Daavlin UV Series Operation Manual
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Daavlin UV Series Operation Manual

Flex controlled clinical
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Flex™ Controlled Clinical Operation Manual
MNL-00007 [3]
Proprietary and Confidential
Page 1 of 63

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  • Page 1 Flex™ Controlled Clinical Operation Manual MNL-00007 [3] Proprietary and Confidential Page 1 of 63...

  • Page 2: Table Of Contents

    Special Functions of the Integrated Dosimeter ............24 18.6 Special Notes ......................24 18.7 Flex Dosimeter Range and Accuracy ................. 24 19.0 Flex Timer Instructions: UV Series, 7 Series, M Series, and 4 Series ....................... 25 19.1 Determining a Treatment Time .................. 25 19.2 Setting Up a Treatment Time ..................
  • Page 3 Special Functions of the Digital Timer ............... 28 20.4 Special Notes ......................28 20.5 Flex Timer Range and Accuracy ................29 21.0 UV Series X and UV Series T Information ........ 29 21.1 Domestic and Non-CE Electrical Requirements ............29 21.2 European CE Electrical Requirements ............... 30 21.3...
  • Page 4 26.1 UVA Clearing Phase Protocols (Skin Types I - III) ........... 45 26.2 UVA Clearing Phase Protocols (Skin Types IV - VI) ..........47 26.3 UVA Maintenance Phase Protocols: ................49 26.4 UVA Treatment Limits for Maintenance & As Required Protocols ......50 26.5 LO Dose Broad Band UVB Clearing Phase Protocols: ..........

  • Page 5: Introduction

    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.

  • Page 6: Indications For Use

    2.0 Indications for Use The UV Series, 7 Series, and M Series, are medical ultraviolet devices, which are intended for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I – VI). The 1 Series Unit is a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders.

  • Page 7: Transport And Storage Specifications

    • Consult the manufacturer or field service technician for help 7.0 Accuracy The measuring device will maintain a 5% level of accuracy if the device is calibrated every one hundred (100) hours of use as recommended. Please contact Daavlin for calibration. MNL-00007 [3] Proprietary and Confidential...

  • Page 8: Labels And Symbols

    8.0 Labels and Symbols Every UV series comes affixed with an orange “safety key code” label located near the Integrated Dosimetry Control System. This label will provide you with important information about the factory default key code needed to unlock the unit.
  • Page 9 Figure 2 Warning and Danger Labels The following is a chart detailing all symbols located on your device and their meanings: Table 1 Symbols Symbol Description DANGEROUS VOLTAGE NON-IONIZING RADIATION EARTH (ground) PROTECTIVE EARTH (ground) OPERATING INSTRUCTIONS KEEP DRY CAUTION, CONSULT ACCOMPANYING DOCUMENTS NBUVB LAMP/TIMER LABEL UVA LAMP/TIMER LABEL MNL-00007 [3]...

  • Page 10: Uv Risk Group 2 Labels (Ce Devices Only)

    Symbol Description PACKAGING LABEL (CE ONLY) MAIN CIRCUIT BREAKER SWITCH (UV SERIES) EU REP LABEL (CE ONLY DEVICE) CE ONLY LABEL 8.1 UV Risk Group 2 Labels (CE Devices Only) According to IEC/EN 62471:2006, sources of optical radiation are classified into risk groups subject to their potential photobiological hazard.

  • Page 11: Delivery And Inspection

    Figure 4 Wiring Materials label (7 & UV Series, Japan & CE Devices Only) Figure 5 7 Series Package Contents Label (7 Series ONLY) Figure 6 Time-Lag 250V Label (Japan 7 Series Only) Figure 7 On/Off Key Switch Label (Japan Only) 9.0 Delivery and Inspection...
  • Page 12 If damage is discovered after unpacking the unit, save all packing materials and call Daavlin at 1 800 322 8546 for inspection and repair. Note: The delivering carrier must be notified of any shipping damage within twenty-four (24) hours to protect your right to an insurance claim.

