KLS Martin diomax Instructions For Use Manual
  1. Manuals
  2. Brands
  3. KLS Martin Manuals
  4. Medical Equipment
  5. diomax
  6. Instructions for use manual

KLS Martin diomax Instructions For Use Manual

Laser surgical unit
Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
English
90-336-52-50
Revision 6
Date of Release: 2019-07
Laser Surgical Unit
Instructions for Use
Valid for software version V5.00
hardware release HW 03 and software version SW 04

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the diomax and is the answer not in the manual?

Questions and answers

Anastasija Novozilova
March 10, 2025

Could you kindly provide the following information: 1. Unit price for the specified products. 2. Delivery cost and terms to Latvia. (Pulkveza Brieza street 10-62, Riga, LV-1010). We are looking to place an order in the near future and would appreciate your prompt response. Should you require any further details to prepare the quotation, please do not hesitate to contact me directly. Thank you in advance for your assistance. I look forward to your reply. Best regards, Anastasija Novožilova

0

Related Manuals for KLS Martin diomax

Summary of Contents for KLS Martin diomax

  • Page 1 Laser Surgical Unit English Instructions for Use 90-336-52-50 Revision 6 Valid for software version V5.00 Date of Release: 2019-07 hardware release HW 03 and software version SW 04...
  • 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 Fragile, avoid pressure and shock 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 6...

  • Page 4: Table Of Contents

    Instructions for Use ® Laser Surgical Unit diomax 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 .................. 9 Hotline....................
  • Page 5 Instructions for Use ® Laser Surgical Unit diomax 4.4.2 Mains Connection ................... 25 4.4.3 Equipotential Grounding Pin ................25 4.4.4 Foot Switch Connection ................... 25 4.4.5 Connection Interlock/Warning ................26 4.4.6 Accessory Port ....................28 4.4.7 Service Interfaces ..................28 4.4.8...
  • Page 6 Instructions for Use ® Laser Surgical Unit diomax 5.14 Pilot Laser ..................57 5.15 Setup ....................58 Abridged Instructions for Use ............62 Maintenance ................63 Periodic Maintenance ................63 7.1.1 Maintenance Schedule ..................63 Cleaning and Disinfecting ............64 Troubleshooting .................

  • Page 7: Product Liability And Warranty

    Product Liability and Warranty 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.

  • Page 8: Intended Use

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

  • Page 9: Frequently Used Functions

    Instructions for Use ® Laser Surgical Unit diomax 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.

  • Page 10: Hotline

    Instructions for Use ® Laser Surgical Unit diomax 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...

  • Page 11: Notices Concerning This Document

    These instructions for use are valid for software version V5.00 or higher hardware release HW 03and software version SW 04. ® The software version currently installed in your diomax is indicated on the initial screen (see section 5.7 “System Check”, page 40). If older hardware and software versions are used, it may be that newer functions described in this document are not available.

  • Page 12: Symbols Used In This Document

    Instructions for Use ® Laser Surgical Unit diomax 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!

  • Page 13: Safety Notes

    Instructions for Use ® Laser Surgical Unit diomax 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 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 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 Laser Safety ® The laser surgery device diomax is a class IIb device acc. to MPG (Medical Devices Act), • is a class 4 laser device (acc. to IEC 60825-1), • has the CE label acc. to directive 93/42/EEC.

  • Page 17: Danger Of Explosion And Fire

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

  • Page 18: Requirements For Treatment Rooms

    Instructions for Use ® Laser Surgical Unit diomax 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 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...

  • Page 20: Fuses

    Instructions for Use ® Laser Surgical Unit diomax 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 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 “Tecnical...

  • Page 22: Fumes

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

  • Page 23: Commissioning

    Instructions for Use ® Laser Surgical Unit diomax 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 (980 nm) with a laser power of up to 20 W that the user can apply via different laser fibers and applicators.

  • Page 24: Front Of Device

    Instructions for Use ® Laser Surgical Unit diomax 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...

