Daavlin ML24000 User manual

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ML24000 with Smart Touch™control system
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 Accuracy..........................................................................................8
8.0 Electrical Specifications.................................................................9
9.0 Labels and Symbols........................................................................9
10.0 Delivery and Inspection...............................................................12
11.0 Site Selection .................................................................................12
12.0 Training Requirements................................................................12
13.0 Important Safeguards and Warnings ........................................13
13.1 Electrical Shock Hazards............................................................................................ 13
13.2 Ultraviolet Light Exposure & Bodily Injury Hazards................................................ 13
13.3 Equipment & Property Damage Hazards ................................................................... 14
14.0 Smart Touch™control system Accessories...............................14
14.1 Printer (Domestic Units Only).................................................................................... 14
14.2 USB Mass Storage Device ......................................................................................... 15
14.3 Glasses and Goggles................................................................................................... 15
15.0 Theory of Operation.....................................................................15
15.1.1 Control System........................................................................................................ 15
15.1.2 System Logon ......................................................................................................... 15
15.1.3 User Profiles............................................................................................................ 15
15.1.4 Treating Patients ..................................................................................................... 16
15.1.5 Treatment Protocols................................................................................................ 16
15.1.6 History..................................................................................................................... 16
16.0 Initial Use ......................................................................................16
16.1 Software Startup ......................................................................................................... 16
17.0 Administrator Selection...............................................................17
17.1 Administrator Setup.................................................................................................... 17
18.0 New User Setup.............................................................................20
19.0 User Logon....................................................................................21
19.1 Initial Logon............................................................................................................... 21
19.2 Subsequent Logon ...................................................................................................... 22
20.0 New Patient Setup ........................................................................22
21.0 Selecting a Patient ........................................................................24

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21.1.1 Search Options........................................................................................................ 25
22.0 Treating a Patient.........................................................................25
22.1 End of Protocol Treatments........................................................................................ 28
22.1.1 History..................................................................................................................... 28
23.0 Changing the Treatment As-You-Go.........................................29
23.1 Changing the Proposed Dose...................................................................................... 29
23.2 Changing Position....................................................................................................... 29
24.0 Warning Rules and Authorities..................................................30
24.1 Rules for Warning Messages...................................................................................... 30
24.1.1 When Treating or Editing a Patient’s Protocol ....................................................... 30
25.0 Edit Patient Data..........................................................................31
25.1 Notes........................................................................................................................... 31
25.2 Delete.......................................................................................................................... 32
25.2.1 Personal Data.......................................................................................................... 32
25.2.2 Treatment Data........................................................................................................ 32
26.0 Protocols........................................................................................32
26.1 As Required Protocols................................................................................................ 32
26.2 End of Protocol –Maintenance Treatments ............................................................... 33
26.2.1 After a protocol has ended...................................................................................... 33
26.3 Edit Protocols ............................................................................................................. 33
26.3.1 Global Protocols...................................................................................................... 33
26.3.2 Patient Specific Protocols....................................................................................... 34
27.0 System Settings .............................................................................36
27.1 Control Panel.............................................................................................................. 36
27.1.1 Treatment Variables................................................................................................ 36
27.1.2 Lamp Information................................................................................................... 37
28.0 Edit User Data ..............................................................................37
29.0 Generating Reports......................................................................38
29.1 Generating an Individual Report ................................................................................ 38
29.2 Generating a Daily Summary Report ......................................................................... 39
29.3 Using the Report Wizard............................................................................................ 39
29.4 Generating a Device Data Report............................................................................... 39
29.5 Generating a Safety Limits History Report................................................................ 39
30.0 Backup/Restoration of Database ................................................39
30.1 Backup the Database to Removable USB Drive (Recommended Daily)................... 39
30.2 Restoring the Database from the Removable USB Drive .......................................... 40
31.0 Care of Your Phototherapy Unit................................................40
31.1 Maintenance................................................................................................................ 40
31.2 Cleaning...................................................................................................................... 41
31.2.1 Between Treatments................................................................................................ 41
31.2.2 Exterior & Dusting.................................................................................................. 41
31.2.3 Filter........................................................................................................................ 41
31.3 Lamp Replacement..................................................................................................... 41

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31.3.1 Relamping............................................................................................................... 41
32.0 Voltage Specification....................................................................42
33.0 Lamp Specification.......................................................................42
34.0 Eyewear Specification..................................................................42
35.0 Troubleshooting............................................................................43
36.0 Spare Parts and Accessories........................................................43
37.0 Warranty and Contact Information...........................................43
37.1 Limited Warranty Policy............................................................................................ 43
37.2 Warranty Coverage..................................................................................................... 44
37.3 Customer Responsibility............................................................................................. 44
37.4 Warranty Service........................................................................................................ 44
37.5 Disposal...................................................................................................................... 45
37.6 Other Services............................................................................................................. 45
37.7 Contact Information.................................................................................................... 45

