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MEDlight 4557, Руководство пользователя и техническое описание, Страница: 6 / 30

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U

SER 

M

ANUAL 

&

 

T

ECHNICAL 

D

ESCRIPTION 

 

 

N-LINEpro_User Manual_2018-09-20.doc 

MEDlight GmbH 
Werrestr. 94 
32049 Herford 
Germany 

Phone: +49 5221 99429-0 
Fax: +49 5221 99429-40 
e-mail: [email protected] 
www.medlight.eu 

Page 6 of 30 

 

1.5

 

Symbols & Definitions 

 

A

TTENTION

 

Sections marked with this symbol 
must be read with special attention 

 

T

YPE 

B

 

E

QUIPMENT

 

 

P

ROTECTIVE 

E

YEWEAR 

M

UST BE 

W

ORN

 

 

R

EFER TO 

U

SER 

M

ANUAL

 

 

M

ANUFACTURER

 

 

D

ATE OF 

M

ANUFACTURE

 

 

S

ERIAL 

N

UMBER

 

 

C

ATALOGUE 

N

UMBER

 

 

D

O 

N

OT 

D

ISPOSE OF 

E

LECTRICAL 

A

PPLIANCES AS 

U

NSORTED 

M

UNICIPAL 

W

ASTE

 

2

 

WARNINGS & SAFETY REGULATIONS 

Note:            Any  serious  incident  that  has  occurred  in  relation  to  the  device  should  be  reported  to  the 

manufacturer and  the  competent  authority of  the Member  State  in  which  the  user  and/or 
patient is established. 

2.1

 

Definitions 

Warning:   Indicates a hazard. If not avoided, the hazard can result in death or serious injury. 
 
Caution:      Indicates  a  potentially  hazardous  situation.  If  not  avoided,  this  hazard  may  result  in  minor 

personal injury and/or product/property damage. 

Содержание 4557

Страница 1: ...User Manual Technical Description N LINEpro ...

Страница 2: ...ING 8 3 1 Handling 8 3 1 1 Optional Features 9 3 2 Operation 10 3 2 1 Stand By Mode 10 3 2 2 Therapy Type 11 3 2 3 Dose or Time Input 11 3 2 4 Ready State 12 3 2 5 Therapy 13 3 3 Menus Settings 13 3 3 1 Settings 13 3 3 2 Protocol 14 3 3 3 Info 14 3 3 4 Set Dose Units 15 3 3 5 Dose Limits Dose Warnings 15 3 3 6 Assigning a Cabin Identifier 15 3 3 7 Set PIN Code 15 3 3 8 Change Therapy Steps 16 3 4 ...

Страница 3: ...3 UVA PUVA Treatment recommendations 24 8 TECHNICAL SPECIFICATIONS INFORMATION 25 8 1 Technical Data 25 8 2 Conditions for Transport Storage Operation 26 8 3 Cleaning Disinfection 26 8 3 1 Cleaning of Lamps Lamp Covers 27 8 3 2 Cleaning underneath the Cabin 27 8 4 Electromagnetic Compatibility EMC 27 8 5 Spectral Ranges 28 8 6 Accuracy 28 8 7 Maintenance Repair 28 8 8 Lamp Ageing Replacement 29 9 ...

Страница 4: ...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 ...

Страница 5: ...on the cabin is equipped with a UV dosimetry which measures the irradiance in real time and corrects the exposure time accordingly The device is operated via a modern touch screen which allows simple practice oriented input of therapy parameters 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 is inte...

Страница 6: ...TE OF MANUFACTURE SERIAL NUMBER CATALOGUE NUMBER DO NOT DISPOSE OF ELECTRICAL APPLIANCES AS UNSORTED MUNICIPAL WASTE 2 WARNINGS SAFETY REGULATIONS Note Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and or patient is established 2 1 Definitions Warning Indicates a hazard If no...

Страница 7: ...hat the mains plug or the mains connection remains easily accessible at all times in order to enable a disconnection from the mains Warning Ensure that the device is serviced at least annually by MEDlight authorised service personnel 2 3 Light Exposure Hazards Warning The UV light of the device can lead to serious eye injury To protect the eyes during operation patients must wear tightly fitting U...

