Vari-Lase Endovenous Laser Users Manual Rev G June 2015

Vari-Lase Laser Console, Instructions For Use Copyright 2009 - 2012 MedArt A/S, Industriholmen 15A, DK-2650 Hvidovre, Denmark. Photographic, mechanical or other reproduction of this manual or any part thereof is not permitted without written permission from MedArt A/S. Date: July 6, 2010

MedArt A/S Industriholmen 15A DK2650 Hvidovre Denmark

Phone: Fax: Mail: Web:

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+45 3634 2300 +45 3634 2323 [email protected] www.medart.dk

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Table of Contents Table of Contents ... 3 Caution ... 4 Handling Precautions ... 5 Introduction ... 5 Intended Use ... 6 Endovenous Procedure Kit ... 7 Installation and User Obligations ... 7 Safety ... 7 Labels and Symbols... 10 Description of Operating Console ... 12 Operation ... 14 Output Power Verification ... 16 Definition and Retrieval of Treatment Parameter Sets ... 17 Remote Interlocking ... 18 Bare Fiber Connection ... 19 Connection and Release of Foot Switch... 19 System Setup and Status Display Controls ... 20 Service/Adjustment Functions ... 21 Cleaning and Maintenance ... 24 Main Power Connection and Replacement of Fuses ... 24 Trouble Shooting ... 25 Warnings and Stop Codes... 26 NOHD (Nominal Optical Hazard Distance) and MPE ... 27 Protective Eye Wear ... 27 Service and disposal... 27 Storing and Transportation ... 28 Technical Specifications for the Vari-Lase laser console... 29 Guidance and manufacturer’s declaration – EMC topics ... 31 Appendix A ... 34

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Caution 1. The Vari-Lase laser console is a Class 4 laser, which emits invisible laser radiation. 2. Avoid exposure to direct or scattered radiation. 3. Patient, operator and others in contact with the laser must wear suitable protective eyewear. Protective eyewear must be of a quality corresponding to the standards IEC 60825 and EN 207. 4. The fiber systems for the Vari-Lase laser console must be used only with a suitable handpiece or as a delivery system in connection with endovenous treatments. 5. Read the operating instructions thoroughly before connecting the laser unit to main power and prior to use. The laser unit must be set, regulated and used in accordance with the instructions for use. Failure to observe usual safety precautions may present a risk of hazardous exposure to laser radiation. 6. When the laser unit is not in use, ensure that it is rendered inaccessible to unauthorized personnel. Remove the key to disable the laser unit.

These warning labels are placed on the laser unit

Restrictions on use of Class 4 laser equipment The Vari-Lase laser system is intended solely for physicians trained in the use of these instruments. The safety precautions for Class 4 laser equipment must be followed. The physician is responsible for evaluating each patient’s suitability to undergo laser surgery and furthermore to inform the patient about any risks involved, the actual treatment, pre- and postoperative care and any other relevant information. All use of the equipment is based on the doctors’ knowledge and experience. The doctor is responsible for correct diagnosis and for all treatment results. MedArt undertakes no liability whatsoever for any damage or injury as a result of an application of a product which is not in strict accordance with intended use and the instructions provided with the product. This waiver also includes liability for any damage and injury arising as a result of the product user’s lack of qualification to evaluate the treatment applied in the actual individual circumstances, or as a result of errors or mistakes committed by such user who would otherwise be considered as having the necessary professional skills to apply such treatment.

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Handling Precautions Do not bend the fiber excessively. Avoid bending diameters smaller than 12cm. Avoid touching the fiber ends.

Introduction We congratulate you on the purchase of this Vari-Lase laser system, among the most advanced and user-friendly diode lasers available. It constitutes the fruition of many years of experience in the manufacturing and development of high technology medical laser equipment. The Vari-Lase laser console is fed by a diode laser module, which can provide a continuous or pulsed wave laser beam. It has a highly intelligent user interaction system - even though it is a very compact system. Rigorous quality control and factory testing ensure the very highest levels of quality and reliability. The laser unit incorporates various fail-safe systems and conforms to international standards for medical electrical equipment, IEC 60601-1 and those specifically for laser equipment IEC 60601-2-22 and IEC 60825. The Vari-Lase laser console conforms to the EU Medical Device Directive (MDD 93/42/EEC). This product is marked with type number MedArt 700. The type number uniquely identifies the product. The type number is placed on the type label located on the rear panel of the product. The Vari-Lase laser console is marked with

MedArt A/S

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Intended Use The Vari-Lase laser console is indicated for endovascular medical therapy of vascular conditions. It transmits through an optical fiber and 21 the power density reaches 11.9kW/cm enabling the laser to coagulate, evaporate and carbonize tissue. The Vari-Lase laser console operates with a wavelength of 810nm. The 810nm wavelength is primarily absorbed in melanin, hemoglobin and dark tissue and only a limited amount of the light is absorbed in water. This enables a fast heat increase in the irradiated area, leading to effective heating of tissue at low output power.

