Instructions for Use
108 Pages
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Surgical Laser Unit English
Instructions for Use
90-636-52-30 Revision 5 Date of Release: 2017-07
Valid from software version V3.00, hardware release HW 04 and software version SW 02
Symbol Explanation Safety alert symbol CAUTION
Indicates a situation which, if not avoided, could result in minor or moderate injury.
WARNING
Indicates a situation which, if not avoided, could result in death or serious injury.
DANGER
Indicates a situation which, if not avoided, will result in death or serious injury.
Instructions for Use
Follow Instructions for Use
Catalog number Serial number Production lot number, batch Store in a place protected from direct sunlight
Store in a place protected from frost
Keep dry
Information on minimum and maximum temperature for storage and transportation. Limax® 120: See section 11 “Technical Data”, page 103 for valid values.
Information on minimum and maximum atmospheric pressure for storage and transportation. Limax® 120: See section 11 “Technical Data”, page 103 for valid values. Information on minimum and maximum atmospheric humidity for storage and transportation. Limax® 120: See section 11 “Technical Data”, page 103 for valid values. 2
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Fragile, avoid pressure and shock
Arrows pointing up, transport and store upright
Date of manufacture Manufacturer Do not use if packaging is damaged
Use-by date Latex-free
CE marking of conformity This product may not be disposed of as normal household garbage, see section 9.3 “Disposal of the Unit”, page 98
NON WOOD
Revision 5
The packaging of the Limax® 120 is “non-wood”, i.e. wood packaging material that is not subject to ISPM 15 and therefore suitable for international shipment.
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Instructions for Use Surgical Laser Unit Limax® 120
Contents 1
Notices concerning this Document ... 8
1.1 1.2 1.3 1.4
Safety ... 8 Terms & Acronyms ... 8 Validity of this Document ... 9 Symbols Used in this Document ... 10
2
Product Liability and Warranty ... 11
2.1 2.2 2.3 2.4 2.5
General Information ... 11 Hotline... 11 Scope of Delivery ... 12 User’s Inspection ... 12 Warranty ... 12
3
Intended Use ... 13
3.1
Intended Purpose of the medical device ... 13
3.1.1
Indications for Use of the medical device ...13
3.1.2
Patient Group/Patient Selection ...13
3.1.3
Environmental conditions ...13
3.1.4
User ...13
3.2
Use Restrictions ... 14
3.2.1
Contraindications ...14
3.3
Warnings and Precautions ... 14
4
Functional Principle ... 15
4.1 4.2 4.3 4.4
General Information on Laser Theory... 15 The Nd:YAG Laser ... 15 Fields of Application ... 15 Frequently Used Functions ... 16
5
Safety Notices & Instructions ... 17
5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 5.10 5.11
General Regulations ... 17 Laser Safety ... 18 Explosion and Fire Hazards... 19 Protecting the Patient ... 19 Treatment Room Requirements... 20 Safety Requirements for the Laser Unit ... 20 Safety Instructions Relating to the Pilot Laser ... 20 Laser Safety Officer ... 21 Electrical Safety ... 21 Grounding the Unit ... 22 Fuses ... 22
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Instructions for Use Surgical Laser Unit Limax® 120
5.12 5.13 5.14 5.15
Safety Devices ... 23 Warning & Information Labels... 24 Laser Smoke ... 25 Proper Handling of Laser Fibers... 25
6
Operation ... 26
6.1 6.2
Front Side ... 26 Rear Panel ... 27
6.2.1
Drawer...28
6.2.2
Handle ...28
6.2.3
Loudspeaker ...28
6.2.4
MCB Socket Limax® 120 ...29
6.2.5
Accessory Port ...29
6.2.6
Interlock/Warning Connector ...29
6.2.7
Foot Switch Connector ...31
6.2.8
Fuses Limax® 120, Version E ...31
6.2.9
Mains Connector Socket Limax® 120, Version E...31
6.2.10
Disconnection Limax® 120 from Power Supply ...32
6.2.11
Connecting the Limax® 120 U-Version to the Power Supply ...33
6.2.12
