user manual med-tester mini rev1 - ferdinand menzl ... manual & technical description user...

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

[email protected]

www.medlight.eu 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



Werrestr. 94

32049 Herford

Germany

Tel.: +49 5221 99429-0

Fax: +49 5221 99429-40

[email protected]


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.



Werrestr. 94

32049 Herford

Germany

Tel.: +49 5221 99429-0

Fax: +49 5221 99429-40

[email protected]


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.



Werrestr. 94

32049 Herford

Germany

Tel.: +49 5221 99429-0

Fax: +49 5221 99429-40

[email protected]


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.



Werrestr. 94

32049 Herford

Germany

Tel.: +49 5221 99429-0

Fax: +49 5221 99429-40

[email protected]


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.



Werrestr. 94

32049 Herford

Germany

Tel.: +49 5221 99429-0

Fax: +49 5221 99429-40

[email protected]


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.



Werrestr. 94

32049 Herford

Germany

Tel.: +49 5221 99429-0

Fax: +49 5221 99429-40

[email protected]


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.



Werrestr. 94

32049 Herford

Germany

Tel.: +49 5221 99429-0

Fax: +49 5221 99429-40

[email protected]


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



Werrestr. 94

32049 Herford

Germany

Tel.: +49 5221 99429-0

Fax: +49 5221 99429-40

[email protected]


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.



Werrestr. 94

32049 Herford

Germany

Tel.: +49 5221 99429-0

Fax: +49 5221 99429-40

[email protected]


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:



Werrestr. 94

32049 Herford

Germany

Tel.: +49 5221 99429-0

Fax: +49 5221 99429-40

[email protected]


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.



Werrestr. 94

32049 Herford

Germany

Tel.: +49 5221 99429-0

Fax: +49 5221 99429-40

[email protected]


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.

user manual med-tester mini rev1 - ferdinand menzl ... manual & technical description user...

Documents