RJ Laser Probes For every need. Operating Instructions

Transcription

1 RJ Laser Probes For every need Operating Instructions

2 Contents 1 Probe product line Introduction Safety information... 6 General information Liability disclaimer Safety standards Personnel Treatment area Prevent unauthorized use Emergency shutdown Radiation injuries Risk of burns Risk of infection Decommissioning 4 Applications... 9 Treatment range Indications for use Contraindications / Limitations 5 Delivery contents and accessories Probe types Startup...13 Checking for transport damage Self-test Automatic probe detection Probe symbols 2

3 8 Working with probes...15 Remote functions Probe display Button functions Changing the therapy set Selecting the therapy program Therapy mode Reduced diagnostic power Changing the contrast 9 Mobile use Error messages Care and maintenance Physical principles of laser therapy...24 Continuous wave and pulsed probes Energy output using CW probes Energy output using pulsed probes Formulas for therapy practice 13 Technical description...34 Technical data Operating conditions Transport and storage Guidelines and manufacturer's declarations Explanation of symbols 14 Warranty and disposal Manufacturer/Distributor

4 The probe product line Multi-cluster probes For two-dimensional applications, Reimers & Janssen offers pulsed and continuous wave probes with various wavelengths. Single probes All probes for point applications are equipped with a display and four control buttons. 1 2 CW multi-cluster probe (model 517 B) * 4 x 40 mw / 655 nm (red) + 8 x 55 mw / 785 nm (infrared) Display, 4 control buttons Pulsed multi-cluster probe (model 516 A) * * 5 x 30 W / 904 nm (infrared) Display, 2 control buttons 3 4 Pulsed single probe (model 515 A) 90 W / 904 nm (infrared) CW single probe 50 mw (model 510 A) 785 nm (infrared) Additional single probes not shown: 5 CW multi-cluster probe, cuff (model 518 A) 4 x 40 mw / 655 nm (red) + 8 x 55 mw / 785 nm (infrared) * Also available in the derma and brush designs (model 517 C / D) and with 6 x 500 mw / 810 nm (model 517 E) * * Also available in the focus design and knee (model 516 C / 516 D) CW single probe 50 mw (model 513 A) 655 nm (red) CW single probe 150 mw (model 514 A) 638 nm (red) CW single probe 200 mw (model 512 A) 670 nm (red) CW single probe 200 mw (model 511 B) 810 nm (infrared) CW single probe 500 mw (model 511 A) 810 nm (infrared) 4

5 Introduction 2 Your RJ laser probe Thank you for choosing a Reimers & Janssen laser probe. Our extensive probe product line provides the optimum laser probe for every therapy and diagnosis need. Whether you're using a surface probe, single probe, or laser needles, all of our highly specialized laser probes are operated by the same control unit, the Physiolaser olympic, the structurally identical Aku-Wave 4, or the Photonic 500. With this modular design, we can combine technological innovations with a sophisticated control concept. This brings several advantages for you as a therapist. Once you have familiarized yourself with the intuitive operation of your control unit, you can use another probe in essentially the same way. This means that there is little change in your work routine if you purchase a new probe for additional applications. Your Physiolaser, Aku-Wave, or Photonic automatically detects which probe is attached and remembers your preferred settings. The Physiolaser and Aku-Wave even let you use two therapy probes at the same time. Thanks to the modular design, you can always benefit from the latest research innovations because your control unit can be easily updated with the latest therapy programs. With laser probes from Reimers & Janssen, you can utilize the versatile capabilities of gentle laser therapy to achieve the best possible results for your patients. RJ laser probes For every need 5

6 Safety information 3 General information This device is a laser probe that can only be operated in combination with a control unit, your Physiolaser, Aku-Wave or Photonic 500. Read the operating instructions for your control unit thoroughly before using the probe. These instructions complement the operating instructions for your Physiolaser, Aku-Wave, or Photonic and cover special functions of the probe. They also describe the commissioning of the device and indicate hazards associated with its use. All individuals who use, care for, service, or supervise this device must read and follow the instructions. These operating instructions must always be kept with the device and must be included with the laser probe if given to others. Liability disclaimer You may use the laser probe only for the purposes described in these operating instructions and only under supervision. The manufacturer is not liable for the device and the consequences resulting from operation or applications that are not described within these operating instructions. The manufacturer reserves the right to make changes based on technological improvements. The laser probe may only be operated with accessories approved by Reimers & Janssen GmbH and only with a control unit manufactured by Reimers & Janssen GmbH. Currently, these are the Physiolaser olympic and the Aku-Wave 4 (models 172 and 174) and the Photonic 500 (model 160A). Never open the device. Any Repair and maintenance work may only be performed by Reimers & Janssen GmbH or a company authorized by Reimers & Janssen GmbH. Functions and safety standards The probes conform to the following international safety standards: IEC Safety of medical electrical devices IEC Electromagnetic compatibility IEC Usability IEC Safety of diagnostic and therapeutic laser devices IEC Safety of laser products 6

