Instructions for Use
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Page 1
Laser Surgical Unit diomax® 1550 English
Instructions for Use
90-458-52-20 Revision 2 Date of Release: 2014-03
Valid from software version V1.00, hardware release HW 02 and software version SW 01
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. Observe instructions for use
Follow instructions for use
Item number (Item no.) Serial number Store in a place protected from direct sunlight
Store in a dry place
Information on minimum and maximum temperature for storage and transportation. See section 11 “Technical Data”, page 66 for valid values.
Information on minimum and maximum atmospheric pressure for storage and transportation. See section 11 “Technical Data”, page 66 for valid values. Information on minimum and maximum atmospheric humidity for storage and transportation. See section 11 “Technical Data”, page 66 for valid values. Fragile, avoid pressure and shock
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Arrows pointing up, transport and store upright
Manufacturing date Manufacturer Do not use if packaging is damaged
CE mark of conformity This product may not be disposed of as normal household garbage
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Instructions for Use Laser Surgical Unit diomax® 1550
Contents 1
Product Liability and Warranty ... 7
1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8
General Information ... 7 Scope of Delivery ... 7 Intended Use ... 8 Frequently Used Functions ... 9 Contraindications ... 9 Warranty ... 9 User’s Inspection ... 9 Hotline... 10
2
Notices Concerning this Document... 11
2.1 2.2
Validity of this Document ... 11 Symbols Used in this Document ... 12
3
Safety Notes ... 13
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 Specifications ... 13 Installation and Initial Commissioning ... 14 Laser Safety ... 16 Danger of Explosion and Fire ... 17 Protection of the Patient ... 17 Requirements for Treatment Rooms ... 18 Safety Requirements for the Laser Device ... 18 Safety Notes for the Pilot Laser ... 18 Laser Safety Officer ... 19 User ... 19 Electrical Safety ... 19 Earthing of the Device ... 19 Fuses ... 20 Safety Systems of the Device ... 20 Usage Restrictions... 20 Warning and Information Labels ... 21 Fumes ... 22 Using Laser Fibers ... 22
4
Commissioning ... 23
4.1 4.2 4.3
Function ... 23 Installation ... 23 Front of Device ... 24
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Instructions for Use Laser Surgical Unit diomax® 1550
4.4
Rear of Device ... 24
4.4.1
Type Plate ...25
4.4.2
Mains Connection ...25
4.4.3
Equipotential Grounding Pin ...25
4.4.4
Foot Switch Connection ...25
4.4.5
Connection Interlock/Warning ...26
4.4.6
Accessory Port ...28
4.4.7
Service Interfaces ...28
4.4.8
Option CAN...28
4.4.9
Speakers ...28
4.5
Preparing the Laser System... 29
5
Operating the Device ... 30
5.1
Control and Display Elements ... 30
5.1.1
Key Switch ...31
5.1.2
EMERGENCY STOP ...31
5.1.3
SMA-X Fiber Connection Socket ...31
5.1.4
Laser Signal Light ...32
5.1.5
Key Field ...33
5.1.6
Display ...34
5.1.7
Rotary Knob with Ring Light ...35
5.1.8
Laser Status Display ...36
5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 5.10 5.11 5.12
Connecting Laser Fibers ... 37 Checking the Laser Fiber Using the Pilot Laser ... 38 Replacing the Laser Fiber ... 39 Connecting Focusing Handpiece/Applicators ... 39 Switching on the Device ... 39 System Check ... 40 Foot Switch ... 40 Applying the Laser ... 41 Switching off the Device ... 42 Emergency Stop ... 42 Working with Programs ... 43
5.12.1
Standard Program ...43
5.12.2
Selecting a Program ...44
5.12.3
Program change ...46
5.12.4
Laser output ...46
5.12.5
Operating modes ...46
5.12.6
Times ...50
5.12.7
Saving the Modified Program ...50
5.12.8
Deleting Programs ...52
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Instructions for Use Laser Surgical Unit diomax® 1550
5.13
Log ... 53
5.13.1
Edit log entries...53
5.13.2
View logfile ...55
5.14 5.15
Pilot Laser ... 56 Setup ... 56
6
Abridged Instructions for Use ... 60
7
Maintenance ... 61
7.1
Periodic Maintenance ... 61
7.1.1
Maintenance Schedule ...61
8
Cleaning and Disinfecting ... 62
9
Troubleshooting ... 63
9.1 9.2
Information Displayed ... 63 Other Malfunctions ... 63
10
Accessories... 64
10.1
Safety Distances (NOHD) ... 65
11
Technical Data ... 66
12
Safety Check (SC) ... 68
13
Guidelines and Manufacturer’s Declaration Regarding Electromagnetic Compatibility (EMC) ... 70
14
Ecological Information ... 74
14.1 14.2 14.3
Disposal of Packing ... 74 Environment-friendly Device Operations ... 74 Disposal of the Unit ... 74
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Instructions for Use Laser Surgical Unit diomax® 1550
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
•
Laser surgical unit diomax® 1550
•
Power supply cable
•
2 keys
•
Equipotential bonding cable
•
2 laser warning signs
•
diomax® 1550 Instructions for Use
•
Interlock connector with bypass
•
Footswitch
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Instructions for Use Laser Surgical Unit diomax® 1550
1.3
Intended Use
