User Manual
67 Pages
Preview
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AURIGA User Manual
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Symbols Used
SYMBOLS USED This manual uses the following symbols:
WARNING The <Warning> symbol implies that non-compliance with these instructions could seriously endanger the health of operator or the patient.
CAUTION The <Caution> safety symbol implies the use of extreme care when operating the device in order to ensure safe and efficient performance.
NOTE Notes contain useful or additional information for the user.
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General Safety Instructions
GENERAL SAFETY INSTRUCTIONS
WARNING The laser radiation can cause fire or explosion hazards with highly flammable materials.
CAUTION Improper use of the device of non-compliance with this manual can cause dangerous laser radiation emissions.
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Contents
CONTENTS Page
1
INTRODUCTION...9
2
GENERAL NOTICES TO USERS ...10
3
SAFETY INSTRUCTIONS ...11
4
5
3.1
Eye Protection ...12
3.2
Protecting the Patient ...13
3.3
Use Restrictions ...14
3.4
Built-In Safety Measures ...15
SYSTEM DESCRIPTION ...16 4.1
System Overview...16
4.2
Switching Elements and Interfaces...17
4.3
Display...20
FUNCTIONAL DESCRIPTION ...21 5.1
Important Procedures Before Using The Device ...21
5.2
Connecting the Fiber ...22
5.3
Removing the Fiber ...23
5.4
Turning On the Device...24
5.5
Application Selection Menu ...25
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Contents Page
5.6
Triggering Laser Pulses...29
5.7
Turning Off the Device...30
5.8
LITT Mode with Intermittent Pulse Operation ...31
5.9
Setting the Aiming Beam Brightness ...32
5.10
Memory Function...33
5.11
Setup Menu ...34
5.11.1 Counter Menu...36 5.11.2 Changing the Language ...38 5.11.3 Setting the Date...39 5.11.4 Setting the Time ...40 5.11.5 Setting the Contrast...41 5.11.6 Setting the Volume ...42 6
ACCESSORIES ...43
7
CARE OF DEVICE AND ACCESSORIES ...45
8
7.1
Cleaning the Device ...45
7.2
Cleaning the Accessories ...45
ERRORS AND HOW TO FIX THEM...46
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Contents Page
9
10
11
12
TECHNICAL SUPPORT ...51 9.1
Service Hotline ...51
9.2
Maintenance...52
9.3
Technical Safety Inspections...53
9.4
Disposal...54
LABELING...55 10.1
Labeling the Laser Device ...55
10.2
Labeling of the Laser Area ...58
TECHNICAL DATA ...59 11.1
Device Data ...59
11.2
Laser Parameters ...60
11.3
Electromagnetic Compatibility ...62
WARRANTY ...67
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Copyright StarMedTec GmbH, Germany All rights reserved. Copying, photocopying, and any other duplication of this instruction manual or parts of it as well as its conversion into electronic or machine-readable media requires the prior written permission of StarMedTec GmbH.
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Introduction
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INTRODUCTION Indented use of the laser system AURIGA: The Ho:YAG laser system AURIGA is suitable for interdisciplinary use (urology, HNO, orthopedics, gynecology and gastrology) in invasive and non-invasive surgical procedures. With its application-dependent settings, AURIGA is suitable for •
Breaking up stones
•
Cutting hard and soft tissues
•
Coagulation of hard and soft tissues
•
Vaporizing tissue fluid.
This laser system emits laser radiation with a wavelength of approx. 2080 nm. This special wavelength is transmitted by a fiber optic cable and allows efficient treatment with minimal impact on the surrounding tissue as well as customized impulse durations and energies. Various fibers are available for this laser system for a diverse range of applications. The accessories as well as type of fibers are subject to continuous expansions and further developments. For further information, please contact StarMedTec GmbH or your local dealer.
For further information please contact:
StarMedTec GmbH Kreuzstaße 22 82319 Starnberg, Germany Hotline Tel: + 49 8151 / 26861 0 Fax: + 49 8151 26861 35 [email protected]
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General Notices to Users
2
GENERAL NOTICES TO USERS The AURIGA laser system is a medical treatment device that is only permitted to be used for surgical treatment purposes. This manual describes the operation, maintenance and service of the device. For medical applications and recommended treatment parameters, refer to the application manual. The use of mobile telephones (cell phones) or similar devices is not permitted while the laser is in operation. In consideration of the possible risks from interference by electromagnetic radiation during operation of the laser, individuals with pacemakers should not be present in the laser area. We also recommend that pregnant women remain outside the laser area.
CAUTION A laser unit, just as any other high performance medical device, requires special knowledge and care with regards to handling and use. The laser may only be operated by physicians who have been thoroughly trained in handling the device in accordance with this operating manual and are familiar with its therapeutic effect and possible risks.