Indications for the Vari-Lase laser console The Vari-Lase laser console is indicated for the medical treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein.

Contra indications for the Vari-Lase laser console The Vari-Lase laser console procedure is contraindicated in patients with an aneurismal section in the vein segment to be treated. The Vari-Lase laser console procedure is contraindicated in patients with severe peripheral vascular disease, as evidenced by an anklebrachial index of < 0.5. The Vari-Lase laser console procedure is contraindicated in patients with thrombus in the vein segment to be treated. The Vari-Lase laser console is contraindicated in patients with a history of deep vein thrombosis.

Caution Caution should be used in advancing the sheath in case of extremely tortuous anatomy of the great saphenous vein to minimize damage to the vessel.

Caution If not properly performed, endovenous laser treatment may form a major risk to the patient’s health. The endovenous laser treatment shall be carried out solely by properly trained physicians.

Caution Caution should be used in patients that have a demonstrated history of peripheral vascular disease to ensure that the nature extent of the disease is known and accounted for in the treatment plan.

1

Max. Power density in a 300µ fiber

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Endovenous Procedure Kit To ensure a safe and efficient treatment, use the Vari-Lase endovenous procedure kit. Details on the nearest dealer can be obtained from Vascular Solutions, Inc. (address on page Error! Bookmark not defined.).

Installation and User Obligations The Vari-Lase laser console is designed to operate within normal room temperature (15-27°C / 59-81°F) and humidity conditions. The unit must be allowed to acclimatize before use following exposure to extreme temperature or humidity. Do not install the unit close to radiators or other sources of heat convection. The Vari-Lase laser console may overheat due to excessive room temperature in combination with operation at high output power. In case of overheating the laser unit will automatically shut down for a short cooling period. Hereafter the laser unit will be ready for continued treatment. We advise against the use of lasers at a distance of less than 2.5m from short-wave or microwave equipment, since unstable laser irradiation may occur. No attempt should be made by unauthorized persons to open the Vari-Lase laser console with a view to repair. Failure to observe this caution may present a serious safety hazard and will void warranty. MedArt cannot be held liable for events resulting from negligence, abuse or incorrect operation of the unit. Please acquaint yourself thoroughly with the instructions for use, and in the event of doubt contact your Vari-Lase dealer.

Safety The Vari-Lase laser console is designed and tested for maximum safety for both the user and patient. It is however, ultimately the operator’s responsibility to introduce safe practices, which ensure the safety of personnel and equipment.

WARNING Only MedArt trained personnel should attempt to inspect and/or repair the Vari-Lase laser console. The Vari-Lase laser console contains no user serviceable parts.

Electrical safety The system must be grounded.

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Optical safety Avoid exposure to laser radiation in excess of the allowable limits listed in Title 21 U.S. Code of Federal Regulation, parts 1040.10 and 1040.11, during the installation and operation of the Vari-Lase laser console.

WARNING Injury to the eyes and the epidermis can result from either direct or scattered radiation. The power density of the light emitted from lasers can be high enough to cause severe burns to the skin when directly exposed to the beam.

WARNING All personnel in the operating room must be protected from stray and scattered radiation by wearing the appropriate protective eye-wear to guard against ocular injury. Never look directly into any laser beam. Use surgical instruments with a dull and dark anodized finish whenever possible. Shiny surfaces can reflect laser beams. Take extreme care if shiny surgical instruments are used.

Fire and explosion precautions Combustible material can ignite if exposed to certain wavelengths of laser radiation.

WARNING Do not operate the laser in the presence of explosive gases and liquids as well as highly concentrated oxygen. The following precautions can minimize the risk of fire: a. b. c.

Surround the surgical field with wet gaze or towels If possible, eliminate flammable materials from the surgical field Have a fire extinguisher nearby

Always place the laser unit in Standby Mode whenever possible. This will prevent accidental firing of the laser.

Precautions against transfer of diseases The cleansing and sterilization instructions provided by this manual shall always be followed to avoid transfer of diseases through patient contact with operation components.

WARNING Insufficient cleansing or sterilization of operation components that get in contact with the patient may result in transfer of diseases.

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Precautions against toxic effects When undertaking endovenous treatments, it is of utmost importance that all materials introduced into the veins of the patient, are fully biocompatible.

