Aktilite CL128 and CL16 ver2.5 User Manual

Foreword Thank you for selecting Aktilite®, a state of the art, LED light source recommended for use in photodynamic therapy (PDT) with Metvix® 160mg/g Cream (methyl aminolevulinate).

About Aktilite® Your Aktilite® lamp has been manufactured to the highest standards. It is designed to be energy efficient, easy to operate and give many years of maintenance-free use. Aktilite® PDT lamps use LED- light and therefore consume power at a fraction of the rate of halogen-bulb systems. Both Aktilite® 16 and 128 are easy to position over the area of skin being treated, and their compact design ensures they are easy to manoeuvre and store. The lamps emit heat-free visible red light at an average wavelength of approx. 630 nm, which allows the deepest possible dermal penetration, and is the optimal wavelength for activation of Metvix® 160mg/g Cream. Your Aktilite® lamp should give many years of trouble-free operation when used as directed in this manual. If you have any comments or questions about Aktilite® or Metvix®, please contact us at: GALDERMA in the United Kingdom: Galderma (UK) Ltd. Galderma House Church Lane Kings Langley Herts. WD4 8JP Tel: 00 44 (0) 1923 276199 Fax: 00 44 (0) 1923 267310

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Table of Contents: About Aktilite®... 2 1

Indication of Use... 4

2

Safety Instructions, Precautions and Warnings ... 4 2.1 2.2

Safety instructions and precautions... 4 Warnings ... 5

3

Description ... 6

4

Parts and Assembly... 8 4.1 4.2

Parts... 8 Assembly... 8

5

Getting Started ... 10

6

Control Panel ... 12 6.1 6.2 6.3 6.4 6.5 6.6

"Start" Key ... 12 "Guide light" key... 12 "Pause" key ... 12 "Stop" key ... 13 "Mode" key ... 13 "+" and "-" keys... 13

7

Maintenance... 14

8

Technical Data ... 15 8.1 Aktilite® CL16 & CL128 Certifications and Standards... 15 8.1.1 Specifications Aktilite® CL16... 16 8.1.2 Specifications Aktilite® CL128... 16 8.2 Power Supplies for Aktilite® CL16... 17 8.3 Power Supply for Aktilite® CL128 ... 18

9

Labels... 20

10

Error Codes ... 21

11

Accessories ... 24 11.1 11.2 11.3 11.4

12

Aktilite® CL128 ... 24 Aktilite® CL16 ... 24 Other accessories... 24 LED Lamp Accessories (Photos) ... 25 Warranty... 26

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1 Indication of Use The Aktilite® 16 and 128 lamps with Light Emitting Diodes (LEDs) are intended for use in PDT (photodynamic therapy) in combination with Metvix® 160mg/g Cream (methyl aminolevulinate). The difference between the two lamps is the size of the area that can be illuminated and therefore treated.

2 Safety Instructions, Precautions and Warnings 2.1

Safety instructions and precautions This device is only to be sold or to be used by or on the order of a physician or a healthcare professional. Aktilite® CL16 & CL128 are for medical professional use only and should only be operated by trained personnel. Patients and operators should use protective goggles during illumination. Use only eyewear which blocks light with wavelengths that correspond to the Aktilite® CL16 & CL128 light spectrum. The Optical Density (O.D.) should be two or greater. Aktilite® CL16 & CL128 should be placed in an environment where a humidity of 10 to 80% (non-condensing) and a room temperature of 15 to 35°C (59 to 86°F) can be maintained. Units should be allowed to warm up under non-condensing conditions before application of power. Do not attempt to perform service, or open the lamp or power supply. Any kind of service should only be carried out by authorised personnel. Aktilite® CL16 & CL128 are safe and do not pose an electrical shock hazard to users if they are installed without alteration, and connected to a power outlet of the required specification (see chapter 8 for more information). The lamps use low voltage (less than 51.5 V) at the user interface. The device is designed for indoor use only. The device will work on voltages from 100 to 240 Vac, 50 to 60 Hz. The power consumption for Aktilite® CL16 is approx. 25 W and Aktilite® CL128 is approx. 180 W. When connecting the leads , connect the lamp lead first, and then the mains lead. Never connect the mains lead to a power outlet with a voltage or frequency different from that indicated on the label on the power supply. Do not expose this appliance to moisture. Page 4 of 26

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Never push objects of any kind into the power supply or the lamp head as this may damage the system and may result in fire or electric shock. When the system is left unattended and unused, unplug the power supply from the mains outlet for added protection. Do not subject the power cord to excessive mechanical stress.