7 Personnel The operator of this device must comply with the applicable national and international regulations for the operation of a Class 3B laser (e.g. IEC and IEC , CAN/ CSA Z386-92). Any person who uses the device must be instructed in the handling of the device and the dangers associated with laser radiation. The low level laser should be used in therapy as stated for its intended use for medical and healthcare clinics. The laser may be operated by professionals and trained personnels such as physiotherapists, acupunctrists, therapists and nurses in healthcare with medical supervision and independently after they had been trained. Treatment area Operate the laser only indoors. The room in which laser therapy is performed must meet the requirements of national accident prevention regulations. All entrances must display a laser warning sign in compliance with IEC Reflective objects, mirrors, and chrome surfaces must be removed. Children may enter the room only as patients and must be under constant supervision. Prevent unauthorized use Your Physiolaser, Aku-Wave, or Photonic is equipped with a safety key to prevent unauthorized use. The laser can be operated only with the key inserted. When the laser is not in use, the key should always be removed and stored separate from the unit in order to prevent unauthorized use. Emergency shutdown Firmly press in the red "Emergency Stop" button on the control unit, turn the safety key to "off", and disconnect the plug for the safety lock "Remote control plug". Radiation injuries Avoid direct or scattered radiation to the eyes. Do not look directly into the laser radiation output area, since visible and invisible laser radiation can cause injury to the eye. SPERIAN RJ laser protective eyewear conforming to the European standard EN 207 must always be worn within the treatment room during treatment. Exercise caution when performing therapy on the head region! If you are performing extended treatments or using a high energy output, adjust the dosage to the specific skin types treated to prevent the risk of burns. Note that the pigmentation of a patient s skin can change over multiple treatments. When treating patients with darkly pigmented skin, birthmarks, tattoos, etc. be aware of the risk of burning because melanin or color in the skin tissue absorbs the light. In this case, reduce the power or energy output. 7

8 Risk of burns The probe tip may become very hot at high power output and an extended treatment time. In this case, avoid direct skin contact by using a cap or applicator. Otherwise, burns may occur. Alternately, reduce the power output and/or treatment time (see page 20). Risk of infection While performing therapy on damaged skin, keep the probe approx. 1 cm from the skin to avoid direct contact and prevent bacterial contamination. After each treatment, disinfect your probe as described in the chapter Care and maintenance on page 23. If you use an applicator, also steam sterilize the applicator after each treatment in order to minimize the risk of patient infection. Decommissioning in the event of a hazard If you believe that the device can no longer be operated safely, it should be decommissioned to prevent against further use and to send it to the distributor for repair. Such cases include: housing components or the probe cable have visible damage the device no longer functions properly the device has been stored or transported for a long period under adverse conditions the display fails or is illegible. 8

9 Applications 4 Treatment range Reimers & Janssen laser probes are suitable for a wide range of treatments in dermatology, rheumatology, orthopedics, physiotherapy, sports and veterinary medicine as well as dentistry. A variety of individually adjustable therapy programs are available on your control unit, the Physiolaser olympic, Aku-Wave 4, or Photonic 500. Please read the operating instructions for your control unit for information about these therapy programs. If you would like an overview of all therapy programs and frequencies currently available for the Physiolaser, Aku-Wave, or Photonic, please contact your distributor. Your probe may be used for irradiation of the skin and for acupuncture treatments. Indications for use The laser probes are indicated for the temporary relief of minor muscle and joint pain and stiffness, to temporarily increase local blood circulation, the relaxation of muscles. Contraindications / Limitations We advise against the irradiation of the following organs and areas: Eyes Areas near the thyroid gland and other endocrine glands Testicular region Epiphyseal region in children Open fontanel Fetuses or in the area above the uterus of pregnant women Dark, pigmented or colored skin, regions with dark hair No irradiation of the head area in patients with (a tendency to) epilepsy In addition, we advise against treatment of patients with the following indications: Cytostatic immunosuppression Tumor/cancer patients 9

10 Delivery contents and accessories 5 Delivery contents Laser probe Carry bag (soft case) Tip attachment No (single probes only) Accessories In addition to manufacturing laser probes in various power output classes and wavelengths, Reimers & Janssen also offers various accessories for our single probes. These applications can be easily screwed onto the product in place of the standard attachment, allowing for even more applications. Available applicators suitable for all CW single probes Item Length Diameter* Item No. Illustration Dental applicator 7 cm 4 mm 5202 Dental applicator 7 cm 2 mm 5204 Dental wand 7 cm (angled 60 ) 8 mm 5207 Dental wand 5 cm (straight) 8 mm

