User Manual & Technical Description
MED-Tester MINI
USER MANUAL & TECHNICAL DESCRIPTION
User Manual MED-Tester MINI Rev1.doc MEDlight GmbH
Werrestr. 94
32049 Herford
Germany
Tel.: +49 5221 99429-0
Fax: +49 5221 99429-40
www.medlight.eu Page 2 of 13
Table of Contents
1 GENERAL INFORMATION ............................................................................................................................3
1.1 Delivery Contents .................................................................................................................................3
1.2 Manual Use ..........................................................................................................................................3
1.3 Device Description ................................................................................................................................3
1.4 Intended Use ........................................................................................................................................4
1.5 Symbols & Definitions ..........................................................................................................................4
2 WARNINGS & SAFETY REGULATIONS .........................................................................................................4
2.1 Definitions ............................................................................................................................................4
2.2 Electrical Shock Hazards .......................................................................................................................5
2.3 Light Exposure Hazards ........................................................................................................................5
2.4 Other Hazards.......................................................................................................................................6
3 HANDLING & OPERATION...........................................................................................................................6
3.1 Handling ...............................................................................................................................................6
3.2 Operation .............................................................................................................................................6
3.2.1 Switiching On & Warm-Up Time ..................................................................................................6
3.2.2 Switching Off & End of Exposure Time ........................................................................................6
3.2.3 Exposure Distance .......................................................................................................................6
3.3 Test Procedure .....................................................................................................................................7
3.3.1 MED Testing ................................................................................................................................7
3.3.2 MPD Testing .................................................................................................................................7
3.3.3 Use of the Graduated Template ..................................................................................................8
3.4 Cleaning & Disinfection ........................................................................................................................9
3.5 Conditions for Transport, Storage & Operation ...................................................................................9
4 TECHNICAL SPECIFICATIONS & INFORMATION ....................................................................................... 10
4.1 Technical Data ................................................................................................................................... 10
4.2 Electromagnetic Compatibility (EMC) ............................................................................................... 10
4.3 Spectral Range ................................................................................................................................... 11
4.4 Accuracy ............................................................................................................................................ 11
4.5 Maintenance & Repair ...................................................................................................................... 11
4.5.1 Lamp Ageing & Replacement ................................................................................................... 12
5 OTHER INFORMATION ............................................................................................................................. 12
5.1 Warranty ........................................................................................................................................... 12
5.2 Expected Service Life ......................................................................................................................... 12
5.3 Disposal Note .................................................................................................................................... 12
5.4 Equipment Classification ................................................................................................................... 13
5.5 Contact Details .................................................................................................................................. 13
USER MANUAL & TECHNICAL DESCRIPTION
User Manual MED-Tester MINI Rev1.doc MEDlight GmbH
Werrestr. 94
32049 Herford
Germany
Tel.: +49 5221 99429-0
Fax: +49 5221 99429-40
www.medlight.eu Page 3 of 13
1 GENERAL INFORMATION
1.1 Delivery Contents
Item No. Description Quantity
3018 MED-Tester MINI, UVB 311nm
1
The particular device type can
be identified by its name
plate.
3019 MED-Tester MINI, UVB Broadband
3017 MED-Tester MINI, UVA
80100 Patient goggles 2
30007 Storage case 1
User manual 1
Optionally available accessories
80100 Patient goggles
80200 Personnel safety goggles
82206 UVB 311 nm Lamp, 9W
40510 UVB Broaband Lamp, 9W
82202 UVA Lamp, 9W
80501 MED-Tester MINI attachment
1.2 Manual Use
This user manual & technical description is an integral part of this device. Anyone operating this 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, can be caused.
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 expressed written
consent is obtained from MEDlight GmbH.
1.3 Device Description
The MED-Tester MINI is used to determine the individual light sensitivity. The versions with UVB lamps
are used to determine the MED (minimal erythema dose). The device version with UVA lamp is used for
the determination of the MPD (minimal phototoxic dose). The MEDlight MED-Tester MINI is a small,
handy device with which such testing can be carried out quick and easy.
USER MANUAL & TECHNICAL DESCRIPTION
User Manual MED-Tester MINI Rev1.doc MEDlight GmbH
Werrestr. 94
32049 Herford
Germany
Tel.: +49 5221 99429-0
Fax: +49 5221 99429-40
www.medlight.eu Page 4 of 13
1.4 Intended Use
The device may only be used for such application areas, as described in the manual. The device finds
application in dermatology, and may only be operated by such persons who can ensure a proper
handling, due to their profession or their knowledge and practical experience. The device may only be
operated under permanent supervision of the user.
