Related Manuals for Chattanooga Cube 3
Summary of Contents for Chattanooga Cube 3
- Page 1 Class IV Laser device Operator manual Operator manual Cube 13-00170-US Rev C Page 1 of 51...
- Page 2 No part of this publication may be reproduced, transmitted, stored or translated into any language, in any form or through any electronic, magnetic, optical, chemical, manual, physical device or other means, without written consent. Title – Operator manual Cube (US market) Date –...
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Page 3: Table Of Contents
Warning and safety information ................5 Highlighting of warning and safety information ............5 Intended use ......................5 Instructions on use of the laser protective goggles..........6 Interferences caused by mobile wireless phones ..........6 Disposal of main unit ..................... 6 Safety precautions .................... - Page 4 Post treatment cleaning ................... 41 Cleaning of the unit ..................... 41 Cleaning of the zoom optical with distal .............. 41 Maintenance and service ..................42 Maintenance ......................42 Troubleshooting of simple defects ............... 42 Safety check ......................43 Technical support, repair and testing ..............43 Manufacturer’s declaration on electromagnetic compatibility ......
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Page 5: Warning And Safety Information
1.2 Intended use The devices are designed in different versions and the following parameters are listed: - Cube 3: 660nm±10nm, 800nm±15nm, 970nm±15nm; ISP peak power 15W; - Cube 4: 660nm±10nm, 800nm±15nm, 905nm±15nm, 970nm±15nm; ISP peak power 20W; Each device is indicated for emitting energy in the Infrared Spectrum to provide topical heating for... -
Page 6: Instructions On Use Of The Laser Protective Goggles
Warning The device must not be used in areas where an explosion hazard exists or in the vicinity of highly flammable materials. Warning Public legal requirements may include special safety regulations concerning protection against laser radiation. These requirements must be fulfilled. Warning Failure to use the settings specified in this manual or perform the actions described here may lead to a dangerous exposure to radiation. -
Page 7: Safety Precautions
1.6 Safety precautions Each device is manufactured in compliance with the provisions of Council Directive 93/42/EEC (MDD) and 2007/47/CE concerning medical devices. Always observe the following precautions: Caution The laser unit and accessories are not sterilizable. Warning When disconnecting the optical fiber from the device, always cover the connector with the special protection cap. - Page 8 Caution Avoid interference between the laser emission and any optical sensors of devices operated in the vicinity of the device. Caution Do not place the unit near heat sources. Do not cover the convection openings for air cooling on the sides of the unit. Caution The device may be operated only by trained and qualified personnel.
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Page 9: Symbols And Abbreviations
2 Symbols and abbreviations 2.1 Symbols on the device Symbol Description Class II unit according to IEC 60601-1. Type B applied part according to IEC 60601-1. CE mark in accordance with Council Directive 93/42/EEC and 2007/47/CE, stating the manufacturer’s Notified Body. 0476 Date of manufacture (year-month-day). -
Page 10: Glossary
Warns of Class 4 laser radiation hazards when using the unit. “LASER STOP” button: Press this button in case of an emergency. Operate the unit exclusively with the MPU100-106 power supply. Pairing button of the wireless footswitch (optional). 2.2 Glossary Continuous emission Continuous laser emission;... -
Page 11: Technical Data
Class IV laser product according to IEC 60825-1 of laser product; Degree of protection according to IEC 60601-1 medical unit IP20 (enclosure not water- proof), IPX5 for footswitch. 3.2 Device specification Specification Cube 3 Cube 4 Laser type Diode GaAlAs Laser system... -
Page 12: Wireless Footswitch Specification
3.3 Wireless footswitch specification Model designation NanoLOC AVR 2.4 GHz – 2.4835 GHz (ISM band) Frequency Transmitting power < 2 mW (short-range device) Modulation type Multi Dimensional Multi Access (MDMA) 3.4 Transport and storage The device comes in a box that ensures proper and easy transport. In its original transport packaging, the device can withstand the following ambient transport conditions ... -
Page 13: Installation
Any national or local regulations stipulating that the device may be installed only by trained personnel must be strictly observed. 4.1 Scope of supply Part Description DJO Part Number Cube 3 Unit Only 3079-USA Cube 4 Unit Only 3080-USA Cube 4 PLUS Unit Only 3081-USA Cube Goggles: 780-<790 DIR LB6 (OD6+);... -
Page 14: Power Supply
Part Description DJO Part Number MP474-USA Distal piece 40 mm MED MP553-USA Optical Plus 40mm (without distal) MP554-USA Optical part of zoom PLUS (without distal) Optical part of zoom PLUS with distal MED MP555-USA MP263-USA Class 4 label, visible/invisible - if open MP264-USA Class 4 label, visible/invisible MP473-USA... -
Page 15: Replacing The Rechargeable Battery
4.3.1 Replacing the rechargeable battery If the rechargeable battery does not charge more than 30% even by charging it overnight, the battery needs to be replaced. Removing and replacing the battery: Extract the handpiece and unroll completely the fiber; ... -
Page 16: Zoom Optical
Detach Attach Notice The user can attach the part, simply connecting it to the handpiece body. When attaching or detaching the parts, we recommend to slightly rotate the two parts. The rotation of the two parts makes the operation easier. The user must hear a sound (click) locking the distal. - Page 17 Approx. Spot size Max beam treatment regulator diameter, mm area, cm Spot size regulator Warning Should any treatment utilize an average power ≥ 8W, enlarge the spot diameter to its maximum. This action will avoid excessive power density to be delivered over the treated area. Caution The distal can be removed for cleaning.