Disconnecting the Limax® 120 U-Version from the Power Supply ...33
6.2.13
Line Fuses for the Optical System ...34
6.2.14
Equipotential Bonding Pin ...34
6.2.15
NIST Socket (AIR) ...34
6.2.16
VAC MCB Socket ...35
6.2.17
Limax® 120 Rating Plate ...35
6.2.18
VAC Rating Plate ...36
6.2.19
Serial Number Structure...36
6.2.20
VAC Mains Connection ...37
6.3
Putting the Limax® 120 into Operation ... 37
6.3.1
Setting up the Limax® 120 ...38
6.3.2
Relocating the Unit ...39
6.3.3
Installation and Initial Start-Up ...40
6.4 6.5 6.6
Measures to Be Taken Prior to Using the Laser System ... 42 Operating the Limax® 120 ... 42 Controls, Indicators and Display Elements ... 43
6.6.1
Keylock Switch ...44
6.6.2
Emergency Stop Switch ...44
6.6.3
STOP Indicator ...45
6.6.4
LASER ACTIVE Indicator ...45
6.6.5
SMAplus Fiber Connecting Socket ...46
6.6.6
Luer-Lock Socket for AIR (Purge Air) ...46
6.6.7
Keypad ...47
6.6.8
Rotary Switch with Backlighting ...49
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Display ...50
6.6.10
Laser Status Indicator ...51
6.6.11
FILTER LIFE ...52
6.7
Applied Parts ... 53
6.7.1
Connecting the Applied Part ...53
6.8 6.9 6.10
Checking the Laser Fiber with the Pilot Laser ... 54 Replacing the Laser Fiber ... 54 AIR (Purge Air) ... 55
6.10.1
Compressed-Air Hose ...56
6.10.2
Testing the Purge Air Flow ...57
6.11
Connecting the Focusing Handpiece/Applicator ... 57
6.11.1
Connecting the Sterile Air Filter ...58
6.11.2
Connecting the Focusing Handpiece ...58
6.11.3
Connecting Applicators ...59
6.12
VAC (Smoke Evacuator) ... 60
6.12.1
Turning VAC on/off with Mains Switch ...60
6.12.2
Replacing the Main Filter ...61
6.12.3
Connecting the Suction Hose ...62
6.12.4
VAC Performance During Laser Operation ...63
6.13 6.14 6.15 6.16 6.17 6.18 6.19 6.20
Switching on the Limax® 120 ... 63 System Test ... 64 Foot Switch with SWAP® Pedal ... 65 Using the Laser Light ... 66 Connecting the Laser Fiber ... 66 Turning off the Limax® 120 ... 67 Emergency Shutdown ... 67 Working with Programs ... 68
6.20.1
Standard Program ...68
6.20.2
Selecting Programs ...69
6.20.3
Adjusting Programs ...71
6.20.4
Laser power ...71
6.20.5
Operating modes ...71
6.20.6
Creating a SWAP® A/B Program ...73
6.20.7
Saving Modified Programs ...74
6.20.8
Overwriting Programs ...76
6.20.9
Deleting Programs ...77
6.20.10
VAC program ...77
6.20.11
AIR program ...79
6.20.12
Setting the Work Flow AIR ...79
6.20.13
AIR/VAC OFF ...80
6.20.14
Setup ...81
6.20.15
Language ...81
6.20.16
Pilot Laser ...82
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Logfile/Save/Reset ...83
6.20.18
Overview ...84
6.20.19
Display Screen ...84
6.20.20
Timeouts ...85
6.20.21
Date & Time ...86
6.20.22
Alerts...87
6.20.23
Service ...87
7
Cleaning and Disinfecting ... 88
7.1
Disposal of consumables ... 89
8
Maintenance ... 90
8.1 8.2
Periodic Maintenance ... 90 Troubleshooting ... 91
8.2.1
Information Displayed ...91
8.2.2
Other Malfunction ...91
8.3 8.4
Safety Check (SC) ... 92 Accessories ... 94
8.4.1
List of Approved Accessories ...94
8.4.2
Hazard distances (NOHD) ...97
9
Ecological Information ... 98
9.1 9.2 9.3
Packaging ... 98 Ecological Aspects of Operation... 98 Disposal of the Unit ... 98
10
Guidelines and Manufacturer’s Declaration on Electromagnetic Compatibility (EMC) ... 99
11
Technical Data ... 103
12
Quick Instructions for Use ... 105
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Instructions for Use Surgical Laser Unit Limax® 120
1
Notices concerning this Document
1.1
Safety
Non-observance of this document can lead to serious patient injury! Improper handling and care as well as non-intended use can lead to premature wear and/or pose a risk to patients and users! It is the operator’s responsibility to ensure that all personnel handling the product have understood and do observe the notes and instructions in this document. •
Every user is required to read this document completely and follow it carefully.