WARNING Material without properly certified bio-compatibility must never be used for endovenous laser treatment.

Precautions against embolic hazard Caution The Vari-Lase Procedure Kit is designed for single use only. Reuse of the fiber may result in hot spots causing combustion and embolisation or fiber fragments.

Precautions against hazardous radiation exposure To ensure a safe and efficient treatment, the user must always follow the procedures of this manual.

Caution Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.

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Labels and Symbols The type label is situated at the rear of the laser system.

Specifies the name and address of the manufacturer of the equipment. Specifies the rating of the main power supply. Specifies the ratings of the fuses to be used for the equipment. Specifies Type BF Applied Part (Body Floating). European Directive 2002/96/EC requires that equipment bearing this symbol must not be disposed of with unsorted municipal waste. For further details, please see page 27 in this manual. Indicates the foot switch inlet.

“DISTRIBUTED BY”

Specifies the name and address of the corporation, which distributes the equipment within Europe. Please notice; this corporation is not the same as the manufacturer. Serial number label is situated at the rear panel of the laser.

The interlock label is situated under the front panel of the laser system.

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A B

Service connector A. For service use only. Service connector B. For service use only. Interlocking socket. See paragraph “Remote Interlocking” on page 18. Explanatory label and Laser Warning label is affixed visibly on the fronttop of the system.

CDRH and production date label – situated at the rear of the system.

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Description of Operating Console

Vari-Lase laser console Parameter selection - accompanying LED lit when active Provides the possibility of choosing any pre-programmed set of treatment parameters - accompanying LED lit when active

1-4

Selector keys

5

Program key

6

Menu key

Provides access to the various menus features by the Vari-Lase laser console

7

Left key

Used for menu browsing and operation

8

Right key

Used for menu browsing and operation

9

Back key

Used for stepping upwards in the menu hierarchy and leaving the selected menu item without saving changed parameters

10

Enter key

Confirms/saves the parameters currently displayed - accompanying LED lit when active

Jog wheel

Turning the jog wheel clockwise will increase any selected parameter, turning it counter-clockwise will decrease the parameter

Ready key

When activated the Vari-Lase laser console is set into Ready Mode. See paragraph “Operation” on page 14 for more details

11

12

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13

Standby key

When activated, the Vari-Lase laser console is set into Standby Mode. Parameters can be modified, but no laser output can be generated

14

Emergency stop key

See paragraph “Operation” on page 14

15

Laser ready indicator

Lit whenever the Vari-Lase laser console is emitting aiming light

16

Laser emission indicator

Flashing when laser emission occurs

17

Key switch

The laser unit is disabled when the key is in off-position or when the key is removed. Text “TURN KEY“ and a key symbol is displayed when the key is turned in off-position

18

Fiber connection

Laser pulses are delivered via a fiber assembly

19

Laser beam input port

20

Display

21

Foot switch inlet

22

Laser input port for verification purpose. See paragraph “Output Power Verification” on page 16 Display used for displaying visual information to the user Air foot switch inlet and release button, situated on rear panel

Remote interlocking

Interlocking socket situated under the front panel. See paragraph “Remote Interlocking” on page 18

23

A

Service connector

Service connector A. Intended for service use only

24

B

Service connector

Service connector B. Intended for service use only

25

Main power switch

25

26

Fuse holder

26

27

Main power cable inlet

27

28

Follow Instructions for Use

Instructions to follow the information in the Instructions for Use See paragraph “Main Power Connection and Replacement of Fuses” on page 24

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Operation Preparing for use 1. Carefully insert the fiber in the fiber connector located at the front of the laser unit (18) 2. Plug the foot switch tube into the socket at the rear of the laser unit (21) 3. Insert the main power cord at the rear of the laser unit (27) 4. Switch on the main power switch at the rear of the laser unit (25) 5. Connect interlock or insert dummy plug in the connector (22), cf. “Remote Interlocking” 6. Enable the laser unit by inserting and turning the key in the switch (17). The aiming light will be activated and the indicator (15) will be lit 7. While the Vari-Lase laser console is powering up, laser emission is disabled, all keys and selectors are disabled. The Vari-Lase laser console is default set into Standby Mode 8. Set the treatment parameters 9. Set the Vari-Lase laser console into Ready Mode by pressing the Ready key (12). After a required 3 seconds safety-delay the unit will become ready and the text in display will show READY 10. Start treatment by pressing the foot switch. Each time the foot switch is activated, laser radiation will be emitted and the Laser emission indicator (16) is lit

Setting of treatment parameters Power, pulse width, and pulse repetition rate can be set to prepare for the required treatment. The treatment parameter to be set is selected by pressing the associated selector (1, 3, or 4) located below the display. When a parameter is selected, it can be modified by turning the jog wheel. When all parameters are properly set for treatment, press Enter (10) to store the parameters. One can also press the Ready key to store the parameters and bring the unit directly into Ready Mode. Pressing the Back key (9) during setting of a parameter terminates the setting without changing the parameter. Output power Power can be set in the range 0-15W in 1W increments. The output power level is shown in the display. Pulse width Pulse width can be set in the range 10-3000msec. The pulse width is shown in the display. Pulse repetition frequency Frequency can be set in the range 0.3 - 100Hz. Further, output can be set to single pulse and CW. The frequency is shown in the display.