11 Item Length Diameter* Item No. Illustration Convex lens 10 mm 523 Quartz tip attachment 2 cm 2 mm 5241 Quartz tip attachment 2 cm 4 mm 5251 PDD/PDT Universal Tip (disposable) 2 cm 0.8 mm 5206 PDD/PDT Endo Tip (disposable) 2 cm 0.4 mm 5205 *Diameter of the light output area 11

12 Probe types 6 Continuous wave and pulsed probes Reimers & Janssen offers two types of lasers in its probe product line: CW probes and pulsed probes. CW ("continuous wave") probes can provide a continuous laser beam, while pulsed probes emit extremely short pulses of light in succession. Light emission on both types of probes can be controlled by modulation frequencies. The Physiolaser, Aku-Wave, or Photonic will automatically detect the connected probe and make the corresponding programs available for use. You can use therapy programs with pre-programmed modulation frequencies or simply program the frequencies yourself. For detailed information, please consult the operating instructions for your Physiolaser, Aku-Wave, or Photonic. When adjusting frequencies, note that the energy output on CW probes is always half that of continuous wave mode regardless of the frequency. In contrast, the energy output on pulsed probes (which cannot operate in continuous wave mode) depends on the selected frequency. Energy emission is highest at the maximum frequency. The power output cannot be changed on pulsed probes. If you would like to know the precise relationship between the amount of energy and the power output on continuous wave and pulsed probes, please read the chapter Physical principles of laser therapy on page

13 Startup 7 Checking for transport damage Inspect your probe for damage that may have occurred during transport, i.e., whether the housing components or the probe cable have visible damage. If your probe has a display, remove the protective film and test the display. If you discover any damage, do not operate your probe. Instead, contact your distributor. Self-test Your probe does not require a particular start-up procedure. You can connect the probe to the control unit using the probe cable at any time. However, if you are operating your Physiolaser, Aku-Wave, or Photonic for the first time, read the operating instructions for your control unit prior to connecting the probe. Your probe will performed a self-test when you turn on the control unit with the probe connected or if you connect the probe to a control unit that is already on. The status indicator flashes briefly during this test. If this does not occur, your laser probe may be connected to the diagnosis socket. The status indicator flashes during the self-test. Automatic probe detection The Physiolaser, Aku-Wave, or Photonic will detect a connected probe automatically and the corresponding symbol will be displayed on the therapy selection screen. The software for your control unit may need to be updated if a corresponding symbol does not appear. This may occur if you purchased the new probe for a pre-existing control unit. If this is the case, an SD card is provided with the probe to help you perform the update yourself. Instructions are supplied with the probe. Please contact your distributor. 13

14 Physiolaser olympic Physiolaser olymic Charge Laser Test Power Diagnosis Laser The two laser sockets on the Physiolaser and Aku-Wave let you use two probes at the same time. Both laser sockets are shown on the therapy selection screen. "Laser 1" corresponds to the left socket and "Laser 2" corresponds to the socket on the right. Probe symbols In addition to single probes and multi-cluster probes, your control unit can also control the LightNeedle acupuncture probe and the Photonic satellite laser scanner. The different probe types can be easily distinguished by different symbols. These instructions do not describe the special functions of the LightNeedle acupuncture probe or the Photonic satellite laser scanner. There are separate operating instructions each for the LightNeedle and the Photonic satellite. Pulsed single probe CW single probe Pulsed multi-cluster probe CW multi-cluster probe LightNeedle Photonic satellite 14

15 Working with probes 8 Remote functions Your probe is operated primarily via the touchscreen on your Physiolaser, Aku-Wave, or Photonic. Read the instructions for your control unit. These instructions only describe the functions specific to the probes. For ease of use, all probes are equipped with buttons for selecting essential program functions directly from the probe. All probes come with remote functions. Probe display A two-line status display provides information on the set parameters and program sequences. If your Physiolaser, Aku-Wave, or Photonic is currently in "Stand by" mode, this will also be indicated on the probe display. The buttons on the probe are inactive in this state. The remote functions can be used once you switch to the therapy selection screen on your control unit by pressing "Ready". RJ Laser Stand by "Stand by" indication on the probe display 15

