Operating Manual
`
`OPERATING MANUAL
`BLU-U® Blue Light Photodynamic Therapy Illuminator
`Model 4170
`When Printed This Document is "For Reference Use Only"
`
`Operating Manual
`
`
`
`BLU-U® Blue Light Photodynamic Therapy
`Illuminator Model 4170
`
`
`
`
` MAN-1211 Rev B
`
`

`

`OPERATING MANUAL
`BLU-U® Blue Light Photodynamic Therapy Illuminator
`Model 4170
`When Printed This Document is "For Reference Use Only"
`Table of Contents
`
`3
`SYMBOLS AND DEFINITIONS:…………………………………………………………………………
`4
`INDICATIONS FOR USE: ………………………………………………………………………………
`4
`CAUTIONS AND WARNINGS: …………………………………………………………………………
`5
`PRODUCT SPECIFICATIONS: …………………………………………………………………………
`5
`DESCRIPTION: ………………………………………………………………………………………..
`6
`CONTROLS: …………………………………………………………………………………………..
`MAIN POWER SWITCH: …………………………………………………………………………….. 6
`6
`KEY SWITCH: ………………………………………………………………………………………
`6
`TIMER: …………………………………………………………………………………………….
`INDICATOR LIGHTS: …………………………………………………………………………………. 7
`INSTRUCTIONS FOR USE WITH THE LEVULAN® KERASTICK® FOR THE TREATMENT OF ACTINIC
`9
`KERATOSES: ………………………………………………………………………………………….
`INITIAL SET-UP: ……………………………………………………………………………………. 9
`SET-UP: …………………………………………………………………………………………… 9
`9
`PROCEDURE FOR TREATING LESIONS ON THE FACE: …………………………………………....
`FOLLOWING PATIENT TREATMENT: ………………………………………………………………. 10
`PROCEDURE FOR TREATING LESIONS ON THE SCALP: ………………………………………….. 10
`FOLLOWING PATIENT TREATMENT: ……………………………………………………………….. 11
`INSTRUCTIONS FOR USE FOR THE LIGHT ONLY TREATMENT OF ACNE: …………………………….. 12
`INITIAL SET-UP: …………………………………………………………………………………… 12
`SET-UP: …………………………………………………………………………………………… 12
`PROCEDURE FOR TREATING ACNE: ………………………………………………………………. 12
`FOLLOWING PATIENT TREATMENT: ………………………………………………………………. 13
`TROUBLESHOOTING/SERVICE AND REPAIR: ………………………………………………………… 14
`TRANSPORT AND STORAGE: …………………………………………………………………………. 16
`CLEANING/DISINFECTING: ……………………………………………………………………………. 16
`CUSTOMER SERVICE: ………………………………………………………………………………… 17
`FOR SERVICE, REPAIR, OR CALIBRATION OF THIS EQUIPMENT CALL: ……………………………. 17
`WARRANTY COVERAGE AND DISCLAIMERS: ……………………………………………………… 17
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`Page 2
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` MAN-1211 Rev B
`
`

`

`OPERATING MANUAL
`BLU-U® Blue Light Photodynamic Therapy Illuminator
`Model 4170
`When Printed This Document is "For Reference Use Only"
`Symbols and Definitions:
`
`
`
`!
`
`
`Reference User Manual
`
`T
`5AL 250V
`Indicates the Electrical Specification and
`Location of the Required Fuses
`
`
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`60 oC
`140 oF
`
`-20 oC
`-4 oF
`
`
`Indicates the Upper and Lower
`Temperatures Allowed for Storage and
`Transport
`
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`Indicates Need to Wear Eye Protection
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`Warning/Caution
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`This Equipment Conforms to the IEC
`Publication 878-02-02 Type B
`Classification
`
`0-95%
`
`
`Indicates the % Humidity Allowed for
`Storage and Transport
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`Page 3
`
` MAN-1211 Rev B
`
`

