ROCAMED SIRIUS User Manual

Thulium fiber laser

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Thulium Fiber Laser

User Manual

DGM001519.01

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Page 1 Thulium Fiber Laser User Manual DGM001519.01...
Page 2 Thank you for choosing a ROCAMED Medical Laser product. In order to attain best results with ROCAMED Laser Systems and to avoid risks of dangerous faults, please be sure that you carefully and completely read this user manual before starting any operation.
Page 3 Keep the equipment away from walls, especially where fans are positioned, ensuring the right ventilation Use protective goggles, ALWAYS Protect the patient from hazardous optical radiations Protect any operator by using personal protection means and environment protection barriers chapter of this manual DGM001519.01 UM Sirius CE/ROTW...
Page 4: Table Of Contents
EVICE INSTALLATION ............................22 RANSPORTATION ..............................22 ACKAGING ..............................22 NSPECTION ............................22 ABELLING CHECK ..........................23 NSTALLATION PROCEDURE Mains connection ..........................24 Remote interlock connection ......................24 Footswitch connections ........................25 Optical fiber connection ........................25 DGM001519.01 UM Sirius CE/ROTW...
Page 5 ANUFACTURER ARRANTY AND ESPONSIBILITY ...................... 59 EPAIRS AND ODIFICATIONS OF THE EVICE ........................60 ERVICE EPARTMENT ONTACTS ........................60 EPORTING OF SERIOUS INCIDENTS TECHNICAL SPECIFICATIONS ......................... 61 ..........................61 ENERAL SPECIFICATIONS ........................62 ASER SOURCE SPECIFICATIONS DGM001519.01 UM Sirius CE/ROTW...
Page 6 ACCESSORIES ............................62 APPENDIX A: RMA REQUEST ......................... 63 APPENDIX B: EMC TABLES ........................64 APPENDIX C: LOGBOOK ........................68 DGM001519.01 UM Sirius CE/ROTW...
Page 7: General Information
Danger of operational fault! Failure to follow this instruction can lead to damage of the laser system, the applicator or the laser fiber. In this manual the following symbol is used to indicate a possible operational fault and the damage of the laser system, which might result from it. DGM001519.01 UM Sirius CE/ROTW...
Page 8: Symbols And Abbreviations
Nominal Ocular Hazard Distance Maximum permissible exposure µm Units, micrometer Units, Second mrad Units, milliradiant Units, watt Units, Joule J/cm Units, Joule for centimeter square Units, centimeter Optical Density Continuous laser according to EN207 Glasses protection degree Units, Kilovolt DGM001519.01 UM Sirius CE/ROTW...
Page 9 Pulse duration laser on T off Pulse duration laser off Units, Pressure °C Units, Celsius degree Units, Kilogram Percentage A label that indicates the key switch off A label that indicates the key switch on Pushing Prohibited DGM001519.01 UM Sirius CE/ROTW...
Page 10: Manufacturer
Combinations Sirius We recommend to use fibers distributed by Rocamed in conjunction with the Laser System. Caution: Products may be incorrectly combined! Injury of the patient, user or damage to the product is possible. The different products may be only applied jointly if the intended use and the relevant technical data, such as working length, diameter, peak voltage, etc.
Page 11: Laser Safety
It is recommended that all operators and support personnel are adequately trained on laser safety standards. This device must only be used by adequately qualified and trained medical personnel with experience in Urology, Thoracic and Pulmonary, ENT, Neurosurgery, Gastroenterology, Gynecology, Lithotripsy and General Surgery. DGM001519.01 UM Sirius CE/ROTW...
Page 12: Working Area
Within the range of the laser, every person must wear laser goggles. Check the laser goggles for perfect condition before each use. The goggles must not be mechanically damaged in any way. Before wearing goggles, make sure that the goggles are in a good condition. DGM001519.01 UM Sirius CE/ROTW...