  • Page 13: Lamp Inspection

    Consult the Lamp Specification Guide below and if there is any question as to whether or not your device it is equipped with the lamps that you have ordered, contact Daavlin immediately. The code numbers shown are generally located at the base of the lamp.

  • Page 14: Important Safeguards And Warnings

    To protect the eyes during operation, the operator and anyone in view of the device must wear the provided UV blocking glasses or goggles designed to block 100% of all UVA and UVB light from the eye area when worn. Always use Daavlin approved eyewear. •...
  • Page 15 EMC Precautions. If the device continues to malfunction cease operation and contact the Daavlin Service Department. •...

  • Page 16: Unlocking The Device

    If you would like to disable or personalize your factory default key code, please contact the Daavlin service department at 1-800-322-8546 for step by step instructions. The Daavlin service department is available to assist you Monday through Thursday 7:30am- 8:00pm EST and Friday 8:30am-5:00pm EST.

  • Page 17: The Backup Time

    Figure 8 UVA J and UVB mJ 17.1 The Backup Time An important safety feature of Daavlin’s Integrated Dosimetry System is the use of a safety backup time. While the dose is entered in Joules or milliJoules, a backup time must also be entered as a safety check.
  • Page 18 4. Press the ◄ key two times. The screen will now read “05:00”. 5. Press the ENTER key one time to lock in the backup time. 6. Press the MODE key one time to switch to dose entry mode. 7. Press the ▲ key five times. The screen will now read “0005”. 8.

  • Page 19: Setting Up A Treatment

    Note: For your convenience, and as an alternative to the UVB backup time chart, the latest version of our free iPhone and Android application “Phototherapy Math” is available for download at the iTunes app store and Android market. It quickly calculates treatment times, backup safety times, and makes the calculation of dose and time increases simple.

  • Page 20: Special Functions Of The Integrated Dosimeter

    1 year or every 100 hours of use 18.0 Flex Dosimeter Instructions: 1 Series Your Daavlin 1 Series features a built-in power meter that measures energy output. Once a dose and backup time have been selected the unit will use the information gathered by the sensor to determine the exact amount of time that each treatment will last.

  • Page 21: The Backup Time

    18.1 The Backup Time An important safety feature of Daavlin’s Integrated Dosimetry System is the use of a backup safety time. While the dose is entered in Joules or milliJoules, a backup time must also be entered as a safety check. The treatment will stop when the dose has been delivered, OR, when the backup time has elapsed, whichever comes first.
  • Page 22 13. Once the treatment begins press the MODE key one time to view the time counting down. Allow the device to run until 30 seconds remains. Stand to the side of the device while waiting. 14. With 30 seconds remaining press the POWER key one time. The system will display the power output of the lamps.

  • Page 23: Setting Up A Treatment

    18.3 Setting Up a Treatment You will first enter a backup time (steps 1 – 8). Continuing the example from the previous page, the back-up time will be 00:30. 1. Press any key to awaken the unit. The word “CODE” will appear. 2.

  • Page 24: Special Functions Of The Integrated Dosimeter

    1. Press the END key one time. This will clear the previous treatment and the display will now read 00:00. 2. Press and release the MODE and POWER keys at the same time. This will reprogram the backup time and dose used in your previous treatment. 3.

  • Page 25: Flex Timer Instructions: Uv Series, 7 Series, M Series, And

    19.0 Flex Timer Instructions: UV Series, 7 Series, M Series, and 4 Series 19.1 Determining a Treatment Time When using time as a dose, there are two treatment methods that can be used. The simplest is to start at a prescribed time and then increase treatment times by a specific time increment or by a percentage.

  • Page 26: Setting Up A Treatment Time

    19.2 Setting Up a Treatment Time To administer a treatment, you must enter your desired treatment time. Based on the example above the treatment time will be 1:10. 1. Press any key to awaken the unit. The word “CODE” will appear. 2.

