CERALAS PDT 633, 633nm +-3nm, 2W User Manual Ver C Feb 2003

biomedical technology

biolitec AG

MEDICAL LASER SYSTEMS Declaration of Conformity

Manufacturer: CeramOptec GmbH a company of biolitec group Siemensstraße 44 D–53121 Bonn -GermanyFon.: +49 (228) 97 967 0 Fax. : +49 (228) 97 967 99

Product Designation: Ceralas PDT 630nm-800nm, 100mW-20W We herewith declare that the above mentioned products meet the essential requirements of the Medical Device Directive 93/42/EEC and are classified as a Class IIb medical device (Annex IX rule 9). The products are designed in conjunction with the following safety standards: EN 60825-1 EN 60601-1 EN 60601-1-2 EN 60601-1-4 EN 60601-2-22

Safety of laser products Medical electrical equipment Medical electrical equipment - 2.Collateral Standard Medical electrical equipment - 4.Collateral Standard Medical electrical equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment

This declaration is based upon a Quality System meeting the requirements of DIN EN ISO 13485, DIN EN ISO 9001 (Annex II, 93/42/EEC).

Notified Body:

DQS Deutsche Gesellschaft zur Zertifizierung von Managementsystemen mbH August-Schanz-Straße 21 D–60433 Frankfurt am Main - Germany –

0297 Certificate No.:

057946 MR2

Place, Date: Bonn, 8. Nov. 2002 Signature:

Name: Dr.Lux Title: Quality Manager of biolitec group

status: released version: B 18.12.2002

file: conformity.doc page 1 to 1

biomedical technology

Ceralas PDT 633 / 2W USER MANUAL Contents 1

WARNINGS AND SAFETY PRECAUTIONS ... 2

2

VIGILANCE ... 4

3

PRODUCT DESCRIPTION ... 5

4

TECHNICAL SPECIFICATIONS... 6

5

PANELS AND CONTROLS ... 7

5.1 5.2 5.3 5.4 6

CERALAS PDT ...7 LABELS ...8 DESCRIPTION OF CONTROLS ...9 DISPLAY, CONNECTORS ...9 OPERATING INSTRUCTIONS ... 12

6.1 6.2 6.3

PREPARING UNIT BEFORE OPERATION...12 POWERING UP SYSTEM ...12 CALIBRATION OF APPLICATION SYSTEM ...12 6.3.1 Step 1... 12 6.3.2 Step 2... 13 6.3.3 Step 3... 13 6.4 TIME MODE ...14 6.5 MICROLENS MODE (IF PART OF DELIVERY)...15 6.6 POWERING DOWN SYSTEM ...15 7

ACCESSORIES... 16

7.1 7.2 7.3

PROTECTIVE GLASSES ...16 STERILE PROTECTION SHEATH ...16 POWER SUPPLY ...17 7.3.1 Ceralas PDT (230V) Transformer ... 17 7.3.2 Ceralas PDT (115V) ... 18 7.4 FOOTSWITCH / HAND SWITCH (IF PART OF DELIVERY)...18 8

APPLICATION AND LIGHT DELIVERY SYSTEMS ... 19

8.1 8.2 8.3 9

APPLICATION SYSTEMS ...19 LIGHT DELIVERY SYSTEMS / MEDICAL PROBES ...19 HANDLING AND USE OF APPLICATION AND LIGHT DELIVERY SYSTEMS ...19 SAFETY... 20

