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OmniGuide FELS-25A, User Manual

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OmniGuide FELS-25A User Manual Download Page 5

 

L-1633 Rev. 3 

© OmniGuide, Inc. 

 Page 5 

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Summary of Contents for FELS-25A

Page 1: ...er FELS 25A FELS 25A E FELS 25A S2 FELS 25A S3 FELS 25A S4 FELS 25A BeamPath with IntelliGuide Fiber Enabled CO2 Laser Users Manual 9 57976 61 1 199 9 61 6 1 61 999 URL http www omni guide com 0483 A...

Page 2: ...or dentist This article is covered by the following patents U S Patent No 7349589 7167622 7331954 7991258 OmniGuide Inc OG is not responsible for injury or damage resulting from improper use of the sy...

Page 3: ...L 1633 Rev 3 OmniGuide Inc Page 3 Table of Contents 5 6 6 6 7 6 7 6 7 7 7 8 7 9 7 01 8 6 67 8 7 68 8 8 68 02 9 6 68 9 7 69 9 8 69 9 9 69 9 69 9 6 04 6 6 7 6 8 75 9 77 14 6 7 7 7 8 7 9 1 7 16 17...

Page 4: ...e 4 6 7 7 7 18 6 7 7 85 8 85 9 85 86 20 65 6 86 65 7 86 65 8 87 65 9 95 65 96 65 96 65 1 97 31 66 6 97 66 7 97 66 8 97 31 67 6 97 67 7 98 67 8 98 67 9 98 67 98 67 98 67 98 32 68 6 98 13 2 Password doe...

Page 5: ...L 1633 Rev 3 OmniGuide Inc Page 5 68 99 33 69 6 99 69 7 9 69 8 9 34 6 6 9 6 7 9 34 36 40 41 6 6 7 6 7 7 42 75 6 0 8...

Page 6: ...nk regulator The Laser system is intended to be used in medicine for medical use only Other non medical uses may cause severe damage to the system It is recommended that any user of the system read th...

Page 7: ...ained to and familiar with such surgical techniques and clinical use of CO2 lasers Usage of gas can increase the chance of embolism see OmniGuide fiber IFUs for additional information 2 3 Definition o...

Page 8: ...______ ________________________________________________________ This symbol is to alert the operator to the danger of exposure to Laser radiation being emitted from the aperture ______________________...

Page 9: ...ion of Warning Labels Figure 2 1 Location of the warning signs showing the front and right side of the Laser top and the back side bottom 6 4 3 5 8 7 1 2 1 Note Emergency Switch Shield may or may not...

Page 10: ...L 1633 Rev 3 OmniGuide Inc Page 10 1 Warning Aperture 2 Laser Stop 3 Laser Warning 4 Laser Danger...

Page 11: ...L 1633 Rev 3 OmniGuide Inc Page 11 5 Laser Compliance 6 ETL 7 Modification Label 8 Product Identification...

Page 12: ...fires A smoke evacuation system must be utilized to remove surgical plume With most fiber assemblies pressurized gas exits the fiber tip during the Laser procedure and may cause venous gas embolism T...

Page 13: ...are equipped with a sensor for internal pressure and a pressure relief valve are recommended Refer to the manufacturer s instructions for equipment set up and detailed instructions For sterile cases w...

Page 14: ...ion of the fiber is missing or detached Excessive bending of OmniGuide fiber will lower its output power Please consult fiber IFUs for the minimum allowable bending radius and angle of the fiber Do no...

Page 15: ...econds after lasing stops The clinician should wear a mask Refer also to the Cautions section of your Laser Manual and to Laser Labeling for additional precautions PRODUCT DESCRIPTION In this section...

Page 16: ...niGuide Inc Page 16 Figure 5 1 Back of the Laser D F7D GFBGF AF GE7 3D 9 9 F GFBGF AAD F7D A5 A 75F A 3E 3 397 7 F 3F3 A 75F A 9 D7EEGD7 3E BGF G6 A BGF AF GE7 AAF 763 A 75FAD 757BF35 7 3 6 5A 75F A E...

Page 17: ...beside the unit 5 1 2 Warning Light Output A door warning light may be connected to this port 5 1 3 USB and RJ45 connections The laser has USB RJ45 port for service use only 5 1 4 High Pressure Gas I...

Page 18: ...g supplied with the system P N 1 0205 007 01 03 can be plugged into the door interlock connection at the back of the laser to defeat the interlock and allow operation of the laser The door interlock f...