  • Page 27: Flex Timer Range And Accuracy

    • If power goes off during a treatment, the system will remember how much of the treatment has elapsed. When power is restored, your device will be on “HOLD”. To continue the treatment, press START. To cancel the treatment press END. •...

  • Page 28: Setting Up A Treatment Time

    The UVA Time Chart (not shown here) is configured the same as the UVB Time Chart however the doses are listed in Joules and the energy output levels and times are different than the UVB output levels. Each chart is clearly marked. 20.2 Setting Up a Treatment Time To administer a treatment, you must enter your desired treatment time.

  • Page 29: Flex Timer Range And Accuracy

    21.0 UV Series X and UV Series T Information 21.1 Domestic and Non-CE Electrical Requirements Daavlin offers the UV Series Phototherapy equipment in a variety of combinations. Units are available with lamp quantities of 12, 16, 24, and 28 with various combinations of UVA, Narrowband UVB, and Broadband UVB.

  • Page 30: European Ce Electrical Requirements

    Table 6 NEMA Outlets 21.2 European CE Electrical Requirements Daavlin offers the UV Series Phototherapy equipment in a variety of combinations. Units are available with lamp quantities of 12, 16, 24, and 28 with various combinations of UVA, Narrowband UVB, and Broadband UVB. While the type of ultraviolet lamp (UVA or UVB) does not influence the electrical requirements, the number of lamps contained in a unit does determine the amperage and wiring necessary to safely support operation.

  • Page 31: How To Position The Patient

    Note: The UV Series sits on top of several castors. If there are no stairs involved, it may be easier to remove the unit from its box at the earliest opportunity so that you can simply roll it into position.

  • Page 32: Series X And 7 Series T Information

    22.0 7 Series X and 7 Series T Information 22.1 Electrical Requirements Daavlin offers the 7 Series X and 7 Series T Phototherapy equipment with lamp quantities of 4, 6, 8, 10, and 12. Units can be equipped with UVA, Narrowband UVB, and Broadband UVB lamps.

  • Page 33: Unpacking And Assembly

    FUSE VOLTAGE BREAKING TYPE RATING RATING CAPACITY Time-Delay 3.15 Time-Delay Time-Delay Tim-Delay 12.5 22.2 Unpacking and Assembly If possible, choose a place close to where the unit will be located to unpack it. Be careful, as fluorescent lamps can be broken if the unit is not unpacked properly The grid that will cover the lamps is not installed for shipping.

  • Page 34: How To Position The Patient

    3. Turn the packing container over so that its wooden bottom can be used as a “worktable”. 4. Set the device, on its back, on top of the packing container. The bottom of the device should extend beyond the edge of the “worktable”. 5.

  • Page 35: Series Lamp Removal And Replacement

    23.0 M Series X and M Series T Information 23.1 Electrical Requirements Daavlin offers the M Series Phototherapy equipment in a variety of combinations. Units contain 10 lamps and can be equipped with various combinations of UVA, Narrowband UVB, and Broadband UVB.

  • Page 36: Unpacking And Assembly

    Note: Daavlin M Series X and M Series T Phototherapy equipment contain no operator replaceable parts. NUMBER AMP RATING VOLTS HERTZ OUTLET OF LAMPS & FUSE 110/120 3 Prong Grounded 220/240 50/60 3.15 Use Local Outlet VOLTAGE BREAKING FUSE TYPE...

  • Page 37: How To Position The Patient

    DO NOT REPLACE LAMPS INDIVIDUALLY. ALL LAMPS SHOULD BE REPLACED AT THE SAME TIME TO AVOID UNEVEN TREATMENTS OR ERYTHEMA. PLEASE CONTACT THE DAAVLIN SERVICE DEPARTMENT PRIOR TO REPLACING YOUR LAMPS TO OBTAIN IMPORTANT INFORMATION ON HOW THE OUTPUT OF YOUR UNIT WILL BE AFFECTED BY THE CHANGE.

