2000 TLC- THERAPEUTIC MEDICAL LASER Table of Contents 1) Safety Information – Please Review Before Using the Theralase™ System ..................1 Labeling and an Explanation ....................................... 1 TLC-2000 Labels and Symbols ..................................2 Key Equipment Safety Features ....................................3 Hardware ............................................. 3 Operational Safety ........................................
2000 TLC- THERAPEUTIC MEDICAL LASER 1) SAFETY INFORMATION – Please Review Before Using the Theralase™ System 2000 The Theralase™ TLC- therapeutic laser is a Class B medical laser and as such is a potential hazard for direct and indirect viewing of the laser light.
2000 TLC- THERAPEUTIC MEDICAL LASER 2000 TLC- Labels and Symbols Canadian Standards Association Symbol (for Canada and US): Certifies that the product bearing this mark meets or surpasses CSA guidelines for Medical Electrical Device Standard 60601-2-22/IEC 60825-1:2007 (2 Edition). ATTENTION Consult ACCOMPANYING DOCUMENTS Symbol: Documents accompanying EQUIPMENT or an ACCESSORY and containing all important information for the USER, OPERATOR, installer or assembler of EQUIPMENT, particularly regarding safety.
THERAPEUTIC MEDICAL LASER Key Equipment Safety Features Hardware In addition to the safety signs placed on each of the elements of the Theralase™ system, key safety features are built into the 2000 TLC- Power Pack and Tablet software as well. These are illustrated below.
Caution: Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure. The Theralase™ TLC-2000 therapeutic laser is a Class 3B medical laser and as such is a potential hazard for direct and indirect viewing of the laser light. As a Class B medical laser, the Theralase™...
• 2000 than the recognized accessories or parts can degrade the performance of the Theralase™ TLC- laser and may result in hazardous radiation exposure. WARNING: NO MODIFICATION OF THIS EQUIPMENT IS ALLOWED.
2000 TLC- THERAPEUTIC MEDICAL LASER Disclaimer Information 2000 The TLC- therapeutic laser system is a medical device and is sold to healthcare practitioners as a tool for the 2000 rehabilitation of their patients. The TLC- therapeutic laser system and attachments are utilized to assist in the 2000 alleviation of their patient’s symptoms.
• The Power Pack (TLC- The Power Pack only supplies power to the Laser Probe(s). The Laser Probes are controlled by Theralase™ software resident on the Tablet. Under software control, the Laser Probes operate in a patient treatment mode with the power level and time 2000 based on the protocol resident in the tablet software.
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2000 TLC- THERAPEUTIC MEDICAL LASER 2003 POWER SUPPLY (TLC- Input Voltage / Current 100 - 240 VAC / 2.2 A, 47 to 73 Hz, single phase Output Voltage / Current + 24 VDC / 4.2 A Maximum Watts 101 W Safety Class 2000 TLC-...
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The Power Pack (TLC- 2000 2002 The Theralase™ TLC- laser system Power Pack (TLC- ) is shown below. The Power Pack consists of an aluminum case, a plastic top and bottom, and a separate plastic stand that the bottom of the Power Pack fits into. There are...
TLC-2002 Power Pack. This is the only Power Supply approved to be used with the TLC- 2000 laser system. • Outside of North America, the proper international cord set must be specified and purchased from Theralase™ Inc. or purchased separately for the country of preference. Document: 600-0013...
2000 TLC- THERAPEUTIC MEDICAL LASER 2001 Laser Probes (TLC- 2002 2001 2001 The TLC- Power Pack is designed to operate with up to four (4) of the TLC- Laser Probes. The TLC- Laser Probe has a POWER ON slide switch and a BLACK pushbutton START switch. The Lasers cannot be activated until the Laser Probe receives a command transmission from the Tablet.
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2000 TLC- THERAPEUTIC MEDICAL LASER Connecting/Disconnecting the Laser Probes (TLC-2001) to/from the Power Pack (TLC-2002) All the Laser Probes feature a very simple medical grade push-pull cable connector. This consists of a cable with a connector assembly on each end and a receptacle assembly in the Power Pack and the Laser Probe. Assurance of proper mating is provided by keying.
0.001% 99.999% 0.0001% 99.9999% 0.00001% 99.99999% Optical Density Ratings of the Theralase™ approved laser safety goggles TLC-901 are as follows: 190-400 nm (ultraviolet range): 5+ O.D. 660-670 nm (visible red): 2+ O.D. 800-915 nm (near infrared): 3+ O.D. Document: 600-0013...
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TLC- THERAPEUTIC MEDICAL LASER Theralase™ uses two wavelengths of diodes; specifically, 660 nm (100 mW average power) and 905 nm (200 mW average power) laser diodes. Therefore, using the Theralase™ approved laser glasses may result in the following levels of light being transmitted to the eye (assuming of course that the laser diode is directly in contact with the laser glasses and pointed at the eyes on the individual’s face):...
2000 TLC- THERAPEUTIC MEDICAL LASER Contraindications in the use of Laser Therapy Do not treat the abdomen of a pregnant woman. 2. Do not treat any types of neoplasia, cancer or cancerous lesions (benign or malignant). Cautions in the use of Laser Therapy Never point the laser in the direction of any person’s eyes.
2000 TLC- THERAPEUTIC MEDICAL LASER 3) START-UP INFORMATION A detailed description of the individual system components. The Power Pack (TLC- 2002 2002 The TLC- Power Pack provides power to each TLC-2001 Laser Probe. The probes’ ports, numbered 1 to 4, are the 2001 same electrical output.
