CO 2 Laser System MCO 25 plus

Transcription

1 Instructions for Use V. 5.4-EN (01.13) Valid for software version V. 5.4 and from hardware revision HW 02 on

2 Symbol explanation Safety alert symbol CAUTION WARNING DANGER Indicates a situation which, if not avoided, could result in minor or moderate injury. Indicates a situation which, if not avoided, could result in death or serious injury. Indicates a situation which, if not avoided, will result in death or serious injury. Observe instructions for use Item number (Item no.) Serial number Laser warning label Store in a dry place Fragile, avoid pressure and shock Arrows pointing up, transport and store upright CE mark of conformity This product may not be disposed of as normal household garbage 2 V. 5.4

3 Contents 1 Product Liability and Warranty General Information Scope of Delivery Intended Use Regularly Used Functions Contraindications Warranty User s Inspection Hotline Validity of these Instructions for Use Notices concerning these Instructions for Use Symbols Used Safety Notes General Specifications Information on Initial Commissioning Laser Safety Danger of Explosion and Fire Protection of the Patient Requirements for Treatment Rooms Safety Requirements for the Laser Device Safety Notes for the Pilot Laser Laser Safety Officer User Electrical Safety Earthing of the Device Fuses Safety Systems of the Device Usage Restrictions Warning and Information Labels, Key Switch, EMERGENCY-STOP Fumes Laser Light Transmission System About this Device General Information on Laser Theory CO 2 Laser Area of Application V

4 5 Commissioning Set-up Information Front of Device: Overview Rear of Device: Overview and Type Plate Connecting the Foot Switch Foot Switch Mounting Mains Connection Cable Bracket Theater Door Interlock Equipotential Grounding Pin Mains Fuses Preparing the Laser Device for Attaching the Mirror Joint Arm Unpacking the Mirror Joint Arm and Preparing it for Mounting Mounting and Securing the Mirror Joint Arm Mounting the Hand Piece Preparing the Mirror Joint Arm for Use with a Scanner Mounting a Scanner (Normal Scan) Scanner Hand Piece Standard, 127 mm Scanner Hand Piece Optional, 200 mm Mounting a Scanner (Fractionated Scan) Relocating the Device Upper Parking Position Mirror Joint Arm Lower Parking Position Mirror Joint Arm Handover of the Device to the Operator Operating the Device Switching on the Device EMERGENCY-STOP Switch Switching Off the Device Basic Setting of the Device Changing Setup Language Selection Control and Display Elements Control Panel Overview Control Panel Keyboard Description of Control Keys Description of Function Keys Display Description Setting Laser System Parameters Continuous Operation Single Pulse Mode Multiple Pulse Mode Super Pulse Mode V. 5.4

5 6.7 Scanner Operations Display Scanner Mode Parameters SOFT FRAC POWER FRAC Additional Accessory for the Scanner Mode MINI POINT Micromanipulator MICRO POINT 2 / 2R Micromanipulator Special Scanner Functions Continuous Scan CYCLE Line Scanning MICRO POINT 2R Connection Line Control Line Scanning with Super Pulse Super Pulse Line Scanning With Cycle Continuous Line Scanning Overlap Memory Functions Storing of Parameters Loading of Parameters Pilot Laser Deactivating the Pilot Laser Pilot Laser in Flashing Mode Applying the Laser System Check LCD Contrast Adjustment Accessories Focusing Handpieces and Tips Micromanipulators Scanner Protective Goggles Special Accessories (ENT Set) Safety Distances (NOHD) Maintenance Functional Checks Check of the Optical System (Visual Check) Check of the Optical System Checking the Air Flow Maintenance V

6 9 Cleaning and Sterilization Cleaning of the Laser Device Cleaning of Hand Pieces Angles Parts of the ENT Set Cleaning Process for Hand Piece Parts Sterilization Process for Hand Piece Parts Malfunctions Messages on the Display Messages and Required Actions Interlock Error Please Connect Scanner Temperature Error Water Flow Error Confirming Other Messages Faults without Display Messages Ecological Information Disposal of Packing Ecological Aspects of Operation Disposal of the Unit Quick Instructions for Use Technical Data Safety Check Guidelines and Manufacturer s Declaration Regarding Electromagnetic Compatibility (EMC) V. 5.4

7 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 Tuttlingen Germany Postfach 60 D Tuttlingen Germany Tel Fax info@klsmartin.com Scope of Delivery Standard version Laser surgery device MCO 25 plus Focusing hand piece 127 mm Two keys Foot switch Mains cable Potential equalization cable Interlock connector Two laser warning signs Instructions for Use MCO 25 plus Medical product log Scanner version: extra Soft Scan Plus R Connection cable Scanner hand piece 127 mm V

8 1.3 Intended Use 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. The laser surgery device may be used only in rooms intended for medical purposes that are marked as laser rooms! For information on safety distances (NOHD) see chapter 7.6 Safety Distances (NOHD), page 83. The operator may use the device only after a function check at the operating site 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 permissible combinations with other medical units, objects and accessories. This responsibly instructed person is to subsequently perform periodical training of the staff on behalf of the operator. We recommend documenting the instruction sessions in a medical product log. A medicine product log is available from Gebrüder Martin. 1.4 Regularly Used Functions The laser device has five 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 chapter 6 Operating the Device, page Contraindications The application of the MCO 25 plus laser is contraindicated where laser-surgical applications are contraindicated. 1.6 Warranty Our Standard Terms and Conditions of Sale as currently valid shall apply. An agreements diverging from these Standard Terms and Conditions shall not limit the statutory 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; 8 V. 5.4

9 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. 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. 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: Fax: Should you have any technical questions, please do not hesitate to turn to our Martin Service Center: Tel: Fax: service@klsmartin.com Should you have any questions concerning maintenance contracts or training courses, please contact our Technical Service Manager: Tel: service@klsmartin.com V

10 NOTICE To answer your technical questions as efficiently as possible, our service technicians require the serial number of the product. Therefore, please have this number at hand when contacting our hotline. It is part of the information provided on the rating plate; see section 5.3 Rear of Device: Overview and Type Plate, page 26). 1.9 Validity of these Instructions for Use These Instructions for Use apply to software version V. 5.4 and hardware revision HW 02. If older software revisions are used, functions described in this user manual may be unavailable. The software version is shown on the startup screen of the MCO 25 plus. Should the software version of the device not correspond to the software version indicated here, you can order matching documentation from the our Martin Service Center (see section 1.8 Hotline, page 9). 2 Notices concerning these Instructions for Use WARNING Non-observance of these Instructions for Use can lead to serious or even lethal patient injury! Be sure to read, understand and follow the instructions given below! Every user is required to read these Instructions completely and follow them carefully. In particular, be sure to heed all cautions, warnings and danger notices. Keep this manual accessible to users at all times. The operator is responsible for ensuring that the patient has been informed about and has understood the preventive, cautionary, warning and hazard notices given in this user manual. 10 V. 5.4

11 2.1 Symbols Used Throughout this manual, 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.)! 3 Safety Notes 3.1 General Specifications MPG 93/42/CE IEC :2007 IEC :1988 +A1:1991+A2:1995 IEC :2000 IEC :2007 IEC :1995 IEC : A1:1999 IEC :2010 Medical Devices Act EC Directive 93/42/EEC for medical devices Safety of laser products Equipment classification and requirements Medical electrical equipment General requirements Safety requirements for medical electrical systems Medical electrical equipment Electromagnetic compatibility; requirements and tests Medical electrical equipment Particular requirements for the safety of diagnostic and therapeutic laser equipment 4. Supplementary standard: Programmable electrical medical systems Usability V

12 MPG IEC 62304:2006 IEC 62353:2007 ISO : BGI 832 Medical Devices Act Medical device software Software life-cycle process Medical electrical equipment Re-testing and testing after repair of medical electrical equipment Medical products- Symbols, indications and information to be provided on labels of medical products part 1: general requirements 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! 3.2 Information on 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 these instructions for use. 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. 12 V. 5.4

13 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 attending physician and other persons present during laser operation. Furthermore, the following additional requirements must be observed: The MCO 25 plus laser may be commissioned only by authorized users. The users must be familiar with the laser 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 MCO 25 plus is a class IIb device acc. to MPG (Medical Devices Act), is a class 4 laser device (acc. to DIN EN ), has the CE label acc. to directive 93/42/EEC. CAUTION Danger of injury to eyes, skin and other organs! The device emits light in the invisible spectral range of 10,600 nm which may cause irreversible 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 harmful! V

14 Wear protective goggles! Required safety goggles: D 10,600 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. 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 DIN EN 207 for laser radiation with a protection class of D 10,600 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 chapter 3.8 Safety Notes for the Pilot Laser, page V. 5.4

15 3.4 Danger of Explosion and Fire WARNING Fire hazard! Class 4 lasers (DIN EN ) can cause fires due to the heating of tissue or fiber ends. Therefore, comply with the following requirements to prevent laser-induced fires and explosions when using the MCO 25 plus: 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 that 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. During respiration, oxygen concentrations of below 25% must be maintained in order to avoid laser-induced fires. 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. Prevention of fires by allowing solvents used for cleaning and disinfection sufficient time to vaporize. V

16 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 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. If you notice any defects on the laser device, the device may no longer be operated! 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 light of the pilot laser can blind the user and temporarily impair his working ability. The protective goggles only protect the eyes against the working laser but do not provide protection against pilot laser light. Do not directly look into the pilot laser light! 16 V. 5.4

17 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 who shall also be 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 Availability of the laser protection goggles Safe storage of the key 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 Electrical Safety The device conforms to protection class 1 (DIN EN 60601), which means that it must be connected to a properly earthed mains according to its technical data (see chapter 13 Technical Data, page 100). Before connecting to the mains, make sure that the mains voltage is correct for the laser or a fume suction system, if applicable. Use only the mains cables 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 light may escape uncontrollably, and dangerous electrical voltages or currents may be exposed. V

18 3.12 Earthing of the Device The device is earthed through 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. For use of the MCO 25 plus in certain operation areas (e. g. during intracardiac operations), the device can additionally be earthed at the equipotential grounding pin using the equipotential grounding cable Fuses Fuses may be replaced only by authorized and qualified personnel. At the rear of the device there are two micro-fuses in the mains input socket (also see chapter Mains Fuses, page Safety Systems of the Device The device was designed taking into account the strictest consideration of personal safety. The built-in safety measures in the system prevent incorrect operations: Upon activation or re-activation of the device after a power failure, the device switches into standby mode the laser cannot be activated. The laser cannot be activated either as long as the mirror joint arm is not connected. Regarding the laser activation duration, the foot switch has absolute priority over the set pulse times for safety reasons, 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. To prevent unintentional changes of the laser parameters during the surgical procedure, all keys are out of function while the foot switch is pressed. Scan shapes can be rotated only in scanner mode. The laser power is monitored just before emission of laser light. Pressing the EMERGENCY-STOP switch will deactivate the emission of laser light immediately in case of emergencies 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. 18 V. 5.4

19 3.16 Warning and Information Labels, Key Switch, EMERGENCY-STOP Information label on the rear of the device containing the maximum output values for the laser light. Average power 25 W Max power 250 W Superpuls Pulse 5 ms 10s, cw Wave length nm Wave length pilot laser 635 ± 10 nm Average power pilot laser 5 mw Class of laser 4 (DIN EN :10.03) Laser warning label and information label for class 4 lasers. Sign near the laser light exit opening on the end of the mirror joint arm. V

