KLS Martin MCO 25 plus User manual

English
CO
2Laser System MCO 25 plus
Instructions for Use
90-238-52-55
Revision 5.5
Date of Release: 2015-08
Valid from software version V5.40,
hardware
release HW 02 and software release SW 02

2 Revision 5.5
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.
Follow Instructions for Use
Follow Instructions for Use
Reference number for ordering Gebrüder Martin products (item number)
Serial number
Lot designation
Not to be reused!
Sterilization by ethylene oxide
Sterilization by irradiation
Sterilization by autoclave (see section 10)
Store in a place protected from direct sunlight
Store in a place protected from frost
Store in a dry place

Revision 5.5 3
Information on minimum and maximum temperature for storage
and transportation.
See section 13 “Technical Data”, page 109 for valid values.
Information on minimum and maximum atmospheric pressure for storage
and transportation.
See section 13 “Technical Data”, page 109 for valid values.
Information on minimum and maximum atmospheric humidity for storage
and transportation.
See section 13 “Technical Data”, page 109 for valid values.
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, see
section 16.2 “Ecological Aspects of Operation”, page 117.
NON WOOD
The packaging of the MCO 25 plus is “non-wood”, i.e. wood packaging
material that is not subject to ISPM 15, and is therefore suitable for
international shipment.

Instructions for Use
CO2Laser System MCO 25 plus
4 Revision 5.5
Contents
1Product Liability and Warranty ...................................................... 8
1.1 General Information ..............................................................................8
1.2 Scope of Delivery..................................................................................8
1.3 Intended Purpose..................................................................................9
1.4 Frequently Used Functions .....................................................................9
1.5 Contraindications ................................................................................ 10
1.6 Warranty ...........................................................................................10
1.7 User’s Inspection ................................................................................11
1.8Hotline............................................................................................... 11
2Notices Concerning this Document................................................12
2.1 Validity of this Document ..................................................................... 12
2.2 Symbols Used in this Document............................................................ 13
3Safety Notes..............................................................................14
3.1 General Specifications ......................................................................... 14
3.2 Installation and Initial Start-Up............................................................. 15
3.3 Laser Safety ....................................................................................... 16
3.4 Danger of Explosion and Fire ................................................................ 18
3.5 Protection of the Patient ...................................................................... 18
3.6 Requirements for Treatment Rooms ...................................................... 19
3.7 Safety Requirements for the Laser Surgery Device .................................. 19
3.8 Safety Notes for the Pilot Laser............................................................. 19
3.9 Laser Safety Officer............................................................................. 20
3.10 User .................................................................................................. 20
3.11 Electrical Safety .................................................................................. 20
3.12 Grounding the Unit.............................................................................. 20
3.13 Fuses ................................................................................................21
3.14 Safety Systems of the Device ............................................................... 21
3.15 Usage Restrictions...............................................................................22
3.16 Warning and Information Labels ........................................................... 22
3.16.1 Positions of safety notes, key switch and EMERGENCY STOP switch ......................23
3.17 Fumes ............................................................................................... 24
3.18 Laser Delivery System ......................................................................... 24
4Description of the CO2Laser System.............................................25
4.1 General Information on Laser Theory..................................................... 25
4.2 CO2Laser........................................................................................... 25
4.3 Area of Application .............................................................................. 26