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Standby Mode and Ready Mode When the Ready key is pressed, the unit enters Ready Mode. In this mode, laser radiation will be emitted when the foot switch is pressed. When pulse length is shorter than 50msec, a steady audible tone will be generated twice a second. When pulse length is longer than 50msec, an audible tone will be generated when laser is emitted. Pressing the M, Back, or P key or any selector key will return the system to Standby Mode.

Ready

If the system remains idle in Ready Mode for 250 seconds, it will automatically return to Standby Mode for the sake of operator and patient safety. When the Standby key is pressed, the unit enters Standby Mode. For safety reasons the laser should always be brought into Standby Mode whenever not treating. In Standby Mode, laser radiation cannot be emitted.

Standby

Start and stop of laser radiation When the treatment laser is active, the yellow Laser emission indicator flashes and an audible tone signal will be heard.

Caution When the Laser ready indicator is on, the Vari-Lase laser console emits aiming laser radiation.

READY

When the text in the display shows READY, the Vari-Lase laser console emits treatment laser radiation immediately upon activation of the foot switch. Foot switch operated When the foot switch is pressed, the Vari-Lase laser console starts radiating. Releasing the foot switch stops emission. Emergency STOP key When the emergency stop key (14) is pressed, the Vari-Lase laser console stops emitting laser radiation and all functions are blocked. The main power switch (25) must be switched OFF for approximately 15 seconds and ON again for restart.

Shut down procedure The Vari-Lase laser console is shut down by pressing the main power switch (25) on the rear of the unit. The Vari-Lase laser console automatically detects that the main switch is pressed and the unit is brought into a safe state where a controlled shut down procedure is executed. The shut down procedure can be initiated regardless of the state of operation.

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Output Power Verification The Vari-Lase laser console provides advanced built-in facilities for output power verification purpose. 1. 2. 3. 4.

Press the M key (6) to enter the Function Menu Press the Right key (8) to enter the second Function Menu Press the “Measure Power” selector (2) Align the output tip of the fiber with the sensor opening (19) and keep it aligned during the entire measuring process 5. Activate the foot switch – and keep the foot switch pressed during the entire measuring process. Any measurement interrupted by the release of the foot switch will be ignored 6. The Vari-Lase laser console automatically tests the laser output by measuring the power level of a number of pulses – wait for this to complete 7. The measured optical output in watts is displayed Repeated measurements may cause the built-in power meter to heat up. If so, a message will appear urging the user to wait 5 minutes before further measurements are undertaken.

Caution All personnel in the operating room must wear protective eyewear during the measurement.

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Definition and Retrieval of Treatment Parameter Sets The Vari-Lase laser console features the possibility of defining sets of treatment parameters. These parameter sets can later be retrieved for fast unit setup. This is an overview of the features of the treatment parameter function: - 16 parameter sets can be stored -

Easy access, stored parameter sets can be retrieved with 2 button presses

-

Each parameter set can have 2 lines of 8 characters to describe the use. The description is shown on the main screens

-

After power off the parameter sets will still be available

-

All parameters are saved including guide beam intensity, fiber diameter and fiber tip. Bare fibers are handled as part of treatment sets as well

Power up defaults When powering up the MedArt 700 laser unit the parameters in program 16 are always retrieved. The parameters in program 16 can be changed and stored by the user if different values are preferred. Note: the default program name “DEFAULT” isn’t stored if changed. The new default parameters will be active next time the MedArt 700 laser unit is powered up. Factory defaults are: 1W, CW (continuous wave) Aiming light level 100% Aiming light ON in STANDBY mode Laser Energy Emission Every 70J Laser Energy Emission Mark ON Laser Energy Beep inc. 30%

Program function modes The program function has 4 modes that are selected with repeated presses of the Program key (5). First press: Shows simple parameter screen with parameter set names only. Press one of the 4 Selector keys (1-4) to recall the intended program or press the Left or Right keys (7, 8) to scroll between blocks of 4 parameters. Second press: Show detailed information about each program. Again the Selector keys (1-4) recall a program and the Left or Right keys (7, 8) scroll. Third press:

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Press a Selector key (1-4) to save the current set of parameters. Fourth press: Press a Selector key (1-4) to change the name of the parameter set. The set parameters will not be changed only the name.