20 Positions of safety notes, key switch and EMERGENCY-STOP switch 1 Warning label for laser light exit opening 3 EMERGENCY-STOP switch 2 Laser warning label 4 Key switch 20 V. 5.4

21 3.17 Fumes CAUTION Risk of infection due to viable tissue particles in laser fumes! The application parts attached at the end of the mirror joint arm are connected to the flushing gas supply of the laser device. Flushing gas exits e.g. together with the laser light at the distal end of the focusing hand piece and blows laser fumes produced during the application of the device out of the optical path. Laser fumes are removed by means of a fume suction system. This system is either permanently installed in the laser application room or can be operated as a separate device (external fume suction system marvac ) together with the laser. Upon request, Gebrüder Martin or an authorized person or company can provide and install a fume suction system. If the external fume suction system marvac is used together with the MCO 25 plus, the activation of the fume suction system can be controlled by activation of the laser. Do not use laser without working fume suction system! 3.18 Laser Light Transmission System NOTICE As the homing beam (pilot laser) takes the same path through the laser light transmission system as the operation beam, it provides a good method to check the integrity of the laser light transmission system. If the homing spot at the distal end of the laser does not appear, has low intensity or is diffuse, this may be a possible indication of a damaged or improperly working laser light transmission system. V

22 4 About this Device 4.1 General Information on Laser Theory LASER is an acronym for Light Amplification by Stimulated Emission of Radiation. The laser consists of an active medium and an excitation source. The excitation source pumps electrons in the active medium from their basic state to an excited energy state. On return to their basic state, photons are emitted. The light is reflected back and forth several times in an optical resonator consisting of one highly reflective and one semi-reflective mirror, and is optically amplified by stimulated emission. Part of the laser light is redirected for medical use at the semi-reflective mirror. Main characteristics of laser light High degree of beam parallelism beam has a very low divergence. Monochromasia a narrowly specified wavelength range corresponding to one single color in the spectrum of electromagnetic radiation. Coherence all photons are synchronous in terms of location and time. The active medium can be a gas, a liquid dye or a solid substance. Most gas lasers consist of atoms or small molecules or of a mixture of both. The active medium of the solid state laser consists of atoms or ions that are bound (doped) in a solid host crystal. The active medium of the dye laser consists of molecules with a higher molecule weight that are dissolved in a liquid. Direct current, high-frequency energy or, in the solid state laser, light is used as pump energy. Under certain pump energy conditions, all these materials show the phenomenon of a population inversion that enables induced laser emission at a wavelength characteristic for the active medium. The strong increase of light intensity is achieved by optical feedback via the laser mirrors of the laser resonator and the amplification by induced emission that occurs with every passing of the resonator. 4.2 CO 2 Laser The CO 2 continuous beam laser is a gas laser that emits high-intensity radiation at a wavelength of 10,600 nm. The medium used is a CO 2 -N 2 -He gas mixture in a sealed tube. Due to the relatively long lifetime, gas needs to be refilled only after thousands of operating hours. The gas molecules are excited by the direct current discharge. The excited CO 2 in turn emits photons. The coherent light generated in the optical resonator exits the mirror joint arm through the semi-reflective laser resonator mirror. The strength of the laser light can be controlled via the discharge current in the laser tube. 4.3 Area of Application The therapeutic effect achieved with the CO 2 continuous beam laser is based on the conversion of radiation energy into heat, which causes reversible as well as irreversible tissue responses (hyperthermia, coagulation, vaporization). 22 V. 5.4

23 As the radiation of the CO 2 laser is strongly absorbed in water and the human tissue, it is characterized by very strong effect on surface tissue, low penetration depth and excellent vaporization qualities. The special therapeutic effect of this radiation type mainly depends on the following three factors: Power density (irradiation intensity) Irradiation duration (treatment duration / exposure time) Tissue characteristics The irradiation intensity achieved on the tissue surface depends on: effective distal laser power (on tissue) diameter of the beam aimed at the tissue The main tissue characteristics relevant for medical laser therapy are: absorption properties of the tissue thermal conductivity and thermal absorption capacity (e. g. water content and perfusion rate) There are numerous possible applications for the MCO 25 plus. Apart from its low penetration depth and precise cutting capabilities, other benefits of the MCO 25 plus in laser surgery are reduced stress for the patient and fast healing process. Main application areas of the MCO 25 plus Otorhinolaryngology Dermatology Gynecology Plastic surgery Tumor surgery Proctology Neurosurgery Bronchology Dental area For the professional application of the MCO 25 plus in bronchology and proctology, theoretical knowledge and sufficient practical experience are imperative. It is recommended to acquire the necessary professional knowledge by participating in special courses for laser surgery, e. g. courses offered by Laser- und Medizin-Technologie Berlin GmbH. Furthermore, compliance with all measures and instructions explained in these instructions for use is a prerequisite for the proper and safe use of the device. Therefore, all potential users of the device should familiarize themselves with the device by reading and understanding the instructions for use before commissioning the system. NOTICE Portable and mobile HF communication systems can influence the MCO 25 plus. Maintain safety distances (see chapter 7.6 Safety Distances (NOHD), page 83)! V

24 5 Commissioning WARNING Dangerous exposure to radiation! The use of control elements or the carrying out or ending of processes in any other way as described herein can result in dangerous exposure to radiation! 5.1 Set-up Information The MCO 25 plus is a state-of-the-art laser surgery device controlled by a microprocessor. The device produces laser light in the infrared wavelength (10,600 nm) with a laser power of up to 25 W that the user can apply via various applicators. NOTICE Before unpacking the device, leave the laser in the application room until it has reached room temperature. When changing locations, make sure that the device temperature has adapted to the ambient temperature before starting the device. Also see chapter 5.7 Relocating the Device, page 40. NOTICE Ensure sufficient ventilation! The cooling air inlets on the sides of the device must not be covered by table cloths, blankets, curtains or other objects. Keep a clearance or distance to the wall of at least 30 cm so that the ventilation of the laser can work properly. WARNING Danger of injuries due to electrical shock resulting from incorrect connection of the device! In order to avoid the risk of electric shock, this device may only be connected to a grounded mains supply. Connect mains cable from the laser in separately secured protective contact sockets. Do not use distribution banks! The device must be positioned in such a way that the mains cable on the rear of the device can be disconnected quickly and easily. Ensure protection of laser area against unauthorized entry. All accesses to the laser area must be equipped with laser warning signs and warning lamps. 24 V. 5.4

25 All reflecting surfaces must be covered with suitable materials. All highly flammable liquids and gases must be removed from the laser area. All persons in the laser area (incl. patient) must be provided with protective goggles. Connect theater door interlock (see also chapter Theater Door Interlock, page 28). 5.2 Front of Device: Overview 1 Display and control panel 5 Laser unit 2 EMERGENCY-STOP switch 6 Focusing hand piece / scanner hand piece 3 Key switch 7 Mirror arm 4 Warning labels V

26 5.3 Rear of Device: Overview and Type Plate Fig. 5-1: Overview of connections on the rear 1 Mains connection socket 4 Theater door interlock 7 Type plate 2 Mains fuses 5 Equipotential grounding pin 3 Cable bracket 6 Connection socket for foot switch The type plate (7) contains important information such as electrical connection values and the serial number of the device that must be indicated if service is required. 26 V. 5.4

27 5.3.1 Connecting the Foot Switch The foot switch cable (8) is to be connected to the 5-pin connection socket (6) and secured by screwing on. The foot switch (9) must be positioned in a way that it is easily accessible for the operator. 6 Connection socket for foot switch 9 Foot switch pedal 8 Connector on foot switch cable 10 Step-on protector Foot Switch Mounting If not used, the foot switch can be placed on the two mounting elements on the side of the laser unit. For this purpose, there are two mounting holes on the bottom of the casing of the step-on protection casing. The foot switch cable can be wrapped around the casing plate for storage. V

28 5.3.3 Mains Connection NOTICE Use only the supplied mains cable or a replacement cable by Gebrüder Martin with the laser system! Plug mains cable into mains connection socket (1, Fig. 5-1). The supply parameters are V, 50 / 60 Hz, max. 4 A. For additional reliability, fuse the earthed mains connection socket for at least 6 A Cable Bracket The cable bracket (3, Fig. 5-1) prevents the device connector from being loosened in the mains connection socket or accidentally pulled out. It may only be used with the original mains cable. Lift up bracket before connecting the device connector, plug connector in and put bracket over device connector Theater Door Interlock NOTICE Do not connect connector of theater door interlock or supplied shorting plug to the foot switch socket (6, Fig. 5-1)! If the connector of the theater door interlock is plugged into the foot switch socket, there will be an interlock error and a foot switch error, and the laser cannot be activated. NOTICE Without the theater door interlock or the supplied shorting plug in the corresponding socket (4, Fig. 5-1), the MCO 25 plus cannot be activated. If a door contact switch is connected, the device will stop the laser emission when the door is opened. The message INT_LOCK ERROR appears on the display. Correct error condition (also see chapter 10 Malfunctions, page 93): Close door. Press the STANDBY key. Press the key and set device to Laser Ready. Only then can the laser treatment be continued. 28 V. 5.4

29 The theater door contact must be a potential-free (floating) contact. The contact on the theater door must be suitable for 24 V / 0.1 A DC. The connection to the laser device is achieved using a 3-pin circular connector that is inserted into the socket (4, Fig. 5-1). If a deactivation by interlock is not desired, the shorting plug, which is equipped with an internal contact bridge, must be inserted into the socket (4, Fig. 5-1) Equipotential Grounding Pin This connection (5, Fig. 5-1) must be used if the theater requires separate device grounding Mains Fuses NOTICE Unplug mains connector before working on the mains fuses! After opening the cover (2, Fig. 5-1) you will have access to two micro-fuses whose electrical parameters are printed on the retainer: T4A H 250 V. V

30 5.4 Preparing the Laser Device for Attaching the Mirror Joint Arm Unscrew protection cap from the thread (1). Remove gray cap from the opening of the 5-mm hexagon spanner (2). Turn the clamping (4) that is located under the cap to the left using the 5-mm hexagon spanner (3). The clamping for the mirror joint arm is turned to the side. The arm can be mounted. Fig. 5-2: Clamping for installation of the mirror joint arm (opened by turning to the left, closed by turning to the right) 1 Thread for mirror joint arm (here without cover) 2 Opening for 5-mm hexagon spanner (gray cap) 3 5-mm hexagon spanner 4 Clamping 30 V. 5.4

31 5.5 Unpacking the Mirror Joint Arm and Preparing it for Mounting During transport, the mirror joint arm is not mounted to the device; it is supplied with the device in a separate packaging. The lower part of the arm (1) is released from the spring force by means of a latch (2) during transport. In mounted state, this latch allows force-free movement the arm and return to the upright parking position when not used. Fig. 5-3: Transport position of the mirror joint arm Remove arm from packaging. Make sure that the latch (2) is set to unlocked. Rotate the lower part of the arm (1) by c In the last bit of the turn, press against the spring force, which requires a certain amount of pressure. Turn spring latch (2) from the unlocked position into the locked position. The spring is tensioned and the arm remains in the position shown in Fig The mirror joint arm can be inserted into the laser device. V

