ZX2 High Power Laser WARNING CLASS 3B & 4 LASER EQUIPMENT IS HAZARDOUS TO THE EYE THE RECOMMENDED SAFETY GOGGLES MUST BE WORN BY BOTH THE PATIENT & OPERATOR AT ALL TIMES DURING TREATMENT DO NOT TREAT AROUND THE EYE, CONSULT PAGES 21 & 22, CONTRA- INDICATIONS & PRECAUTIONS BEFORE COMMENCING ANY TREATMENT READ THIS MANUAL BEFORE USE PRESCRIPTION USE ONLY Operating Manual Firmware Rev 1.6 onwards (c) LZR7 2015 1
CONTENTS Page Introduction 3 Safety Procedure 4 Quick Start Guide 5 General Care & Use 8 Disposal 8 Advanced Operation Probe Selection 9 Joules Display 9 Beep Settings 10 Temp Settings 10 Tissue Depth Units 11 Contrast 11 Brightness 12 Joules Time Priority 12 Usage Data & Temperature 12 Treatment Time Setting 14 Joules Setting 15 Frequency Setting 15 Tissue Depth 16 Probe Output Test 16 Fault Condition 17 High Temperature 17 Remote Interlock Connector 18 FDA Declaration 19 Maintenance & Servicing 20 Warranty & Repairs 22 Contra-indications 23 Precautions 24 Specifications System General 25 ZX2 Laser Unit 26 Warning Labels 27 Laser Safety Goggles 28 750mW Deep Probe 29 1.5W Deep Probe 30 6.1W Multi Probe 31 SP4 Probe 32 Typical Skin Temperature Heating Times 33 (c) LZR7 2015 2
INTRODUCTION The ZX2 Laser System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle. A selection of probes are available, from single laser to large multi heads. This together with a variable power output ensures, all applications are catered for. Two completely independent probe outputs allow use by two operators at once and/or treatment using two probes at once. This is a professional device, built to withstand years of everyday use, with many advanced features, such as programmable tissue depth and dosage. Please read this operating manual thoroughly before use to ensure safety of both the operator and patient. EYE PROTECTION MUST BE WORN AT ALL TIMES BY BOTH THE OPERATOR AND PATIENT (c) LZR7 2015 3
SAFETY PROCEDURE READ THIS BEFORE SWITCHING ON CAUTION - Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure 1. THE PATIENT & OPERATOR MUST WEAR APPROVED SAFETY GOGGLES AT ALL TIMES DURING TREATMENT. 2. DO NOT LEAVE THE KEY IN THE EQUIPMENT 3. DO NOT TREAT THE EYE OR SURROUNDING AREA 4. DO NOT DIRECT LASER RADIATION INTO THE EYES OR FROM A REFLECTED SURFACE 5. THIS APPLIANCE MUST BE EARTHED. ENSURE THE ELECTRICAL SUPPLY HAS A SUITABLE EARTH CONNECTION. 6. DO NOT TREAT AROUND THE EYE, CONSULT PAGES 21 & 22, CONTRA-INDICATIONS & PRECAUTIONS BEFORE COMMENCING ANY TREATMENT 7. THIS DEVICE COMPLIES WITH THE RELEVANT EMC STANDARDS, HOWEVER IT IS POSSIBLE THAT OPERATING IT IN CLOSE PROMIETRY TO A PULSED SHORT WAVE MACHINE COULD DAMAGE THE LASER DIODES, THEREFORE THIS IS NOT RECOMMENDED. 8. AS DEFINED IN IEC60601-1, THIS PRODUCT IS CONSIDERED STATIONARY, THEREFORE ONCE INSTALLED, IT SHOULD NOT BE MOVED. 9. THIS DEVICE SHOULD NOT BE INSTALLED IN SUCH A WAY THAT REMOVAL OF THE MAINS PLUG IS OBSTRUCTED. WARNING TO AVOID THE RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE CONNECTED TO A SUPPLY MAINS WITH PROTECTIVE EARTH WARNING NO MODIFICATION OF THIS EQUIPMENT IS ALLOWED LASER TREATMENT ROOM SIGNS IEC60601-1 specifies a laser warning sign should be placed above the treatment area. However it should be noted that some local health authorities will also require a laser warning sign above the entrance door to the treatment room. (c) LZR7 2015 4
QUICK START GUIDE This laser therapy device is designed for localised heating of the tissue for therapeutic purposes, which has number of benefits to the patient, notably pain reduction. The infra red radiation penetrates the skin and heats both the surface and deeper tissue. Clinical research suggests therapeutic benefits begin when tissue temperature is heated to between 40 and 45 deg C. The time taken for this can vary considerably depending on ambient temperature, skin temperature at the start of the treatment and the depth of the target tissue. The generally considered useful dosages are 4 to 20 Joules at the target depth. See Appendix A for typical skin temperature heating data. PROBE TEMPERATURE It should be noted that when operating in very high ambient temperatures (25 to 30 deg C) its possible with prolonged use the probe temperature could exceed 48 deg C. Should the probe temperature become uncomfortable for either the patient or operator, either switch to another probe, if one is available, or allow the probe to cool before re-commencing treatment. SKIN COLOUR High power laser therapy devices can cause discomfort and even a minor burn under extreme cases on patients with very dark skin. Patients with