KLS Martin group Laser Surgical Unit diomax 1550 Instructions For Use Manual
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KLS Martin group Laser Surgical Unit diomax 1550 Instructions For Use Manual

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English
90-458-52-20
Revision 2
Date of Release: 2014-03
Laser Surgical Unit diomax
Instructions for Use
Valid from software version V1.00,
hardware release HW 02 and software version SW 01
®
1550

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  • Page 1 ® Laser Surgical Unit diomax 1550 English Instructions for Use 90-458-52-20 Valid from software version V1.00, Revision 2 hardware release HW 02 and software version SW 01 Date of Release: 2014-03...
  • Page 2 Symbol explanation Safety alert symbol CAUTION Indicates a situation which, if not avoided, could result in minor or moderate injury. WARNING Indicates a situation which, if not avoided, could result in death or serious injury. DANGER Indicates a situation which, if not avoided, will result in death or serious injury.
  • Page 3 Arrows pointing up, transport and store upright Manufacturing date Manufacturer Do not use if packaging is damaged CE mark of conformity This product may not be disposed of as normal household garbage Revision 2...

  • Page 4: Table Of Contents

    Instructions for Use ® Laser Surgical Unit diomax 1550 Contents Product Liability and Warranty ............7 General Information ................7 Scope of Delivery .................. 7 Intended Use ..................8 Frequently Used Functions ..............9 Contraindications .................. 9 Warranty ..................... 9 User’s Inspection ..................
  • Page 5 Instructions for Use ® Laser Surgical Unit diomax 1550 Rear of Device ..................24 4.4.1 Type Plate ..................... 25 4.4.2 Mains Connection ................... 25 4.4.3 Equipotential Grounding Pin ................25 4.4.4 Foot Switch Connection ................... 25 4.4.5 Connection Interlock/Warning ................26 4.4.6 Accessory Port ....................
  • Page 6 Instructions for Use ® Laser Surgical Unit diomax 1550 5.13 Log ....................53 5.13.1 Edit log entries ....................53 5.13.2 View logfile ....................55 5.14 Pilot Laser ..................56 5.15 Setup ....................56 Abridged Instructions for Use ............60 Maintenance ................61 Periodic Maintenance ................

  • Page 7: Product Liability And Warranty

    We are the manufacturer of this product: Gebrüder Martin GmbH & Co. KG A company of the KLS Martin Group KLS Martin Platz 1 · D-78532 Tuttlingen · Germany Postfach 60 · D-78501 Tuttlingen · Germany Tel. +49 7461 706-0 · Fax +49 7461 706-193 info@klsmartin.com ·...

  • Page 8: Intended Use

    Instructions for Use ® Laser Surgical Unit diomax 1550 Intended Use ® The diomax 1550 is a laser surgical device operating on a diode laser. It is intended for treating biological tissue by way of: hyperthermia • cutting • coagulation •...

  • Page 9: Frequently Used Functions

    Instructions for Use ® Laser Surgical Unit diomax 1550 Frequently Used Functions Section 5 “Operating the Device”, page 30 describes applications that explain frequently used functions of the laser in form of saved programs. Contraindications There are currently no known contraindications for the application. Warranty Our Standard Terms and Conditions of Sale effective at the time shall apply.

  • Page 10: Hotline

    Instructions for Use ® Laser Surgical Unit diomax 1550 Hotline Should you have any questions on how to handle the product or use it for clinical • applications, please do not hesitate to contact the Product Management: Tel: +49 7461 706-243 Fax: +49 7461 706-190 Should you have any technical questions, please do not hesitate to turn to our...

  • Page 11: Notices Concerning This Document

    Instructions for Use ® Laser Surgical Unit diomax 1550 Notices Concerning this Document Non-observance of this document can lead to serious or even lethal patient injury! Improper handling and care as well as non-intended use can lead to premature wear and/or pose a risk to patients and users! Be sure to read, understand and follow the instructions given below! •...

  • Page 12: Symbols Used In This Document

    Instructions for Use ® Laser Surgical Unit diomax 1550 Symbols Used in this Document Throughout this document, important information (such as general or safety-related notices) is marked with the following symbols and signal words: WARNING Danger of death or serious injury! Indicates a situation which, if not avoided, could result in death or serious injury! CAUTION Danger of minor injury!

