OCTA
derm
U
SER
M
ANUAL
&
T
ECHNICAL
D
ESCRIPTION
Page 1: ...OCTAderm USER MANUAL TECHNICAL DESCRIPTION...
Page 2: ...rds 9 2 4 Other Hazards 11 3 HANDLING OPERATION 12 3 1 Assembly Instructions 12 3 2 Handling 13 3 3 Operation 14 3 4 Advanced Options 19 4 INDICATIONS 21 4 1 UVB 311 nm Indications 21 4 2 UVA PUVA Ind...
Page 3: ...magnetic Compatibility EMC 34 8 5 Spectral Range 37 8 6 Accuracy 38 8 7 Maintenance Repair 38 8 8 Lamp Ageing Replacement 38 9 OTHER INFORMATION 39 9 1 Warranty 39 9 2 Expected Service Life 40 9 3 Dis...
Page 4: ...UVA 1 The particular device type can be identified by the corresponding name plate on the device 1005 OCTAderm UVB 311 nm 80100 Patient goggles 2 User Manual 1 10092 Key 2 10115 Spacer 1 Optionally a...
Page 5: ...re 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...
Page 6: ...ribed in the manual The device finds application in dermatology and is intended for the treatment of skin diseases like psoriasis atopic dermatitis and vitiligo on all skin types It may only be operat...
Page 7: ...TURE MASS OF MOBILE EQUIPMENT IN KILOGRAMS SERIAL NUMBER CATALOGUE NUMBER DO NOT DISPOSE OF ELECTRICAL APPLIANCES AS UNSORTED MUNICIPAL WASTE 2 WARNINGS SAFETY REGULATIONS Note Any serious incident th...
Page 8: ...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 or...
Page 9: ...emains 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 authorized service personnel 2 3 Light...
Page 10: ...d in the middle of the cabin Instruct your patients to remain in this position throughout the entire treatment to avoid partial overdosing Caution Use of controls or adjustment or performance of proce...
Page 11: ...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 The...
Page 12: ...USER MANUAL TECHNICAL DESCRIPTION OCTAderm_User Manual_2020 01 10 Page 12 of 44 3 HANDLING OPERATION 3 1 Assembly Instructions Fig 1 Components of the unit...
Page 13: ...rests in the opposing bush 3 2 Handling Prior to the first use a device training must be carried out by MEDlight authorised personnel Additional trainings can be arranged upon request Plug the mains p...
Page 14: ...button which is located on the right side of the operating panel and marked with the label EMERGENCY STOP This will immediately stop the treatment and turn off all UV tubes To reset the emergency sto...
Page 15: ...ase that the device shows e g 2 x or 4 x instead of 1 x below the word DOSE you must read section 3 4 2 AUTOMATIC THERAPY REPETITION first before you start a therapy With the and keys of the controlle...
Page 16: ...he previously set dose In case that a correction is required press the ESC KEY to return to the menu described in section 3 3 1 The patient and everyone in sight of the device must now wear tightly fi...
Page 17: ...gnal four short beeps Fig 6 Display during the first seconds after therapy start Like with normal fluorescent tubes the UV tubes also need a few seconds for the ignition process During this time the m...
Page 18: ...ly indicated Now the device can be switched off by turning the key switch to position 0 In case that you need to abort a therapy simply press the ESC KEY of the controller or turn the key switch into...
Page 19: ...Hours Display The output of the UV tubes decreases with time and also the switching frequency affects the life of the tubes For a corresponding overview the number of switching cycles as well as the...
Page 20: ...in Fig 4 The therapy with pre set therapy repetitions doesn t differ significantly from the single therapy that is described in section 3 3 However when the first exposure time is over the tubes will...
Page 21: ...Prophylaxis of polymorphic light dermatosis Vitiligo recommendable superior Source Prof Dr E H lze et Al Empfehlungen zur Phototherapie und Photochemotherapie DDG Berlin 2009 4 2 UVA PUVA Indications...
Page 22: ...et Al Empfehlungen zur Phototherapie und Photochemotherapie DDG Berlin 2009 6 SIDE EFFECTS 6 1 UVB Side Effects The most common acute side effects include sunburn like erythema after UVB irradiation...
