Daavlin UV Series User manual

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Flex™Controlled 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................................................................6
5.0 Transport and Storage Specifications..........................................7
6.0 EMC Precautions ...........................................................................7
7.0 Accuracy..........................................................................................7
8.0 Labels and Symbols........................................................................8
8.1 UV Risk Group 2 Labels (CE Devices Only)............................................................. 10
9.0 Delivery and Inspection...............................................................11
10.0 Lamp Inspection...........................................................................13
11.0 Site Selection .................................................................................13
12.0 Training Requirements................................................................13
13.0 Important Safeguards and Warnings ........................................14
14.0 Unlocking the Device....................................................................16
15.0 Changing or Disabling the Key Code.........................................16
16.0 Operating the Control Systems...................................................16
17.0 Flex Dosimeter Instructions: UV Series, 7 Series, M Series, and
4 Series....................................................................................................16
17.1 The Backup Time ....................................................................................................... 17
17.2 Measuring the Power Output of Your Device............................................................ 17
17.3 Setting up a Treatment................................................................................................ 19
17.4 Special Functions of the Integrated Dosimeter........................................................... 20
17.5 Special Notes.............................................................................................................. 20
17.6 Flex Dosimeter Range and Accuracy......................................................................... 20
18.0 Flex Dosimeter Instructions: 1 Series.........................................20
18.1 The Backup Time ....................................................................................................... 21
18.2 Measuring the Power Output of Your 1 Series........................................................... 21
18.3 Setting Up a Treatment............................................................................................... 23
18.4 Repeat Treatments...................................................................................................... 23
18.5 Special Functions of the Integrated Dosimeter........................................................... 24
18.6 Special Notes.............................................................................................................. 24
18.7 Flex Dosimeter Range and Accuracy......................................................................... 24
19.0 Flex Timer Instructions: UV Series, 7 Series, M Series, and 4
Series.......................................................................................................25
19.1 Determining a Treatment Time .................................................................................. 25
19.2 Setting Up a Treatment Time ..................................................................................... 26
19.3 Special Functions of the Digital Timer....................................................................... 26

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19.4 Special Notes.............................................................................................................. 26
19.5 Flex Timer Range and Accuracy................................................................................ 27
20.0 Flex Timer Instructions: 1 Series ...............................................27
20.1 Determining a Treatment Time .................................................................................. 27
20.2 Setting Up a Treatment Time ..................................................................................... 28
20.3 Special Functions of the Digital Timer....................................................................... 28
20.4 Special Notes.............................................................................................................. 28
20.5 Flex Timer Range and Accuracy................................................................................ 29
21.0 UV Series X and UV Series T Information................................29
21.1 Domestic and Non-CE Electrical Requirements........................................................ 29
21.2 European CE Electrical Requirements....................................................................... 30
21.3 Circuit Breaker ........................................................................................................... 30
21.4 Unpacking and Assembly........................................................................................... 30
21.5 How to Position the Patient........................................................................................ 31
21.6 UV Series Lamp Removal and Replacement............................................................. 31
22.0 7 Series X and 7 Series T Information .......................................32
22.1 Electrical Requirements.............................................................................................. 32
22.2 Unpacking and Assembly........................................................................................... 33
22.3 How to Position the Patient........................................................................................ 34
22.4 7 Series Lamp Removal and Replacement................................................................. 35
23.0 M Series X and M Series T Information....................................35
23.1 Electrical Requirements.............................................................................................. 35
23.2 Unpacking and Assembly........................................................................................... 36
23.3 Special Notes.............................................................................................................. 36
23.4 How to Position the Patient........................................................................................ 37
23.5 M Series Lamp Removal and Replacement ............................................................... 37
24.0 4 Series Information.....................................................................38
24.1 Electrical Requirements.............................................................................................. 38
24.2 Unpacking and Assembly........................................................................................... 39
24.3 How to Position the Patient........................................................................................ 39
24.4 4 Series Lamp Removal and Replacement................................................................. 39
25.0 1 Series X and 1 Series T Information .......................................40
25.1 Electrical Requirements.............................................................................................. 40
25.2 Unpacking and Assembly........................................................................................... 41
25.3 How to Position the Patient........................................................................................ 41
25.3.1 Hand and Foot Treatments:..................................................................................... 41
25.3.2 Larger Area Treatment:........................................................................................... 41
25.4 1 Series Lamp Removal and Replacement................................................................. 42
25.5 Special Notes for 1 Series Units Equipped with Integrated Dosimetry ..................... 42
25.5.1 Treatment Distance................................................................................................. 42
25.5.2 Calibration Output Certificate................................................................................. 43
25.6 Special Notes for 1 Series Units Equipped with the Digital Timer............................ 43
25.6.1 Treatment Distances and Your Calibration Output Certificate............................... 43
26.0 Treatment Protocols.....................................................................45