`

`OPERATING MANUAL
`BLU-U® Blue Light Photodynamic Therapy Illuminator
`Model 4170
`When Printed This Document is "For Reference Use Only"
`
`Indications for Use:
`DUSA Pharmaceuticals, Inc.® BLU-U® Blue Light Photodynamic Therapy Illuminator Model
`4170, in combination with the Levulan® Kerastick® (aminolevulinic acid HCl) for Topical
`Solution, 20%, is indicated for the treatment of non-hyperkeratotic actinic keratoses (AK) of
`the face or scalp.
`The BLU-U® Blue Light Photodynamic Therapy Illuminator Model 4170 is intended to provide
`phototherapeutic light to the body. The BLU-U® 4170 is generally indicated to treat
`dermatological indications. The BLU-U® 4170 is specifically indicated to treat moderate
`inflammatory acne vulgaris.
`
`Cautions and Warnings:
`
`
`
`WARNING:
`The BLU-U® Blue Light Photodynamic Therapy Illuminator, in combination with the Levulan®
`Kerastick® for Topical Solution, 20% is indicated for the treatment of non-hyperkeratotic
`actinic keratoses of the face or scalp. Do not use this device with other photosensitizing
`drugs. Refer to the Levulan® Kerastick® for Topical Solution, 20% Package Physician Insert
`for additional information.
`When using the BLU-U® for acne, do not use this device with photosensitizing drugs.
`WARNING:
`All personnel should read and understand the instructions in this manual before the system
`is used. Failure to do so may result in improper operation of the system.
`WARNING:
`Use only eyewear which blocks light with wavelengths of at least 500nm and shorter with an
`Optical Density (OD) of two or greater.
`
`WARNING:
`To avoid risk of electrical shock, connect the power cord to a properly wired grounding
`receptacle only.
`
`WARNING:
`Never attempt to service the device when it is connected to a power source. Hazardous
`voltages inside the device may cause severe electrical shock. Disconnect the power cord
`before servicing.
`
`WARNING:
`Do not allow fluids to enter the device. Damage to the device may result.
`CAUTION:
`The device should not be serviced or opened except by qualified service technicians.
`Tampering by unqualified persons may cause damage to the unit or personal injury.
`CAUTION:
`Federal law restricts this device to sale by or on the order of a physician or licensed medical
`practitioner.
`
`
`
`Page 4
`
` MAN-1211 Rev B
`
`

`

`OPERATING MANUAL
`BLU-U® Blue Light Photodynamic Therapy Illuminator
`Model 4170
`When Printed This Document is "For Reference Use Only"
`
`Product Specifications:
`The BLU-U® is an electrical Class I, Type B device designed for indoor use only. It has
`been tested to the following standards: UL2606.1, CAN/CSA C22.2 No.601.1, EN60601-1,
`and EN 60601-1-2. General specifications are listed below.
`Power cord
`3-conductor hospital grade electrical cord
`Power requirements
`117 VAC, 2.5 Amps, 60 Hz
`Footprint (light unit + stand)
`Width: 99.70 cm (39.25 inches)
`Depth: 67.31 cm (26.5 inches)
`Height Minimum: 127 cm (50 inches)
`Height Maximum: 160 cm (63 inches)
`Overall dimensions of the light unit Width: 52.71 cm (20.75 inches)
`Depth: 47.63 cm (18.75 inches)
`Height: 38.74 cm (15.25 inches)
`72.6 kg (160 lbs.)
`20 – 30o C (68 – 86o F)
`
`Weight (light unit + stand)
`Operating Temperature Range
`
`
`Description:
`The BLU-U® is a compact light source designed to provide a uniform distribution of blue
`light to areas of the patient’s face or scalp for the use stated above. It is comprised of 7
`horizontally mounted U-shaped fluorescent tubes within a plastic chassis. The tubes are
`covered by a polycarbonate shield, which directs cooling airflow within the unit and
`significantly minimizes the risk of glass-patient contact in the event of tube breakage.
`The BLU-U® is mounted on a floor-stand, which permits rapid positioning as well as
`adjustment for patient height. The control panel is also affixed to the floor stand.
`The BLU-U® has a built-in power output monitoring and diagnostic system, which
`illuminates a neon light to inform the user of the system’s status.
`The BLU-U® has a system timer used to set the light dose delivered to the patient.
`The BLU-U® is rated for short-time operation.
`
`Page 5
`
` MAN-1211 Rev B
`
`

