AngioDynamics DELTA 15 Operator's Manual
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AngioDynamics DELTA 15 Operator's Manual

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DELTA 15/30
DIODE LASER
OPERATOR MANUAL
Version 2.2
March 2010
MAN/26/0068 US
Manufactured in the United Kingdom by AngioDynamics UK Limited
AngioDynamics is a Registered Trademark of AngioDynamics Inc.
EVLT is a Registered Trademark of AngioDynamics Inc.
 2010 AngioDynamics UK Ltd.

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  • Page 1 DIODE LASER OPERATOR MANUAL Version 2.2 March 2010 MAN/26/0068 US Manufactured in the United Kingdom by AngioDynamics UK Limited AngioDynamics is a Registered Trademark of AngioDynamics Inc. EVLT is a Registered Trademark of AngioDynamics Inc.  2010 AngioDynamics UK Ltd.
  • Page 2 AngioDynamics to complete the registration process. INTRODUCTION This manual describes the operation of the DELTA 15 and the DELTA 30 (referred to as DELTA 15/30 in this manual). These lasers are to be used only by experienced, trained operators familiar with laser procedures.
  • Page 3 DELTA 15/30 DESCRIPTION OF THE DELTA 15/30 The DELTA 15/30 has been designed for use with the AngioDynamics range of procedure kits, such as ® those for EVLT (EndoVenous Laser Treatment). It can also be used with a wide range of standard fibers and accessories, further details of which are in section 4 of this manual.
  • Page 4 (Note: This is shown on the screen displayed at start-up.) Date Installed ............................Installed by.............................. Signed ..............................Print Name ............................. Organization ............................For service, parts or repair, contact your local AngioDynamics representative: DELTA 15/30 Operator Manual Page 1.4 Version 2.2...

  • Page 5: Table Of Contents

    DELTA 15/30 SECTION 2 SAFETY & WARNINGS CONTENTS Symbols used in this Manual ........................ 2.2 Symbols used on AngioDynamics products ..................2.3 Warnings............................... 2.4 EMC Warning............................2.5 Safety Classifications, Hazards and Precautions ................. 2.6 Eye Injury .............................. 2.8 Burns..............................2.9 Reflection Warning..........................

  • Page 6: Symbols Used In This Manual

    This symbol indicates personnel within the vicinity of the equipment should wear appropriate eye protection. This symbol indicates an important point to be noted. DELTA 15/30 Operator Manual Page 2.2 Version 2.2...

  • Page 7: Symbols Used On Angiodynamics Products

    DELTA 15/30 SYMBOLS USED ON ANGIODYNAMICS PRODUCTS The following symbols are used on the DELTA 15/30 laser and on accessories provided by AngioDynamics. Consult instructions for use Caution, consult accompanying documents Power Off Power Off (only for a part of equipment)

  • Page 8: Warnings

    This product contains a lithium battery, which should only be replaced by authorized service personnel. Replace the battery only with the same or equivalent type. Dispose of used batteries according to the manufacturer’s instructions and local disposal requirements. DELTA 15/30 Operator Manual Page 2.4 Version 2.2...

  • Page 9: Emc Warning

    Portable and Mobile RF communications equipment can affect medical electrical equipment. The DELTA 15/30 should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the DELTA 15/30 should be observed to verify normal operation in the configuration in which it will be used.

  • Page 10: Safety Classifications, Hazards And Precautions

    DELTA 15/30 SAFETY CLASSIFICATIONS, HAZARDS AND PRECAUTIONS The DELTA 15/30 is classified as a Class IV laser product in compliance with FDA 21 CFR 1040.10 and 1040.11, UL 60601-1, EN 60601-1, EN 60601-1-2, EN 60601-2-22 and EN 60825-1. The DELTA 15/30 conforms to the requirements of Council Directive 93/42/EEC of the Council of European Communities (Medical Devices Directive).
  • Page 11 Protective caps should be in place over SMA connectors. All screws and ports should be secure. Do not use if there is any sign of damage. The DELTA 15/30 Laser is a portable laser weighing 26lb. All standard safety procedures for lifting should be applied when moving the instrument.