  • Page 13: Safety Notes

    Instructions for Use ® Laser Surgical Unit diomax 1550 Safety Notes General Specifications The following standards, laws, directives and regulations were observed in the design and manufacture of this product: Standard Title MPG (MDA) Medical Devices Act 93/42/EEC (MDD) EU Directive 93/42/EEC concerning medical devices Safety of laser products –...

  • Page 14: Installation And Initial Commissioning

    Instructions for Use ® Laser Surgical Unit diomax 1550 Installation and Initial Commissioning Installation and initial commissioning may be performed only by Gebrüder Martin or authorized service partners. CAUTION Danger of physical injury! Any person that handles the device in any way must have fully read and understood the contents of this document.
  • Page 15 Instructions for Use ® Laser Surgical Unit diomax 1550 Furthermore, the following additional requirements must be observed: The device may be commissioned by authorized users only. The users must be familiar • with the laser device and know the applicable safety precautions. The persons authorized to use the device must be listed in the medical product log.

  • Page 16: Laser Safety

    Instructions for Use ® Laser Surgical Unit diomax 1550 Laser Safety ® The laser surgery unit diomax 1550 is a class IIb device acc. to MPG (Medical Devices Act), • is a class 4 laser device (acc. to IEC 60825-1), •...

  • Page 17: Danger Of Explosion And Fire

    Instructions for Use ® Laser Surgical Unit diomax 1550 Danger of Explosion and Fire WARNING Fire hazard! Class 4 lasers (IEC 60825-1) can cause fires due to heating of tissue or laser fiber ends acting as sources of ignition. Therefore, comply with the following requirements to prevent laser- ®...

  • Page 18: Requirements For Treatment Rooms

    Instructions for Use ® Laser Surgical Unit diomax 1550 Requirements for Treatment Rooms Rooms in which the device is to be operated must be marked with a laser warning sign • (included in the delivery) at all accesses. All access doors to the laser area must be equipped with a warning lamp. When the •...

  • Page 19: Laser Safety Officer

    Instructions for Use ® Laser Surgical Unit diomax 1550 Laser Safety Officer According to the German accident prevention directive BGV B2 (laser radiation), the operator must appoint a laser safety officer in writing. The laser safety officer is responsible for the following: Implementation of safety measures •...

  • Page 20: Fuses

    Instructions for Use ® Laser Surgical Unit diomax 1550 3.13 Fuses Fuses may be replaced only by authorized and qualified personnel. At the rear of the device there are the fuses of the mains input socket whose fuse rating is printed on the rear of the device (see section 4.4 “Rear of Device”, page 24).

  • Page 21: Warning And Information Labels

    Instructions for Use ® Laser Surgical Unit diomax 1550 3.16 Warning and Information Labels Information label on the rear of the device, see section 4.4 “Rear of Device”, page 24 containing the maximum output values of the laser light. For further Technical Data please also see section 11 “Technical Data”, page 66.

  • Page 22: Fumes

    Instructions for Use ® Laser Surgical Unit diomax 1550 3.17 Fumes CAUTION Risk of infection due to viable tissue particles in laser fumes! The fumes that are created in particular by vaporization during the laser treatment can be harmful to health. ©...

  • Page 23: Commissioning

    Instructions for Use ® Laser Surgical Unit diomax 1550 Commissioning Function The device is a microprocessor-controlled laser surgery device according to the latest state of the art. It produces laser light in the infrared wavelength range (1550 nm) with a laser power of up to 15 W that the user can apply via different laser fibers and applicators.

  • Page 24: Front Of Device

    Instructions for Use ® Laser Surgical Unit diomax 1550 Front of Device The functions of the control and display elements are described in detail in section 5.1 “Control and Display Elements”, page 30. Rear of Device 1 Type plate 6 Accessory port connection 2 Mains connection with fuses 7 Service interface 3 Equipotential grounding pin...