`

`OPERATING MANUAL
`BLU-U® Blue Light Photodynamic Therapy Illuminator
`Model 4170
`When Printed This Document is "For Reference Use Only"
`
`Controls:
`Controls for the BLU-U® are located on the floor stand.
`
`Main Power Switch:
`The Main Power Switch is a two-position rocker switch, labeled “l” and “0,” located next to
`the electrical cord.
` l
`=
`ON
`0
`=
`OFF
`Push the Main Power Switch to “l” to turn on power to the system.
`Push the Main Power Switch to “0” to disconnect all electrical components within the
`BLU-U® from the AC line.
`
`
`
`Key Switch:
`The Key Switch is the “ON/OFF” switch for the BLU-U® and requires a special key to
`operate.
`(cid:206) Remove the key and store it securely whenever the unit is not in use, to prevent
`unauthorized use of the BLU-U®.
`Turn the Key Switch to “l” to turn on power to the BLU-U® control electronics. This
`activates the Timer so that the prescribed exposure time can be entered. When activated,
`the timer will remember and display the last treatment time setting.
`Note:
`When the Key Switch is turned off, it should not be turned back on again for at least
`thirty (30) seconds to ensure that the control electronics have properly powered
`down and reset.
`
`Timer:
`The system Timer is used to control the operation of the fluorescent tubes. Use the Timer
`to:
`• Set the exposure time,
`Initiate light exposure,
`•
`and after the set exposure time has elapsed,
`• Automatically turn off the tubes.
`
`Page 6
`
` MAN-1211 Rev B
`
`

`

`OPERATING MANUAL
`BLU-U® Blue Light Photodynamic Therapy Illuminator
`Model 4170
`When Printed This Document is "For Reference Use Only"
`The following buttons control operation of the Timer:
`
`FUNCTION / OPERATION
`
`BUTTON
`Time Select
`
` (cid:199) (cid:200)
`
`Start/Stop
`
`
`The Time Select buttons are used to set the exposure time.
`Depress the (cid:199) (up arrow) button to increase time.
`Depress the (cid:200) (down arrow) button to decrease time.
`When first depressed, these buttons change the displayed reading
`slowly; if they remained depressed, the display changes quickly.
`Depressing and releasing these buttons quickly makes small
`adjustments to the displayed time.
`The Start/Stop button toggles between the running and stopped
`states of the Timer and Tubes.
`After the exposure time has been set, depress this button once to
`turn on the tubes and initiate the Timer countdown sequence.
`Depress it a second time to turn off the tubes and stop the Timer.
`
`Note:
` If the light treatment for actinic keratoses of the face or scalp is interrupted, see
`the Levulan® Kerastick® for Topical Solution, 20% package insert for further
`details before proceeding.
`If the light treatment for acne is interrupted, reset and continue treatment.
`Indicator Lights:
`Indicator lights for the BLU-U® are located on the control panel on the floor stand.
`
`INDICATOR
`System Status
`Indicator
`
`
`FUNCTION / OPERATION
`The red neon light, located to the right of the Timer, indicates
`system status. At the beginning of each light treatment, the System
`Status Indicator flashes three (3) times to indicate that the system
`control electronics and the neon light are functioning normally, and
`that the BLU-U® is ready for use.
`
`If System Status Indicator light fails to flash three (3) times immediately after the initiation
`of timed light treatment, the BLU-U® should not be used until the problem has been
`identified or a qualified service technician has serviced the unit.
`(See the Troubleshooting Table)
`
`If a patient has been dosed with the Levulan® Kerastick® for Topical Solution, 20%, for the
`treatment of actinic keratoses of the face or scalp, see the Levulan® Kerastick® for Topical
`Solution, 20% Package Physician Insert for further instructions on early termination or
`cancellation of light treatment.
`If the System Status Indicator lights at any other time, refer to Table 1 on the
`following page.
`
`Page 7
`
` MAN-1211 Rev B
`
`