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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 ML24000 PC UVA-1 Phototherapy Unit is a full body medical ultraviolet device, which is
intended for use, by or under the direction of a physician, for therapeutic treatment for
individuals who require ultraviolet of visible 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 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.
ML24000 with Smart Touch™control system manual is an integral part of the ML24000 device.
Anyone operating the device must read and understand this manual in its entirety before
operating the device, including all warnings, cautions, and instructions. Instructions vital to the
safety of persons operating the device, receiving treatment from the device and property,
including but not limited to the device, are contained in this manual. If these instructions are not
understood and followed, damage and serious injury, including death, may occur.
This manual conforms to all regulatory standards applicable to the device at the time of
manufacture of the device and the original printing of the manual. All rights are reserved for the
device design and all associated materials, including software and mechanical applications and
methods, trade names and logos used. The device and manual are subject to change without
notification. No part of this manual may be reproduced or used for any purpose other than
operating the device unless express written consent is obtained from Daavlin.
The ML24000 PC, full body phototherapy device, is a medical ultraviolet cabinet, which is
intended for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types
(I –VI).
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 treatments greater than 20 minutes in duration
the device should be either turned off or left idling for a minimum of 50% of the administered
treatment time, e.g., a treatment lasting 40 minutes in duration should be followed by a cool
down period of 20 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
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
Altitude:
≤ 2000m
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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The ML24000 should be used in an electromagnetic environment as listed below.
Table 1 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 ML24000 device is suitable for healthcare
environment operation in hospitals and clinics
Mains Harmonics Following
IEC 61000-3-2
Class A
The ML24000 device is suitable for healthcare
environment operation in hospitals and clinics
Mains Voltage Dips and
Flicker Following IEC
61000-3-3
Compliant
The ML24000 device is suitable for healthcare
environment operation in hospitals and clinic
Table 2 Electromagnetic Immunity
Emissions Test
IEC 60601 Test Level
Actual Level
ESD Following IEC 61000-
4-2
+/-2kv, 4kv, 6kv, and 8kv
(conductive surfaces)
+/-2kv, 4kv, 8kv, and 15kv
(non-conductive surfaces)
+/-2kv, 4kv, 6kv, and 8kv (conductive
surfaces)
+/-2kv, 4kv, 8kv, and 15kv (non-
conductive surfaces)
Bursts following IEC
61000-4-4
+/- 2kv
+/- 2kv
Surges following IEC
61000-4-5
+/- 2kv
+/- 2kv
Voltage drops, etc.
following IEC 61000-4-11
5% for 10ms, 40% for 100ms,
30% for 500ms, 0% for
5000ms
5% for 10ms, 40% for 100ms, 30% for
500ms, 0% for 5000ms
H-Field following IEC
61000-4-8
3 A/m
3A/m
7.0 Accuracy
The measuring device will maintain a 5% level of accuracy if the device is calibrated every one hundred
(100) hours as recommended. The Smart Touch™control system will display a reminder message when
calibration is due. Please contact Daavlin for Calibration Instructions.

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8.0 Electrical Specifications
The device is manufactured in the following electrical configurations. Always refer to the identification
label of the device to determine which electrical configuration the device is manufactured to.
•Mains Input = 230VAC, 3Φ, 60Hz, 100A; Operating = 230VAC, 3Φ, Line-to-Line
•Mains Input = 400VAC, 3Φ with Neutral (Wye), 50Hz, 100A; Operating = 230VAC
single phase, Line-to-Neutral
9.0 Labels and Symbols
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.
In addition to the warning label mentioned above, an identification label indicates the serial number and
date of manufacture that is specific to your device.
ML2400 PC models feature one Ethernet port located on the back of the Device. This Ethernet port is
only to be used as a data only connection to the Smart Touch™control system PC. This Ethernet port is
identified by the following label.
Figure 1 Warning Label
Figure 2 Identification Label
Figure 3 Data Only Ethernet Port Label

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Risk Group 2 Label (CE Devices Only)
The following is an example of the information required for the risk label placed on all CE
devices. The Xs in this example will be filled in with the correct lamp type, UV spectrum,
primary emission range, and the min and max output.
CE Packaging Label (CE Devices Only)
Figure 5 CE Packaging Label
The following is a chart detailing all symbols located on the cabinet and their definitions:
Symbol
Definition
DANGEROUS VOLTAGE
NON-IONIZING RADIATION
EARTH (ground)
PROTECTIVE EARTH (ground)
Figure 4 Risk Group 2 Label