  • Page 25: Type Plate

    Instructions for Use ® Laser Surgical Unit diomax 4.4.1 Type Plate The type plate is on the rear of the device (see • also section 4.4 “Rear of Device”, page 24). • See also section 11 “Tecnical Data”, page 67.

  • Page 26: Connection Interlock/Warning

    Instructions for Use ® Laser Surgical Unit diomax 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).
  • Page 27 Instructions for Use ® Laser Surgical Unit diomax 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.

  • Page 28: Accessory Port

    Instructions for Use ® Laser Surgical Unit diomax 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. 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 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).

  • Page 30: Operating The Device

    Instructions for Use ® Laser Surgical Unit diomax Operating the Device WARNUNG 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.

  • Page 31: Emergency Stop

    Instructions for Use ® Laser Surgical Unit diomax NOTICE The key switch fully disconnects the device from the grid! 5.1.2 EMERGENCY STOP EMERGENCY-STOP Switch This switch interrupts the power supply to the device and immediately stops the emission of laser light.

  • Page 32: Laser Signal Light

    Instructions for Use ® Laser Surgical Unit diomax 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 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 •...

  • Page 34: Display

    Instructions for Use ® Laser Surgical Unit diomax 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 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 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.

  • Page 37: Connecting Laser Fibers

    Instructions for Use ® Laser Surgical Unit diomax 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 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

    • — Check cap nut on the SMA-X plug for tight fit. ® — Ensure that the laser fiber is approved for use with the diomax Note: The laser parameters adjusted before the fiber change are preserved. Connecting Focusing Handpiece/Applicators The basic procedures for the connection of a focusing handpiece or other additional applicators are identical.

  • Page 40: Switching On The Device

    Instructions for Use ® Laser Surgical Unit diomax Switching on the Device EMERGENCY-STOP switch is in pulled • position. Insert key and turn clockwise to position 1. • — The device is switched on. Note: The key cannot be removed as long as it is in position 1.

  • Page 41: Foot Switch

    Instructions for Use ® Laser Surgical Unit diomax Foot Switch The casing (2) of the foot switch (1) item no. 79-800-01-04, securely rests on the floor and is connected to the foot switch socket (section 4.4.4 “Foot Switch Connection”, page 25) on the rear of the device (item 4, section 4.4 “Rear of Device”, page 24) via the...

  • Page 42: Applying The Laser

    Instructions for Use ® Laser Surgical Unit diomax Applying the Laser CAUTION Risk of injury! All persons in the operating room, including the patient, must now wear laser protection goggles. Avoid looking directly into the red pilot laser light! •...

  • Page 43: Switching Off The Device

    Instructions for Use ® Laser Surgical Unit diomax 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.

  • Page 44: Working With Programs

    Instructions for Use ® Laser Surgical Unit diomax 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.

  • Page 45: Selecting A Program

    Instructions for Use ® Laser Surgical Unit diomax 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.
  • Page 46 Instructions for Use ® Laser Surgical Unit diomax 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.

  • Page 47: Program Change

    Instructions for Use ® Laser Surgical Unit diomax 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 48 Instructions for Use ® Laser Surgical Unit diomax 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 49 Instructions for Use ® Laser Surgical Unit diomax 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 50 Instructions for Use ® Laser Surgical Unit diomax 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 51: Times

    Instructions for Use ® Laser Surgical Unit diomax 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 52 Instructions for Use ® Laser Surgical Unit diomax 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 53: Deleting Programs

    Instructions for Use ® Laser Surgical Unit diomax Overwriting 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. • — The program is saved with the new parameters.