32 5.5.1 Mounting and Securing the Mirror Joint Arm NOTICE Remove latch for removing or mounting the mirror joint arm! Remove the cap (7) from the arm. Screw mirror joint arm into the connection thread (1, Fig. 5-2) on the laser device. 1 Lower part of the arm (is connected to laser device) 2 Arm latch (locked / unlocked) Working position locked: Arm remains in upright position 3 Setting for spring tension: (hand piece / scanner) normal spring force = hand piece strong spring force = scanner 4 Setting screw for rotary fixation of the mirror joint arm 5 Elastic arm holder 6 Cover ring 7 Protective cap on mounting thread 8 Opening on laser device for mounting of the arm 9 Air outlet for flushing gas hose Fig. 5-4: Overview of mounting process Loosen setting screw (4). Insert arm with thread in vertical position into the designated opening on the laser device (8). Carefully tighten in clockwise direction. Avoid jamming. Approximately 15 turns are required until the mirror joint arm is fully inserted into the opening (8) on the laser device. 32 V. 5.4

33 Then connect the flexible plastic air hose to the air outlet for the flushing gas hose (9) behind the joint arm of the laser. Slide cover ring (6) fully down. Perform steps in reverse order to dismount the mirror joint arm. After mounting the arm it must be secured by engaging the latch. By doing so, unintentional loosening of the arm in the thread, which would result in imprecise beam generation, can be avoided. Turn latch (4) to the right using the 5-mm hexagon spanner (3). The latch (4) is moved over the edge of the mirror joint arm. The mirror joint arm is secured against unscrewing. After mounting the arm, cover the opening for the 5-mm hexagon screw (2) again with the gray cap. V

34 5.5.2 Mounting the Focusing Hand Piece WARNING Risk of injury to eyes by laser light! Never start device as long as the protective caps cover the beam path. Never activate laser without focusing hand piece. The laser light that is emitted from the mirror joint arm has a divergence that is so low that even in a distance of several meters the laser beam is still focused, which bears significant hazard potential. Preparing the arm for the focusing hand piece Ensure that the lever (2) is set to hand piece. Note: the lever (2) is set to hand piece by factory default. Unscrew the protective plastic cap that is located on the end of the mirror joint arm (see Fig. 5-4). Screw on the selected focusing hand piece (see chapter 7 Accessories, page 81) fingertight. After connecting the focusing hand piece, insert the transparent flushing gas hose into the hose connection of the focusing hand piece (see red circle in figure below). Fig. 5-5: Connection for flushing gas hose, example: focusing handpiece with a focal length of 127 mm. 34 V. 5.4

35 5.6 Preparing the Mirror Joint Arm for Use with a Scanner In order to balance the higher weight of the scanner hand piece compared to other focusing hand pieces, the tension of the mirror joint arm must be set to the stronger value. Unburden the mirror joint arm by pulling it towards the user. Change arm latch (1) from locked position to unlocked position. Swivel arm slightly backwards until adjusting lever (2) can be turned to the scanner position. This requires little effort if the arm has been sufficiently relaxed. If required, relax arm further. Now pull arm again forwards against the spring force and set arm latch (1) to locked position. The arm now has the correct spring force for use with a scanner. V

36 5.6.1 Mounting a Scanner (Normal Scan) Scanner operations with the MCO 25 plus are possible if the laser is equipped with the required accessory equipment. A B C Scanner casing Soft Scan Plus R Scanner hand piece 127 mm Scanner hand piece 200 mm (optional) 1 Connection thread for mirror joint arm 2 Socket for scanner cable connected to laser device 3 Connection for gas hose 4 Beam exit with spacer (tip) 5 Connection thread (red) of scanner and scanner hand pieces 6 Socket for control cable MICRO POINT R Fig. 5-6: Scanner for the MCO 25 plus NOTICE Damage to activated device The scanner and laser must never be connected or disconnected electrically while the device is activated. Switch off the laser before connecting or disconnecting the scanner cable. Unscrew focusing hand piece. Screw connection thread Soft Scan Plus R (1) onto the end of the mirror joint arm. Connect cable connector (7) to laser device. The connection (8) is located on the top of the laser device behind the mirror joint arm. Use ferrite side of the cable (10). Connect the other cable end to the socket on the scanner (2, Fig. 5-6). To remove the scanner cable, pull the connector (7) off the ring (9). First connect flushing gas hose (12, Fig. 5-7:) to the connection (3, Fig. 5-8) on the scanner hand piece. 36 V. 5.4

37 Connect the other end of the flushing gas hose to the connection on the laser device (11, Fig. 5-9). Laying the scanner cable The scanner cable is laid along the mirror joint arm. Leave enough room for the cable on the joints of the arm. Only thus is unimpeded movement of the arm possible. 2 Scanner cable connection on scanner 3 Flushing hose connection on scanner hand piece 8 Scanner cable connection on laser device 10 Ferrite core on scanner cable 11 Flushing gas hose connection on laser device 12 Flushing gas hose 13 Scanner cable 14 Fixing clip for scanner cable 15 Fixing strap for scanner cable and gas hose Fig. 5-10: Laying the cable for the MCO 25 plus scanner V

38 5.6.2 Scanner Hand Piece Standard, 127 mm Standard scanner operation with the MCO 25 plus is possible if the laser is equipped with the required accessory equipment. Connect the scanner hand piece 127 mm (B, Fig. 5-6) included in the delivery after connecting the scanner casing and cable. SCAN settings, example scan shape square Setting ranges scanner hand piece 127 mm Power Figure size Scan shapes Scan speed W 2 8 mm Triangle, rectangle, polygon, ring, line low, middle, high The scan speed defines the dwell time of the laser at the application site. The laser light is evenly lead over the area of the selected shape by the scanner so that the area is treated homogeneously Scanner Hand Piece Optional, 200 mm An optional 200 mm scanner hand piece is available that can be used to achieve larger figure shapes. Select 200 mm in the list (D4, Fig. 6-3). Table 6-12, page 59 indicates the sizes of scanning shapes available with this scanner hand piece. 38 V. 5.4

39 5.6.4 Mounting a Scanner (Fractionated Scan) Fractionated scanner operation with MCO 25 plus is possible if the laser is equipped with the required accessory equipment. Scanner casing and scanner cable are connected as done for normal scanner operations (see chapter Mounting a Scanner (Normal Scan), page 36). For fractionated scanning, the scanner hand pieces SOFT FRAC and POWER FRAC are used. Fig. 5-11: Fractionated scanner for the MCO 25 plus A Scanner casing Soft Scan Plus R B Scanner hand piece SOFT FRAC C Scanner hand piece POWER FRAC 1 Connection thread for mirror joint arm 2 Socket for scanner cable connected to laser device 4 Beam exit with spacer (tip) 5 Scanner connection thread scanner hand pieces 3 Connection for gas hose 6 Socket for control cable MICRO POINT R V

40 5.7 Relocating the Device NOTICE Damage may be caused by vibrations! Move device carefully to avoid exposing the optical components to strong shocks or vibrations. NOTICE Risk of damage to property The device may be placed only on floors with a maximum inclination of 5! Remove key and store safely before transport within the building. Secure mirror joint arm before transport within the building (see following chapter). Unblock the front casters before any transport. The cooling water of the laser is frost-proof down to a temperature of -10 C (14 F). Do not transport the laser at temperatures of below -10 C (14 F) outside the building. For transport of the device in a vehicle, dismount the mirror joint arm and transport it separately. See chapter Mounting and Securing the Mirror Joint Arm, page 32. Transport the laser lying on its front side. Place a soft pad under the display on the load area. Place another pad at the end of the laser over the castor holders. Place the laser with its front on this pad and secure against toppling. 40 V. 5.4

41 5.7.1 Upper Parking Position Mirror Joint Arm Lock arm into blue clip (1) The arm with its two branches is held in parallel position. Turn arm in such a way that it tilts slightly forwards. Tighten setting screw of the rotary fixation (2) Rotation of the mirror joint arm is prevented. For use of the laser, the arm can be removed from the holder by slightly pulling the focusing hand piece For working, the setting screw is loosened by a half turn to the left, allowing the arm to be swiveled freely. Fig. 5-12: Laser with locked arm in upper parking position V

42 5.7.2 Lower Parking Position Mirror Joint Arm The lower parking position provides better protection of the mirror joint arm. This parking position is used if the device is to be stored in a space-saving manner (longer break) or if the laser is to be transported over longer distances. Loosen rotary fixation (2) and then first turn the arm as is done for the upper parking position. Slightly pull the arm forwards at position 3. Set arm latch (4) to the unlocked position and then carefully press the arm into parallel position to the floor at position 3. Keep holding the arm at (3) and it move forwards in a curve Press arm into lateral holder (5). The laser is secured. The device can now be moved safely. 5.8 Handover of the Device to the Operator After installation, set-up and functional check by an authorized KLS Martin service partner, the device and all accessory equipment and documents are handed over to the operator. The operator appoints a laser safety officer according to the regional and national regulations. All persons present during the device instruction are to be names in the medical product log. Medical product log, instruction protocol and instructions for use as well as the key are handed over to the employee responsible for the laser device. 42 V. 5.4

43 6 Operating the Device WARNING Danger of physical injury There is the danger of severe injury by laser light if the device is not used in accordance with these instructions for use, or if settings are changed in a manner contrary to what is explained in the listed instructions. Also see chapter 1.3 Intended Use page 8. Any laser device that is not being used must be protected against unauthorized use. If the device is not being used, remove the key and store it in a safe location. 6.1 Switching on the Device CAUTION All persons present in the laser room must wear laser protection goggles! Furthermore, avoid direct eye contact with the red pilot laser light! NOTICE The red EMERGENCY-STOP switch (see chapter 5.2 Front of Device: Overview, page 25) must not be activated. Otherwise unlock the EMERGENCY-STOP switch (see chapter 6.2 EMERGENCY-STOP Switch, page 44) The device is switched on and off via the key switch (see chapter 5.2 Front of Device: Overview, page 25). 1 Vertical key position: OFF 2 Horizontal key position: ON The key can only be removed when it is in vertical position (OFF). V

44 6.2 EMERGENCY-STOP Switch NOTICE Do not use the EMERGENCY-STOP switch for normal shutdown of the MCO 25 plus. The EMERGENCY-STOP switch immediately stops the emission of laser light (see chapter 5.2 Front of Device: Overview, page 25). Activating the EMERGENCY-STOP Press EMERGENCY-STOP switch The emission of laser light is stopped immediately. The device is not de-energized. The switch locks in place when pressed. Deactivating the EMERGENCY-STOP Turn EMERGENCY-STOP switch to the right or to the left until the latch unlocks and the red switch slides out forwards. You can now continue working with the device. 6.3 Switching Off the Device Press the key (standby). Turn key switch by 90 in counterclockwise direction. Remove key. Store key in a safe location. 6.4 Basic Setting of the Device The user can adjust the laser parameters as desired. The user can choose between Time Setup and Frequency Setup. Five languages are available. 44 V. 5.4

45 The user can individually select the settings. It is, however, recommended to have a service technician define the default settings upon initial commissioning of the device. Time Setup Time Setup is the default setting when the device is delivered to the customer. The pulse parameters are selected by entering the pulse duration and pause time. Frequency Setup The pulse parameters are selected by entering the pulse duration and pulse frequency Changing Setup Simultaneously press the key (standby) when switching on the device with the key switch. The following options appear on the display * TIME SETUP FREQ SETUP The asterisk marks the current selection Move the asterisk to the desired mode (Time Setup or Freq Setup) using the arrow keys. Press SELECT to confirm your selection. The starting screen of the laser appears on the display. Further control panel operations are described in chapter Control Panel Keyboard, page Language Selection The user can select from among the following languages: German, English, French, Spanish, Italian Language Selection When switching on the device with the key switch, keep the SELECT key pressed until a selection list of the available languages appears on the display. Use the arrow keys to move the cursor to the desired language. Briefly press the SELECT key again. The laser software program restarts, and the user interface appears in the selected language. For the instructions for use, German was selected as the language. V