Page 13: Nominal Ocular Hazard Distance
The use of mobile phones is prohibited in the working area while using the device, because it could interfere with its proper operation. Be careful that the laser system key is in a safe place when not in use. DGM001519.01 UM Sirius CE/ROTW...
Page 14: Electrical Connection Requirements
Current medical literature recommends that a smoke evacuator and in-line filter can be used to capture this plume. The plume should be regarded as a source of active biological material and possibly carcinogenic. Warning: Laser plume may contain viable tissue particles. DGM001519.01 UM Sirius CE/ROTW...
Page 15: Emission Of Toxic Gas Or Vapor
WEEE Directive (Waste Electrical and Electronic Equipment). The penalties for violating law requirements are severe. Labelling plan Label 1 Laser characteristics Label 2 Footswitch connector label Label 3 Emergency laser off label according to IEC 60601-2-22 Label 4 ON and OFF label DGM001519.01 UM Sirius CE/ROTW...
Page 16 Rating label Label 10 High Voltage warning label Label 11 Warning label hazard label according to IEC 60825-1 Label 12 Read instructions for use label Label 13 Remote interlock connector label Label 14 Equipotential connector label DGM001519.01 UM Sirius CE/ROTW...
Page 17: Front View
Label 15 Circuit breaker ON(I)/OFF(0) Label 16 Frontal button ON/OFF label Label 17 UDI label Label 18 Ready/Standby Label 19 Prêt/En attente Front view DGM001519.01 UM Sirius CE/ROTW...
Page 18: Rear View
Rear view Footswitch DGM001519.01 UM Sirius CE/ROTW...
Page 19: Device Description
Handle Optical fiber connector USB port for Service (WARNING: this is a laser aperture) (only for Service personnel) RFID Antenna Blast Shield access Led indicator Air exhaust Warning: USB port is accessible to service personnel only. DGM001519.01 UM Sirius CE/ROTW...
Page 20: Electrical Control
The emergency red push button is designed for emergencies or when the operator must immediately turn off the device. To switch the device off immediately, press this button. To reset the emergency red push button, turn the knob. DGM001519.01 UM Sirius CE/ROTW...
Page 21: Frontal Button On/Off
Warning: Before performing any laser emission, make sure that the probe is properly inserted and pay attention to the pointing direction. Caution: The use of fibers or accessories different from those supplied by the Manufacturer does not guarantee the achievement of security requirements. DGM001519.01 UM Sirius CE/ROTW...
Page 22: System Installation
Verifying the integrity and readability of the security labels placed on the device is responsibility of the user. If labels are damaged, they must be replaced immediately with the labelling shown in the label plan (Section 2.13). DGM001519.01 UM Sirius CE/ROTW...
Page 23: Installation Procedure
Turn on the system Check the system and verify if alert messages are displayed Connect the RFID fiber and wait that the Sirius system recognizes the type and the number of uses of connected fiber Check the system and verify if alert messages are displayed...
Page 24: Mains Connection
The interlock connector is wired on the laser side in the following way: The external door microswitch has to be connected to pins A and B. Contacts C and D close signal lamp circuit (max current 1A, 24Vdc). Interlock male movable connector (inner view) DGM001519.01 UM Sirius CE/ROTW...
Page 25: Footswitch Connections
External protection shutter Caution: It is very important to tighten the fiber nut to the device by hand until it is firmly fixed. Improper connection may cause a low output power. Optical fiber check Please see Section 7.5. DGM001519.01 UM Sirius CE/ROTW...
Page 26: Instructions For Use
Once the system has checked for the proper functioning and status of device elements, the Main screen will appear (see section 5.2.1 Main Screen). Through the , the Settings screen is reachable (see section 5.3 Settings). DGM001519.01 UM Sirius CE/ROTW...
Page 27: Operating Instructions
Frequency settings for blue footswitch Aiming beam settings Frequency settings for orange footswitch Pulse mode and duration settings for blue Shutdown footswitch Pulse mode and duration settings for orange Custom Presets / User profiles footswitch Device status settings Settings DGM001519.01 UM Sirius CE/ROTW...