  • Page 25: Type Plate

    Instructions for Use ® Laser Surgical Unit diomax 1550 4.4.1 Type Plate The type plate is on the rear of the device • (see section 4.4 “Rear of Device”, page 24). See also section 11 “Technical Data”, page 66. • 4.4.2 Mains Connection The device is equipped with a universal power supply unit.

  • Page 26: Connection Interlock/Warning

    Instructions for Use ® Laser Surgical Unit diomax 1550 4.4.5 Connection Interlock/Warning Interlock/warning The connection has two functions: Laser warning lamp contact • Door interlock • Laser warning lamp contact This contact activates the warning lamps when switching on the device (key switch on I). All accesses to the laser area should be equipped with laser warning lamps.
  • Page 27 Instructions for Use ® Laser Surgical Unit diomax 1550 Door interlock If a door contact switch is connected to this contact (1), the device will stop the laser emission immediately when the door is opened. The message INT_LOCK ERROR appears on the display. The interlock connector that is supplied with the laser surgery device may be used.

  • Page 28: Accessory Port

    Instructions for Use ® Laser Surgical Unit diomax 1550 4.4.6 Accessory Port Connection for external flushing gas supply (MY GAS 2) © and/or fume suction system (e. g. marVAC ). Upon request, connection cables can be supplied by Gebrüder Martin. (see section 10 “Accessories”, page 64). Through use of the foot switch a potential-free changeover contact is activated that can be used to control accessory components.

  • Page 29: Preparing The Laser System

    Instructions for Use ® Laser Surgical Unit diomax 1550 Preparing the Laser System WARNING Dangerous laser radiation! Secure the laser area against access by unauthorized persons. Secure all accesses to the • laser area with laser warning labels and warning lamp(s). Cover surfaces that can reflect the laser beam with suitable materials.

  • Page 30: Operating The Device

    Instructions for Use ® Laser Surgical Unit diomax 1550 Operating the Device WARNING Danger of injury due to operating errors! Operation or adjustment of the device in a manner different from that described in this document can lead to dangerous radiation. Control and Display Elements EMERGENCY-STOP switch Display...

  • Page 31: Key Switch

    Instructions for Use ® Laser Surgical Unit diomax 1550 5.1.1 Key Switch The device can be switched on and off using the key switch. Key position 0: Device switched off Key position 1: Device switched on The key can be removed only in position 0. NOTICE The key switch fully disconnects the device from the grid! 5.1.2...

  • Page 32: Laser Signal Light

    Instructions for Use ® Laser Surgical Unit diomax 1550 5.1.4 Laser Signal Light The laser signal light shows the following statuses: • Laser fiber correctly connected to the SMA-X socket. Foot switch not activated. • Laser fiber not connected. Yellow •...

  • Page 33: Key Field

    Instructions for Use ® Laser Surgical Unit diomax 1550 5.1.5 Key Field (1) STANDBY key Pressing this key switches the device into STANDBY mode. Laser parameters can be adjusted. • • Apart from the pilot laser light, no other laser light can be emitted.

  • Page 34: Display

    Instructions for Use ® Laser Surgical Unit diomax 1550 5.1.6 Display The figure on the left shows the laser during laser power setting (item 4, highlighted in orange). Use the rotary knob to select and adjust the • laser power, see section 5.1.7 “Rotary Knob with Ring Light”, page 35.

  • Page 35: Rotary Knob With Ring Light

    Instructions for Use ® Laser Surgical Unit diomax 1550 5.1.7 Rotary Knob with Ring Light All settings on the device are adjusted using the rotary knob (6). The rotary knob can be turned and pressed. It is inactive after switching on the device and can be activated by pressing it.

  • Page 36: Laser Status Display

    Instructions for Use ® Laser Surgical Unit diomax 1550 5.1.8 Laser Status Display Laser status display No laser fibers connected. • The laser can be adjusted but not activated. Laser STANDBY • A suitable laser fiber is connected. The laser can be adjusted but not activated. LASER READY The laser is ready for the emission of laser light.

  • Page 37: Connecting Laser Fibers

    Instructions for Use ® Laser Surgical Unit diomax 1550 Connecting Laser Fibers NOTICE The laser is equipped with a coded SMA socket (SMA-X), thus only laser fibers with SMA-X plugs allow the activation of the laser. Remove laser fibers and applicators approved for the device (see section 10 “Accessories”, •...