9.1 9.1.1

SAFETY ELEMENTS ...20 Possible risk ... 20

10

MAINTENANCE... 21

10.1 10.2 10.3 10.4

ROUTINE MAINTENANCE ...21 CLEANING ...21 CHANGE FUSES ...22 PLANNED PREVENTATIVE MAINTENANCE ...22

11

SERVICE POLICY ... 23

12

WARRANTY POLICY... 23

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1

Warnings and safety precautions

VISIBLE LASER RADIATION AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATON CLASS 4 LASER PRODUCT DIODE LASER 633 +/- 3nm DIODE LASER 635 +/- 10nm EN 60825-1

cw 2W (max) cw 4mW (max) EN 60601-2-22

Always wear protective eye-wear when using this unit. The optical power output from this system can cause severe eye damage or other injuries. Always wear protective eye-wear when using this unit. Exercise extreme caution to prevent injury. This equipment is intended for use by trained physicians or scientists only, and should only be operated by qualified personnel who have familiarized themselves with the operating parameters of this product prior to use. Caution: Use controls or adjustments or performing procedures other than those specified in this manual may result in hazardous radiation exposure. To prevent the risk of electrical shock do not remove the cover. All servicing of this unit should be preformed by qualified personnel. This unit contains no user serviceable parts. If the fuse located in the rear panel beside the main power switch blow, replace with an identical fuse. (see Section: “Changing fuses”). If service is required contact a factory service representative. Danger: Do not use the unit near flammable anesthetics or other flammable substances. Note: Opening this unit or adjusting components inside the unit will void the warranty since such actions may compromise the performance of the laser system. The CeralasTM PDT Diode laser is a class 4 laser according to Directives EN 608251:1994+A11:1996 / EN 60601-2-22. A class 4 laser is hazardous to the eye from both direct beam and diffuse reflection of the beam. It also represents significant skin and fire hazards. Avoid eye or skin exposure to direct or scattered radiation. Take all necessary precautions in areas in which the laser is being used. Only protective glasses designed for protection from cw-diode laser radiation at a wavelength of 633nm +/- 3nm with an optical density of greater than OD ≥ 4 should be used. Glasses not designed to this specification are not suitable for eye protection. Suitable glasses are available from your CeramOptec representative.

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Avoid eye or skin exposure to direct or scattered radiation. Take all necessary protective measures in the areas where the laser is being used. All personnel must wear protective eye-wear to eliminate the risk of eye damage. Do not stare into the aiming beam or view the aiming beam directly through optical instruments. Avoid direct exposure to the aiming beam. Avoid placing reflective material, such as metal and glass, into the beam. Do not use flammable or explosive anesthetic gasses that may be ignited by the laser. Avoid using other flammable or fume-emitting substances in the operational field. The user should read and be thoroughly familiar with this manual before operating the laser unit. The equipment should be routinely inspected and maintained in accordance with the instructions given in the maintenance section of this manual. Note: Laser equipment not in use should be protected against unqualified use by removing the key from the key switch.

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2

Vigilance

biolitec group maintains a procedure to review the experience gained from devices in the post-production phase and to implement any necessary corrective action. This medical device vigilance system is designed to improve the protection of the health and safety of patients, users, and others by reducing the likelihood of the same type of adverse incident recurring. This will be achieved by the evaluation of reported incidents, and where appropriate, the dissemination of information to prevent repetitions, and/or alleviate the consequences. Organizations and individuals involved in the purchasing of medical devices and in the provision of health-care should be aware that their co-operation is vital in providing the first link in the Vigilance chain. This includes organizations and individuals responsible for providing calibration and maintenance of medical devices. The following incidents should be reported to biolitec immediately upon them becoming known: •

Any malfunction or deterioration in the characteristics and/or performance of a device, or inadequacy in the labeling or instructions for use, which led to or might have led to: •

Death of a patient or user

•

Serious deterioration in the state of health of a patient or user

Reports should be made to the following: biolitec AG Winzelaerstr.2a D-07745 Jena

CeramOptec GmbH Siemensstr. 44 D-53121 Bonn

- GERMANY -

- GERMANY-

Fon: +49 (3641) 508 - 550 Fax: +49 (3641) 508 599

Fon: +49 (228) 97 967 - 0 Fax: +49 (228) 97 967 99

e-mail:

[email protected]