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Page 18: Care Of The Optical Fiber
4.4.2 Care of the optical fiber The optical fiber comes with a metal hose with a coating to protect it from damage. For proper functioning and upkeeping, it must be handled with care, especially when winding and unwinding in its proper seat about the device. Warning Do not unwind once the yellow sticker on the fiber appears. -
Page 19: Interlock
4.5 Interlock As foreseen by the normative the device is supplied with connector interlock for the automatic interruption of the emission laser at distance. Such connector is normally connected to a switch which interrupts the functioning of the laser in case a person enters in the room in which it is used. -
Page 20: Operation
5 Operation 5.1 Start the device for the first time Notice Touchscreen functionality: When the touchscreen is touched by the finger the touch field is highlighted. As soon as the finger leaves the touchscreen the action will be activated. Notice Symbols/Icons on the LCD: Name Explanation... -
Page 21: Switch On/Off Power
5.2 Switch on/off power After starting the device by switching on the on/off button on the backside of the control unit the yellow LED will be on. Notice Remember to switch on also the power supply, in case the switch is present. Notice While the device is booting, a screen will remember the user to carefully read the manual before unit use. -
Page 22: Enter Pin Code
5.3 Enter pin code The device may be operated only by authorized personnel. So for security purposes the device has an electronic key. After boot, the device will ask to digit the pin code, which consists of a sequence of 4 keys. 0 0 0 0 The code is Press it to delete in case of wrong typing. - Page 23 After choosing Programs, you can enter in the following screen. Body types are the following: Ectomorph: typical skinny body; Mesomorph: athletic body. Endomorph: solid and generally soft body; Head, Cervical, Shoulder, Thoracic, Body parts. The operator can select one Arm, Elbow, Lumbar, of the listed treatment areas.
- Page 24 After the selection, the device will ask the operator to select the patient skin type on the basis of the Fitzpatrick scale. I White, very fair, red or blond hair, blue eyes, freckles II White, fair, red or blonde hair, blue hazel, or green eyes. III Cream white, fair with any eye or hair color, very common.
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Page 25: Treatment Creation From Additional
5.4.1 Treatment creation from additional After the selection of from the main menu the device will show the following screen. These treatments are not strictly connected to the body part of the human body. Pressing the desired treatment, it will be highlighted. Rename treatment. - Page 26 Peak power is delivered only in pulsed mode and it is called ISP (Intense Super Pulse). It is a pulsed mode which delivers the following average power: Cube 3: average power 0.1 – 8 W; Cube 4: average power 0.1 – 12 W;...
- Page 27 Power increments by typing in the numbers or by touching The following power: Cube 3: CW power 0.1 – 12 W; Cube 4: CW power 0.1 – 15 W; Notice In ISP modality power emission is automatically set.
- Page 28 The following picture shows the treatment area coming from main menu or additional. Images of the selected body part can be seen. Body mass and position of Chronicity/pain level matrix. Treatment phases are shown. In particular for each phase emission modality is shown (CW, Hz o ISP). The current phase will be highlighted.
- Page 29 Notice Before starting a laser treatment in battery operation please reconfirm the battery status. The following fields allow the operator to manage the treatment parameters. Power/ Press one of the fields and the numeric keyboard. It allows the operator to set the desired value.
- Page 30 Peak power is delivered only in pulsed mode and it is called ISP (Intense Super Pulse). It is a pulsed mode which delivers the following average power: Cube 3: average power 0.1 – 8 W; Cube 4: average power 0.1 – 12 W;...
- Page 31 Power increments by typing in the numbers or by touching The following power can be set: Cube 3: CW power 0.1 – 12 W; Cube 4: CW power 0.1 – 15 W; Notice For the use of other optional distals, please read carefully the specific instructions and the attached warnings.
- Page 32 Press to arm the laser. Device warns to wear protective goggles. After acknowledging the advice the green LEDs start flashing. After a delay of 2 seconds, the aiming beam is switched on. The laser is now ready for operation. Notice Before the laser emission starts, the device will ask the operator to verify the optics in use.