`

`OPERATING MANUAL
`BLU-U® Blue Light Photodynamic Therapy Illuminator
`Model 4170
`When Printed This Document is "For Reference Use Only"
`System Status Indicator Error Conditions:
`
`
`Table 1
`
`CONDITION
`Rapid Flashing
`Continuous rapid flashing of the
`System Status Indicator immediately
`after initiation of the timed light
`treatment indicates a problem with the
`electronic control system.
`If this happens, the BLU-U® will not be
`operational and will not light.
`
`Slow Flashing
`Continuous slow flashing of the
`System Status Indicator (3 flashes
`every 4 seconds) after initiation of the
`timed light treatment indicates that
`either:
`• The BLU-U® output power is too
`high, or
`• A problem exists with the BLU-U®
`electronic control system.
`
`Steady On
`The System Status Indicator lights
`steadily during the treatment (for at
`least 10 seconds at a time)
`This indicator code, which may occur
`after initiation of the timed light
`treatment, indicates that:
`• The BLU-U® output power is too
`low, or
`• The end of tube lifetime has been
`reached.
`Exposure Time Indicator
`
`
`ACTION
`
`
`Discontinue the treatment.
`Turn the Key Switch and the Main Power Switch to
`the “0” (off) position, and call customer service.
`If the patient has been dosed with the Levulan®
`Kerastick® for Topical Solution, 20%, see the
`Levulan® Kerastick® for Topical Solution, 20%
`Package Physician Insert for further instructions on
`early termination or cancellation of light treatment.
`
`
`Discontinue the treatment.
`Turn the Key Switch and the Main Power Switch to
`the “0” (off) position, and call DUSA’s customer
`service department.
`If the patient has been dosed with the Levulan®
`Kerastick® for Topical Solution, 20%, see the
`Levulan® Kerastick® for Topical Solution, 20%
`Package Physician Insert for further instructions on
`early termination or cancellation of light treatment.
`
`• Complete the treatments of any patients who have
`already been dosed with the Levulan® Kerastick®,
`and
`• Call customer service.
`
`This four-digit red LED located on the Timer unit
`displays the remaining exposure time in minutes and
`seconds. Prior to pushing the Start button to begin
`light exposure, the display indicates the amount of
`exposure time set.
`When you press the Start button, the Exposure Time
`Indicator display counts down the amount of exposure
`time remaining. The tubes turn off automatically when
`the display reaches “00:00”.
`
`Page 8
`
` MAN-1211 Rev B
`
`

`

`OPERATING MANUAL
`BLU-U® Blue Light Photodynamic Therapy Illuminator
`Model 4170
`When Printed This Document is "For Reference Use Only"
`
`Instructions for Use with the Levulan® Kerastick® for the treatment of Actinic
`Keratoses:
`Note - If a patient’s light treatment is interrupted, terminated prematurely, or cannot
`be administered, see the Levulan® Kerastick® for Topical Solution, 20% Package
`Physician Insert for important further instructions.
`
`Initial Set-Up:
`1.
`Inspect the unit power fuse holder to ensure the correct line voltage has been selected.
`2. Plug the female end of the supplied electrical cord into the mating jack on the floor
`stand base and plug the other end into a standard 120∼ outlet.
`3. Press the Main Power Switch to the “l” (on) position.
`
`Set-Up:
`1. Using the key, turn the Key Switch to the “l” (on) position. Verify that the red Timer
`display is active.
`2. Position the eye protection on the patient prior to treatment. Place the eye protection
`over the patient’s eyes and insure the eye protection is secure against the patient’s
`face. Verify that the eye protection does not cover or shadow any area intended for
`treatment.
`3. Place the patient in an upright, sitting position. The procedure for positioning the
`BLU-U® depends on the location of the lesions to be treated and is found in the
`following 2 sections. The patient’s head may be supported during treatment. Ensure
`that the method of head support does not cover or shadow any area intended for
`treatment.
`
`Procedure for Treating Lesions on the Face:
`1. Loosen the knobs on either side of the light unit and rotate it to the vertical position (the
`“U” shaped bulbs stacked vertically). Retighten the knobs to lock the light unit in place.
`2. Position the BLU-U® around the patient’s head so the entire surface area to be treated
`lies between 2” and 4” from the BLU-U® surface:
`a.) The patient’s nose should be no closer than 2” from the surface
`
`and
`b.) The patient’s forehead and cheeks should be no further than 4” from the surface
`
`and
`c.) The sides of the patient’s face and the patient’s ears should be no closer than 2”
`from the BLU-U® surface
`
`Note:
`The patient’s hair should not cover or shadow the area to be treated.
`However, the patient’s hair may be closer than 2” to the surface of the
`BLU-U® without any deleterious effects.
`
`Page 9
`
` MAN-1211 Rev B
`
`