  • Page 12: Eye Injury

    DELTA 15/30 EYE INJURY Extreme caution should be taken when operating the DELTA 15/30 near the eyes. Near infrared light (810nm) from the DELTA 15/30 passes through the transparent components of the eye and is focused on the retina at the back of the eye.

  • Page 13: Burns

    Avoid using other flammable or fume-emitting substances (e.g. ether, iodine solution, collodion, and alcohol) in the operative field. VAPOR PLUME AngioDynamics recommends that a smoke evacuator or in-line filter be used when lasing. Caution – Laser Plume may contain viable tissue particulates.

  • Page 14: Clinical Indications & Contra-Indications

    DELTA 15/30 CLINICAL INDICATIONS & CONTRA-INDICATIONS Indications The DELTA 15/30 is intended for the following contact or non-contact laser procedures: • Incision (only contact) • Excision (only contact) • Vaporization • Coagulation / hemostasis - of soft tissue in Endovascular, open and endoscopic procedures in Vascular Surgery;...
  • Page 15 DELTA 15/30 Contraindications The DELTA 15/30 should only be used in conditions where its use is appropriate and of proven efficacy. It should never be operated except under the direct supervision of a trained operator. The potential for complications encountered in surgical laser procedures will be the same as those encountered in any surgical procedures.

  • Page 16: Clinical Warnings

    Use cautiously with patients who have had difficulty with previous laser procedures. The DELTA 15/30 should be used only on tissue that is fully observable. Do not use the laser if the desired field is not visible, either directly or via an imaging modality such as ultrasound.

  • Page 17: Clinical Precautions

    Only operators who have been trained in the use of lasers and are thoroughly familiar with this Operator Manual should use the DELTA 15/30. The information provided in this section is not intended to be all-inclusive and it is not intended to replace operator training or experience.

  • Page 18: Safety Labeling

    DELTA 15 DELTA 30 Safety Label Safety Label Product Identification Labeling Product identification labeling is located on the rear of the DELTA 15/30. Made in the United Kingdom by: AngioDynamics DELTA This product complies with AngioDynamics UK Ltd. IP21 21 CFR 1040.10 and 1040.11, UL60601-1,...

  • Page 19: Safety Features

    DELTA 15/30 SAFETY FEATURES The DELTA 15/30 includes a number of safety features, which are provided in accordance with the requirements of the appropriate standards. protective housing • remote interlock bypass • key switch • laser radiation emission indicator, visible and audible •...

  • Page 20: Emc Declaration

    Guidance and manufacturer’s declaration – electromagnetic emissions The DELTA 15/30 is intended for use in the electromagnetic environment specified below. The customer or user of the DELTA 15/30 should ensure it is used in such an environment. Emissions test Compliance Electromagnetic emissions –...
  • Page 21 DELTA 15/30 Guidance and manufacturer’s declaration – electromagnetic immunity The DELTA 15/30 is intended for use in an electromagnetic environment specified below. The customer or the user of the DELTA 15/30 should assure that it is used in such an environment.
  • Page 22 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the DELTA 15/30 is used exceeds the applicable RF compliance level above, the DELTA 15/30 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the DELTA 15/30.
  • Page 23 Recommended separation distances between portable and mobile RF communications and the DELTA 15/30. The DELTA 15/30 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the DELTA 15/30 can help prevent electromagnetic interference...

  • Page 24: Esd Precautionary Procedures

    (1) First, momentarily touch a grounded object to remove any existing static charge (2) Connect one end of the 9-way interface lead to the DELTA 15/30, taking care not to touch the pins of the connector...
  • Page 25 OPERATING INSTRUCTIONS INTRODUCTION The DELTA 15/30 laser is capable of working with a wide range of fibers and accessories. The FRS system fitted as standard also allows it to identify the type of fiber or accessory that is connected. This enables the laser to automatically display suitable preset parameters with the minimum of user intervention.