Page 28 Press the desired pulse mode section to choose between Pulsed mode or Continuous mode (CW): Pulsed mode: Short pulse Medium pulse Long pulse Continuous mode (CW): The chosen mode will become highlighted and its description will appear under the output power indication. DGM001519.01 UM Sirius CE/ROTW...
Page 29 If the energy setting is too high for the selected frequency, the laser will automatically decrease the pulse energy value (output frequency is permitted to increase). The emitted sound, when firing, changes according to the selected frequency. Note: in case of CW mode selected, the user can modify directly the output power. DGM001519.01 UM Sirius CE/ROTW...
Page 30 Follow the description detailed on the screen in order to perform this procedure. Counters The emitted energy (Joules) and Lasing time counters are shown in the main screen and increase during radiation emission. Press the highlighted button to reset the counters. DGM001519.01 UM Sirius CE/ROTW...
Page 31: Settings
Increase or decrease the sound volume using + / - buttons. Press OK to give confirmation and return to the main interface. Press to return to the Main Screen. Note: the percentage of the brightness, related to the max available, is shown on the screen. DGM001519.01 UM Sirius CE/ROTW...
Page 32: Sound
Software Version (SW) Firmware Version (FW) Hardware Version (HW) Date time Total emission energy Total emission time Total emission pulses Move through the pages using + / - buttons. Press to return to the Main Screen. DGM001519.01 UM Sirius CE/ROTW...
Page 33 Without inserting the Service Password, it is possible to access the Service Screen. On this screen, it is possible to check the device functioning parameters. Move through the pages using + / - buttons. Press to return to the Main Screen. DGM001519.01 UM Sirius CE/ROTW...
Page 34: Database
SAVE a desired set of treatment parameters (and overwrite a previous one); Select the preset (previously saved set of treatment parameters) and click to LOAD a preset; Select the preset and click to DELETE a preset. Press to confirm the deletion. DGM001519.01 UM Sirius CE/ROTW...
Page 35: Laser Emission
One can use the dedicated button on the footswitch element to change the system status from Standby to Ready or vice versa. The button on the footswitch, or the Ready/Standby display area can be used interchangeably. DGM001519.01 UM Sirius CE/ROTW...
Page 36: Ready Mode
The operator must ensure that the set laser parameters are correct before actuating the footswitch. Warning: All the personnel present in the laser working area must wear all the protective items. LASING inactive. DGM001519.01 UM Sirius CE/ROTW...
Page 37: Laser Parameters
When an error occurs, the System behaviour is different depending on the issue level of severity: ERROR Status: starts running in a safe mode or gets restarted. This Error occurs every time the Control finds the System in a DGM001519.01 UM Sirius CE/ROTW...
Page 38 Critical Error: FW_RAM FW error Message on screen - Fail safe status Critical Error: FW_CRC32 Critical Error: FW_FSCM Critical Error: FW Communication Critical Warning: FW watch dog FW error Message on screen - Fail safe status DGM001519.01 UM Sirius CE/ROTW...
Page 39: Shutdown Procedure And Protection Against Unauthorized Use
In order to avoid improper use of the device, keys shall be removed when the device is not being used. Mains disconnection In order to disconnect the device from the mains it is necessary to detach the supply cable plug from the mains. DGM001519.01 UM Sirius CE/ROTW...
Page 40: Clinical Application
Laryngeal lesions Airway obstructions including carcinoma Palliation of obstructing carcinoma of the tracheobronchial tree Lung Resection ENT: Endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) including: Sialolitiasis Endonasal/sinus Surgery Partial turbinectomy Polyps DGM001519.01 UM Sirius CE/ROTW...