Страница 8: ... 180 kg 395 lb must not be treated in this cabin Caution Lay the power cord so that there is no danger of tripping up a person Caution Ensure that the ventilation slots of the device are not covered so that sufficient air circulation is ensured Caution For reasons of hygiene we recommend to lay a new disposable paper towel on the floor plate of the cabin before each treatment 3 OPERATION HANDLING ...

Страница 9: ...audible alarm is activated On top of the cabin is a patient fan mounted that comes on automatically with the other fans of the cabin during treatment This fan delivers an airstream which makes in particular longer treatments more comfortable for patients In case a patient doesn t want this airstream the patient fan can be switched off with the switch in the patient panel 3 1 1 Optional Features Th...

Страница 10: ...e only the output of the corresponding spectrum will be displayed The green bar to the right of the mW cm value is for orientation with respect to the condition of the UV tubes The more the UV tubes lose power over time due to wear the more the green bar decreases At very low output of the UV tubes the colour of the bar then changes to red In order to ensure an uninterrupted use of the cabin it is...

Страница 11: ...ab In this menu you can specify the order in which the treatment should take place In the example shown the UVA treatment would be carried out first followed by the UVB treatment For a reverse order UVB first followed by UVA please push the lower of the two selection buttons After you have made your settings for a single therapy or a combined therapy please press the CONTINUE button to go to the n...

Страница 12: ... right to left across the screen or tap the TIME ENTRY menu tab Tap on the input field and enter the desired treatment time in minutes and seconds via the on screen keyboard and press the enter key The dose that corresponds to the set treatment time is displayed below the input field To confirm the entered treatment time and to go to the next program step press the CONTINUE button 3 2 4 Ready Stat...

Страница 13: ...n this case the lamps switch off immediately and the program also returns to the menu described in section 3 2 1 However if you only want to interrupt the treatment for a short while rather than to cancel it completely press the SUSPEND THERAPY button or simply open the cabin door In this case the UV tubes switch off and the exposure time is paused As soon as the SUSPEND THERAPY button is pressed ...

Страница 14: ...t relevant information such as the spectrum of UV tubes used dose and treatment time For treatments that have not been completed the corresponding entry is shown in red To view older entries simply swipe your finger from the bottom to the top of the list area 3 3 3 Info In the INFO menu you can see the operating hours of the UV tube types used You will also find information about the next required...

Страница 15: ...dose warning threshold The dose can still be used but the user must confirm the message so that entering a higher dose becomes a conscious act 3 3 6 Assigning a Cabin Identifier In particular if more than one cabin is operated it makes sense to assign an identifier to the cabins in order to avoid confusion of the devices Do this tap the input field CABIN IDENTIFIER and enter a unique name for the ...

Страница 16: ... tabs are available as shown in the example To change the dose values for the therapy steps simply tap on the respective input field and enter the desired dose After making the desired changes in the EXTENDED SETTINGS menu press the arrow button in the upper left corner of the screen to exit the menu 3 4 System Messages 3 4 1 Warning Level Exceeded If a dose warning level has been set as described...

Страница 17: ...ssigned PIN and press the enter key The window with the PIN prompt closes and you can now continue with the operation as usual 3 4 3 Maintenance Required To ensure the safe operation of the device annual maintenance is recommended To ensure that maintenance is not forgotten an authorized technician can set a service interval in the service menu as needed In this case a corresponding reminder appea...

Страница 18: ...overed the device aborts the treatment and a corresponding message appears on the display In this case check if all UV tubes are actually working see section 3 3 3 Afterwards carry out a test treatment without patient which takes more than two minutes Should the fault still persist after the test treatment please contact the MEDlight service 3 4 5 No Connection The touchscreen is connected to the ...

