Chattanooga Cube 3 Operator'S Manual Download

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Operator manual Cube

13-00170-US Rev C

Page 1 of 51

Class IV

Laser device

Operator manual

Summary of Contents for Cube 3

Page 1: ...Operator manual Cube 13 00170 US Rev C Page 1 of 51 Class IV Laser device Operator manual ...

Page 2: ...ent Title Operator manual Cube US market Date 20th June 2018 Rev C Manufactured by Via Castagnole 20 H 31100 Treviso Italy Distributed by DJO LLC A DJO Global Company 1430 Decision Street Vista CA 92081 8553 USA T 1 800 494 3395 USA Email ChattProductSupport djoglobal com DJOGlobal com The device is manufactured in compliance with the provisions of Council Directive 93 42 EEC and 2007 47 CE concer...

Page 3: ... Operating conditions 12 4 Installation 13 4 1 Scope of supply 13 4 2 Spare parts and optional 13 4 3 Power supply 14 4 3 1 Replacing the rechargeable battery 15 4 4 Optical fiber and zoom optical with distal 15 4 4 1 Zoom optical 16 4 4 2 Care of the optical fiber 18 4 5 Interlock 19 4 6 Wireless footswitch optional 19 5 Operation 20 5 1 Start the device for the first time 20 5 2 Switch on off po...

Page 4: ... 42 8 1 Maintenance 42 8 2 Troubleshooting of simple defects 42 8 3 Safety check 43 8 4 Technical support repair and testing 43 9 Manufacturer s declaration on electromagnetic compatibility 44 9 1 Definitions 44 9 1 1 Emission electromagnetic 44 9 1 2 Interference immunity 44 9 1 3 Immunity level 44 10 Appendix 47 10 1 Appendix A Certification 47 10 2 Appendix B Label positions 48 ...

Page 5: ...ice is indicated for emitting energy in the Infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain muscle spasm pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation The device does not store preset treatments the operato...

Page 6: ...es supplied from an outside source that are not included in the scope of delivery of the device 1 4 Interferences caused by mobile wireless phones Caution To ensure safe operation of medical electrical equipment the use of mobile wireless phones in practice or hospital environments must be prohibited 1 5 Disposal of main unit If you plan to discontinue the use of your device and you intend to disp...

Page 7: ... on the device Warning Operation of this laser unit by unauthorized persons must be prohibited in order to prevent incorrect or improper use Laser equipment not in use must be protected against unauthorized access This can be achieved for example by switching off the laser unit after use so that the electronic access key must be entered prior to further operation Warning Never direct the laser bea...

Page 8: ...cal installations must be observed Warning Verify that the line voltage corresponds to the voltage indicated on the rating plate of the adapter or in the technical specifications Warning Do not use the device if a visual inspection shows that it has been damaged Warning If you accidentally spill any liquid on the unit immediately stop treatment disconnect the power cable and contact the authorized...

Page 9: ...ufacturer s Notified Body 20XX XX XX Date of manufacture year month day Please refer to manual first Do not dispose with domestic waste Connection socket for DC input from the power supply Connection socket for interlock Connection socket for USB Laser radiation warning Specification of laser output power and wavelength of IR and aiming beam see also Chapter Technical data Verifies the compliance ...

Page 10: ... laser emission Pulsed emission Pulsed laser emission Chopped Mode Frequency Number of laser pulses per second Hertz Unit of measure for frequency Interlock Safety device that stops laser radiation when the door of the treatment room is opened Joule Unit of measure for emitted energy Watt Unit of measure for laser power 2 3 Abbreviations cm2 Square centimeter Hz Hertz s Seconds W Watt mW Milliwatt...

Page 11: ...er system Class IV according to IEC 60825 1 Device classification Class IIb according to Council Directive 93 42 EEC Wavelength nm 15 nm 800 970 800 905 970 660nm 10 nm 660 660 ISP peak power W 15 20 ISP average power W 8 12 CW power W 20 12 15 Max power 660 nm mW 120 Emission mode CW continuous wave modulated 1 Hz to 20 kHz ISP IP degree of protection Laser unit IP20 footswitch cover not waterpro...