Page 41 Tissue dissection Excision of external tumors and lesions Complete or partial resectomy of internal organs, tumors and lesions Tonsillectomy Partial Nephrectomy Pilonidal Cystectomy Hemorrhoids Zenker Diverticulum Incision, excision, resection, ablation, vaporization, couagulation and hemostasis of soft tissues DGM001519.01 UM Sirius CE/ROTW...
Page 42: Treatment Parameters And Instructions
If bleedings are found, coagulate the tissue surrounding the bleeders; the surgeon may choose to defocus the laser energy by increasing the distance between tissue and fiber tip or by decreasing the laser power. DGM001519.01 UM Sirius CE/ROTW...
Page 43 The thulium wavelength provides effective haemostasis without damaging surrounding or non-targeted tissues. Coagulation can be achieved by reducing the energy or power density over the vascularized tissue or by increasing the distance between fiber tip and point of bleeding. DGM001519.01 UM Sirius CE/ROTW...
Page 44 Bladder Calculi max 60 Ureteral Calculi max 15 Renal Calculi max 20 *pulsed mode only Note: Laser settings are guidelines only; always start with low settings and increase them progressively to achieve the desired tissue effect. DGM001519.01 UM Sirius CE/ROTW...
Page 45: Treatment Parameters And Instructions For Open Surgery & Laparoscopic Procedures
If bleedings are found, coagulate the tissue surrounding the bleeders; the surgeon may choose to defocus the laser energy by increasing the distance between tissue and fiber tip or by decreasing the laser power keeping the same distance from the tissue. DGM001519.01 UM Sirius CE/ROTW...
Page 46: General Laser Warnings
The laser should be used only on tissues that are fully observable. Do not use the laser if the desired target is not visible. Extra caution should be used when lasing tissue close to known arteries, nerves and veins. DGM001519.01 UM Sirius CE/ROTW...
Page 47 Different energy densities induce different effects upon tissues, therefore using fibers with different diameters with the same output power could have different outcomes on irradiated tissues. Employed laser power has to be tuned also according to fiber diameter. DGM001519.01 UM Sirius CE/ROTW...
Page 48: General Laser Precautions
The rate of irrigation should be carefully adjusted to avoid flux of calculi into the kidney. Other medical specialties: Please refer to General Laser Warning and General Lasr Precautions for additional information DGM001519.01 UM Sirius CE/ROTW...
Page 49: General Laser Complications
Hypertension; Arrhythmia; Pain; Distension due to gases; Pneumothorax; Infection Complications and thermal risks (acute) Induced hemorrhage; Ulceration; Perforation; Edema; Pain; Fever; Leukocytosis; Chills Complications and thermal risks (critical) Healing delay; Perforation; Stenosis; Delayed hemorrhage; Sepsis; Embolism. DGM001519.01 UM Sirius CE/ROTW...
Page 50: Complications For Urology
The use of flexible endoscopes carries a risk of stricture formation; these rates may improve with further advances in ureteroscope design. For other complications related specifically to a certain medical specialty, further refer to the relevant section. DGM001519.01 UM Sirius CE/ROTW...
Page 51: Contraindications For Laser Surgery
Patients with compromised renal function, i.e. serum creatinine level > 1.8 mg/dl or upper urinary tract obstructive diseases. Patients who still wish to have children. Patients with an ASA classification of physical status 5. Patients with a prostate gland > 120g. DGM001519.01 UM Sirius CE/ROTW...
Page 52 Inappropriate candidates for endoscopic or laparoscopic treatment Contraindicated for patients with previous multiple abdominal surgery Intolerance to anaesthesia Contraindicated for patients with Intestinal obstruction Read General contraindications for laser surgery earlier in this chapter for further information. DGM001519.01 UM Sirius CE/ROTW...
Page 53 Resection or excision of large, highly vascularized organs (e.g. spleen, liver) Read General contraindications for laser surgery earlier in this chapter for further information. Other medical specialties: No specific information, refer to General Contraindications and precautions. DGM001519.01 UM Sirius CE/ROTW...