dark skin should commence treatment on 30% power, medium skin 60% and light skin 90 to 100%. If the patient does not report any discomfort the power output can be incremented at 10% every 10 seconds, until the warming effect becomes uncomfortable. At this point back off the power 20% and complete the treatment at that power level. The ZX2 laser unit will run 2 probes at once. The LCD screen is split in two halves, one for each probe. Each probe will operate independently, although FUNCTION parameters can only be adjusted when both probes are switched off. Power output can be adjusted independently for each probe while the probe is on. This allows the power to be turned down during treatment if the patient complains that the treatment area is getting too warm. 1. Connect the ZX2 Laser Unit to a suitable mains supply using the mains cord provided. The internal power supply is multi voltage and so will automatically operate on all worldwide standard mains voltages. 2. Insert the key into the keyswitch and rotate to the right to switch on. The power up sequence takes around 20 seconds. (c) LZR7 2015 5
3. Connect a probe cable to probe socket 1 or 2. Connect the other end of the probe cable to the probe. The connectors have a key, so rotate them until the keyway is found then push and they should click and lock. To remove a connector, just pull the collar back then pull the connector out of the socket. 4. Press the "MENU" switch. Using the power UP/DOWN switches on the left side of the device, scroll the arrow to "Probe Type 1" or "Probe Type 2", as required. Press "ADJUST". Using the power UP/DOWN switches, scroll the display to select the probe type in use, then press "EXIT" to get back to the main screen. S E T U P > P r o b e T y p e 1 P r o b e T y p e 2 J o u l e s D i s p l a y 5. The display will initially show "STB" (Standby), then after 4 seconds shown "RDY" (Ready). The laser probe can now be switched on by pressing the switch on the probe. During treatment, the power setting of the probe is displayed on the top row. When the output is off, the probe type is displayed. 1 3 5 0 m W 6. 1 W M u l t 0 : 1 8 1 4 J 2 : 0 0 7 3 2 J 2 0 H z 9 0 % C W 1 0 0 % O N! 1 ½ C m R D Y 0 C m 6. To stop the treatment, just press the switch on the probe again. 7. The power output can be adjusted both before and during treatment by pressing the appropriate POWER UP/DOWN switches. In the event of an emergency, the emergency stop switch can be pressed. This immediately stops both outputs and requires a power reset to continue. 8. Treatment time, joules, pulse frequency & tissue depth can only be adjusted when both probe outputs are off. To adjust any of these, press the "FUNCTION" switch. The cursor will flash on the parameter to be adjusted. Press the "FUNCTION" switch again to move to the required parameter. To adjust the parameter, press the "ADJUST" switch. The cursor flashes for approximately 4 seconds after the last switch press. (c) LZR7 2015 6
S e t T i m e 6. 1 W M u l t 0 : 2 0 3 I 2 : 0 0 7 6 I C W 1 0 0 % C W 1 0 0 % R D Y ½ C m R D Y 0 C m 9. For more details of the menu and programmable functions see "Advanced Operation" below. (c) LZR7 2015 7
General Care & Use DO NOT EXPOSE OR IMERESE THE UNIT OR PROBES INTO WATER The laser unit should be wiped clean with a cloth soaked in a 70% alcohol solution. DISCONNECT from the mains supply before cleaning. Cleaning of Probes WARNING Always switch off and remove the key from the laser unit before cleaning or viewing the lens The lens of each probe should be kept clear of impurities at all times so that the optical path of light remains unobstructed. The probes may be cleaned using a medi-swab or similar swab soaked 70% alcohol solution. Use of Probes on Broken Skin & Wounds Where probes are used on broken skin, in order to prevent spread of infection, the probes should not be applied direct to the area to be treated. Instead treat through a suitable transparent barrier, such as Smith & Nephew OpSite Transparent Dressing. This is an adhesive disposable sterilised film which can be applied to probes before treatment and then removed and disposed of afterwards. Disposal All LZR7 products contain small traces of Lead (Pb) and so should not be disposed of in landfill sites. If you have to scrap LZR7 products that you wish to dispose of and you are not sure how to do it in a manner that is safe for the environment, return the equipment to the address on page 20 or to your nearest LZR7 dealer, who will arrange correct disposal/recycling of the equipment. This is a legal requirement in the European Union (EU) under the Waste Electrical & Electronic Equipment (WEEE) Directive 2002/96/EC. The Restriction of the use of certain Hazardous Substances (RoHS) Directive 2011/55/EU also becomes a legal requirement in the European Union for Medical Devices from 22 nd July 2014. (c) LZR7 2015 8
