KLS Martin group MCO25plus Manuale utente

CO2Laser System MCO25plus

Operating Instructions and Technical Description

MCO25plus Operating Instructions

2 V 4.1

Table of Contents

1Product Liability and Warranty ......................................................6

2Safety Instructions......................................................................7

2.1General Provisions ...............................................................................7

2.2Laser Safety........................................................................................9

2.3Explosion and Fire Hazards..................................................................10

2.4Protecting the Patient.........................................................................11

2.5Treatment Room Requirements............................................................11

2.6Safety Requirements for the Laser Unit and its Accessories......................11

2.7Pilot Laser Safety Instructions .............................................................12

2.8Laser Smoke.....................................................................................12

2.9Laser Safety Officer............................................................................13

2.10Treating Surgeon...............................................................................13

2.11Electrical Safety.................................................................................13

2.12Grounding the Unit ............................................................................14

2.13High-Voltage Danger..........................................................................14

2.14Fuses...............................................................................................14

2.15Safety Devices ..................................................................................14

2.16Rating Plate and Warning & Information Labels......................................16

2.17Nominal Ocular Hazard Distances (NOHD).............................................18

3Description of the Unit...............................................................19

3.1Some General Remarks on the Laser Principle........................................19

3.2The CO2Laser ...................................................................................19

3.3Range of Application ..........................................................................20

3.4General Description of the System .......................................................21

3.5System Design Options.......................................................................21

4Installation ..............................................................................23

4.1Unpacking the Unit & User’s Inspection.................................................23

4.2Laser Location...................................................................................23

4.3Laser Operation Notices......................................................................23

4.4Rear Side of the Unit (with Connections)...............................................24

4.4.1Rating Plate (Nameplate) .............................................................................. 24

4.4.2Footswitch Connection .................................................................................. 24

4.4.3Mains Connection......................................................................................... 24

4.4.4Cable Holder................................................................................................ 24

4.4.5OR Door Interlock ........................................................................................ 25

4.4.6Equipotential Bonding Pin.............................................................................. 25

4.4.7Fuses Located in Mains Filter.......................................................................... 25

MCO25plus Operating Instructions

V 4.1 3

4.5Connecting the Articulated Mirror Arm ..................................................25

4.5.1Preparing the Laser Unit................................................................................ 26

4.5.2Unpacking the Articulated Mirror Arm.............................................................. 27

4.5.3Mounting the Articulated Mirror Arm ............................................................... 28

4.5.4Securing the Articulated Mirror Arm ................................................................ 29

4.6Application Handpiece ........................................................................29

4.7Switching on the Unit .........................................................................30

4.8Adjusting the LCD Contrast .................................................................30

4.9Basic Setting.....................................................................................30

4.9.1Time Mode .................................................................................................. 30

4.9.2Frequency Mode........................................................................................... 31

4.9.3Operating Mode Selection.............................................................................. 31

4.10Language Options..............................................................................31

4.10.1Selecting a Language.................................................................................... 31

4.11Functional Checks..............................................................................31

4.11.1Checking the Optical System (Visual Inspection)............................................... 32

4.11.2Testing the Optical System............................................................................ 32

4.11.3Testing the Irrigation Air Output..................................................................... 32

4.12Handing Over the Unit to the User........................................................33

5Controls, Indicators & Display.....................................................34

5.1Starting the Unit................................................................................34

5.2Button Explanations ...........................................................................35

5.3Control Panel (Time Mode)..................................................................36

5.4Control Panel (Frequency Mode) ..........................................................37

5.5Control Button Explanation..................................................................38

5.6Function Key Explanation....................................................................39

5.7Display Content Explanation................................................................41

5.8Switching off the Laser Unit.................................................................43

5.8.1Upper Parking Position.................................................................................. 44

5.8.2Lower Parking Position.................................................................................. 45

5.9Emergency Shutdown.........................................................................47

5.10Relocating the Unit ............................................................................47

6Operating the Unit ....................................................................48

6.1Setting the Laser System Parameters ...................................................48

6.2Continuous-Wave Mode ......................................................................48