46 6.5 Control and Display Elements Control Panel Overview Fig. 6-1: MCO 25 plus control panel 1 LCD display 2 Laser activation light 3 Control panel 46 V. 5.4

47 6.5.2 Control Panel Keyboard In the following text, the laser keyboard is used with the descriptions below. SELECT (selection) Memory M1 Arrow down (decrease) Memory M2 Arrow up (increase) Memory M3 Standby (laser operation not possible) Memory M4 PILOT (pilot laser on / off) Memory M5 Laser Ready (laser can be activated) Triangle (scan shape triangle) CW (continuous laser output) Square / rectangle (scan shapes) Pulse (single laser pulse) Hexagon / circle (scan shapes) Multiple pulse (continuous pulses) Rings (scan shapes) SUPER PULSE (continuous super pulse) Line (scan shapes, different curves) CYCLE (repetitions) Fig. 6-2: Control panel keyboard V

48 Time Mode In Time Mode the following parameters are displayed: Fig. 6-3: Control panel with display in Time Mode (CW and pulse operation) D Display and display elements M Memory keys- L Laser emission display P Keys for parameter pre-settings F Function keys S Keys for operation mode selection C Scanner control keys 48 V. 5.4

49 Frequency Mode In Frequency Mode the following parameters are shown: Fig. 6-4: Control panel with display in Frequency Mode (CW and pulse operation) D Display and display elements M Memory keys L Laser emission display P Keys for parameter pre-settings F Function keys S Keys for operation mode selection C Scanner control keys V

50 6.5.3 Description of Control Keys No. Name Function Description L1 Emission indicator Indicator lit when laser light is being emitted Function indicator and laser warning indicator lit yellow S1 Standby When this key is pressed, the device switches to a safe operating mode; laser emission is not possible Default operating mode after switching on the device; green-lit S2 PILOT When this key is pressed, the pilot laser light is activated or deactivated Operating mode of the pilot laser, on and off, yellow-lit S3 Laser Ready Laser is ready and laser light can be activated by pressing the foot switch Button lit yellow, flashing in alternation with S1 during power check P1 Selection of laser parameters This key cyclically scrolls through the parameters shown on the display from top to bottom The selected parameter appears inverted on the display P2 Decrease Pressing this key gradually decreases the selected parameter value Single decrease upon pressing once briefly, repeated decrease when keeping pressed P3 Increase Pressing this key gradually increases the selected parameter value Single increase upon pressing once briefly, repeated increase when keeping pressed P2 / P3 Rotating Rotate the scan shapes line and curved line Rotation of the line scan shapes M1 M2 M3 M4 M5 Memory 1 Memory 2 Memory 3 Memory 4 Memory 5 Load the stored settings with all parameters. If the key is pressed for more than 5 s, the current settings are stored, which is confirmed by an acoustic signal. Memory keys Loading (short press) Storing (long press) Table 6-5: Control keys on the control panel 50 V. 5.4

51 6.5.4 Description of Function Keys No. Name Function Description F1 CW Continuous laser light Selects continuos laser mode (CW). Function key, lit yellow, laser stops after release of foot switch F2 Single pulse Selects single pulse mode, laser emits one individual light pulse Function key, lit yellow, laser stops at end of pulse F3 Multiple pulse Selects multiple pulse mode, laser emits repeated light pulses Function key, lit yellow, laser stops after release of foot switch, can be combined with cycle F5 F4 Super pulse Selects super pulse mode, laser emits very short, intensive repeated pulses Function key, lit yellow, laser stops after release of foot switch, can be combined with cycle F5 F5 Cycle The cycle mode generates repeated pulse packets together with F3 or F4, and generates automatically recurring scan shapes / lines when combined with C Function key, lit yellow C1 Scan shape triangle Selects the scanner function; repeated pressing rotates the triangle by 90 counterclockwise Scanner key, lit yellow, single scan, (periodic with F5, laser stops after release of foot switch) C2 Scan shape square / rectangular Selects the scanner function; repeated pressing rotates the square and then the rectangle by 45 Scanner key, lit yellow, single scan, (periodic with F5, laser stops after release of foot switch) C3 Scan shape hexagon / circle Selects the scanner function; pressing twice rotates the hexagon by 30, pressing three times selects the circle Scanner key, lit yellow, single scan, (periodic with F5, laser stops after release of foot switch) C4 Scan shape ring Selects the scan function; repeated pressing selects thin or thick ring Scanner key, lit yellow, single scan, (periodic with F5, laser stops after release of foot switch) C5 Scan shape line / curved line / strongly curved line Selects the line scan shape Scanner key, lit yellow, single scan, (periodic with F5, laser stops after release of foot switch) Table 6-6: Function keys on the control panel V

52 6.5.5 Display Description No. Mode Name Function Description D1 F, C Power, Max Power Laser output power in W, maximum power in pulse or multiple pulse mode 2 W 25 W cont. (F1), 10 W 25 W pulse and scan (F2, F3, C1 C5) D2 F Pulse D2 C Figure size D3 TM Pause D3 FM Pulse rate Duration of the pulse in ms or s Side length or diameter of the scanned shape in mm Pause between two pulses, displayed in ms or s Pulse frequency or pulse rate, number of pulses per second in Hz 5 ms 10 s (F2, F3) See table for sizes 5 ms 10 s (F3) 5 ms 0.1 s (F4) 0.1 Hz 5 Hz (F3) 0.1 Hz 200 Hz (F4) D3 F4 Average Power Super pulse output average power W D3 C Scanner speed Selects the speed of the scanned laser light slow (1-fold) medium (2-fold) fast (4-fold) D3 SC Scanner overlap Frequency of the super pulse rate light (0 %), medium (50 %), strong (80 %) overlapping D3 FC Scanner fill factor Amount of treated area light (20 %), medium (50 %), strong (80 %) D4 Cycle Length Duration of a cycle in ms or s 0.1 s 10 s (F3, F4) D4 C Hand piece Selects the scanner hand piece Scanner hand piece 127 and 200 mm, micromanipulators and special optics D5 TM Cycle Pause D5 FM Cycle Rate Duration between two cycles, displayed in ms or s Cycle rate, number of cycles per second in Hz 0.1 s 10 s (F3, F4) 10 ms 10 s (C) 0.1 Hz 5 Hz (F3, F4, C) D6 Pilot Intensity of pilot laser light, operating mode Adjustable brightness 1 % 100 %, Flashing (long pressing), temporary OFF (double pressing) D7 F Average Power Average laser energy calculated from pulse, pause time and maximum power 0.1 W 25 W, is calculated and displayed D7 C Energy area density Laser energy per area (constant when changing shape / size) Energy area density in J/cm² D8 Displays function symbol Laser mode symbol (F, FC) scan shape with type and orientation (C, SC) Function key symbol and selection for scanner function D8 C5 Line scan shape Shape of the line with gradual rotations Rotation of the line scan shape with keys P2 and P3 Table 6-7: TM = Time Mode, FM = Frequency Mode (F) = Function F1 F5, (C) = Scanner function C1 C5, (SC) = Super pulse scanning, (FC) = Fractionated scanning 52 V. 5.4

53 6.6 Setting Laser System Parameters The user can select the operating mode (continuous wave, single pulse, pulse sequence, super pulse and scanner) as well as the corresponding parameters such as laser power output, pulse duration, size of the scan shapes, as desired. The selected values will always be shown on the LCD display. In addition, the average laser output is displayed. These parameters can be changed any time and in any order after the device has been switched on. The keyboard is automatically locked when the foot switch is activated during laser treatment Continuous Operation This operating mode works with continuous laser light at continuous laser output as long as the foot switch is activated. This mode is only available for CO 2 lasers with direct current excitation, which is possible with the MCO 25 plus. This laser mode is often called CW (continuous wave). Parameters in Continuous Operation Power output (average power) Use the SELECT key to select the field POWER. Increase or decrease the power output value using the arrow keys. Both keys have an automatic repetition function which increases or decreases the value repeatedly when the key is held down. The selected value is shown on the LCD display. Setting range: 2 25 W in steps of 1 W Single Pulse Mode NOTICE Interruption of the laser treatment in case of inadvertent release of foot switch! For safety reasons, the foot switch control has absolute priority. If the foot switch is released, the laser is deactivated immediately regardless of the time setting. The single pulse allows a one-time laser application with defined time and power. While the foot switch is pressed, the emission of laser light is stopped after the preset time has elapsed. If the foot switch is released during the preset single pulse time, the emission of laser light is interrupted immediately. V

54 Parameters in single pulse mode Power output (POWER) Use the SELECT key to select the field POWER. Increase or decrease the power output value using the arrow keys. Both keys have an automatic repetition function which increases or decreases the value repeatedly when the key is held down. The selected value is shown on the LCD display. Setting range: W in steps of 1 W Pulse duration Use the SELECT key to select the field Pulse. Increase or decrease the pulse duration value using the arrow keys. Both keys have an automatic repetition function which increases or decreases the value gradually when the key is held down. Setting ranges From To In steps of 5 ms 10 ms 1 ms 10 ms 100 ms 10 ms 0.1 s 1 s 0.1 s 1 s 10 s 1 s Fig. 6-8: Single pulse display 54 V. 5.4

55 6.6.3 Multiple Pulse Mode When the foot switch is activated, the laser emits a sequence of laser pulses until the foot switch is released. The display also shows the average laser output (AVERAGE POWER) that is derived from the power output (MAX POWER), the PULSE and the pause time (PAUSE) or the PULSE RATE, respectively. Parameters in multiple pulse mode Power output (MAX POWER): The output of the laser is set as in single pulse or continuous wave mode Setting range: W in steps of 1 W Pulse duration: The pulse duration is set as in single pulse mode. Setting range: 5 ms 10 s Pulse pause (Pause) Use the SELECT key to select the Pause field. Now increase or decrease the pulse pause value using the arrow keys. Both keys have an automatic repetition function which increases or decreases the value gradually when the key is held down. The selected time defines the duration from the end of one pulse to the beginning of the next pulse. Setting ranges From To In steps of 5 ms 10 ms 1 ms 10 ms 100 ms 10 ms 0.1 s 1 s 0.1 s from 1 s 10 s 1 s Pulse frequency (pulse rate), in frequency mode, the pulse frequency can be set alternatively. This is the number of pulses per second: Setting ranges From To In steps of 0.1 Hz 10 Hz 0.1 Hz 1 Hz 10 Hz 1 Hz 10 Hz 50 Hz 10 Hz V

56 CYCLE In CYCLE mode, the CYCLE key is pressed in addition to the multiple pulse key. The display shows the parameters CYCLE LENGTH and CYCLE PAUSE or CYCLE RATE, respectively. Setting ranges for cycle length From To In steps of 0.1 s 1 s 0.1 s 1 s up to 10 s 1 s Setting ranges for cycle pause From To In steps of 0.1 s 1 s 0.1 s 1 s 10 s 1 s Setting ranges for cycle rate From To In steps of 0.1 Hz 10 Hz 0.1 Hz 1 Hz 10 Hz 1 Hz 10 Hz 50 Hz 10 Hz Fig. 6-9: Times in multiple pulse mode 1 Duration of a pulse: Pulse 2 Duration of pause between two pulses: Pause 3 Duration of cycle: Cycle length 4 Duration of pause between two cycles: Cycle pause 56 V. 5.4