•
In particular, be sure to heed all cautions, warnings and danger notices.
•
Keep this document accessible to users at all times.
•
Observe the Instructions for Use supplied with the focusing handpiece or other accessory applicators.
1.2
Terms & Acronyms
Designation
Description
AIR
Purge airflow
AIR
Medical compressed-air
CGS
Central gas supply system
CW
Continuous wave, pulse type
EMV
Electromagnetic compatibility
HT
High temperature
IP X1
Protection against dripping water falling vertically
LASER
Light Amplification by Stimulated Emission of Radiation
LED
Light-emitting diode
marTray®
Product name of a Gebrüder Martin tray
marVac®
Product name of the Gebrüder Martin external smoke evacuator
MCB
Martin Communication Bus, enables communication between the Limax® 120 and the integrated smoke evacuator (VAC)
MPR
Maximum Permissible Radiation
Nd:YAG laser
Neodymium-doped yttrium-aluminum-garnet laser
NIST
Gas type-specific screw connector acc. to the National Institute of Standards and Technology
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Instructions for Use Surgical Laser Unit Limax® 120 Designation
Description
NOHD
Nominal Ocular Hazard Distance Safety distances applying to accessories used with the Limax® 120
SC
Safety check
SMA
Sub-miniature A, connector; SMAplus socket: mechanically coded SMA socket for laser fibers with SMAplus plugs, which allow activation of the Limax® 120
VAC
Smoke evacuator integrated into the Limax® 120
1.3
Validity of this Document
These instructions for use are valid for software version V3.00, hardware release HW 04 and software release SW 02. The software currently installed in your Limax® 120 is indicated on the start-up screen, see section 6.14 “System Test”, page 64. If the software version indicated on the screen does not comply with the version number specified above, please do not hesitate to contact the Martin Service Center, see section 2.2 “Hotline”, page 11. We will be glad to send you the appropriate version of the Instruction of Use.
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Instructions for Use Surgical Laser Unit Limax® 120
1.4
Symbols Used in this Document
Words marked with ® are trademarks owned by the respective proprietors. Throughout this document, important information (such as general or safety-related notices) is marked with the following symbols and signal words:
Life hazard or serious injury! Indicates a situation which, if not avoided, could result in death or serious injury!
Danger of minor injury! Indicates a situation which, if not avoided, could result in minor or moderate injury!
Risk of material damage Indicates a situation which, if not avoided, could lead to material damage (loss of time, data loss, device/machine failure, etc.)!
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Instructions for Use Surgical Laser Unit Limax® 120
2
Product Liability and Warranty
2.1
General Information
We thank you for having decided to buy one of our products. This product bears the CEmarking, which means that it satisfies the essential requirements laid down in the EC Directive concerning medical devices. We are the manufacturer of this product: Gebrüder Martin GmbH & Co. KG A company of the KLS Martin Group KLS Martin Platz 1 · 78532 Tuttlingen · Germany Postfach 60 · 78501 Tuttlingen · Germany Tel. +49 7461 706-0 · Fax +49 7461 706-193 [email protected] · www.klsmartin.com
2.2 •
•
Hotline
Should you have any questions on how to handle the product or use it for clinical applications, please do not hesitate to contact the Product Management Tel:
+49 7461 706-243
Fax:
+49 7461 706-190
Should you have any technical questions or questions concerning maintenance contracts or training courses, please contact our Martin Service Center: Tel:
+49 7461 706-343
Fax:
+49 7461 706-408
E-mail: [email protected]
To answer your technical questions as efficiently as possible, our service technicians require the serial number of the product. Therefore, please have this number at hand when contacting our hotline. It is part of the information provided on the rating plate; see section 6.2.17 “Limax® 120 Rating Plate”, page 35.
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Instructions for Use Surgical Laser Unit Limax® 120
2.3
Scope of Delivery
•
Limax® 120 surgical laser unit with integrated smoke evacuator (VAC)
•
2 keys
•
Foot switch with SWAP® pedal
•
Mains cable with Europlug for Limax® 120
•
Mains cable for Limax® VAC
•
Equipotential bonding cable
•
MCB cable
•
Interlock plug with bypass
•
1 main filter for VAC
•
2 laser warning signs
•
Limax® 120 Instructions for Use
•
Medical device logbook
2.4
User’s Inspection
•
Immediately upon receipt, the goods must be checked for completeness and potential damage in transit.