1.5 Symbols & Definitions
ATTENTION Sections marked with this symbol must be read with special
attention
TYPE B EQUIPMENT
PROTECTIVE EYEWEAR MUST BE WORN
UV-TYPE 4
2 WARNINGS & SAFETY REGULATIONS
2.1 Definitions
Warning: A warning indicates a hazard. If not avoided, the hazard can result in death or serious injury.
Caution: A caution indicates a potentially hazardous situation. If not avoided, this hazard may result in
minor personal injury and/or product/property damage.
USER MANUAL & TECHNICAL DESCRIPTION
User Manual MED-Tester MINI Rev1.doc MEDlight GmbH
Werrestr. 94
32049 Herford
Germany
Tel.: +49 5221 99429-0
Fax: +49 5221 99429-40
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Transmission of (a) personnel safety glasses and (b) patient goggles
2.2 Electrical Shock Hazards
Warning: To avoid the risk of an electric shock, the device must only be connected to a
power supply with a protective earth. The AC outlet must be in accordance with all national
and local installation regulations. The device may only be operated with the power supply
voltage specified on the nameplate.
Warning: Prior to each use, always verify that the device is in correct working order and
operating condition. Therefore check also plugs, wires, switches and other control devices, as
well as the irradiation unit and all mechanical components. Upon discovery of faulty, worn,
or damaged component(s), MEDlight authorized service personnel must replace the
component(s) and test the device prior to placing the device in use again.
Warning: If you notice unusual noises, smoke, sparks or burning smell from the device,
immediately disconnect the power plug and do not put it back in operation. Contact
MEDlight for a repair, and do not use the device again until it is repaired, tested and released
by MEDlight authorized service personnel.
Warning: Open under no circumstances the device housing. Turn off the device when it is not
used. For a complete disconnection from the mains, disconnect the power plug from the AC
socket. To unplug, always grasp the plug, not the power cord. Orient the power cord to
protect it from being pulled or otherwise damaged.
Warning: Always place the device so that the mains plug is easily accessible at any time for
disconnection from the mains supply.
Warning: Ensure that the device is serviced at least annually, by MEDlight authorized service
personnel.
2.3 Light Exposure Hazards
Warning: The UV light of the device
can lead to retinal damage. To protect
the eyes during operation, the
operator, the patient and anyone in
view of the device must wear the
protective glasses or goggles, that are
included in the delivery contents. If
required, further goggles can be
obtained from MEDlight. Furthermore
it should be avoided to look directly into the light, during operation. Operating personnel
exposed to UV radiation for any prolonged periods of time should wear gloves or use barrier
creams with a high light protection factor on exposed skin areas.
Warning: Before any application, make sure that the device is equipped with a lamp that
emits light in the required spectral range.
USER MANUAL & TECHNICAL DESCRIPTION
User Manual MED-Tester MINI Rev1.doc MEDlight GmbH
Werrestr. 94
32049 Herford
Germany
Tel.: +49 5221 99429-0
Fax: +49 5221 99429-40
www.medlight.eu Page 6 of 13
2.4 Other Hazards
Warning: Modifications of the device are not allowed. Operate the unit therefore only with
original equipment, supplied by MEDlight.
Warning: Do not store or operate the device in humid areas. The device must never be
directly exposed to flowing or splashing liquid or water. Also be careful when cleaning with a
damp cloth to ensure that no liquid enters the device.
Warning: In explosive areas, or areas where flammable substances such as alcohol, fuel or
similar substances are used, the device must not be operated.
Caution: The device is designed for a short-term operation of a maximum of 15 minutes
(KB15). If the maximum operating time of the device is reached, it must be switched off and
may only be operated after it has completely cooled down.
Caution: Lay the power cord so that there is no danger of tripping up a person.
3 HANDLING & OPERATION
3.1 Handling
Hold the device during application always on the hand piece. Do not operate the device without the
template attachment.
3.2 Operation
3.2.1 Switiching On & Warm-Up Time
After switching the device on, a warm-up time of 2 minutes prior to testing is required, so that the full
intensity of the light source is reached.
3.2.2 Switching Off & End of Exposure Time
At the end of the exposure time you have to switch the device off - the device does not switch off
automatically!