ADVANCED OPERATION Menu Functions Probe Selection Press "MENU" from the main screen and you will see the setup menu:- S E T U P > P r o b e T y p e 1 P r o b e T y p e 2 J o u l e s D i s p l a y Use the UP/DOWN POWER switches or the FUNCTION switch to scroll the arrow to the probe to be adjusted, then press ADJUST S E T U P P r o b e T y p e 2 6. 1 W M u l t i Once the correct selection has been made, press EXIT to return to the main screen, or press MENU to return to the setup screen. NOTE correct probe selection is essential for the joules to be calculated correctly. The device might also go into fault condition if the wrong probe type is selected as the feedback signal from the probe will be incorrect and this will be interpreted as a fault. Joules Display Scroll down to "Joules Display" and press ADJUST S E T U P J o u l e s D i s p l a y T o t a l J o u l e s (c) LZR7 2015 9
Using the UP/DOWN POWER switches select either "Total Joules" or "Irradiance J/Cm 2 ". Total Joules gives the total joules the probe will give for the treatment time selected as is denoted by a "J" on the main screen. Irradiance J/Cm 2 is denoted an "I" on the main screen. Note the depth setting is limited to 4.5Cm for Joules and 1Cm for J/Cm 2. Once the correct selection has been made, press EXIT to return to the main screen, or press MENU to return to the setup screen. Beep Settings Scrolling further down will show the 2nd setup menu S E T U P > B e e p S e t t i n g s T e m p S e t t i n g s D e p t h U n i t s Press the ADJUST switch for the Beep Settings menu B e e p S E T U P I n c r e a s e D e c r e a s e 1 0 S e c The beep settings adjust the time of the warning beep when the probe is on. Use the UP/DOWN POWER switches on the left to select the required time. The options are, off, 1 sec, 5 sec, 10 sec. Once the correct selection has been made, press EXIT to return to the main screen, or press MENU to return to the setup screen. Temp Settings Selecting "Temp Settings" from the 2nd menu screen allows the temperature measurement units to be changed S E T U P T e m p S e t t i n g s C e n t i g r a d e (c) LZR7 2015 10
Use the UP/DOWN POWER switches to select either Centigrade or Fahrenheit Tissue Depth Units Select "Depth Units" from the 2nd menu screen to bring up the Depth Units Menu S E T U P D e p t h U n i t s C e n t i m e t r e s Use the UP/DOWN POWER switches to select either Centimetres or Inches for the issue depth display. Adjusting the tissue depth to the required depth automatically adjusts either the Total Joules or J/Cm2 setting to compensate for attenuation of tissue. Once the correct selection has been made, press EXIT to return to the main screen, or press MENU to return to the setup screen. Contrast From the 2nd setup menu continue to scroll down to the 3rd setup menu S E T U P > C o n t r a s t B r i g h t n e s s J / T P r i o r i t y Press the ADJUST switch to select "Contrast" S E T U P C o n t r a s t I n c r e a s e D e c r e a s e The contrast of the LCD display can be adjusted by the UP/DOWN POWER switches. Once the correct selection has been made, press EXIT to return to the main screen, or press MENU to return to the setup screen. (c) LZR7 2015 11
Brightness Scroll down to "Brightness" and press the ADJUST switch S E T U P B r i g h t n e s s I n c r e a s e D e c r e a s e The brightness of the LCD display can be adjusted by the UP/DOWN POWER switches. Once the correct selection has been made, press EXIT to return to the main screen, or press MENU to return to the setup screen. Joules Time Priority Select J/T Priority from the 3rd setup menu to adjust the joules time priority S E T U P J / T P r i o r i t y J o u l e s Use the UP/DOWN POWER switches to select either Joules or Time priority. Time priority will keep the treatment time the same when the power or depth are adjusted, joules priority will keep the joules or J/Cm 2 the same when the power or depth are adjusted. Once the correct selection has been made, press EXIT to return to the main screen, or press MENU to return to the setup screen. Usage Data and Temperature Pressing the MENU switch twice from the main screen will display the usage screen U S A G E D A T A H O U R S 0 0 9 0 h r 0 2 m i n T E M P 3 9 C 4 6 C M a x F A U L T C O D E N o n e (c) LZR7 2015 12