  • Page 26: Summary

    Menu items are expressed in bold mixed case. SUMMARY 1. Place the DELTA 15/30 in a convenient position on an instrument table no farther than 1.8 metres (6 feet) from the patient. Ensure that all controls are within easy reach of the operator. The viewing angle of the front panel may be altered by raising or lowering the folding foot located under the DELTA 15/30.
  • Page 27 Statistics from the Main Menu. 15. To turn the DELTA 15/30 OFF turn the key switch and remove the key, then switch off the rear power switch. If an error message is displayed, refer to section 5 - Technical Information.

  • Page 28: Installation And Set-Up

    Installation of the DELTA 15/30 can be carried out by the end-user. Inspection Inspect the DELTA 15/30 and accessories for signs of damage. If the unit is damaged DO NOT USE - contact AngioDynamics or your local AngioDynamics representative. If there are no signs of damage and all components are present, assemble the DELTA 15/30.
  • Page 29 Connecting to the Laser Aperture Laser energy is delivered to the optical fiber or spot handpiece via the laser aperture located on the front panel of the DELTA 15/30. The fiber or handpiece is connected by means of an SMA-905 type optical fiber connector.

  • Page 30: Front Panel Controls

    Scroll/Confirm Standby/Ready The main operating controls for the DELTA 15/30 are located on the lower section of the front panel. The display and other indicators are located in the top section of the panel, as illustrated in the figure above.
  • Page 31 AngioDynamics label. An AngioDynamics memory card available as an accessory (see section 4). The memory card may be used to transfer data between the DELTA 15/30 and a PC equipped with a suitable memory card reader interface and the AngioDynamics EVLT-PDM software program.

  • Page 32: Rear Panel Controls

    AngioDynamics supplies two remote interlock bypasses for facilities without or not wishing to use the door switch option. The DELTA 15/30 will not operate without either a remote interlock or remote interlock bypass inserted into the remote interlock socket on the rear of the laser.
  • Page 33 Equalization Point equipment, if needed. Fuseholder 2 x T6.3A H 250V Use of controls or adjustments, and or performance of procedures other than those specified herein may result in hazardous radiation exposure. DELTA 15/30 Operator Manual Page 3.9 Version 2.2...

  • Page 34: Fiber Recognition System

    Therefore, by identifying the fiber, the laser can also tell what procedure is going to be performed. So the DELTA 15/30 can automatically select suitable preset parameters with the optimum values for that procedure. Compared to setting the parameters manually, this process is much quicker and far less prone to user error.
  • Page 35 DELTA 15/30 What are the benefits of FRS? Operation of the DELTA 15/30 is simplified, because the FRS is able to automatically recognize • the attached fiber or Spot Handpiece and load preset parameters that are suitable for the selected procedure.

  • Page 36: Operating Instructions

    DELTA 15/30 OPERATING INSTRUCTIONS Once the DELTA 15/30 has been correctly installed and switched on, it is operated using just two controls: SCROLL / CONFIRM Turn the knob in either direction to SCROLL through the available options highlighted on the screen.
  • Page 37 CONFIRM the selection. When Set at start is set to Yes, this screen will occur every time that the DELTA 15/30 is switched on. To prevent this, change the selection to No as follows: Turn the SCROLL knob until Set at start is •...
  • Page 38 “uses” are available and whether it is within its sterility expiration date. The DELTA 15/30 will normally only permit a procedure to be carried out if a AngioDynamics FRS fiber is used. An incompatible fiber will be shown on the screen as Invalid Fiber.
  • Page 39 At this point, calibration may be required for certain fibers and procedures. In this case, follow the instructions on page 3.16. The DELTA 15/30 will set the default operating parameters for the selected procedure. Some procedures also allow the default parameters to be varied within lower and upper limits, which are defined in the procedure’s specification.
  • Page 40 To turn the DELTA 15/30 off, turn the key switch anti- clockwise, remove the key and switch off at the rear panel. Screen Symbols When the DELTA 15/30 is in the READY mode the screen may show various symbols. The meanings of which are explained below: Power output setting...
  • Page 41 7. To proceed, highlight Continue and press SELECT. Transmission Acceptability The DELTA 15/30 will calculate the percentage transmission of the fiber system, and the results will be shown on screen as Acceptable or Unacceptable. A percentage rating of 75% - 96% indicates that the fiber is Acceptable. The power displayed •...