Page 54: Maintenance, Cleaning And Sterilization
Device cleaning The Sirius laser device does not need special maintenance by the user. Switch off the device before starting the cleaning procedure. Clean the visible surfaces with a damp cloth, taking care not to let the water enter the device (in particular attention must be paid in not spilling any drop on monitor frame interstice and monitor itself).
Page 55: Fiber Management (Application Cycles)
The RFID system keeps record of the number of uses (correlated with the required sterilization cycles) that the fiber undergoes. Only the use of RFID Rocamed Fibers is allowed with the Sirius Laser System. Caution: A disposable laser fiber cannot be used a second time after the first use!
Page 56 Example of new blast shield Example of damaged blast shield 6. Reinsert the blast shield and firmly screw the knob 7. Close the protective door by screwing firmly the door knob 8. If you need assistance, please contact Service Department DGM001519.01 UM Sirius CE/ROTW...
Page 57: Troubleshooting
Energy output fault emission is too high or low Laser source error Restart the system Laser source fault Call service Critical Errors and Warnings appearing during start-up procedure FW error installation Shut down and restart FW error DGM001519.01 UM Sirius CE/ROTW...
Page 58 Critical Errors and Warnings appearing during start-up procedure FW error installation FW error In case the device must be sent back to the company, fill the RMA request enclosed in Appendix A and send it to your local distributor. DGM001519.01 UM Sirius CE/ROTW...
Page 59: Customer Service
The Sirius system is warranted against any defect in material and workmanship for a period of one (1) full year from its delivery. Repairs necessary as a result of natural disasters, accidents, electrical circuit failures, negligence, improper use or misuse of the appliance, or servicing or repairs carried out by persons not authorized by the Manufacturer, or by Rocamed S.A.M, are not covered by warranty.
Page 60: Service Department Contacts
Service Department Contacts Rocamed provides its customers with e-mail and telephone troubleshooting, in addition to customer trainings, repairs and maintenance. Please contact Rocamed Customer Service through the contacts reported below. Please keep on hand the Serial Number of your device. ROCAMED S.A.M.
Page 61: Technical Specifications
10 years after the manufacturing is discontinued) With a room temperature between 25°C and 30°C, continuous operation is granted with a maximum power up to 40 W. DGM001519.01 UM Sirius CE/ROTW...
Page 62: Laser Source Specifications
150 up to 1000 µm. requirements) Fiber stripper 1 Fiber stripper for 0,3-1 mm diameter Fiber stripper 2 Fiber stripper for 0,1-0,4 mm diameter Fiber cutter Ceramic fiber cutter Safety Goggles Safety Goggles DGM001519.01 UM Sirius CE/ROTW...
Page 63 Please contact Rocamed S.A.M. to report the malfunctions, manufacturing defects and non-conformities of your device. If you need to send back goods or medical devices to Rocamed S.A.M. , send this document by fax and wait to ship the goods until the Service Department assigns a RMA number.
Page 64 IEC 60601-1-2 Table 201 electromagnetic emission The equipment SIRIUS is intended for use in the electromagnetic environment specified below. The customer or the end user of the SIRIUS should assure that it is used in such an environment Emission test compliance...
Page 65 IEC 60601-1-2 Table 202 electromagnetic immunity The equipment SIRIUS is intended for use in the electromagnetic environment specified below. The customer or the end user of the SIRIUS should assure that it is used in such an environment IEC 60601-1-2 Electromagnetic...
Page 66 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SIRIUS is used exceeds the applicable RF compliance level above, the SIRIUS should be observed to verify normal operation.
Page 67 Recommended separation distances between portable and mobile RF communication equipment and the SIRIUS The equipment SIRIUS is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SIRIUS can help prevent electromagnetic...
Page 68 Diario / Logbook Data # Colpi Operazioni Eseguite Firma Date # Shots Operations Done Signature Collaudo Finale / Final Test DGM001519.01 UM Sirius CE/ROTW...