This screen shows the total number of treatment hours, the current internal temperature of the laser unit and the maximum internal temperature that has been recorded. Also displayed are any fault codes that have been recorded. These can be useful in identifying problems with the laser unit, probe cable and probes. If you are having any problems with the device make a note of the fault code number before contacting your LZR7 service engineer. FAULT CODES 1=IC2 Fault detected on power up 2=PHOTODIODE CIRCUIT FAULT 3=PROBE 1 CABLE FAULT 4=PROBE 2 CABLE FAULT 5=TEMP has exceeded 50 deg C 6=F1 present on power up IC2 FAULT 7=F2 present on power up IC2 FAULT 8=Output 1 out of limits (-20%) during treatment OUTPUT POWER FAULT 9=Output 2 out of limits (-20%) during treatment OUTPUT POWER FAULT 10=Output 1 out of limits (+20%) during treatment OUTPUT POWER FAULT 11=Output 2 out of limits (+20%) during treatment OUTPUT POWER FAULT 12=Loss of EEPROM Data - CONTRAST 13=Loss of EEPROM Data - BRIGHTNESS 14=Loss of EEPROM Data - BEEP CODE 15=Loss of EEPROM Data - USAGE MIN 16=Loss of EEPROM Data - USAGE MINx10 17=Loss of EEPROM Data - USAGE HOUR 18=Loss of EEPROM Data - USAGE HOURx10 19=Loss of EEPROM Data - USAGE HOURx100 20=Loss of EEPROM Data - USAGE HOURx1000 21=Loss of EEPROM Data - MAX TEMP 22=Loss of EEPROM Data - POWER SETTING 1 23=Loss of EEPROM Data - POWER SETTING 2 24=Loss of EEPROM Data - FREQ SETTING 1 25=Loss of EEPROM Data - FREQ SETTING 2 26=Loss of EEPROM Data - TC1 1MIn 27=Loss of EEPROM Data - TC1 10Sec 28=Loss of EEPROM Data - TC1 1Sec 29=Loss of EEPROM Data - TC2 1MIn 30=Loss of EEPROM Data - TC2 10Sec 31=Loss of EEPROM Data - TC2 1Sec 32=Loss of EEPROM Data - DISPLAY FLAG 33=Loss of EEPROM Data - FAULT CODE 34=Loss of EEPROM Data - DEPTH Cm/Inch (c) LZR7 2015 13
35=Loss of EEPROM Data - TEMP F/C 36=Loss of EEPROM Data - Joules J/I 37=Loss of EEPROM Data - Tissue Depth 1 38=Loss of EEPROM Data - Tissue Depth 2 39=Loss of EEPROM Data - CH1 Prog Setting 40=Loss of EEPROM Data - CH2 Prog Setting 41=Loss of EEPROM Data - T/J Priority 42=Loss of EEPROM Data - CH1 Joules setting 43=Loss of EEPROM Data - CH2 Joules setting 44=Loss of EEPROM Data - CH1 Probe Type 45=Loss of EEPROM Data - CH2 Probe Type 46=Interlock operated NOTE fault codes 12-45 can often occur due to a spike on the mains supply or other electrical noise, this will cause a default value to be stored in the memory. All data is stored in 3 separate memory locations and in the event of any 2 locations not being equal, default values are loaded and the fault code is stored. This does occur from time to time and is not generally anything to worry about, but if loss of data is occurring regularly, consult your LZR7 Engineer. Press EXIT to return to the main screen, or press MENU to return to the setup screen. Treatment Time Setting In the main screen, press the FUNCTION switch. Two fully independent channels are provided, although FUNCTION settings can only be changed when both probes are off. To adjust the 2nd channel, just keep pressing the FUNCTION switch until the 2nd channel parameters are highlighted by the cursor. S e t T i m e 6. 1 W M u l t 0 : 2 0 3 I 2 : 0 0 7 6 I C W 1 0 0 % C W 1 0 0 % R D Y ½ C m R D Y 0 C m Press the ADJUST switch to scroll though preset treatment times. 5 sec, 10, sec, 15 sec, 20 sec, 30 sec, 45 sec, 1min, 1min 15 sec, 1min 30 sec and 2 min are available. For more precise treatment time adjustments, the UP/DOWN POWER switches of the relevant channel can be use to change the setting by 1 second increments so any treatment time from 1 second to 2 minutes is available. Adjustment of the treatment time setting automatically calculates the Joules display. (c) LZR7 2015 14
Joules Setting Press the FUNCTION switch to scroll to the Joules display S e t J / C m ² 6. 1 W M u l t 0 : 2 0 3 I 2 : 0 0 7 6 I C W 1 0 0 % C W 1 0 0 % R D Y ½ C m R D Y 0 C m The UP/DOWN POWER switches of the relevant channel can be adjusted to increment or decrement the Joules setting by 1. This will automatically recalculate the treatment time required. Note "I" denotes "Irradiance" in J/Cm 2. "J" denotes the total number of Joules. This shows the total dosage for the treatment time shown and will count down to zero along with the treatment time counter. Note the depth setting is limited to 4.5Cm for Joules and 1Cm for J/Cm 2. Due to the high attenuation and irregular beam dispersion at depth, working in J/Cm 2 is not recommended at depths greater than 1Cm, therefore working in Joules is more accurate at depth. Frequency Setting Press the FUNCTION switch to scroll to the frequency display S e t F r e q 6. 