  • Page 42: Spot Handpiece Mode

    This section includes special instructions to be followed when using a spot handpiece with the DELTA 15/30. Spot Handpiece mode is only available when the DELTA 15/30 is fitted with a calibration port. This port is optional on the DELTA 15.
  • Page 43 4. Place the DELTA 15/30 in READY mode. 5. Follow the instructions on screen. 6. Fire the DELTA 15/30 by pressing the footswitch until release is indicated on the display. 7. The screen will display the handpiece acceptability and transmission percentage.
  • Page 44 Repeat this process for the other parameters as required. When you have set up the required value of fluence of the DELTA 15/30, turn the SCROLL knob to move the highlight to Confirm and press CONFIRM.

  • Page 45: Manual Settings

    Please contact your AngioDynamics representative for further details of this feature. For best results always use the DELTA 15/30 with an AngioDynamics FRS fiber. This will be detected by the laser, which will automatically select suitable preset parameters.
  • Page 46 1 sec 1 sec Selecting Manual Operation Manual operation allows the operator complete freedom over the settings of the DELTA 15/30 and is enabled by selecting Manual from the Procedure menu. Next, highlight Continue using the SCROLL knob and press CONFIRM.
  • Page 47 To end treatment, release the footswitch and return the unit to STANDBY. To turn the DELTA 15/30 off, turn the key switch anti- clockwise, remove the key and switch off at the rear panel. Countdown Timer Countdown mode is enabled by selecting the Countdown procedure when Manual operation is enabled.

  • Page 48: Emergency Override

    The Emergency Override must be reset by means of a special reset device (AngioDynamics part number AS/598). One of these is supplied with the DELTA 15/30. Each device can only be used once, after which it is advisable to contact your AngioDynamics representative as soon as possible to obtain a replacement.

  • Page 49: Set-Up Menu

    CONFIRM. When Set at start is set to Yes, this language selection screen will occur every time that the DELTA 15/30 is switched on. This option can be toggled between Yes and No by using the SCROLL knob to highlight Set at start and pressing CONFIRM.
  • Page 50 To observe the different modes of the aiming beam, place the DELTA 15/30 into READY mode by pressing the STANDBY/READY button. The aiming beam will be activated if Continuous or Follow Laser are selected.
  • Page 51 Press CONFIRM when finished. The intensity adjustment will be ignored if the aiming mode is Off. To observe the intensity of the aiming beam, place the DELTA 15/30 into READY state by pressing the STANDBY/READY key. The aiming beam will be activated.
  • Page 52 DELTA 15/30, to the memory card. The card can then be removed from the DELTA 15/30, inserted into a reader attached to a PC and the details transferred to the PC. Contact Details Selecting this option will display the telephone, e-mail and website contact details for AngioDynamics.

  • Page 53: Statistics

    Setup will be added to the current Treatment. The DELTA 15/30 can display the statistics of the Setups for the current and previous Treatments. A new Treatment is started when the DELTA 15/30 is switched on, when the fiber is changed or when New treatment is selected on the Statistics menu.
  • Page 54 SCROLL knob until Treatments to save is highlighted and press CONFIRM. Choose the number of Treatments to save by turning the SCROLL knob and highlighted value and press CONFIRM to accept and move DELTA 15/30 Operator Manual Page 3.30 Version 2.2...
  • Page 55 SECTION 4 PROCEDURES The DELTA 15/30 lasers are optimized to operate with AngioDynamics fibers and procedure kits that are equipped with the AngioDynamics Fiber Recognition System (FRS). For a full description of this system please see section 3 of this manual.