2.2

Warnings Before using the Aktilite® CL16 & CL128 you should carefully read the User Manual. Consult the Metvix® 160mg/g Cream package insert or summary of product characteristics for additional information. Any use of Aktilite® CL16 & CL128 which is not in accordance with the User Manual instructions or the Metvix® 160mg/g Cream package insert shall be considered as misuse of the device and shall discharge Galderma from any liability thereof.

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3 Description The Aktilite® CL16 & CL128 lamps emit red light, and are intended for use only in topical Photodynamic Therapy (PDT) of skin lesions in combination with Metvix® 160mg/g Cream. Aktilite® CL16 illuminates areas up to 40 x 50 mm, and Aktilite® CL128 illuminates areas up to 80 x 180 mm. The light dose can easily be adjusted, but dosage of 37 J/cm² is recommended with Metvix® 160mg/g Cream DPT, with a working distance between 50 and 80 mm. The dose time is approximately the same for working distances in this range. The LED light has a narrow spectrum with average wavelength of approx. 630 nm. The recommended light dose of 37 J/cm2 at the lesion surface corresponds to 75 J/cm2 for PhotoCure's halogen PDT lamp (model: CureLight 01) with wavelength filters. Light spectra for the two lamps are shown below.

The emission spectrum of Aktilite CL16 and CL128 LED light

The Aktilite® 16 & 128 consists of two main parts: a lamp with a parallel arm and a power supply. It is essential that none of these elements are replaced by non-original parts. Galderma assumes no responsibility for any product where such replacement has occurred.

The lamps can be table-mounted, wall-mounted or mounted on a trolley stand. (See Chapter 11 for further details on lamp accessories.)

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If any component of the Aktilite® 16 & 128 needs to be replaced, please contact your local supplier.

Figure 1 – Aktilite® CL16 & CL128

Weight of Lamp Swivel of light head Tilt of light head (in/out)

Aktilite® CL16 3 kg with arm 200 degrees +/- 180 degrees

Aktilite® CL128 8.5 kg with arm 270 degrees +/- 180 degrees

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4 Parts and Assembly 4.1

Parts

Prior to assembly, please make sure that you have received all of the following: Qty. 1 1 1 1 1 1 1 1 1

4.2

Description Lamp with Parallel Arm Universal Power Supply Protective Goggles for the patient (black) Professional Protective Glasses Protective Caps (for patients) Set of leads User Manual Table Clamp (Aktilite® CL16 only) Distance Piece (Aktilite® CL16 only)

Assembly When using a table clamp, make sure that maximum extension of the lamp does not cause tilting of the table. Also make sure that the table clamp is properly fastened. • •

Place the lamp arm in the table clamp or the optional trolley stand. Connect the cable from the lamp to the power supply with the bayonet plug. Fasten the plug by twisting the metal bayonet ring in a clockwise direction (see picture below).

Aktilite CL128

Aktilite CL16

• •

Connect the mains plug to the power supply and to an appropriate mains outlet. If the lamp is table-mounted, test that the unit does not tip over when the arm is stretched out to its maximum length.

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For Aktilite® CL16 only: •

Mount the distance piece by pressing it straight down into the holes on the underside of the lamp head (see pictures below).

•

The distance piece is made of stainless steel. It assures a minimum distance of 50 mm to the lesion surface and indicates the area of the light field.

NOTE: Between treatments, the distance piece should be cleaned with solutions suitable for stainless steel.

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5 Getting Started NOTE: The patient and operator must always wear eye protection when the Aktilite® is operated at full brightness.