16 Button functions on single probes Start/Stop Brief press: Start therapy; stop therapy Long press: Start therapy with reduced diagnostic power Right arrow Change to next program group, program series, or next therapy program Left arrow Change to previous program group, program series, or previous therapy program Group Change from program groups to program series and therapy programs Buttons on CW multi-cluster probes LASER ON GROUP Buttons on pulsed multi-cluster probes Left arrow Change to previous program group, program series, or previous therapy program Right arrow Change to next program group, program series, or next therapy program Group Change from program groups to program series and therapy programs Start/Stop Start therapy; stop therapy Pause 1x pauses therapy 1x resumes therapy Start/Stop Brief press: Start therapy; stop therapy 16

17 Selecting therapy programs* You can select the desired therapy program on your probe without touching the screen of your control unit. You can scroll through the program groups and series as well as change between the individual programs. A red frame on the therapy selection screen provides orientation when navigating using the buttons. Basis Cont. beam The program series and the therapy program are shown on the probe display. Navigating using buttons* Use the Group button to switch between the levels program group, program series, and therapy programs. The display on your control unit indicates that the "Continuous Beam" therapy program in the "Basis" programs series has been selected for the attached probe. Use the arrow buttons to navigate within a level. *The pulsed multi-cluster probe does not have this function. PROT.2 P2 The red frame provides orientation with navigating with the buttons. 17

18 Therapy mode You can start therapy at any time from the therapy selection mode by briefly pressing the "Start/Stop" button. This is also possible if another probe has been selected or if another probe is already in therapy mode. In both cases, the most recently selected therapy program is started. Do not forget to put laser protective eyewear on your patient and yourself prior to starting therapy. P2 1.1 :150mW 04:45 Therapy program Energy output Power output Remaining therapy time Once you press the Start button, a twosecond signal tone will sound and the status LED will flash until the onset of the therapy mode.. During this time, you can still press the "Start/Stop" button to end the program, for example if you have forgotten to put on protective eyewear. During the two-second period, the 50 mw single probe emit a visible but harmless pilot beam that helps you find the exact therapy location. The status indicator remains on during therapy. The end of therapy is indicated by a long signal tone. The current therapy program can be stopped at any time by pressing the "Start/Stop" button. When you press the "Start/Stop" button, the status LED flashes until the onset of the therapy mode. The status indicator remains on during therapy. On the pulsed multi-cluster probe, you can press the "Pause" button to interrupt therapy and the "Start/Stop" button to resume. All buttons are active in therapy mode so you can also change the program during a treatment. Stop the current therapy program using the Start/Stop button. 18

19 Reduced diagnostic power All single probes offer the option of reducing the therapy power output to 5 mw for diagnostic testing. Simply press and hold the "Start/Stop" button on your probe instead of pressing briefly. The program sequence is the same; the therapy screen and the probe display only show "R 5 MW" in the power output section. Cont. Beam 0.8 R: 5mw 59:19 Start/Stop button "5MW" is indicated on probe display Indikation Visite 115 If the probe display is difficult to read (e.g., in bright sunlight), you can change the contrast in the "Setup Laser" menu on your control unit. Indikation Visite 115 Changing the contrast "Setup Laser 1" screen on the Physiolaser, Aku-Wave, or Photonic; "+" and "-" change the contrast on the probe display. 19

20 Caution when using the 500 mw CW single probe The tip of the 500 mw CW single probe may overheat if operated at full power for an extended treatment time. As a result, this probe must never be used without an attachment or applicator. Otherwise, the probe tip may become too hot and cause burns on skin contact. The 500 mw CW single probe should not be operated at full power for more than five minutes. For longer treatments at full power, pause treatment for at least one minute after every five minutes of treatment. Caution when using pulsed probes The maximum recommended modulation frequency for pulsed probes is 10,000 Hz. For therapeutic reasons, we have enabled frequencies up to 40,000 Hz to, for example, transmit more energy in a shorter period. This will, however, accelerate aging of the laser diodes. The laser diodes should therefore be checked more frequently than usual, at the very least during the annual safety check (see the chapter Care and maintenance on page 23). Caution when using infrared probes You should occasionally test your infrared probe for proper function using the laser test diode on your control unit. Consult the chapter Laser function test in the operating instructions for your Physiolaser, Aku-Wave, or Photonic. 20