  • Page 54: Log

    Instructions for Use ® Laser Surgical Unit diomax 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 55 Instructions for Use ® Laser Surgical Unit diomax 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 56: View Logfile

    Instructions for Use ® Laser Surgical Unit diomax 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 57: Pilot Laser

    Instructions for Use ® Laser Surgical Unit diomax 5.14 Pilot Laser Select Pilot laser. • Pilot brightness • The brightness of the pilot laser can be adjusted from 1 – 100%. Pilot flash frequency • The pilot laser can be set to either CW (continuous wave) or to pulse mode from 0.5 Hz to 5 Hz.

  • Page 58: Setup

    Instructions for Use ® Laser Surgical Unit diomax 5.15 Setup In the Setup menu the user can adjust certain device settings. Select Setup. • — The Setup menu appears. Settings can be adjusted in the following sub- menus: Language •...
  • Page 59 Instructions for Use ® Laser Surgical Unit diomax Setup / Screen Adjust screen brightness (2 – 100%). • Store screen brightness by pressing the • rotary knob. Setup / Timeouts Menu timeout • The menu timeout determines the time until inactivity of the rotary knob after its last use.
  • Page 60 Instructions for Use ® Laser Surgical Unit diomax Setup / Date / Time / Summer time As date and time of the treatments are stored in the log, it is required to keep date and time up to date. Select the sub-menu item Date / Time in •...
  • Page 61 Instructions for Use ® Laser Surgical Unit diomax 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 62: Abridged Instructions For Use

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

  • Page 63: Maintenance

    Instructions for Use ® Laser Surgical Unit diomax 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...

  • Page 64: Cleaning And Disinfecting

    Optics and optical application components must always be checked for proper functioning ® (light transmission) prior to using them with the diomax . The pilot laser light can be used for this purpose.

  • Page 65: Troubleshooting

    Instructions for Use ® Laser Surgical Unit diomax Troubleshooting Messages on the Display 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 66: Accessories

    Instructions for Use ® Laser Surgical Unit diomax 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 67: Tecnical Data

    Instructions for Use ® Laser Surgical Unit diomax Tecnical Data ® Description diomax data Laser type Diode laser Laser wavelength 980 nm ± 2% Laser output 0.1 – 20 W ± 20% Pulse forms Continuous mode: Output: 0.1 – 20 W...
  • Page 68 Instructions for Use ® Laser Surgical Unit diomax ® Description diomax 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 69: Safety Check (Sc)

    Instructions for Use ® Laser Surgical Unit diomax 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! Once a year a safety check must be carried out acc.
  • Page 70 Instructions for Use ® Laser Surgical Unit diomax See IEC 62353, Sections 5.4, for functional tests Control of calibration with an external power meter (allowed tolerance ± 20%): 0.5 W / 2 W / 10 W / 15 W / 20 W...

  • Page 71: Guidelines And Manufacturer's Declaration Regarding Electromagnetic Compatibility (Emc)

    Instructions for Use ® Laser Surgical Unit diomax Guidelines and Manufacturer’s Declaration Regarding Electromagnetic Compatibility (EMC) Regarding EMC, medical electrical devices are subject to special safety measures, and they must be installed and operated according to the EMC regulations laid out in this document.
  • Page 72 Instructions for Use ® Laser Surgical Unit diomax Guidance and manufacturer’s declaration – Electromagnetic immunity The device is intended for use in an electromagnetic environment as specified below. The user of the device must ensure that it is used in such an environment.
  • Page 73 Instructions for Use ® Laser Surgical Unit diomax Guidance and manufacturer’s declaration – Electromagnetic immunity The device is intended for use in an electromagnetic environment as specified below. The user of the device must ensure that it is used in such an environment.
  • Page 74 Instructions for Use ® Laser Surgical Unit diomax Test levels between the portable and mobile HF telecommunications equipment and the ® surgical laser unit diomax Requirements for high-frequency wireless communication equipment Frequency Test frequency Modulation Compliance level (V/m) band (MHz) (MHz) 380–390...

  • Page 75: Ecological Information

    Instructions for Use ® Laser Surgical Unit diomax 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.
  • 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: 2019-07 ·...

Table of Contents