Internet:

http://www.biolitec.de/iQM/sie.asp

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3

Product description

The Ceralas PDT -Fiber-Coupled Diode Laser system is a compact, air-cooled unit. It is a complete self-contained instrument, which includes a high efficiency power supply, a microprocessor controlled, adjustable light output with automatic power stabilization, (fan cooled), as well as a switch panel and display panel designed to be user friendly. The system includes high power lasers, safety features and an SMA fiber output connector. The diodes are made from GaAs semiconductor material for high output and superior reliability. The diode lasers are enclosed in a rugged, factory-aligned, replaceable, environmentally protective module. High-capacity fans eliminate the need for water cooling, and assure low maintenance and reliable laser operation. Attention: The energy of the laser light lies above the compatibility of the eye and leads to irreversible eye damage. In order to avoid eye damage, all persons in the area have to carry the protective eye-wear. The Ceralas PDT 633 / 2W model has a maximum optical output power of 2 watts. The Ceralas PDT laser meets the intent of Directive EN60601-1-2 Part 2: Medical Electrical Equipment, Collateral Standard: Electromagnetic Compatibility, dated 1993-05, Compliance was demonstrated to the following specifications: CISPR 11 (1990), IEC 801-2 (1994-04), IEC 801-3 (1993, Draft 5), IEC 801-4 (1988) and IEC 801-5 (1992-07). Potential electromagnetic or other influences between the equipment and other devices can be not completely excluded despite appropriate design precautions. Please inform CeramOptec in such a case.

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4

Technical specifications

2W +/- 10% Ceralas PDT 633 / 2W Laser Type GaAs-Semiconductor laser 633+/- 3nm Wavelength Application / Delivery Systems Core PDT: ≥ 400µm (max.2W) Size (Use only approved systems with Ceralas PDT laser) Numerical Aperture NA = 0.37 Fiber Connector SMA 905 Exposure Mode Continuous (cw) Treatment Time Variable 1 to 9999 seconds (1sec step) Power Calibration Built in integrating sphere Aiming Beam; Aiming Power 635+/-10nm; 4mW (max) Safety Standards EN 60601-1 EN 60601-1-2 EN 60601-1-4 EN 60601-2-22 EN 60825-1 Laser Class 4 Power Supply (Transformer) (if part of delivery) Fuse (Transformer) Power Supply (Device) (use without external transformer) Fuse (Device) Cooling Footswitch Safety Standards

230V /115V (-20% / +15%) AC; 50-60 Hz 2x 4amps (slow blow) 115V (-20% / +15%) AC; 50-60 Hz 2x 8amps (slow blow) Air cooling EN60204-1 EN60947-5-1 VDE0660 Part200 IEC 947-5-1 Safetytype IP67 EN 60529

Hand switch Safety Standards Class of Product

Safetytype IP67 EN 60529 1

Dimensions Weight

190 mm x 430 mm x 380 mm (HxWxD) ca.20 kg

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5 Panels and controls 5.1 Ceralas PDT

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5.2

Labels

Laser aperture LASER APERTURE AT DISTAL END OF FIBER

Certification and power rating label Model : Ceralas PDT 633/ 2W Input Voltage 230V / 2x 8A 50-60 Hz Example:

Siemensstraße 44-D53121 Bonn

MADE IN GERMANY Model Ceralas PDT<xxx>/<x>W Input Voltage <x>V/<x>A 50-60Hz EN 60601-1 Class 1

SN-XXXX-G Danger and Laser Warning DIODEN LASER 633 +/- 3nm DIODEN LASER 635 +/-10nm

CW 2W (MAX) CW 4mW (MAX)

Example:

VISIBLE LASER RADIATION AVOID EYE OR SKIN EXPOSUERE TO DIRECT OR SCATTERED RADIATION

CLASS 4 LASER PRODUCT DIODEN LASER <xxx>+/-<x>nm CW <x> W (MAX) DIODEN LASER <xxx>+/-<x>nm CW <x> mW (MAX) EN 60825-1 EN 60601-2-22

Laser warning label

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5.3

Description of controls

The display indicates the information required for safe operation of the laser system. It will displays selected treatment time settings, indicate if the system is in standby, calibration or laser ready mode, and indicates which keys have been pressed. Any entries made from the keypad are shown. Treatment time, remaining time, and delivered energy information will also be displayed. All information is shown on the display screen, and changes can be made using the operating keys on the side or at the bottom of the screen.