  • Page 38: Series Information

    24.0 4 Series Information 24.1 Electrical Requirements Daavlin offers the 4 Series Phototherapy equipment with either 10 or 20 lamps. Units can be equipped with UVA, UVA-1, Blue Light, Narrowband UVB, and Broadband UVB lamps. While the type of ultraviolet lamp (UVA, UVB, or Blue) does not influence the electrical requirements, the number of lamps contained in a unit does determine the amperage necessary to safely support operation.

  • Page 39: Unpacking And Assembly

    VOLTAGE BREAKING FUSE TYPE RATING RATING CAPACITY Time-Delay 3.15 Time-Delay Time-Delay 24.2 Unpacking and Assembly 1. Once you have opened the box, place your hands on each side of the device and pull the 4 series, along with the foam packers, up and out of the box. Remove the foam packers. Note: Be sure to remove all of the accessories such as the manual, time chart, power cord, eyewear, and stability feet before discarding the box.

  • Page 40: Series X And 1 Series T Information

    25.0 1 Series X and 1 Series T Information 25.1 Electrical Requirements Daavlin 1 Series Phototherapy equipment can be equipped with UVA, UVA-1, Blue Light, Narrowband UVB, and Broadband UVB lamps. While the type of ultraviolet lamp (UVA, UVB, or Blue) does not influence the electrical requirements, the number of lamps contained in a unit does determine the amperage necessary to safely support operation.

  • Page 41: Unpacking And Assembly

    Note: Daavlin 1 Series X and 1 Series T Phototherapy equipment contain no operator replaceable parts. NUMBER VOLTS/HERTZ RATING OUTLET LAMPS & FUSE 100/125V 60/50Hz 3 Prong Grounded 200/240V 60/50Hz Use Local Outlet FUSE VOLTAGE BREAKING TYPE RATING RATING CAPACITY...

  • Page 42: Series Lamp Removal And Replacement

    DO NOT REPLACE LAMPS INDIVIDUALLY. ALL LAMPS SHOULD BE REPLACED AT THE SAME TIME TO AVOID UNEVEN TREATMENTS OR ERYTHEMA. PLEASE CONTACT THE DAAVLIN SERVICE DEPARTMENT PRIOR TO REPLACING YOUR LAMPS TO OBTAIN IMPORTANT INFORMATION ON HOW THE OUTPUT OF YOUR UNIT WILL BE AFFECTED BY THE CHANGE.

  • Page 43: Calibration Output Certificate

    “ENTER” will lock in your desired treatment distance. 25.5.2 Calibration Output Certificate Here at Daavlin we measure the power output of each end every unit that we manufacture before allowing it to leave our facilities. Included with your literature you will also find a “Calibration Output Certificate”...
  • Page 44 treatments conducted 9 inches away, such as the face or other localized areas of the body, always use the lower output value to calculate your treatment times. MNL-00007 [3] Proprietary and Confidential Page 44 of 63...

  • Page 45: Treatment Protocols

    26.0 Treatment Protocols 26.1 UVA Clearing Phase Protocols (Skin Types I - III) Maximum Number of Treatments = 25 UVA, Skin Type I, 11011 TREATMENT # PRIMARY DOSE (JOULES) SECONDARY DOSE (JOULES) UVA, Skin Type I, 3/week TREATMENT # PRIMARY DOSE (JOULES) SECONDARY DOSE (JOULES)
  • Page 46 UVA, Skin Type II, 11011 TREATMENT # PRIMARY DOSE (JOULES) SECONDARY DOSE (JOULES) UVA, Skin Type II, 3/week TREATMENT # PRIMARY DOSE (JOULES) SECONDARY DOSE (JOULES) UVA, Skin Type II, 2/week TREATMENT # PRIMARY DOSE (JOULES) SECONDARY DOSE (JOULES) UVA, Skin Type III, 11011 TREATMENT # PRIMARY DOSE 10.0 10.5 11.0 11.5 12.0 12.0 12.0 12.0 12.0 12.0...