21 Mobile use 9 Battery life With the compact Physiolaser olympic or the structurally identical Aku-Wave 4, you can also use your probe in battery mode. Many different factors determine how long you can actually perform treatment in practice with a full battery. The ambient temperature as well as the selected program and CW multi-cluster probe in CW mode the power output all play a role. We have conducted a test run for both probe types and documented the results below. The testing conditions were: battery fully charged at the start, with treatments of 10 minutes each at room temperature. Pulsed single probe at 10 khz 1.3 hours 8 treatments can be performed Therapy time: 10 minutes Power output: 600 mw Therapy program: CW 500 mw CW single probe at 10 khz 4 hours 24 treatments can be performed Therapy time: 10 minutes Frequency: 10,000 Hz Power output of 90 W Pulsed multi-cluster probe at 10 khz 1.5 hours 9 treatments can be performed Therapy time: 10 minutes Power output: 500 mw Therapy program: CW 4 hours 24 treatments can be performed Therapy time: 10 minutes Frequency: 10,000 Hz Power output of 5 x 30 W 21

22 Error messages 10 Defective laser diodes Please also read the chapter "Error messages" in the operating instructions for your Physiolaser, Aku-Wave, or Photonic. Error messages only appear on the probe itself in case of defective laser diodes. The therapy program can no longer be started or it is automatically stopped (in an error occurs during ongoing therapy). Please contact your distributor for repair. Error messages on single probes Laser 1 defect Error message on single probe displays Error messages on multi-cluster probes Laser x defect The "X" stands for the number of the defective diode. 22

23 Care and maintenance 11 Cleaning and disinfection Unplug the power cord of your control unit before beginning any cleaning or maintenance. Note that harsh or caustic agents (e.g., acetone) must not be used for regular cleaning of the plastic components. Prevent moisture from entering the housing. It is best to use a damp cloth for cleaning. For disinfection, please wipe the surface with a standard commercial disinfectant. Always use a damp cloth for cleaning and disinfection. Never flush water over the device. Do not use solvents! If you use an applicator, steam sterilize the applicator after each treatment in order to minimize the risk of patient infection. Calibration and safety check Your laser probe does not contain any user-serviceable internal parts or components. There is thus no reason to open the device's housing. To comply with IEC (Safety of laser products), your Physiolaser olympic, Aku-Wave 4, or Photonic 500, along with all probes and accessories, must be inspected and recalibrated by the manufacturer at least once annually. Please contact your distributor. 23

24 Physical principles of laser therapy 12 Continuous wave and pulsed probes Relatively low-power lasers are typically used in gentle, non-invasive laser therapy, also known as LLLT (Low Level Laser Therapy). Within the field of LLLT, Reimers & Janssen offers two different laser types with very different power profiles. CW (continuous wave) probes provide a continuous laser beam at a power of mw in continuous wave mode. Pulsed probes emit pulses of light in succession that are very brief but at a power of up to 90 W Reimers & Janssen CW probes Light emission on both types of probes can be controlled by a modulation frequency. Modulation involves periodically switching the laser beam on and off. This modulation is referred to as the "frequency" in your control unit's software. You can use therapy programs with pre-programmed modulation frequencies or simply program the frequencies yourself. Please consult the operating instructions for your control unit for more information. When adjusting frequencies, note that on CW probes the laser beam is on and off for equal amounts of time. Energy output is thus half that of continuous wave mode regardless of the modulation frequency. In contrast, the energy output on pulsed probes (which cannot operate in continuous wave mode) depends on the selected frequency. Energy emission is highest at the maximum frequency. Reimers & Janssen pulsed probes 24

25 Power Energy output using CW probes CW probes provide a laser beam at relatively low power in continuous wave mode. These probes can be turned on and off using a modulation frequency. On Reimers & Janssen CW probes, the laser beam is on exactly as long as it is off. The following graphs show the different ways of operating a 50 mw CW single probe. Small modulation frequencies are used for illustration. In continuous wave mode In the first example, the CW probe is operated at full power, without a modulation frequency, in continuous wave mode for 2 seconds. Power and energy are emitted continuously. Reimers & Janssen CW probes Energy output in CW mode Red area = Energy in joules = Power x time = 0.05 W x 2 s = 0.1 J 100 in milliwatt THz 50 mw continuous waveform (CW) ,5 1 sec. 1,5 Time in seconds 2 The magnifying glass indicates a light frequency of 461 THz, corresponding to a wavelength of 650 nm. 25