  • Page 38: Checking The Laser Fiber Using The Pilot Laser

    Instructions for Use ® Laser Surgical Unit diomax 1550 Checking the Laser Fiber Using the Pilot Laser The laser fiber must be checked before beginning the treatment or after changing the laser fiber: Press the PILOT key, • — select the menu Pilot laser using the rotary knob, —...

  • Page 39: Replacing The Laser Fiber

    Instructions for Use ® Laser Surgical Unit diomax 1550 Replacing the Laser Fiber Replace the laser fiber as follows: Press the STANDBY key. • Loosen the cap nut of the SMA-X plug at the proximal end of the laser fiber and remove •...

  • Page 40: System Check

    Instructions for Use ® Laser Surgical Unit diomax 1550 System Check The laser is switched on and performs a self • check for 10 – 30 s. The blue starting screen shows the • ® KLS Martin and diomax 1550 logo and the software version, e.

  • Page 41: Applying The Laser

    Instructions for Use ® Laser Surgical Unit diomax 1550 Upon release of the foot switch, the emission of laser light stops immediately. • — The laser signal lamp turns dark. — The display shows LASER READY again. NOTICE When the foot switch is activated, rotary knob and key field are blocked. NOTICE Accessory devices are activated when the foot switch is pressed even if no laser light is emitted.

  • Page 42: Switching Off The Device

    Instructions for Use ® Laser Surgical Unit diomax 1550 5.10 Switching off the Device Turn key in the key switch from position 1 to 0. • CAUTION Risk of injury Any laser device that is not being used must be protected against unauthorized use. Remove the key from the key switch and store it in a safe location.

  • Page 43: Working With Programs

    Instructions for Use ® Laser Surgical Unit diomax 1550 5.12 Working with Programs Due to the large variety of settings, adjusting every single parameter before an operation is time-consuming. Loading of saved programs facilitates operation of the device. Settings that are used regularly can be saved as programs with program names on the device. Up to 50 programs can be saved.

  • Page 44: Selecting A Program

    Instructions for Use ® Laser Surgical Unit diomax 1550 5.12.2 Selecting a Program List of previously used programs (Last used programs) Up to four program names are directly displayed in the main menu. The four program names are those of the most recently used programs. Activate rotary knob by pressing it and •...
  • Page 45 Instructions for Use ® Laser Surgical Unit diomax 1550 The stored programs are now displayed as a list in the menu area. When navigating through the list of programs, a preview of the currently selected program is shown in the display area on the left. Forward •...

  • Page 46: Program Change

    Instructions for Use ® Laser Surgical Unit diomax 1550 5.12.3 Program change The active program can be changed and saved. The rotary knob is used to select the parameter to be changed. Pressing the rotary knob activates the selected parameter. Its type or value can then be changed by turning the rotary knob.
  • Page 47 Instructions for Use ® Laser Surgical Unit diomax 1550 Continuous mode • The defined laser output is emitted continuously while the foot switch is engaged. Continuous rate • Continuous rate sends the user a feedback signal when the defined amount of energy per cm is reached.
  • Page 48 Instructions for Use ® Laser Surgical Unit diomax 1550 Rate • The RATE display field shows the time required for treating one centimeter of the vein. This serves as a time limit for retraction of the VENEX fiber. Retraction during treatment is controlled by the cm-lines on the fiber or catheter.
  • Page 49 Instructions for Use ® Laser Surgical Unit diomax 1550 Pulse rate • Pulse rate sends the user a feedback signal when the defined amount of energy per cm is reached. An additional, brief sound is heard. The rate (time per cm) results from average laser output and energy density.

  • Page 50: Times

    Instructions for Use ® Laser Surgical Unit diomax 1550 5.12.6 Times Up to four pulse parameters can be adjusted depending on the pulse mode: Pulse duration (5 ms – 10 s) • Duration of one laser pulse Pulse pause (5 ms – 10 s) •...
  • Page 51 Instructions for Use ® Laser Surgical Unit diomax 1550 Adjust the name using the text editor. • — Select the letters/symbols by turning the rotary knob. — Enter the respectively selected letter by pressing the rotary knob. — Use the arrow keys to move the insertion marker forward/backward.

