Instructions for Use
90 Pages
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Page 1
Surgical Laser Unit
Instructions for Use
V. 1.0-EN (03.13)
Valid from software version and hardware release 0000
Symbol explanation Safety alert symbol CAUTION WARNING DANGER
Indicates a situation which, if not avoided, could result in minor or moderate injury. Indicates a situation which, if not avoided, could result in death or serious injury. Indicates a situation which, if not avoided, will result in death or serious injury.
Instructions for Use
Observe instructions for use
Item number (Item no.) Serial number Lot designation Not to be reused!
Sterilization by ethylene oxide Sterilization by irradiation Store in a place protected from direct sunlight
Store in a place protected from frost
Store in a dry place
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Information on minimumand maximum temperature for storage and transportation LIMAX® 60: 39 °F to 122 °F (+4 °C – +50 °C) Information on minimum and maximum atmospheric pressure for storage and transportation Limax® 60: 700 hPa – 1,060 hPa Information on minimum and maximum atmospheric humidity for storage and transportation Limax® 60: 10% – 90%, non-condensing Fragile, avoid pressure and shock
Arrows pointing up, transport and store upright
Manufacturing date Manufacturer Do not use if packaging is damaged
Use before
Not to be resterilized!
Latex-free
CE mark of conformity
This product may not be disposed of as normal household garbage
NON WOOD
V. 1.0
The packaging of the Limax® 60 is “non-wood”, i.e. wood packaging material that is not subject to ISPM 15, and is therefore suitable for international shipment.
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Instructions for Use Surgical Laser Unit Limax® 60
Contents 1
Product Liability and Warranty ... 8
1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9
General Information ... 8 Scope of Delivery ... 8 Intended Use ... 9 Frequently Used Functions ... 9 Contraindications ... 9 Warranty ... 10 User’s Inspection ... 10 Hotline... 11 Safety Check ... 11
2
Notices concerning this Document ... 12
2.1 2.2
Validity of this Document ... 12 Symbols Used in this Document ... 13
3
Safety Notices & Instructions ... 14
3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 3.10 3.11 3.12 3.13 3.14 3.15 3.16 3.17 3.18
General Regulations ... 14 Installation and Initial Start-Up ... 15 Laser Safety ... 16 Explosion and Fire Hazards... 17 Protecting the Patient ... 18 Treatment Room Requirements... 18 Safety Requirements for the Laser Unit ... 18 Safety Instructions Relating to the Pilot Laser ... 19 Laser Safety Officer ... 19 Users... 19 Electrical Safety ... 20 Grounding the Unit ... 20 Fuses ... 20 Safety Devices ... 21 Employment Restriction ... 21 Warning & Information Labels... 22 Laser Smoke ... 24 Proper Handling of Laser Fibers... 24
4
Description of the Unit ... 25
4.1 4.2 4.3
General Information on Laser Theory... 25 The Nd:YAG Laser ... 25 Fields of Application ... 26
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Instructions for Use Surgical Laser Unit Limax® 60
5
Putting the Limax® 60 into Operation ... 27
5.1 5.2 5.3 5.4 5.5
General Information ... 27 Setting up the Limax® 60 ... 27 Relocating the Unit ... 28 Front Side ... 29 Rear Panel ... 30
5.5.1
Loudspeaker ...31
5.5.2
Laser MCB Interface ...31
5.5.3
Service Interface ...31
5.5.4
Service Connector ...31
5.5.5
Accessory Port ...31
5.5.6
Interlock / Warning Connector ...32
5.5.7
Foot Switch Connector ...33
5.5.8
Mains Laser Connector Socket ...33
5.5.9
Connecting U-Version Lasers to the Power Supply ...34
5.5.10
Line Fuses for the Optical System ...35
5.5.11
Equipotential Bonding Pin ...35
5.5.12
NIST Socket (AIR) ...35
5.5.13
Laser Rating Plate ...36
5.6
Measures to Be Taken Prior to Using the Laser System ... 37
6
Operating the Limax® 60 ... 38
6.1
Controls, Indicators and Display Elements ... 38
6.1.1
Keylock Switch ...39
6.1.2
Emergency Stop Switch ...39
6.1.3
STOP Indicator ...40
6.1.4