6.2.1Parameters in Continuous-Wave (CW) Mode .................................................... 48

6.3Single-Pulse Mode..............................................................................48

6.3.1Parameters in Single-Pulse Mode.................................................................... 49

6.4Pulse-Train Mode...............................................................................49

6.4.1Parameters in Pulse-Train Mode ..................................................................... 49

6.5Superpulse Mode ...............................................................................50

MCO25plus Operating Instructions

4 V 4.1

6.5.1Parameters in Superpulse Mode ..................................................................... 51

6.6Scanner Operation* ...........................................................................51

6.6.1Mounting the Scanner................................................................................... 51

6.6.2Articulated Mirror Arm for Scanner Operation................................................... 54

6.6.3Display....................................................................................................... 55

6.6.4Scanner Operating Modes (C1…C4)................................................................. 56

6.6.5Line Scan (C5)............................................................................................. 56

6.6.6Parameters in Scanner Mode.......................................................................... 58

6.6.7Permanent Scanning..................................................................................... 64

6.7Memory Functions..............................................................................65

6.7.1Storing and Accessing Parameters .................................................................. 65

6.8Pilot Laser ........................................................................................69

6.8.1Switching off the Pilot Laser........................................................................... 69

6.9Performing the Laser Treatment...........................................................69

7Accessories..............................................................................71

7.1General Accessories ...........................................................................71

7.2Protective Goggles.............................................................................72

7.3Micromanipulators .............................................................................72

7.4Scanner............................................................................................73

7.5Special Accessories ............................................................................73

8Maintenance.............................................................................74

8.1Routine Maintenance Work..................................................................74

8.1.1Cleaning the Unit ......................................................................................... 75

8.1.2Cleaning the Focusing Handpieces .................................................................. 75

8.1.3Cleaning the Scanner Handpieces................................................................... 76

8.1.4Cleaning the Backstops and Angled Tips .......................................................... 77

8.1.5Cleaning the ENT Set Components.................................................................. 78

8.1.6Coded Accessories........................................................................................ 79

8.2Maintenance Work to Be Performed by Gebrüder Martin’s Technical Service80

8.3Safety Checks ...................................................................................80

9Troubleshooting........................................................................83

9.1Error Indication on the Display ............................................................83

9.2Error Messages and Measures to Be Taken ............................................83

9.2.1Interlock Error............................................................................................. 83

9.2.2Please Connect Scanner................................................................................ 83

9.2.3Temperature Error........................................................................................ 83

9.2.4Water Flow Error.......................................................................................... 83

9.2.5“Confirm”.................................................................................................... 84

9.3Other Messages.................................................................................85

9.4Error Symptoms Without LCD Messages................................................85

MCO25plus Operating Instructions

V 4.1 5

10Quick Reference Guide...............................................................86

10.1Preparatory Measures/Checks..............................................................86

10.2Switching on the Unit .........................................................................86

10.3Setting Parameters ............................................................................87

10.4Performing the Therapy......................................................................87

10.5Switching off the Unit.........................................................................87

11Technical Specifications .............................................................88

12Test Certificates........................................................................90

MCO25plus Operating Instructions

6 V 4.1

1Product Liability and Warranty

Gebrüder Martin will accept no responsibility for the safety, reliability and proper functioning of

the unit unless:

•all readjustments, modifications or repairs that become necessary are carried out by

persons authorized to perform such work,

•all electrical installations of the treatment room comply with the relevant IEC regulations in

force at the time,

•the unit is used in accordance with the Operating Instructions supplied with the product.

Any modification or repair work performed by persons not specially authorized by the

manufacturer to carry out such tasks shall void the warranty.

The user is strictly required to observe all operating instructions provided herein.

Consequently, the manufacturer will assume no liability – whether within or after the warranty

period – for any damage caused by improper handling of the unit, the articulated arm or the

accessories.

Therefore, be sure to read and understand these Operating Instructions before putting the unit

into service.

Our Standard Terms and Conditions of Sale effective at the time shall apply.

Notice:

This system is subject to a 24-month warranty except for the laser tube, which is

warranted for 2,000 operating hours or 24 months at a maximum.