  • Page 52: Deleting Programs

    Instructions for Use ® Laser Surgical Unit diomax 1550 Overwrite Select Programs / Overwrite. • Before the saved program can be • overwritten with the new parameters, you have to answer the confirmation question. Confirm the question with Yes. • —...

  • Page 53: Log

    Instructions for Use ® Laser Surgical Unit diomax 1550 5.13 5.13.1 Edit log entries Logfile / Save / Reset • The current counter readings are recorded in the log book, and the counters are reset to zero. The log book entry contains date, time, applied energy, total time of laser light emission and number of pulses.
  • Page 54 Instructions for Use ® Laser Surgical Unit diomax 1550 Removing the laser fiber • — An automatic log book entry is created after confirmation by the user. — The following question appears: Save values to logfile? — Selection Yes: a log book entry is created.

  • Page 55: View Logfile

    Instructions for Use ® Laser Surgical Unit diomax 1550 5.13.2 View logfile Select Logfile / Overview • — The log is displayed. The log facilitates control of the applied laser energy and the number of laser pulses. These parameters are stored manually or automatically together with the start time for a treatment and can be loaded by the user.

  • Page 56: Pilot Laser

    Instructions for Use ® Laser Surgical Unit diomax 1550 5.14 Pilot Laser Select Pilot laser. • Pilot brightness • The brightness of the pilot laser can be adjusted from 1 – 100%. Pilot blinking frequency • The pilot laser can be set to either CW (continuous wave) or to pulse mode from 0.5 Hz to 5 Hz.
  • Page 57 Instructions for Use ® Laser Surgical Unit diomax 1550 Settings can be adjusted in the following sub- menus: Language • Screen • Timeouts • Date / Time • Alerts • Service • (for service technicians with PIN code only) Setup / Language Select the display language from the list.
  • Page 58 Instructions for Use ® Laser Surgical Unit diomax 1550 Setup / Timeouts Menu timeout • The menu timeout determines the time until inactivity of the rotary knob after its last use. Light ring bright –> timeout (30 s – 6 min) –>...
  • Page 59 Instructions for Use ® Laser Surgical Unit diomax 1550 Setup / Alert Select Alert and adjust the volume. • Select Laser activation tone and adjust • the volume. The laser activation tone has a minimum volume in accordance with IEC 60601 that can be increased if required.

  • Page 60: Abridged Instructions For Use

    Instructions for Use ® Laser Surgical Unit diomax 1550 Abridged Instructions for Use Preparation Read the instructions for use • Connect the device to the mains power • Switching on the device • Insert key in position 0 and turn to 1 Wait for self-test •...

  • Page 61: Maintenance

    Instructions for Use ® Laser Surgical Unit diomax 1550 Maintenance Periodic Maintenance NOTICE Repairs may only be performed by authorized Gebrüder Martin service technicians. 7.1.1 Maintenance Schedule Inspection & Maintenance Maintenance interval To be carried out by Checking the EMERGENCY-STOP switch for prior to the first operation on Hospital staff proper functioning...

  • Page 62: Cleaning And Disinfecting

    Instructions for Use ® Laser Surgical Unit diomax 1550 Cleaning and Disinfecting The responsibility for cleaning and disinfection lies with the operator/user of the product. Be sure to observe your local cleaning and hygiene regulations! WARNING Danger of serious injury when using defective accessories! Using a unit that is not in perfect working order or using defective accessories can pose a hazard to patients or users and compromise the proper functioning of the device.

  • Page 63: Troubleshooting

    Instructions for Use ® Laser Surgical Unit diomax 1550 Troubleshooting Information Displayed Information on the procedure is shown in the information line of the display (item 2, section 5.1.6 “Display”, page 34). Example: Connect fiber Information line Other Malfunctions If there are any malfunctions that the user cannot fix, this will be indicated by the laser signal lamp that flashes red.