  • Page 56: Angiodynamics Fibers And Procedures

    Also, the settings used for a treatment are retained in the DELTA 15/30 and restored the next time that the procedure is selected. Note that the new values are only stored in the memory of the DELTA 15/30 when the laser is put into the READY mode.

  • Page 57: Ordering Information

    To obtain information about the availability of procedure kits that are suitable for your application, please contact your AngioDynamics representative. Accessories The codes in the following table should be quoted when ordering accessories for your DELTA 15/30. Description AngioDynamics part number...

  • Page 58: Evlt Tm Procedures

    The third is intended to allow the operator some freedom in setting parameters manually. Note: If the DELTA 15/30 laser is enabled for full Manual operation, then it may also be configured for any parameters within its design specifications.
  • Page 59 DELTA 15/30 Selecting the Procedure For full instructions on operating the DELTA 15/30 laser, please refer to section 3 of the operator manual. The following assumes that the system has been correctly set up, switched on and with an EVLT fiber connected.

  • Page 60: Pvak Procedures

    The pulse duration and interval can each be adjusted between 0.1 and 5 seconds. Also, the settings used for a treatment are retained in the DELTA 15/30 and restored the next time that the PVAK Manual procedure is selected.
  • Page 61 DELTA 15/30 Selecting the Procedure For full instructions on operating the DELTA 15/30 laser, please refer to section 3 of the operator manual. The following assumes that the system has been correctly set up, switched on and with a PVAK fiber connected.

  • Page 62: Linear Fluence

    DELTA 15/30 before commencing a procedure. The total energy for the procedure is then automatically calculated. This function is only available when the DELTA 15/30 is used with compatible procedures, such as Venacure EVLT and PVAK described above.

  • Page 63: Spot Handpieces

    DELTA 15/30 SPOT HANDPIECES When an AngioDynamics spot handpiece is connected to the DELTA 15/30, FRS will recognize the type of handpiece and automatically displays suitable preset parameters. Follow the operating instructions in section 3. BARE-ENDED FIBER When an AngioDynamics bare-ended fiber is connected to the DELTA 15/30, FRS will recognize the type of fiber and automatically select the manual mode for the laser.
  • Page 64 DELTA 15/30 THIS PAGE LEFT BLANK DELTA 15/30 Operator Manual Page 4.10 Version 2.2...
  • Page 65 DELTA 15/30 and its accessories. The DELTA 15/30 has been designed to operate reliably with minimal maintenance. There are no user- serviceable parts in the DELTA 15/30. Always disconnect the DELTA 15/30 from the AC supply before performing any cleaning or maintenance procedures.

  • Page 66: Specifications

    Internal power calibration meter for handpiece or fiber calibration (Optional on DELTA 15) Spot Handpiece Mode Spot handpiece mode is available on the DELTA 30 and on the DELTA 15 when fitted with the optional calibration meter Spot size Ø 2mm Ø...

  • Page 67: Classification

    The system enclosure may be wiped down periodically with a cloth dampened with a mild antiseptic solution. Before cleaning always disconnect the DELTA 15/30 from the AC supply. Do not use any other solutions, solvents or abrasives. Take care not to get any liquid inside the enclosure.

  • Page 68: Troubleshooting

    TROUBLESHOOTING Error Messages The DELTA 15/30 is continuously monitoring its operation and performance. Should it detect a problem it will display a code and short message on the screen. To clear a message, carry out the instructions on the display. Outlined below are some messages and the appropriate action that the user should take.
  • Page 69 Invalid Fiber The fiber attached to the DELTA 15/30 is either not recognized or not equipped with the FRS system. Replace with an appropriate fiber or, if a Session Fault is indicated, use the Emergency Override option.