Maintenance and repair work may only be performed by service representatives of StarMedTec GmbH or by specialists specifically authorized by StarMedTec GmbH. Any tampering with the unit by non-authorized personnel will void our warranty as well as any liability. Always transport the laser system in the original packaging. When disposing of a laser unit, StarMedTec GmbH will assist you in contributing towards an environmentally friendly recycling (see chapter 9.4 “Disposal” on page 54).
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Safety Instructions
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SAFETY INSTRUCTIONS National requirements for the installation and operation of medical products and medical lasers must be complied with at all times. The operator must investigate whether or not the operation of laser devices is subject to registration with national authorities. The AURIGA laser unit is a class IIb active medical product complying with medical device directive 93/42/EEC. Improper use of any laser can cause health risks. The AURIGA laser device employs a class 4 laser. Please note that reflective materials and instruments can deflect the laser beam uncontrollably. Use particular caution with glass surfaces and highly-polished metal surfaces, which at a distance of several meters can still cause dangerous leakage radiation. Be sure to wear laser protective goggles in the laser area during laser emission. When operating optical devices for observation or adjustment purposes, the use of proper protection filters of the appropriate protection level is required. During operation, the laser area must be enclosed and properly marked according to safety norm EN / IEC 60825-1. Before transport of the AURIGA laser system, all accessory parts (fibers, power cable, Foot Pedal, fiber holder,…) must be removed. In case of applications where ablation products are generated and these are released to the surrounding air, it may be necessary to use an extraction and filter system. The laser device may not be operated with a defective display. The menu structure is interactive. Do not continue the treatment if the display is dark or cannot be read clearly (contrast). The operator is responsible for providing safety measures against fire and explosion hazards in case of medical laser applications in areas of organs, body cavities and tubes containing flammable gases or vapors. The service life of this medical product is limited to 10 years. After this time, the suitability of the technology used must be reevaluated by StarMedTec GmbH.
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Safety Instructions 3.1 Eye Protection Due to the high energy density of the device’s laser radiation emission, the eyes are particularly at risk since damage can be caused even by low laser radiation. Therefore, laser radiation protection serves two different purposes: 1.
Protecting the patient through competent laser device operation by the physician and
2.
Protecting everybody involved as well as the laser treatment operator from inadvertent radiation exposure.
Define the Nominal Ocular Hazard Area (NOHA) according to EN / IEC 60825 or according to national regulations.
CAUTION Within the NOHA all persons must wear protective eyewear of the type indicated below. Non-compliance can cause irreversible eye damage!
The protective eyewear for the AURIGA laser system must at least meet the following requirements: I 2080 nm L2 (according to DIN EN 207) Laser operation modes I = Pulsed Laser Wavelength at which the laser protection goggles provide protection Protection level
In order to avoid confusion, protective eyewear must be marked according to the above pattern. Please verify the perfect condition of the protective eyewear before use, i.e. the glasses must be free of any mechanical damage.
CAUTION Never not look directly into the laser beam.
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Safety Instructions 3.2 Protecting the Patient Only individuals trained in the application of the laser and possessing sufficient medical knowledge are permitted to use the AURIGA laser device. When handling accessories, disposable products or substances that came in contact with the patient, safety precautions must be taken in order to avoid the transmission of infectious germs. See chapter 7 “Care of Device and Accessories” on page 45. If the patient cannot wear laser safety goggles during the treatment due to treatment in the area of the eye, other adequate safety precautions must be taken. Only “single use” or “multiple use” fibers approved by StarMedTec GmbH (not available in all countries) may be used with the AURIGA laser system. The “sidefire” and “LITT” fibers available in the accessory selection may only be used as single-use articles.
ATTENTION Only fibers in perfect condition that have been sterilized according to the instructions may be used for treatment. The specified cleaning and sterilization cycles must be observed, damaged or dirty fibers may never be used.
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Safety Instructions 3.3 Use Restrictions
CAUTION The AURIGA laser system is a device checked and certified according to EN / IEC 60601-1-2 (EMC). For any further details, please refer to chapter 11.3 “Electromagnetic Compatibility”, page 61, table 2 - 5.
The AURIGA Laser Device may be used only with the accessories that are delivered with the product. Every accessory has been tested and approved by StarMedTec GmbH for use with the laser device according to the EC directive 93/42/EEC . The AURIGA laser system may not be connected to multiple socket power outlets or sockets that are not permanently installed. The AURIGA laser device may not be operated in rooms and areas susceptible to explosion hazards! The AURIGA laser device may only be operated in a medical environment. National requirements must be met at all times! The laser device was tested for electromagnetic compatibility (EMC) and complies with all applicable EMC requirements. Malfunctions, however, cannot be excluded entirely. It is recommended that the AURIGA XL Laser Device is operated only in rooms with a room temperature between 18°C - 28°C and relative h umidity of ≤ 80%, without condensation. The AURIGA XL Laser Device may not be operated more than 2000 m above sea level. The AURIGA laser device is designed for a intermittent operation of 66% laser on and 34% laser off during a period of 45 minutes. The maximum continuous laser on time should be limited to approx. 5 minutes. In case of using the laser device beyond this time restrictions, in unfavorable circumstances the unit will shut down.