“LASER ACTIVE” Indicator ...40
6.1.5
SMAplus Fiber Connecting Socket ...41
6.1.6
Luer-Lock Socket for AIR (Purge Air) ...41
6.1.7
Keypad ...42
6.1.8
Rotary Switch with Backlighting ...43
6.1.9
Display ...44
6.1.10
Laser Status Indicator ...45
6.2 6.3 6.4 6.5 6.6
Applied Parts ... 45 Connecting the Laser Fiber ... 46 Checking the Laser Fiber with the Pilot Laser ... 47 Replacing the Laser Fiber ... 48 AIR (Purge Air) ... 49
6.6.1
Connecting the Compressed-Air Hose ...50
6.7
Connecting the Focusing Handpiece / Applicator ... 51
6.7.1
Connecting the Sterile Air Filter ...51
6.7.2
Connecting the Focusing Handpiece ...52
6.7.3
Connecting Applicators ...53
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Instructions for Use Surgical Laser Unit Limax® 60
6.8 6.9 6.10 6.11 6.12 6.13 6.14 6.15
Switching on the Laser Unit ... 54 System Test ... 54 Foot Switch ... 55 Using the Laser ... 56 Connecting the Laser Fiber ... 56 Turning off the Limax® 60 ... 57 Emergency Shutdown ... 57 Working with Programs ... 58
6.15.1
Standard Program ...58
6.15.2
Selecting Programs ...59
6.15.3
Adjusting Programs ...61
6.15.4
Saving Modified Programs ...62
6.15.5
Overwriting Programs ...64
6.15.6
Deleting Programs ...64
6.15.7
AIR (Purge Air) ...65
6.15.8
AIR OFF ...66
6.16
Setup ... 67
6.16.1
Language ...67
6.16.2
Pilot Laser ...68
6.16.3
Logfile / Save / Reset ...69
6.16.4
Overview ...70
6.16.5
Display Screen ...70
6.16.6
Timeouts ...71
6.16.7
Date & Time ...72
6.16.8
Alerts...73
6.16.9
Service ...73
7
Quick Instructions for Use Instructions for Use ... 74
8
Maintenance and Cleaning ... 76
8.1
Cleaning and Disinfecting ... 77
9
Technical Description ... 78
9.1 9.2
Technical Data ... 78 Accessories ... 80
9.2.1
List of Approved Accessories ...80
9.2.2
Hazard distances (NOHD) ...81
10
Safety Check (SC) ... 82
11
Troubleshooting ... 84
11.1 11.2
Information Displayed ... 84 Other Malfunction ... 84
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12
Guidelines and Manufacturer’s Declaration on Electromagnetic Compatibility (EMC) ... 85
13
Ecological Information ... 89
13.1 13.2 13.3
Packaging ... 89 Ecological Aspects of Operation ... 89 Disposal of the Unit ... 89
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Instructions for Use Surgical Laser Unit Limax® 60
1
Product Liability and Warranty
1.1
General Information
We thank you for having decided to buy a KLS Martin product. This product carries the CE mark, 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 · D-78532 Tuttlingen · Germany Postfach 60 · D-78501 Tuttlingen · Germany Tel. +49 7461 706-0 · Fax +49 7461 706-193 [email protected] · www.klsmartin.com
1.2
Scope of Delivery
Limax® 60 surgical laser unit
Two keys
Foot switch
Mains cable
Equipotential bonding cable
MCB cable
Interlock plug
Smoke filter
Five sterile AIR filters
Air tube, sterile
Two laser warning signs
Limax® 60 Instructions for Use (user manual)
Medical device logbook
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Instructions for Use Surgical Laser Unit Limax® 60
1.3
Intended Use
The Limax® 60 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. The safe surgical use of laser light requires users to be fully familiar with the respective techniques and forms of applications. The surgical laser may only be operated in medically used rooms specifically marked as “laser rooms”! The operator may operate the device only if an on-site functional test has previously been performed by Gebrüder Martin or a person authorized by Gebrüder Martin. In addition, a responsible person designated by the operator must have been instructed in the proper handling, application and operation of the unit, as well as in its permissible combination with other medical devices, objects and accessories. This duly instructed officer shall subsequently be responsible for familiarizing the operator’s staff with the unit as the need arises. We recommend documenting all user instructions in a medical device logbook. A copy of the logbook is available from Gebrüder Martin.