Before you start, it may be helpful to consult the picture of the control panel at the beginning of chapter 6 of this user manual. Switching On the Aktilite®: - Connect the lamp to the power supply, and then the power supply to the mains supply. - Press and hold down the "Start" key until a beep is heard. The display will switch on. - The Aktilite® will perform a self-diagnostic test and after a few seconds it will be ready for use. Switching Off the Aktilite®: - Press and hold down the "Stop" key until a long beep is heard. (NB One press of the "Stop" key will not switch off the Aktilite® lamp if the lamp is in use, i.e. during illumination or when an illumination is paused. Pressing the "Stop" key in this case will only switch off the light (not the entire lamp) and the ongoing illumination will be aborted.) - The Aktilite® should be disconnected from the mains supply when not in use. - The Aktilite® will automatically go to standby if not used for 15 minutes (NB The Aktilite® will not automatically switch off if the guide light is on) Positioning the Aktilite® by Use of Guide Light: - Press and release the "Guide light" key. - Aktilite® will illuminate at the reduced guide-light brightness. - Position the Aktilite® over the area to be illuminated. Note that the area to be treated should be set between 5 to 8 cm from the lamp. - Press and release the "Guide light" key to turn off the light, or press and release the "Start" key to start the illumination Adjusting the Aktilite® Light Dose: - Press and release the "Mode" key to display "Adjust Dose". - Use the "+" and "-" keys to adjust the dose to the required value. - A light dose of 37 J/cm2 is recommended for Metvix® 160mg/g Cream PDT for Actinic Keratosis (AK) and Basal Cell Carcinoma (BCC). - Press and release the "Mode" key when the adjustment is completed, or press and release the "Start" key to start the illumination at the selected dose.

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To Start an Aktilite® Treatment: - Press and release the "Start" key. - Aktilite® will illuminate at full brightness. - The display will show the time remaining for this illumination. - At the end of the illumination, five beeps will be heard (these can be stopped by pressing and releasing the "Stop" key). To Pause an Aktilite® Treatment: - Press and release the "Pause" key. - The light will go out and the counter for remaining time will stop. - Press and release either the "Pause" key or the "Start" key to continue the illumination. To Interrupt (Abort) an Aktilite® Treatment: - Press and release the "Stop" key during an illumination - The light will go out.

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6 Control Panel

Figure 2 – The Aktilite® Control Panel.

The keys are marked with “Guide light”, “Start”, “Pause”, “Stop”, “+”, “-”, and “Mode” and function according to the descriptions below.

6.1

"Start" Key • • • •

6.2

The Aktilite® is switched on by pressing the "Start" key for about ½ second. A diagnostic test will be performed and the lamp’s serial number, version, and operating hours will be shown. The display will then show the selected dose setting and "Lamp Ready". Pressing, "Start" again will start the illumination with the selected dose.

"Guide light" key This key toggles the guide light on and off. The guide light is used to position the Aktilite® lamp correctly, making sure that the intended area is covered. It is important that the area is in the centre of the field and kept there during illumination. To avoid movement during illumination, it is important to make sure that the patient is placed in a comfortable position with good physical support. The patient should always be under supervision during illumination.

6.3

"Pause" key Use this key if the illumination has to be paused. Pressing this key again or pressing the "Start" key will continue the illumination from the time it was paused.

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6.4

"Stop" key The "Stop" key is used to interrupt (abort) an illumination or to switch off the Aktilite®. If the "Stop" key is pressed and released during illumination or when an illumination is paused, the illumination will be interrupted (aborted). The Aktilite® will still be switched on and the message "Lamp Ready" will appear on the display. Pressing the "Stop" key for more than 2 seconds when the message "Lamp Ready" is displayed, will switch off the Aktilite®.

6.5

"Mode" key The "Mode" key is used to enter the "Adjust Dose" mode. After setting the required dose, a brief press of the "Mode" key returns the Aktilite® to the "Lamp Ready" state.

6.6

"+" and "-" keys When you are in "Adjust Dose" mode, the "+" and "-" keys are used to adjust the dose value. The buttons adjust the dose in steps of 1 J/cm², and the corresponding dose time will be calculated and displayed simultaneously in minutes and seconds. The recommended dose is 37 J/cm². To obtain a rapid increase/decrease of the dose value, hold the buttons down.