1 W M u l t 0 : 2 0 1 6 J 2 : 0 0 7 3 2 J 2 0 H z 9 0 % C W 1 0 0 % R D Y ½ C m R D Y 0 C m Press the ADJUST switch to select the desired frequency. 2.5Hz, 5Hz, 10Hz, 20Hz, 50Hz and 100Hz are available. Note the frequency output is only available for 10 to 90% power settings. When 100% power is selected, CW is shown on the display regardless of the frequency setting. To explain this an understanding of how the power level is adjusted is necessary: To vary the power, the duty cycle is adjusted from 10 to 100%, therefore only the average power is reduced and the peak power remains the same regardless of the power setting. This is a better method of power reduction as it still gives good penetration and still allows the average power to be reduced to adjust localised heating. (c) LZR7 2015 15
Tissue Depth Press the FUNCTION switch to scroll to the tissue depth display S e t D e p t h 6. 1 W M u l t 0 : 2 0 1 6 J 2 : 0 0 7 3 2 J 2 0 H z 9 0 % C W 1 0 0 % R D Y 1 ½ C m R D Y 0 C m Press the ADJUST switch to select the desired tissue depth. Tissue depth can be set from zero to 4.5 Cm in half centimetre increments (1Cm max when using J/Cm 2 ), or zero to 2 inches in 0.2 inch increments. Adjusting the tissue depth to the required depth automatically adjusts either the Total Joules or J/Cm 2 setting to compensate for attenuation of tissue. Note the depth setting is limited to 4.5Cm for Joules and 1Cm for J/Cm 2. Due to the high attenuation and irregular beam dispersion at depth, working in J/Cm 2 is not recommended at depths greater than 1Cm, therefore working in Joules is more accurate at depth. Probe Output Test To test the output of a probe, switch the probe on, then press the FUNCTION switch, and place over the "TEST" window. The display will show "TEST" and the measured power reading will be displayed 1 3 5 6 m W 6. 1 W M u l t 0 : 1 8 1 4 J 2 : 0 0 7 3 2 J 2 0 H z 9 0 % C W 1 0 0 % T E S T R D Y 0 C m For an accurate measurement the probe should be adjusted to find the position for the maximum reading. When measuring Multi probes, position the probe head approximately over the aperture of each laser, with care the output of each individual laser can be measured. The photodiode is calibrated to measure the Infra Red lasers. The visible laser in the 6.1W Multi probe can be measured, but not accurately, as this typically shows twice the power it should. Power measurement is best performed on 100% power. Note, the test function will only work when one probe is in use; it is disabled when the output of both probes is on. (c) LZR7 2015 16
Fault Condition Should a fault be detected the display will show FAULT 1 3 5 0 m W 6. 1 W M u l t 0 : 0 3 2 J 2 : 0 0 7 3 2 J 2 0 H z 9 0 % C W 1 0 0 % F A U L T F A U L T If this occurs, the power will need to be switched off, then back on again to reset the system. Fault conditions can occur for the following reasons:- 1. Operation of the EMERGENCY STOP SWITCH 2. Operating of the REMOTE INTERLOCK CONNECTOR 3. Removal of the probe cable during treatment 4. 20% over or under set power is detected by the internal circuitry If fault conditions persist, checking the fault code as detailed above. Fault codes 3,4 and 8-11 can all indicate a probe cable fault, so change this if you have a spare. If faults persist, contact your LZR7 service engineer. High Temperature The ZX2 unit is rated to run both probe outputs continuously at 50% power. It is safe to run at higher power settings for long periods as long as the probe temperature does not get too hot. The internal circuitry has a high temp cut out that will operate above 50 deg C as well as a software algorithm designed to limit skin and probe temperature to below 45 deg C. If this should occur the following screen will be displayed:- 1. 5 W D e e p 6. 1 W M u l t 0 : 2 0 3 I 2 : 0 0 7 6 I C W 1 0 0 % C W 1 0 0 % T E M P - W A I T T E M P - W A I T The temp warning should go off in a minute or so once the temperature has reduced. If this high temp warning is shown repeatedly, check the vents on the lower part of enclosure and the fan opening on the rear of the unit are not obstructed. The fan should operate when a probe is on and at any time when the internal temperature exceeds 45 deg C. (c) LZR7 2015 17