26 At a frequency of 1 Hz Here, the CW probe is operated at a modulation frequency of 1 Hz for two seconds. With identical on and off times, power is emitted only half the time and the energy output is halved. At a frequency of 2 Hz Here, the continuous wave probe is modulated at 2 Hz and the energy output is exactly the same as at 1 Hz One period 75 One period 50 mw 50 mw ,5 1 sec. 1, ,5 1 sec. 1,5 2 During a cycle, the laser beam is on 1x and off 1x. At 2 Hz, the laser beam is on 2x and off 2x during a second. Energy output in frequency mode Red area = Energy in joules = (Power x time) / 2 = (0.05 W x 2 s) / 2 = 0.05 J If you use a frequency program on your CW probe, the energy output is always half that of continuous wave mode regardless of the modulation frequency. If you want to deliver more energy, you need to extend the treatment time or select a continuous wave program. Reduce the therapy time or power output if you want to deliver less energy. Modulation frequencies Frequency = Number of cycles / 1 second Light frequencies 1 Hz = 1 cycle / 1 second Frequency = Speed (light) / wavelength 1,000 Hz = 1,000 cycles / 1 second 461 THz = ~ 300,000 km / s / 650 nm 1 MHz = 1 x 106 cycles / 1 second 1 THz = 1,000 x 1,000 x 1,000 x 1,000 Hz 26

27 Calculation of therapy duration when using CW probes If you change either the energy output or therapy time on your control unit, the software automatically calculates the other value. This applies both to CW and frequency programs. Adjustable values T = Time in minutes/seconds E = Energy in joules P = Power in milliwatts You can change the parameters on the "Setup Laser" screen. Formula for continuous wave programs T = E / P Formula for frequency programs T = (E / P ) x 2 Example calculation with the 500 mw CW single probe If you want to deliver 4 joules in a continuous wave program, the therapy should last for 8 seconds. Pre-set values Energy output = 4 joules Power = 500 mw Calculation of therapy time The 500 mw CW single probe T = 4 J / 0.5 W = 8 s If you want to deliver the same amount of energy using a frequency program, the therapy should last for 16 seconds. Calculation of therapy time T = (4 J / 0.5 W) x 2 = 16 s 27

28 Energy output using pulsed probes Pulsed probes emit light pulses that are relatively strong but extremely short compared with continuous wave probes. The pulse always lasts for the same time and has the same power. The frequency determines the number of pulses per second and thus the average power output. A higher frequency emits more energy. The following graphics show this relationship based on the pulsed single probe operated at 90 W. For illustration, a very low frequency is contrasted with a high frequency. At a frequency of 1 Hz The pulsed probe has a peak power output of 90 W. One pulse is emitted per second at a modulation frequency of 1 Hz. Reimers & Janssen pulsed probes General formulas Total energy (E) Average power Pre-set values = = Average power (P) x therapy time (T) Peak power x pulse duration x frequency Treatment duration = 10 s Modulation frequency = 1 Hz 331 THz W ns Energy in watt sek. 3 Duration in seconds 4 The light frequency is 331 THz, corresponding to a wavelength of 904 nm. The energy is emitted on each pulse over a duration of 100 ns, i.e., 100 billionths of a second. Calculation E = 90 W x 100 ns x 1 Hz x 10 s = 90 W x (100 x 10-9 )s x 1 Hz x 10 s = 90 μj (microjoules) 28

29 At a frequency of 20 khz Using same probe at a modulation frequency of 20,000 Hz, 20,000 times as much energy is emitted per second as at 1 Hz W khz The magnifying glass indicates that energy is emitted in individual pulses 20,000 times per second. The energy output on your pulsed probe changes according to the modulation frequency. If you want to deliver more energy, you need to increase the frequency or extend the treatment time. Reduce the therapy time or the frequency if you want to deliver less energy. 2 sec. 3 General formulas Total energy (E) Average power Pre-set values = = 4 Average power (P) x time (T) Peak power x pulse duration x frequency Treatment duration = 10 s On Reimers & Janssen pulsed probes, the pulse duration is 200 ns at modulation frequencies of up to 9,999 Hz. The pulse lasts 100 ns at modulation frequencies of 10,000 Hz or higher. Modulation frequency Calculation of energy output = 20,000 Hz E = 90 W x 100 ns x 20 khz x 10 s = 90 W x (100 x 10-9 ) s x (20 x 10 3 ) Hz x 10 s = 1.8 J 29

30 Calculation of therapy duration when using pulsed probes Only the parameters for energy output and therapy time can be adjusted on pulsed probes; the power output cannot be adjusted. If you change the frequency on your control unit, the software will automatically calculate the energy output. Example calculation with the pulsed single probe The pulsed single probe has a power output of 90 W with a pulse duration of 100 ns. If you want to deliver 4 joules at a frequency of 10 khz on this probe, the therapy should last for approximately 44 seconds. You can set the modulation frequency on the "Edit frequencies" screen. General formulas Time (T) = Average power = Total energy (E) / average power (P) Peak power x pulse duration x frequency Pre-set values Reimers & Janssen pulsed single probe Energy = 4 J Frequency = 10,000 Hz Calculation of therapy time T = 4 J / 90 W x 100 ns x 10,000 Hz = 4 J / 90 W x (100 x 10-9 ) s x (10 x 10 3) Hz = s * At less than 10,000 Hz, the pulse duration is 200 ns 30