`

`4.
`
`OPERATING MANUAL
`BLU-U® Blue Light Photodynamic Therapy Illuminator
`Model 4170
`When Printed This Document is "For Reference Use Only"
`3. Set the Timer to the prescribed treatment time of 16 minutes 40 seconds by
`depressing the Time Select buttons. Continue to depress these buttons until the correct
`time is displayed.
`Insure that all personnel are wearing appropriate eye protection and then depress the
`Start/Stop switch on the BLU-U® Timer. The System Status Indicator will flash three
`(3) times and go off. If it does not flash three times, try the remedies in the
`Troubleshooting Table. If the System Status Indicator still does not flash three
`times, do not use the BLU-U® even if the Timer works and the tubes light; system
`output may be incorrect under these circumstances. [See the Levulan® Kerastick® for
`Topical Solution, 20% Package Physician Insert for further instructions on cancellation
`of light treatment.]
`5. Verify that all seven tubes are lit. If one or more does not light, discontinue the light
`treatment and call for service. See the Levulan® Kerastick® for Topical Solution, 20%
`Package Physician Insert for further details on early termination or cancellation of light
`treatment.
`6. Periodically check the System Status Indicator. If the System Status Indicator lights
`during treatment, see “Indicator Lights” in the Controls section.
`7. Take care that the patient does not move during the time the BLU-U® is on as this may
`result in under exposure of the lesion(s).
`8. At the end of the treatment period, the Timer will automatically turn off the BLU-U®.
`
`Following Patient Treatment:
`1. Remove the patient from the BLU-U® and remove the patient’s eye protection.
`2. Turn the Key Switch on the BLU-U® to the “0” position
`3. Remove the key from the BLU-U® and store it in a secure location where unauthorized
`personnel cannot use it.
`
`Procedure for Treating Lesions on the Scalp:
`1. Loosen the knobs on either side of the light unit and rotate it to the horizontal position
`(the “U” shaped bulbs stacked horizontally). Retighten the knobs to lock the light unit in
`place.
`2. Position the BLU-U® around the patient’s head so the entire surface area to be treated
`lies between 2” and 4” from the BLU-U® surface:
`a.) The patient’s scalp should be no closer than 2” from the surface
`
`and
`b.) The patient’s scalp should be no further than 4” from the surface
`
`and
`c.) The sides of the patient’s face and the patient’s ears should be no closer than 2”
`from the BLU-U® surface
`
`Note:
`The patient’s hair should not cover or shadow the area to be treated.
`However, the patient’s hair may be closer than 2” to the surface of the
` BLU-U® without any deleterious effects.
`
`Page 10
`
` MAN-1211 Rev B
`
`