Page 12: ...60 hPa Caution Do not leave the device in a vehicle parked in the sun The inside temperature of the car could thus heat up to a point where individual components may be damaged Notice The rechargeable battery must be fully charged regularly After 6 months of no charging storage the rechargeable battery might lose its loading capacity and might not be rechargeable anymore 3 5 Operating conditions T...

Page 13: ...6 1 E6254473 USA Cube Power cord USA Canada 1 MP111B USA New packaging KIT Cube Laser 1 MP500 USA Cube Operating manual MED 1 13 00170 US 4 2 Spare parts and optional Part Description DJO Part Number Zoom optical without distal Cube3 4 MP486 USA Cube Distal Piece MED MP513 USA Cube Goggles PF002P USA Cube Dark Goggles MP503 USA Cube Child Goggles MED MP478 USA Cube Warning sign MP130GC USA Cube Op...

Page 14: ... the entire unit automatically becomes void and the warranty expires Warning The use of any power supplies other than the one recommended may cause overheating and failure of the laser unit or damage of batteries The device is supplied with a rechargeable battery and therefore can be used without connected power cable The status of the rechargeable battery and whether the power cable is actually c...

Page 15: ... Press OK to confirm Unplug the power supply connector and wait until the device switches off automatically Then plug in the power supply connector and charge for 2 hours Caution Only use the specific battery pack provided see chapter spare parts and optional 4 4 Optical fiber and zoom optical with distal The optical fiber is supplied ready to be used The operator is able to perform needed treatme...

Page 16: ... not to scratch and damage the foil on the lens 4 4 1 Zoom optical The zoom optical is supplied assembled and ready to be used The operator is able to manage the energy density by turning the ring On the ring a spot size regulator is present and allows you to select a different treatment diameter and thus a different power density Warning There is a locking system in the ring and a warning symbol ...

Page 17: ...e light source even when set to a low power level Always wear protective goggles Warning Before and during the emission laser verify that the aiming beam is present and that it projects a regular shape If it does not come projected some shape or if it is much irregular the optical fiber or the device could be damaged In this case proceed as follows Switch off the laser and check the optical fiber ...

Page 18: ...ay damage the optical fiber irreparably Marker of optical fiber s end Warning The fiber must be wound around the device counter clockwise Should it be wound differently will damage the fiber irreparably Warning The arrow of the label shows the correct winding of the fiber Caution The optical fiber may be damaged if it is seriously bent pitched or improperly routed Caution Bear in mind the maximum ...

Page 19: ...nnel or patients must also be observed 4 6 Wireless footswitch optional The device can be operated using the fingerswitch which is integrated in the handpiece as well as by using the optional wireless footswitch Caution Touch a grounded metal part before opening the housing to prevent damage to the PC board due to electrostatic discharge Caution Prior to changing the batteries switch the device of...

Page 20: ...s the icon to check the battery percentage Connected char ging battery Battery is connected to power supply and charging Information Press it to see device information OK Operator confirms and activates action Back Operator goes back one screen Clear Press it to delete in case of wrong typing New Operator wants to generate a new application Save Operator saves an application OK Laser Laser is bein...

Page 21: ...fter treatment the laser can be switched off by switching on the on off button on the backside of the unit Here the laser diode is permanently disconnected from power supply In case of emergency press the laser stop button Note that the laser is interrupted and restarted in a safe mode but not switched off Notice The device can be switched off in two ways Keep pressed the on off button on the back...

Page 22: ...ng Press it to confirm the pin code Press it to see device information Warning The device may be operated only by qualified personnel Do not give the access to unauthorized third parties Do not write down the electronic access key somewhere else to reduce the risk of misuse of the laser by unqualified persons Please turn off the unit after the use 5 4 Main menu screen After entering the pin code t...

Page 23: ...st Additional treatments Press it to go to the treatments not related to any anatomical body part Notice The device is able to store all the steps performed by the operator during the device use In particular the operator can set as default the body mass and always know the performed choice The following scheme describes how to set the default value and how to visualize the performed steps Keeping...

Page 24: ...already selected body type and treatment area These are modifiable in order to rectify a wrong choice Acute Moderate Chronic Chronicity of the treatment Low Mid High Pain level of the treatment Each square into the grid is editable and it corresponds to each skin type chronicity and pain level combination Skin type based on Fitzpatrick tone scale The blue point shows the selected skin type Press i...