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Safety Instructions 3.4 Built-In Safety Measures General requirements with regard to the design and manufacture of the AURIGA laser device were determined according to the applicable safety norms such as EN / IEC 60601 and EN / IEC 60825. Additional built-in safety measures offer a high level of safety and operating comfort. • After the laser device is turned on, the microcontroller performs an internal SELF TEST. If any malfunction is detected, the device shuts off automatically. • After the internal SELF TEST, the Main Menu appears on the display, in which the fiber type must be selected. After accepting the fiber selection, the device enters STANDBY Mode in the Application Menu. • The microprocessor unit scans various sensors and issues warnings or error messages if necessary. • The laser and treatment parameters are monitored and displayed on the laser device’s display. • If the power supply does not conform to requirements, for example in case of undervoltage, which would result in the chosen parameters not being displayed due to the inadequate power supply, the device automatically reduces the frequency. If the supply is more than 20% below the required level, the device adjusts to the next lower frequency and shows this by issuing an audible alarm. • The laser device is equipped with a remote interlock connector (see chapter 4.2 “Switching Elements and Interfaces”, figure 3). • Locking wheels ensure secure positioning of the device.
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System Description
4
SYSTEM DESCRIPTION
4.1 System Overview
Fiber
Laser Aperture (Fiber Connection)
Fiber Holder
Display with Operating Unit
Emergency Laser Emission Stop Switch
Key Switch
Fig. 1: AURIGA Basic Laser Unit
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System Description 4.2 Switching Elements and Interfaces
1
Emergency Laser Emission Stop Switch
2
Key Switch
123
Fig. 2: Front of the Laser Device
Emergency Laser Emission Stop Switch The Emergency Laser Emission Stop Switch immediately turns off the laser emission so that risks to individuals and the device can be prevented by the user’s reaction. The switch is activated by pressing the red key. After the switch has been activated, it must be released by turning the red key clockwise before restarting the device. If the switch is not released, the system cannot be started. Activating the Emergency Laser Emission Stop Switch does not disconnect the device itself from the power supply; this can only be achieved by switching the Main Power Switch on the rear of the device. Key Switch The Key Switch turns the laser device on and off. By removing the key, you can secure the device against unauthorized use. The Key Switch has three positions: 1=OFF; 2=ON; 3=START.
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System Description
3
Main Power Switch
4
Remote Interlock Connection
5
Foot Pedal Connection
6
Electrical Power Cord
Fig. 3: Connections on the Rear
Main Power Switch The Main Power Switch switches the laser device on. After the Main Power Switch is activated, the device is in Operative Mode and it can be turned on with the Key Switch. Remote Interlock Connection A sensor can be attacked to the remote interlock connection, which stops the laser emission immediately when the door opens. If no sensor is attached, connect the remote interlock connector plug.
NOTE If neither sensor nor remote interlock connector is connected, the laser unit does not operate. The following message is output to the display: “Remote interlock connector”
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System Description
Foot Pedal Connection Connection socket for the Foot Pedal. Foot Pedal The Foot Pedal turns on the laser emission. Electrical Power Cord The electrical power cord is connected to the laser device; it can be detached and it is equipped with a power plug. Fiber connection (applicator connection) The fiber plug is a standard SMA connector according DIN EN 186100. Attach only fibers with following specifications: -
The fiber has to be cleared for invasive human applications with holmium lasers. The fiber must match to the wavelength of 2080 nm. The fibers must be cleared to transmit the maximum laser energy of 3 J and the frequency of 20 Hz. The fibers may not transmit electricity. Metallic materials are prohibited. Side fire fibers must emit the laser beam diffuse on one side. LITT fibers must emit the laser light in a diffuse and radial way.
Note The quality of the treatment depends on the quality of the fibers. For optimum output use fibers approved by StarMedTec GmbH only.
The fibers approved by StarMedTec GmbH are listed in chapter 6 “Accessories”. If you use other equipment not approved by StarMedTec GmbH you do it at your own risk.
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System Description 4.3 Display
1 Function Keys
2 Selection Keys
3 Display
Fig. 4: Display with Soft Touch Keyboard
4 LASER READY Key
Display Unit The display unit consists of the display and integrated Function and Command Keys. All laser parameters are entered via the integrated Function and Command Keys.
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