The exposure time can be interrupted any time by pressing the rocker switch. After the device has been
switched off, wait 3 - 5 minutes before the next application!
3.2.3 Exposure Distance
For the test the template attachment of device must be placed evenly on the skin, but without applying
pressure. An uneven placement of the template might lead to wrong results.
USER MANUAL & TECHNICAL DESCRIPTION
User Manual MED-Tester MINI Rev1.doc MEDlight GmbH
Werrestr. 94
32049 Herford
Germany
Tel.: +49 5221 99429-0
Fax: +49 5221 99429-40
www.medlight.eu Page 7 of 13
3.3 Test Procedure
3.3.1 MED Testing
MED testing must be carried out with the same lamp type that will be used for the treatment.
For the test, a gradated template is applied to skin, that is normally not exposed to sunlight
(e.g. buttocks). Suitable test doses are being suggested in the below table. The MED is defined,
as the lowest irradiation dose that provokes a just perceptible erythema. The MED will be
determined 24 hours after exposure.
Recommended UVB dose gradations (mJ/cm²)
UVB Broadband 20 40 60 80 100 120
UVB 311nm Narrowband 200 400 600 800 1000 1200
Source: Prof. Dr. E. Hölze, et Al. ‚Empfehlungen zur UV-Phototherapie und Photochemotherapie‘ DDG Berlin 2009
3.3.2 MPD Testing
The minimal phototoxic dose is determined, analogous to UVB phototherapy, with the same spectral
emission as that of the therapy device. It is also important for this test that the same dose respectively
concentration and administration form of the photosensitizer is being used, as intended for the
treatment. For systemic application and bath-PUVA therapy, usual test doses are summarized
depending on the skin type in the table below. Differences in other dosages or 8-MOP concentrations in
the bath water, must be considered. During the test irradiation, the rest of the body must be completely
covered. The test areas must be assessed, 72-96 hours (for oral administration) and 96-120 hours (for
bath-PUVA) after irradiation. The most light-sensitive i.e. the least sun-exposed areas of the body, such
as the buttocks, are recommended as test area. The determination of the MPD for oral-PUVA is not
completely reliable, due to the not always constant absorption of the photosensitizer. However, the
values are reproducible for bath-PUVA, and helpful for the controlling of the treatment. In cream-PUVA
the application quantity and absorption may fluctuate and lead to varying results. For the
photochemotherapy of palmoplantar dermatoses, the determination of MPD is not sensible.
Dose recommendations for the determination of the minimal phototoxic dose (MPD)
Method Skin Type UVA Dose (J/cm²)
Oral-PUVA, 8-MOP I-IV 0,50 1,00 2,00 3,00 4,00 5,00
Oral-PUVA, 5-MOP I-IV 1,00 2,00 4,00 6,00 8,00 10,00
Bath-PUVA (1 mg/l 8-MOP) I, II
III, IV
0,25
0,50
0,50
1,00
1,00
2,00
1,50
3,00
2,00
4,00
2,50
5,00
For cream-PUVA treatment apply individual test regimens, which closely follow bath-PUVA therapy, and
dosage depends on the concentration of the used cream.
The scheme in the below table serves to assess the MPD. The field that reveals a barely visible erythema
with edges sharply demarcated, represents the endpoint of erythema determination. The UVA dose that
corresponds to this test field is referred to as MPD.
USER MANUAL & TECHNICAL DESCRIPTION
User Manual MED-Tester MINI Rev1.doc MEDlight GmbH
Werrestr. 94
32049 Herford
Germany
Tel.: +49 5221 99429-0
Fax: +49 5221 99429-40
www.medlight.eu Page 8 of 13
Test fields of the template
Skin Response
no erythema
MPD > barely visible erythema with edges sharply demarcated
pink erythema
distinct erythema, no edema, no pain
fiery red erythema, mild edema, mild pain
livid erythema, distinct edema, intense pain, occasionally blistering
The maximum PUVA erythema appears no earlier than 48 hours, but usually 72 hours after irradiation.
Therefore, no therapy should start earlier than 72 hours after phototesting.
Source: Prof. Dr. E. Hölze, et Al. ‚Empfehlungen zur UV-Phototherapie und Photochemotherapie‘ DDG Berlin 2009
3.3.3 Use of the Graduated Template
The template of the MED-Tester MINI consists of an acrylic glass insert with ten test fields. Each field is
printed with a different grid, by which the light transmittance gradually decreases from field 1 to field 10
(except for field 9).