•
Notice of any such damage must be given immediately.
2.5
Warranty
Our Standard Terms and Conditions of Sale effective at the time shall apply. Agreements diverging from these Standard Terms and Conditions do not restrict the legal rights of the buyer. Any warranty exceeding the above provisions shall require a contractual form and shall exclude component-related vandalism, software updates and consumables. Important Notices The product may only be repaired by Gebrüder Martin or a qualified person or firm expressly authorized by Gebrüder Martin to perform such work. If the repair is carried out by a person or firm specially authorized by Gebrüder Martin, the operator of the product is required to obtain from the repairer a certificate with details about the nature and scope of the repair work done. This certificate must be dated and signed and include the firm’s details. In all cases where a party other than the product manufacturer performed the work, repaired products must be additionally marked with the repairer’s ID label. Improper interventions or alterations performed by third parties during the period of limitation shall void any and all warranty claims. Performing unauthorized actions on the product is strictly prohibited at any time. Non-compliance will void any liability claim against Gebrüder Martin. 12
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Instructions for Use Surgical Laser Unit Limax® 120
3
Intended Use
3.1
Intended Purpose of the medical device
The Limax® 120 is a surgical laser device operating on the basis of a diode-pumped Nd:YAG laser. It is intended to be used for treating biological tissue in the form of •
hyperthermia
•
cutting
•
coagulating
•
vaporization
To this end, the electric energy input from the supply system is converted into infrared laser light that is subsequently used for the above-mentioned surgical applications. 3.1.1
Indications for Use of the medical device
The product is indicated in the operative treatment of diseases in lungs, airway system, liver and prostate. 3.1.2
Patient Group/Patient Selection
The intended patient group is not limited in terms of age, weight, health or condition of the patient. The treating surgeon has to decide whether a patient should be treated with the laser or not. 3.1.3
Environmental conditions
The surgical laser unit may only be operated in medically used rooms specifically marked as “laser rooms”! 3.1.4
User
The treating physician is responsible for the safe and proper use of the medical laser system. He/she must check and ensure that all safety measures are duly observed and must be familiar with laser-specific operating techniques.
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Instructions for Use Surgical Laser Unit Limax® 120
3.2
Use Restrictions
The Limax® 120 should only be used by professional, qualified and skilled medical staff that knows safety rules and risks of laser application. The Limax® 120 should only be used by staff that has been trained and instructed for it. 3.2.1
Contraindications
The Limax® 120 laser surgery unit must not be used in cases where laser-surgical procedures are contraindicated.
3.3
Warnings and Precautions
Special precautions for handling the medical laser device are described in section 5 “Safety Notices & Instructions”, page 17.
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Instructions for Use Surgical Laser Unit Limax® 120
4
Functional Principle
4.1
General Information on Laser Theory
LASER is an acronym meaning “Light Amplification by Stimulated Emission of Radiation”. The laser (light source) consists of an active medium and an excitation source. This excitation source “pumps” the electrons of the active medium from their normal state into a stimulated energy state (high energy level). The medium then starts to return to its normal state (transition to lower energy levels). In this process, photons are emitted. The laser light is then reflected multiply in an optical resonator (laser cavity) consisting of a highly reflecting mirror and a partially transparent one. At the same time, it is amplified by stimulated emission while traveling back and forth between the mirrors. Through the semitransparent mirror, part of the laser light is coupled out and subsequently used for medical purposes. Main characteristics of laser light: •
Beam quality – high focusability thanks to low transversal mode number.
•
Monochromaticity – light of a very narrow wavelength range, equivalent to a single color in the spectrum of electromagnetic radiation.
•
Coherence – all photons emitted are in phase (in terms of both space and time).
4.2
The Nd:YAG Laser
The Nd:YAG laser is a solid-state laser which emits high-intensity laser light at a wavelength of 1,320 nm (belonging to the near infrared range of the spectrum). The medium used is a cylindrical YAG (yttrium-aluminum-garnet) crystal doped (mixed) with Nd3+ ions (neodymium ions). The intensive light of laser diodes is used as an excitation/stimulation mechanism. The wavelength of the light produced by the laser diodes matches perfectly with an excitation line of the absorption spectrum of the Nd3+ ions of the YAG host crystal. Adjusting the output power of the laser diodes allows for direct control of the output power of the Nd:YAG laser.