Page 19: ...The OmniGuide fiber The flexible OmniGuide fiber guides CO2 Laser light with a wavelength of 10 6 microns and delivers energy from the laser to the surgical site enabling minimally invasive procedure...

Page 20: ...s pressure regulator gas tank selection valve pressure transducers to sense the amount of gas left in each of the gas tanks gas management data electrical connection and gas supply quick disconnect ga...

Page 21: ...sure that the gas tank valves are open ____________________________________________________________ ____________________________________________________________ Prior to replacing the compressed tank...

Page 22: ...utput Power Maximum 30 Watt at Laser output Power Stability 20 Spot size Dependent on fiber used and distance from tissue Please refer to OmniGuide Fiber instructions for use IFU Weight 33 6 kg 74 lbs...

Page 23: ...L 1633 Rev 3 OmniGuide Inc Page 23 Figure 5 7 Dimensions of the FEL 25A Laser...

Page 24: ...L 1633 Rev 3 OmniGuide Inc Page 24 Figure 5 8 Dimensions for the Fiber Enabled Laser on OG designed Cart...

Page 25: ...FELS 25A Laser has undergone extensive testing to ensure that with proper usage it is a safe and reliable device Laser light because of its special properties poses safety hazards not associated with...

Page 26: ...all times Always follow the safe Laser usage guidelines law or regulations relevant to the country state province etc when you are operating or installing the Laser Use protective eye wear when opera...

Page 27: ...e standards of the CE Mark Please see section 17 for more details TRANSPORTATION AND STORAGE If the system has been transported or stored at temperatures below 10 C 50 F unpack the device and leave it...

Page 28: ...ack to OmniGuide you MUST ship it in the OmniGuide shipping container and packing material If the Laser is not packed properly and damage occurs during shipment the customer will incur all charges for...

Page 29: ...T The dimensions of the Laser are given in Figure 5 7 and the dimensions of the entire FELS 25A system with a cart with gas handling capability are given in Figure 5 8 If the cart is not available wit...

Page 30: ...between the Laser and the wall outlet 9 2 1 Fuse Ratings for the Laser Different input voltages require a different fuse rating 230 V 5A 115 V 10A 90 V 12A 9 3 Compressed Gas Requirement The OmniGuid...

Page 31: ...the back of the Laser Figure 5 1 The foot pedal can be removed by pulling the connector from the rear of the laser The foot pedal is shielded with a protection cover SYSTEM OPERATION 10 1 Switch on L...

Page 32: ...back of the Laser 10 3 User interface Once the Laser initializes it will prompt the user to enter the password as shown in Figure 10 2 Once the correct password is entered the Laser will go to the hom...

Page 33: ...down arrows above and below the corresponding parameter that needs to be changed The user can change the mode of operation by pressing the corresponding waveform on the left most part of the screen an...

Page 34: ...tion and whether superpulse is an appropriate choice _________________________________________________________________ 10 3 1 2 Output Modes The Laser has three different firing modes depending on whi...

Page 35: ...as well as the large blue letters to the right of the bars The up and down arrow control the power output set point 10 3 1 6 Fiber Output When Laser energy is fired into a fiber optic a certain amoun...

Page 36: ...an be selected as well If the edit surgeon key as shown in Figure 8 5 is selected then the user can delete or edit a particular surgeon If the user presses the delete key then that surgeon and all of...

Page 37: ...or Delete Surgeons Figure 10 7 Surgeon Presets 7 75F GD97A A 76 F EGD97A A 67 7F7 EGD97A EGD97A E 5DA 6AI 8AD AD7 EGD97A E J F F 7 P 6 F GD97A 7 75F A P A67 7 75F 7 6 FA 47 76 F76 F F 7 8 DEF 3 6 3EF...

Page 38: ...eturn to the home screen This button is disabled while the unit is firing 10 3 6 Laser Log The Laser log button displays Laser firing information since the last time the system was powered on This but...

Page 39: ...em Settings The system settings button allows you to alter Laser settings such as language screen brightness and system time as shown in Figure 10 9 Figure 10 9 System Settings AG 6 7AGF 3F7 D 9 F 7EE...

Page 40: ...ly active in the Laser output control screen and is disabled for all other screens 10 4 OmniGuide Fiber Instructions for Use OmniGuide s BeamPath flexible fiber connects to a CO2 Laser via a custom op...

Page 41: ...ode when not in use __________________________________________________________________________ 10 6 System operation during surgical procedure During the procedure be sure to observe sterile technique...