`

`4.
`
`OPERATING MANUAL
`BLU-U® Blue Light Photodynamic Therapy Illuminator
`Model 4170
`When Printed This Document is "For Reference Use Only"
`3. Set the Timer to the prescribed treatment time of 16 minutes 40 seconds by
`depressing the Time Select buttons. Continue to depress these buttons until the correct
`time is displayed.
`Insure that all personnel are wearing appropriate eye protection and then depress the
`Start/Stop switch on the BLU-U® Timer. The System Status Indicator will flash three
`(3) times and goes off. If it does not flash three times, try the remedies in the
`Troubleshooting Table. If the System Status Indicator still does not flash three
`times, do not use the BLU-U® even if the Timer works and the tubes light; system
`output may be incorrect under these circumstances. [See the Levulan® Kerastick® for
`Topical Solution, 20% Package Physician Insert for further instructions on cancellation
`of light treatment.]
`5. Verify that all seven tubes are lit. If one or more does not light, discontinue the light
`treatment and call customer service. See the Levulan® Kerastick® for Topical Solution,
`20% Package Physician Insert for further details on early termination or cancellation of
`light treatment.
`6. Periodically check the System Status Indicator. If the System Status Indicator lights
`during treatment, see “Indicator Lights” in the Controls section.
`7. Take care that the patient does not move during the time the BLU-U® is on as this may
`result in under exposure of the lesion(s).
`8. At the end of the treatment period, the Timer will automatically turn off the BLU-U®.
`
`Following patient treatment:
`1. Remove the patient from the BLU-U® and remove the patient’s eye protection.
`2. Turn the Key Switch on the BLU-U® to the “0” position.
`3. Remove the key from the BLU-U® and store it in a secure location where unauthorized
`personnel cannot use it.
`
`Page 11
`
` MAN-1211 Rev B
`
`

`

`OPERATING MANUAL
`BLU-U® Blue Light Photodynamic Therapy Illuminator
`Model 4170
`When Printed This Document is "For Reference Use Only"
`
`Instructions for Use for the Light Only treatment of Acne:
`Initial Set-Up:
`1.
`Inspect the unit power fuse holder to ensure the correct line voltage has been selected.
`2. Plug the female end of the supplied electrical cord into the mating jack on the floor
`stand base and plug the other end into a standard 120 ∼ outlet.
`3. Press the Main Power Switch to the “l” (on) position.
`
`Set-Up:
`1. Using the key, turn the Key Switch to the “l” (on) position. Verify that the red Timer
`display is active.
`2. Position the eye protection on the patient prior to treatment. Place the eye protection
`over the patient’s eyes and insure the eye protection is secure against the patient’s
`face. Verify that the eye protection does not cover or shadow any area intended for
`treatment.
`3. Place the patient in an upright, sitting position. The patient’s head may be supported
`during treatment. Ensure that the method of head support does not cover or shadow
`any area intended for treatment.
`
`Procedure for treating Acne:
`1. Loosen the knobs on either side of the light unit and rotate it to the vertical position (the
`“U” shaped bulbs stacked vertically). Retighten the knobs to lock the light unit in place.
`2. For treatment of the face, position the BLU-U® around the patient’s head so the entire
`surface area to be treated lies between 2” and 4” from the BLU-U® surface:
`a.) The patient’s nose should be no closer than 2” from the surface
`
`and
`b.) The patient’s forehead and cheeks should be no further than 4” from the surface
`
`and
`c.) The sides of the patient’s face and the patient’s ears should be no closer than 2”
`from the BLU-U® surface
`
`Note:
`The patient’s hair should not cover or shadow the area to be treated.
`However, the patient’s hair may be closer than 2” to the surface of the
`BLU-U® without any deleterious effects.
`3. Set the Timer for the desired treatment time by depressing the Time Select buttons.
`Continue to depress these buttons until the correct time is displayed. The
`recommended exposure time is 16 minutes and 40 seconds per treatment (10
`joules/cm²). Light treatments should be performed two to three times per week until the
`desired clinical results have been achieved with a maximum recommended total
`cumulative light exposure of 320 joules/cm². Insure that all personnel are wearing
`appropriate eye protection and then depress the Start/Stop switch on the BLU-U®
`Timer. The System Status Indicator will flash three (3) times and go off. If it does
`not flash three times, try the remedies in the Troubleshooting Table. If the System
`
`Page 12
`
` MAN-1211 Rev B
`
`