Remote Interlock Connector This device features a Remote Interlock Connector that enables the door into the treatment room to be connected to the interlock jack on the rear panel. This will put unit into the Fault condition (and therefore stop the laser emission) in the event of the door being opened during treatment in order to comply with IEC60601-2-22. Fit a magnetic contact switch to the entrance door of the treatment room that is closed circuit when the door is shut and open circuit when the door is open. Wire this switch into a standard (mono 2 pin) quarter inch jack plug and plug this into the rear panel "Interlock" jack socket. These components can be supplied and installed by LZR7 Inc. or one of its distributors if required. (c) LZR7 2015 18
FDA DECLARATION LZR7 Inc confirms that the ZX2 Laser unit and probes as specified in this operating manual meet and fully comply with the following Federal guidelines, 21 CFR 1002.10, 21 CFR 1040.10, 21 CFR 1040.11. This device does not cause radio interference with other equipment and complies with Federal guidelines on Radio Interference as defined in IEC60601-1-2, Cispr 11 Radiated Emissions, EN61000-4-2 ESD & EN61000-4-3 Radiated Immunity. This device complies with IEC60601-1/UL60601-1 Edition 3 Medical Electrical Equipment, inc ISO14971, IEC60601-2-22:2007 Ed 3 Therapeutic Laser Equipment, IEC60825-1:2007 Safety of Laser Products & ISO10933-1:2009 Biocompatibility. The ZX2 Laser unit and probes, as detailed in this operating manual, have been cleared for medical use by the FDA as Infrared Heating Devices under 510(k) application K150466 (Pending). Randy Rinkleib Cheif Executive Officer LZR7 Inc Date (c) LZR7 2015 19
MAINTANANCE & SERVICING All Medical Devices should be periodically checked for electrical safety and effectiveness i.e. correct output. Electrical safety tests in accordance with IEC60601-1 should be performed every 12 months and the output of all probes verified on a suitable calibrated optical power meter. Contact your sales & service representative if you require your equipment to be serviced. No user maintenance to be carried out. Please refer all technical servicing to your supplier. However, your supplier will make available such diagrams, components lists and parts and other information which will assist the user's appropriately qualified technical staff to repair the parts of the equipment which are classified by your supplier as repairable. NOTE There are high voltages present inside the ZX2 Laser Unit. Do not attempt to dismantle the equipment without first disconnecting from the mains supply. Replacement of the Mains Cable/Cord The mains cable/cord supplied with this device should be checked at routine service intervals for damage, continuity and correct wiring. Should the cable/cord need replacing the correct orientation of the wiring MUST BE CHECKED. Incorrect wiring poses a risk of electric shock, especially if the earth (E) and live (L) are reversed. Shown below are the correct connections for the plug (on the laser device) and the socket (on the mains cable/cord). The cable plug required is an IEC 60320 C13. Cable length should be no more than 2.5m (8Ft) and have a minimum of 10A rating. If the plug connection on the other end is fused, this should be a 5A rating. (c) LZR7 2015 20
Notes for MEDICAL ELECTRONICS ENGINEERS When performing electrical safety tests on this unit using a Rigel safety tester or similar high voltage test device please note the following procedures in order to avoid damage to Laser Probes:- All Laser Diodes are easily susceptible to damage from static or high voltage sources. The ZX2 unit grounds both laser drive pins when the probe is off. Therefore it recommended that high voltage tests are only performed on probes when they are plugged into the unit & switched off. Calibration of the Laser Measuring System The ZX2 unit contains a calibrated laser power meter that has built in compensation for probe type, therefore once calibrated the power meter will give accurate readings. Should re-calibration be necessary proceed as follows:- Remove the right hand end plate from the laser unit, by removing the four outermost screws. The adjustment potentiometer (VR1) will now be visible on the upper front panel PCB. Adjust the potentiometer as required to obtain an accurate reading on the power meter. NOTE this adjustment should only be performed by qualified medical service engineers, since the unit will need to be tested for electrical safety once reassembled. (c) LZR7 2015 21