Instructions for Use
CO2Laser System MCO 25 plus
Revision 5.5 5
5Putting the MCO 25 plus into Operation.........................................27
5.1 General Information ............................................................................ 27
5.2 Setting up the MCO 25 plus.................................................................. 27
5.3 Relocating the Device .......................................................................... 28
5.4 Front Side ..........................................................................................29
5.5 Rear Panel ......................................................................................... 30
5.5.1 Type Plate .....................................................................................................30
5.5.2 Mains Connection ...........................................................................................31
5.5.3 Equipotential Grounding Pin.............................................................................31
5.5.4 Mains Fuses...................................................................................................31
5.5.5 Foot Switch Connection...................................................................................32
5.5.6 Foot Switch Mounting .....................................................................................33
5.5.7 Cable Clamp ..................................................................................................33
5.5.8 Interlock Connector Connection........................................................................33
5.6 Preparing the MCO 25 plus Laser for Attaching the Mirror Joint Arm .......... 34
5.7 Unpacking the Mirror Joint Arm and Preparing it for Mounting................... 35
5.7.1 Mounting and Securing the Mirror Joint Arm ......................................................36
5.7.2 Mounting the Focusing Handpiece.....................................................................38
5.8 Preparing the Mirror Joint Arm for Use with a Scanner ............................. 39
5.8.1 Mounting a Scanner (Normal Scan) ..................................................................40
5.8.2 Laying the cable for the scanner.......................................................................41
5.8.3 Scanner Handpiece Standard, 127 mm .............................................................42
5.8.4 Scanner Handpiece Optional, 200 mm ..............................................................42
5.8.5 Mounting Scanner SOFT FRAC / POWER FRAC....................................................43
5.8.6 Upper Parking Position Mirror Joint Arm ............................................................44
5.8.7 Lower Parking Position Mirror Joint Arm ............................................................45
5.9 Handover of the Device to the Operator ................................................. 45
6Operating the MCO 25 plus..........................................................46
6.1 Switching on the Device....................................................................... 46
6.2 EMERGENCY STOP Switch .................................................................... 47
6.3 Switching Off the Device ...................................................................... 47
6.4 Basic Setting of the Device................................................................... 47
6.4.1 Changing Modes.............................................................................................48
6.4.2 Language Selection ........................................................................................49
6.5 Control Elements and Display ............................................................... 50
6.5.1 Key Pad ........................................................................................................51
6.5.2 Control Keys and Display Field .........................................................................54
6.5.3 Function Keys and Scanner control keys............................................................55
6.5.4 Display Fields on the Display ...........................................................................56
6.6 Selecting the operating mode ............................................................... 57
6.6.1 Continuous Operation .....................................................................................57
6.6.2 Single Pulse Mode ..........................................................................................57

Instructions for Use
CO2Laser System MCO 25 plus
6 Revision 5.5
6.6.3 Multiple Pulse Mode ........................................................................................59
6.6.4 Super Pulse Mode...........................................................................................61
6.7 Scanner Operations............................................................................. 62
6.7.1 Display .........................................................................................................62
6.7.2 Scanner Mode Parameters ...............................................................................63
6.7.3 SOFT FRAC ....................................................................................................65
6.7.4 POWER FRAC .................................................................................................66
6.8 Additional optical application parts for the Scanner Mode ......................... 67
6.8.1 MINI POINT Micromanipulator..........................................................................68
6.8.2 MICRO POINT 2/2R Micromanipulator ...............................................................69
6.9 Special Scanner Functions.................................................................... 71
6.9.1 Continuous Scan ............................................................................................71
6.9.2 CYCLE...........................................................................................................71
6.9.3 Line Scanning ................................................................................................72
6.10 Micromanipulator MICRO POINT 2R with MICRO SWITCH ......................... 74
6.10.1 Connection ....................................................................................................74
6.10.2 Line Control ...................................................................................................75
6.10.3 Line Scanning with Super Pulse........................................................................76
6.10.4 Super Pulse Line Scanning With Cycle...............................................................77
6.10.5 Continuous Line Scanning................................................................................77
6.10.6 Overlap.........................................................................................................78
6.11 Memory Functions...............................................................................78
6.11.1 Storing of Parameters .....................................................................................78
6.11.2 Adapting the Name and Number of the Memory Cell ...........................................79
6.11.3 Recalling Parameters ......................................................................................81
6.12 Checking the Laser Light Using the Pilot Laser ........................................ 82
6.12.1 Activating the Pilot Laser.................................................................................83
6.12.2 Deactivating the Pilot Laser .............................................................................83
6.12.3 Pilot Laser in Flashing Mode.............................................................................84
6.13 Applying Laser Light ............................................................................85
6.14 System Check ....................................................................................87
6.14.1 Adjusting the Display Contrast .........................................................................88
7Quick Instructions for Use ...........................................................89
8Maintenance ..............................................................................91
8.1 Periodic Maintenance ........................................................................... 91
8.2 Functional Checks ...............................................................................92
8.2.1 Check of the Optical System (Visual Check).......................................................92
8.2.2 Test of the Optical System...............................................................................92
8.2.3 Checking the Flushing Air Flow.........................................................................93