5.4

Display, connectors

Display

Function keys

Arrow keys Optical power output

Laser warning sound Tuning knob

Key switch

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Display indicates: Unit status (Laser Ready / Standby) Treatment time (1s-9999s), Laser power setting Calibration mode Settings of the unit can be changed using function keys or arrow keys. Enable / Standby Calibration mode Laser ready mode Aiming beam on and off Reset time Reset all Treatment time can be increased or decreased using arrow keys. Treatment Time value: 1 – 9999 seconds. SMA fiber connector located on the front panel is the high power light output port. If fiber is not properly connected to SMA fiber connector, an error message will appear on display. Attention: Only application and light delivery systems approved by CeramOptec may be used with the Ceralas PDT laser. The use of unapproved application systems can result in damage the whole unit and potential laser safety hazards, and will invalidate the warranty. Laser warning sound is heard when the laser emits radiation. Tuning knob will allow the user to select the wanted power output. The power can be changed in increments of 0.01W or 0.1W. Increment can be changed by pressing tuning knob once. Laser unit is equipped with a key switch. Key must be removed when laser is not in use.

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Emergency off

Main power switch

Power supply

Interlock

Footswitch or hand switch (3 PIN)

Interlock light delivery system and door interlock (2 PIN interlock)

Light delivery system

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Pressing red button on top of unit will instantly turn off power and shut down laser. Use this button for emergency shut down only. Attention: Using emergency switch to shut down system does not allow a computer-controlled temperature adaptation of the semiconductor laser and may cause severe damage to the system. Unit is equipped with a main power switch and standard power entry module located at the rear panel. On (I) / Off (0). You are allowed to use the laser in the supplied power supply configuration only. See section: “Power supply”. Before plug in power supply check all connections. Interlock connectors are located at rear of the unit. If interlock plugs (footswitch or hand switch-plug and door-plug) are not plugged in properly, laser will not work and an error message will appears on the display “Interlock-error – check footswitch, door”. Attention: Danger of electrical shock or damage. Do not connect the interlock to a power source. Footswitch or hand switch must be connected to unit via 3 PIN interlock socket at rear of unit. Footswitch is located inside the footswitch housing. Laser radiation emission is started by pressing footswitch or hand switch down. Laser emits radiation for selected treatment time. Treatment can be interrupted at any time by enable footswitch or hand switch. The laser emits output radiation only as long as the user depresses the footswitch. Treatment can be resumed by pressing footswitch or hand switch again. If interlock plugs (footswitch or hand switch-plug and doorplug) are not plugged in properly, laser will not work and an error message will appears on the display “Interlock-error – check footswitch, door”. Interlock connectors are located at rear of the unit. A remote interlock switch can be connected via this socket. This can be fitted to door of treatment room. Unit remains inoperative unless this interlock switch is closed or the special blanking plug is used. Attention: Danger of electrical shock or damage. Do not connect the interlock to a power source. The laser can be used with light delivery systems with a core diameter of PDT 633: ≥ 400µm (max.2W) The use of fibers with a smaller core diameter, fibers of lower quality material or fiber optic light delivery systems not approved by CeramOptec can result in both damage to the system and potential laser safety hazards and will invalidate the warranty.

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Connection diagram 2 PIN Interlock:

Display

Supposed cause

Suggested action

Emergency Off Switch Enable Emergency Off Switch. pressed Key switch off Black display Switch on the key switch. andere Ursachen Black display Service required. *** Laser Overheated *** Obverheating for a Laser changes to standby mode until the short time proper operating temperature is reached. *** Laser Overheated *** Cooling system Service required. failure *** SHUTTER FAILURE *** Shutter failure Service required. Fiber interlock Fibre connection not Connect Application system again, no complete axial and radial clearance allowed. Fiber interlock Fibre connection Change application system. failure Door interlock Door interlock not Connect door interlock again, pay complete attention to the red mark. Door interlock Door interlock failure Check and repair door interlock system. Door interlock Blanking plug not Connect blanking plug again, pay complete attention to the red mark. Door interlock Blanking plug failure Change blanking plug, available over the service. Fiber & door interlock Both interlock failure Do the suggested actions for fibre and door interlock. Energy Application system Change application system. Out of Tolerance failure Energy Laser defekt Service required. Out of Tolerance Black display