31 Calculation formulas for therapy practice The previous examples are based on the assumption that a 1 mm² laser beam is aimed directly from the outlet onto the skin and thus a 1 mm² area of the skin is treated. However, in practice you may work with an applicator, have to maintain a safety margin, or simply want to treat a larger area. Laser beam on impact area: 100 mm 2 Energy density: 0,01 J / mm 2 Laser beam with exit angle Laser beam at exit: 1 mm 2 Energy density: 1 J / mm 2 Because the laser beam is not perfectly focused but rather is emitted at an angle, the power and energy at the surface decrease with distance. This factor is expressed in the formulas for power density and energy density as: General formulas The laser beam has a beam size of 1 mm 2 at the exit. Because of the exit angle, the surface area increases and the energy density decreases with distance. Power density and energy density decrease proportionally as the irradiated area increases. Power density (W/cm 3 ) Energy density (J / cm 2 ) = = Average power / beam size Power density x time (therapy time) 31

32 Example using 500 mw CW single probe If we assume that the laser beam on the 500 mw CW single probe has a diameter (beam size) of 1 mm² directly at the outlet, the power density at maximum power is 500 mw / mm². The 500 mw CW single probe If we now assume that the irradiated surface area is 1 cm 2, the power density is only W/cm². If you want to deliver 4 joules to this 1 cm 2 area, you will need a treatment time of 13 minutes + 20 seconds. General formulas General formulas Power density (W/cm 2 ) = Average power / beam size Energy density (J / cm 2 ) = Power density x time (therapy time) Pre-set values Pre-set values Power = 500 mw Power = 500 mw Energy = 4 J Calculation of power density on 1 cm² Calculation of therapy time on 1 cm² Power density (W/cm 2 ) = 500 mw/mm 2 = 0.5 W/0.01 cm 2 = W/cm 2 T = Energy density / power density = 4 J / cm 2 / W / cm 2 = 800 s = 13 minutes + 20 seconds 32

33 Example using CW multi-cluster probe If we assume that the laser beam on the CW multi-cluster probe with its 12 laser diodes has a diameter (beam size) of 1 mm² at each outlet, the power density at maximum power is 600 mw/mm² divided across 12 laser diodes. The power density per laser diode is thus 50 mw/mm². If we now assume that the irradiated surface area is 1 cm², the power density per diode is only W/cm². If you want to achieve an energy density of 6 joules/cm², you will need a treatment time of 16 minutes + 40 seconds. General formulas Pre-set values Power density per diode (W/cm 2 ) = Average power / beam size Power = 600 mw Energy = 6 J Pre-set values Calculation of therapy time on 1 cm² Power = 600 mw T = (Energy density / power density) / number of diodes Calculation of power density on 1 cm² Power density (W/cm 2 ) = = (600 mw/12) / mm 2 = 6 J / cm 2 / W / cm 2 / 12 = 1,000 s = 16 minutes + 40 seconds = 50 mw/mm 2 = W/cm 2 33

34 Technical description 13 Technical data The device meets the requirements of Directive 93/42/EEC concerning medical devices Class 3B laser therapy device Absolute uncertainty of laser power measurement 20 % Modulation frequency 1 Hz to 99,999 Hz Accuracy of the electric conductance measurement +/- 10 % Operating conditions Ambient temperature + 10 C to +30 C Relative humidity 30 % to 75 % Air pressure 700 hpa to 1060 hpa Transport and storage Ambient temperature -20 C to +40 C 34

35 Single probes Wavelength Power output Laser type Pulse duration NOHD* Beam divergence Pulsed single probe Model 515 A 904 nm max. 90 W Pulse 100 / 200 ns 0.10 m rad CW single probe 50 mw Model 513 A CW single probe 50 mw Model 510 A CW single probe 150 mw Model 514 A CW single probe 200 mw Model 512 A CW single probe 200 mw Model 511 B CW single probe 500 mw Model 511 A 655 nm max. 50 mw Continuous wave (CW) 785 nm max. 50 mw Continuous wave (CW) 638 nm max. 150 mw Continuous wave (CW) 670 nm max. 200 mw Continuous wave (CW) 810 nm max. 200 mw Continuous wave (CW) 810 nm max. 500 mw Continuous wave (CW) 0.09 m rad 0.10 m rad 0.08 m rad 0.14 m rad 0.19 m rad 0.29 m rad * Safety margin (NOHD): The distance at which the radiation intensity or radiation is equal to the corresponding limit for the maximum permissible radiation of the cornea (MPE = maximum permissible exposure). 35

