2.2 Low-Level Disinfection .......................................................................................... 49
24.2.3 High-Level Disinfection ......................................................................................... 50
24.3 Resetting Your Lamp Hours....................................................................................... 50
25.0 EMC Guidelines ...........................................................................50
26.0 Warranty and Contact Information...........................................53
26.1 Limited Warranty Policy ............................................................................................ 53
26.2 Warranty Coverage..................................................................................................... 54
26.3 Customer Responsibility............................................................................................. 54
26.4 Warranty Service ........................................................................................................ 54
26.5 Disposal ...................................................................................................................... 55
26.6 Other Services............................................................................................................. 55
26.7 Contact Information.................................................................................................... 55

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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,
Daavlin Distributing Company
205 West Bement Street
P.O. Box 626
Bryan, OH 43506-0626
Phone: [phone]
Fax: [phone]
Email: [email protected]
Website: www.Daavlin.com

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2.0 Indications for Use
The ClearLink Controlled Phototherapy Equipment are medical ultraviolet devices, which are
intended for use, by or under the direction of a physician, for therapeutic treatment for
individuals who require ultraviolet radiation for diagnosed skin disorders. When equipped with
blue lamps the ClearLink Controlled Phototherapy Equipment is intended for use for the
treatment of acne vulgaris.
Note: Only Daavlin’s 1 Series or 4 Series devices, when equipped with blue lamps and
controlled with the ClearLink Controlled Phototherapy Equipment, have intended use for the
treatment of acne vulgaris.
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.
The 7 Series Phototherapy Device is not a Class III or implantable device. The Summary of Safety
and Clinical Performance is not required.
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 more than 10 minutes. After such time, the unit
should either be turned off or left idling for at least 10 minutes.

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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)
Ambient Luminance:
250 –500 lux
Atmospheric Pressure
70 kPa to 106 kPa
WARNING: Equipment not suitable for use in the presence of a flammable anesthetic mixture
with air or with oxygen or nitrous oxide.
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
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

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7.0 Labels and Symbols
7.1 Domestic and International Units
Each device comes affixed with an orange “unlock code” label on top of the ClearLink Control
System. This label will provide you with important information about the factory default key
code needed to unlock the unit.
Figure 1 Unlock Code
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.
Figure 2 Warning Labels
In addition to the warning labels mentioned above, an identification label, see Figure 3
Identification Label, indicates the serial number and date of manufacture that is specific to your
device.
Figure 3 Identification Label

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Figure 4 Medical Device Label
The following is a chart detailing all symbols located on the cabinet and their definitions:
Table 1 Symbols
Symbol
Description
DANGEROUS VOLTAGE
!
ATTENTION, CONSULT ACCOMPANYING
DOCUMENTS
NON-IONIZING RADIATION
TYPE B EQUIPMENT (3 Series NeoLux & M Series) *
FAN (3 Series NeoLux Only)
LIGHTS (3 Series NeoLux Only)
PROTECTIVE EARTH (ground)
INSTRUCTION MANUAL
KEEP DRY
MEDICAL DEVICE
*The only applied part in the M Series is the acrylic lamp cover, a Type B part

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7.2 UV Risk Group 2 Labels (CE Devices Only)
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 also includes the primary
emission range and potential output range, is affixed to your device in a prominent and easily
readable position.
Figure 5 Risk Group 2 Warning Labels
8.0 Delivery and Inspection
When you first receive the device, please inspect the shipping crate or box.
Any signs of shipping damage must be noted on the delivery receipt that you will be asked to
sign by the delivery driver. Be sure to open the crate and verify that there is no damage to your
unit before the driver leaves. If it is not possible for you to inspect your unit before the driver
leaves, we recommend you write “Concealed damage possible. Further inspection required”
on the delivery receipt. If damage is discovered after unpacking the unit, save all packing
materials and call Daavlin at 1 800 322 8546 for inspection and repair.
Note: The delivering carrier must be notified of any shipping damage within twenty-four (24)
hours to protect your right to an insurance claim.
Note: As part of the claims process the delivering carrier may require that a damage inspection
be conducted. The delivering carrier may request to conduct the inspection at the delivery site,
provided that a mutually agreed upon date and time can be established, or they may elect to
collect the package for inspection at their facilities.