57 Fig. 6-10: Display of multiple pulse with cycle function Super Pulse Mode In super pulse mode, the laser generates very short laser light pulses that have enhanced intensity due to the physical process in the laser tube. This enables the user to work very athermally thanks to the high maximum power output and low pulse energy. While the foot switch is activated, the laser generates a sequence of short light pulses in the set intervals until the foot switch is released again. Only the pulse intervals and the pulse frequency can be set on the display. Pulse width and output level are non-adjustable. In addition, the average laser output is shown. Parameters in super pulse mode Setting range: Average laser power W The super pulse mode can be combined with CYCLE. The cycle times are set as done in multiple pulse mode (see chapter Multiple Pulse Mode, page 55). Fig. 6-11: Display of super pulse with cycle function V

58 6.7 Scanner Operations Display When any of the scanner keys C1...C5 is pressed, the display switches to the screen shown below: D Display D1 Maximum power D2 Size of scan shape D3 Scanner speed D4 Focal length of scanner hand piece D5 Cycle pause option (when F5 is held down) D6 Pilot laser brightness D7 Resulting energy density D8 Scan shape with orientation C1...C5 Scan shapes S1 Standby S3 Laser ready L1 Laser emission display P1 Select key P2, P3 Adjustment keys M1...M5 Memory keys F1...F4 Operating mode F5 Cycle key S2 Pilot laser 58 V. 5.4

59 6.7.2 Scanner Mode Parameters Setting range for maximum power: from W in steps of 1 W. Figure size: Use the SELECT key to select the field Figure size. Now increase or decrease the value using the arrow keys. Setting ranges: The size range of the scan shapes depends on the scanner hand piece connected to the scanner. Shape 127 mm 200 mm Triangle 2 8 mm 3 13 mm Square Rectangle 2 8 mm 3 13 mm 4 8 mm 6 13 mm Hexagon 2 8 mm 3 13 mm Circle Thick ring 2 8 mm 3 13 mm 6 8 mm 9 13 mm Thin ring 4 8 mm 6 13 mm Straight line Curved line 1 5 mm 1 9 mm 1 5 mm 1 9 mm Strongly curved line 1 5 mm 1 9 mm Table 6-12: Size of scan shapes for scanner hand pieces NOTICE The energy density is the important parameter for the effects on the tissue. When the size of the scan shape is changed, the set energy density is not. This means that the effects on the tissue remain constant. Settings for scan speed: low, middle, hight The exposure times of the laser per location resulting from the speeds are below the thermal tissue relaxation time of 0.7 ms. The scanning speed is doubled when changed from low to middle and again from middle to high. V

60 NOTICE If the energy density is constant, the thermal strain on the tissue is reduced with increased scan speed. Hand piece versions: Scanner hand piece 127 mm, 200 mm The scanner hand pieces are different from the focusing hand pieces for normal laser applications. To avoid confusion, the scanner hand pieces are color-coded. In addition, the connection threads differ to avoid connecting the focusing hand piece to the scanner. The size of the scanned area and the diameter of the beam focus change depending on the focal length of the scanner hand piece. Cycle pause: The field D5 (Fig. 6-3) displays the duration between two successive scans. While the foot switch is activated, you can perform successive scans, enabling you to treat larger tissue areas faster. The scanner hand piece can be repositioned in the pause time that can be selected. The pause time can be set to OFF for forced ablation using the scanner. To do this, reduce the duration by pressing the key until OFF appears. Energy density: The field D7 (Fig. 6-3) shows the calculated energy density in mj/cm² which is derived from the laser power output, the scan speed and the size of the focal point. The energy density is the parameter that is important for the effects on the tissue. When the size of the scan shape is changed, the set energy density is not. This means that the effects on the tissue remain constant. The range in which the energy density can be adjusted is shown in the following table. Scanner hand piece Selectable laser output [W] Energy density [J/cm²] Scan speed Scanner hand piece 127 mm HIGH MIDDLE LOW Scanner hand piece 200 mm HIGH MIDDLE LOW Table: 6-13: Energy density ranges when scanning with scanner hand pieces 60 V. 5.4

61 6.7.3 SOFT FRAC For a surface scanning effect with low penetration depth, connect the scanner hand piece SOFT FRAC to the scanner and select the setting SOFT FRAC in the menu HAND PIECE. Via control of the scanner, the laser generates a surface-filling number of spots with a diameter of 0.8 mm. Setting SOFT FRAC, example scan shape square Hand piece selection SOFT FRAC Setting ranges POWER 10 W 25 W Energy density FIGURE SIZE SCAN SHAPES 2 mm 10 mm Triangle, rectangle, polygon FILL FACTOR LIGHT 20 % of area filled MEDIUM STRONG J/cm² 50 % of area filled 80 % of area filled The fill factor determines the number of fractionated laser spots on the selected scan shape (filling density). The number of dots per area can be determined using the fill factor. There are 3 different fill factors to choose from. The following illustration shows the dot density for the different fill factors. Effect of the FILL FACTOR using the scan shape square as an example LIGHT MEDIUM STRONG V

62 The order in which the laser dots are generated is irregular, which minimizes the thermal strain on the tissue. Fig. 6-14: Generation of individual dots in irregular order (example: square) POWER FRAC For a dotted scanning effect with high penetration depth, connect the scanner hand piece POWER FRAC to the scanner and select the setting POWER FRAC in the menu HAND PIECE. When using the scanner, the laser generates a surface-filling number of spots with a diameter of 0.2 mm. Setting POWER FRAC, example scan shape square Hand piece selection POWER FRAC Setting ranges POWER 10 W 20 W FIGURE SIZE 1 mm 5 mm SCAN SHAPES Triangle, rectangle, polygon FILL FACTOR LIGHT 20 % of area filled MEDIUM 50 % of area filled STRONG 80 % of area filled Energy density J/cm² The FILL FACTOR determines the number of fractionated laser spots on the selected scan shape. 62 V. 5.4

63 6.8 Additional Accessory for the Scanner Mode Via the menu item hand piece selection (D4, see chapter Display, page 58) you can select the micromanipulators MINI POINT and / or MICRO POINT with their respective selectable focal lengths. Selecting this option in the selection menu HAND PIECE is done upon installation of the laser or any time later by the service. The micromanipulators allow scanning shapes and lines as described in the following chapters. NOTICE The application parts available in the menu HAND PIECE can be expanded or modified by our technical service. Should an application part not be selectable, contact the Martin Service Center that will add the part to the selection list MINI POINT Micromanipulator By selecting the MINI POINT in D4 (see chapter Display, page 58) and its focal length, this micromanipulator can be used with the scanner. Shape Focal length MINI POINT 200 mm 250 mm 300 mm 350 mm 400 mm Triangle 3 12 mm 4 15 mm 4 18 mm 5 21 mm 6 24 mm Square 3 12 mm 4 15 mm 4 18 mm 5 21 mm 6 24 mm Rectangle 6 12 mm 7 15 mm 9 18 mm mm mm Hexagon 3 12 mm 4 15 mm 4 18 mm 5 21 mm 6 24 mm Circle 3 12 mm 4 15 mm 4 18 mm 5 21 mm 6 24 mm Thick ring 9 12 mm mm mm mm mm Thin ring 6 12 mm 7 15 mm 9 18 mm mm mm Straight line 1 8 mm 1 11 mm 1 13 mm 1 15 mm 1 17 mm Curved line 1 8 mm 1 11 mm 1 13 mm 1 15 mm 1 17 mm Strongly curved line 1 8 mm 1 11 mm 1 13 mm 1 15 mm 1 17 mm Table: 6-15: Sizes of scan shapes when scanning with the MINI POINT micromanipulator V

64 6.8.2 MICRO POINT 2 / 2R Micromanipulator By selecting the MICRO POINT 2 / 2R in D4 (Fig. 6-3) and its focal length, this micromanipulator can be used with the scanner. MICRO POINT Selectable laser output [W] Energy density [J/cm²] Scanning speed HIGH MICROPOINT 225 mm MIDDLE LOW HIGH MICROPOINT 250 mm MIDDLE LOW HIGH MICROPOINT 300 mm MIDDLE LOW HIGH MICROPOINT 350 mm MIDDLE LOW HIGH MICROPOINT 400 mm MIDDLE LOW HIGH MICROPOINT 450 mm MIDDLE LOW HIGH MICROPOINT 500 mm MIDDLE LOW Table 6-16: Setting ranges of laser power and resulting energy densities when using MICRO POINT 2 / 2R 64 V. 5.4

65 The scan shapes can also be selected via the setting MICRO POINT 2 / 2R. Focal length MICRO POINT 2 / 2R Shape 225 mm 300 mm 400 mm 450 mm 500 mm Triangle 1 5 mm 2 6 mm 2 8 mm 2 10 mm 3 11 mm Square 1 5 mm 2 6 mm 2 8 mm 2 10 mm 3 11 mm Rectangle 3 5 mm 3 6 mm 4 8 mm 5 10 mm 5 11 mm Hexagon 1 5 mm 2 6 mm 2 8 mm 2 10 mm 3 11 mm Circle 1 5 mm 2 6 mm 2 8 mm 2 10 mm 3 11 mm Thick ring 4 5 mm 5 6 mm 6 8 mm 7 10 mm 8 11 mm Thin ring 3 5 mm 3 6 mm 4 8 mm 5 10 mm 5 11 mm Straight line 1 3 mm 1 4 mm 1 6 mm 1 7 mm 1 7 mm Curved line 1 3 mm 1 4 mm 1 6 mm 1 7 mm 1 7 mm Strongly curved line 1 3 mm 1 4 mm 1 6 mm 1 7 mm 1 7 mm Table 6-17: Sizes of scan shapes when scanning with the MICRO POINT micromanipulator When using the micromanipulator MICRO POINT 2 / 2R, you can perform micro scanning with the laser. For this purpose, you can select the setting MICRO-FINE with the corresponding focal length of the MICRO POINT 2 / 2R in the menu HAND PIECE. This setting combined with the different scan shapes allows minimal laser areas down to 0.4 mm. The following table shows the different figure sizes in relation to the focal length of the micromanipulator MICRO POINT 2 / 2R: Focal length MICRO POINT 2 / 2R, setting MICRO-FINE Shape 225 mm 300 mm 400 mm 450 mm 500 mm Triangle mm mm mm mm mm Square mm mm mm mm mm Rectangle mm mm mm mm mm Hexagon mm mm mm mm mm Circle mm mm mm mm mm Thick ring mm mm mm mm mm Thin ring mm mm mm mm mm Straight line mm mm mm mm mm Curved line mm mm mm mm mm Strongly curved line mm mm mm mm mm Table 6-18: Sizes of scan shapes when scanning using the micromanipulator MICRO POINT 2 / 2R with setting MICRO-FINE V

66 6.9 Special Scanner Functions Continuous Scan CYCLE PAUSE / CYCLE RATE Setting: OFF When setting a cycle pause of less than 10 ms or a cycle rate of more than 5 Hz, OFF appears on the display and continuous scanning without pause is activated as long as the foot switch is pressed CYCLE CYCLE PAUSE (Setting TIME MODE) Setting range: 10 ms 10 s CYCLE RATE (Setting FREQUENCY MODE) Setting range: 0.1 Hz 5 Hz Fig. 6-19: Setting CYCLE SCAN, Frequency Mode in example above When selecting the repetition function CYCLE for multiple use of the scan shapes, the time between two scans (Time Mode) or the repetition frequency (number of scans per second, Frequency Mode) appears in the menu line D5. The scan shape is repeated as long as the foot switch is activated. 66 V. 5.4