Page 42: ...oth moistened with 70 IPA 11 2 Sterilization Guidelines Each single use fiber is already sterilized For sterile procedures use the Gas Filter Unit cat ACC GFU 100 to sterilize the gas path Please refe...

Page 43: ...om the gas management assembly to the rear of the laser 12 5 3 1 8 o rings for the low pressure hose from the front of the laser to the adapter 12 5 4 Yoke washers for the CGA 930 fitting that connect...

Page 44: ...p and down rocking or rotational movement relative to the Laser discontinue use and contact OmniGuide for assistance 4 Set the Laser power to 4W in CW mode Keep the cannula of the handpiece if present...

Page 45: ...s not cover damage or misuse or damages due to setup adjustment or repairs that are performed by the unauthorized personnel that have not been trained by OG PACKING PROCEDURE 15 1 Packing of the syste...

Page 46: ...EF3DF 3E7D 8 F E 7DDAD A55GDE 8 3F5 A9 DDAD 7 EKEF7 FGD E A88 F 7 3F5 A9 G E7 8DA A6G 7 3 6 5 75 E 38F7D E75A 6E 8 D7E7F I3E 35F H7 8 H 7EF DDAD E 9 3 E AGF A8 EB75 8 53F A 8 H 7EF DDAD E 9 3 E AGF A8...

Page 47: ...397 6AI 47D GE76 BD7H AGE K 3E7D 67D D7EEGD7 3E 7F 8 AI FAA AI GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSION 9 7 3E7D E F7 676 8AD GE7 F 7 7 75FDA 39 7F 5 7 H DA 7 F EB75 8 76 47 AI...

Page 48: ...BAI7D EGBB K 7E M 8AD BGF AGFBGF 7E 5A B 7E I F 3 E BAI7D CG3 FK E AG 6 47 F 3F A8 3 FKB 53 5A 7D5 3 AD AEB F3 7 H DA 7 F GD97 M 5A A A67 M 6 887D7 F 3 A67 5A B 7E I F 3 E BAI7D CG3 FK E AG 6 47 F 3F...

Page 49: ...88 L FA L 788 5A 8AD E FA ADF34 7 3 6 A4 7 5A G 53F A E 7CG B 7 F E AG 6 47 GE76 A 5 AE7D FA 3 K B3DF A8 F 7 3E7D 5 G6 9 534 7E F 3 F 7 D75A 7 676 E7B3D3F A 6 EF3 57 53 5G 3F76 8DA F 7 7CG3F A 3BB 534...

Page 50: ...H7 34AH7 F 7 3E7D E AG 6 47 A4E7DH76 FA H7D 8K AD 3 AB7D3F A 8 34 AD 3 B7D8AD 3 57 E A4E7DH76 366 F A 3 73EGD7E 3K 47 757EE3DK EG5 3E D7AD 7 F 9 AD D7 A53F 9 F 7 3E7D 4 H7D F 7 8D7CG7 5K D3 97 L FA L...

Page 51: ...0 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from s...

Page 52: ...e Rd Lexington MA 02421 Phone 617 551 8444 or 888 OMNI GUIDE Fax 617 551 8445 Email service omni guide com URL www omni guide com 19 2 European Authorized Representative A R C LASER GmbH Bessemerstr 1...

Page 53: ...222222 4 26 2222222222222222222222222 80 26 F 3 7FGB 7 6 7DH 57 7BAF 7DH 57 24 3 834 30 4 A 53DF I F F E EKEF7 8 F E 4AJ E 5 75 76 F 7 D7EF A8 E75F A 7 EKEF7 E I F 3 53DF 3F F 7 F 7 A8 E7DH 57 3DF E5D...

Page 54: ...7D FA F 7 3E7D 3 6 H7D 8 76 BAI7D GB I F AGF 7DDADE 75AD6 FAF3 EKEF7 3E 9 F 7 7 222222222222222222 3 A8FI3D7 7DE A 4 4 6 23 6 23 AI 7H7 F7 G 67 9 7H7 F7 G 67 9 7H7 7 4 AI7D 73EGD7 7 F 3 G7E AGFBGF FG4...

Page 55: ...e at 8W CW N A ______W N A Percentage transmission through far field aperture at 8W CW 5 0 ______ 4 7DDG 7 7EF 9 Parameter Specified Value Measured Value Pass Fail Power out of laser at 4W CW 4W 0 4W...

Page 56: ...22222222222222222222222222222222222222222222222222222 22222222222222222222222222222222222222222222222222222222222222222222222222 AF7E2222222222222222222222222222222222222222222222222222222222222222222...

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