1.4
Frequently Used Functions
Section 6.15 “Working with Programs”, page 58, provides applications which explain frequently used functions of the laser on the basis of stored programs.
1.5
Contraindications
No contraindications limiting the use of the Limax® 60 are currently known.
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Instructions for Use Surgical Laser Unit Limax® 60
1.6
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. Unauthorized actions performed on the product shall invalidate any liability claims vis-à-vis Gebrüder Martin.
1.7
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.
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Instructions for Use Surgical Laser Unit Limax® 60
1.8
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, please do not hesitate to turn to our Martin Service Center Tel:
+49 7461 706-343
Fax:
+49 7461 706-408
E-mail:
Should you have any questions concerning maintenance contracts or training courses, please contact our Technical Service Manager: Tel:
+49 7461 706-332
E-mail:
NOTICE 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 5.5.13 “Laser Rating Plate”, page 36.
1.9
Safety Check
The operational safety of the unit must be verified at regular intervals, see section 8 “Maintenance and Cleaning”, page 76 and section 10 “Safety Check (SC)”, page 82. If the device is not functionally reliable and / or safe to operate, it must be marked as such and withdrawn from service.
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Instructions for Use Surgical Laser Unit Limax® 60
2
Notices concerning this Document
Non-observance of this document can lead to serious or even lethal patient injury! Be sure to read, understand and follow the instructions given below!
Every user is required to read this document completely and follow them 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.
2.1
Validity of this Document
This document is valid from hardware / software version 0000. The software currently installed in your Limax® 60 is indicated on the start-up screen (see section 6.9 “System Test”, page 54). 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. We will be glad to send you the appropriate version of the user manual.
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Instructions for Use Surgical Laser Unit Limax® 60
2.2
Symbols Used in this Document
Throughout this document, important information (such as general or safety-related notices) is marked with the following symbols and signal words:
WARNING Danger of death or serious injury! Indicates a situation which, if not avoided, could result in death or serious injury!
CAUTION Danger of minor injury! Indicates a situation which, if not avoided, could result in minor or moderate injury!
NOTICE 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® 60
3
Safety Notices & Instructions
3.1
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 DIN EN 60825-1:1994 + A1:2002 + A2:2001
Safety of laser products – Part 1: Equipment classification and requirements
EN 60601-1:1990 + A1:1993 + A2:1995 IEC 601-1:1988 + A1:1991 + A2:1995
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
EN 60601-1-1:2001 IEC 60601-1-1:2000
Medical electrical equipment – Part 1-1: General requirements for safety
EN 60601-2-2:2007 IEC 60601-2-2:2006
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility – Requirements and tests
EN 60601-2-22:1996 IEC 601-2-22:1995
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
EN 60601-1-6:2010 IEC 60601-1-6:2010
Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
EN 62304:2006 IEC 62304:2006
Medical device software – Software life-cycle processes
EN 62353:2008 IEC 62353:2007
Medical electrical equipment – Recurrent test and test after repair of medical electrical equipment
EN ISO 15223-1:2012 ISO 15223-1:2012
Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements
BGI 832
Operation of laser devices – (Application of the accident prevention regulation concerning laser radiation (BGV B2))
NOTICE Observe national safety regulations! MPG (Medical Devices Act) and BGV (accident prevention rules) specifically refer 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® 60
3.2
Installation and Initial Start-Up
The installation and first start-up of the device may only be performed by Gebrüder Martin or an authorized service partner. For further information, please refer to section 5.2 “Setting up the Limax® 60”, page 27.
CAUTION Danger of injury! Any person involved in any way in the handling of this device must be fully familiar with the contents of these Instructions for Use. Improper handling (non-compliance) can lead to bodily harm or equipment damage! Prior to putting the device into service, the operator must ensure the following:
Acceptance of the unit by the purchasing department.
Formal appointment of a Laser Safety Officer by the operator of the unit (acc. to section 6, BGV B2 (Germany), or equivalent national regulations concerning the prevention of accidents).
Appointment of a person specifically responsible for the unit; familiarization of that person and the staff with the unit.
Setting up the medical device logbook supplied with the product.
Registration of the unit with the respective employers' liability insurance association and the official body responsible for labor safety matters (as applicable).
Handing over of the unit in a ready-for-use condition with appropriate user instruction, either by Gebrüder Martin or an authorized representative.
Observance of all safety instructions.