The diomax® 1550 is a laser surgical device operating on a diode laser. It is intended for treating biological tissue by way of: •
hyperthermia
•
cutting
•
coagulation
•
vaporization
To this end, the electric energy provided by the power supply network is converted into infrared laser light enabling the surgical applications specified above. Safe laser surgery presupposes that the user is fully familiar with the surgical technique and its various forms of application. Prior to using the laser unit, be sure to read and understand the information contained herein! This document describes how to handle the unit properly. Please note that improper use of the laser or its accessories releases the manufacturer from any liability for damage, irrespective of whether such damage is caused within or after the period of warranty! The laser surgery device may be used only in rooms intended for medical purposes that are 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. The operating safety of the device must be checked in regular intervals, see section 7 “Maintenance”, page 61 and section 12 “Safety Check (SC)”, page 68. If the device is not functionally reliable and/or safe to operate, it must be marked as such and withdrawn from service. A technical check is mandatory in any such case.
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Instructions for Use Laser Surgical Unit diomax® 1550
1.4
Frequently Used Functions
Section 5 “Operating the Device”, page 30 describes applications that explain frequently used functions of the laser in form of saved programs.
1.5
Contraindications
There are currently no known contraindications for the application.
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 show the date of the repair and the details of the person or firm carrying out the work and must be signed. 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 against 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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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 4.4.1 “Type Plate”, page 25.
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2
Notices Concerning this Document
Non-observance of this document can lead to serious or even lethal 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! 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 software version V1.00, hardware release HW 02 and software version SW 01. If older hardware and software versions are used, it may be that newer functions described in this document are not available. On the startup screen, the diomax® 1550 software indicates which version of this document matches the software version currently implemented, see section 5.7 “System Check”, page 40. This ensures that it is always clear which software versions are covered by this document. If the software version of the unit does not match the version in the Instructions of Use, the appropriate documentation can be obtained from the Martin Service Center.
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Instructions for Use Laser Surgical Unit diomax® 1550
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 Laser Surgical Unit diomax® 1550
3
Safety Notes
3.1
General Specifications
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 60825-1:2003-10
Safety of laser products – Part 1: Equipment classification and requirements
IEC 60601-1:1996-03
Medical electrical equipment – General requirements
IEC 60601-1-1:2002-08
Medical electrical equipment – General requirements for safety
IEC 60601-1-2:2007-12
Medical electrical equipment – Electromagnetic compatibility – Requirements and tests
IEC 60601-2-22:1996-12
Medical electrical equipment – Particular requirements for the safety of diagnostic and therapeutic laser equipment
IEC 60601-1-4:2001-04
4. Collateral standard: Programmable electrical medical systems
IEC 60601-1-6:2010-10
Usability
IEC 62304:2007-03
Medical device software – Software life-cycle processes
IEC 62353:2008-08
Medical electrical equipment – Recurrent test and test after repair of medical electrical equipment
IEC 15223-1:2012-10
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 Comply with national safety regulations! MPG and BGV are applicable law in Germany. Compliance with all national laws, regulations and rules is likewise required!
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Instructions for Use Laser Surgical Unit diomax® 1550
3.2
Installation and Initial Commissioning
Installation and initial commissioning may be performed only by Gebrüder Martin or authorized service partners.
CAUTION Danger of physical injury! Any person that handles the device in any way must have fully read and understood the contents of this document. Improper handling that does not comply with these instructions can lead to injury or to damage to the device. Before commissioning, the operator must ensure that the following points are complied with: •
Acceptance by a medical technician of the customer.
•
Written appointment of a laser safety officer by the operator (see § 6 BGV B2).
•
Training of a person responsible for the device and the personnel.
•
Medical product log created.