Instructions for Use
CO2Laser System MCO 25 plus
Revision 5.5 7
9Cleaning and Disinfection ............................................................93
9.1 Cleaning of Focusing/Scanner Handpieces .............................................. 94
9.1.1 Parts of the focusing handpieces ......................................................................95
9.1.2 Parts of the scanner handpieces .......................................................................96
9.2 Parts of the Angles .............................................................................. 96
9.3 Parts of the ENT Set ............................................................................ 97
9.4 Cleaning Process................................................................................. 98
10 Sterilization ...............................................................................99
11 Troubleshooting ....................................................................... 101
11.1 Messages on the Display .................................................................... 101
11.2 Messages and Required Actions .......................................................... 101
11.2.1 Interlock Error .............................................................................................101
11.2.2 Please Connect Scanner ................................................................................101
11.2.3 Temperature Error........................................................................................102
11.2.4 Water Flow Error ..........................................................................................102
11.2.5 Confirming ..................................................................................................102
11.3 Other Messages ................................................................................ 103
11.4 System Troubles without Display Messages .......................................... 104
12 Accessories.............................................................................. 105
12.1 List of Approved Accessory Equipment................................................. 105
12.2 Laser Protective Goggles.................................................................... 105
12.3 Focusing Handpieces and Tips ............................................................ 105
12.4 Foot Switch ...................................................................................... 106
12.5 Scanner ........................................................................................... 106
12.6 Special Accessories (ENT Set)............................................................. 107
12.7 Micromanipulators............................................................................. 107
12.8 Fume extraction system marVAC®....................................................... 108
12.9 Safety Distances (NOHD) ................................................................... 108
13 Technical Data ......................................................................... 109
14 Safety Check (SC) ....................................................................111
15 Guidelines and Manufacturer’s Declaration Regarding
Electromagnetic Compatibility (EMC) .......................................... 113
16 Ecological Information ..............................................................117
16.1 Packaging ........................................................................................ 117
16.2 Ecological Aspects of Operation........................................................... 117
16.3 Disposal........................................................................................... 117

Instructions for Use
CO2Laser System MCO 25 plus
8 Revision 5.5
1Product Liability and Warranty
1.1 General Information
We thank you for having decided to buy one of our products. 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. [phone] · Fax [phone]
[e-mail] · www.klsmartin.com
1.2 Scope of Delivery
Laser surgery device MCO 25 plus/MCO 25 plus HNO
•Laser surgery device MCO 25 plus
•Mirror joint arm
•Focusing handpiece 127 mm
•Air hose
•2 keys
•Foot switch
•Mains cable
•Potential equalization cable
•Interlock connector with bypass
•2 laser warning signs
•Instructions for Use MCO 25 plus
•Medical product log
Laser surgery device MCO 25 plus/MCO 25 plus HNO with Scanner
additionally comprises:
•Scanner casing Soft Scan Plus R
•Connection cable
•Scanner handpiece 127 mm
Further optional application parts such as micromanipulators, see section 12.1 “List of
Approved Accessory Equipment”, page 105.

Instructions for Use
CO2Laser System MCO 25 plus
Revision 5.5 9
1.3 Intended Purpose
The MCO 25 plus is a laser surgery device that is based on a DC-excited gas laser and used for
the treatment of biological tissue by:
•Hyperthermia
•Cutting
•Coagulation
•Vaporization
To this purpose, electrical energy from the grid is converted into infrared laser light which
makes this surgical application possible.
Safe use of laser surgery requires the user to be familiar with the technology and the
applications.
Before start-up of this device, you must read and understand this
document!
This document describes the proper handling of the device. Improper handling
of the device or any accessory equipment shall exclude liability by the
manufacturer even for damage during the warranty period!
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 device, 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 device 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 operational safety of the device must be verified at regular intervals, see section 8
“Maintenance”, page 91 and section 14 “Safety Check (SC)”, page 111.
The hazard distances (NOHD) applying to the accessories are listed in section 12.9 “Safety
Distances (NOHD)”, page 108.
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.
1.4 Frequently Used Functions
The laser surgery device has 5 preprogrammed storage locations. These are factory-
preprogrammed with programs that offer the functions most regularly used by the user.
For a detailed description of programs and functions, see section 6 “Operating the”, page 46.