Observance of the notices on electromagnetic compatibility provided in section 12 “Guidelines and Manufacturer’s Declaration on Electromagnetic Compatibility (EMC)”, page 85.
Making sure that all operational procedures, including measures to be taken in case of trouble / failure, are fully understood. Please note that when using the unit in medical practice, all relevant regulations for the prevention of accidents must be strictly observed! Such medical use includes all diagnostic, surgical or therapeutic applications involving laser light (in the widest sense). The operator of the unit and the Safety Officers (specifically, the Laser Safety Officer) are responsible for the proper performance of all required safety measures, thus ensuring that neither the patient, nor the treating physician, nor any other person present can be endangered during laser operation.
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Instructions for Use Surgical Laser Unit Limax® 60 Moreover, the following supplementary provisions must be observed:
The Limax® 60 laser may be operated only by qualified and duly authorized personnel. These users must be fully familiar with the laser system and have a complete understanding of all safety measures required. The names of these authorized persons must be recorded in the medical device logbook.
Operating staff training must be repeated on an annual basis (refresher courses); all participants in such training must confirm their participation in writing.
When the unit is not in use, it must be protected against unauthorized access (e.g. by locking it and keeping the key in a safe place).
The unit must be operated and serviced in accordance with these Instructions for Use; this includes periodic safety checks as specified.
The operator of the unit is required to keep the following documents accessible at all times and ensure they are up-to-date:
medical device logbook or equipment ID card,
Instructions for Use for the laser and user instructions for accessories used,
In case of accidents or damage involving personal injuries, such incidents must be reported to the appropriate body immediately.
3.3
Laser Safety
The Limax® 60 laser
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).
CAUTION 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 1,320 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.
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Instructions for Use Surgical Laser Unit Limax® 60 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 1,320 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.
3.4
Explosion and Fire Hazards
WARNING 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® 60, 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.
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Instructions for Use Surgical Laser Unit Limax® 60
3.5
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 antilaser 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 intestinal gases, and of tissue when using artificial respiration techniques involving oxidizing gases.
3.6
Treatment Room Requirements
The access doors of all rooms in which the Limax® 60 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.
3.7
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.
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3.8
Safety Instructions Relating to the Pilot Laser
CAUTION 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!
3.9
Laser Safety Officer
According to the relevant (German) regulations for the prevention of accidents (relating to laser radiation – BGV B2), the operator of the system is required to formally appoint a Laser Safety Officer, whose responsibilities include the following:
carry out all safety measures required;
provide instruction, to all persons involved, on required safety measures and the proper use and operation of the unit;
mark the laser area;
check the alarm signals for proper functioning;
ensure the availability of laser protective goggle;
keep the key to the laser system in a safe plac;
ensure the proper connection of the laser after relocatio;
proper maintenance of the medical device logbook.
3.10
Users
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® 60
3.11
Electrical Safety
The unit is a Class 1 system (acc. to IEC 60601) and therefore must be connected to a duly grounded power supply system in accordance with the specifications contained herein (see section 9.1 “Technical Data,” page 78.
Prior to connecting the unit to the power supply, verify that the mains voltage is the correct one for the laser.
When connecting the 200 – 240 V mains cable, be sure to follow the instructions provided in section 5.5.9 “Connecting U-Version Lasers to the Power Supply”, page 34.
Only the mains cables provided may be used.
The mains cables and their connectors must be in perfect working order and may never be used if in any way defective.
Never turn on the laser system if any part of its housing is not fixed in place as intended. Be aware that laser radiation can be emitted from an open laser unit in an uncontrolled manner! Moreover, there is a risk of exposure to dangerously high electric voltages or currents.
3.12
Grounding the Unit
The unit is grounded via the ground conductor integrated in the mains cable. This is an important prerequisite for the safe operation of the unit. If the mains cable is correctly connected in accordance with relevant electrotechnical regulations, proper grounding is automatically ensured. The yellow-and-green equipotential bonding cable is intended for use in cases where potential equalization is required for laser operation (e.g. when using the Limax ® 60 for intracardiac interventions).
3.13
Fuses
Defective fuses may be replaced only by authorized service personnel. The fuses are installed on the rear panel of the unit. They include two line fuses located in the mains connector socket assembly plus two overcurrent fuses (see section 5.5 “Rear Panel”, page 30).
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