Page 25: ...hows the current page the second one the total number of pages For a new treatment press After that treatment area will be shown The following screen shows how to create a new treatment Select the field to be modified Green selected field Black not selected field Press it to count up and down numerical value Press it to scroll forward and backward the phases The first number shows the current page...

Page 26: ...1 20000 Hz In particular in case of CW frequency is automatically converted into 20000 Hz The following steps allow the operator to set parameters Select Add phase to create a new phase for the treatment Select the needed parameters To manage the parameters select the field that will be highlighted with a green square and then press Minus Plus key or to enter in a Keyboard to implement the modific...

Page 27: ... 0 1 15 W Notice In ISP modality power emission is automatically set The device calculates the average power from the power values and duty cycle Notice In ISP modality average power can be set in base of model Frequency is adjustable between CW 1 20000 Hz or ISP It is adjustable by typing in the numbers or touching Increments are adjustable as follows from 1 to 20000 Hz step of 1 Hz Time of the e...

Page 28: ...vised during use Notice Before starting a laser treatment in battery operation please reconfirm the battery status The user can modify parameters and if needed the user can press and the following screen will appear Select the field to be modified and then press the key to count up and down numerical value Green selected field Black not selected field Press it to count up and down numerical value ...

Page 29: ...lected one or delete the current one The treatment is composed up to twelve phases 800nm Selectable wavelengths and ISP modality Green selected field Blue not selected field ISP ISP Intense super pulse modality can be selected For each treatment phase the device keeps trace of the performed modifications The followings images show the colors used for the status identification The operator is worki...

Page 30: ...y frequency values are defined between 1 20000 Hz In particular in case of CW frequency is automatically converted into 20000 Hz The following steps allow the operator to set parameters Press the from the treatment area and select the phase to be modified Select the needed parameters To manage the parameters select the field that will be highlighted with a green square and then press Minus Plus ke...

Page 31: ... please read carefully the specific instructions and the attached warnings Notice In ISP modality power emission is automatically set The device calculates the average power from the power values and duty cycle Notice In ISP modality average power can be set in base of model Frequency is adjustable between CW 1 20000 Hz or ISP It is adjustable by typing in the numbers or touching Increments are ad...

Page 32: ... of laser arming icon it is necessary to press the sound icon Thanks to this option during laser emission the laser will be disabled only for the treatment to be performed Notice In base of the selected frequency CW chopped or ISP modality the aiming beam emits in a different way as described CW the aiming beam is fixed not flashing Modulated the aiming beam is slowly flashing ISP the aiming beam ...

Page 33: ...y created patient the device will show the main menu In this way the operator can select the body part to be treated After that the operator can set the treatment from the patient s chronicity pain level matrix Notice At the selection of an already created patient with an already performed treatment the device will directly show the patient s chronicity pain level matrix Notice In order to have th...

Page 34: ... code See related paragraph for further explanation Select volume level of warning sound and press button sound by using Battery calibration process Follow the instruction displayed on screen Configure the switch emission modalities Single touch laser active if fingerswitch is kept pressed Double touch laser is active at the first pressure of the fingerswitch Second pressure enables the emission R...

Page 35: ... the new pin code Confirm by pressing OK The numeric pad always displays the used key code Press it to confirm the new P I N Press it to go back one screen Warning The device may be operated only by qualified personnel Do not give the access to unauthorized third parties Do not write down the electronic access key somewhere else in order to minimize the risk of misuse of the laser by unqualified p...

Page 36: ...en bar shows the selected modality Notice Single touch If the switch is kept pressed the message LASER ON appears and at the same time yellow LEDs light up audible alarm sounds and laser starts emitting At the switch release the laser is deactivated but remains ready for operation Notice Double touch At the first pressure of the switch the message LASER ON appears at the same time yellow LEDs ligh...

Page 37: ...be deleted from the History file by pressing the proper key to confirm the action The operation is irreversible Press View history to visualize the screen to set year and month to be consulted Use the arrows to scroll the date Confirming the choice with OK the device will show the treatment s parameters as in the following screen Press it to go back one screen Press it to export performed treatmen...