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26.1 UVA Clearing Phase Protocols (Skin Types I - III)................................................... 45
26.2 UVA Clearing Phase Protocols (Skin Types IV - VI)................................................ 47
26.3 UVA Maintenance Phase Protocols: .......................................................................... 49
26.4 UVA Treatment Limits for Maintenance & As Required Protocols.......................... 50
26.5 LO Dose Broad Band UVB Clearing Phase Protocols:.............................................. 50
26.6 LO Dose Broad Band UVB Maintenance Phase Protocols:....................................... 50
26.7 LO Dose Broad Band UVB Treatment Limits for Maintenance & As Required
Protocols 51
26.8 HI Dose Broad Band UVB Clearing Phase Protocols: 11011, 3/week, 2/week....... 51
26.9 HI Dose Broad Band UVB Maintenance Phase Protocols: 1/WEEK ..................... 51
26.10 LO Dose Narrow Band UVB Clearing Phase Protocols: 11011, 3/week, 2/week.... 52
26.11 LO Dose Narrow Band UVB Maintenance Phase Protocols: 1/WEEK.................... 52
26.12 LO Dose Narrow Band UVB Treatment Limits for Maintenance & As Required
Protocols 52
26.13 HI Dose Narrow Band UVB Clearing Phase Protocols: ............................................ 53
26.14 HI Dose Narrow Band UVB Maintenance Phase Protocols: ..................................... 54
26.15 HI Dose Narrow Band UVB Treatment Limits for Maintenance & As Required
Protocols 54
27.0 Care of Your Phototherapy Unit................................................55
27.1 Recommended Maintenance Schedule....................................................................... 55
27.2 Cleaning/Disinfection................................................................................................. 55
27.2.1 General Cleaning .................................................................................................... 55
27.2.2 Low-Level Disinfection.......................................................................................... 55
27.2.3 High-Level Disinfection ......................................................................................... 56
27.3 Resetting Your Lamp Hours....................................................................................... 56
28.0 EMC Guidance .............................................................................56
29.0 Flex Controller Trouble Shooting Guide...................................58
29.1 Power-On-Self-Test.................................................................................................... 58
29.2 Error Code E8yz: yz = address of first location with range error.............................. 59
29.3 Sensing Errors............................................................................................................. 59
30.0 Warranty and Contact Information...........................................61
30.1 Limited Warranty Policy............................................................................................ 61
30.2 Warranty Coverage..................................................................................................... 61
30.3 Customer Responsibility............................................................................................. 62
30.4 Warranty Service........................................................................................................ 62
30.5 Disposal...................................................................................................................... 62
30.6 Other Services............................................................................................................. 62
30.7 Contact Information.................................................................................................... 63

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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 UV Series, 7 Series, and M Series, are medical ultraviolet devices, which are intended for
the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I –VI).
The 1 Series Unit is a therapeutic product designed for individuals who require ultraviolet
radiation for diagnosed skin disorders. The 1 Series, equipped with PL-L36w/03 blue lamps, is
indicated for the treatment of mild to moderate acne vulgaris.
The 4 Series Unit is a therapeutic product designed for individuals who require ultraviolet
radiation for diagnosed skin disorders.
WARNING: Do not use these devices for anything other than their intended purposes.
CAUTION: Federal law restricts this device to be sold by or on the order of a physician or any
other practitioner licensed by the law of the state in which he/she practices.
3.0 Classifications
FDA:
Class II Device
93/42/EEC:
Class IIa Device
IEC 60601-1:
Class I Device
Pollution Degree:
Class II
Mode of Operation:
Non-continuous
IEC/EN
62471:2006 UV
Risk Group:
Risk Group 2 (Moderate-Risk)
WARNING: This device is designed for intermittent operation only and not for continuous use.
The device should not be cycled continuously for more than 10 minutes. After such time, the unit
should either be turned off or left idling for at least 10 minutes.
4.0 Operating Specifications
Ambient
Temperature:
15°C to 30°C (59°F to 86°F)
Relative Humidity:
10% to 95%, Non-condensing
Liquid Ingress
Rating:
IPX0 (This device does not have protection
against ingress of water.)
Ocular Hazard
Distance:
3 Meters (9.84 Feet)
Ambient
Luminance:
250 –500 lux

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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
7.0 Accuracy
The measuring device will maintain a 5% level of accuracy if the device is calibrated every one
hundred (100) hours of use as recommended. Please contact Daavlin for calibration.

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8.0 Labels and Symbols
Every UV series comes affixed with an orange “safety key code” label located near the
Integrated Dosimetry Control System. This label will provide you with important information
about the factory default key code needed to unlock the unit.
If your unit has been equipped with our FlexRx™exposure limiting software there will be a pink
label, in addition to the orange “safety key code” label, informing you that your unit has been
equipped with this feature.
Figure 1 Safety Key Code
A warning and danger labels are affixed to your Daavlin phototherapy device, see Figure 2
Warning and Danger Labels in a prominent and easily readable position. Please read the label
carefully as they contain important safety information for you. In addition to the warning and
danger labels, an identification label indicates the serial number and date of manufacture that is
specific to your device. A chart detailing all symbols located on your unit can be found on in
Table 1 Symbols on page 8.

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Figure 2 Warning and Danger Labels
The following is a chart detailing all symbols located on your device and their meanings:
Table 1 Symbols
Symbol
Description
DANGEROUS VOLTAGE
NON-IONIZING RADIATION
EARTH (ground)
PROTECTIVE EARTH (ground)
OPERATING INSTRUCTIONS
KEEP DRY
CAUTION, CONSULT ACCOMPANYING DOCUMENTS
NBUVB LAMP/TIMER LABEL
UVA LAMP/TIMER LABEL

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Symbol
Description
PACKAGING LABEL (CE ONLY)
MAIN CIRCUIT BREAKER SWITCH (UV SERIES)
EU REP LABEL (CE ONLY DEVICE)
CE ONLY LABEL
8.1 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. CE devices have this label in English and French. See Figure 3 English and
French UV Risk Group Labels
Figure 3 English and French UV Risk Group Labels