  • Page 47: Uva Clearing Phase Protocols (Skin Types Iv - Vi)

    UVA, Skin Type III, 3/week TREATMENT # PRIMARY DOSE 10.0 10.5 11.0 11.5 12.0 12.0 12.0 12.0 12.0 12.0 12.0 12.0 (JOULES) SECONDARY 10.0 10.5 11.0 11.5 12.0 12.0 12.0 12.0 12.0 DOSE (JOULES) UVA, Skin Type III, 2/week TREATMENT # PRIMARY DOSE 11.0 12.0 12.0 12.0 12.0 12.0 12.0 12.0 12.0 12.0 12.0 12.0 12.0 12.0 12.0 12.0 12.0 12.0 12.0 12.0 (JOULES)
  • Page 48 UVA, Skin Type IV, 2/week TREATMENT # PRIMARY DOSE 10.5 11.5 12.5 13.5 14.0 14.0 14.0 14.0 14.0 14.0 14.0 14.0 14.0 14.0 14.0 14.0 14.0 14.0 14.0 (JOULES) SECONDARY 10.0 11.0 12.0 13.0 14.0 14.0 14.0 14.0 14.0 14.0 14.0 14.0 14.0 14.0 14.0 14.0 14.0 14.0 DOSE (JOULES) UVA, Skin Type V, 11011 TREATMENT #...

  • Page 49: Uva Maintenance Phase Protocols

    UVA, Skin Type VI, 11011 TREATMENT # PRIMARY DOSE 10.0 10.0 11.5 11.5 13.0 13.0 14.5 14.5 16.0 16.0 17.5 17.5 19.0 19.0 20.0 20.0 20.0 20.0 20.0 (JOULES) SECONDARY 10.0 11.0 12.0 13.0 14.0 15.0 16.0 17.0 18.0 19.0 20.0 20.0 20.0 20.0 20.0 20.0 20.0 20.0 20.0 DOSE (JOULES) UVA, Skin Type VI, 3/week TREATMENT #...

  • Page 50: Uva Treatment Limits For Maintenance & As Required Protocols

    26.4 UVA Treatment Limits for Maintenance & As Required Protocols Skin Type DOSE LIMITS with WARNING 12 J 14 J 16 J 20 J SYSTEM DOSE LIMITS 12 J 16 J 20 J 24 J 28 J 26.5 LO Dose Broad Band UVB Clearing Phase Protocols: 11011, 3/week, 2/week Maximum Number of Treatments = 29 ALL SKIN TYPES, ALL SCHEDULES...

  • Page 51: Protocols

    26.7 LO Dose Broad Band UVB Treatment Limits for Maintenance & As Required Protocols Skin Type MED RANGE 20-60 mJ 30-75 mJ 40-90 mJ 50-110 mJ 60-120 mJ 70-140 mJ DOSE LIMITS with WARNING 320 mJ 400 mJ 500 mJ 610 mJ 680 mJ 800 mJ...

  • Page 52: Lo Dose Narrow Band Uvb Clearing Phase Protocols: 11011, 3/Week, 2/Week

    Skin Type MED RANGE 20-60 mJ 30-75 mJ 40-90 mJ 50-110 mJ 60-120 mJ 70-140 mJ DOSE LIMITS with WARNING 1400 mJ 1700 mJ 2000 mJ 2500 mJ 2700 mJ 3100 mJ SYSTEM DOSE LIMITS 1600 mJ 1900 mJ 2200 mJ 2700 mJ 3000 mJ 3400 mJ...

  • Page 53: Hi Dose Narrow Band Uvb Clearing Phase Protocols

    26.13 HI Dose Narrow Band UVB Clearing Phase Protocols: 11011, 3/week, 2/week Maximum Number of Treatments = 29 SKIN TYPES I & II, ALL SCHEDULES % of % INCREASE OVER PREVIOUS DOSE TREATMENT # PRIMARY DOSE (MILLIJOULES) 10 10 10 10 % OF PRIMARY DOSE SECONDARY DOSE (MILLIJOULES) 50 50 50 50...