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Page 33: Patients
5.4.2 Patients After choosing Patients, you can enter in the following screen. A quick touch of the chosen patient, allows you to enter in the multi choice screen (treatment repetition, view history and delete). Press it to go back one screen. Arrows used to scroll forward and backwards, if more than one page on the list is present. -
Page 34: Set-Up
5.5 Set-up The following area allows the operator to personalize the device. Select the interested area to enter in the following screen and so set the function. Set date and time of the device. Date format (dd/mm/yy or mm/dd/yy). Time format (24hours notation): hh:mm. See related paragraph for further explanation. -
Page 35: Date&Time
5.5.1 Date&Time The key allows the operator to set date and time. Press it to increase and decrease the Date. Press it to increase and decrease the Time. Press it to confirm date and time. Press it to go back one screen. 5.5.2 Change P.I.N. -
Page 36: Set Touch
5.5.3 Set touch This key allows the operator to set the switch modality. Single Laser active if fingerswitch is kept pressed. touch Double Laser is active at the first press of the fingerswitch. touch Second press terminates the emission. Remote Remote Restart Control. -
Page 37: History
5.5.4 History The history stores the performed treatments and allows the operator to download them onto a USB stick. View View history. Press the button to check data of the History performed treatments. Save history. Press the button to download data of Export the performed treatments. - Page 38 At the end of each application the device stores the following parameters in the History file. In the upper part of the screen date&time and treatment’s parameters are shown. Number of the treatment phases (in case the operator performs more than 12 phases, the device will show only the last 12).
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Page 39: Error Messages And Warnings
5.6 Error messages and warnings The laser has been Please wait until the deactivated by pressing interlock is closed. Laser Stop Interlock open “Laser Stop” button. Check interlock plug on back of machine. Before proceeding it is Wrong pin code was Wear protective Pin code not advised to put the laser... -
Page 40: Indications, Contraindications And Medical Precautions
6 Indications, contraindications and medical precautions 6.1 Indications Each device 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. -
Page 41: Post Treatment Cleaning
7 Post treatment cleaning Warning Following treatment, switch off the device and disconnect the power cable from the power supply. Warning Unit and accessories are not sterilizable. 7.1 Cleaning of the unit Clean the device and the accessories with a dry, soft cloth to remove dust from the device. More stubborn spots can be removed with a damp cloth. -
Page 42: Maintenance And Service
8 Maintenance and service 8.1 Maintenance The device does not require special maintenance. In case of malfunctioning, see chapter Technical support, repair and testing. However, it is recommended to take the following actions at regular intervals: Action Frequency Responsible Check of the optical fiber Before each treatment session Operator Safety checks... -
Page 43: Safety Check
Wireless foot control is not working. Check the battery of the wireless footswitch. Check the registry of the wireless footswitch. Check if the wireless footswitch is chosen in the set-up submenu. If you cannot solve the malfunctioning, switch off the laser and contact an Authorized Service Center. -
Page 44: Manufacturer's Declaration On Electromagnetic Compatibility
Manufacturer’s declaration on electromagnetic compatibility 9.1 Definitions Notice The device complies with all requirements for electromagnetic compatibility according to IEC 60601-1-2. 9.1.1 Emission (electromagnetic) When electromagnetic energy is emitted by a source. 9.1.2 Interference immunity The ability of a device or system to work without errors even if there is electromagnetic interference. - Page 45 INTERFERNCE IMMUNITY The unit is intended for use in the electromagnetic environment specified below. The customer or user should ensure that it is used in such an environment. Electromagnetic environment – Immunity test EN 60601-1-2 test Compliance level level guidance Electrostatic discharge +/- 6 kV contact +/- 6 kV contact...
- Page 46 RF IMMUNITY The unit is intended for use in the electromagnetic environment specified below. The customer or user should ensure that it is used in such an environment. Electromagnetic environment – Immunity test EN 60601-1-2 Compliance level Test level guidance Conducted RF 3 Vrms from 3 Vrms from...
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Page 47: Appendix
10 Appendix 10.1 Appendix A – Certification The unit is manufactured in compliance with the provisions of Council Directive 93/42/EEC and 2007/47/CE concerning medical devices. DECLARATION OF CONFORMITY Manufacturer’s declaration of conformity (directive 93/42 EEC and 2007/47/CE) The product: Medical class: IIB Type: Laser diode Is manufactured in compliance with the standards of Council Directive 93/42/EEC and 2007/47/CE concerning medical equipment in application to the annexes I and II (except point 4) as per... -
Page 48: Appendix B - Label Positions
10.2 Appendix B – Label positions The following figures show the positions of the labels on the device. Label 11 Label 5 Label 13 Label 5 Picture 1: front side Label 1 Label 5 Label 4 Label 7 Label 8 Label 9 Label 14 Picture 2: rear side... - Page 49 Picture 3: inner side Label 6 Label 2 Label 3 Label 10 Label 12 Picture 4: bottom Operator manual Cube 13-00170-US Rev C Page 49 of 51...
- Page 50 Label_2: Warns of potential laser radiation 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.
- Page 51 Label_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...