MCO25plus Operating Instructions

V 4.1 7

2Safety Instructions

The following provisions and recommendations are based on:

DIN EN 60825-1 (2003-10) Safety of laser products – Part 1: Equipment classification,

requirements and user’s guide

DIN EN 60601-1 (1996-03) Medical electrical equipment – Part 1: General requirements

for safety

DIN EN 60601-1-2 (2002-10) Medical electrical equipment – Part 1–2: Electromagnetic

compatibility; Requirements and tests

DIN EN 60601-1-4 (2001-04) Medical electrical equipment – Part 1–4: Programmable

electrical medical systems

DIN EN 60601-2-22 Medical electrical equipment – Part 2–22: Particular

requirements for the safety of diagnostic and therapeutic

laser equipment

BGI 832 “Betrieb von Lasereinrichtungen (Anwendung der

Unfallverhütungsvorschrift ‘Laserstrahlung’” (BGV B2))

(Regulations for the prevention of accidents – laser

radiation)

MDA (MPG) German Medical Devices Act (see Medical Devices Directive

/MDD)

In addition to the above, all relevant local provisions and regulations – which may provide

otherwise – must be observed as well!

2.1 General Provisions

Installation and initial start-up of the unit must be carried out by qualified persons who have

been specially trained and authorized by Gebrüder Martin to perform such work.

Please use the unit only after the following steps have been performed:

•Handing over of the unit in perfect working order plus user training/instruction (to be

provided by Gebrüder Martin or an authorized agent);

•acceptance of the unit by the purchasing department;

Important notice!

All persons involved in the operation of this unit must be fully familiar with these

Operating Instructions. Note that improper handling (i.e. any action not in

compliance with the instructions given in this manual) may lead to injuries

and/or equipment damage.

Improper handling as well as modifications or repairs performed by non-

authorized persons shall void the manufacturer’s warranty!

MCO25plus Operating Instructions

8 V 4.1

•formal appointment of a Laser Safety officer by the owner/operator of the unit (in acc. with

§ 6 BGV B2 (Germany) or equivalent local regulations concerning the prevention of

accidents);

•appointment of a person who is responsible for the unit; providing user instruction to that

person as well as to other potential operators of the unit;

•setting up a logbook for the medical device;

•registration of the unit with the respective employers’ liability insurance association and the

official body responsible for labor safety matters (if applicable);

•carrying out all safety measures;

•making sure that all operational procedures, as well as measures to be taken in case of

trouble/failure, are fully understood.

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 radiation (in the broadest sense). The owner/operator of the unit

and the Safety officers (e.g. the Laser Safety officer) are responsible for the proper

performance of all required safety measures, thus ensuring that the use of the laser will pose

no danger to the patient, the treating physician or any other person present during laser

operation.

Moreover, the following supplementary provisions should be observed:

•The MCO25plus may be operated only by qualified and duly authorized personnel. These

persons 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 should be repeated on an annual basis (refresher courses); all

participants in such training should confirm their participation in writing.

•Whenever the unit is not in operation, it must be protected against unauthorized use (e.g.

by locking it and keeping the key in a safe place).

•The unit must be operated and serviced in accordance with these Operating Instructions;

this also applies to the regular safety checks that are required.

The MCO25plus is a Class IIb unit (acc. to the MDD),

classifies as a Class IV laser (acc. to DIN EN 60825-1)

and carries the CE-mark in acc. with Directive 93/42/EEC.

We recommend the owner/operator of the unit to maintain the following documents and keep

them accessible at any time:

•medical device logbook or equipment ID card

•Operating Instructions

MCO25plus Operating Instructions

V 4.1 9

Accidents involving personal injuries must be reported to the appropriate authority without

delay.

2.2 Laser Safety

This unit is a Class IV laser, which means that both the laser beam as such and the diffuse

laser light reflected from surfaces may be harmful.

The laser area is defined as the area in which the maximum permissible exposure (MPE) values

that are normally binding may be exceeded. This includes any accidental deflections of the

laser beam. All doors providing access to the laser area must be marked with warning lamps.