`

`OPERATING MANUAL
`BLU-U® Blue Light Photodynamic Therapy Illuminator
`Model 4170
`When Printed This Document is "For Reference Use Only"
`Status Indicator still does not flash three times, do not use the BLU-U® even if the
`Timer works and the tubes light; system output may be incorrect under these
`circumstances.
`4. Verify that all seven tubes are lit. If one or more does not light, discontinue the light
`treatment and call for service.
`5. Periodically check the System Status Indicator. If the System Status Indicator lights
`during treatment, see “Indicator Lights” in the Controls section.
`6. Take care to minimize patient movement during the time the BLU-U® is in use.
`7. At the end of the treatment period, the Timer will automatically turn off the BLU-U®.
`
`Following Patient Treatment:
`1. Remove the patient from the BLU-U® and remove the patient’s eye protection.
`2. Turn the Key Switch on the BLU-U® to the “0” position
`3. Remove the key from the BLU-U® and store it in a secure location where unauthorized
`personnel cannot use it.
`
`Page 13
`
` MAN-1211 Rev B
`
`

`

`OPERATING MANUAL
`BLU-U® Blue Light Photodynamic Therapy Illuminator
`Model 4170
`When Printed This Document is "For Reference Use Only"
`
`Troubleshooting/Service and Repair:
`
`
`
`There are no service parts in the equipment.
`
`
`
`
`
`Components of the system should not be opened, except by a Qualified Service Person.
`Tampering by Unqualified Persons can harm the person and/or damage the unit.
`
`CAUTION:
`
`The following chart has been included to assist in determining a solution for a problem or error
`Symptom
`Possible Cause
`What To Do
`BLU-U® is not
`No power /
`Verify that the proper line voltage has been
`selected on the fuse holder.
`plugged in.
`Fans not running /
`Verify that the BLU-U® is plugged into a standard
`No Timer display upon
`120 ∼ wall outlet.
`turning Key Switch to the
`“l” (on) position.
`Verify that power is present at the outlet.
`
`
`Verify that the Main Power Switch is in the “l” (on)
`position.
`Verify that the Key Switch is in the “l” (on)
`position by rotating it clockwise 1/4 turn until a
`“click” is felt.
`If the fans now run, but the Timer still does not
`light or lights intermittently, there is an internal
`electrical fault. In this case use of the BLU-U® will
`not be possible. Call for service.
`Check the fuses in the Fused Power Entry
`Module, located next to the socket for the
`electrical cord on the base of the floor stand.
`• Turn the Key Switch and Main Power Switch
`to the “0” (off) position
`• Unplug the unit
`• With a small screwdriver, slide out the fuse
`holder
`• Check the status of the two fuses by using the
`fuse key. If either or both fuses are blown (as
`indicated by a break in the thin wire
`connecting the two metal ends of the fuse),
`replace with 5A fuses (0.5 x 20 mm slo-blo,
`Bussman # GMC-5A or equivalent).
`• Reinsert the fuse holder
`• Plug the unit into a standard 120 ∼ wall outlet
`• Turn the Main Power Switch and Key
`Switch to the “l” (on) position.
`
`
`
`
`
`No power is present
`at the wall outlet.
`Main Power Switch
`is not set to “l” (on).
`Key Switch is not
`fully turned to “l” (on).
`
`One or more fuses in
`the Fused Power
`Entry Module have
`blown.
`
`Page 14
`
` MAN-1211 Rev B
`
`