•
Registration of the device with the trade association and with the authority responsible for occupational safety.
•
Handover of the fully operational device and training of the personnel by Gebrüder Martin or an authorized representative.
•
Compliance with all safety notes.
•
Observance of all notes regarding electromagnetic compatibility. See also section 13 “Guidelines and Manufacturer’s Declaration Regarding Electromagnetic Compatibility (EMC)”, page 70.
•
Knowledge of the operational procedures and measures in case of faults and malfunctions. The accident prevention directive (BGV B2) for the protection of medical personnel must be complied with during the medical application of the device. Medical applications include diagnostic, surgical or therapeutic applications with laser light in the broadest sense. The operator and the security officers (e. g. laser safety officer) are responsible for the implementation of all safety measures to protect the patient, the attending physician and other persons present during laser operation.
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Instructions for Use Laser Surgical Unit diomax® 1550 Furthermore, the following additional requirements must be observed: •
The device may be commissioned by authorized users only. The users must be familiar with the laser device and know the applicable safety precautions. The persons authorized to use the device must be listed in the medical product log.
•
The training of the personnel is to be repeated annually and must be documented by the users in written form.
•
When the device is not in use, it must be protected against unauthorized use. -
•
Remove key and store it in a safe location.
Operation, maintenance and regular safety-related checks must be performed as described in this document.
The operator must ensure that the following documents are always accessible and updated regularly: •
Medical product log or device card, respectively.
•
Instructions of use for device and accessory equipment.
Accident and damage reports for cases of personal injury must be submitted to the relevant authorities immediately.
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Instructions for Use Laser Surgical Unit diomax® 1550
3.3
Laser Safety
The laser surgery unit diomax® 1550 •
is a class IIb device acc. to MPG (Medical Devices Act),
•
is a class 4 laser device (acc. to IEC 60825-1),
•
has the CE label acc. to directive 93/42/EEC.
WARNING Danger of injury to eyes, skin and other organs! The device emits light in the invisible spectral range of 1,550 nm, which can cause irreversible damage to eyes, skin and other organs! Both the direct laser beam of a class 4 laser device itself and the laser light that is reflected diffusely from surfaces can be harmful! Wear protective goggles!
Required safety goggles: D 1550 nm L4/LB3
The laser range is the range in which the values for the permitted maximum radiation can be exceeded. However, be aware that the laser beam may be deflected unintentionally. Therefore, the following safety precautions must be strictly complied with: •
All accesses to the laser areas must be marked with warning lamps.
•
Persons working in the laser area must be informed about safety regulations and precautions and instructed in the operation of the device at least once per year. This training must be documented in written form including a list of all participants.
•
All persons present in the laser area during laser operation must – without exception – wear protective goggles when the mode is switched from “STANDBY” to “LASER READY”: Laser protection goggles according to EN 207 for diode laser radiation with a protection class of D 1550 nm L4/LB3 or higher.
•
The patient's eyes must be protected.
•
The operator is responsible for provision of appropriate protective equipment.
•
Do not directly look into the red pilot laser light! The protective goggles mentioned above do not protect from the red pilot laser light.
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3.4
Danger of Explosion and Fire
WARNING Fire hazard! Class 4 lasers (IEC 60825-1) can cause fires due to heating of tissue or laser fiber ends acting as sources of ignition. Therefore, comply with the following requirements to prevent laserinduced fires and explosions when using the diomax® 1550: •
The device must not be activated near flammable anesthetics or highly volatile mixtures such as alcohol or gasoline.
•
There is risk of fire or explosion if the laser light is used in the presence of flammable materials, solutions or gases or in an oxygen-enriched environment.
•
The operation area is to be prepared in such a way that even if the laser beam is activated unintentionally the patient or personnel cannot be endangered, and highly flammable materials cannot ignite. Therefore, oxygen must not be used as flushing medium in endoscopic applications.
•
When laser light is used in areas of organs, body cavities and tubi that may contain flammable gases or vapors, protective measures against fire and explosion must be taken.
3.5
Protection of the Patient
The patient must under all circumstances be protected from injury by improper handling of the laser. This applies to the following in particular: •
Protection of the eyes by appropriate protective goggles or a light-proof/radiation-proof cover.
•
Protection of the organs and tissue regions in the operation area that must not come into contact with laser light by covering them with materials that reflect laser light diffusely or with light-absorbing materials, such as damp cloths or compresses.
•
Prevention of laser-induced fires, especially during endolaryngeal operations.
•
Prevention of ignition of intestinal gases and tissue in case of respiration methods using oxidizing gases.