Retrieving a parameter set Go through the following steps to retrieve a predefined set of parameters: 1. Make sure the laser unit is in Standby Mode 2. Press the Program key (5) 3. The contents of the program memory slots are displayed on the screen. Press the Left, Right keys (7, 8) to access the remaining program locations 4. Press the Selector key (1-4) corresponding to the parameter set to be used 5. The previously saved parameter set is recalled and the laser unit is ready to be set into Ready Mode

Changing the name of a program 1. Make sure the laser unit is in Standby Mode 2. Press the Program key (5) 4 times 3. Press the Selector key (1-4) corresponding to the program who’s name you wish to change. Use the Left, Right keys (7, 8) to access other program locations 4. Use the Left, Right keys (7, 8) and jog wheel (11) to change the name 5. Press Enter (10) to return to Standby Mode

Note: The name of program 16 is overwritten by system defaults at the next system power up.

Remote Interlocking The Vari-Lase laser console provides an interlocking feature that can be employed for deactivation of laser emission when doors are opened to the treatment area.

If remote interlocking is not required The unit is supplied with a special interlocking dummy plug that has to be inserted in the interlocking socket (22).

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If remote interlocking is required If the interlocking feature is required to ensure a safe entry to the treatment area, an appropriate switch may be mounted on the doorframe in a way that ensures contact closure when the door is closed. Pin 1 and 6 in the interlocking socket must be connected to the switch and multiple doors can be wired in series if needed. A special plug giving access to pin 1 and pin 6 in the interlocking socket (22) can be supplied by Vascular Solutions, Inc.

Bare Fiber Connection Caution Not following the recommendations provided below may lead to damage to the fiber or delivery system and/or harm to the patient or user. Connecting bare fibers To facilitate endovenous laser treatment, a bare fiber equipped with a standard SMA-905 connector (as specified by International Electrotechnical Commission IEC document 86B/1903/CDV, connector plug FSMA I) may be connected to the Vari-Lase laser console using a SMAto-QSC adapter. Remove the protection cap from the fiber SMA-905 connector. While the QSC adapter is installed in the laser, insert the SMA-905 into the QSC adapter and carefully tighten the nut.

Caution Keep the fiber cap on, when the fiber system is not connected. Do not touch the fiber connector tip, as this will reduce fiber lifetime.

Connection and Release of Foot Switch A connector (21) for the foot switch is provided on the rear panel. For connection simply plug-in the foot switch connector. Release the foot switch by pressing the adjacent button.

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System Setup and Status Display Controls A number of system features, which may be setup by the user, exist. To do this please follow the below procedure: 1. Make sure the unit is in Standby Mode 2. Press the M key (6) to enter the ‘Function menu 1’ 3. Press Selector key (2) to enter the ‘User Setup 1’ menu Four setup options are displayed. Press the Right key (8) or the Menu key (6) to display the last three options in ‘User Setup 2’. These seven options are described below:

Sound Level Turn the jog wheel (11) to change the volume of the internal speaker. Press the Enter key (10) when a satisfactory volume is found. For safety reasons the level cannot be set to values lower than 30%.

Display Contrast Turn the jog wheel (11) to change the display contrast. Press Enter key (10) when a satisfactory display contrast is found.

Aiming Beam Turn the jog wheel (11) to adjust the brightness of the aiming beam. Press the Enter key (10) when the desired brightness is found. The effect will be visible next time Ready Mode is entered.

Choose Language Turn the jog wheel (11) to see the languages, which can be selected for display text. Press the Enter key (10) when the desired language is found.

Status Display 1/Status Display 2 The user can choose two selectable status readings to be displayed during operation. The two readings can be chosen from a group of four:    

None: No status is displayed Pulses: The number of pulses generated ActiveTime: The amount of time laser has been radiated Joules: The amount of joules generated

The one reading is chosen by using menu entry ‘Status Display 1’ and the other by using menu entry ‘Status Display 2’. Use the jog wheel (11) to browse through the four options. Press the Enter key (11) when the desired status reading is found. The reading will be displayed whenever the unit is in Standby or Ready Mode.

Reset Counters The user may want to reset the readings; e.g. before a patient treatment is initiated. To do this, please follow the below procedure: 1. Make sure the unit is in Standby Mode 2. Press the Menu key (6) to enter the ‘Function menu 1’ 3. Press Selector key (3) to reset the status display readings

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