Page 38: ...ws the user to choose the following different file formats TXT Format available on any text program CSV Format used to exchange data between spreadsheets There are two different kinds of history Global history that shows a complete list of performed treatments Press Export history or to export the treatments directly into the USB stick Class 2 0 Notice The file name of the complete list has the fo...

Page 39: ...ated power for 180 s The battery level is very low remaining power for 180 seconds and needs to be charged Battery low The battery level is low and needs to be charged Fan not working Switch off the device Cooling fan is not working To avoid damage please switch off the device and let it cool down for a while Wait laser source cooling To avoid damage of the laser source please wait and let the dev...

Page 40: ...ard a person s eye or thyroid gland All persons present in the room patient operator and assistant must always wear the laser protective goggles delivered along with the device 6 3 Precautions Warning It is recommended not to use the handpiece in direct contact to skin of the patient but to keep distance from the skin and always move it Warning Before starting treatment please try to treat fix poi...

Page 41: ...oceed carefully not to scratch and damage the foil on the touchscreen Notice The device may be disinfected only by wiping it Notice Optical fiber can be damaged easily if it suffers excessive flexion or is used in an incorrect way This fact can compromise the usefulness of the treatment Notice Clean the lens with a dry soft cloth Please proceed carefully not to scratch and damage the foil on the l...

Page 42: ...laser unit or repair work may be performed only by authorized personnel The electrical installations in the rooms where the device is used must fulfill the applicable legal requirements The unit must be used in compliance with the instructions provided in the present manual 8 2 Troubleshooting of simple defects In case of malfunctioning proceed as follows First of all be sure that operation steps ...

Page 43: ...neral function check Check of the visual and audible indicators Check the electrical power Check the power emission of the laser 8 4 Technical support repair and testing In case technical support contact the following address UNITED STATES T 1 800 494 3395 USA Email ChattProductSupport djoglobal com Before sending the device to the Service Center it is required to disinfect the device and accessor...

Page 44: ...ISSION TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT GUIDANCE RF emissions CISPR 11 Group 1 The unit uses RF energy only for its internal function The RF emission is therefore very low and it is improbable that nearby electronic devices might be disturbed RF Emission CISPR 11 Class A The unit is suitable for use in all establishments excluded domestic establishments and those directly connected to t...

Page 45: ... that of a typical commercial or hospital environment Surge EN 61000 4 5 1 kV differential mode 1 kV differential mode The quality of the line power supply should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines EN 61000 4 11 5 Ut del 95 dip of Ut for 0 5 cycles 40 Ut 60 dip in UT for 5 cycles 70 Ut 30 dip i...

Page 46: ... with the following symbol RECOMMENED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE UNIT The model is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment tr...

Page 47: ...ion the product has been designed and manufactured according to the following standards Electro medical equipment General requirements for safety Electro medical equipment General requirements for safety Secondary standard Electromagnetic compatibility Prescriptions and tests Medical electrical equipment Part 1 General requirements for basic safety and essential Performance Collateral standard Usa...

Page 48: ...ge 48 of 51 10 2Appendix B Label positions The following figures show the positions of the labels on the device Picture 1 front side Picture 2 rear side Label 11 Label 5 Label 5 Label 1 Label 4 Label 7 Label 8 Label 9 Label 14 Label 13 Label 5 ...

Page 49: ...Operator manual Cube 13 00170 US Rev C Page 49 of 51 Picture 3 inner side Picture 4 bottom Label 2 Label 3 Label 10 Label 12 Label 6 ...

Page 50: ...tion hazards when opening the laser unit Label_3 use only with power supply Sinpro MPU 100 106 Label_4 for Cube 3 Specification of laser output power and wavelength of diode and aiming beam Label_4 for Cube 4 Specification of laser output power and wavelength of diode and aiming beam Label_5 Laser radiation warning Label_6 Fingerswitch Label_7 DC in for power supply Label_8 socket for Interlock ...

Page 51: ...el_9 socket for USB Label_10 Cube 3 Identification serial number of the device Label_10 Cube 4 Identification serial number of the device Label_11 Laser stop Label_12 FDA clearance Only for Us market Label_13 Correct fiber winding Label_14 On off the device ...

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