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3.6
Requirements for Treatment Rooms
•
Rooms in which the device is to be operated must be marked with a laser warning sign (included in the delivery) at all accesses.
•
All access doors to the laser area must be equipped with a warning lamp. When the warning lamp is activated, the laser area may be accessed only by authorized persons wearing the required laser protection goggles.
•
The doors to the laser area must be kept closed during laser application.
•
Avoid surfaces in the laser area that may reflect laser radiation, or cover them appropriately.
3.7
Safety Requirements for the Laser Device
•
The instruments to be used must have a shape and surface finish to eliminate dangerous reflections as far as possible.
•
Optical systems for observation of the operation area must be designed for laser applications. They may be used only with suitable attachment filters that meet the requirements for laser protection goggles.
•
If any defects on the laser device are noted, the device may no longer be operated! The defects must be recorded in the medical product log and reported to the laser safety officer. Immediately contact Gebrüder Martin or an authorized service technician.
3.8
Safety Notes for the Pilot Laser
CAUTION Possible distraction caused by pilot laser light! Direct or reflected light of the pilot laser can blind the user and temporarily impair his/her working ability. The laser protection goggles D 1550 nm L4/LB3 provide protection only against the working laser light, not however against the pilot laser light. •
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Do not directly look into the pilot laser light!
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Instructions for Use Laser Surgical Unit diomax® 1550
3.9
Laser Safety Officer
According to the German accident prevention directive BGV B2 (laser radiation), the operator must appoint a laser safety officer in writing. The laser safety officer is responsible for the following: •
Implementation of safety measures
•
Instruction of all persons working with the device in the safety measures and operation of the device
•
Marking of the laser area with signs
•
Check of the warning signals
•
Availability of the laser protection goggles
•
Safe storage of the keys
•
Correct connection of the device in case of relocation
•
Keeping of the medical product log
3.10
User
The user is responsible for safe and proper use of the medical laser system. He or she must ensure that all safety precautions are complied with, and be familiar with the laser-specific surgical technique.
3.11
Electrical Safety
The device conforms to protection class 1 (IEC 60601), which means that it must be connected to a properly earthed mains according to its technical data (see section 11 “Technical Data”, page 66). •
Use only the mains cable included in the delivery.
•
Mains cable and plugs must not show any signs of damage.
•
The laser system must never be activated if any part of the casing is not attached correctly. If the casing is not properly closed, laser radiation may escape uncontrollably, and dangerous electrical voltages or currents may be exposed.
3.12
Earthing of the Device
The device is earthed via the earthing conductor in the mains cable. This is an indispensable prerequisite for safe operation of the device. Proper earthing is ensured if the mains cable is connected according to the VDE regulations. The equipotential bonding required for use of the device in certain operation areas (e. g. during intracardiac operations) can be established via the green-yellow equipotential bonding cable.
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Instructions for Use Laser Surgical Unit diomax® 1550
3.13
Fuses
Fuses may be replaced only by authorized and qualified personnel. At the rear of the device there are the fuses of the mains input socket whose fuse rating is printed on the rear of the device (see section 4.4 “Rear of Device”, page 24).
3.14
Safety Systems of the Device
The device was designed taking into account the strictest standards of personal safety. The safety measures built into the system make incorrect operation impossible: •
Upon activation or re-activation of the device after a power failure, the device switches into STANDBY mode – the laser beam cannot be activated.
•
The laser beam cannot be activated either as long as the laser fiber is not connected.
•
Regarding the duration of laser activation, for safety reasons the foot switch has absolute priority over the set pulse times, i. e. when the foot switch is not pressed any longer, the emission of laser light is stopped immediately even if the preset pulse time has not ended yet.
•
The foot switch has two switches, one for accessory devices and one for the laser activation itself. Laser light can be emitted only while both switches are activated.
•
When the foot switch is activated, all buttons and the rotary knob are blocked to avoid unintentional changing of the radiation parameters during the operation.
•
The laser power is continuously monitored during the emission of laser light.
•
The coding of the SMA-X fiber connection socket ensures that only appropriate laser fibers can be connected to the device.
•
Using the EMERGENCY-STOP switch, the device can immediately be separated from the electric circuit in case of emergencies.
3.15
Usage Restrictions
Youths below the age of 16 must not work with lasers or in laser areas (applies to laser classes 3R, 3B and 4, see BGV B2 §11). Youths below the age of 16 may work with lasers or in laser areas under supervision and if safety is ensured by a qualified person, and if such work is required in the context of training.
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