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7

Maintenance

Between treatments: the CL16 distance piece should be cleaned with solutions suitable for stainless steel. Daily:

Clean the window under the lamp with a slightly moist clean cloth. Do not use strong detergents or solvents (e.g. acetone) as this may cause damage to the surface.

Weekly:

Clean the lamp and power supply with a soft, dry or slightly moist clean cloth. Do not use strong detergents or solvents (e.g. acetone) as this may cause damage to the surface.

Monthly:

Inspect all cables and check for damage.

Disposal of old lamps: Electronic waste should not be thrown in the municipal waste. Please contact your supplier for information on how to dispose of old Aktilite lamps.

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8 Technical Data 8.1

Aktilite® CL16 & CL128 Certifications and Standards EC/EEA Declaration of Conformity PhotoCure declares conformity with the provisions laid down in Council Directive 93/42/EEC in order to place Aktilite® CL16 & CL128, medical devices of risk class IIa, on the market. Aktilite®, which is a lamp for medical therapy (photodynamic therapy), meets the essential requirements in the directive, and the provisions in 93/42/EEC Annex VII are fulfilled. It has been certified by Nemko (notified body) that the production quality system conforms with the relevant provisions in Annex V of 93/42/EEC. CE-marking with Nemko's EC notification number will be affixed to each conforming product.

Certifications and Standards Aktilite® CL16 & CL128 Nemko Certified to:

CB Certified to: CSA/US standards*:

• • • • • •

Safety standard: EN 60601-1:1990 + A1:1993 + A2:1995 + A13:1996 EMC standard: EN 60601-1-2:2001 IEC 60601-1 (2 ed.); am1; am2 EMC:IEC 60601-1-2 (2 ed.) Class 8750 01 Medical Electric Equipment Class 8750 81 Medical Electrical Equipment – Certified to U.S. standards

* The "C" and "US" indicators adjacent to the CSA mark on the labels signify that the product has been evaluated to the applicable CSA and ANSI/UL standards, for use in Canada and U.S., respectively. This "US" indicator includes products eligible to bear the NRTL indicator. NRTL, i.e. National Recognized Testing Laboratory, is a designation granted by the U.S. Occupational Safety and Health Administration (OSHA) to laboratories that have been Recognized to perform certification to U.S Standard.

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8.1.1 Specifications Aktilite® CL16

Type

Aktilite®, model CL16 Class I Type B applied part

Specifications No. Of Light-Emitting Diodes Light Output Average Wavelength Dose Regulation Nominal Voltage Input

16 Approx. 830 lumen @ 350 mA/LED Approx. 630 nm 1-99 J/cm2 48 Vdc 25 W 100-240 Vac 50/60 Hz

8.1.2 Specifications Aktilite® CL128

Type

Aktilite®, model CL128 Class I Type B applied part

Specifications No. Of Light-Emitting Diodes Light Output Average Wavelength Dose Regulation Nominal Voltage Input

128 Approx. 6600 lumen @ 350 mA/LED Approx. 630 nm 1-99 J/cm2 48 Vdc 180 W 100-240 Vac 50/60 Hz

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8.2

Power Supplies for Aktilite® CL16 Type Features

Mascot model 9920 Medical Global Performance Switcher, Running at approx. 25 VA • High efficiency (85%) • Medical approved to UL2601, EN60601-1, EN 60950, CSA C22.2 • CE marked

Specifications: DC Output 51.5 Vdc ±0.5 V 90-264 Vac, 47-63 Hz single phase. AC Input Maximum Output 0.8 A Current Minimum Output 0 A Current Normal maximum output power is 40 W continuous. Output Power < 1% Load Regulation Mains Regulation < 0.5% Mains variation 198-264 volt, 100% load 40 kHz (approx.) Switch frequency < 300 mV 90-10% load variation Overshoot < 350 mV 10-90% load variation Undershoot > 20 ms Hold up time Temperature range Operating: -20 - +40 °C (With derating: +60°C). Storage: -25 - +85 °C Yes Current-limiting 50 mV p-p Ripple Class I Insulation Class Insulation Voltage 4000 Vac/5640 Vdc Primary - secondary EN 60601-1, EN 60950 Safety Standards Medical EN 60601-1-2, Emission: EN 50081-1. Immunity: EN EMC Standards 50082-1 3 pin IEC 320 connector Input Terminal FCI UTG0104SH Output Terminal 107 x 67 x 36.5 mm Dimensions (L/W/H) 250 g Weight