  • Page 70: Accessories

    DELTA 15/30 FRS Troubleshooting The AngioDynamics FRS system has been extensively tested. In the unlikely event of a problem being experienced please perform the following checks before contacting your local AngioDynamics representative for further advice. “Invalid Fiber” is displayed (1) Disconnect and then reconnect the fiber to the DELTA 15/30.

  • Page 71: Sterilization Of Optical Fibers

    Quality Assurance of 10 SURGICAL HANDPIECES Surgical handpieces with either rigid or malleable cannulae can be obtained from your AngioDynamics representative. These are available in a range of lengths and internal /external diameters.

  • Page 72: Fixed Focus Spot Handpiece Maintenance

    SOFTWARE UPDATES From time to time AngioDynamics may issue new procedures, upgrades and feature enhancements for the DELTA 15/30. As a registered owner you will be notified of these when they become available. SERVICING The DELTA 15/30 does not require regular servicing or maintenance, with the exception of annual checks of the calibration of the internal power meter (if fitted) and the output power of the laser.

  • Page 73: Calibration

    Checking the Calibration of the Internal Power Meter The LASER SAFETY OFFICER or suitably trained service personnel should check the calibration of the internal power meter of the DELTA 15/30 at least annually from the date of installation, by following the procedure described below.
  • Page 74 ONLY TRAINED LASER SERVICE PERSONNEL AUTHORIZED BY ANGIODYNAMICS SHOULD PERFORM SERVICE AND MAINTENANCE. AngioDynamics will not accept liability for the use of this equipment when calibrated by unauthorized personnel. To ensure accurate calibration of the delivery fiber, the internal power meter Calibrating the should be checked at least annually and re-calibrated if necessary.
  • Page 75 Fire the laser into the meter and, when the power reading has settled, make adjustments using the rotary control until the power displayed is as close as possible to 1W. When the power setting is achieved, release the footswitch and press the DELTA 15/30 Operator Manual Page 5.11 Version 2.2...
  • Page 76 10W port power, while the calibration point was taken with 10W distal power, so the calibration point should be 1.1x the previous ADC reading at 10W, allowing for a 90% fiber. DELTA 15/30 Operator Manual Page 5.12 Version 2.2...

  • Page 77: Laser Power Output

    LASER POWER OUTPUT Measuring the Laser Power Output The LASER SAFETY OFFICER or suitably trained service personnel should check the output power of the DELTA 15/30 at least annually from the date of installation, by following the procedure described below. Equipment Required •...
  • Page 78 Repeat this process for the 5W and 15W settings, starting with default values of 400 and 1000 respectively. Finally, check that the laser outputs the correct power at all three settings. DELTA 15/30 Operator Manual Page 5.14 Version 2.2...

  • Page 79: Technical Description

    The DELTA 15/30 lasers are built in a modular fashion, enabling ease of test, assembly and service. The system has been designed so that any one module can be replaced with no performance effect on the other modules or the product as a whole.
  • Page 80 This card is used to transfer usage data from the laser to the user’s PC. It can also be used to transfer updated software and new procedure information into the laser. DELTA 15/30 Operator Manual Page 5.16 Version 2.2...
  • Page 81 The Optical Power Calibration Meter (OPCM) is only fitted as standard to the DELTA 30 laser. It is optional on the DELTA 15. If the DELTA 15 laser is not fitted with an OPCM, then the laser’s software does not permit the use of a spot handpiece.
  • Page 82 DELTA 15/30 THIS PAGE LEFT BLANK DELTA 15/30 Operator Manual Page 5.18 Version 2.2...
  • Page 83 Operator Manual by any person not authorized by AngioDynamics, will invalidate the Warranty. To make a warranty claim the purchaser shall, promptly following discovery of the WARRANTY basis of claim, contact AngioDynamics in writing, by telephone, fax or Email at the CLAIMS following address: AngioDynamics Inc 603 Queensbury Ave.
  • Page 84 DELTA 15/30 THIS PAGE LEFT BLANK DELTA 15/30 Operator Manual Page 6.2 Version 2.2...

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Delta 30

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