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6

Operating instructions

Attention: All personnel must wear protective eye-wear to eliminate the risk of eye damage when operating the laser system. Caution: Use of the Ceralas PDT laser in any way other than described in the operating instructions can lead to dangerous radiation exposure. The operator must care that the operating room is properly labeled and that nobody can enter the operating room without wearing protective eye-wear. The Ceralas PDT laser is operated in continuous wave mode (cw).

6.1

Preparing unit before operation

Plug in the footswitch or hand switch cable into the 3-PIN-interlock-connector at the rear of the unit. Plug either the interlock-plug or the door-interlock-cable in the 2-PIN-interlockconnector at the rear of the unit. Connect a Ceralas delivery system or a laser probe approved by CeramOptec for the use with the system to the SMA connector located at the front panel. Insert the key into the key switch. Make sure that the emergency switch is not in pressed down. Built up the power supply like described in section: “Power supply”. Connect an approved light delivery system by the SMA connector. Screw the cup nut till the end. The light delivery System is complete connected, if there is no axial and radial clearance and no turn of fibre is possible.

6.2

Powering up system

Insert the key into the key switch. Make sure that the emergency switch is not in pressed down. To power up unit, first turn on the main power switch located at the rear of the system. Then, turn the key switch clockwise one step. The messages “Wait... laser cooling down” and “Selftest in progress” are shown on the display.

6.3

Calibration of application system

Each time a new application system (laser probe) is connected to the Ceralas PDT system, the laser switches automatically into the calibration mode. The calibration procedure assures that the selected output power corresponds with the delivered output power at the distal end of the applicator. To perform the calibration, follow these steps.

6.3.1 Step 1 Screw the PTFE ring over the sterile protection sheath and insert the sterile protection sheath into the calibration port of the Ceralas PDT laser system. Caution: Assure that the protection sheath is sterile in order to avoid any contamination of the application system.

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Sterile Protection Sheath

PTFE Ring

6.3.2 Step 2 Insert the application system into the protection sheath until it hits the bottom of the sheath. Than pull the device back approximately 15mm. Caution: To avoid any damage of the protection sheath and the application system, the device should not come into contact with the bottom of the protection sheath during calibration.

Sterile Protection Sheath (inside)

Application System

6.3.3 Step 3 Initiate the calibration procedure by switching the function key “Start calibration” and start the calibration by pressing down the footswitch or hand switch. During the calibration the footswitch or hand switch must be permanently pressed down. The progress of the calibration is shown by a bar chart. The calibration will be terminated automatically either when the applicator is removed from the calibration port or when the footswitch or hand switch is released. In this case the message “Applicator not calibrated” will be displayed. The calibration can be either restarted by pressing the function key Repeat calibration or skipped by pressing the function key “Skip calibration”. If the calibration is stopped several times by the system, the applicator may be damaged and should not be used with Ceralas PDT laser anymore. After the calibration is successfully completed, the maximum selectable output power will be shown on the display. By pressing the function key, “Start treatment” the system changes into standby mode. The desired treatment time can be selected with the arrow keys (Treatment Time Setting [s]). By pressing the function key Enable/standby the laser system will be enabled. This is indicated by an acoustic warning signal and the message “Laser ready – press footswitch to fire laser”. Attention: Make sure that the correct output power is selected. The laser radiation emission is started by pressing the footswitch or hand switch down. The laser radiation emission is accompanied by an acoustic warning signal and LED light on top of the laser system. The laser emits radiation for the selected treatment time. The remaining treatment time is shown on the display. The laser changes into standby mode at the end of the pre-selected treatment time. The treatment can be interrupted at any time by pressing the footswitch or hand switch no longer. The treatment can be resumed by pressing the footswitch or hand switch again. A change into standby mode is possible by pressing the function key, Enable/standby. version: C / 28.02.2003