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8.3

Power Supply for Aktilite® CL128 Type Features

Condor GPFM 250-48, 250 Watt Medical Global Performance Switcher, running at 180 VA • Power factor corrected to IEC 1000-3-2, Class A • Less than 300 µA leakage current • Conducted EMI exceeds FCC Class B and CISPR 11 Class B • Medical approved to UL2601, IEC601-1 and CSA 22.2 No. 601.1 • CE marked to LVD

Specifications: AC Input Input Current

Hold-upTime Overload Protection

Output Noise

Transient Response

Overvoltage Protection Voltage Adjustment Input Protection EMI/EMC Compliance

85-264 Vac, 47-63 Hz single phase. Maximum input current 2.3 A at 90 Vac, 60 Hz with full rated load. Input current harmonic content meets the requirements of IEC10003-2 for all load conditions greater than 75%, 230 Vac input. 25 ms minimum from loss of ac input at full load, nominal line (115 Vac). Fully protected against short circuit and output overload. Short circuit protection is cycling type power limit. Recovery after fault is automatic. Individual output current limits are a function of load distribution and degree of overload. 0.5% rms, 1% pk-pk, 20 MHz Bandwidth, differential mode. Measured with noise probe directly across output terminals of the power supply. Main Output: 500 µs typical response time for return to within 0.5% of final value for a 50% load step change, ∆i/∆t< 0.2 A/µs. Maximum voltage deviation is 3.5%. Load must not go below stated minimum. Built-in. Output voltage decay is dependent upon loading. Main output ±5%. Internal ac fuse provided. Fuse does not blow on overload or short circuit-fuse blows only if catastrophic failure occurs in the unit. Built-in EMI filtering to meet emissions requirements: EMI SPECIFICATIONS COMPLIANCE LEVEL Conducted Emissions EN55011 Class B; FCC Class B Static Discharge EN61000-4-2, 6 kV contact, 8 kV air RF Field Susceptibility EN61000-4-3, 3 V/meter Fast Transients/Bursts EN61000-4-4, 2 kV, 5 kHz Surge Susceptibility EN61000-4-5, 1 kV diff., 2 kV c

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Specifications (continued) Inrush Current

Thermal Shutdown Power Fail

Inrush 240 Vac is less than 37 A, averaged over the first ac halfcycle under cold start conditions. Limiting provided by internal thermistors. Designed to protect unit from prolonged over temperature. TTL or CMOS compatible output goes low (<0.5 V) 8 ms before output voltage drops more than 4% below nominal voltage upon loss of ac power. The signal is factory set to trip when input power can no longer sustain the output. 0.03% / °C typical on all outputs.

Temperature Coefficient Leakage Current 70 µA under normal conditions (132 Vac @ 60 Hz). Maximum under single fault conditions (254 Vac @ 50 Hz), 130 µA. Patient sink leakage with 120 Vac, 60 Hz applied to any output with respect to the chassis will be less than 500 µA. Environmental Specification Temperature (A) Humidity (A) Shock (B) Vibration (C)

Operating 0 to 40ºC 0 to 95% RH 20gpk 1.5 grms, 0.003 g2/Hz

A. Units should be allowed to warm up/operate under non-condensing conditions before application of power. B. Shock testing - half-sinusoidal, 10 ±3 ms duration, ± direction, 3 orthogonal axes, total 6 shocks. C. Random vibration - 10 to 2000 Hz, 6 dB/octave roll-off from 350 to 2000 Hz, 3 orthogonal axes. Tested for 10 min./axis operating and 1 hr./axis non-operating.

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9 Labels Manufacturing label on the lamp arm:

Warning and special waste label on the lamp arm:

Label on the Power Supplies The Power Supply is equipped with model number and operating voltages.

Aktilite® CL128 Power Supply

Aktilite® CL16 Power Supply

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