WARARANTY LZR7 Inc warrants that the ZX2 laser unit, probes and probe cables are free from manufacturing defect from the date of purchase and will guarantee and undertake to remedy free of charge by repair or replacement any defects in the equipment that occur within 1 year of delivery, which arise under proper use and normal conditions. This warranty does not cover damage caused by negligence or misuse, nor does it cover routine servicing costs. Note dismantling this equipment during the warranty period will invalidate the warranty. Warranty does not cover carriage charges to and from the factory, nor will LZR7 Inc be liable for any loss of business caused by failure of the equipment. LZR7 and its service agents, reserve the right to refuse to service or repair under warranty any equipment supplied without a completed HSG(93)26 form or any equipment that is seriously contaminated with bodily fluids. REPAIRS & SERVICING For routine servicing during the warranty period, consult your supplier, who will arrange for suitably qualified personnel to service this equipment at competitive rates. If you have purchased your equipment through an agent, initially refer any technical queries or servicing requirements to them. Before contacting your service engineer, make a note of the serial number of your laser unit (located on the rear panel) and your date of purchase. It is also helpful to make a note of any fault codes (see "Usage data & Temperature") and the firmware version installed on your device. The firmware version is displayed on power up L Z R 7 I n c Z X 2 H i g h P o w e r L a s e r F i r m w a r e V e r s i o n 1. 1 (c) LZR7 2015 22
CONTRA-INDICATIONS DIRECT IRRADIATION OF THE EYES Class 3B & 4 lasers are harmful to the retina. Safety goggles must be worn by both patient and operator at all times. Do not treat around the eye area, even if safety goggles are worn. PREGNANCY Laser is contra-indicated for use over the pregnant uterus. It may be used on the pregnant woman as an adjunct to the other modalities being used for the treatment of back pain or other complaints. CARCINOMA Do not use the laser over any known primary or secondary lesions, tumours or carcinoma. THYROID Laser should not be used over the thyroid gland. IMMUNE SUPPRESSANT DRUGS Laser Therapy is contra-indicated for patients on these drugs. TREATMENT OVER SYMPATHETIC GANGLIA, THE VAGUS NERVES & CARDIAC REGION IN PATIENTS WITH HEART DISEASE Laser Therapy may significantly alter neural function, and is therefore contraindicated over these regions in patients with heart disease. (c) LZR7 2015 23
PRECAUTIONS INDIRECT IRRADIATION OF THE EYES Reflected light, or even looking at the bright crescent around the probe where it is in full contact with the skin, can induce eye strain and headache. Therefore safety goggles should be worn by both patient and operator at all times, even when direct viewing of the laser aperture is unlikely. PHOTOSENSITIVITY REACTIONS Some patients are on drugs known to cause photosensitivity reactions. It is unlikely that a combination of laser and drug will trigger this response. We recommend that "at risk" patients or patients with a history of such reactions be "patch tested" for the minimum recommended treatment time, for that probe, with each probe expected to be used on that patient. ANTI COAGULANTS It is possible that probe pressure may cause slight bruising after treatment. N.S.A.I.D. AND STEROIDAL A.I. Patients using topical or systemic steroids or NSAID's (non steroidal antiinflammatory drugs) for pain or skin conditions may experience a mild "flare up" of their symptoms. If such a reaction occurs, laser therapy should be stopped. The reaction should be allowed to settle. Laser treatment can then be recommenced at minimum or half minimum treatment times - if necessary building up to an "effective dose" if the patient does not respond to the lowered treatment times. For patients with persisting treatment reactions, Laser therapy should be discontinued. EPILEPSY Take care when using laser therapy for these patients especially around the head and neck. Cover the area being treated with a towel draped over the probe. REACTIONS TO TREATMENT Some patients may suffer a slight increase in pain - patients should be warned of this prior to laser therapy treatment. In patients with persisting treatment reactions, laser treatment should be discontinued. (c) LZR7 2015 24
PINS, METAL PLATES, PLASTICS AND PACEMAKERS ARE NOT CONTRAINDICATED Laser may be safely used over metal implants, plastics and stitches and on patients fitted with a pacemaker. DARK SKIN High power laser therapy devices can cause discomfort and even a minor burn under extreme cases on patients with very dark skin. Patients with dark skin should commence treatment on 30% power, medium skin 60% and light skin 90 to 100%. If the patient does not report any discomfort the power output can be incremented at 10% every 10 seconds, until the warming effect becomes uncomfortable. At this point back off the power 20% and complete the treatment at that power level. SKIN SENSITIVITY 1. Do not use the laser probe if there are any cracks or marks on the lens. 2. Watch for any signs of skin irritations from the use of this device. Discontinue use if signs of skin irritations, redness or itching are observed. (c) LZR7 2015 25