  • Page 64: Accessories

    Instructions for Use ® Laser Surgical Unit diomax 1550 Accessories Accessories and disposable articles may be used only if they are CE-labeled and correspond to the articles in the following list. The list of accessories may be updated and changed. The most current list can be requested from the manufacturer.

  • Page 65: Safety Distances (Nohd)

    Instructions for Use ® Laser Surgical Unit diomax 1550 10.1 Safety Distances (NOHD) For accessories there are the following safety distances (NOHD = Nominal Ocular Hazard Distance) defined for which the irradiation strength or irradiation is under the approved limits. Accessory NOHD Divergence...

  • Page 66: Technical Data

    Instructions for Use ® Laser Surgical Unit diomax 1550 Technical Data ® Description diomax 1550 data Laser type Diode laser Laser wavelength 1,550 nm ± 2% Laser output 0.1 – 15 W ± 20% Pulse forms Continuous mode: Output: 0.1 – 15 W Continuous rate: Output: 1 –...
  • Page 67 Instructions for Use ® Laser Surgical Unit diomax 1550 ® Description diomax 1550 data Noise level Noise at rest 42 dB(A), at full load 57 dB(A) Dimensions (W × H × D) 381 mm × 195 mm × 390 mm Weight 13.8 kg -25 °C to +50 °C...

  • Page 68: Safety Check (Sc)

    Instructions for Use ® Laser Surgical Unit diomax 1550 Safety Check (SC) NOTICE Safety checks may be performed only by Gebrüder Martin or by authorized Gebrüder Martin service partners. Performance of the safety check must be entered into the medical product log, and the results are to be documented! Compliance of the laser unit with the safety requirements must be checked annually by a safety check.
  • Page 69 Instructions for Use ® Laser Surgical Unit diomax 1550 Additional test items: Battery Check of internal battery (Ubatt ≥ 2.8 V); replace battery if required (CR2032 Lithium) Error memory Select and retrieve internal memory “Event log” and record messages. Take any required actions. Emergency-Stop Check of EMERGENCY-STOP function WARNING...

  • Page 70: Guidelines And Manufacturer's Declaration Regarding Electromagnetic Compatibility (Emc)

    Instructions for Use ® Laser Surgical Unit diomax 1550 Guidelines and Manufacturer’s Declaration Regarding Electromagnetic Compatibility (EMC) Guidance and manufacturer’s declaration according to IEC 60601-1-2, clause 6.8.3.201 a) 3) Table 201: Electromagnetic emission ® The device diomax 1550 is intended for use in an electromagnetic environment as specified below. The user should assure that it is used in such an environment.
  • Page 71 Instructions for Use ® Laser Surgical Unit diomax 1550 Guidance and manufacturer’s declaration according to IEC 60601-1-2, clause 6.8.3.201 a) 3) Table 201: Electromagnetic emission The device is intended for use in an electromagnetic environment as specified below. The user should assure that it is used in such an environment.
  • Page 72 Instructions for Use ® Laser Surgical Unit diomax 1550 Guidance and manufacturer’s declaration according to IEC 60601-1-2, clause 6.8.3.201 b) Table 204: Electromagnetic immunity The device is intended for use in an electromagnetic environment as specified below. The user should assure that it is used in such an environment.
  • Page 73 Instructions for Use ® Laser Surgical Unit diomax 1550 Recommended separation distances between portable and mobile ® RF telecommunications equipment and the Gebrüder Martin device diomax 1550 according to IEC 60601-1-2 clause 6.8.3.201 b), Table 206 The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.

  • Page 74: Ecological Information

    Instructions for Use ® Laser Surgical Unit diomax 1550 Ecological Information 14.1 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.
  • Page 75 Instructions for Use ® Laser Surgical Unit diomax 1550 Revision 2...
  • Page 76 Gebrüder Martin GmbH & Co. KG A company of the KLS Martin Group KLS Martin Platz 1 · 78532 Tuttlingen · Germany Postfach 60 · 78501 Tuttlingen · Germany Tel. +49 7461 706-0 · Fax 706-193 info@klsmartin.com · www.klsmartin.com Date of Release: 2014-03 ·...

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