4.3
Fields of Application
The therapeutic effect produced by the continuous-wave Nd:YAG laser light is based on the conversion of light energy into heat, a process that triggers both reversible and irreversible tissue reactions (hyperthermia, coagulation, vaporization). The specific therapeutic effect of this type of laser light mainly depends on the following 4 factors: •
wavelength of the light
•
power density (irradiation intensity)
•
irradiation time (treatment/exposure time)
•
tissue characteristics
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Instructions for Use Surgical Laser Unit Limax® 120 The irradiation intensity achieved on the surface of the tissue depends on •
the effective distal laser output power (tissue side),
•
the diameter of the beam hitting the tissue (beam spot size), which in turn is a function of the distance between the fiber tip and the tissue.
The irradiation intensity can be significantly increased in the focal area by additional beam focusing, for example by using a focusing handpiece. The tissue characteristics that are of primary importance with respect to medical laser therapy include: •
tissue absorptivity
•
heat conductivity and thermal capacity (particularly, water content and perfusion rate)
It is noteworthy in this connection that these characteristics/parameters may change during irradiation. For example, the absorptivity of the tissue increases as a result of superficial carbonization, which in turn enhances the cutting or ablating effect of the laser beam. This effect is utilized, for example, in connection with the bare fiber technique. Here, the fiber tip is brought in direct contact with the tissue. Given sufficiently high power densities, this leads to initial discoloration of the skin in the contact area, followed by a tissue cutting effect.
4.4
Frequently Used Functions
Section 6.20 “Working with Programs”, page 68, provides applications which explain frequently used functions of the laser on the basis of stored programs.
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Instructions for Use Surgical Laser Unit Limax® 120
5
Safety Notices & Instructions
5.1
General Regulations
The following standards, laws, directives and regulations were observed in the design and manufacture of this product: Standard
Title
MPG (MDA)
Medical Devices Act
93/42/EEC (MDD)
EU Directive 93/42/EEC concerning medical devices
IEC 60825-1:1993 + A1:1997 + A2:2001
Safety of laser products – Part 1: Equipment classification and requirements
DIN EN 60825-1:1994 + A1:2002 + A2:2001 IEC 60601-1:2005 + corr.1 (2006) + corr.2 (2007) IEC 60601-1:1988 + A1:1991 + A2:1995 UL 60601-1:1988 + A1:1991 + A2:1995 ANSI AAMI ES 60601-1:2005 CAN/CSA-C22.2 No. 601.1-M90 (Update No. 2, 11/2003)
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
DIN EN 60601-1:2007-07
IEC 60601-1-2:2007
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
IEC 60601-2-22:1995
Medical electrical equipment – Part 2-22: Particular requirements for the safety of diagnostic and therapeutic laser equipment
IEC 60601-1-4:1996 + A1:1999
Medical electrical equipment – Part 1-4: General requirements for safety; Collateral standard: Programmable electrical medical systems
IEC 60601-1-6:2010
Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
IEC 62304:2006
Medical device software – Software life-cycle processes
IEC 62353:2015-10
Medical electrical equipment – Recurrent test and test after repair of medical electrical equipment
ISO 15223-1:2012-10
Medical devices – Symbols to be used with medical device labels, labeling and information to be supplied – Part 1: General requirements
Observe national safety regulations! MPG (Medical Devices Act) specifically refers to regulations in force in Germany. Be sure to observe your relevant national/local regulations (laws, directives, rules, etc.) as well!
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Instructions for Use Surgical Laser Unit Limax® 120
5.2
Laser Safety
The Limax® 120 •
is a Class IIb unit acc. to the Medical Devices Act (or MDD, respectively),
•
is a Class 4 laser unit (acc. to IEC 60825-1),
•
bears the CE-mark in compliance with EU Directive 93/42/EEC (MDD).
Danger of damage to eyes, skin and other organs! The unit emits radiation in the non-visible spectral range of 1,320 nm. Be aware that such radiation can cause irreversible damage to the eyes, skin and other organs! With Class 4 laser units, both the direct laser beam and the laser light reflected diffusely from surfaces can be dangerous! Wear protective goggles!