Page 23: ...6 2 UVA Side Effects The most common acute side effects are phototoxic reactions due to an overdose irradiation in the context of photochemotherapy Without eye protection acute conjunctivitis keratit...
Page 24: ...h a high number of individual treatments In modern PUVA therapy cancer risk is probably much lower than in the prospectively conducted American PUVA cohort from the 70s because nowadays a much more ca...
Page 25: ...ell carcinoma Melanoma high risk moderate risk low risk due to known mechanisms of action not likely in principle possible but no data available Because of the potential acute and chronic risks of pho...
Page 26: ...nt with Azathioprine UVA may have a mutagenic effect by oxidative DNA damage Source Prof Dr E H lze et Al Empfehlungen zur Phototherapie und Photochemotherapie DDG Berlin 2009 7 TREATMENT RECOMMENDATI...
Page 27: ...Regular treatment will assure a satisfactory healing process until symptoms disappear There is no treatment scheme uniformly applicable to all patients Phototherapy should always be adapted to the ind...
Page 28: ...2 0 35 J cm Day 7 0 60 J cm Day 3 0 40 J cm Day 8 0 70 J cm Day 4 0 45 J cm Day 9 0 70 J cm Day 5 0 50 J cm Day 10 0 80 J cm Depending on the individual response of the patient the dose can be accordi...
Page 29: ...ends almost to the absence of clinical symptoms Irradiations are carried out two to four times per week but at least twice a week Dose increases should not be made more frequently than at intervals of...
Page 30: ...ose according to skin type respectively 30 of MPD 3 Continuation of the treatment two to four times per week No erythema good response Increase by 30 max twice per week Increase by 30 max twice per we...
Page 31: ...pe I or II the tolerance development is slow therefore the dose should be increased very carefully In patients with skin types III IV V and VI the UV tolerance develops rapidly accordingly quickly can...
Page 32: ...9 x 69 x 195 cm 27 x 27 x 77 Weight 35 5 kg 78 lb Mode of operation Continuous Electrical appliance class Class I Equipment Applied parts classification The appliance is a Type B Applied Part Ingress...
Page 33: ...a 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 r...
Page 34: ...ion 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 fo...
Page 35: ...ified below The user should ensure that the device is used in such an environment Immunity test Compliance EMC environment Guide Electrostatic discharge ESD IEC 61000 4 2 Can lead to a safety shutdown...
Page 36: ...lines IEC 61000 4 11 Can lead to a safety shutdown of the UV light sources If a treatment could not be completed for this reason the treatment can be made up when needed the next day Mains power quali...
Page 37: ...USER MANUAL TECHNICAL DESCRIPTION OCTAderm_User Manual_2020 01 10 Page 37 of 44 8 5 Spectral Range Fig 10 Spectrum of UVA lamps Fig 11 Spectrum of UVB 311 nm lamps...
Page 38: ...asurements and calibrations are carried out which are necessary to ensure the safe functioning of the equipment During maintenance and repair work the device or parts thereof must not be used on a pat...
Page 39: ...fects Signs of use are excluded MEDlight bears all costs related to parts and labour during the term of the warranty MEDlight reserves the right that defective devices might be sent back to the factor...
Page 40: ...a period of ten 10 years from the date of delivery the supply of original spare parts or adequate alternatives The date of manufacture of the device is indicated on the nameplate next to the adjacentl...
Page 41: ...met by the use of the relevant standards EN 60601 1 2006 AC 2010 A1 2013 and IEC 60601 1 2 2015 The product quality assurance of our manufacture conforms to standard ISO 13485 2016 AC 2016 A copy of t...
Page 42: ...USER MANUAL TECHNICAL DESCRIPTION OCTAderm_User Manual_2020 01 10 Page 42 of 44 10 PATIENT REPORT Name Therapy Device MEDlight OCTAderm Dose in J cm Date Time Comments...
Page 43: ...USER MANUAL TECHNICAL DESCRIPTION OCTAderm_User Manual_2020 01 10 Page 43 of 44 Dose in J cm Date Time Comments...
Page 44: ...USER MANUAL TECHNICAL DESCRIPTION OCTAderm_User Manual_2020 01 10 Page 44 of 44 Dose in J cm Date Time Comments...