Страница 19: ...erapie und Photochemotherapie DDG Berlin 2009 4 2 UVA1 Indications Atopic Dermatitis Source Prof Dr E Hölze et Al Empfehlungen zur Phototherapie und Photochemotherapie DDG Berlin 2009 4 3 UVA PUVA Indications Indication PUVA orally PUVA bath PUVA hand foot bath Psoriasis vulgaris Palmoplantar Psoriasis Atopic Dermatitis Dyshidrotic hand and foot eczema Parapsoriasis en plaques Source Prof Dr E Höl...

Страница 20: ...on is used Provocation of photodermatoses UV Lentigines Photoaging of the skin Actinic keratoses and squamous cell carcinoma Melanoma high risk moderate risk low risk in principle possible but no data available Source Prof Dr E Hölze et Al Empfehlungen zur Phototherapie und Photochemotherapie DDG Berlin 2009 6 2 UVA Side Effects The most common acute side effects are phototoxic reactions due to an...

Страница 21: ...l this question is resolved a strict indication selection for bath PUVA therapy must be demanded Basal cell carcinomas are probably not induced by the photo chemo therapy controversial is the induction of melanoma due to PUVA treatment or higher dosed UVA irradiation Side Effect UVA UVA1 20 J cm UVA UVA1 20 J cm PUVA Erythema or phototoxic reaction due to overdosing Phototoxic reaction due to unin...

Страница 22: ...t must be instructed to stand as still as possible in the middle of the cabin to ensure all around uniform exposure distances to the UV tubes during treatment Special attention must be paid to very tall patients who are 2 meter 6 5 or taller There should always be a clearance of at least 5 cm 2 between the head of the patient and the roof of the cabin This ensures that the head of the patient does...

Страница 23: ...d of this prior to the commencement of therapy Should itching irritation occur doses should not be increased for several days until these complaints have subsided Emollient treatment of the skin is recommended after every phototherapy treatment UVB 311 nm Dose Examples Treatment scheme Example for skin type II Day 1 0 30 J cm Day 6 0 60 J cm Day 2 0 35 J cm Day 7 0 60 J cm Day 3 0 40 J cm Day 8 0 ...

Страница 24: ... individual sensitivity to photochemotherapy A barely recognizable erythema is seen as clinical indicator for an adequate UVA dosage Ahead of each UV treatment patients should be asked regarding subjective signs of intolerance or overdosage The below described procedure has proven in practice Photochemotherapy treatment regimen Steps PUVA orally PUVA bath 1 optional Determination of the minimal ph...

Страница 25: ...the UV tolerance develops rapidly accordingly quickly can the UVA dose be increased To avoid an overdosing by accumulation it must be taken into account for the dose adjustments that the maximum PUVA erythema appears 72 to 120 hours after irradiation Because of the higher level of sensibilization the irradiation doses for bath PUVA treatments are generally lower It has to be noted that the MPD can...

Страница 26: ...nt temperature 30 C to 55 C Humidity 10 to 90 Atmospheric pressure 500 hPa to 1060 hPa Operation Conditions Ambient temperature 5 C to 35 C Humidity 30 to 75 Atmospheric pressure 700 hPa to 1060 hPa 8 3 Cleaning Disinfection The device and in particular all components made of plastic should not be cleaned with abrasive cleaners solvents or alcohol containing agents For cleaning we recommend the us...

Страница 27: ... removed To do so open the cabin door and unscrew the knob on the front side below the floor plate Then lift the foot plate with the rear side first upwards from the base frame and out of the cabin 8 4 Electromagnetic Compatibility EMC This device has been tested and found to comply with the EMC limits of the international standard EN 60601 1 2 These limits are designed to provide reasonable prote...

Страница 28: ...ry one hundred 100 hours as recommended The spatial variation of the output across the treatment area complies with EN 60601 2 57 2011 and does not deviate by more than 20 from the average irradiance A reduced output greater than 20 is possible for the edges of the treatment area ends of the UV tubes 8 7 Maintenance Repair MEDlight devices are high quality medical devices for which an annual maint...

Страница 29: ...ring 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 technic...

Страница 30: ...ntact their local authority or retailer for information concerning the correct disposal of their old appliance WEEE Reg Number DE 11726256 9 4 Equipment Classification MEDlight 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 requir...

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