SPECIFICATIONS System General Operating Temperature Certified and tested at 23 +/-2 deg C, Recommended limits +5 to +30 deg C Storage Temperature -25 to +70 deg C Relative Humidity Certified and tested at 60% +/-15 Recommended limits 10 to 90% Atmospheric Pressure Certified and tested at 860 to 1060hPA 645 to 795 mm HG Compliance Standards IEC60601-1 Ed3, ISO14971, IEC60601-2-22:2007, IEC60825-1:2007, IEC60601-1-2, Cispr 11, EN61000-4-2, EN61000-4-3, ISO10933-1:2009, ISO14971:2012 21CFR1002.10, 21CFR1040.10; 21CFR1040.11 ZX2 Laser Unit Voltage Certified and tested at 115 to 230V 50-60Hz Recommended limits 100 to 250V Power Consumption 200VA max Current 2A max Power Supply Classification Class I Insulation Classification Type B Dimensions 175mm(L) x 220mm(W) x 120mm(H) 7(L) x 9(W) x 5(H) Inches Weight 3Kg 6.5lb Mode of Operation Continuous at 50% power, or below Protection IPX0 Display 80 Character Alphanumeric LCD Laser Class Class 3B & 4 Laser Product (probe dependant) Emission Timer 1sec to 2min fully programmable Timer Accuracy ±1second Programming parameters Treatment time Total Joules Joules/Cm 2 Tissue depth Frequency 2.5Hz, 5Hz, 10Hz, 20Hz, 50Hz, 100Hz, CW Duty (power) 10 to 100% in 10% steps (50-100% SP probes) Standby/Ready Delay 4 seconds Output measurement Silicon Photodiode Calibration Accuracy ±20%. (c) LZR7 2015 26
Warning Labels Laser warning label on front of device Ratings label on rear of device Serial number label on rear of device, which also indicates date of manufacture (DOM) (c) LZR7 2015 27
Laser Safety Goggle Specifications Lens type EN207 Classification ML3 DIR 630-660 L3 DIR 800-915 L3 ANSI Classification 630-660 OD5+ 800-915nm OD3+ WARNING: use of laser safety goggles, other than those supplied or meeting the above specification could result in hazardous eye exposure. Should the lenses of the laser safety goggles get excessively scratched, cracked or damaged, they should be discarded and replaced. (c) LZR7 2015 28
750mW Deep Probe (Applied Part) Type CW Single Point Total Maximum Power Output 750mW No. of Laser Diodes 1 Wavelength 808nm Aperture 15mm Laser Classification Class 4 NOHD* 90Cm, 3ft Safety goggle requirement OD3 minimum @ 808nm Treatment Time for 4 J/Cm 2 9.4 seconds Total Energy delivery per minute 45 Joules, 25 J/Cm 2 Emitter Type Ga Al As Semiconductor Laser Beam Divergence 5º x 12º Spot Size 1.76Cm 2 Power Density (Irradiance) 0.425W/Cm 2 (4,250Wm -2 ) * Nominal Ocular Hazard Distance (c) LZR7 2015 29
1.5W Deep Probe (Applied Part) Type CW Single Point Total Maximum Power Output 1.5W No. of Laser Diodes 1 Wavelength 808nm Aperture 15mm Laser Classification Class 4 NOHD* 150Cm, 5ft Safety goggle requirement OD3 minimum @ 808nm Treatment Time for 4 J/Cm 2 4.7 seconds Total Energy delivery per minute 90 Joules, 51 J/Cm 2 Emitter Type Ga Al As Semiconductor Laser Beam Divergence 5º x 12º Spot Size 1.76Cm 2 Power Density (Irradiance) 0.85W/Cm 2 (8,500Wm -2 ) * Nominal Ocular Hazard Distance (c) LZR7 2015 30
6.1W Multi Probe (Applied Part) Type CW Large area Multi Total Maximum Power Output 6.1W No. of Laser Diodes 5 Wavelength 658nm x1 & 808nm x 4 Aperture 25mm Laser Classification Class 4 NOHD* 150Cm, 5ft Safety goggle requirement OD3 minimum @ 808nm and 658nm Treatment Time for 4 J/Cm 2 6.2 seconds Total Energy delivery per minute 366 Joules, 38.5 J/Cm 2 Spot Size 9.35Cm 2 Power Density (Irradiance) 0.642W/Cm 2 (6,420Wm -2 ) 658nm Emitter Emitter Type: Ga Al In P Semiconductor Laser Beam Divergence 9.5º x 17º Maximum Output Power 100mW 808nm Emitter Emitter Type: Ga Al As Semiconductor Laser Beam Divergence 8º x 30º Maximum Output Power 1.5W * Nominal Ocular Hazard Distance (c) LZR7 2015 31
SP4 Probe (Applied Part) Type Super Pulsed at 100KHz Total Maximum Power Output 100W peak, 200mW Average No. of Laser Diodes 4 Wavelength 904nm x 4 Aperture 25mm Laser Classification Class 3R NOHD* 30Cm, 1ft Safety goggle requirement OD3 minimum @ 808nm Treatment Time for 4 J/Cm 2 22.7 seconds Total Energy delivery per minute 12 Joules, 10.5 J/Cm 2 Emitter Type Ga As Semiconductor Laser Pulsed Beam Divergence 9º x 38º Spot Size 0.28Cm 2 Power Density (Irradiance) 0.176W/Cm 2 (1,760Wm -2 ) * Nominal Ocular Hazard Distance (c) LZR7 2015 32
Typical skin temperature heating times (c) LZR7 2015 33