Instructions for Use
CO2Laser System MCO 25 plus
10 Revision 5.5
1.5 Contraindications
Application of the laser surgery device MCO 25 plus is contraindicated where laser-surgical
applications are contraindicated.
1.6 Warranty
Our Standard Terms and Conditions of Sale effective at the time shall apply. Agreements di-
verging 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.
Gebrüder Martin shall be liable for the safety, reliability and the proper operations of the device
only if
•all necessary re-adjustments, modifications or repairs are performed by authorized and
qualified personnel;
•all electrical installations in the respective room comply with all applicable IEC regulations;
•the device is used in accordance with the supplied instructions for use.
Any manipulation of the device by persons not authorized by the manufacturer voids the
warranty.
The user must comply with the operating instructions. Improper handling of the device, the
mirror joint arm or any accessory equipment shall exclude liability by the manufacturer even
for damage during the warranty period. Therefore, carefully read and understand the
instructions before commissioning the device.
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. Performing unauthorized actions on the product is
strictly prohibited at any time. Non-compliance will void any liability claim against
Gebrüder Martin.

Instructions for Use
CO2Laser System MCO 25 plus
Revision 5.5 11
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.
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: [phone]
Fax: [phone]
•Should you have any technical questions or questions concerning maintenance contracts or
training courses, please contact our Martin Service Center:
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]
NOTICE
To answer your technical questions as efficiently as possible, our service technicians require
the s
erial number of the product. Therefore, please have this number at hand when
contac
ting our hotline. It is part of the information provided on the rating plate; see
section “5.5 “Rear Panel”, page 30.

Instructions for Use
CO2Laser System MCO 25 plus
12 Revision 5.5
2Notices 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!
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.
•In addition, observe the Instructions for Use of the micromanipulators (Minipoint and
Micropoint 2/2R).
2.1 Validity of this Document
This document is valid for software version V5.40, hardware release HW 02 and software
release SW 02.
The current software version is indicated on the startup screen, see section 6.14 “System
Check”, page 87. This ensures that it is always clear which software versions are covered by
this document. Should the software version of the device not correspond to the software
version indicated here, you can order matching documentation from our Martin Service Center,
see section 1.8 “Hotline”, page 11.

Instructions for Use
CO2Laser System MCO 25 plus
Revision 5.5 13
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
Life hazard
or serious injury!
Indicates a situation which, if not avoided,
could result in death or serious injury!
CAUTION
Danger of m
inor 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, co
uld lead to material damage (loss of time, data
loss, device/machine failure, etc.)!

Instructions for Use
CO2Laser System MCO 25 plus
14 Revision 5.5
3Safety Notes
3.1 General Specifications
Standard Title
MPG (MDA) Medical Devices Act
93/42/EEC (MDD) EU Directive 93/42/EEC concerning medical devices
IEC 60825-1:2008-05 Safety of laser products – Equipment classification and requirements
IEC 60601-1:2007-07 Medical electrical equipment – General requirements
IEC 60601-1-1:2002-08 Safety requirements for medical electrical systems
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 equipment (Application of the accident prevention
directive “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!

Instructions for Use
CO2Laser System MCO 25 plus
Revision 5.5 15
3.2 Installation and Initial Start-Up
Installation and initial commissioning may be performed only by Gebrüder Martin or authorized
service partners. For further information see section 5.2 “Setting up the MCO 25 plus”,
page 27.
CAUTION
Danger of physical injury!
Any person that handles the device in any way must have fully read
and understood the
contents of these instructions for use. Improper handling that does not comply with these
i
nstructions 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 section 15 “Guidelines
and Manufacturer’s Declaration Regarding Electromagnetic Compatibility (EMC)”, page 113.
•Knowledge of the 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 security officers (e.g. laser safety officer) are responsible for the
implementation of all safety measures to protect the patient, the user and other persons
present during laser operation.