To calculate the exposure time (seconds), the dose (mJ/cm²) must be divided by the UV output
(mW/cm²):
mJ/cm² : mW/cm² = seconds
For a convenient calculation of the exposure time an online DOSE CALCULATOR can be found at our
website www.medlight.eu in the SERVICE menu.
The exact UV output must be taken from the test report, which is delivered with every device. The
specified value refers to the UV output of field 1 (unprinted field). Based on this value, the dose for each
field can be calculated, by using an individual multiplication factor, that can be found in the following
table.
USER MANUAL & TECHNICAL DESCRIPTION
User Manual MED-Tester MINI Rev1.doc MEDlight GmbH
Werrestr. 94
32049 Herford
Germany
Tel.: +49 5221 99429-0
Fax: +49 5221 99429-40
www.medlight.eu Page 9 of 13
Dose mJ/cm² Multiplication Factor Dose mJ/cm² for
Dose [mJ/cm²] for Field 1 .
1,00
=
Field 1
0,80 Field 2
0,60 Field 3
0,45 Field 4
0,30 Field 5
0,24 Field 6
0,20 Field 7
0,14 Field 8
0,16 Field 9
0,13 Field 10
3.4 Cleaning & Disinfection
The device and in particular all the components made of plastic should not be cleaned with abrasive
cleaners, solvents, or alcohol-containing agents. For cleaning we recommend the use of a normal
household cleaner, such as dishwasher liquid. For surface disinfection we recommend "Mikrozid
sensitive liquid®" (Schülke & Mayr GmbH, Germany), which can also be obtained from MEDlight.
A dust layer on the acrylic cover can reduce the irradiance. Therefore, it is recommended to wipe this
part clean whenever needed, preferably with a dry soft microfibre cloth.
Clean or disinfect the equipment only when it is switched off, and unplugged. All surfaces
should only be wiped with a slightly damp cloth to avoid liquid entering the device.
3.5 Conditions for Transport, Storage & Operation
After each transport, check the device for damage. Do not operate a damaged unit, but
inform our customer service department!
Transport and storage conditions must be adhered to.
Storage Conditions:
(these values apply in the appropriate packaging for a period of 10 weeks):
Ambient temperature -30°C to +65°C
Humidity 10% to 90%
Atmospheric pressure 500hPa to 1060hPa
Operation Conditions:
Ambient temperature +10°C to +40°C
Humidity 30% to 75%
Atmospheric pressure 700hPa to 1060hPa
USER MANUAL & TECHNICAL DESCRIPTION
User Manual MED-Tester MINI Rev1.doc MEDlight GmbH
Werrestr. 94
32049 Herford
Germany
Tel.: +49 5221 99429-0
Fax: +49 5221 99429-40
www.medlight.eu Page 10 of 13
4 TECHNICAL SPECIFICATIONS & INFORMATION
4.1 Technical Data
Netzspannung: 230 V, 50 Hz
Single phase
Power consumption: max. 16VA
Dimensions (LxWxH): 355 x 47 x 42 mm
Weight: 695 g
Class I equipment
Equipment Type B
Mode of operation: Short time, max. 15 Minutes (KB15)
Ingress protection classification: IPX0
4.2 Electromagnetic Compatibility (EMC)
This device has been tested and found to comply with the EMC limits of the international standard EN
60601-1-1-2. 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:
a) Re-orient or relocate the receiving device.
b) Increase the separation between the equipment.
c) Connect the system to an outlet socket on a circuit different from that to which the other
device(s) is connected.
USER MANUAL & TECHNICAL DESCRIPTION
User Manual MED-Tester MINI Rev1.doc MEDlight GmbH
Werrestr. 94
32049 Herford
Germany
Tel.: +49 5221 99429-0
Fax: +49 5221 99429-40
www.medlight.eu Page 11 of 13
4.3 Spectral Range
4.4 Accuracy
Measured directly on the acrylics glass insert, the average UV output of a new MED-Tester MINI xx
mW/cm² for field 1. Due to manufacturing tolerances in the production of UV lamps, the actual mW/cm²
value can differ by -x.x / +x.x from this average.