36 Multi-cluster probes Wavelength Power output Laser type Pulse duration NOHD* Beam divergence Pulsed multicluster probe Model 516 A / 516 C / 516 D 904 nm 5 x max. 30 W Pulse 100 / 200 ns 0.06 m rad CW multi-cluster probe Model 519 B 655 nm 405 nm 2 x max. 40 mw 22 x max. 5 mw LED Continuous wave (CW) 0.09 m rad CW multi-cluster probe Model 517 A 785 nm 655 nm 655 nm 4 x max. 55 mw 4 x max. 40 mw 4 x max. 5 mw Continuous wave (CW) 0.10 m 0.09 m rad rad rad CW multi-cluster probe Model 517 B / 517 C / 517 D 785 nm 655 nm 8 x max. 55 mw 4 x max. 40 mw Continuous wave (CW) 0.10 m 0.09 m rad rad CW multi-cluster probe Model 517 E 810 nm 6 x max. 500 mw Continuous wave (CW) 0,29 m rad CW multi-cluster probe Model 518 A 785 nm 655 nm 8 x max. 55 mw 4 x max. 40 mw Continuous wave (CW) 0.10 m 0.09 m rad rad CW multi-cluster probe Model nm 12 x max. 50 mw Continuous wave (CW) 0.09 m rad CW multi-cluster probe Model 508 A 655 nm 405 nm 4 x max. 50 mw 2 x max. 50 mw Continuous wave (CW) 0.09 m rad CW multi-cluster probe Model nm 638 nm 1 x max. 500 mw 1 x max. 150 mw Continuous wave (CW) > 10 m rad * Safety margin (NOHD): The distance at which the radiation intensity or radiation is equal to the corresponding limit for the maximum permissible radiation of the cornea (MPE = maximum permissible exposure). All probes are equipped with a red LED that functions as the status indicator. 36

37 CW multi-cluster probe: Position of labels on the device Laser warning label 2. Type label 3. Laser warning labels 4. Rating label CW multi-cluster probe: Explanation of symbols and labels on the device Type label Signs on the type label 0482 The device complies with European directives applicable to the product. Rating and warning labels 4 x 40 mw / 655 nm cw 8 x 55 mw / 785 cw EN :2007 Laser beam exit aperture Avoid direct exposure to beam Rating label Laser warning labels IPX0 No rating against harmful ingress of water Observe the accompanying documentation. Type B applied part Date of production Month - Year 37

38 Single probes: Position of labels on the device Laser warning label on top 2. Laser warning label on bottom 3. Rating label 4. Type label Single probes: Explanation of symbols and labels on the device Type label Signs on the type label 0482 The device complies with European directives applicable to the product. Rating and warning labels Pmax 500 mw λ = 810 nm cw EN :2007 Laser beam exit aperture Laser category 3B Avoid direct exposure to beam Rating label Laser warning labels IPX0 No rating against harmful ingress of water Observe the accompanying documentation. Type B applied part Date of production Month - Year 38

39 Pulsed multi-cluster probe: Position of labels on the device Laser warning labels 2. Laser warning labels 3. Rating label 4. Type label Pulsed multi-cluster probe: Explanation of symbols and labels on the device Type label Signs on the type label 0482 The device complies with European directives applicable to the product. Rating and warning labels Pmax 5 x 30 W λ = 904 nm imp pulse 200 ns EN :2007 Laser beam exit aperture Avoid direct exposure to beam Rating label Laser warning labels IPX0 No rating against harmful ingress of water Observe the accompanying documentation. Type B applied part Date of production Month - Year 39

40 Warranty and disposal 14 Warranty The manufacturer s warranty is valid for 24 months. The manufacturer is only responsible for the features as warranted by the operating instructions if the device has been operated carefully and in accordance with the operating instructions. Readjustment, calibration, and maintenance or repairs may only be performed by the distributor, otherwise the warranty is void. Any alterations to the device by unauthorized third parties void the warranty. The manufacturer guarantees spare parts availability for a period of ten years after the date of purchase. Disposal Due to the hazards of laser radiation, probes and control units may not be disposed of as normal electronic waste. The devices must be sent to the manufacturer for decommissioning and disposal. 40

41 Manufacturer/Distributor 15 REIMERS & JANSSEN GmbH Medical Laser Technology Fabrikstraße Waldkirch, Germany Tel. +49 (0) Fax +49 (0) Quality management EN ISO Publisher Reimers & Janssen GmbH Medical Laser Technology Editor Ulrich Sackenreuter Design & Illustrations Eike Otto Photographs Volker Weinhold Version Feb-2015 Distributor 41