2003 Caution: Use only the TLC- Power Supply for the Theralase™ system. Probe Power Ports: Power supply ports for up to four (4) TLC-2001 Laser Probes. 6. Power IN LED: This LED is illuminated only when the external power supply is connected and the key switch is in the ON position, the Remote Interlock Connector is installed and the Emergency Stop is not activated.
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It keeps the lasers clean and can be wiped with isopropyl alcohol. Windows that become scratched should be replaced. Replacement windows can be ordered directly from Theralase™. 7. Laser Probe Cover: The Laser Probe cover attaches to the probe by magnets. The cover protects the window during storage.
The Computer Tablet (TLC-2004) The Computer Tablet comes with the Theralase™ software already installed and the keyboard and touch screen together. The touch screen can be separated from the keyboard if desired. There is a pop up touch screen keyboard; however, it may be easier to input data using the attached keyboard.
2000 TLC- THERAPEUTIC MEDICAL LASER Set-Up Procedure Unpack the contents of the case and identify each of the pieces as outlined in the figure below. Identify the following components of your TLC-2000 system: 1. Computer tablet (TLC-2004) 6. Laser Probe(s) 1 to 4 (TLC-2001) 2.
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Note: There is a user name and password for the Computer Tablet and also for the TLC-2000 software. At this point the Theralase™ TLC-2000 Clinic Desktop screen should be displayed with icons for the actions. Turn on the Power Pack by: a.
Steps for Advanced Treatment To operate the Advanced TLC-2000, the basic steps are: From the Theralase™ TLC-2000 Clinic Desktop, tap the Advanced Treatment tab. Enter the patient’s name in the search field. If the patient is not in the database, tap the New Patient button and input patient data into the software database and save.
To operate the Basic TLC-2000, the steps are: From the Theralase™ TLC-2000 Clinic Desktop, tap the Basic Treatment tab. Select the diagnosis that is to be treated, followed by the protocol to be used: Standard, Sport and High BMI, Low BMI and Geriatric, or Dark Skin, and press the Save button.
2000 TLC- THERAPEUTIC MEDICAL LASER Overview of the Menu Custom Settings Create Custom Protocols Use this tab to create a custom protocol. Enter the power level for 905nm and 660nm, treatment duration, protocol name, and body region to be treated. Advanced Treatment Customized Treatment Options Basic Treatment...
2000 TLC- THERAPEUTIC MEDICAL LASER System Settings Administrator Access Permissions: This tab is used by an administrator to set up control of access to the TLC-2000 software. Users: This tab is used by an administrator to set-up TLC-2000 system users. Synchronize: This tab is used to Upload client data and Download cloud data.
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Launching the TLC-2000 software To launch the Theralase™ application, double touch the icon and the application Sign In window will appear. Enter the username and password and tap the sign in button once. The main menu will be displayed on the screen.
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2000 TLC- THERAPEUTIC MEDICAL LASER For existing patients, enter Patient Name in Search field. Select the Patient and press the Edit Patient button and Patient Profile window will open. For new patients, select the New Patient button and the Patient Profile window will open. Fill in all the data fields and save.
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2000 TLC- THERAPEUTIC MEDICAL LASER Treating the Patient From the main menu, select the advanced treatment tab. The Patient Menu will open. Enter the patient name to search for the patient. The patient’s name will be listed. Select the patient and select the To Diagnoses button. Select the condition to be treated.
2000 TLC- THERAPEUTIC MEDICAL LASER Advanced Operations How to Create Custom Protocols From the main menu, select the Custom Settings tab. The Custom Settings menu window will open. Hit the plus button to start inputting the new information. Enter the power levels that you would like assigned to the 905nm laser diodes and the 660nm laser diodes and then the duration of time.
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2000 TLC- THERAPEUTIC MEDICAL LASER To Add/Remove Users Select the Users Tab. Hit the plus button to start inputting the new information. Fill in the data fields with the user name, password, and name of the person. Check the box to determine the group: usually Practitioner. Reserve Administrator for one or two users.
5) MAINTENANCE AND SERVICE This section deals with maintenance and serviceability of the Theralase™ system by the end user. If further detailed service of your laser system is required, contact Theralase™ Inc directly for assistance. Detailed contact information is supplied at the end of this section.
Calibration or repair of the real-time Laser Probe Cover is not a process that can be performed in the field. There are no user serviceable parts in the probe. In the event, if such a situation does arise, it is recommended to call Theralase™...
Power Outlet None Warning: The use of Power Cord other than the one provided by Theralase™ Inc. for the TLC-2000 may result increased EMISSIONS or decreased IMMUNITY of the TLC-2000 system. Warning: The TLC-2000 should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the TLC-2000 should be observed to verify normal operation in the configuration in which it will be used.
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2000 TLC- THERAPEUTIC MEDICAL LASER IMMUNITY test IEC60601 Test level Compliance level Electromagnetic environment-guidance Mains power quality should be that of Electrical fast ±2KV for power ±2KV for power typical commercial or hospital environment. transient/burst supply lines supply lines Criteria A Level 3 IEC 61000-4-4 ±1KV for input/ ±1KV for input/...
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TLC- THERAPEUTIC MEDICAL LASER Guidance and THERALASE™ INC’s declaration- electromagnetic IMMUNITY The TLC-2000 is intended for use in the electromagnetic environment specified below. The customer or the user of the TLC-2000 should assure that it is used in such an environment.
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2000 TLC- THERAPEUTIC MEDICAL LASER Recommended separation distances between portable and mobile RF communications equipment and the TLC-2000 The TLC-2000 is intended for use in the electromagnetic environment in which radiated RF disturbances are con- trolled. The customer or the user of the TLC-2000 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the TLC- 2000 as recommended below, according to the maximum output power of the communications equipment.
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