Therefore, the following safety measures must be strictly observed:

•Any person present in the laser area while the laser is being used must be aware of the

dangers posed by laser radiation and must wear protective goggles. The patient’s eyes

must be adequately protected as well.

•The owner/operator of the unit is responsible for providing suitable protective equipment.

•The organ most endangered by laser radiation is the human eye. Therefore, all persons

present in the laser area must wear protective goggles (rated 10,600 nm L4 or higher)

whenever the unit is switched from “standby” to “laser ready” mode.

•Never stare directly into the red pilot laser light! Please note that the protective goggles

just mentioned do not protect against the red pilot laser radiation!

•When performing open surgery, the entire operating room is considered the laser area.

•Never keep potentially explosive substances in the laser area, as easily flammable

materials could catch fire!

•If laser radiation is applied to organs, body cavities or tubular structures in which easily

flammable gases or vapors may be present, protective measures must be taken to

eliminate any fire and explosion hazards.

•Objects capable of reflecting the CO2radiation must either be covered or removed

altogether from the laser area. Windows and reflecting walls should also be covered with

suitable materials. Moreover, adequate protective measures must be taken if harmful

gases, dust, smoke or secondary radiation could be generated, or if potentially explosive

gas mixtures could be formed, as a result of the impact of laser radiation on certain

substances or materials.

•Instruments that need to be brought into the beam path in the course of the treatment

must have such a shape and finish that dangerous reflections are largely excluded.

The unit emits radiation in the non-visible spectral range of 10,600 nm. Such

radiation can cause irreversible damage to the eyes, skin and other organs!

Use protective goggles – D 10,600 nm L4 – in accordance with DIN EN 207

requirements!

MCO25plus Operating Instructions

10 V 4.1

•The laser area should always be kept as small as possible and should be screened off,

making sure that this area cannot be accessed by unauthorized persons. The number of

people present in the laser area should always be kept to a minimum.

•At least once a year, all persons working in the laser area must be informed about

pertinent safety requirements and measures to be taken, and must be instructed in using

the device. Such training must be recorded, including a list of all participants.

2.3 Explosion and Fire Hazards

Class IV laser systems (DIN EN 60825-1) represent a potential ignition source. When laser

radiation is absorbed, the laser energy is transformed into heat. This increases the reactivity of

the irradiated material. When working with the MCO25plus, the user therefore is required to

observe the following measures in order to prevent laser-induced fires and explosions:

•Materials that have a high ignition potential (such as flammable liquids of all danger

classes) should never be used either during or prior to the laser treatment.

•Highly flammable or oxidizing (fire-stimulating) gases – such as oxygen and nitrous oxide –

may be used for endolaryngeal operations only in conjunction with special safety measures

(use of a laser-proof tube) in order to prevent laser-induced tube ignition.

•Be very careful when using easily flammable materials (such as pads, compresses, etc.) in

the operating area. In specific,

•never bring the laser beam in direct contact with flammable objects;

•always use the pilot beam for aiming purposes;

•moisten potentially flammable materials;

•switch off the laser beam immediately after use;

•protect the laser unit against accidental/improper use by switching it from “laser

ready” to “standby” mode; switch off or lock all applicator systems connected to

the laser unit whenever those systems are not being used.

•In the event of an accidental laser beam release, it must always be guaranteed that neither

the patient nor staff members present in the operating room are exposed to dangers and

that easily flammable materials will not catch fire.

•The use of combustible anesthetic gases or oxidizing gases, such as nitrous oxide (N2O) or

oxygen, should be avoided. When saturated with oxygen, some materials (such as cotton)

may catch fire at the high temperatures generated during the normal use of the laser unit.

The solvents of adhesives and flammable solutions used for cleaning and disinfection

should be given sufficient time for evaporation before using the laser.

Attention should also be given to endogenous gases that could catch fire.

Attention!

Never operate the unit in the vicinity of easily flammable narcotics or highly

volatile mixtures such as alcohol or benzine/petroleum spirit. Never use oxygen

for gastro-intestinal irrigation in endoscopic applications!

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