Instructions for Use
CO2Laser System MCO 25 plus
16 Revision 5.5
Furthermore, the following additional requirements must be observed:
•The laser surgery device MCO 25 plus may be commissioned only by authorized users. The
users must be familiar with the laser surgery device and know the applicable safety
precautions. Persons authorized to use the device must be listed in the medical product
log.
•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 the instructions for use.
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 reported to the relevant
authorities immediately.
3.3 Laser Safety
The laser surgery device MCO 25 plus
•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.
CAUTION
Danger of injury to eyes, skin and other organs!
The device e
mits light in the invisible spectral range of 10,600 nm which may cause
irrevers
ible damage to eyes, skin and other organs!
The direct laser beam of a class
4 laser device itself and also the laser light that is reflected
diffusely from surfaces can be har
mful!
Wear protective
goggles!
Required safety goggles
D 10600 nm L4/LB4
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.

Instructions for Use
CO2Laser System MCO 25 plus
Revision 5.5 17
Therefore, the following safety precautions must be strictly complied with:
•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 people that participated.
•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 laser radiation with a protection
class of D 10600 nm L4/LB4 or higher.
•The patient's eyes must be protected.
•The operator is responsible for the availability 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. Also
see section 3.8 “Safety Notes for the Pilot Laser”, page 19.
•During open surgeries, the entire operating theater is considered a laser area.
•No explosive substances may be present in the laser area! Highly flammable materials may
catch fire!
•Objects that can reflect CO2radiation must be either covered or removed from the laser
area. Windows and reflective walls must likewise be covered with suitable materials. If
under the influence of laser light any substances or materials could release gases, dust,
smoke, secondary radiation or highly flammable gaseous mixtures, protective measures
must also be taken.
•All instruments that are to be brought into the beam path must have a shape and surface
structure to eliminate dangerous reflections as far as possible.
•The laser area should be kept as small as possible and also be protected against
unauthorized entry. The number of persons present in the laser area should always be kept
to a minimum.

Instructions for Use
CO2Laser System MCO 25 plus
18 Revision 5.5
3.4 Danger of Explosion and Fire
WARNING
Danger of Explosion and Fire
!
Class
4 laser surgery devices (IEC 60825-1) can act as sources of ignition due to heating of
tissue or fiber ends. Therefore, comply with the
following requirements to prevent laser-
induced fires and explosions when using the device:
•
The device must not be used near flammable anesthetics or highly volatile mixtures such
as alcohol or gasoline.
•
There is the danger of fire or explosion if the laser light is used when flammable
materials, solutions or gases are present in an oxygen-enriched environment.
•
The operation area is to be prepared in such a way that even if the laser light 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 contain flammable
gases or vapors, protective measures against fire and explosion must be taken.
•
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.
3.5 Protection of the Patient
The patient must under all circumstances be protected from injury by improper handling of the
laser surgery device. 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.
•Effective removal of toxic fumes, especially in the laryngeal area;
•avoidance of ignition of highly flammable intestinal gases during rectoscopic operations;
•avoidance of ignition by direct laser light when artificial respiration methods such as jet
ventilation are applied, especially when using highly flammable, oxidizing gases.

Instructions for Use
CO2Laser System MCO 25 plus
Revision 5.5 19
3.6 Requirements for Treatment Rooms
•Rooms in which the MCO 25 plus is to be operated must be marked with a 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 light or cover them appropriately.
3.7 Safety Requirements for the Laser Surgery Device
•The instruments used must have a shape and surface treatment 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.
•The laser system must never be turned on as long as not all parts of the casing are
attached properly and the casing is closed. If the laser surgery device is not properly
closed, laser light may escape uncontrollably! There is also the risk of contact with
dangerous electric voltages and currents.
•If you notice any defect on the laser surgery device, the device may no longer be used!
The defects must be noted 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 laser light from the pilot laser can blind the user and temporarily impair his
or her working ability.
The protecti
ve laser goggles D 10600 nm L4/LB4 protect against infrared laser radiation but
not against pilot laser light!
•
Do not directly look into the pilot laser light!

Instructions for Use
CO2Laser System MCO 25 plus
20 Revision 5.5
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. This person is also responsible for the following:
•Implementation of safety measures
•Instruction of all persons working with the device in the safety measures
•Instruction of all persons using the device in the operation of the device
•Marking of the laser area with signs
•Inspection of the warning signals
•Safe storage of the keys
•Correct connection of the device in case of location changes
•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 13 “Technical Data”,
page 109.
•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 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®120 for intracardiac
interventions).