`

`
`
`Symptom
`
`
`System Status Indicator
`does not flash three (3)
`times when the Start/Stop
`button on the Timer is
`pressed
`System Status Indicator
`rapidly flashing
`Tubes not lit
`System Status Indicator
`slowly flashing
`Tubes lit
`
`System Status Indicator
`on steady or intermittently
`Tubes lit
`Tubes not all lit
`
`F001 Error Code
`Displayed on Timer
`F101 Error Code
`Displayed on Timer
`F002 Error Code
`Displayed on Timer
`F202 Error Code
`Displayed on Timer
`F303 Error Code
`Displayed on Timer
`
`
`OPERATING MANUAL
`BLU-U® Blue Light Photodynamic Therapy Illuminator
`Model 4170
`When Printed This Document is "For Reference Use Only"
`Possible Cause What To Do
`
`If normal operation does not resume or the fuse
`continues to blow, there is an internal electrical
`fault. In this case use of the BLU-U® will not be
`possible.
`Call for service.
`Use of the BLU-U® will not be possible.
`Call for service.
`Discontinue use of the BLU-U®.
`Call for service.
`
`Internal electrical
`fault.
`
`Neon light or control
`circuitry is not
`functioning properly.
`
`Control circuitry is not
`functioning properly.
`
`Use of the BLU-U® will not be possible.
`Call for service.
`
`Power output is
`above specified
`range.
`Control circuitry is not
`functioning properly.
`
`Power below
`specified range.
`
`Discontinue use of the BLU-U®.
`Call for service
`
`Discontinue use of the BLU-U®.
`Call for service.
`Complete treatment of patients.
`Call for service.
`
`Tube(s) cracked or
`broken.
`
`Control circuitry is
`not functioning
`properly.
`Timer error
`
`Timer error
`
`Timer error
`
`Timer error
`
`Timer error
`
`Discontinue use of the BLU-U®.
`Call for service.
`Discontinue use of the BLU-U®.
`Call for service.
`
`With the Key Switch turned to “l” (on), press the
`Start/Stop button to clear the Timer display.
`Call customer service to receive further
`instructions.
`With the Key Switch turned to “l” (on), press the
`Start/Stop button to clear the Timer display.
`Call customer service to receive further
`instructions.
`Call customer service to receive further
`instructions.
`
`Page 15
`
` MAN-1211 Rev B
`
`

`

`OPERATING MANUAL
`BLU-U® Blue Light Photodynamic Therapy Illuminator
`Model 4170
`When Printed This Document is "For Reference Use Only"
`
`Transport and Storage:
`
`1. The BLU-U® can be safely stored in a cool dry area. Care should be taken to avoid
`rough handling or jarring of the unit.
`
`•
`
`2. Storage Conditions:
`-20°C to 60°C
`0 to 95% RH, Non-Condensing
`500hPa to 1600hPa
`
`•
`
`•
`
`Cleaning/Disinfecting:
`
`
`
`WARNING:
`
`Turn the power off and disconnect the power cord before cleaning the machine.
`Failure to do so may result in severe electrical shock or death.
`
`CAUTION:
`
`Never immerse machine in liquids. Do not use abrasive materials to clean the machine.
`Do not allow water to enter this device. Do not clean the inside of this device. Doing so
`will cause damage to this machine.
`
`1. The exterior surface of the BLU-U® may be wiped down with a mild disinfectant or
`isopropyl alcohol. Dry with a clean dry cloth.
`
`2. The outside surface of the plastic shield may be wiped down with a mild disinfectant or
`isopropyl alcohol. Dry with a clean dry cloth.
`
`3.
`
`If goggles are used for eye protection, their surface may be wiped down with a mild
`disinfectant or isopropyl alcohol after each use. Dry with a clean dry cloth.
`
`Page 16
`
` MAN-1211 Rev B
`
`

`

`OPERATING MANUAL
`BLU-U® Blue Light Photodynamic Therapy Illuminator
`Model 4170
`When Printed This Document is "For Reference Use Only"
`
`
`
`Customer Service:
`For service, repair, or calibration of this equipment call:
`
`DUSA Pharmaceuticals, Inc.®
`Phone: 1-877-533-3872
`or
`978-657-7500
`Warranty Coverage and Disclaimers:
`See the Terms and Conditions of your contract for specific information.
`Manufactured For:
`DUSA Pharmaceuticals, Inc.®
`25 Upton Drive
`Wilmington, MA 01887
`www.dusapharma.com
`
`Page 17
`
` MAN-1211 Rev B
`
`