67 6.9.3 Line Scanning The laser has the function key C5 for line scanning that is especially intended for surgical laser applications of the scanner. The line can be straight, curved or strongly curved. You can switch between the selections by pressing the key C5. D1 D2 D3 D4 D5 D6 Maximum power Size of scan shape Scanner speed Focal length of scanner hand piece Cycle pause option (when F5 is held down) Pilot laser brightness D7 D8 Resulting energy density Type and orientation of line C5 Selection key for line scanning; press repeatedly to select line type Fig. 6-20: Display for scanner mode LINE SCANNING Press the key SELECT repeatedly to turn the line Field D8 is displayed inverted The arrow keys (counterclockwise rotation) and (clockwise rotation of the line) are used to select the rotating direction of the line. The shape is rotated in steps of 5. Control the effect of the rotation with the pilot beam pattern. Rotate line until the desired setting is achieved. NOTICE No energy area density is shown during the line scanning process. These scan shapes are intended for surgical cutting procedures and have a high energy density. HIGH is shown on the display. V

68 NOTICE The angle setting of the line on the display does not correspond to that in the operation area. It depends on the position of the laser relative to the user and on the current position of the scanner, as well as on the orientation of the application optics. To achieve a precise orientation of the scan shape in the application area, do not change the position of the laser device, mirror joint arm, scanner and application optics after they have been positioned MICRO POINT 2R Connection 1 MICRO POINT 2R 4 MICRO SWITCH connector 2 Soft Scan Plus R 5 MICRO SWITCH 3 Control socket for MICRO SWITCH connector Connect Soft Scan Plus R (2) to the joint arm (see chapter Mounting a Scanner (Normal Scan), page 36). Insert signal cable of the MICRO SWITCH (4) into the control socket (3). The MICRO POINT 2R (1) is ready for use. The line scanning function can now be controlled from the display or directly via the MICRO SWITCH or MICRO POINT 2R, respectively, if the laser is set to Laser Ready. 68 V. 5.4

69 Line Control When using the micromanipulator MICRO POINT 2R with MICRO SWITCH, the selection of the straight or curved line and its orientation can be done via the micromanipulator. 1 Key for clockwise rotation 2 Key for selection of line curve 3 Key for counterclockwise rotation 4 Joystick for positioning the line scanning shape display when rotation the line Fig. 6-21: Micromanipulator MICRO POINT 2R Rotation and line selection 1 Line rotation 2 Line selection V

70 Line Scanning with Super Pulse When using the line scanning shapes you can also use the super pulse mode instead of continuous laser light. Press the super pulse key (F4) and then directly the line key (C5). This function is shown next to the scanning line on the display. 70 V. 5.4

71 Super Pulse Line Scanning With Cycle By pressing the key F5, you can activate the repetition function for the super pulse line scan. The line is scanned cyclically as long as the foot switch is activated. Between every scan and the next, the laser is stopped for the duration of the cycle pause time Continuous Line Scanning The cycle pause can be set to OFF for continuous scanning. To this purpose, decrease the cycle pause setting until OFF appears on the display. The line is continuously scanned with super pulses as long as the foot switch is activated. V

72 Overlap Using the parameter OVERLAP you can adjust the effect of the super pulse line scan. A stronger overlap results in a higher power density and a stronger effect. Effect of the overlap parameter used with line scanning LIGHT (0 %, no overlap) MEDIUM (50 %, half of the area overlaps) STRONG (80 %, large part of the area overlaps) 6.11 Memory Functions Storing of Parameters NOTICE When switching from Time Mode to Frequency Mode and back, the stored parameters are lost. The names of the storage locations can be carried over Using the memory keys M1 M5 (Fig. 6-3), the laser parameter settings shown on the display are stored and loaded. You can store up to five different settings. The parameters remain stored even when the laser device is switched off. Saving the settings To save the current settings, press a memory key (M1 M5) and hold it down for about 5 seconds. Fig. 6-22: Storing the setting CW, 15 W, pilot brightness 55 % 72 V. 5.4

73 After holding M1 for several seconds, a menu appears in which you can enter the name for a memory location. The menu allows deleting existing names, changing them or entering a new name for the memory location. D8 Display of the memory location whose name can be entered or changed P2, P3 Selection of NO or YES P1 M1 Confirmation of NO or YES Memory key In the menu, the number of the memory location is shown together with the name of the memory location. If no name is saved, only the title M1...M5 is shown in the first line of the display. Option NO: the existing name is kept unchanged and the set parameter values are stored in this memory location. Option YES: another menu opens where you can enter or change the memory name. V

74 D8 D7 F1 F5 P2 P3 P1 S1 Display of the memory and the entered text Letter / number field Keys used to move the cursor in the field D7 Key used to confirm a letter or number Key used to delete a letter or number After entry, select the field STORE and confirm by pressing P1 (SELECT). The device accepts the name and the parameters and saves them in the selected storage location (M1 in the example). In addition to the parameters laser power, operating mode, pulse and pause times, frequencies, focusing / scanner hand piece, scan shapes, scanning speed, cycle values, the parameter pilot laser brightness is saved as well Loading of Parameters NOTICE If no scanner is connected and you try to load a memory location in which a scanner setting is stored, the display will show the message PLEASE CONNECT SCANNER. You can dismiss this message with Standby. Install scanner only when laser is switched off! 74 V. 5.4

75 The stored parameters appear on the display when the memory keys (M1 M5, Fig. 6-3) are briefly pressed. The number of the memory location and the saved name of the memory or the application are shown above the symbol of the operating mode (D8). V

76 6.12 Pilot Laser The red pilot laser light is used to mark the spot where the CO 2 laser beam will be applied. The protective laser goggles do not protect against pilot laser light! Do not directly look into the pilot laser! Activate the pilot laser light by pressing the key PILOT (S2). Use the SELECT key (P1) to select the lower menu line on the display. Adjust the pilot beam brightness to a value from 1 % to 100 % using the arrow keys (P2 and P3). When the laser is activated by pressing the key Laser Ready (S3), the red pilot laser beam is automatically switched on. The yellow lamp on the PILOT key (S2) indicates that the pilot laser is activated Deactivating the Pilot Laser Sometimes it may be necessary to deactivate the pilot laser either in standby or in active mode. Deactivation while in standby Laser is set to Standby Press the PILOT key twice within three seconds. S1 Standby S2 PILOT S3 Laser Ready Pilot laser is deactivated. You can switch the pilot laser on again by pressing the key Laser Ready or Standby 76 V. 5.4

77 Deactivation while in active mode Deactivation of the pilot laser in active mode is permissible only if the location of the laser application is clearly indicated by the needle-shaped tip of the focusing hand piece. Set laser to Laser Ready. Press the PILOT key twice within 3 seconds. When pressed once, the yellow indicator lamp starts blinking. Indicator lamp turns dark after pressing the PILOT key a second time within three seconds. If the key is not pressed a second time within three seconds, the pilot laser remains activated. If the key is pressed a second time within three seconds, the pilot laser is deactivated. You can switch the pilot laser on again by pressing the key Laser Ready Pilot Laser in Flashing Mode In order to increase the visibility of the pilot laser, you can, if required, select the flashing operating mode. Press the PILOT key (S2) and hold it for more than four seconds. The pilot laser now blinks with approx. 5 Hz Higher visibility thanks to stronger contrast To turn off the flashing (continuous operating mode), press the PILOT key (S2) and hold it for more than four seconds Applying the Laser CAUTION Risk of injury to eyes if used without protective goggles! Ensure that all persons present in the room including the patient are wearing protective laser goggles. Put on protective laser goggles before pressing the key Laser Ready. Make sure that all persons present are wearing protective goggles. Also make sure the patient is wearing protective goggles. Make sure that no one looks directly into the pilot laser light. V

78 CAUTION Danger of fire! Do not press the key Laser Ready before the focusing hand piece is pointed at the operation area and all measures to avoid laser-induced fires and explosions described above are complied with. NOTICE Danger of damage to optics of the focusing hand piece! Make sure that no blood, tissue or fume enters the hand piece during the treatment. The optics of the focusing hand piece could be damaged due to the absorption increased thereby. Particles that may stick to the optics must be removed, taking into account the cleaning regulations. The focusing hand piece must be removed before any cleaning processes. For this purpose, set the laser to Standby. NOTICE Danger of unintentional laser activation! For safety reasons, the laser device must be set to Standby if use is interrupted for a longer period. As long as the green Standby key is lit, the laser cannot be activated inadvertently. Press the key Laser Ready (S3) to set the laser to readiness. The laser now internally checks the set laser power. During this check, the lamps of the keys Standby (S1) and Laser Ready (S3) flash in alternating fashion. After the check, the key Laser Ready (S3) is permanently lit yellow. CAUTION Danger of physical injury due to wrong parameters! Before activating the foot switch on the control panel, check the set parameters once more. 78 V. 5.4

79 Switch on the laser light by pressing the foot switch. The laser emission display L1 is lit At the same time, a high warning sound can be heard for the duration of the laser treatment. If the foot switch is released before the set pulse time has elapsed, the laser emission stops immediately. The originally set pulse time will be used again if the foot switch is pressed again System Check When the MCO 25 plus is switched on, the display shows the starting screen for some ten seconds. It shows the KLS Martin logo and the software version number. Check the blue display for screen errors. After a system check, the starting screen switches to the display of the laser parameters with default settings. V

80 LCD Contrast Adjustment NOTICE If you cannot see the symbols properly after switching on the display, adjust the contrast until the display appears correctly. The contrast of the LCD display can be adjusted and adapted to the ambient conditions. Press and hold the SELECT key. Additionally, press one of the two arrow keys. The key combination SELECT and darkens the contrast. The key combination SELECT and brightens the contrast. The contrast is adjusted after the key has been pressed for one second and stops as soon as you release the key. 80 V. 5.4

81 7 Accessories Use only the original accessory equipment listed below. The list may be updated and changed. The current list can be requested from Gebrüder Martin. 7.1 Focusing Hand Pieces and Tips Name Illustration Focusing hand piece, focal length 50 mm Item no Tip for focusing hand piece 50 mm Item no Focusing hand piece, focal length 127 mm Item no Tip for focusing hand piece 127 mm Item no Focusing hand piece, focal length 200 mm Item no Tip for focusing hand piece 200 mm Item no Backstop for focusing hand piece 127 mm Item no Backstop for focusing hand piece 200 mm Item no Angle for focusing hand piece 127 mm Item no Angle for focusing hand piece 127 mm, 120 Item no Adapter for focusing hand piece 200 mm Item no V

82 7.2 Micromanipulators MINI POINT Name Item number Micromanipulator MINI POINT (gynecology) Adapter, System Zeiss for MINI POINT Adapter, System Kaps for MINI POINT Adapter, System Möller-Wedel for MINI POINT Adapter, System Leica for MINI POINT Adapter, Zeiss OPMI FC 1 for MINI POINT Adapter, Möller-Wedel VM 500 MINI POINT MICRO POINT 2 / 2R Name Micromanipulator MICRO POINT 2 (ENT, neurosurgery) ZEISS adapter included Micromanipulator MICRO POINT 2R (with MicroSwitch) ZEISS adapter included Item number Adapter, Möller-Wedel VM 900 for MICRO POINT 2 / 2R Adapter, Leica M650 / 651 / 655 for MICRO POINT 2 / 2R Scanner Name Item number Add-on kit scanner Soft Scan Plus R for MCO 25 plus Scanner installation Scanner head complete Scanner connection cable Scanner hand piece 127 mm Scanner hand piece 200 mm Connection adapter for scanner to MINI POINT Connection adapter for scanner to MICRO POINT 2 / 2R Scanner hand piece SOFT FRAC for fractionated scan Scanner hand piece POWER FRAC for fractionated scan V. 5.4