Protective goggles required (rating): D 1320 nm L6/LB6
The “laser area” is defined as the area in which the maximum permissible exposure (MPE) values that are normally binding may be exceeded, taking any accidental deflection of the laser beam into consideration as well. Therefore, the following safety measures must be strictly observed: •
All doors providing access to the laser area must be marked by warning lamps.
•
At least once a year, the persons working in the laser area must be informed on relevant safety requirements and measures to be taken, and must be instructed in the correct use of the device. Such instruction must be recorded in writing, together with a list of all participants.
•
All persons present in the laser area, without exception, must wear protective goggles when the laser is switched from STANDBY to LASER READY: Acc. to EN 207, the goggles required for protection against laser radiation must be rated “D 1320 nm L6/LB6” or higher.
•
The patient’s eyes need to be protected as well.
•
It is the responsibility of the operator of the unit to provide suitable protective equipment.
•
Never stare directly into the red pilot laser light! Be aware that the afore-mentioned protective goggles do not protect against the red pilot laser radiation see section 5.7 “Safety Instructions Relating to the Pilot Laser” page 20.
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Instructions for Use Surgical Laser Unit Limax® 120
5.3
Explosion and Fire Hazards
Fire hazard! Class 4 lasers (IEC 60825-1) represent a potential ignition source due to heat building up in the tissue or at the fiber ends. When working with the Limax® 120, the user therefore is required to observe the following measures in order to prevent laser-induced fires and explosions: •
Never use the unit in the vicinity of flammable narcotics or highly volatile mixtures such as alcohol or petroleum spirit (white gas).
•
There is a fire or explosion hazard if the laser light is used in the presence of flammable materials, solutions or gases or in an oxygen-enriched atmosphere.
•
The surgical site must be arranged so that neither the patient nor the surgical staff could be endangered even in the event of an accidental release of the laser beam, and that ignition of easily flammable materials is prevented at the same time! Consequently, no oxygen may be used for purging during endoscopic interventions.
•
When using laser light in the area of organs, body cavities and tubi that could contain flammable gases or vapors, protective measures must be taken to prevent fire and explosion hazards.
•
If surgical interventions pose a danger of using the laser in the region of the tracheal tube, which could lead to laser-induced tube ignition, it is mandatory to use metal or laser-safe tubes. This also applies, in particular, when using oxidizing gases such as oxygen and nitrous oxide.
5.4
Protecting the Patient
Under any circumstances, the patient must be protected against injuries that could be caused by improper use of the laser. This means in particular: •
protecting his/her eyes with suitable anti laser goggles or by using a light-/radiation-proof cover
•
protecting those organs and tissues of the surgical site which must not be exposed to laser radiation, covering them with diffuse-reflection or light-absorbing materials such as moist towels or compresses
•
preventing laser-induced fires, especially in endolaryngeal interventions
•
preventing ignition of endogenous gases and of tissue when using artificial respiration techniques involving oxidizing gases.
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Instructions for Use Surgical Laser Unit Limax® 120
5.5
Treatment Room Requirements
•
The access doors of all rooms in which the Limax® 120 is used must be marked with a laser radiation warning sign (supplied with the product).
•
A warning lamp must be installed at all doors leading to the laser area. When these lamps are on, the laser area may only be entered by authorized persons wearing the prescribed protective goggles.
•
All doors leading to the laser area must be kept shut during use of the laser system.
•
Surfaces capable of reflecting laser radiation should not be used in the laser area or must be adequately covered.
5.6
Safety Requirements for the Laser Unit
•
All instruments used must have such a form and surface finish that dangerous reflections of the laser light are largely prevented.
•
Optical equipment used for surgical site observation must have been specially designed for use with laser systems and may only be used in conjunction with suitable auxiliary filters meeting the requirements applying to laser protective goggles.
•
If the laser is found to be malfunctioning, it must be withdrawn from service at once! The problem(s) must be entered in the medical device logbook and reported to the Laser Safety Officer. Make sure to contact either Martin Service Center or an authorized service technician as soon as possible.
5.7
Safety Instructions Relating to the Pilot Laser
Risk of irritation by pilot laser light! The direct or reflected pilot laser light can have a glaring effect that may temporarily affect the working ability of users. The protective goggles provide protection only against the working laser light, not however against the pilot laser light. Never stare directly into the pilot laser light!
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