  • Page 54: Hi Dose Narrow Band Uvb Maintenance Phase Protocols

    26.14 HI Dose Narrow Band UVB Maintenance Phase Protocols: 1/WEEK Maximum Number of Treatments = 4 ALL SKIN TYPES: Dose should be held steady at last clearance phase dose 26.15 HI Dose Narrow Band UVB Treatment Limits for Maintenance & As Required Protocols Skin Type MED RANGE 50-300 mJ...

  • Page 55: Care Of Your Phototherapy Unit

    70% Isopropyl Alcohol 3 min Table 7 Daavlin Tested Cleaners 1. Thoroughly wipe down the surfaces and allow contact time listed in Table 7 Daavlin Tested Cleaners. 2. Allow to air dry and inspect for visible contaminants. 3. If contaminants remain repeat until no visible containments remain repeat steps 0 and 2.

  • Page 56: High-Level Disinfection

    27.2.3 High-Level Disinfection Follow a high-level disinfection protocol between the use of the device on different patients. Use a high-level disinfectant, such as Steris Corporation’s Resert XL-HLD, and follow the manufactures guidelines. See also “FDA-Cleared Sterilants and High Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices”...
  • Page 57 Table 9 Electromagnetic Immunity Emissions Test IEC 60601 Test Level Actual Level +/- 8kV (conductive +/- 8kV (conductive surfaces, coupling planes) surfaces, coupling planes) Electrostatic discharge immunity test following IEC +/- 2kV, +/- 4kV, +/- 8kV, +/- 2kV, +/- 4kV, +/- 8kV, 61000-4-2 and +/- 15kV (non- and +/- 15kV (non-...

  • Page 58: Flex Controller Trouble Shooting Guide

    • For E5 or E6 errors, try powering the system down and back up again to see if the error reoccurs, • If this error re-occurs, contact the Daavlin Service Department. 2. Verify processor 1/0 are at their expected levels.

  • Page 59: Error Code E8Yz: Yz = Address Of First Location With Range Error

    0e=Maximum OFF Current Sensor Level 07=Software Calibration Factor 0f=Hardware Gain Constant For E8 errors, Contact the Daavlin Service Department to record the software version, check and correct, as required, all variables in the maintenance menu, Sensor Variable Menu. 29.3 Sensing Errors Sensor levels are checked during Treatment, Idle, and End of Treatment mode only -- not during sleep, editing, in Maintenance Menu, or during treatment Hold.
  • Page 60 Sensor Board is greater than the system limits while the lamps are on. • Contact the Daavlin Service Department to verify the Safety Setting -05- EE07 = Current On level lower than minimum allowed value. The current measured by the Sensor Board is less than the system limits while the lamps are on.

  • Page 61: Warranty And Contact Information

    30.0 Warranty and Contact Information 30.1 Limited Warranty Policy This Limited Warranty is provided to the original purchaser (the “Purchaser”) of the Daavlin device (the “Equipment”). Daavlin warrants Equipment to conform with the Equipment specifications and be free from defects in material and workmanship during the device Warranty Period.

  • Page 62: Customer Responsibility

    Daavlin. Even with Daavlin’s authorization, Daavlin shall not be responsible or liable for any such work (in or out of warranty). Daavlin reserves the right to bill for labor, expenses, and services for requested "warranty" service trips which result in work not covered by this Limited Warranty.

  • Page 63: Contact Information

    30.7 Contact Information USA & Canada: 1-800-322-8546 Overseas: 1-419-636-6304 Fax: 1-419-636-1739 E-Mail: service@daavlin.com Website: www.daavlin.com Daavlin Distributing Company EMERGO EUROPE 205 W. Bement Street PO Box 626 Westervoortsedijk 60 EC REP Bryan, Ohio 43506 USA 6827 AT Arnhem The Netherlands MNL-00007 [3]...

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