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6.4

Time mode

TIME MODE, the treatment parameters of the Ceralas PDT laser are selected by setting the treatment time with the arrow keys. The power is selected with the tuning knob. The display indicates the remaining treatment time, the running time and the delivered energy. To reset the time press the reset button once. To reset time and energy, press the reset button twice. The system is powered down (possible only in standby mode) by pressing the function key, Reset all/power off four times. The message “Wait…laser heat up” is displayed. When the message “Laser ready for switch off” is displayed, the laser can be switched off using the key switch or the main power switch. Attention: Make sure that the correct output power and treatment time was selected in order to deliver the correct amount of energy

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6.5

Microlens mode (if part of delivery)

MICROLENS MODE, the treatment parameters of the Ceralas PDT laser system are calculated automatically according to the selected spot diameter (with the tuning knob). The parameters are calculated according to the: FOSCAN® Microlens treatment parameter protocol (20 J/cm2, 100 mW/cm2, and 200 sec treatment time). Parameters can only be changed in standby mode. The spot diameter can be selected: - in a range of 1.5 cm to 5.0 cm - in increments of 0.1 cm or 0.5 cm. If the maximum output power for large spot sizes (e.g., 4 cm to 5 cm in diameter) is not reached because of losses in the calibrated microlens fiber, the treatment time will be adapted automatically to achieve the correct energy density. - To reset time, press reset button once. -

To reset time and energy, press reset button twice.

-

System is powered down (only possible in standby mode) by pressing function key, Reset all/power off four times. Message “Wait…laser heat up” is displayed.

-

When message “Laser ready for switch off” is displayed, laser can be switched off using key switch or main power switch. Attention: It is important Make that the distance of the microlens to the surface is properly chosen to achieve the selected spot diameter. Refer also to FD1 (Frontal Light Distributor) microlens manual. Make sure that the illumination of surface is at a perpendicular angle to achieve a homogenous illumination. Use only biolitec-approved and calibrated microlens fibers.

6.6

Powering down system

The Ceralas PDT laser system is powered down (in standby mode) by pressing the function key Reset all/power off four times. The message “Wait... laser heat up” is displayed. When the message “Laser ready for switch off” is displayed, the laser can be switched off by using the key switch or the main power switch.

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7 Accessories 7.1 Protective glasses Note: Always wear protective goggles when operating the laser. Make sure only to use glasses with an effective optical density around the wavelength of 633nm. CeramOptec recommends “LSR Gard Diode 614-666” (D 614-666 L2).protective goggles that are certified according to ANSI Z136.1 and CE / EN 207 manufactured by the company Glendale

7.2

Sterile protection sheath

Sterile Protection Sheath

PTFE Ring Application System

The sterile protection sheath is made out of PTFE, is reusable and can be disinfected with common disinfection liquids. The recommended sterilization method is autoclave / steam sterilization at a temperature of 121°C.

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7.3 Power supply 7.3.1 Ceralas PDT (230V) Transformer Footswitch or Hand switch Laser PDT Connecting Cable

Transformer

Power Cord

230V AC

Connecting Cable Power Cord Transformer 230V /115V Hand switch (if part of delivery)

Footswitch (if part of delivery) Laser PDT

Connecting Cable Transformer 230V /115V

Power Cord Inlet Fuses Power Cord

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7.3.2 Ceralas PDT (115V) Footswitch or Hand switch Laser PDT

115V AC

Power Cord

Power Cord

Hand switch (if part of delivery)

Laser PDT

Footswitch (if parts of delivery)

115V Power Cord plug

Fuses

7.4

Footswitch / Hand switch (If part of delivery)

3 PIN Connector Footswitch

Hand switch

3 PIN Connector

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