83 7.4 Protective Goggles Order data Laser protection goggles CO 2 D ,600 L5 RH DIN CE acc. to 89/686/EEC (PSA) Laser protection goggles CO 2 for spectacle wearers D L4 RH DIN CE acc. to 89/686/EEC (PSA) Laser protection goggles CO 2 and Nd:YAG D 1060 L6 RH DIN CE acc. to 89/686/EEC (PSA) / DI 10,600 nm L4 RH DIN CE Laser protection goggles CO 2 and Nd:YAG for spectacle wearers D 1060 L7 RH DIN CE acc. to 89/686/EEC (PSA) / DI 10,600 nm L4 RH DIN CE Laser protection goggles universal DI L4 Item no Special Accessories (ENT Set) Name Item no. Special optics set for rhinoplasty consisting of: Optics Attachment 0 for optics Attachment 90 for optics Attachment 120 for optics Brush for attachments Connection adapter for MCO 25 plus to Storz laparoscope Storz coupler laparoscope Olympus coupler laparoscope Storz coupler MCO Connection adapter for scanner to Storz laparoscope Safety Distances (NOHD) For the accessory equipment used with the laser, the following safety distances (NOHD = nominal ocular hazard distance) must be observed. If these distances are exceeded, the allowed limit values for laser treatment and radiation intensity are not complied with. The table also contains the ray divergences for each handpiece. Name NOHD Divergence Data Item no. Focusing hand piece 50 mm 3 m 60 mrad Focal length 50 mm Focusing hand piece 127 mm 5 m 24 mrad Focal length 127 mm Focusing hand piece 200 mm 7 m 16 mrad Focal length 200 mm Special optics set for rhinoplasty 14 m 8 mrad Cannula straight and angled Scanner Soft Scan Plus R 5 m 24 mrad Focal length 127 mm Scanner Soft Scan Plus R 7 m 16 mrad Focal length 200 mm Scanner hand piece SOFT FRAC 6 m 21 mrad Focal length 144 mm Scanner hand piece POWER FRAC 3 m 50 mrad Focal length 63 mm V

84 8 Maintenance When contacting Gebrüder Martin in regard to repairs and maintenance work on the laser device, always indicate the model and the complete serial number. This information can be found on the type plate. The current software version is displayed under the logo when the device is switched on. In case of obvious defects, especially of the mains connector or the connection cable, the operator must have the device repaired immediately. Regular checks and maintenance ensure a long and safe service life of the device. 8.1 Functional Checks The checks described below were performed by the technical service as part of the system check after installation of the device. On occasion, they can be repeated by an experienced user in order to confirm the proper condition of the laser and the optical components. They also serve as the first source of information when contacting the laser service technician Check of the Optical System (Visual Check) The optical system (mirror joint arm, focusing hand piece) must always be checked for proper condition before starting a laser treatment. Ensure that the mirror joints arm is tightly screwed onto the laser. Use backlight to check if the focusing hand piece is clean. Use the SELECT key to select the line PILOT and set a high brightness (approx. 50 %) for the pilot laser. Focus the pilot laser light on a bright (white) surface. The pilot laser beam must regardless of the position of the focusing hand piece and the mirror joint arm be emitted centrally from the focusing hand piece. There must be no diffused red light Check of the Optical System Use laser with focusing hand piece f = 127 mm. Set device to single pulse mode, 10 W, pulse duration 50 ms 0.1 s. Make sure that all persons present are wearing protective laser goggles. Set pilot laser brightness to approx. 20 %. Hold a suitable test object (wooden applicator, paper) into the focal point. Ensure a distance of at least 50 cm under the test object and place non-reflective material there (e. g. operation cloth, floor). Set device to Laser Ready. Activate foot switch. Keep foot switch pressed during the single impulse. Do not move the test object! 84 V. 5.4

85 The focal spot burnt into the test object should exactly match the red pilot beam focus. If, for example, a small hole is burned into the wooden applicator, the red pilot laser beam ideally disappears through the hole and appears on the material below as a red spot. If CO 2 laser beam and pilot beam are not perfectly aligned, the red pilot laser focus appears besides the focal spot. In case of differences of more than 1 mm, the service must be contacted for adjustment of the laser Checking the Air Flow CAUTION Danger of physical injury! Do not activate the foot switch while testing the air flow! Set the device to single pulse mode (10 W, pulse duration 8 ms). Press the key Laser Ready. You can feel a slight air flow at the end of the focusing hand piece. V

86 8.2 Maintenance Inspection Maintenance Frequency To be performed by Inspection of accessory equipment before every surgery Hospital staff Inspection of the pilot beam for coaxial exit from the focusing hand piece Verification that CO 2 beam and pilot laser beam match before every surgery before every surgery Hospital staff Hospital staff Inspection of the laser warning lamp before every surgery Hospital staff Inspection of electrical connections and cables Cleaning and disinfection of device surfaces during every surgery according to internal regulations Hospital staff Hospital staff Safety checks 1 annually Martin Service Center Inspection / replacement of the air cooler filter Inspection of the cooling water level or refilling cooling water, respectively 1 annually Martin Service Center 1 annually Martin Service Center Inspection of the power output level 1 annually Martin Service Center Replacement of the clean air filter every 2 years Martin Service Center Replacement of cooling water 0.75 l distilled water and 0.75 l propylene glycol every 2 years Martin Service Center Table 8-1: Recommended and mandatory maintenance and inspection plan NOTICE Repairs may be performed solely by authorized service technicians of Gebrüder Martin. 86 V. 5.4

87 9 Cleaning and Sterilization 9.1 Cleaning of the Laser Device All outer surfaces of the device including the front plate can be cleaned with commercial cleaning agents that do not contain alcohol. NOTICE Damage to the device! Make sure that no liquids can enter the device openings. Pay special attention to ventilation openings and connections of the mirror joint arm and scanner. Do not use spray for cleaning! The device surfaces can be disinfected with commonly used disinfection agents. Before re-commissioning, make sure that there are no disinfection agent residues on the device. 9.2 Cleaning of Focusing / Scanner Hand Pieces Unscrew and remove focusing hand piece from mirror joint arm or scanner hand piece from scanner. Tips and tubes can be cleaned and steam-sterilized. The optics of the focusing hand piece and the scanner hand pieces must not be immersed in water and not be steam-sterilized. If the surface is visibly contaminated, clean it carefully with a lint-free wipe (e. g. lens cleaning paper) using acetone or pure alcohol. Hold optics tight. Remove dust or deposits from the surface using a hand-held blower. Apply cleaning agent to the lens surface. Fold wipe several times and run the wipe edge once over the surface. The lens is cleaned. At the same time, the cleaning agent is removed. V

88 NOTICE If the optical surface is wiped properly, it is cleaned without visible drying edges or streaks. Wipe in one direction only. Do not wipe in a circle. Clean both sides in the same manner. In case of a high degree of soiling, leave solvent on the surface for a while before wiping. Replace optics if the degree of soiling is too high or if they are damaged. Do not dispose of optics as normal household waste. Defective optics will be disposed of by the technical service of Gebrüder Martin or an authorized service partner. Parts of the focusing hand pieces 1 Tip 2 Tube 3 Optics Focusing hand piece Item no. 1: Tip 2: Tube 3: Optics A: 50 mm B: 127 mm C: 200 mm V. 5.4

89 Parts of the scanner hand pieces 1 Tip 2 Tube 3 Optics Description Item no. 1: Tip 2: Tube 3: Optics A: Scanner 127 mm B: Scanner 200 mm C: Soft Frac D: Power Frac V

90 9.3 Angles Description Backstop 127 mm Backstop 200 mm Adapter Angle Angle Parts of the ENT Set ENT set Illustration Item number 3: Optics : Tube Attachment Attachment Attachment V. 5.4

91 9.5 Cleaning Process Name Tip Item number Tube Focusing hand piece 50 mm Focusing hand piece 127 mm Focusing hand piece 200 mm Scanner hand piece 127 mm Scanner hand piece 200 mm Scanner hand piece SOFT FRAC Scanner hand piece POWER FRAC Backstop 127 mm Backstop 200 mm Adapter Angle Angle ENT hand piece tube ENT attachment ENT attachment ENT attachment Manual precleaning Immerse into cold water for 5 minutes Automatic cleaning Cleaning and disinfection machine Cleaning program Positioning Pre-washing Type of cleaning agent acc. to EN ISO e. g. RDA G7735 CD / Miele Vario TD MIC tray, preferably in own sieve tray 2 min in cold water alkaline Possible cleaning agents Temperature Cleaning time Neutralizing Rinsing 0.5% Mediclean (Dr. Weigert, Hamburg) 55 C (131 F) 5 min 3 min in cold water 2 min in cold water V

92 NOTICE After the cleaning process, the angular pieces and the ENT attachments must be checked for proper function. 9.6 Sterilization Process Name Tip Item number Tube Focusing hand piece 50 mm Focusing hand piece 127 mm Focusing hand piece 200 mm Scanner hand piece 127 mm Scanner hand piece 200 mm Scanner hand piece SOFT FRAC Scanner hand piece POWER FRAC Backstop 127 mm Backstop 200 mm Adapter Angle Angle ENT hand piece tube ENT attachment ENT attachment ENT attachment Steam sterilization Pre-vacuum 3 Sterilization temperature Duration Drying time 132 C (131 F) 3 min depending on loading, 10 min NOTICE Cleaning and sterilization must take into account the aging effects of the material. 92 V. 5.4

93 10 Malfunctions 10.1 Messages on the Display An automatic self-test routine permanently monitors the system and ensures the safety of patients, surgical team and device. Operational and functional faults are indicated by messages on the display. Additionally, the device automatically switches into Standby mode. The messages remain on the display until the Standby key is pressed. After pressing the Standby key, the cause is checked. If the cause does no longer exist, normal operation of the device can be resumed Messages and Required Actions Interlock Error The text line INTERLOCK ERROR appears on the display. There are two causes possible for this message: The external interlock circle was interrupted. It is connected to the socket (4, Fig. 5-1) on the rear of the device. Check door switch. Check connection on the rear of the laser. The mirror joint arm is not connected or not fully screwed on. This is controlled by a micro switch that triggers the message INTERLOCK ERROR if there is a fault. Check the mounting condition of the mirror joint arm Please Connect Scanner The message PLEASE CONNECT SCANNER appears if the scanner mode is selected but the scanner is not connected. Switch off laser. Connect scanner cable to laser device and scanner head. Check plug connections. Switch laser on again and activate scanner function. V