4.5 Maintenance & Repair
MEDlight devices are high-quality medical products, for which an annual maintenance is
required. As part of the maintenance safety tests, measurements and calibrations are
carried out, which are necessary to ensure the safe functioning of the equipment. If
maintenance is required, a relevant message is automatically shown on the display of the
device. Besides the replacement of fuses, all further work must be carried out only by an authorized
MEDlight technician. Circuit diagrams, service manuals etc. are available upon request. If required, get in
touch with MEDlight to arrange an appointment with one of our service technicians.
Spectrum of 311nm UVB narrowband lamps:
Spectrum of UVB broadband lamps:
Spectrum of UVA Lamps:
USER MANUAL & TECHNICAL DESCRIPTION
User Manual MED-Tester MINI Rev1.doc MEDlight GmbH
Werrestr. 94
32049 Herford
Germany
Tel.: +49 5221 99429-0
Fax: +49 5221 99429-40
www.medlight.eu Page 12 of 13
4.5.1 Lamp Ageing & Replacement
The used UV lamps are high quality products, but which are of course also subject to aging. Due to the
design of the MED-Tester MINI, a lamp replacement can be carried out by the user. To do this, first the
mains plug must be pulled, and the lamp should have cooled for a while. Replacement lamps can be
purchased directly from MEDlight.
5 OTHER INFORMATION
5.1 Warranty
MEDlight uses only high-quality, tested components. We work closely with our suppliers. All devices are
manufactured and tested according to our high quality standards.
For the device described in this manual we provide a two (2) year warranty for end users and one (1)
year for commercial users, from the date of delivery. Deviating from that, the warranty for the lamps
used is limited on six (6) months and does not include glass breakage. Prerequisite is the normal use and
the compliance with the required maintenance in the designated intervals. The warranty covers defects
due to workmanship or material defects. Signs of use are excluded. MEDlight bears all costs, related to
parts and labor, during the term of the warranty. MEDlight reserves the right, that defective devices
might be sent back to the factory for repair. MEDlight takes care of the settlement of the repair or a
complete replacement of equipment. It will be at MEDlight’s discretion whether subcontractors or
MEDlight technicians perform any required work.
The warranty is void, if maintenance or repairs were performed by a technician who was not authorized
in writing by MEDlight, and if components, test equipment and procedures are used that were not
recommended by MEDlight. This warranty does not apply to any unit which has been used, repaired or
altered outside the factory in any way so as to affect the design, or which has been subject to misuse
negligence or accident, or operated in any way other than in accordance with our operating instructions.
In these cases MEDlight will not accept any liability for any consequential damages, even if MEDlight has
been informed about the possibility of such damages. MEDlight may require the return of devices
claimed to be defective for its examination and shall be the sole judge as to whether material is in fact
defective under the terms of this warranty. MEDlight reserves the right to bill for travel time, expenses
and service cost for requested "warranty" service trips which result in work not covered by the
warranty. This may include, but is not limited to, a blown fuse, or an unplugged device.
5.2 Expected Service Life
Basically, the service life of the device is unlimited, as any defective components may be replaced. Only
the availability of the necessary replacement parts may limit the service life. MEDlight guarantees,
however, for a period of ten (10) years from the date of delivery, the supply of original spare parts or
adequate alternatives.
5.3 Disposal Note
Please, contact MEDlight regarding the disposal of old MEDlight devices including accessories.
USER MANUAL & TECHNICAL DESCRIPTION
User Manual MED-Tester MINI Rev1.doc MEDlight GmbH
Werrestr. 94
32049 Herford
Germany
Tel.: +49 5221 99429-0
Fax: +49 5221 99429-40
www.medlight.eu Page 13 of 13
5.4 Equipment Classification
M EDlight phototherapeutic systems for skin treatment are devices of Class IIa, Rule 9, Annex IX of the
Medical Device Directive 93/42/EEC, implemented into German law by the Medical Products Act ‘MPG’.
Compliance with the essential requirements, annex I of the directive, is met by the use of the relevant
standards EN 60601-1:2006 and EN 60601-1-2:2006. The product quality assurance of our manufacture
conforms to standards ISO 9001:2008 and ISO 13485:2003. Copies of the relevant certificates can be
found on our website at www.medlight.eu
5.5 Contact Details
MEDlight GmbH
Werrestr. 94
32049 Herford
Germany
Phone: +49 5221 99429-0
Fax: +49 5221 99429-40
E-Mail: [email protected]
Internet: www.medlight.eu
All rights for the device design and the materials associated with it, including software, trade names and
logos are owned by MEDlight GmbH.