94 Temperature Error The message TEMPERATURE ERROR appears if the cooling water temperature is too high. Check if the ventilation slots on the side of the laser device are blocked. Leave the device switched on until it has cooled down, but do not activate it. As soon as the temperature in the device has reached permissible values, the laser can be activated again after pressing the Standby key Water Flow Error The cooling water flow is monitored by the device. If there are any faults in the cooling water flow cycle, the message WATER FLOW ERROR is displayed. This message often appears in case of air bubbles in the cooling water cycle. Keep the laser activated for a while until the bubbles have exited the water cycle. Should this error message keep appearing, contact the customer service Confirming Every time the key Laser Ready is pressed, or whenever parameters are changed, an internal check of the laser power output is performed. If the power output is not within the allowed tolerance of ± 20 %, the measured power output appears on the display D7. D1 selected power output D7 measured power output S3 Laser ready The user is prompted to press the key Laser Ready (S3) again to confirm that the measured power output is suitable for the use of the laser. 94 V. 5.4

95 The display then shows ACTUAL AVERAGE POWER that may differ from the selected power output. D1 Maximum power D7 actual power Fig. 10-1: Actual average power output after confirmation The current power output is used for the application as usual. Should the message that prompts the user to confirm the current power output appear more often than expected, contact the Martin Service Center Other Messages The display shows messages that have not been listed so far and indicate a fault of the device. Contact the technical service, see chapter 1.8 Hotline, page 9. V

96 10.4 Faults without Display Messages In case of the following fault symptoms, proceed as described in the right column. If the fault cannot be fixed by the recommended measures, contact the technical service (see chapter 1.8 Hotline, page 9.). CAUTION Do not open the casing, as mains voltage and high voltage are present inside the device. Symptom Possible cause Troubleshooting No reaction after activating the key switch No laser emission when pressing the foot switch 1) No power supply Check cables for proper connection 2) Emergency switch activated (pressed) 1) Foot switch is not connected Turn emergency switch and pull out Connect foot switch 2) Device is in standby mode Set device to Laser Ready Pilot laser light is not visible Pilot laser light and CO 2 light are not coaxial 1) Brightness level set too low 2) Optical system is not properly adjusted Optical system is not properly adjusted Increase brightness level Contact the Martin Service Center Contact the Martin Service Center No air flow on the focusing hand piece in Laser Ready mode LCD display is not visible 1) Hose ends are not connected Check hose 2) Air hose is bent or leaky Check hose 3) Functional fault of compressor Contact the Martin Service Center 1) Wrong contrast setting Adjust contract setting 2) Power supply or key illumination defective Contact the Martin Service Center 96 V. 5.4

97 11 Ecological Information 11.1 Disposal of Packing Gebrüder Martin will, as a matter of course, take back the full packaging if so desired, to recycle as many parts of the packaging as possible. If you do not wish to make use of this offer, you can dispose of the packaging with the normal paper or domestic garbage Ecological Aspects of Operation If the treatment is interrupted and the unit is not being used for an extended period, we recommend you to switch it off for safety as well as economic reasons (energy saving). The MCO 25 plus is low-maintenance. There are such wastes produced as can be disposed of as household waste or waste water. Read the respective instructions for accessory equipment Disposal of the Unit In designing the unit, we tried to avoid using composite materials wherever possible. This allows a high degree of recycling after the lifetime of the unit. We therefore offer to take the unit back for proper disposal and recycling. Be sure to observe your national/local rules and regulations governing disposal! Marking of electric and electronic equipment in accordance with Directive 2002/96/EC (WEEE Directive) and the German Electrical and Electronic Equipment Act (ElektroG) This symbol on the product or its packaging indicates that the product may not be disposed of as normal household garbage. V

98 12 Quick Instructions for Use Preparation Read the instructions for use Connection Connect the device to the mains power using the original cable Check Unlock EMERGENCY STOP switch Put on protective goggles Protect the eyes of the patient Mark the laser area Close the doors of the treatment room Activate warning lamp Switch on the device Insert key in vertical position and turn to horizontal position, wait for self-test Choose the operating mode Set parameters Use storage locations 98 V. 5.4

99 Activate the device Press the key Laser Ready (LED lit yellow) Activate foot switch Apply laser light Switch off the device Turn key switch to vertical position. Remove key and store it in a safe location. Keep application logs V

100 13 Technical Data Name Laser type: Laser wavelength: Laser power output Laser class: Device class: Protection class: Data MCO 25 plus CO 2 laser λ = 10,600 nm 2 25 W IV IIb acc. to MPG I / IP X1 Operating modes: 1) Continuous (CW): 2 25 W Mode structure TEM 00 2) Pulse mode: Single pulse: 5 ms 10 s; power output W Repeating pulses: Frequency selectable Hz Minimum pulse duration 5 ms Average power output < W Super pulse: 0.3 ms / W 3) Cyclically repeated pulses Cycle duration: permanent, 10 ms 10 s Beam divergence Laser tube Minimum tube lifetime Pilot laser Pilot laser power Beam guidance 2.5 ± 0.5 mrad (without focusing hand piece) sealed off, DC-excited 2000 h 635 nm, laser class 3R diode laser 5 mw, can be adjusted steplessly Spring joint arm with 7 joints / mirrors, arm length 1,300 mm, hand piece replaceable Scope of delivery Standard applicator Alternative applicator Mirror joint arm with 7 mirrors, foot switch, standard applicator Focusing hand piece, f = 127 mm Focusing hand pieces f = 50 mm, f = 200 mm Scanner Soft Scan Plus R, scanner hand pieces 127 mm and 200 mm Scanner hand pieces SOFT FRAC, POWER FRAC Focal size 0.1 mm at 50 mm focal length 0.20 mm at 127 mm standard focal length 0.32 mm at 200 mm focal length 100 V. 5.4

101 Name Cooling, heat exchange Temperature, relative humidity Control panel Program memory locations Power supply Nominal frequency Power consumption Dimensions (H W D) Data MCO 25 plus closed water cycle, air C ( F), % (no condensed moisture) Bluemode LCD display, integrated scanner function 5 freely assignable memory locations; can also be used with scanner V AC 50 / 60 Hz max W mm (mirror joint arm retracted) mm (mirror joint arm in working position) Weight Warranty Safety checks: 57 kg 24 months 1 annually This symbol means that the device complies with the basic requirements of the EC Directive 93/42/EEC for medical products. The symbol can be found on the rear of the device. V

102 14 Safety Check NOTICE Performance of the safety check must be entered into the medical product log, and the results are to be documented! The compliance of the laser device with the safety requirements must be checked annually by a safety check according to DIN EN The proper working condition of the device shall be confirmed in the medical product log by the inspector after every check. Scope and intervals of the safety check Intervals: Device type: Device name: Device class (MPG): annually CO 2 laser device MCO 25 plus IIb Serial no.:... Inv. no.:... Operating hours:... Operator:... Location:... 1 Visual check [ ] 1.1 Laser labels (laser class, max. output power, wavelength...) [ ] 1.2 Information / warning labels; visible and complete on the device [ ] 1.3 Instructions for use and medical product log available [ ] 1.4 Mains cable in proper condition [ ] 1.5 Accessory equipment complete [ ] 1.6 Outer device surfaces OK [ ] 1.7 Optical accessory has been checked 2 Functionality check [ ] 2.1 Foot switch, key switch [ ] 2.2 Beam guidance system / pilot laser [ ] 2.3 Optical accessory, e. g. focusing hand piece [ ] 2.4 Laser protection goggles 102 V. 5.4

103 3 Check of the required monitoring / safety display and message system [ ] 3.1 Shutter (protection against laser beams) [ ] 3.2 Laser protection goggles [ ] 3.3 Emission control (acoustic, visual) [ ] 3.4 Power measuring device (Comparison of internal / external power) [ ] 3.5 Interlock system (functional check) [ ] 3.6 ext. EMERGENCY-STOP switch connection Warning lamps / warnings (functional check) 4 Electrical safety (DIN EN ) [ ] 4.1 Protective grounding conductor resistance: 0.2 Ω [ ] 4.2 Ground leakage current: 0.5 ma NOTICE To avoid damaging the device, measuring the insulation resistance is not allowed. ( DIN EN 62353) 5 Measurement of the safety-relevant output parameters [ ] 5.1 Control of calibration with an external power meter (allowed tolerance ± 20 %): 2 W / 5 W / 10 W / 15 W / 20 W / 25 W WARNING If there are any safety-relevant problems after the safety check, the device must not be used any longer. Actions taken: [ ] Service contacted on:... [ ] Device decommissioned on:... [ ] Entry in medical product log on:... Inspector: Date: Signature: V

104 15 Guidelines and Manufacturer s Declaration Regarding Electromagnetic Compatibility (EMC) Guidance and manufacturer s declaration according to DIN EN , clause a) 3) Table 201: Electromagnetic emissions This device is intended for operation in an electromagnetic environment as specified below. The user must ensure that it is used in such an environment. Stability tests Compliance level Electromagnetic environment guidelines RF emissions according to EN RF emissions according to EN Harmonic emissions according to IEC Voltage fluctuations / flicker emissions according to IEC Group 1 Class B Class A Complies The device uses electromagnetic energy exclusively for the performance of its internal functions. Therefore, its RF emissions are very low and are not likely to cause interference in nearby electronic equipment. The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes. 104 V. 5.4

105 Guidance and manufacturer s declaration according to DIN EN , clause a) 3) Table 201: Electromagnetic emissions The device is intended for operation in an electromagnetic environment as specified below. The user must ensure that it is used in such an environment. Immunity test DIN EN test level Compliance level Electromagnetic environment Guidance Electrostatic discharge (ESD) according to IEC ±6 kv contact discharge ±8 kv air discharge ±6 kv contact discharge ±8 kv air discharge Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Fast electrical transients / bursts according to IEC ±2 kv for mains power lines ±1 kv for input and output lines ±2 kv for mains power lines ±1 kv for input and output lines Mains power quality should be that of a typical commercial or hospital environment. Surge according to IEC ±1 kv Push-pull voltage ±2 kv Push-push voltage ±1 kv Push-pull voltage ±2 kv Push-push voltage Mains power quality should be that of a typical commercial or hospital environment. Voltage dips, short power interruptions and supply voltage fluctuations according to IEC <5% U T (>95% drop in U T ) for ½ period 40% U T (60% drop in U T ) for 5 periods 70% U T (30% drop in U T ) for 25 periods <5% U T (>95% drop in U T ) for 5 seconds <5% U T (>95% drop in U T ) for ½ period 40% U T (60% drop in U T ) for 5 periods 70% U T (30% drop in U T ) for 25 periods <5% U T (>95% drop in U T ) for 5 seconds Mains power quality should be that of a typical commercial or hospital environment. If the user requires continued operation during mains power interruptions, it is recommended to power the device from an uninterruptible power supply. Power frequency (50 / 60 Hz) magnetic field according to IEC A/m 3 A/m Power-frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Note: U T is the a. c. mains voltage prior to application of the test level. V

106 Guidance and manufacturer s declaration according to DIN EN , clause b) Table 204: Electromagnetic immunity The device is intended for operation in an electromagnetic environment as specified below. The user must ensure that it is used in such an environment. Immunity test DIN EN test level Compliance level Electromagnetic environment Guidance Portable and mobile RF communications equipment should be used no closer to any part of the device (including cables) than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: d = P d = P for 80 MHz to 800 MHz Conducted RF according to IEC Radiated RF according to IEC V eff 150 khz to 80 MHz 3 V/m 80 MHz to 2.5 GHz 3 V eff 150 khz to 80 MHz 3 V/m 80 MHz to 2.5 GHz d = P for 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol. Note 1: Note 2: At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio stations and AM and FM radio and TV stations, cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level specified above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. b Over the frequency range of 150 khz to 80 MHz, field strengths should be less than 3 V/m. 106 V. 5.4